Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency

Cited as:85 FR 19230
Court:Centers For Medicare & Medicaid Services
Publication Date:06 Apr 2020
Record Number:2020-06990
Federal Register, Volume 85 Issue 66 (Monday, April 6, 2020)
[Federal Register Volume 85, Number 66 (Monday, April 6, 2020)]
                [Rules and Regulations]
                [Pages 19230-19292]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-06990]
                [[Page 19229]]
                Vol. 85
                Monday,
                No. 66
                April 6, 2020
                Part II
                Department of Health and Human Services
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                Centers for Medicare and Medicaid
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                42 CFR Parts 400, 405, 409, et al.
                Medicare and Medicaid Programs; Policy and Regulatory Revisions in
                Response to the COVID-19 Public Health Emergency; Interim Final Rule
                Federal Register / Vol. 85 , No. 66 / Monday, April 6, 2020 / Rules
                and Regulations
                [[Page 19230]]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Centers for Medicare & Medicaid Services
                42 CFR Parts 400, 405, 409, 410, 412, 414, 415, 417, 418, 421, 422,
                423, 425, 440, 482, and 510
                [CMS-1744-IFC]
                RIN 0938-AU31
                Medicare and Medicaid Programs; Policy and Regulatory Revisions
                in Response to the COVID-19 Public Health Emergency
                AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
                ACTION: Interim final rule with comment period.
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                SUMMARY: This interim final rule with comment period (IFC) gives
                individuals and entities that provide services to Medicare
                beneficiaries needed flexibilities to respond effectively to the
                serious public health threats posed by the spread of the 2019 Novel
                Coronavirus (COVID-19). Recognizing the urgency of this situation, and
                understanding that some pre-existing Medicare payment rules may inhibit
                innovative uses of technology and capacity that might otherwise be
                effective in the efforts to mitigate the impact of the pandemic on
                Medicare beneficiaries and the American public, we are changing
                Medicare payment rules during the Public Health Emergency (PHE) for the
                COVID-19 pandemic so that physicians and other practitioners, home
                health and hospice providers, inpatient rehabilitation facilities,
                rural health clinics (RHCs), and federally qualified health centers
                (FQHCs) are allowed broad flexibilities to furnish services using
                remote communications technology to avoid exposure risks to health care
                providers, patients, and the community. We are also altering the
                applicable payment policies to provide specimen collection fees for
                independent laboratories collecting specimens from beneficiaries who
                are homebound or inpatients (not in a hospital) for COVID-19 testing.
                We are also expanding, on an interim basis, the list of destinations
                for which Medicare covers ambulance transports under Medicare Part B.
                In addition, we are making programmatic changes to the Medicare
                Diabetes Prevention Program (MDPP) and the Comprehensive Care for Joint
                Replacement (CJR) Model in light of the PHE, and program-specific
                requirements for the Quality Payment Program to avoid inadvertently
                creating incentives to place cost considerations above patient safety.
                This IFC will modify the calculation of the 2021 and 2022 Part C and D
                Star Ratings to address the expected disruption to data collection and
                measure scores posed by the COVID-19 pandemic and also to avoid
                inadvertently creating incentives to place cost considerations above
                patient safety. This rule also amends the Medicaid home health
                regulations to allow other licensed practitioners to order home health
                services, for the period of this PHE for the COVID-19 pandemic in
                accordance with state scope of practice laws. We are also modifying our
                under arrangements policy during the PHE for the COVID-19 pandemic so
                that hospitals are allowed broader flexibilities to furnish inpatient
                services, including routine services outside the hospital.
                DATES:
                 Effective date: These regulations are effective on March 31, 2020.
                 Applicability date: These regulations are applicable beginning on
                March 1, 2020.
                 Comment date: To be assured consideration, comments must be
                received at one of the addresses provided below, no later than 5 p.m.
                on June 1, 2020.
                ADDRESSES: In commenting, please refer to file code CMS-1744-IFC.
                Comments, including mass comment submissions, must be submitted in one
                of the following three ways (please choose only one of the ways
                listed):
                 1. Electronically. You may submit electronic comments on this
                regulation to http://www.regulations.gov. Follow the ``Submit a
                comment'' instructions.
                 2. By regular mail. You may mail written comments to the following
                address ONLY: Centers for Medicare & Medicaid Services, Department of
                Health and Human Services, Attention: CMS-1744-IFC, P.O. Box 8016,
                Baltimore, MD 21244-8016.
                 Please allow sufficient time for mailed comments to be received
                before the close of the comment period.
                 3. By express or overnight mail. You may send written comments to
                the following address ONLY: Centers for Medicare & Medicaid Services,
                Department of Health and Human Services, Attention: CMS-1744-IFC, Mail
                Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
                 For information on viewing public comments, see the beginning of
                the SUPPLEMENTARY INFORMATION section.
                FOR FURTHER INFORMATION CONTACT: Jamie Hermansen, (410) 786-2064, for
                general information, contact one of the following:
                 [email protected], for issues related to telehealth
                services, and communication technology-based services; frequency limits
                on subsequent care services in inpatient and non-facility settings,
                critical care consultations, required ``hands-on'' visits for ESRD
                monthly capitation payments; removal of restrictions on technology, and
                supervision of interactive telecommunications technology; clinical
                laboratory fee schedule; services furnished by opioid treatment
                programs; payment under Medicare Part B for teaching physician services
                and resident moonlighting; remote physiologic monitoring; physician
                supervision flexibility for outpatient hospital services; payment for
                office/outpatient evaluation and management visits; counting of
                resident time at alternate locations; Ambulance Fee Schedule; rural
                health clinic services; federally qualified health center services; and
                inpatient hospital services furnished under arrangements outside of the
                hospital. (Note this email address has an underscore ``_'' between
                ``HAPG'' and ``COVID-19''.)
                 [email protected], for issues related to the Medicare
                inpatient rehabilitation facility benefits.
                 [email protected], for issues related to
                national coverage determination and local coverage determination
                requirements.
                 [email protected], for issues related to Medicare
                Parts C and D quality rating system.
                 [email protected], for issues related to Medicaid
                home health provider flexibility.
                 Hillary Loeffler, (410) 786-0456, [email protected], or
                [email protected], for issues related to the Medicare home
                health and hospice benefits.
                 Megan Hyde, (410) 786-3247, and Rebecca Cole, (410) 786-1589, for
                issues related to Innovation Center Models, and alternative payment
                model treatment under the Quality Payment Program.
                 Kim Spalding Bush, (410) 786-3232, and Fiona Larbi, (410) 786-7224,
                for issues related to the Medicare Shared Savings Program.
                 Molly MacHarris, (410) 786-4461, for issues related to the Merit-
                based Incentive Payment System (MIPS).
                 Heather Holsey, (410) 786-0028, for Comprehensive Care for Joint
                Replacement model.
                 Amanda Rhee, (410) 786-3888, and Elizabeth Matthews, (410) 786-
                5433, for Medicare Diabetes Prevention Program expanded model.
                [[Page 19231]]
                 Brittany LaCouture, (410) 786-0481, for Alternative Payment Model
                provisions of the Quality Payment Program.
                 CAPT Scott Cooper, USPHS, (410) 786-9496, for issues related to
                special requirements for psychiatric hospitals.
                SUPPLEMENTARY INFORMATION:
                 Inspection of Public Comments: All comments received before the
                close of the comment period are available for viewing by the public,
                including any personally identifiable or confidential business
                information that is included in a comment. We post all comments
                received before the close of the comment period on the following
                website as soon as possible after they have been received: http://regulations.gov. Follow the search instructions on that website to view
                public comments.
                Table of Contents
                I. Background
                II. Provisions of the Interim Final Rule
                 A. Payment for Medicare Telehealth Services Under Section
                1834(m) of the Act
                 B. Frequency Limitations on Subsequent Care Services in
                Inpatient and Nursing Facility Settings, and Critical Care
                Consultations and Required ``Hands-on'' Visits for ESRD Monthly
                Capitation Payments
                 C. Telehealth Modalities and Cost-sharing
                 D. Communication Technology-Based Services (CTBS)
                 E. Direct Supervision by Interactive Telecommunications
                Technology
                 F. Clarification of Homebound Status Under the Medicare Home
                Health Benefit
                 G. The Use of Telecommunications Technology Under the Medicare
                Home Health Benefit During the PHE for the COVID-19 Pandemic
                 H. The Use of Technology Under the Medicare Hospice Benefit
                 I. Telehealth and the Medicare Hospice Face-to-Face Encounter
                Requirement
                 J. Modification of the Inpatient Rehabilitation Facility (IRF)
                Face-to-Face Requirement for the PHE During the COVID-19 Pandemic
                 K. Removal of the IRF Post-Admission Physician Evaluation
                Requirement for the PHE for the COVID-19 Pandemic and Clarification
                Regarding the ``3-Hour'' Rule
                 L. Rural Health Clinics (RHCs) and Federally Qualified Health
                Centers (FQHCs)
                 M. Medicare Clinical Laboratory Fee Schedule: Payment for
                Specimen Collection for Purposes of COVID-19 Testing
                 N. Requirements for Opioid Treatment Programs (OTP)
                 O. Application of Teaching Physician and Moonlighting
                Regulations During the PHE for the COVID-19 pandemic During the PHE
                for COVID-19
                 P. Special Requirements for Psychiatric Hospitals (Sec.
                482.61(d))
                 Q. Innovation Center Models
                 R. Remote Physiologic Monitoring
                 S. Telephone Evaluation and Management (E/M) Services
                 T. Physician Supervision Flexibility for Outpatient Hospitals--
                Outpatient Hospital Therapeutic Services Assigned to the Non-
                Surgical Extended Duration Therapeutic Services (NSEDTS) Level of
                Supervision
                 U. Application of Certain National Coverage Determination and
                Local Coverage Determination Requirements During the PHE for the
                COVID-19 Pandemic
                 V. Change to Medicare Shared Savings Program Extreme and
                Uncontrollable Circumstances Policy
                 W. Level Selection for Office/Outpatient E/M Visits When
                Furnished Via Medicare Telehealth
                 X. Counting of Resident Time During the PHE for the COVID-19
                Pandemic
                 Y. Addressing the Impact of COVID-19 on Part C and Part D
                Quality Rating Systems
                 Z. Changes to Expand Workforce Capacity for Ordering Medicaid
                Home Health Services, Medical Equipment, Supplies and Appliances and
                Physical Therapy, Occupational Therapy or Speech Pathology and
                Audiology Services
                 AA. Origin and Destination Requirements Under the Ambulance Fee
                Schedule
                 BB. Merit-Based Incentive Payment System Updates
                 CC. Inpatient Hospital Services Furnished Under Arrangements
                Outside the Hospital During the Public Health Emergency (PHE) for
                the COVID-19 Pandemic
                 DD. Advance Payments to Suppliers Furnishing Items and Services
                Under Part B
                III. Waiver of Proposed Rulemaking
                IV. Collection of Information Requirements
                V. Response to Comments
                VI. Regulatory Impact Analysis
                Regulations Text
                Addenda Available Only Through the Internet on the CMS Website
                 The Addenda along with other supporting documents and tables
                referenced in this interim final rule with comment period (IFC) are
                available through the internet on the CMS website at https://www.cms.gov/. For this IFC, refer to item CMS-1744-IFC. Readers who
                experience any problems accessing any of the Addenda or other documents
                referenced in this IFC and posted on the CMS website identified above
                should contact [email protected].
                CPT (Current Procedural Terminology) Copyright Notice
                 Throughout this IFC, we use CPT codes and descriptions to refer to
                a variety of services. We note that CPT codes and descriptions are
                copyright 2019 American Medical Association. All Rights Reserved. CPT
                is a registered trademark of the American Medical Association (AMA).
                Applicable Federal Acquisition Regulations (FAR) and Defense Federal
                Acquisition Regulations (DFAR) apply.
                I. Background
                 The United States is responding to an outbreak of respiratory
                disease caused by a novel (new) coronavirus that was first detected in
                China and which has now been detected in more than 190 locations
                internationally, including in all 50 States and the District of
                Columbia. The virus has been named ``SARS-CoV-2'' and the disease it
                causes has been named ``coronavirus disease 2019'' (abbreviated
                ``COVID-19'').
                 On January 30, 2020, the International Health Regulations Emergency
                Committee of the World Health Organization (WHO) declared the outbreak
                a ``Public Health Emergency of international concern'' (PHEIC). On
                January 31, 2020, Health and Human Services Secretary, Alex M. Azar II,
                declared a PHE for the United States to aid the nation's healthcare
                community in responding to COVID-19 (hereafter referred to as the PHE
                for the COVID-19 pandemic). On March 11, 2020, the WHO publicly
                characterized COVID-19 as a pandemic. On March 13, 2020 the President
                of the United States declared the COVID-19 outbreak a national
                emergency.
                 Coronaviruses are a large family of viruses that are common in
                people and many different species of animals, including camels, cattle,
                cats, and bats. Rarely, animal coronaviruses can infect people and then
                spread between people such as with MERS-CoV, SARS-CoV, and now with
                this new virus (COVID-19).
                 The complete clinical picture with regard to COVID-19 is not fully
                known. Reported illnesses have ranged from very mild (including some
                with no reported symptoms) to severe, including illness resulting in
                death. While information so far suggests that most COVID-19 illness is
                mild, a report out of China suggests serious illness occurs in 16
                percent of cases. Older people and people of all ages with severe
                chronic medical conditions--like heart disease, lung disease and
                diabetes, for example--seem to be at higher risk of developing serious
                COVID-19 illness.\1\
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                 \1\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html.
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                 A pandemic is a global outbreak of disease. Pandemics happen when a
                new virus emerges to infect people and can spread between people
                sustainably. Because there is little to no pre-existing
                [[Page 19232]]
                immunity against the new virus, it spreads worldwide. The virus that
                causes COVID-19 is infecting people and spreading easily from person-
                to-person. This is the first pandemic known to be caused by the
                emergence of a new coronavirus.\2\
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                 \2\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html.
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                 People in places where ongoing community spread of the virus that
                causes COVID-19 has been reported are at elevated risk of exposure,
                with the level of risk dependent on the location. Healthcare workers
                caring for patients with COVID-19 are at elevated risk of exposure.
                Close contacts of persons with COVID-19 also are at elevated risk of
                exposure.
                 Early information out of China, where COVID-19 first started, shows
                that some people are at higher risk of getting very sick from this
                illness. This includes:
                 Older adults, with risk increasing by age.
                 People who have serious chronic medical conditions like:
                 ++ Heart disease.
                 ++ Diabetes.
                 ++ Lung disease.
                 The Centers for Disease Control and Prevention (CDC) has developed
                guidance to help in the risk assessment and management of people with
                potential exposures to COVID-19, including recommending that health
                care professionals make every effort to interview a person under
                investigation for infection by telephone, text monitoring system, or
                video conference.\3\
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                 \3\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html.
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                 As the healthcare community works to implement and establish
                recommended infection prevention and control practices, regulatory
                agencies under appropriate waiver authority granted by the PHE for the
                COVID-19 pandemic declaration are also working to revise and implement
                regulations that work in concert with healthcare community infection
                prevention and treatment practices. Based on the current and projected
                increase in rate of incidence of the COVID-19 disease in the US
                population, and observed fatalities in the elderly population, who are
                particularly vulnerable due to age and co-morbidities, and
                additionally, impact on health workers that are at increased risk due
                to treating the population, we believe that certain Medicare and
                Medicaid regulations that may offer providers flexibilities in
                furnishing services to combat the COVID-19 pandemic should be reviewed
                and revised as appropriate. We are addressing some of these regulations
                in this interim final rule with comment period (IFC) to ensure that
                sufficient health care items and services are available to meet the
                needs of individuals enrolled in the programs under Title XVIII
                (Medicare) and Title XIX (Medicaid) of the Social Security Act (the
                Act).
                 In this extraordinary circumstance, we recognize that public
                exposure greatly increases the overall risk to public health. We
                believe that this increased risk produces an immediate change, not only
                in the circumstances under which services can safely occur, but also
                results in an immediate change to the business relationships between
                providers, suppliers, and practitioners. By increasing access to
                services delivered using telecommunications technology, increasing
                access to testing in a patient's home, and improving infection control,
                this IFC will provide the necessary flexibility for Medicare
                beneficiaries to be able to receive medically necessary services
                without jeopardizing their health or the health of those who are
                providing those services, while minimizing the overall risk to public
                health.
                II. Provisions of the Interim Final Rule
                 In this IFC, we are defining the term, ``Public Health Emergency,''
                in the regulation at 42 CFR 400.200, which contains definitions that
                apply under the entirety of chapter 400 of title 42 of the CFR. The
                definition identifies the PHE determined to exist nationwide by the
                Secretary of Health and Human services under section 319 of the Public
                Health Service Act on January 31, 2020, as a result of confirmed cases
                of COVID-19, including any subsequent renewals.
                A. Payment for Medicare Telehealth Services Under Section 1834(m) of
                the Act
                 Section 1834(m) of the Act specifies the payment amounts and
                circumstances under which Medicare makes payment for a discrete set of
                services, all of which must ordinarily be furnished in-person, when
                they are instead furnished using interactive, real-time
                telecommunication technology. When furnished under the telehealth
                rules, many of these specified Medicare telehealth services are still
                reported using codes that describe ``face-to-face'' services but are
                furnished using audio/video, real-time communication technology instead
                of in-person. The list of these eligible telehealth services is
                published on the CMS website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
                 In contrast, Medicare pays separately for other professional
                services that are commonly furnished remotely using telecommunications
                technology, but that do not usually require the patient to be present
                in-person with the practitioner when they are furnished. These
                services, including remote physician interpretation of diagnostic
                tests, care management services and virtual check-ins among many
                others, are considered physicians' services in the same way as services
                that are furnished in-person without the use of telecommunications
                technology. They are covered and paid in the same way as services
                delivered without the use of telecommunications technology, but are not
                considered Medicare telehealth services and are not subject to the
                conditions of payment under section 1834(m) of the Act.
                 On March 17, 2020, we announced the expansion of telehealth
                services on a temporary and emergency basis pursuant to waiver
                authority added under section 1135(b)(8) of the Act by the Coronavirus
                Preparedness and Response Supplemental Appropriations Act, 2020 (Pub.
                L. 116-123, March 6, 2020). Starting on March 6, 2020, Medicare can pay
                for telehealth services, including office, hospital, and other visits
                furnished by physicians and other practitioners to patients located
                anywhere in the country, including in a patient's place of residence.
                In the context of the PHE for the COVID-19 pandemic, we recognize that
                physicians and other health care professionals are faced with new
                challenges regarding potential exposure risks, for people with
                Medicare, for health care providers, and for members of the community
                at large. For example, the CDC has urged health care professionals to
                make every effort to interview persons under investigation for
                infection by telephone, text messaging system, or video conference
                instead of in-person. To facilitate the use of telecommunications
                technology as a safe substitute for in-person services, we are, on an
                interim basis, adding many services to the list of eligible Medicare
                telehealth services, eliminating frequency limitations and other
                requirements associated with particular services furnished via
                telehealth, and clarifying several payment rules that apply to other
                services that are furnished using telecommunications technologies that
                can reduce exposure risks.
                 As discussed in this IFC and in prior rulemaking, several
                conditions must be met for Medicare to make payment for telehealth
                services under the Physician Fee Schedule (PFS). For further details,
                see the full discussion of the scope of
                [[Page 19233]]
                Medicare telehealth services in the ``Medicare Program; Revisions to
                Payment Policies Under the Physician Fee Schedule and Other Revisions
                to Part B for CY 2018; Medicare Shared Savings Program Requirements;
                and Medicare Diabetes Prevention Program'' final rule (82 FR 53006,
                November 17, 2017) (hereinafter referred to as the CY 2018 PFS final
                rule) and in our regulations at 42 CFR 410.78 and 414.65.
                1. Site of Service Differential for Medicare Telehealth Services
                 Under the PFS, there are two payment rates for many physicians'
                services: The facility rate; and the non-facility, or office, rate. The
                PFS non-facility rate is the single amount paid to a physician or other
                practitioner for services furnished in their office. The PFS facility
                rate is the amount generally paid to a professional when a service is
                furnished in a setting of care, like a hospital, where Medicare is
                making a separate payment to an entity in addition to the payment to
                the billing physician or practitioner. This separate payment, often
                referred to as a ``facility fee'' reflects the facility's costs
                associated with the service (clinical staff, supplies and equipment)
                and is paid in addition to what is paid to the professional through the
                PFS.
                 We note that, in accordance with section 1834(m)(2)(B) of the Act,
                a facility fee is, in most cases, paid to the ``originating site''
                where the beneficiary is located at the time a telehealth service is
                furnished. The payment amount for the telehealth originating site
                facility fee is a nationally applicable flat fee, paid without
                geographic or site of service adjustments that generally apply to
                payments for different kinds of services furnished by Medicare
                providers and suppliers.
                 For Medicare telehealth services, we currently make payment to the
                billing physician or practitioner at the PFS facility rate since the
                facility costs (clinical staff, supplies, and equipment) associated
                with furnishing the service would generally be incurred by the
                originating site, where the patient is located, and not by the
                practitioner at the distant site; and because the statute requires
                Medicare to pay an originating site facility fee to the site that hosts
                the patient.
                 When a physician or practitioner submits a claim for their
                services, including claims for telehealth services, they include a
                place of service (POS) code that is used to determine whether a service
                is paid using the facility or non-facility rate. Currently, CMS
                requires that claims for Medicare telehealth services include the POS
                code 02, which is specific to telehealth services.
                 Under the waiver authority exercised by the Secretary in response
                to the PHE for the COVID-19 pandemic, Medicare telehealth services can
                be furnished to patients wherever they are located, including in the
                patient's home. As provided by the amendments to section 1135(b)(8) of
                the Act, when telehealth services are furnished under the waiver to
                beneficiaries located in places that are not identified as permissible
                originating sites in section 1834(m)(4)(C)(ii)(I) through (IX) of the
                Act, no originating site facility fee is paid. We also recognize that
                as physician practices suddenly transition a potentially significant
                portion of their services from in-person to telehealth visits in the
                context of the PHE for the COVID-19 pandemic, the relative resource
                costs of furnishing these services via telehealth may not significantly
                differ from the resource costs involved when these services are
                furnished in person. For example, we expect that physician offices will
                continue to employ nursing staff to engage with patients during
                telehealth visits or to coordinate pre- or post-visit care, regardless
                of whether or not the visit takes place in person, as it would have
                outside of the PHE for the COVID-19 pandemic, or through telehealth in
                the context of the PHE for the COVID-19 pandemic. Consequently, the
                assumptions that have supported payment of telehealth services at the
                PFS facility rate would not apply in many circumstances for services
                furnished during the PHE for the COVID-19 pandemic. Instead, we believe
                that, as more telehealth services are furnished to patients wherever
                they are located rather than in statutory originating sites, it would
                be appropriate to assume that the relative resource costs of services
                furnished through telehealth should be reflected in the payment to the
                furnishing physician or practitioner as if they furnished the services
                in person, and to assign the payment rate that ordinarily would have
                been paid under the PFS were the services furnished in-person. For
                example, a physician practicing in an office setting who, under the PHE
                for the COVID-19 pandemic, sees patients via telehealth instead of in
                person would be paid at the non-facility, or office, rate for these
                services. Similarly, a physician who typically sees patients in an
                outpatient provider-based clinic of a hospital would be paid the
                facility rate for services newly furnished via telehealth.
                 To implement this change on an interim basis, we are instructing
                physicians and practitioners who bill for Medicare telehealth services
                to report the POS code that would have been reported had the service
                been furnished in person. This will allow our systems to make
                appropriate payment for services furnished via Medicare telehealth
                which, if not for the PHE for the COVID-19 pandemic, would have been
                furnished in person, at the same rate they would have been paid if the
                services were furnished in person. Given the potential importance of
                using telehealth services as means of minimizing exposure risks for
                patients, practitioners, and the community at large, we believe this
                interim change will maintain overall relativity under the PFS for
                similar services and eliminate potential financial deterrents to the
                clinically appropriate use of telehealth. Because we currently use the
                POS code on the claim to identify Medicare telehealth services, we are
                finalizing on an interim basis the use of the CPT telehealth modifier,
                modifier 95, which should be applied to claim lines that describe
                services furnished via telehealth. We note that we are maintaining the
                facility payment rate for services billed using the general telehealth
                POS code 02, should practitioners choose, for whatever reason, to
                maintain their current billing practices for Medicare telehealth during
                the PHE for the COVID-19 pandemic.
                2. Adding Services to the List of Medicare Telehealth Services
                 In the ``Medicare Program; Revisions to Payment Policies Under the
                Physician Fee Schedule for Calendar Year 2003 and Inclusion of
                Registered Nurses in the Personnel Provision of the Critical Access
                Hospital Emergency Services Requirement for Frontier Areas and Remote
                Locations'' final rule with comment period (67 FR 79988, December 31,
                2002) (hereinafter referred to the CY 2003 PFS final rule with comment
                period), we established a process for adding services to or deleting
                services from the list of Medicare telehealth services in accordance
                with section 1834(m)(4)(F)(ii) of the Act. This process provides the
                public with an ongoing opportunity to submit requests for adding
                services, which we then review. We have also routinely reviewed
                potential services for addition to the list of telehealth services and
                sought comment on any such proposed additions. Under this process, we
                assign any potential addition to the list of telehealth services to one
                of the following two categories:
                [[Page 19234]]
                 Category 1: Services that are similar to professional
                consultations, office visits, and office psychiatry services that are
                currently on the list of telehealth services. In reviewing these
                requests, we look for similarities between the requested and existing
                telehealth services for the roles of, and interactions among, the
                beneficiary, the physician (or other practitioner) at the distant site
                and, if necessary, the telepresenter, a practitioner who is present
                with the beneficiary in the originating site. We also look for
                similarities in the telecommunications system used to deliver the
                service; for example, the use of interactive audio and video equipment.
                 Category 2: Services that are not similar to those on the
                current list of telehealth services. Our review of these requests
                includes an assessment of whether the service is accurately described
                by the corresponding code when furnished via telehealth and whether the
                use of a telecommunications system to furnish the service produces
                demonstrated clinical benefit to the patient. Submitted evidence should
                include both a description of relevant clinical studies that
                demonstrate the service furnished by telehealth to a Medicare
                beneficiary improves the diagnosis or treatment of an illness or injury
                or improves the functioning of a malformed body part, including dates
                and findings, and a list and copies of published peer reviewed articles
                relevant to the service when furnished via telehealth. Our evidentiary
                standard of clinical benefit does not include minor or incidental
                benefits.
                 Some examples of clinical benefit include the following:
                 Ability to diagnose a medical condition in a patient
                population without access to clinically appropriate in-person
                diagnostic services.
                 Treatment option for a patient population without access
                to clinically appropriate in-person treatment options.
                 Reduced rate of complications.
                 Decreased rate of subsequent diagnostic or therapeutic
                interventions (for example, due to reduced rate of recurrence of the
                disease process).
                 Decreased number of future hospitalizations or physician
                visits.
                 More rapid beneficial resolution of the disease process
                treatment.
                 Decreased pain, bleeding, or other quantifiable symptom.
                 Reduced recovery time.
                 The list of telehealth services, including the additions described
                later in this section, can be located on the CMS website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
                 On an interim basis, we are adding the following services to the
                Medicare telehealth list on a Category 2 basis for the duration of this
                PHE for the COVID-19 pandemic, for telehealth services with dates of
                service beginning March 1, 2020 through the end of the declared PHE
                including any subsequent renewals. When we previously considered adding
                these services to the list of telehealth services, either through a
                public request or through our own internal review, we considered
                whether or not these services met the category 1 or category 2
                criteria. In many cases we reviewed requests to add these services on a
                category 1 basis but did not receive or identify information that
                allowed us to review the services on a category 2 basis. While we do
                not believe the context of this PHE for the COVID-19 pandemic changes
                the assessment of these services as category 1, we have reassessed all
                of these services on a category 2 basis in the context of the
                widespread presence of COVID-19 in the community. Given the exposure
                risks for beneficiaries, the health care work force, and the community
                at large, in-person interaction between professionals and patients
                poses an immediate potential risk that would not have been present when
                we previously reviewed these services. This new risk creates a unique
                circumstance where health care professionals need to weigh the risks
                associated with disease exposure so they can bill Medicare for the
                service. For example, certain persons, especially older adults who are
                particularly vulnerable to this specific virus, those considered at
                risk because of underlying health conditions, and those known to be
                recently exposed or diagnosed, and therefore, likely to spread the
                virus to others, are often being directed by local public health
                officials to self-isolate as much as possible. At the same time, we
                note that the risks to medical professionals treating patients is high
                and we consider it likely that medical professionals will try to treat
                patients as effectively as possible without exposing themselves or
                their patients unnecessarily. In some cases, use of telecommunication
                technology could mitigate the exposure risk, and in such cases, there
                is a clear clinical benefit of using such technology in furnishing the
                service. In other words, patients who should not be seen by a
                professional in-person due to the exposure risk are highly likely to be
                without access to clinically appropriate treatment or diagnostic
                options unless they have access to services furnished through
                interactive communication technology. Therefore, in the context of the
                PHE for the COVID-19 pandemic, we believe all of the following services
                meet the category 2 criteria to be added to the list of telehealth
                services on the basis that there is a patient population that would
                otherwise not have access to clinically appropriate treatment. We note
                that, as with other services on the Medicare telehealth list, it may
                not be clinically appropriate or possible to use telecommunications
                technology to furnish these particular services to every person or in
                every circumstance. However, in the context of the PHE for the COVID-19
                pandemic with specific regard to the exposure risks noted above, we
                recognize the clinical benefit of access to medically reasonable and
                necessary services furnished using telecommunications technology as
                opposed to the potential lack of access that could occur to mitigate
                the risk of disease exposure. In light of the PHE for the COVID-19
                pandemic, the demand for physicians in areas heavily impacted by COVID-
                19 or under served by clinicians may intensify, resulting in a need for
                critical care services for patients with suspected or diagnosed COVID-
                19 and those who are in acute care settings due to other conditions.
                These practitioners may be working with nurses, consulting with other
                healthcare professionals, writing orders, looking at images,
                communicating with family members for patients with a number of acute
                conditions. The CPT codes describing E/M services reflect an assumption
                that the nature of the work involved in evaluation and management
                visits varies, in part, based on the setting of care and the patient's
                status. Consequently, there are separate sets of E/M codes for
                different settings of care, such as office/outpatient codes, nursing
                facility codes, or emergency department codes. We expect physicians and
                other practitioners to use the E/M code that best describes the nature
                of the care they are providing, regardless of the physical location or
                status of the patient. Under ordinary circumstances, we would expect
                the kind of E/M code reported to generally align with the physical
                location or status of the patient. In the context of the PHE, we
                recognize that the relationship among the setting of care, patient
                status, and kind of E/M code reported may depend on the needs of local
                communities and the capacity of local health care institutions.
                Consequently, we are reiterating that practitioners should report the
                E/M code that best describes the nature of the care they are providing.
                [[Page 19235]]
                 We are adding the following codes to the existing list of
                telehealth services on a Category 2 basis for the PHE for the COVID-19
                pandemic:
                3. Emergency Department Visits: CPT Codes
                 99281 (Emergency department visit for the evaluation and
                management of a patient, which requires these 3 key components: A
                problem focused history; A problem focused examination; and
                Straightforward medical decision making. Counseling and/or coordination
                of care with other physicians, other qualified health care
                professionals, or agencies are provided consistent with the nature of
                the problem(s) and the patient's and/or family's needs. Usually, the
                presenting problem(s) are self limited or minor.)
                 99282 (Emergency department visit for the evaluation and
                management of a patient, which requires these 3 key components: An
                expanded problem focused history; An expanded problem focused
                examination; and Medical decision making of low complexity. Counseling
                and/or coordination of care with other physicians, other qualified
                health care professionals, or agencies are provided consistent with the
                nature of the problem(s) and the patient's and/or family's needs.
                Usually, the presenting problem(s) are of low to moderate severity.)
                 99283 (Emergency department visit for the evaluation and
                management of a patient, which requires these 3 key components: An
                expanded problem focused history; An expanded problem focused
                examination; and Medical decision making of moderate complexity.
                Counseling and/or coordination of care with other physicians, other
                qualified health care professionals, or agencies are provided
                consistent with the nature of the problem(s) and the patient's and/or
                family's needs. Usually, the presenting problem(s) are of moderate
                severity.)
                 99284 (Emergency department visit for the evaluation and
                management of a patient, which requires these 3 key components: A
                detailed history; A detailed examination; and Medical decision making
                of moderate complexity. Counseling and/or coordination of care with
                other physicians, other qualified health care professionals, or
                agencies are provided consistent with the nature of the problem(s) and
                the patient's and/or family's needs. Usually, the presenting problem(s)
                are of high severity, and require urgent evaluation by the physician,
                or other qualified health care professionals but do not pose an
                immediate significant threat to life or physiologic function.)
                 99285 (Emergency department visit for the evaluation and
                management of a patient, which requires these 3 key components within
                the constraints imposed by the urgency of the patient's clinical
                condition and/or mental status: A comprehensive history; A
                comprehensive examination; and Medical decision making of high
                complexity. Counseling and/or coordination of care with other
                physicians, other qualified health care professionals, or agencies are
                provided consistent with the nature of the problem(s) and the patient's
                and/or family's needs. Usually, the presenting problem(s) are of high
                severity and pose an immediate significant threat to life or
                physiologic function.)
                4. Initial and Subsequent Observation, and Observation Discharge Day
                Management: CPT Codes
                 99217 (Observation care discharge day management (This
                code is to be utilized to report all services provided to a patient on
                discharge from outpatient hospital ``observation status'' if the
                discharge is on other than the initial date of ``observation status.''
                To report services to a patient designated as ``observation status'' or
                ``inpatient status'' and discharged on the same date, use the codes for
                Observation or Inpatient Care Services [including Admission and
                Discharge Services, 99234-99236 as appropriate.])
                 99218 (Initial observation care, per day, for the
                evaluation and management of a patient which requires these 3 key
                components: A detailed or comprehensive history; A detailed or
                comprehensive examination; and Medical decision making that is
                straightforward or of low complexity. Counseling and/or coordination of
                care with other physicians, other qualified health care professionals,
                or agencies are provided consistent with the nature of the problem(s)
                and the patient's and/or family's needs. Usually, the problem(s)
                requiring admission to outpatient hospital ``observation status'' are
                of low severity. Typically, 30 minutes are spent at the bedside and on
                the patient's hospital floor or unit.)
                 99219 (Initial observation care, per day, for the
                evaluation and management of a patient, which requires these 3 key
                components: A comprehensive history; A comprehensive examination; and
                Medical decision making of moderate complexity. Counseling and/or
                coordination of care with other physicians, other qualified health care
                professionals, or agencies are provided consistent with the nature of
                the problem(s) and the patient's and/or family's needs. Usually, the
                problem(s) requiring admission to outpatient hospital ``observation
                status'' are of moderate severity. Typically, 50 minutes are spent at
                the bedside and on the patient's hospital floor or unit.)
                 99220 (Initial observation care, per day, for the
                evaluation and management of a patient, which requires these 3 key
                components: A comprehensive history; A comprehensive examination; and
                Medical decision making of high complexity. Counseling and/or
                coordination of care with other physicians, other qualified health care
                professionals, or agencies are provided consistent with the nature of
                the problem(s) and the patient's and/or family's needs. Usually, the
                problem(s) requiring admission to outpatient hospital ``observation
                status'' are of high severity. Typically, 70 minutes are spent at the
                bedside and on the patient's hospital floor or unit.)
                 99224 (Subsequent observation care, per day, for the
                evaluation and management of a patient, which requires at least 2 of
                these 3 key components: Problem focused interval history; Problem
                focused examination; Medical decision making that is straightforward or
                of low complexity. Counseling and/or coordination of care with other
                physicians, other qualified health care professionals, or agencies are
                provided consistent with the nature of the problem(s) and the patient's
                and/or family's needs. Usually, the patient is stable, recovering, or
                improving. Typically, 15 minutes are spent at the bedside and on the
                patient's hospital floor or unit.)
                 99225 (Subsequent observation care, per day, for the
                evaluation and management of a patient, which requires at least 2 of
                these 3 key components: An expanded problem focused interval history;
                An expanded problem focused examination; Medical decision making of
                moderate complexity. Counseling and/or coordination of care with other
                physicians, other qualified health care professionals, or agencies are
                provided consistent with the nature of the problem(s) and the patient's
                and/or family's needs. Usually, the patient is responding inadequately
                to therapy or has developed a minor complication. Typically, 25 minutes
                are spent at the bedside and on the patient's hospital floor or unit.)
                 99226 (Subsequent observation care, per day, for the
                evaluation and management of a patient, which requires at least 2 of
                these 3 key components: A detailed interval history; A detailed
                examination; Medical
                [[Page 19236]]
                decision making of high complexity. Counseling and/or coordination of
                care with other physicians, other qualified health care professionals,
                or agencies are provided consistent with the nature of the problem(s)
                and the patient's and/or family's needs. Usually, the patient is
                unstable or has developed a significant complication or a significant
                new problem. Typically, 35 minutes are spent at the bedside and on the
                patient's hospital floor or unit.)
                 99234 (Observation or inpatient hospital care, for the
                evaluation and management of a patient including admission and
                discharge on the same date, which requires these 3 key components: A
                detailed or comprehensive history; A detailed or comprehensive
                examination; and Medical decision making that is straightforward or of
                low complexity. Counseling and/or coordination of care with other
                physicians, other qualified health care professionals, or agencies are
                provided consistent with the nature of the problem(s) and the patient's
                and/or family's needs. Usually the presenting problem(s) requiring
                admission are of low severity. Typically, 40 minutes are spent at the
                bedside and on the patient's hospital floor or unit.)
                 99235 (Observation or inpatient hospital care, for the
                evaluation and management of a patient including admission and
                discharge on the same date, which requires these 3 key components: A
                comprehensive history; A comprehensive examination; and Medical
                decision making of moderate complexity. Counseling and/or coordination
                of care with other physicians, other qualified health care
                professionals, or agencies are provided consistent with the nature of
                the problem(s) and the patient's and/or family's needs. Usually the
                presenting problem(s) requiring admission are of moderate severity.
                Typically, 50 minutes are spent at the bedside and on the patient's
                hospital floor or unit.)
                 99236 (Observation or inpatient hospital care, for the
                evaluation and management of a patient including admission and
                discharge on the same date, which requires these 3 key components: A
                comprehensive history; A comprehensive examination; and Medical
                decision making of high complexity. Counseling and/or coordination of
                care with other physicians, other qualified health care professionals,
                or agencies are provided consistent with the nature of the problem(s)
                and the patient's and/or family's needs. Usually the presenting
                problem(s) requiring admission are of high severity. Typically, 55
                minutes are spent at the bedside and on the patient's hospital floor or
                unit.)
                5. Initial Hospital Care and Hospital Discharge Day Management: CPT
                Codes
                 99221 (Initial hospital care, per day, for the evaluation
                and management of a patient, which requires these 3 key components: A
                detailed or comprehensive history; A detailed or comprehensive
                examination; and Medical decision making that is straightforward or of
                low complexity. Counseling and/or coordination of care with other
                physicians, other qualified health care professionals, or agencies are
                provided consistent with the nature of the problem(s) and the patient's
                and/or family's needs. Usually, the problem(s) requiring admission are
                of low severity. Typically, 30 minutes are spent at the bedside and on
                the patient's hospital floor or unit.)
                 99222 (Initial hospital care, per day, for the evaluation
                and management of a patient, which requires these 3 key components: A
                comprehensive history; A comprehensive examination; and Medical
                decision making of moderate complexity. Counseling and/or coordination
                of care with other physicians, other qualified health care
                professionals, or agencies are provided consistent with the nature of
                the problem(s) and the patient's and/or family's needs. Usually, the
                problem(s) requiring admission are of moderate severity. Typically, 50
                minutes are spent at the bedside and on the patient's hospital floor or
                unit.)
                 99223 (Initial hospital care, per day, for the evaluation
                and management of a patient, which requires these 3 key components: A
                comprehensive history; A comprehensive examination; and Medical
                decision making of high complexity. Counseling and/or coordination of
                care with other physicians, other qualified health care professionals,
                or agencies are provided consistent with the nature of the problem(s)
                and the patient's and/or family's needs. Usually, the problem(s)
                requiring admission are of high severity. Typically, 70 minutes are
                spent at the bedside and on the patient's hospital floor or unit.)
                 99238 (Hospital discharge day management; 30 minutes or
                less)
                 99239 (Hospital discharge day management; more than 30
                minutes)
                6. Initial Nursing Facility Visits and Nursing Facility Discharge Day
                Management: CPT Codes
                 99304 (Initial nursing facility care, per day, for the
                evaluation and management of a patient, which requires these 3 key
                components: A detailed or comprehensive history; A detailed or
                comprehensive examination; and Medical decision making that is
                straightforward or of low complexity. Counseling and/or coordination of
                care with other physicians, other qualified health care professionals,
                or agencies are provided consistent with the nature of the problem(s)
                and the patient's and/or family's needs. Usually, the problem(s)
                requiring admission are of low severity. Typically, 25 minutes are
                spent at the bedside and on the patient's facility floor or unit.)
                 99305 (Initial nursing facility care, per day, for the
                evaluation and management of a patient, which requires these 3 key
                components: A comprehensive history; A comprehensive examination; and
                Medical decision making of moderate complexity. Counseling and/or
                coordination of care with other physicians, other qualified health care
                professionals, or agencies are provided consistent with the nature of
                the problem(s) and the patient's and/or family's needs. Usually, the
                problem(s) requiring admission are of moderate severity. Typically, 35
                minutes are spent at the bedside and on the patient's facility floor or
                unit.)
                 99306 (Initial nursing facility care, per day, for the
                evaluation and management of a patient, which requires these 3 key
                components: A comprehensive history; A comprehensive examination; and
                Medical decision making of high complexity. Counseling and/or
                coordination of care with other physicians, other qualified health care
                professionals, or agencies are provided consistent with the nature of
                the problem(s) and the patient's and/or family's needs. Usually, the
                problem(s) requiring admission are of high severity. Typically, 45
                minutes are spent at the bedside and on the patient's facility floor or
                unit.)
                 99315 (Nursing facility discharge day management; 30
                minutes or less)
                 99316 (Nursing facility discharge day management; more
                than 30 minutes)
                7. Critical Care Services: CPT Codes
                 99291 (Critical care, evaluation and management of the
                critically ill or critically injured patient; first 30-74 minutes)
                 99292 (Critical care, evaluation and management of the
                critically ill or critically injured patient; each additional 30
                minutes (List separately in addition to code for primary service))
                [[Page 19237]]
                8. Domiciliary, Rest Home, or Custodial Care Services: CPT Codes
                 99327 (Domiciliary or rest home visit for the evaluation
                and management of a new patient, which requires these 3 key components:
                A comprehensive history; A comprehensive examination; and Medical
                decision making of moderate complexity. Counseling and/or coordination
                of care with other physicians, other qualified health care
                professionals, or agencies are provided consistent with the nature of
                the problem(s) and the patient's and/or family's needs. Usually, the
                presenting problem(s) are of high severity. Typically, 60 minutes are
                spent with the patient and/or family or caregiver.)
                 99328 (Domiciliary or rest home visit for the evaluation
                and management of a new patient, which requires these 3 key components:
                A comprehensive history; A comprehensive examination; and Medical
                decision making of high complexity. Counseling and/or coordination of
                care with other physicians, other qualified health care professionals,
                or agencies are provided consistent with the nature of the problem(s)
                and the patient's and/or family's needs. Usually, the patient is
                unstable or has developed a significant new problem requiring immediate
                physician attention. Typically, 75 minutes are spent with the patient
                and/or family or caregiver.)
                 99334 (Domiciliary or rest home visit for the evaluation
                and management of an established patient, which requires at least 2 of
                these 3 key components: A problem focused interval history; A problem
                focused examination; Straightforward medical decision making.
                Counseling and/or coordination of care with other physicians, other
                qualified health care professionals, or agencies are provided
                consistent with the nature of the problem(s) and the patient's and/or
                family's needs. Usually, the presenting problem(s) are self-limited or
                minor. Typically, 15 minutes are spent with the patient and/or family
                or caregiver.)
                 99335 (Domiciliary or rest home visit for the evaluation
                and management of an established patient, which requires at least 2 of
                these 3 key components: An expanded problem focused interval history;
                An expanded problem focused examination; Medical decision making of low
                complexity. Counseling and/or coordination of care with other
                physicians, other qualified health care professionals, or agencies are
                provided consistent with the nature of the problem(s) and the patient's
                and/or family's needs. Usually, the presenting problem(s) are of low to
                moderate severity. Typically, 25 minutes are spent with the patient
                and/or family or caregiver.)
                 99336 (Domiciliary or rest home visit for the evaluation
                and management of an established patient, which requires at least 2 of
                these 3 key components: A detailed interval history; A detailed
                examination; Medical decision making of moderate complexity. Counseling
                and/or coordination of care with other physicians, other qualified
                health care professionals, or agencies are provided consistent with the
                nature of the problem(s) and the patient's and/or family's needs.
                Usually, the presenting problem(s) are of moderate to high severity.
                Typically, 40 minutes are spent with the patient and/or family or
                caregiver.)
                 99337 (Domiciliary or rest home visit for the evaluation
                and management of an established patient, which requires at least 2 of
                these 3 key components: A comprehensive interval history; A
                comprehensive examination; Medical decision making of moderate to high
                complexity. Counseling and/or coordination of care with other
                physicians, other qualified health care professionals, or agencies are
                provided consistent with the nature of the problem(s) and the patient's
                and/or family's needs. Usually, the presenting problem(s) are of
                moderate to high severity. The patient may be unstable or may have
                developed a significant new problem requiring immediate physician
                attention. Typically, 60 minutes are spent with the patient and/or
                family or caregiver.)
                9. Home Visits: CPT Codes
                 99341 (Home visit for the evaluation and management of a
                new patient, which requires these 3 key components: A problem focused
                history; A problem focused examination; and Straightforward medical
                decision making. Counseling and/or coordination of care with other
                physicians, other qualified health care professionals, or agencies are
                provided consistent with the nature of the problem(s) and the patient's
                and/or family's needs. Usually, the presenting problem(s) are of low
                severity. Typically, 20 minutes are spent face-to-face with the patient
                and/or family.)
                 99342 (Home visit for the evaluation and management of a
                new patient, which requires these 3 key components: An expanded problem
                focused history; An expanded problem focused examination; and Medical
                decision making of low complexity. Counseling and/or coordination of
                care with other physicians, other qualified health care professionals,
                or agencies are provided consistent with the nature of the problem(s)
                and the patient's and/or family's needs. Usually, the presenting
                problem(s) are of moderate severity. Typically, 30 minutes are spent
                face-to-face with the patient and/or family.)
                 99343 (Home visit for the evaluation and management of a
                new patient, which requires these 3 key components: A detailed history;
                A detailed examination; and Medical decision making of moderate
                complexity. Counseling and/or coordination of care with other
                physicians, other qualified health care professionals, or agencies are
                provided consistent with the nature of the problem(s) and the patient's
                and/or family's needs. Usually, the presenting problem(s) are of
                moderate to high severity. Typically, 45 minutes are spent face-to-face
                with the patient and/or family.)
                 99344 (Home visit for the evaluation and management of a
                new patient, which requires these 3 key components: A comprehensive
                history; A comprehensive examination; and Medical decision making of
                moderate complexity. Counseling and/or coordination of care with other
                physicians, other qualified health care professionals, or agencies are
                provided consistent with the nature of the problem(s) and the patient's
                and/or family's needs. Usually, the presenting problem(s) are of high
                severity. Typically, 60 minutes are spent face-to-face with the patient
                and/or family.)
                 99345 (Home visit for the evaluation and management of a
                new patient, which requires these 3 key components: A comprehensive
                history; A comprehensive examination; and Medical decision making of
                high complexity. Counseling and/or coordination of care with other
                physicians, other qualified health care professionals, or agencies are
                provided consistent with the nature of the problem(s) and the patient's
                and/or family's needs. Usually, the patient is unstable or has
                developed a significant new problem requiring immediate physician
                attention. Typically, 75 minutes are spent face-to-face with the
                patient and/or family.)
                 99347 (Home visit for the evaluation and management of an
                established patient, which requires at least 2 of these 3 key
                components: A problem focused interval history; A problem focused
                examination; Straightforward medical decision making. Counseling and/or
                coordination of care with other physicians, other qualified health care
                professionals, or agencies are provided
                [[Page 19238]]
                consistent with the nature of the problem(s) and the patient's and/or
                family's needs. Usually, the presenting problem(s) are self limited or
                minor. Typically, 15 minutes are spent face-to-face with the patient
                and/or family.)
                 99348 (Home visit for the evaluation and management of an
                established patient, which requires at least 2 of these 3 key
                components: An expanded problem focused interval history; An expanded
                problem focused examination; Medical decision making of low complexity.
                Counseling and/or coordination of care with other physicians, other
                qualified health care professionals, or agencies are provided
                consistent with the nature of the problem(s) and the patient's and/or
                family's needs. Usually, the presenting problem(s) are of low to
                moderate severity. Typically, 25 minutes are spent face-to-face with
                the patient and/or family.)
                 99349 (Home visit for the evaluation and management of an
                established patient, which requires at least 2 of these 3 key
                components: A detailed interval history; A detailed examination;
                Medical decision making of moderate complexity. Counseling and/or
                coordination of care with other physicians, other qualified health care
                professionals, or agencies are provided consistent with the nature of
                the problem(s) and the patient's and/or family's needs. Usually, the
                presenting problem(s) are moderate to high severity. Typically, 40
                minutes are spent face-to-face with the patient and/or family.)
                 99350 (Home visit for the evaluation and management of an
                established patient, which requires at least 2 of these 3 key
                components: A comprehensive interval history; A comprehensive
                examination; Medical decision making of moderate to high complexity.
                Counseling and/or coordination of care with other physicians, other
                qualified health care professionals, or agencies are provided
                consistent with the nature of the problem(s) and the patient's and/or
                family's needs. Usually, the presenting problem(s) are of moderate to
                high severity. The patient may be unstable or may have developed a
                significant new problem requiring immediate physician attention.
                Typically, 60 minutes are spent face-to-face with the patient and/or
                family.)
                10. Inpatient Neonatal and Pediatric Critical Care: CPT Codes
                 99468 (Initial inpatient neonatal critical care, per day,
                for the evaluation and management of a critically ill neonate, 28 days
                of age or younger)
                 99469 (Subsequent inpatient neonatal critical care, per
                day, for the evaluation and management of a critically ill neonate, 28
                days of age or younger)
                 99471 (Initial inpatient pediatric critical care, per day,
                for the evaluation and management of a critically ill infant or young
                child, 29 days through 24 months of age)
                 99472 (Subsequent inpatient pediatric critical care, per
                day, for the evaluation and management of a critically ill infant or
                young child, 29 days through 24 months of age)
                 99473 (Self-measured blood pressure using a device
                validated for clinical accuracy; patient education/training and device
                calibration)
                 99475 (Initial inpatient pediatric critical care, per day,
                for the evaluation and management of a critically ill infant or young
                child, 2 through 5 years of age)
                 99476 (Subsequent inpatient pediatric critical care, per
                day, for the evaluation and management of a critically ill infant or
                young child, 2 through 5 years of age)
                11. Initial and Continuing Intensive Care Services: CPT Codes
                 99477 (Initial hospital care, per day, for the evaluation
                and management of the neonate, 28 days of age or younger, who requires
                intensive observation, frequent interventions, and other intensive care
                services)
                 99478 (Subsequent intensive care, per day, for the
                evaluation and management of the recovering very low birth weight
                infant (present body weight less than 1500 grams))
                 99479 (Subsequent intensive care, per day, for the
                evaluation and management of the recovering low birth weight infant
                (present body weight of 1500-2500 grams))
                 99480 (Subsequent intensive care, per day, for the
                evaluation and management of the recovering infant (present body weight
                of 2501-5000 grams))
                12. Care Planning for Patients With Cognitive Impairment: CPT Code
                 99483 (Assessment of and care planning for a patient with
                cognitive impairment, requiring an independent historian, in the office
                or other outpatient, home or domiciliary or rest home, with all of the
                following required elements: Cognition-focused evaluation including a
                pertinent history and examination; Medical decision making of moderate
                or high complexity; Functional assessment (eg, basic and instrumental
                activities of daily living), including decision-making capacity; Use of
                standardized instruments for staging of dementia (eg, functional
                assessment staging test [FAST], clinical dementia rating [CDR]);
                Medication reconciliation and review for high-risk medications;
                Evaluation for neuropsychiatric and behavioral symptoms, including
                depression, including use of standardized screening instrument(s);
                Evaluation of safety (eg, home), including motor vehicle operation;
                Identification of caregiver(s), caregiver knowledge, caregiver needs,
                social supports, and the willingness of caregiver to take on caregiving
                tasks; Development, updating or revision, or review of an Advance Care
                Plan; Creation of a written care plan, including initial plans to
                address any neuropsychiatric symptoms, neuro-cognitive symptoms,
                functional limitations, and referral to community resources as needed
                (eg, rehabilitation services, adult day programs, support groups)
                shared with the patient and/or caregiver with initial education and
                support. Typically, 50 minutes are spent face-to-face with the patient
                and/or family or caregiver.)
                13. Group Psychotherapy: CPT Code
                 90853 (Group psychotherapy (other than of a multiple-
                family group))
                14. End-Stage Renal Disease (ESRD) Services: CPT Codes
                 90952 (End-stage renal disease (ESRD) related services
                monthly, for patients younger than 2 years of age to include monitoring
                for the adequacy of nutrition, assessment of growth and development,
                and counseling of parents; with 2-3 face-to-face visits by a physician
                or other qualified health care professional per month)
                 90953 (End-stage renal disease (ESRD) related services
                monthly, for patients younger than 2 years of age to include monitoring
                for the adequacy of nutrition, assessment of growth and development,
                and counseling of parents; with 1 face-to-face visit by a physician or
                other qualified health care professional per month)
                 90959 (End-stage renal disease (ESRD) related services
                monthly, for patients 12-19 years of age to include monitoring for the
                adequacy of nutrition, assessment of growth and development, and
                counseling of parents; with 1 face-to-face visit by a physician or
                other qualified health care professional per month)
                 90962 (End-stage renal disease (ESRD) related services
                monthly, for patients 20 years of age and older; with 1 face-to-face
                visit by a physician or other qualified health care professional per
                month)
                [[Page 19239]]
                15. Psychological and Neuropsychological Testing: CPT Codes
                 96130 (Psychological testing evaluation services by
                physician or other qualified health care professional, including
                integration of patient data, interpretation of standardized test
                results and clinical data, clinical decision making, treatment planning
                and report, and interactive feedback to the patient, family member(s)
                or caregiver(s), when performed; first hour)
                 96131 (Psychological testing evaluation services by
                physician or other qualified health care professional, including
                integration of patient data, interpretation of standardized test
                results and clinical data, clinical decision making, treatment planning
                and report, and interactive feedback to the patient, family member(s)
                or caregiver(s), when performed; each additional hour (List separately
                in addition to code for primary procedure))
                 96132 (Neuropsychological testing evaluation services by
                physician or other qualified health care professional, including
                integration of patient data, interpretation of standardized test
                results and clinical data, clinical decision making, treatment planning
                and report, and interactive feedback to the patient, family member(s)
                or caregiver(s), when performed; first hour)
                 96133 (Neuropsychological testing evaluation services by
                physician or other qualified health care professional, including
                integration of patient data, interpretation of standardized test
                results and clinical data, clinical decision making, treatment planning
                and report, and interactive feedback to the patient, family member(s)
                or caregiver(s), when performed; each additional hour (List separately
                in addition to code for primary procedure))
                 96136 (Psychological or neuropsychological test
                administration and scoring by physician or other qualified health care
                professional, two or more tests, any method; first 30 minutes)
                 96137 (Psychological or neuropsychological test
                administration and scoring by physician or other qualified health care
                professional, two or more tests, any method; each additional 30 minutes
                (List separately in addition to code for primary procedure))
                 96138 (Psychological or neuropsychological test
                administration and scoring by technician, two or more tests, any
                method; first 30 minutes)
                 96139 (Psychological or neuropsychological test
                administration and scoring by technician, two or more tests, any
                method; each additional 30 minutes (List separately in addition to code
                for primary procedure))
                16. Therapy Services
                 We have received a number of requests, most recently for CY 2018
                PFS rulemaking, that we add therapy services to the Medicare telehealth
                list. In the CY 2018 PFS final rule, we noted that section
                1834(m)(4)(E) of the Act specifies the types of practitioners who may
                furnish and bill for Medicare telehealth services as those
                practitioners under section 1842(b)(18)(C) of the Act. Physical
                therapists, occupational therapists and speech-language pathologists
                are not among the practitioners identified in section 1842(b)(18)(C) of
                the Act. We stated in the Medicare Program; Revisions to Payment
                Policies under the Physician Fee Schedule and Other Revisions to Part B
                for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare
                Advantage and Part D Medical Loss Ratio Data Release; Medicare
                Advantage Provider Network Requirements; Expansion of Medicare Diabetes
                Prevention Program Model; Medicare Shared Savings Program
                Requirements'' final rule (81 FR 80198, November 15, 2016) (hereinafter
                referred to as the CY 2017 PFS final rule) that because these services
                are predominantly furnished by physical therapists, occupational
                therapists and speech-language pathologists, we did not believe it
                would be appropriate to add them to the list of telehealth services at
                this time. In a subsequent request to consider adding these services
                for 2018, the original requester suggested that we might propose these
                services to be added to the list so that they can be furnished via
                telehealth when furnished by eligible distant site practitioners. Since
                the majority of the codes are furnished over 90 percent of the time by
                therapy professionals, who are not included on the statutory list of
                eligible distant site practitioners, we stated that we believed that
                adding therapy services to the telehealth list could result in
                confusion about who is authorized to furnish and bill for these
                services when furnished via telehealth.
                 In light of the PHE for the COVID-19 pandemic, we believe that the
                risks associated with confusion are outweighed by the potential
                benefits for circumstances when these services might be furnished via
                telehealth by eligible distant site practitioners. We believe this is
                sufficient clinical evidence to support the addition of therapy
                services to the Medicare telehealth list on a category 2 basis.
                However, we note that the statutory definition of distant site
                practitioners under section 1834(m) of the Act does not include
                physical therapists, occupational therapists, or speech-language
                pathologists, meaning that it does not provide for payment for these
                services as Medicare telehealth services when furnished by physical
                therapists, occupational therapists, or speech-language pathologists.
                 CPT codes:
                 97161 (Physical therapy evaluation: low complexity,
                requiring these components: A history with no personal factors and/or
                comorbidities that impact the plan of care; An examination of body
                system(s) using standardized tests and measures addressing 1-2 elements
                from any of the following: body structures and functions, activity
                limitations, and/or participation restrictions; A clinical presentation
                with stable and/or uncomplicated characteristics; and Clinical decision
                making of low complexity using standardized patient assessment
                instrument and/or measurable assessment of functional outcome.
                Typically, 20 minutes are spent face-to-face with the patient and/or
                family.)
                 97162 (Physical therapy evaluation: moderate complexity,
                requiring these components: A history of present problem with 1-2
                personal factors and/or comorbidities that impact the plan of care; An
                examination of body systems using standardized tests and measures in
                addressing a total of 3 or more elements from any of the following:
                body structures and functions, activity limitations, and/or
                participation restrictions; An evolving clinical presentation with
                changing characteristics; and Clinical decision making of moderate
                complexity using standardized patient assessment instrument and/or
                measurable assessment of functional outcome. Typically, 30 minutes are
                spent face-to-face with the patient and/or family.)
                 97163 (Physical therapy evaluation: high complexity,
                requiring these components: A history of present problem with 3 or more
                personal factors and/or comorbidities that impact the plan of care; An
                examination of body systems using standardized tests and measures
                addressing a total of 4 or more elements from any of the following:
                body structures and functions, activity limitations, and/or
                participation restrictions; A clinical presentation with unstable and
                unpredictable characteristics; and Clinical decision making of high
                complexity using standardized patient assessment instrument and/or
                measurable assessment of functional outcome. Typically, 45 minutes are
                spent face-to-face with the patient and/or family.)
                 97164 (Re-evaluation of physical therapy established plan
                of care,
                [[Page 19240]]
                requiring these components: An examination including a review of
                history and use of standardized tests and measures is required; and
                Revised plan of care using a standardized patient assessment instrument
                and/or measurable assessment of functional outcome. Typically, 20
                minutes are spent face-to-face with the patient and/or family.)
                 97165 (Occupational therapy evaluation, low complexity,
                requiring these components: An occupational profile and medical and
                therapy history, which includes a brief history including review of
                medical and/or therapy records relating to the presenting problem; An
                assessment(s) that identifies 1-3 performance deficits (ie, relating to
                physical, cognitive, or psychosocial skills) that result in activity
                limitations and/or participation restrictions; and Clinical decision
                making of low complexity, which includes an analysis of the
                occupational profile, analysis of data from problem-focused
                assessment(s), and consideration of a limited number of treatment
                options. Patient presents with no comorbidities that affect
                occupational performance. Modification of tasks or assistance (eg,
                physical or verbal) with assessment(s) is not necessary to enable
                completion of evaluation component. Typically, 30 minutes are spent
                face-to-face with the patient and/or family.)
                 97166 (Occupational therapy evaluation, moderate
                complexity, requiring these components: An occupational profile and
                medical and therapy history, which includes an expanded review of
                medical and/or therapy records and additional review of physical,
                cognitive, or psychosocial history related to current functional
                performance; An assessment(s) that identifies 3-5 performance deficits
                (ie, relating to physical, cognitive, or psychosocial skills) that
                result in activity limitations and/or participation restrictions; and
                Clinical decision making of moderate analytic complexity, which
                includes an analysis of the occupational profile, analysis of data from
                detailed assessment(s), and consideration of several treatment options.
                Patient may present with comorbidities that affect occupational
                performance. Minimal to moderate modification of tasks or assistance
                (eg, physical or verbal) with assessment(s) is necessary to enable
                patient to complete evaluation component. Typically, 45 minutes are
                spent face-to-face with the patient and/or family.)
                 97167 (Occupational therapy evaluation, high complexity,
                requiring these components: An occupational profile and medical and
                therapy history, which includes review of medical and/or therapy
                records and extensive additional review of physical, cognitive, or
                psychosocial history related to current functional performance; An
                assessment(s) that identifies 5 or more performance deficits (ie,
                relating to physical, cognitive, or psychosocial skills) that result in
                activity limitations and/or participation restrictions; and Clinical
                decision making of high analytic complexity, which includes an analysis
                of the patient profile, analysis of data from comprehensive
                assessment(s), and consideration of multiple treatment options. Patient
                presents with comorbidities that affect occupational performance.
                Significant modification of tasks or assistance (eg, physical or
                verbal) with assessment(s) is necessary to enable patient to complete
                evaluation component. Typically, 60 minutes are spent face-to-face with
                the patient and/or family.)
                 97168 (Re-evaluation of occupational therapy established
                plan of care, requiring these components: An assessment of changes in
                patient functional or medical status with revised plan of care; An
                update to the initial occupational profile to reflect changes in
                condition or environment that affect future interventions and/or goals;
                and A revised plan of care. A formal reevaluation is performed when
                there is a documented change in functional status or a significant
                change to the plan of care is required. Typically, 30 minutes are spent
                face-to-face with the patient and/or family.)
                 97110 (Therapeutic procedure, 1 or more areas, each 15
                minutes; therapeutic exercises to develop strength and endurance, range
                of motion and flexibility)
                 97112 (Therapeutic procedure, 1 or more areas, each 15
                minutes; neuromuscular reeducation of movement, balance, coordination,
                kinesthetic sense, posture, and/or proprioception for sitting and/or
                standing activities)
                 97116 (Therapeutic procedure, 1 or more areas, each 15
                minutes; gait training (includes stair climbing)
                 97535 (Self-care/home management training (eg, activities
                of daily living (ADL) and compensatory training, meal preparation,
                safety procedures, and instructions in use of assistive technology
                devices/adaptive equipment) direct one-on-one contact, each 15 minutes)
                 97750 (Physical performance test or measurement (eg,
                musculoskeletal, functional capacity), with written report, each 15
                minutes)
                 97755 (Assistive technology assessment (e.g., to restore,
                augment or compensate for existing function, optimize functional tasks
                and/or maximize environmental accessibility), direct one-on-one
                contact, with written report, each 15 minutes)
                 97760 (Orthotic(s) management and training (including
                assessment and fitting when not otherwise reported), upper
                extremity(ies), lower extremity(ies) and/or trunk, initial orthotic(s)
                encounter, each 15 minutes)
                 97761 (Prosthetic(s) training, upper and/or lower
                extremity(ies), initial prosthetic(s) encounter, each 15 minutes)
                 92521 (Evaluation of speech fluency (eg, stuttering,
                cluttering)
                 92522 (Evaluation of speech sound production (eg,
                articulation, phonological process, apraxia, dysarthria)
                 92523 (Evaluation of speech sound production (eg,
                articulation, phonological process, apraxia, dysarthria); with
                evaluation of language comprehension and expression (eg, receptive and
                expressive language)
                 92524 (Behavioral and qualitative analysis of voice and
                resonance)
                 92507 (Treatment of speech, language, voice,
                communication, and/or auditory processing disorder; individual)
                17. Radiation Treatment Management Services
                 The code used to report radiation treatment management services
                includes several components, including reviewing the radiation dose and
                various treatment parameters, as well as weekly face-to-face visits
                with the patient to assess the patient's response to treatment and
                manage any symptoms the patient may be experiencing. We believe that in
                the context of the PHE for the COVID-19 pandemic, the weekly face-to-
                face visit component of this service could be conducted via telehealth
                when the billing practitioner weighs the exposure risks against the
                value of in-person assessment on a case-by-case basis. Therefore, we
                are adding CPT code 77427 (Radiation treatment management, 5
                treatments) to the telehealth list so that the required face-to-face
                visit can be furnished via telehealth.
                 We believe that allowing the services listed above to be furnished
                as Medicare telehealth services will significantly increase the ability
                of Medicare physicians and practitioners to work without increasing
                exposure risk to themselves, their patients, and the broader community.
                Given widespread concerns regarding the health and safety
                [[Page 19241]]
                of our beneficiaries and health care providers during the PHE for the
                COVID-19 pandemic, we seek input on whether there are other services
                where the use of telecommunications technology could mitigate the
                exposure risk, and where there is clear clinical benefit to using such
                technology in furnishing the service.
                 We note that the inclusion of this code on the telehealth list to
                ensure that the included visits can be furnished via telehealth is
                similar to the inclusion of the transitional care management codes on
                the telehealth list. In both of these cases, the non-face-to-face
                portions of the service are not considered telehealth services that are
                subject to any of the payment provisions specific to telehealth
                services under section 1834(m) of the Act.
                 CPT code 77427 (Radiation treatment management, 5
                treatments)
                 As we noted above, we have previously considered adding many of
                these services to the Medicare telehealth list in prior rulemaking and
                declined, in many cases citing concerns over patient acuity and the
                feasibility of fulfilling all of the required elements of a service via
                communication technology. However, in the context of the PHE for the
                COVID-19 pandemic with specific regard to the exposure risks noted
                above, we recognize the clinical benefit of access to medically
                reasonable and necessary services furnished using telecommunications
                technology as opposed to the potential lack of access that could occur
                to mitigate the risk of disease exposure. We are also interested in
                learning of any potential negative consequences of adding these CPT
                codes to the list of telehealth services on an interim basis.
                B. Frequency Limitations on Subsequent Care Services in Inpatient and
                Nursing Facility Settings, and Critical Care Consultations and Required
                ``Hands-On'' Visits for ESRD Monthly Capitation Payments
                 In adding some services to the Medicare telehealth list, we have
                done so while including certain restrictions on how frequently a
                service may be furnished via Medicare telehealth to ensure that the
                services met the category 1 or 2 criteria. For example, in the CY 2011
                PFS final rule (75 FR 73317 through 73318), we added the subsequent
                hospital care services to the Medicare telehealth list. We stated that,
                because of our concerns regarding the potential acuity of hospital
                inpatients, we would limit the provision of subsequent hospital care
                services through telehealth to once every 3 days. Similarly, when we
                added subsequent nursing facility visits to the Medicare telehealth
                list, we stated our concerns regarding the potential acuity and
                complexity of nursing facility (NF) patients, we would limit the
                provision of subsequent nursing facility care services furnished
                through telehealth to once every 30 days.
                 Given our assessment that under the PHE for the COVID-19 pandemic,
                there is a patient population that would otherwise not have access to
                clinically appropriate in-person treatment, we do not believe these
                frequency limitations are appropriate or necessary. In our prior
                analysis, for example, we were concerned that patients might not
                receive the necessary in-person services for nursing facility or
                hospital inpatient services. Since in the context of this PHE,
                telehealth visits mitigate exposure risk, fewer in-person visits may
                reflect the most appropriate care, depending on the needs of individual
                patients. Consequently, on an interim basis, we are removing the
                frequency restrictions for each of the following listed codes for
                subsequent inpatient visits and subsequent NF visits furnished via
                Medicare telehealth for the duration of the PHE for the COVID-19
                pandemic. Similarly, we note that we previously limited critical care
                consultations through telehealth to only once per day, given the
                patient acuity involved in critical care. However, we also understand
                that critical care patients have significant exposure risks such that
                more frequent services furnished via telehealth may reflect the best
                available care in the context and for the duration of the PHE for the
                COVID-19 pandemic. For this reason, we are also removing the
                restriction that critical care consultation codes may only be furnished
                to a Medicare beneficiary once per day. These restrictions were
                established through rulemaking and implemented through systems edits.
                1. Subsequent Inpatient Visits: CPT Codes
                 99231 (Subsequent hospital care, per day, for the
                evaluation and management of a patient, which requires at least 2 of
                these 3 key components: A problem focused interval history; A problem
                focused examination; Medical decision making that is straightforward or
                of low complexity. Counseling and/or coordination of care with other
                physicians, other qualified health care professionals, or agencies are
                provided consistent with the nature of the problem(s) and the patient's
                and/or family's needs. Usually, the patient is stable, recovering or
                improving. Typically, 15 minutes are spent at the bedside and on the
                patient's hospital floor or unit.)
                 99232 (Subsequent hospital care, per day, for the
                evaluation and management of a patient, which requires at least 2 of
                these 3 key components: An expanded problem focused interval history;
                An expanded problem focused examination; Medical decision making of
                moderate complexity. Counseling and/or coordination of care with other
                physicians, other qualified health care professionals, or agencies are
                provided consistent with the nature of the problem(s) and the patient's
                and/or family's needs. Usually, the patient is responding inadequately
                to therapy or has developed a minor complication. Typically, 25 minutes
                are spent at the bedside and on the patient's hospital floor or unit.)
                 99233 (Subsequent hospital care, per day, for the
                evaluation and management of a patient, which requires at least 2 of
                these 3 key components: A detailed interval history; A detailed
                examination; Medical decision making of high complexity. Counseling
                and/or coordination of care with other physicians, other qualified
                health care professionals, or agencies are provided consistent with the
                nature of the problem(s) and the patient's and/or family's needs.
                Usually, the patient is unstable or has developed a significant
                complication or a significant new problem. Typically, 35 minutes are
                spent at the bedside and on the patient's hospital floor or unit.)
                2. Subsequent Nursing Facility Visits: CPT Codes
                 99307 (Subsequent nursing facility care, per day, for the
                evaluation and management of a patient, which requires at least 2 of
                these 3 key components: A problem focused interval history; A problem
                focused examination; Straightforward medical decision making.
                Counseling and/or coordination of care with other physicians, other
                qualified health care professionals, or agencies are provided
                consistent with the nature of the problem(s) and the patient's and/or
                family's needs. Usually, the patient is stable, recovering, or
                improving. Typically, 10 minutes are spent at the bedside and on the
                patient's facility floor or unit.)
                 99308 (Subsequent nursing facility care, per day, for the
                evaluation and management of a patient, which requires at least 2 of
                these 3 key components: An expanded problem focused interval history;
                An expanded problem focused examination; Medical decision making of low
                complexity.
                [[Page 19242]]
                Counseling and/or coordination of care with other physicians, other
                qualified health care professionals, or agencies are provided
                consistent with the nature of the problem(s) and the patient's and/or
                family's needs. Usually, the patient is responding inadequately to
                therapy or has developed a minor complication. Typically, 15 minutes
                are spent at the bedside and on the patient's facility floor or unit.)
                 99309 (Subsequent nursing facility care, per day, for the
                evaluation and management of a patient, which requires at least 2 of
                these 3 key components: A detailed interval history; A detailed
                examination; Medical decision making of moderate complexity. Counseling
                and/or coordination of care with other physicians, other qualified
                health care professionals, or agencies are provided consistent with the
                nature of the problem(s) and the patient's and/or family's needs.
                Usually, the patient has developed a significant complication or a
                significant new problem. Typically, 25 minutes are spent at the bedside
                and on the patient's facility floor or unit.)
                 99310 (Subsequent nursing facility care, per day, for the
                evaluation and management of a patient, which requires at least 2 of
                these 3 key components: A comprehensive interval history; A
                comprehensive examination; Medical decision making of high complexity.
                Counseling and/or coordination of care with other physicians, other
                qualified health care professionals, or agencies are provided
                consistent with the nature of the problem(s) and the patient's and/or
                family's needs. The patient may be unstable or may have developed a
                significant new problem requiring immediate physician attention.
                Typically, 35 minutes are spent at the bedside and on the patient's
                facility floor or unit.)
                3. Critical Care Consultation Services: HCPCS Codes
                 G0508 (Telehealth consultation, critical care, initial,
                physicians typically spend 60 minutes communicating with the patient
                and providers via telehealth.)
                 G0509 (Telehealth consultation, critical care, subsequent,
                physicians typically spend 50 minutes communicating with the patient
                and providers via telehealth.)
                 We are seeking information on how these services are furnished via
                telecommunications technology to ensure that patients are safe and
                receiving adequate care.
                4. Required ``Hands-On'' Visits for ESRD Monthly Capitation Payments
                 In the ``Medicare Program; Revisions to Payment Policies Under the
                Physician Fee Schedule for Calendar Year 2005'' final rule with comment
                period (69 FR 66236, November 15, 2004) (hereinafter referred to the CY
                2005 PFS final rule with comment period), we added ESRD related
                services to the Medicare telehealth list; however, we specified that
                the required clinical examination of the vascular access site must be
                furnished face-to-face ``hands on'' (without the use of an interactive
                telecommunications system) by physician, clinical nurse specialist
                (CNS), nurse practitioner (NP), or physician assistant (PA) (69 FR
                66278). On an interim basis in light of the PHE for the COVID-19
                pandemic, we are instead permitting the required clinical examination
                to be furnished as a Medicare telehealth service during the PHE for the
                COVID-19 pandemic. We note that sections 1881(b)(3) and 1834(m) of the
                Act allow an individual determined to have ESRD receiving home dialysis
                to choose to receive certain monthly ESRD-related clinical assessments
                via telehealth on or after January 1, 2019. The Bipartisan Budget Act
                of 2018 (Pub. L. 115-123, enacted on February 9, 2018) (BBA of 2018)
                amended section 1881(b)(3)(B) of the Act to require that such an
                individual must receive a face-to-face visit, without the use of
                telehealth, at least monthly in the case of the initial 3 months of
                home dialysis and at least once every 3 consecutive months after the
                initial 3 months. Due to the conditions presented by the PHE, we are
                also exercising enforcement discretion on an interim basis to relax
                enforcement in connection with the requirements under section
                1881(b)(3)(B) of the Act that certain visits be furnished without the
                use of telehealth for services furnished during the PHE. Specifically,
                CMS will not conduct review to consider whether those visits were
                conducted face-to-face, without the use of telehealth. The following
                CPT codes, when furnished via Medicare telehealth, are impacted by
                these policies:
                 90951 (End-stage renal disease (ESRD) related services
                monthly, for patients younger than 2 years of age to include monitoring
                for the adequacy of nutrition, assessment of growth and development,
                and counseling of parents; with 4 or more face-to-face visits by a
                physician or other qualified health care professional per month)
                 90952 (End-stage renal disease (ESRD) related services
                monthly, for patients younger than 2 years of age to include monitoring
                for the adequacy of nutrition, assessment of growth and development,
                and counseling of parents; with 2-3 face-to-face visits by a physician
                or other qualified health care professional per month)
                 90953 (End-stage renal disease (ESRD) related services
                monthly, for patients younger than 2 years of age to include monitoring
                for the adequacy of nutrition, assessment of growth and development,
                and counseling of parents; with 1 face-to-face visit by a physician or
                other qualified health care professional per month)
                 90954 (End-stage renal disease (ESRD) related services
                monthly, for patients 2-11 years of age to include monitoring for the
                adequacy of nutrition, assessment of growth and development, and
                counseling of parents; with 4 or more face-to-face visits by a
                physician or other qualified health care professional per month)
                 90955 (End-stage renal disease (ESRD) related services
                monthly, for patients 2-11 years of age to include monitoring for the
                adequacy of nutrition, assessment of growth and development, and
                counseling of parents; with 2-3 face-to-face visits by a physician or
                other qualified health care professional per month)
                 90957 (End-stage renal disease (ESRD) related services
                monthly, for patients 12-19 years of age to include monitoring for the
                adequacy of nutrition, assessment of growth and development, and
                counseling of parents; with 4 or more face-to-face visits by a
                physician or other qualified health care professional per month)
                 90958 (End-stage renal disease (ESRD) related services
                monthly, for patients 12-19 years of age to include monitoring for the
                adequacy of nutrition, assessment of growth and development, and
                counseling of parents; with 2-3 face-to-face visits by a physician or
                other qualified health care professional per month)
                 90959 (End-stage renal disease (ESRD) related services
                monthly, for patients 12-19 years of age to include monitoring for the
                adequacy of nutrition, assessment of growth and development, and
                counseling of parents; with 1 face-to-face visit by a physician or
                other qualified health care professional per month)
                 90960 (End-stage renal disease (ESRD) related services
                monthly, for patients 20 years of age and older; with 4 or more face-
                to-face visits by a physician or other qualified health care
                professional per month)
                 90961 (End-stage renal disease (ESRD) related services
                monthly, for patients 20 years of age and older; with
                [[Page 19243]]
                2-3 face-to-face visits by a physician or other qualified health care
                professional per month)
                 90962 (End-stage renal disease (ESRD) related services
                monthly, for patients 20 years of age and older; with 1 face-to-face
                visit by a physician or other qualified health care professional per
                month)
                 90963 (End-stage renal disease (ESRD) related services for
                home dialysis per full month, for patients younger than 2 years of age
                to include monitoring for the adequacy of nutrition, assessment of
                growth and development, and counseling of parents)
                 90964 (End-stage renal disease (ESRD) related services for
                home dialysis per full month, for patients 2-11 years of age to include
                monitoring for the adequacy of nutrition, assessment of growth and
                development, and counseling of parents)
                 90965 (End-stage renal disease (ESRD) related services for
                home dialysis per full month, for patients 12-19 years of age to
                include monitoring for the adequacy of nutrition, assessment of growth
                and development, and counseling of parents)
                 90966 (End-stage renal disease (ESRD) related services for
                home dialysis per full month, for patients 20 years of age and older)
                 90967 (End-stage renal disease (ESRD) related services for
                dialysis less than a full month of service, per day; for patients
                younger than 2 years of age)
                 90968 (End-stage renal disease (ESRD) related services for
                dialysis less than a full month of service, per day; for patients 2-11
                years of age)
                 90969 (End-stage renal disease (ESRD) related services for
                dialysis less than a full month of service, per day; for patients 12-19
                years of age)
                 90970 (End-stage renal disease (ESRD) related services for
                dialysis less than a full month of service, per day; for patients 20
                years of age and older)
                C. Telehealth Modalities and Cost-Sharing
                1. Clarifying Telehealth Technology Requirements
                 Our regulation at Sec. 410.78(a)(3) states that telephones,
                facsimile machines, and electronic mail systems do not meet the
                definition of an interactive telecommunications systems for purposes of
                Medicare telehealth services. As we interpret it, this regulation does
                not apply to mobile computing devices that include audio and video
                real-time interactive capabilities, even though such devices are now
                referred to colloquially as ``phones'' since they can also be used for
                audio-only telecommunications. In light of the PHE for the COVID-19
                pandemic, we believe it is important to avoid the potential perception
                that this language might prohibit use of any device that could
                otherwise meet the interactive requirements for Medicare telehealth,
                especially given that leveraging use of such readily available
                technology may be of critical importance.
                 Therefore, we are revising Sec. 410.78(a)(3) to add an exception
                to this language on an interim basis for the duration of the PHE for
                the COVID-19 pandemic providing that for the duration of the public
                health emergency as defined in Sec. 400.200, ``interactive
                telecommunications system'' means multimedia communications equipment
                that includes, at a minimum, audio and video equipment permitting two-
                way, real-time interactive communication between the patient and
                distant site physician or practitioner.
                 In addition, the HHS Office for Civil Rights (OCR) is exercising
                enforcement discretion and waiving penalties for HIPAA \4\ violations
                against health care providers that serve patients in good faith through
                everyday communications technologies, such as FaceTime or Skype, during
                the PHE for the COVID-19 pandemic. For more information, see https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/index.html. While OCR is not imposing penalties for
                noncompliance with the regulatory requirements under HIPAA against
                covered providers in connection with the good faith provision of
                telehealth during the PHE for the COVID-19 pandemic, HHS, OIG, and DOJ
                continue to actively monitor for any healthcare fraud and abuse,
                including potential Medicare coronavirus scams.
                ---------------------------------------------------------------------------
                 \4\ Health Insurance Portability and Accountability Act of 1996
                (Pub. L. 104-191, enacted August 21, 1996).
                ---------------------------------------------------------------------------
                2. Beneficiary Cost-Sharing
                 In response to the unique circumstances resulting from the outbreak
                of COVID-19 and the Secretary's January 31, 2020 determination under
                section 319 of the Public Health Service Act that a PHE exists and has
                existed since January 27, 2020 (COVID-19 Declaration), the Office of
                Inspector General (OIG) issued a Policy Statement \5\ to notify
                physicians and other practitioners that they will not be subject to
                administrative sanctions for reducing or waiving any cost-sharing
                obligations Federal health care program beneficiaries may owe for
                telehealth services furnished consistent with the then applicable
                coverage and payment rules. OIG's Policy Statement is not limited to
                the services governed by Sec. 410.78 but applies to a broad category
                of non-face-to-face services furnished through various modalities,
                including telehealth visits, virtual check-in services, e-visits,
                monthly remote care management, and monthly remote patient monitoring.
                The Policy Statement applies to a physician or other practitioner
                billing for services provided remotely through information or
                communication technology or a hospital or other eligible individual or
                entity billing on behalf of the physician or practitioner for such
                services when the physician or other practitioner has reassigned his or
                her right to receive payments to such individual or entity.
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                 \5\ https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/policy-telehealth-2020.pdf.
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                D. Communication Technology-Based Services (CTBS)
                 In the ``Medicare Program; Revisions to Payment Policies Under the
                Physician Fee Schedule and Other Revisions to Part B for CY 2019;
                Medicare Shared Savings Program Requirements; Quality Payment Program;
                Medicaid Promoting Interoperability Program; Quality Payment Program-
                Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS
                Payment Year; Provisions From the Medicare Shared Savings Program-
                Accountable Care Organizations-Pathways to Success; and Expanding the
                Use of Telehealth Services for the Treatment of Opioid Use Disorder
                Under the Substance Use-Disorder Prevention That Promotes Opioid
                Recovery and Treatment (SUPPORT) for Patients and Communities Act''
                final rule (83 FR 59452 through 60303) (hereinafter referred to as the
                CY 2019 PFS final rule), we noted that under current PFS payment rules,
                Medicare routinely pays for many kinds of services that are furnished
                via telecommunications technology (83 FR 59482), but are not considered
                Medicare telehealth services. These communication technology-based
                services (CTBS) include, for example, certain kinds of remote patient
                monitoring (either as separate services or as parts of bundled
                services), and interpretations of diagnostic tests when furnished
                remotely. These services are different than the kinds of services
                specified in section 1834(m) of the Act, in that they are not the kind
                of services that are ordinarily furnished in person but are routinely
                furnished using a telecommunications system.
                 In the CY 2019 PFS final rule, we finalized separate payment for a
                number
                [[Page 19244]]
                of services that could be furnished via telecommunications technology,
                but that are not Medicare telehealth services. Specifically, we
                finalized Healthcare Common Procedure Coding System (HCPCS) code G2010
                (Remote evaluation of recorded video and/or images submitted by an
                established patient (e.g., store and forward), including interpretation
                with follow-up with the patient within 24 business hours, not
                originating from a related E/M service provided within the previous 7
                days nor leading to an E/M service or procedure within the next 24
                hours or soonest available appointment), and HCPCS code G2012 (Brief
                communication technology-based service, e.g. virtual check-in, by a
                physician or other qualified health care professional who can report
                evaluation and management services, provided to an established patient,
                not originating from a related E/M service provided within the previous
                7 days nor leading to an E/M service or procedure within the next 24
                hours or soonest available appointment; 5-10 minutes of medical
                discussion). We finalized these codes as part of the set of codes that
                is only reportable by the physicians and practitioners who can furnish
                evaluation and management (E/M) services. We stated that we believed
                this was appropriate since the service describes a check-in directly
                with the billing practitioner to assess whether an office visit is
                needed. However, we did note that similar check-ins provided by nurses
                and other clinical staff can be important aspects of coordinated
                patient care (83 FR 59486).
                 We also finalized that these services be limited to established
                patients, and that beneficiary consent must be documented in the
                patient's medical record for each service (83 FR 59487). This latter
                provision was amended in the CY PFS 2020 final rule to allow for a
                single beneficiary consent to be obtained annually (84 FR 62699). These
                requirements also apply to monthly care management and remote patient
                monitoring services.
                 In the context of the PHE for the COVID-19 pandemic, when brief
                communications with practitioners and other non-face-to-face services
                might mitigate the need for an in-person visit that could represent an
                exposure risk for vulnerable patients, we believe that these services
                should be available to as large a population of Medicare beneficiaries
                as possible. In some cases, use of telecommunication technology could
                mitigate the exposure risk, and in such cases, the clinical benefit of
                using technology to furnish the service is self-apparent. This would be
                especially true should a significant increase in the number of people
                or health care professionals needing treatment or isolation occur in a
                way that would limit access to brief communications with established
                providers. Therefore, on an interim basis, during the PHE for the
                COVID-19 pandemic, we are finalizing that these services, which may
                only be reported if they do not result in a visit, including a
                telehealth visit, can be furnished to both new and established
                patients. We are also making clear that the consent to receive these
                services can be documented by auxiliary staff under general
                supervision. While we continue to believe that beneficiary consent is
                necessary so that the beneficiary is notified of any applicable cost
                sharing, we do not believe that the timing or manner in which
                beneficiary consent is acquired should interfere with the provision of
                one of these services. Therefore, we are finalizing on an interim basis
                during the PHE for the COVID-19 pandemic that, while consent to receive
                these services must be obtained annually, it may be obtained at the
                same time that a service is furnished. We are also re-emphasizing that
                this consent may be obtained by auxiliary staff under general
                supervision, as well as by the billing practitioner. We are retaining
                the requirement that in instances when the brief communication
                technology-based service originates from a related E/M service
                (including one furnished as a telehealth service) provided within the
                previous 7 days by the same physician or other qualified health care
                professional, that this service would be considered bundled into that
                previous E/M service and would not be separately billable.
                 In the ``Medicare Program; CY 2020 Revisions to Payment Policies
                Under the Physician Fee Schedule and Other Changes to Part B Payment
                Policies; Medicare Shared Savings Program Requirements; Medicaid
                Promoting Interoperability Program Requirements for Eligible
                Professionals; Establishment of an Ambulance Data Collection System;
                Updates to the Quality Payment Program; Medicare Enrollment of Opioid
                Treatment Programs and Enhancements to Provider Enrollment Regulations
                Concerning Improper Prescribing and Patient Harm; and Amendments to
                Physician Self-Referral Law Advisory Opinion Regulations Final Rule''
                (84 FR 62568, November 15, 2019) (hereinafter referred to as the CY
                2020 PFS final rule), we finalized separate payment for CPT codes 99421
                (Online digital evaluation and management service, for an established
                patient, for up to 7 days, cumulative time during the 7 days; 5-10
                minutes), 99422 (Online digital evaluation and management service, for
                an established patient, for up to 7 days, cumulative time during the 7
                days; 11-20 minutes), and 99423 (Online digital evaluation and
                management service, for an established patient, for up to 7 days,
                cumulative time during the 7 days; 21 or more minutes). We also
                finalized separate payment for HCPCS codes G2061 (Qualified
                nonphysician healthcare professional online assessment and management,
                for an established patient, for up to seven days, cumulative time
                during the 7 days; 5-10 minutes), G2062 (Qualified nonphysician
                healthcare professional online assessment and management service, for
                an established patient, for up to seven days, cumulative time during
                the 7 days; 11-20 minutes), and G2063 (Qualified nonphysician qualified
                healthcare professional assessment and management service, for an
                established patient, for up to seven days, cumulative time during the 7
                days; 21 or more minutes) (84 FR 62796).
                 In the context of the PHE for the COVID-19 pandemic, where
                communications with practitioners might mitigate the need for an in-
                person visit that could represent an exposure risk for vulnerable
                patients, we do not believe the limitation of these services to
                established patients is warranted. While some of the code descriptors
                refer to ``established patient,'' during the PHE, we are exercising
                enforcement discretion on an interim basis to relax enforcement of this
                aspect of the code descriptors. Specifically, we will not conduct
                review to consider whether those services were furnished to established
                patients.
                 Additionally, in the CY 2020 PFS final rule (84 FR 62796), we
                stated that HCPCS codes G2061-G2063, specific to practitioners who do
                not report E/M codes, may describe services outside the scope of
                current Medicare benefit categories and as such, may not be eligible
                for Medicare payment. We have received a number of questions regarding
                which benefit categories HCPCS codes G2061-G2063 fall under. In
                response to these requests, we are clarifying here that there are
                several types of practitioners who could bill for these service. For
                example, the services described by these codes could be furnished as
                licensed clinical social worker services, clinical psychologist
                services, physical therapist services, occupational therapist services,
                or speech language pathologist services, so practitioners that report
                services in
                [[Page 19245]]
                those benefit categories could also report these online assessment and
                management services.
                 On an interim basis, during the PHE for the COVID-19 pandemic, we
                are also broadening the availability of HCPCS codes G2010 and G2012
                that describe remote evaluation of patient images/video and virtual
                check-ins. We recognize that in the context of the PHE for the COVID-19
                pandemic, practitioners such as licensed clinical social workers,
                clinical psychologists, physical therapists, occupational therapists,
                and speech-language pathologists might also utilize virtual check-ins
                and remote evaluations instead of other, in-person services within the
                relevant Medicare benefit to facilitate the best available appropriate
                care while mitigating exposure risks. We note that this is not an
                exhaustive list and we are seeking input on other kinds of
                practitioners who might be furnishing these kinds of services as part
                of the Medicare services they furnish in the context of the PHE for the
                COVID-19 pandemic.
                 Further, to facilitate billing of the CTBS services by therapists
                for the reasons described above, we are designating HCPCS codes G2010,
                G2012, G2061, G2062, or G2063 as CTBS ``sometimes therapy'' services
                that would require the private practice occupational therapist,
                physical therapist, and speech-language pathologist to include the
                corresponding GO, GP, or GN therapy modifier on claims for these
                services. CTBS therapy services include those furnished to a new or
                established patients that the occupational therapist, physical
                therapist, and speech-language pathologist practitioner is currently
                treating under a plan of care.
                E. Direct Supervision by Interactive Telecommunications Technology
                 Many services paid under the PFS can be paid when provided under a
                level of physician or nonphysician practitioner (NPP) supervision
                rather than personal performance. In many cases, the supervision
                requirements in physician office settings necessitate the presence of
                the physician or NPP in a particular location, usually in the same
                location as the beneficiary when the service is provided. For example,
                as described at Sec. 410.26, services incident to a physicians'
                service usually require the direct supervision of a physician. As
                currently defined in Sec. 410.32(b)(3)(ii), direct supervision means
                that the physician must be present in the office suite and immediately
                available to furnish assistance and direction throughout the
                performance of the procedure. It does not mean that the physician must
                be present in the room when the procedure is performed.
                 Given the circumstances of the PHE for the COVID-19 pandemic, we
                recognize that in some cases, the physical proximity of the physician
                or practitioner might present additional exposure risks, especially for
                high risk patients isolated for their own protection or cases where the
                practitioner has been exposed to the virus but could otherwise safely
                supervise from another location using telecommunications technology. In
                these cases, we believe that the current requirement would necessarily
                limit access to procedures and tests that could be appropriately
                supervised by a physician isolated for purposes of limiting exposure to
                COVID-19. For example, we consider the possibility that patients
                routinely receiving medically necessary physician-administered drugs at
                the office of a physician may lose access to the provision of that drug
                should the physician who regularly supervises the provision of that
                drug be isolated for purposes of minimizing exposure risks. Likewise,
                should that same patient need to be isolated for purposes of exposure
                risk based on presumed or confirmed COVID-19 infection, administering
                such a drug in the patient's home would require the billing
                professional to accompany the clinical staff to the patient's home,
                presumably with the necessary personal protective equipment (PPE)
                available to both the physician and the clinical staff.
                 In some cases, depending upon the unique circumstances of
                individual patients and billing physicians, we believe that
                telecommunications technology could be used in a manner that would
                facilitate the physician's immediate availability to furnish assistance
                and direction without necessarily requiring the physician's physical
                presence in the location where the service is being furnished, such as
                the office suite or the patient's home. For example, we believe that
                use of real-time, audio and video telecommunications technology allows
                for a billing practitioner to observe the patient interacting with or
                responding to the in-person clinical staff through virtual means, and
                thus, their availability to furnish assistance and direction could be
                met without requiring the physician's physical presence in that
                location. We note that to be covered under Part B, drugs furnished
                ``incident to'' are typically injectable drugs that are bought by the
                physician, in ordinary circumstances are administered in the
                physician's office, and then billed by the physician to the Medicare
                Administrative Contractor (MAC). By definition, ``incident to a
                physician's professional service'' requires the item or service to be
                billed by the physician. We also note that the supervision requirements
                that apply to both services incident to a physicians' service and
                diagnostic tests do not necessarily reflect the appropriate level of
                supervision for particular patients, services, and health care workers.
                Instead, we view these levels as the minimum possible requirement for
                provision of the service for purposes of Medicare payment. Likewise,
                even in the context of the PHE for the COVID-19 pandemic and the
                inherent exposure risks for Medicare beneficiaries, physicians and
                other health care providers, we believe that in many cases furnishing
                services without the physical presence of the physician in the same
                location would not be appropriate. However, we recognize that in some
                cases, technology would allow appropriate supervision without the
                physical presence of a physician. In the context of the PHE for the
                COVID-19 pandemic, given the risks of exposure, the immediate potential
                risk to needed medical care, the increased demand for health care
                professionals in the context of the PHE for the COVID-19 pandemic, and
                the widespread use of telecommunications technology, we believe that
                individual practitioners are in the best position to make decisions
                based on their clinical judgement in particular circumstances.
                Consequently, we are revising the definition of direct supervision to
                allow, for the duration of the PHE for the COVID-19 pandemic, direct
                supervision to be provided using real-time interactive audio and video
                technology. We are seeking information from commenters as to whether
                there should be any guardrails and what kind of risk might this policy
                introduce for beneficiaries while reducing risk of COVID-19 spread. We
                note that this change is limited to only the manner in which the
                supervision requirement can be met, and does not change the underlying
                payment or coverage policies related to the scope of Medicare benefits,
                including Part B drugs. We also note that any and all applicable rules
                regarding safe transportation and proper waste disposal continue to
                apply.
                 We note that in specifying that direct supervision includes virtual
                presence through audio/video real-time communications technology during
                the PHE for the COVID-19 pandemic, this can include instances where the
                physician enters into a contractual arrangement for auxiliary personnel
                as
                [[Page 19246]]
                defined in Sec. 410.26(a)(1), to leverage additional staff and
                technology necessary to provide care that would ordinarily be provided
                incident to a physicians' service (including services that are allowed
                to be performed via telehealth). For example, physicians may enter into
                contractual arrangements with a home health agency (defined under
                section 1861(o) of the Act), a qualified infusion therapy supplier
                (defined under section 1861(iii)(3)(D) of the Act), or entities that
                furnish ambulance services in order to utilize their nurses or other
                clinical staff as auxiliary personnel under leased employment (Sec.
                410.26(a)(5)). In such instances, the provider/supplier would seek
                payment for any services they provided from the billing practitioner
                and would not submit claims to Medicare for such services. For
                telehealth services that need to be personally provided by a physician,
                such as an E/M visit, the physician would need to personally perform
                the E/M visit and report that service as a Medicare telehealth service.
                However, we acknowledge that there may be instances where the physician
                may want to use auxiliary personnel to be present in the home with the
                patient during the telehealth service, though this is not required for
                telehealth services under section 1834(m) of the Act. Other services,
                including both face-to-face and non-face-to-face services, could be
                provided incident to a physicians' service by a nurse or other
                auxiliary personnel, as long as the billing practitioner is providing
                appropriate supervision through audio/video real-time communications
                technology (or in person), when needed. We would not expect that
                services furnished at a patient's home incident to a physician service
                would usually occur during the same period as a home health episode of
                care, and we will be monitoring claims to ensure that services are not
                being inappropriately unbundled from payments under the home health
                PPS.
                 For the reasons discussed above, on an interim basis for the
                duration of the PHE for the COVID-19 pandemic, we are altering the
                definition of direct supervision at Sec. 410.32(b)(3)(ii), to state
                that necessary presence of the physician for direct supervision
                includes virtual presence through audio/video real-time communications
                technology when use of such technology is indicated to reduce exposure
                risks for the beneficiary or health care provider. We are revising
                Sec. 410.32(b)(3)(ii) to include, during a PHE, as defined in Sec.
                400.200 of this chapter, the presence of the physician includes virtual
                presence through audio/video real-time communications technology when
                use of such technology is indicated to reduce exposure risks for the
                beneficiary or health care provider.
                1. Supervision Changes for Certain Hospital and CAH Diagnostic and
                Therapeutic Services
                 For all of the same reasons described above, we are adopting
                similar changes in the regulations at Sec. 410.28(e)(1) with respect
                to the supervision of diagnostic services furnished directly or under
                arrangement in the hospital or in an on-campus or off-campus outpatient
                department of the hospital, as defined in Sec. 413.65. We note that
                under current Medicare rules, most therapeutic services in the hospital
                require only general supervision and the supervision requirements for
                diagnostic services generally conform to the service-level supervision
                levels required for payment under the PFS. Because we have every reason
                to believe that potential exposure risks and limits on the availability
                of medical professionals could equally apply to hospital services, we
                are amending the definition of direct supervision for hospital services
                for the duration of the PHE for the COVID-19 pandemic so it continues
                to conform with the applicable definitions for services paid under the
                PFS. As stated above, we believe this change is necessary due to the
                circumstances of the PHE for the COVID-19 pandemic. Specifically, we
                recognize that in some cases, the physical proximity of the physician
                or practitioner might present additional exposure risks, especially for
                high risk patients isolated for their own protection or cases where the
                practitioner has been exposed to the virus but could otherwise safely
                supervise from another location using telecommunications technology. In
                these cases, we believe that the current definition would necessarily
                limit access to diagnostic procedures and tests that could be
                appropriately supervised by a physician, including one who is isolated
                for purposes of limiting exposure to COVID-19.
                 In addition, with respect to pulmonary rehabilitation, cardiac
                rehabilitation, and intensive cardiac rehabilitation services described
                in the regulations at Sec. Sec. 410.47 and 410.49, respectively, we
                are adopting a similar change under Sec. 410.27(a)(1)(iv)(D), for the
                duration of the PHE for the COVID-19 pandemic, for all the reasons
                described above, to specify that direct supervision for these services
                includes virtual presence through audio/video real-time communications
                technology when use of such technology is indicated to reduce exposure
                risks for the beneficiary or health care provider.
                F. Clarification of Homebound Status Under the Medicare Home Health
                Benefit
                 Sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act state that
                payment for home health services is made when a physician certifies
                that such services are or were required because the individual is or
                was confined to his home and needs or needed skilled nursing care
                (other than solely venipuncture for the purpose of obtaining a blood
                sample) on an intermittent basis or physical or speech therapy or, in
                the case of an individual who has been furnished home health services
                based on such a need and who no longer has such a need for such care or
                therapy, continues or continued to need occupational therapy. In
                addition, the physician must certify that a plan for furnishing such
                services to such individual has been established and is periodically
                reviewed by the physician and that such services are or were furnished
                while the individual was under the care of a physician. Also, in the
                case of a certification made by a physician after January 1, 2010,
                prior to making such certification the physician must document that the
                physician himself or herself, or an NP or clinical nurse specialist
                (CNS) (as those terms are defined in section 1861(aa)(5) of the Act)
                who is working in collaboration with the physician in accordance with
                State law, or a certified nurse-midwife (as defined in section 1861(gg)
                of the Act) as authorized by State law, or a PA (as defined in section
                1861(aa)(5) of the Act) under the supervision of the physician, has had
                a face-to-face encounter (including through use of telehealth, subject
                to the requirements in section 1834(m) of the Act, and other than for
                encounters that are incident to services involved, as described in
                section II.E. of this IFC) with the individual within a reasonable
                timeframe as determined by the Secretary.
                 Most recently, we have been asked by stakeholders to provide more
                clarity on whether patients who are instructed to remain in their homes
                or are under ``self-quarantine'' are considered ``confined to the
                home'' or ``homebound'' for purposes of the Medicare home health
                benefit in the context of the PHE for the COVID-19 pandemic. Per
                sections 1814(a) and 1835(a) of the Act, an individual shall be
                considered to be ``confined to his home'' if the individual has a
                condition, due to an illness or injury, that restricts the ability of
                the individual to leave his
                [[Page 19247]]
                or her home except with the assistance of another individual or the aid
                of a supportive device (such as crutches, a cane, a wheelchair, or a
                walker), or if the individual has a condition such that leaving his or
                her home is medically contraindicated. While an individual does not
                have to be bedridden to be considered ``confined to his home'', the
                condition of the individual should be such that there exists a normal
                inability to leave home and, that leaving home requires a considerable
                and taxing effort by the individual.
                 The definition of ``confined to the home'' (that is, ``homebound'')
                allows patients to be considered ``homebound'' if it is medically
                contraindicated for the patient to leave the home. As an example for
                the PHE for COVID-19 pandemic, this would apply for those patients: (1)
                Where a physician has determined that it is medically contraindicated
                for a beneficiary to leave the home because he or she has a confirmed
                or suspected diagnosis of COVID-19; or (2) where a physician has
                determined that it is medically contraindicated for a beneficiary to
                leave the home because the patient has a condition that may make the
                patient more susceptible to contracting COVID-19. A patient who is
                exercising ``self-quarantine'' for one's own safety would not be
                considered ``confined to the home'' unless a physician certifies that
                it is medically contraindicated for the patient to leave the home. For
                the PHE for the COVID-19 pandemic, the CDC is currently advising that
                older adults and individuals with serious underlying health conditions
                stay home (CDC's guidance is interim and is expected to continue to be
                updated as warranted).\6\ As such, we expect that many Medicare
                beneficiaries could be considered ``confined to the home''. However,
                determinations of whether home health services are reasonable and
                necessary, including whether the patient is homebound and needs skilled
                services, must be based on an assessment of each beneficiary's
                individual condition and care needs.
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                 \6\ https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/high-risk-complications.html.
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                 In cases where it is medically contraindicated for the patient to
                leave the home, the medical record documentation for the patient must
                include information as to why the individual condition of the patient
                is such that leaving the home is medically contraindicated. With
                regards to a pandemic outbreak of an infectious disease, this can
                include reviewing and applying any guidance on risk assessment and
                public health management issued by the CDC. For example, the CDC
                interim guidance ``Preventing the Spread of Coronavirus Disease 2019 in
                Homes and Residential Communities'' applies for both confirmed or
                suspected COVID-19 states that patients who are medically stable enough
                to receive care in the home must isolate at home during their
                illness.\7\ Additionally, these guidelines state that patients should
                restrict activities outside the home, except for getting medical care.
                These restrictions include that the individual not go to work, school,
                or public areas, as well as avoiding use of public transportation,
                ride-sharing, or taxis; making it such that there exists a normal
                inability for an individual to leave home and leaving home would
                require a considerable and taxing effort.
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                 \7\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-prevent-spread.html.
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                 In regards to those circumstances in which the patient does not
                have confirmed or suspected diagnosis of an infectious disease, such as
                COVID-19, but the patient's physician states that it is medically
                contraindicated for the patient to leave the home because the patient's
                condition may make the patient more susceptible to contracting a
                pandemic disease, the patient would be considered ``confined to the
                home'' or ``homebound'' for purposes of this eligibility requirement.
                For example, if a patient is having an exacerbation of chronic
                obstructive pulmonary disease (COPD) and the physician certifies that
                it is medically contraindicated to leave the home because the patient's
                compromised respiratory system makes him or her more likely to contract
                an infectious disease, such as COVID-19, the patient would be
                considered ``confined to the home'' in alignment with Medicare home
                health eligibility criteria. Another example of this type of scenario
                would be a cancer patient receiving chemotherapy treatment and where
                the physician states that it is medically contraindicated for the
                patient to leave the home because the patient may be more at risk of
                contracting an infectious disease because of the patient's
                immunocompromised state. In both examples, the medical contraindication
                makes it such that there exists a normal inability for an individual to
                leave home and leaving home safely would require a considerable and
                taxing effort.
                 In addition to being considered ``confined to the home'' or
                ``homebound'', the patient must meet the other Medicare home health
                eligibility requirements to receive Medicare home health services. That
                is, the beneficiary must be under the care of a physician; receiving
                services under a plan of care established and periodically reviewed by
                a physician; be in need of skilled nursing care on an intermittent
                basis or physical therapy or speech-language pathology; or have a
                continuing need for occupational therapy. Even if the patient is
                confined to the home because of a suspected diagnosis of an infectious
                disease as part of a pandemic event, a home health visit solely to
                obtain a nasal or throat culture would not be considered a skilled
                service because it would not require the skills of a nurse to obtain
                the culture as the specimen could be obtained by an appropriately-
                trained medical assistant or laboratory technician. However, a home
                health nurse, during an otherwise covered skilled visit, could obtain
                the nasal or throat culture to send to the laboratory for testing.
                Please see section II.M. of this IFC for further discussion about how a
                Medicare patient without a skilled need who is under self-quarantine
                may be tested at home.
                 We believe this clarification is not limited to the PHE for the
                COVID-19 pandemic, but would also apply for other outbreaks of an
                infectious disease and instances where the condition of a patient is
                such that it is medically contraindicated for the patient to leave his
                or her home. We solicit comments on this clarification.
                G. The Use of Technology Under the Medicare Home Health Benefit During
                the PHE for the COVID-19 Pandemic
                 Section 1895 of the Act outlines the statutory parameters of the
                home health prospective payment system (HH PPS) that was implemented on
                October 1, 2000. The HH PPS provides payment for all services furnished
                under the Medicare home health benefit as outlined in section 1861(m)
                of the Act in the form of a ``bundled'' 30-day unit of payment that is
                adjusted for case-mix and area wage differences in accordance with
                section 1895(b) of the Act. Section 1895(e)(1)(A) of the Act states
                that nothing under section 1895 of the Act prevents a home health
                agency (HHA) from furnishing services via a telecommunications system,
                as long as such services do not: (1) Substitute for in-person home
                health services ordered as part of a plan of care certified by a
                physician; and (2) are not considered a home health visit for purposes
                of eligibility or payment. In the CY 2019 HH PPS proposed rule (83 FR
                32425), we stated that ``remote patient monitoring'' is one type of
                service that can be furnished via a telecommunications system to
                augment a home health plan of care without
                [[Page 19248]]
                substituting for an in-person visit. In the CY 2019 HH PPS final rule
                with comment (83 FR 56527), for purposes of the Medicare home health
                benefit, we finalized the definition of ``remote patient monitoring''
                in regulation at 42 CFR 409.46(e) as the collection of physiologic data
                (for example, ECG, blood pressure, glucose monitoring) digitally stored
                and/or transmitted by the patient and/or caregiver to the HHA. We also
                included in regulation at Sec. 409.46(e) that the costs of remote
                patient monitoring are considered allowable administrative costs
                (operating expenses) if remote patient monitoring is used by the HHA to
                augment the care planning process (83 FR 56527).
                 We received positive feedback from the policy changes finalized in
                the CY 2019 HH PPS final rule with comment period. Commenters
                encouraged us to even go further in adopting and promoting technology
                use in home health. Recently, we have been asked by stakeholders to
                provide more clarity on how HHAs can leverage technology to keep home
                health clinicians and patients safe during outbreaks of an infectious
                disease, such as the PHE for the COVID-19 pandemic. While we remain
                statutorily-prohibited from paying for home health services furnished
                via a telecommunications system if such services substitute for in-
                person home health services ordered as part of a plan of care and for
                paying directly for such services under the home health benefit, for
                the duration of the PHE for the COVID-19 pandemic, we are amending the
                regulations at Sec. 409.43(a) on an interim basis to provide HHAs with
                the flexibility, in addition to remote patient monitoring, to use
                various types of telecommunications systems (that is, technology) in
                conjunction with the provision of in-person visits. Specifically, we
                are amending the regulations at Sec. 409.43(a) on an interim basis to
                state that the use of technology must be related to the skilled
                services being furnished by the nurse/therapist/therapy assistant to
                optimize the services furnished during the home visit or when there is
                a home visit. We are also amending the regulations at Sec. 409.43(a)
                on an interim basis to state that the use of technology must be
                included on the home health plan of care along with a description of
                how the use of such technology will help to achieve the goals outlined
                on the plan of care without substituting for an in-person visit as
                ordered on the plan of care. As a reminder, the plan of care must be
                signed prior to submitting a final claim to Medicare for payment (Sec.
                409.43(c)(2)); therefore, HHAs have flexibility on the timing in which
                they obtain physician signatures for changes to the plan of care when
                incorporating the use of technology into the patient's plan of care. In
                addition, HHAs may also provide services based on verbal orders in
                accordance with the regulations at Sec. Sec. 484.60(b) and 409.43(d).
                Finally, on an interim basis HHAs can report the costs of
                telecommunications technology as allowable administrative and general
                (A&G) costs by identifying the costs using a subscript between line
                5.01 through line 5.19.
                 We reiterate that by law the use of technology may not substitute
                for an in-person home visit ordered as part of the plan of care and
                services furnished via a telecommunications system cannot be considered
                a home health visit for purposes of eligibility or payment. However, we
                acknowledge that the use of such technology may result in changes to
                the frequency or types of visits outlined on the plan of care,
                especially to combat the PHE for the COVID-19 pandemic. For example, a
                patient recently discharged from the hospital after coronary bypass
                surgery was receiving home health skilled nursing visits three times a
                week for medication management, teaching and assessment. The patient
                developed a fever, cough, sore throat and moderate shortness of breath
                and now has a confirmed COVID-19 diagnosis, which the doctor has
                determined can be safely managed at home with home health services. The
                patient has been prescribed new medications for symptom management and
                oxygen therapy to support the patient's respiratory status. The
                patient's home health plan of care was updated to include an in-person
                skilled nursing visit once a week to assess the patient and to monitor
                for worsening symptoms. The plan of care was updated also to include a
                video consultation twice a week between the skilled nurse and the
                patient for medication management, teaching and assessment, as well as
                to obtain oxygen saturation readings that the patient relays to the
                nurse during the consultation.
                 With regards to payment under the HH PPS, if the primary reason for
                home health care is to provide care to manage the symptoms resulting
                from COVID-19, this 30-day period of care would be grouped into the
                Medication, Management, Teaching and Assessment (MMTA)--Respiratory
                clinical group, and it would be an early 30-day period of care with an
                institutional admission source. Assuming a medium functional impairment
                level with ``low'' comorbidities, the low-utilization payment
                adjustment (LUPA) threshold would be 4 visits. Regardless if the
                patient continued to receive the original 3 in-person skilled nursing
                visits per week (12 visits total in the 30-day period) rather than the
                once per-week in-person skilled nursing visits (4 visits total in the
                30-day period) the HHA would still receive the full 30-day payment
                amount (rather than paying per visit if the total number of visits was
                below the LUPA threshold). In this example, the use of technology is
                not a substitute for the provision of in-person visits as ordered on
                the plan of care, as the plan of care was updated to reflect a change
                in the frequency of the in-person visits and to include ``virtual
                visits'' as part of the management of the home health patient.
                 As discussed previously in section II.E ``Direct Supervision by
                Interactive Telecommunications Technology'' in this IFC, there may be
                instances during the PHE for the COVID-19 pandemic where physicians can
                enter into a contractual arrangement, that meets the definition of
                auxiliary personnel at Sec. 410.26, with another provider/supplier
                type. For example, physicians may enter into contractual arrangements
                with a HHA, a qualified infusion therapy supplier, or other entity to
                leverage auxiliary personnel under leased employment (Sec.
                410.26(a)(5)), including nurses or other clinical staff, to provide
                virtual visits for patients in their homes. These virtual visits are
                considered provided incident to a physician's service, as long as the
                billing practitioner is providing appropriate supervision through
                audio/video real-time communications technology, when needed. Payment
                for such services would be made to the billing practitioner who would
                then make the appropriate payment to the contracted entity (for
                example, the HHA). This payment would be made in accordance with the
                PFS and would not be considered a home health service under the
                Medicare home health benefit. This particular flexibility can enable
                more patients to receive services at home via telehealth for instances
                in which there are no in-person visits that would trigger payment under
                the Medicare HH PPS. As such, we would not expect that services
                furnished at a patient's home incident to a physician service will
                usually occur during the same period as a home health episode of care,
                and we will be monitoring claims that practitioners are billing under
                arrangement to ensure appropriate
                [[Page 19249]]
                services are being billed by the practitioner and not being
                inappropriately unbundled from payments under the HH PPS.
                 The remainder of this section includes information on examples of
                technology that can be leveraged in providing care in the home setting,
                such as telemedicine, interactive clinician ``consulting'' and other
                patient-facing technologies; and provides a summary of the regulations
                text we are amending in this IFC.
                 In general, technology has become an integral part of medicine
                across the entire spectrum of healthcare. Telemedicine, in particular
                has the potential to play a large role in enhancing the delivery of
                healthcare in the home for Medicare beneficiaries, including the
                provision of information, education, and services provided via
                telecommunications systems. One of the biggest benefits of
                telemedicine, separate from its potential to minimize risk to
                clinicians and patients during an outbreak of an infectious disease, is
                to increase access to healthcare to geographically disadvantaged and
                medically underserved populations, providing an improved quality of
                care.\8\ Telemedicine and remote monitoring can also be used to
                encourage patient involvement and autonomy, and to increase the tools
                available for the home health provider.
                ---------------------------------------------------------------------------
                 \8\ Int J Environ Res Public Health. 2013 Dec; 10(12): 6472-
                6484. Published online 2013 Nov 28. doi: 10.3390/ijerph10126472.
                ---------------------------------------------------------------------------
                 Recent CMS site visits with HHAs, as well as meetings with industry
                associations detailed the extent to which HHAs are researching and
                integrating technology into their care. These organizations provided
                examples of technology they have tested and/or are currently using,
                ranging from patient facing apps on cell phones to robotics.
                Additionally, they provided examples of patients with specific home
                health needs that they believe would benefit most from leveraging
                technology in home health care. They indicated a wide variety of uses
                for technology in home health including medication management and
                teaching, behavioral/crisis or social work counseling, post-transplant
                monitoring, dietary counseling, and even functional training through
                remote occupational or physical therapy. In particular, they
                highlighted certain diagnoses and conditions for which they are already
                utilizing telecommunications systems. For diagnoses/conditions such as
                COPD, congestive heart failure (CHF), sepsis, and wounds, technology
                can offer an efficient way of monitoring chronic respiratory and
                cardiovascular diseases that represent an increasingly high burden on
                healthcare systems.\9\ We referenced some of the benefits of remote
                patient monitoring of chronic diseases in the CY 2019 HH PPS proposed
                rule (83 FR 32425), including readmission prevention and improved
                patient involvement and accountability.
                ---------------------------------------------------------------------------
                 \9\ Breathe (Sheff). 2016 Dec; 12(4): 350-356. doi: 10.1183/
                20734735.014616.
                ---------------------------------------------------------------------------
                 Certain HHAs and industry groups have implemented technology that
                goes beyond remote patient monitoring for the treatment of chronic
                diseases. One such HHA utilizes two-way, interactive ``consulting''
                between the nurse furnishing the home visit and a specialty clinician
                at the agency. The nurse furnishing the home visit can use a tablet to
                visually connect the patient with the specialty clinician or advanced
                practice nurse at the agency to assess swelling, breathing, or to
                review and reconcile medications. These specialty clinicians are also
                beneficial in treating acute conditions, such as wounds, or monitoring
                for the prevention of sepsis. Wound, Ostomy, and Continence Nurses
                (WOCNs) are being utilized for their specialized skills as consultants
                for the nurse in the home. The nurse furnishing the home visit can use
                a tablet to connect visually with the WOCN at the agency to consult on
                the management of the wound. If necessary, the WOCN can contact the
                physician or surgeon to relay progress or request a change in
                treatment. Specialized software can even be utilized to assess the
                wound with precision and accuracy, including measuring surface area and
                depth, to improve consistency of care.\10\ Additionally, incorporating
                technology into home health may be beneficial in attracting these
                specialty clinicians, such as cardiac nurses and WOCNs, to homecare,
                which promotes the provision of a more advanced level of care; a
                benefit that will become imperative if the home health patient
                population, as a whole, exhibits more characteristics of an acute care
                population. Allowing advanced practice clinicians to consult virtually
                with the RN in the home may minimize transportation and labor costs and
                potentially improve patient access to specialty care.
                ---------------------------------------------------------------------------
                 \10\ https://parablehealth.com/post-acute-inpatient.
                ---------------------------------------------------------------------------
                 Telecommunications systems are also playing a valuable role in
                managing patients at risk for sepsis after a hospitalization. Sepsis
                continues to be a top diagnosis for hospital 30-day readmission rates
                amongst Medicare patients.\11\ Utilizing individualized software
                platforms to monitor appetite, mental changes, biometrics, etc., which
                alert care providers of any changes that may indicate a problem, can be
                helpful in treating the patient in the home prior to the patient
                requiring hospitalization. These patient-facing devices (tablets or
                apps) can be programmed to require the patient to perform a virtual
                daily ``check-in'' to monitor for potential issues. If the ``check-in''
                goes beyond specified individualized parameters, an alert will signal
                the HHA to follow-up with the critical care team following the patient
                to accelerate treatment. The software can also be programmed to deliver
                specific care instructions and reminders regarding hygiene or
                medications. In addition to disease-specific monitoring, patient-facing
                technologies can also be integral in promoting patient involvement and
                compliance. Certain scheduling and communication platforms allow HHAs
                to interface with patients in more ways than in-person visits or
                telephone calls. Some devices can ``talk'' to the patient, even
                utilizing multiple languages. Others can provide medication reminders,
                daily health tips, and assist in arranging for community or caregiver
                support.
                ---------------------------------------------------------------------------
                 \11\ https://www.hcup-us.ahrq.gov/reports/statbriefs/sb225-Inpatient-US-Stays-Trends.pdf.
                ---------------------------------------------------------------------------
                 Overall, we have seen how technology can expand the reach of
                healthcare into the home, through consultation with specialized
                clinicians and critical care teams, as well as through the integration
                of devices designed to increase patient involvement and compliance. As
                outlined above, incorporating these various forms of technology, in
                addition to remote patient monitoring as defined under the home health
                benefit (Sec. 409.46(e)), can be appropriate in furnishing home health
                services when used in conjunction with the provision of in-person
                visits. In addition, technology can be used to minimize the risk of
                exposure to clinicians, patients, and the public during an outbreak of
                an infectious disease, such as the PHE for the COVID-19 pandemic.
                Although HHAs have the flexibility, in addition to remote patient
                monitoring, to use various types of technology, payment for home health
                services remains contingent on the furnishing of a visit. Therefore,
                the use of technology must be related to the skilled services being
                furnished by the nurse or therapist or therapy assistant to optimize
                the services furnished during the home visit or when there is a home
                visit. To be eligible for the home health benefit, beneficiaries must
                need intermittent
                [[Page 19250]]
                skilled nursing or therapy services and must be considered homebound.
                Covered home health services include skilled nursing, home health aide,
                physical therapy, speech-language pathology, occupational therapy,
                medical social services, and medical supplies, provided on a visiting
                basis in a place of residence such as the individual's home (section
                1861(m) of the Act). A visit is defined at Sec. 409.48(c) as an
                episode of personal contact with the beneficiary by staff of the HHA or
                others under arrangements with the HHA, for the purpose of providing a
                covered service. Generally, one visit may be covered each time an HHA
                employee or someone providing home health services under arrangement
                with the HHA enters the beneficiary's home and provides a covered
                service to a beneficiary.
                 To appropriately recognize the role of technology in furnishing
                services under the Medicare home health benefit, the use of such
                technology must be included on the plan of care. The inclusion of
                technology on the plan of care must continue to meet the requirements
                at Sec. 484.60, and must be tied to the patient-specific needs as
                identified in the comprehensive assessment and the measurable outcomes
                that the HHA anticipates will occur as a result of implementing the
                plan of care. For example, if a physician orders an in-person skilled
                nursing visit once a week to assess the patient and to monitor for
                worsening symptoms and a video consultation twice a week between the
                skilled nurse and the patient for medication management, teaching and
                assessment, as well as to obtain oxygen saturation readings that the
                patient relays to the nurse during the consult; the plan of care could
                specify that the goal of the video consultation is to increase patient
                adherence with medication regimen and oxygen use with no worsening
                respiratory symptoms.
                 In summary, we are amending the plan of care requirements at Sec.
                409.43(a) on an interim basis, for the purposes of Medicare payment, to
                state that the plan of care must include any provision of remote
                patient monitoring or other services furnished via a telecommunications
                system, and that these services cannot substitute for a home visit
                ordered as part of the plan of care and cannot be considered a home
                visit for the purposes of patient eligibility or payment. The plan of
                care must include a description of how the use of such technology will
                help to achieve the goals outlined on the plan of care. We believe that
                this change will help to increase access to technologies, such as
                telemedicine and remote patient monitoring, that enable the necessary
                flexibility for Medicare beneficiaries to be able to receive medically
                necessary services without jeopardizing their health or the health of
                those who are providing such services, while minimizing the overall
                risk to public health during the PHE for the COVID-19 pandemic. As we
                stated above, HHAs can report the costs of telecommunications
                technology as allowable A&G costs on an interim basis by identifying
                the costs using a subscript between line 5.01 through line 5.19. We
                invite feedback on our interim changes to the plan of care requirements
                at Sec. 409.43(a).
                H. The Use of Telecommunications Technology Under the Medicare Hospice
                Benefit
                 As outlined in section II.G. of this IFC, The Use of Technology
                Under the Medicare Home Health Benefit, technology has become an
                integral part of medicine across the entire spectrum of healthcare.
                Telemedicine, in particular has the potential to play a large role in
                enhancing the delivery of healthcare in the home, including the
                provision of information, education, and services provided via
                telecommunications systems. One of the benefits of telemedicine is its
                potential to minimize risk to clinicians and patients during an
                outbreak of an infectious disease, such as the PHE for the COVID-19
                pandemic. Recently, we have been asked by stakeholders to provide more
                clarity on how hospices can leverage technology to keep clinicians and
                patients safe during the PHE for the COVID-19 pandemic.
                 For the duration of the PHE for the COVID-19 pandemic, we are
                amending the hospice regulations at 42 CFR 418.204 on an interim basis
                to specify that when a patient is receiving routine home care, hospices
                may provide services via a telecommunications system if it is feasible
                and appropriate to do so to ensure that Medicare patients can continue
                receiving services that are reasonable and necessary for the palliation
                and management of a patients' terminal illness and related conditions
                without jeopardizing the patients' health or the health of those who
                are providing such services during the PHE for the COVID-19 pandemic.
                To appropriately recognize the role of technology in furnishing
                services under the hospice benefit, the use of such technology must be
                included on the plan of care. The inclusion of technology on the plan
                of care must continue to meet the requirements at Sec. 418.56, and
                must be tied to the patient-specific needs as identified in the
                comprehensive assessment and the measurable outcomes that the hospice
                anticipates will occur as a result of implementing the plan of care.
                The following is an example of where it could be appropriate to furnish
                hospice services via a telecommunications system during the PHE for the
                COVID-19 pandemic:
                 A terminally ill 85-year-old male with heart failure has been
                receiving hospice services and recently developed a fever, sore
                throat and cough. The patient has been diagnosed with suspected
                COVID-19 and his hospice plan of care now includes medications for
                symptom management. He is mildly short of breath but does not
                require supportive oxygen therapy. The patient's wife is concerned
                about potential for worsening cardiac and respiratory symptoms as a
                result of the patient's risk for increased complications due to
                COVID-19. The hospice plan of care has been updated to include
                remote patient monitoring with a telecommunications system to assess
                the patient's daily weight and oxygen saturation levels. The plan of
                care identifies the measurable goal that the patient will maintain
                an oxygen level above 92 percent and the patient will not gain more
                than 2 pounds in a 24-hour period. The plan of care identifies
                interventions if either of these goals are not met. The remote
                patient monitoring allows for more expedited modifications to the
                plan of care in response to the patient's changing needs.
                 We believe that this clarification in the regulations at Sec.
                418.204 will help to increase access to technologies, such as
                telemedicine and remote patient monitoring, that enable the necessary
                flexibility for patients to be able to receive necessary services
                without jeopardizing their health or the health of those who are
                providing those services, while minimizing the overall risk to public
                health during the PHE for the COVID-19 pandemic. Hospices are paid a
                per diem payment amount based on the level of care for each day that a
                patient is under a hospice election (Sec. 418.302). There is no
                payment beyond the per diem amount for the use of technology in
                providing services under the hospice benefit. For the purposes of the
                hospice claim submission, only in-person visits (with the exception of
                social work telephone calls) should be reported on the claim. However,
                hospices can report the costs of telecommunications technology used to
                furnish services under the routine home care level of care during the
                PHE for the COVID-19 pandemic as ``other patient care services'' using
                Worksheet A, cost center line 46, or a subscript of line 46 through
                46.19, cost center code 4600 through 4619, and identifying this cost
                center as ``PHE for COVID-19''. We invite feedback on our changes to
                the
                [[Page 19251]]
                special requirements for coverage at Sec. 418.204.
                I. Telehealth and the Medicare Hospice Face-to-Face Encounter
                Requirement
                 To receive hospice services under the Medicare hospice benefit, a
                beneficiary must be certified as terminally ill with a medical
                prognosis of a life expectancy of 6 months or less if the illness runs
                its normal course, in accordance with section 1814(a)(7) of the Act and
                as codified in Sec. 418.22. A written certification is required at the
                beginning of the first 90-day period of hospice care, a subsequent 90-
                day period and each 60-day period thereafter. The hospice must obtain
                written certification of terminal illness for each benefit period, even
                if a single election continues in effect. In accordance with section
                1814(a)(7)(D)(i) of the Act, a hospice physician or hospice NP must
                have a face-to-face encounter with each Medicare hospice patient whose
                total stay across all hospices is anticipated to reach the 3rd benefit
                period. The face-to-face encounter must occur prior to, but no more
                than 30 calendar days prior to, the 3rd benefit period recertification,
                and every benefit period recertification thereafter, to gather clinical
                findings to determine continued eligibility for hospice care.
                 The Medicare hospice face-to-face encounter is an administrative
                requirement related to certifying the terminal illness as required in
                section 1814(a)(7)(D)(i) of the Act. By itself, it is not billable, as
                it is considered administrative (see Pub. 100-04, Medicare Claims
                Processing Manual, chapter 11, section 40.1.1). However, if a hospice
                physician, or a hospice NP who is also the patient's designated
                attending physician, provides reasonable and necessary non-
                administrative patient care during the face-to-face visit, that portion
                of the visit would be billable under the Medicare rules. There are
                additional requirements for billing physician services provided by NPs
                (see Pub. 100-04, chapter 11, section 40.1.3.2). Therefore, if a
                hospice physician or the hospice NP acting as the patient's designated
                attending physician provides direct patient care during the course of
                the face-to-face encounter, the physician or NP may bill for such
                direct care services for Medicare beneficiaries under the PFS. As a
                reminder, the hospice benefit defines an ``attending physician'' as a
                doctor of medicine or osteopathy, an NP, or a PA designated by the
                individual at the time he or she elects to receive hospice care as
                having the most significant role in the determination and delivery of
                the individual's medical care (Sec. 418.3). However, we note that PAs
                are not authorized to perform the required face-to-face encounter under
                section 1814(a)(7)(D)(i) of the Act. In the event of a pandemic
                outbreak of an infectious disease, such as COVID-19, an example of
                direct patient care during the course of an in-person face-to-face
                visit for recertification for Medicare beneficiaries could be as
                follows:
                 An 85-year-old male with a primary diagnosis of end stage heart
                failure with diabetes, peripheral vascular disease, and hypertension
                is being seen by the hospice physician for hospice recertification
                and has developed a fever, cough and mild shortness of breath over
                the last 24 hours. After discussion with his caregiver, the hospice
                physician discovers that the patient had a visit from his niece who
                was found to be COVID-19 positive. The physician washes his hands,
                puts on gloves and then places a mask on himself, the patient and
                caregiver. After examining the patient, the physician discusses with
                the patient and caregiver if he would like to be tested for COVID-19
                and if he would like to continue to be treated at home. The patient
                decides that he would like to be treated at home and that he would
                like to be tested. The nasopharyngeal and oropharyngeal swabs are
                performed. The hospice physician discusses with the patient's
                caregiver infection control techniques, symptomatic treatment, and
                provides them with gloves and disposable masks. During the course of
                this recertification visit, the hospice physician provided direct
                patient care, and therefore, can bill for such services.
                 While we do not believe that direct patient care for Medicare
                hospice patients will typically be furnished via telehealth, we note
                that nothing in statute or regulation precludes a hospice designated
                attending physician from furnishing services via telehealth in
                accordance with section 1834(m) of the Act. In response to the PHE for
                the COVID-19 pandemic, The Coronavirus Preparedness and Response
                Supplemental Appropriations Act, 2020 was signed into law on March 6,
                2020. Section 102 of the Coronavirus Preparedness and Response
                Supplemental Appropriations Act, 2020 gives the Secretary the authority
                to waive: (1) The telehealth originating site requirements under
                section 1834(m)(4)(C) of the Act (both geographic and site of service)
                for telehealth services furnished in an emergency area; and (2) the
                restriction on use of a telephone for furnishing telehealth services
                (in Sec. 410.78(a)(3)), but only if the telephone has audio and video
                capabilities that are used for two-way, real-time interactive
                communication. The originating site facility fee would be paid to
                originating sites on the current list of permissible sites (except for
                the patient's home) in any geographic location. The provision
                established a definition of ``qualified providers'' that specifies the
                practitioners eligible for furnishing distant site services under the
                waiver. Specifically, the practitioners currently permitted to furnish
                distant site telehealth services under section 1834(m) of the Act--
                physicians (as defined in section 1861(r) of the Act) and NPPs (as
                defined in section 1842(b)(18)(C) of the Act)--would be eligible to
                furnish telehealth services under the waiver to patients with an
                established relationship with the practitioner or a practitioner in the
                same practice (defined by tax identification number (TIN)). This would
                be determined based on a patient for whom Medicare payment was made for
                an item or service furnished by the practitioner (or another
                practitioner within the same practice) within the previous 3 years.\12\
                The telehealth waiver is in effect and is limited to the PHE for the
                COVID-19 pandemic.
                ---------------------------------------------------------------------------
                 \12\ We note that HHS will not conduct audits to ensure that
                such prior relationship existed for claims submitted during this
                PHE. Also, effective immediately, the HHS Office for Civil Rights
                (OCR) will exercise enforcement discretion and waive penalties for
                HIPAA violations against health care providers that serve patients
                in good faith through everyday communications technologies, such as
                FaceTime or Skype, during the COVID-19 nationwide PHE.
                ---------------------------------------------------------------------------
                 The statute is silent as to whether a face-to-face encounter solely
                for the purpose of Medicare hospice recertification (meaning there is
                no direct patient care) could be conducted via telecommunications
                technology by the hospice physician or NP. Given that a face-to-face
                visit solely for the purpose of recertification for Medicare hospice
                services is considered an administrative requirement related to
                certifying the terminal illness as required in section 1814(a)(7)(D)(i)
                of the Act, we believe that such visit could be performed via
                telecommunications technology as a result of the PHE for the COVID-19
                pandemic. We recognize that public exposure during a pandemic event of
                an infectious disease greatly increases the overall risk to public
                health and terminally ill patients are exceptionally vulnerable to
                complications associated with COVID-19. Therefore, we are amending the
                regulations at Sec. 418.22(a)(4) on an interim basis to allow the use
                of telecommunications technology by the hospice physician or NP for the
                face-to-face visit when such visit is solely for the purpose of
                recertifying a patient for hospice services during the PHE for the
                COVID-19 pandemic. By telecommunications
                [[Page 19252]]
                technology, we mean the use of multimedia communications equipment that
                includes, at a minimum, audio and video equipment permitting two-way,
                real-time interactive communication between the patient (from home, or
                any other site permissible for receiving services under the hospice
                benefit) and distant site hospice physician or hospice NP.\13\ Such
                encounters solely for the purpose of recertification would not be a
                separately billed service, but rather considered an administrative
                expense. We request feedback on the amendments to the face-to-face
                visit requirement for hospice recertification during the PHE for the
                COVID-19 pandemic.
                ---------------------------------------------------------------------------
                 \13\ Section 410.78(a)(2) defines a ``distant site'' as the site
                at which the physician or practitioner delivering the service is
                located at the time the service is provided via a telecommunications
                system.
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                J. Modification of the Inpatient Rehabilitation Facility (IRF) Face-to-
                Face Requirement for the PHE During the COVID-19 Pandemic
                 Under 42 CFR 412.622(a)(3)(iv), for an inpatient rehabilitation
                facility (IRF) claim to be considered reasonable and necessary under
                section 1862(a)(1) of the Act, there must be a reasonable expectation
                at the time of the patient's admission to the IRF that the patient
                requires physician supervision by a rehabilitation physician, defined
                as a licensed physician with specialized training and experience in
                inpatient rehabilitation. The requirement for medical supervision means
                that the rehabilitation physician must conduct face-to-face visits with
                the patient at least 3 days per week throughout the patient's stay in
                the IRF to assess the patient both medically and functionally, as well
                as modify the course of treatment as needed to maximize the patient's
                capacity to benefit from the rehabilitation process.
                 The purpose of the physician supervision requirement is to ensure
                that the patient's medical and functional statuses are being
                continuously monitored as the patient's overall plan of care is being
                carried out.
                 We continue to believe it is in the patient's best interest to be
                seen in person by a rehabilitation physician to assess their medical
                and functional statuses while at the IRF, and we encourage
                rehabilitation physicians to continue to visit IRF patients in person
                as long as all necessary precautions, including the use of PPE, are
                taken to ensure the health and safety of the patient and the physician.
                However, during the PHE for the COVID-19 pandemic, we believe that it
                is essential to temporarily allow the face-to-face visit requirements
                at Sec. Sec. 412.622(a)(3)(iv) and 412.29(e) to be conducted via
                telehealth to safeguard the health and safety of Medicare beneficiaries
                and the rehabilitation physicians treating them. This allows
                rehabilitation physicians to use telehealth services as defined in
                section 1834(m)(4)(F) of the Act, to conduct the required 3 physician
                visits per week during the PHE for the COVID-19 pandemic. By increasing
                access to telehealth, this IFC will provide the necessary flexibility
                for Medicare beneficiaries to be able to receive medically necessary
                services without jeopardizing their health or the health of those who
                are providing those services, while minimizing the overall risk to
                public health.
                 To effectuate these changes, on an interim basis we are finalizing
                revisions to the regulations at Sec. Sec. 412.622(a)(3)(iv) and
                412.29(e) during the PHE for the COVID-19 pandemic.
                 In Sec. 412.622(a)(3)(iv), we are revising this paragraph to state
                that physician supervision by a rehabilitation physician is required,
                except that during the PHE, as defined in Sec. 400.200, such visits
                may be conducted using telehealth services (as defined in section
                1834(m)(4)(F) of the Act). The requirement for medical supervision
                means that the rehabilitation physician must conduct face-to-face
                visits with the patient at least 3 days per week throughout the
                patient's stay in the IRF to assess the patient both medically and
                functionally, as well as to modify the course of treatment as needed to
                maximize the patient's capacity to benefit from the rehabilitation
                process. The post-admission physician evaluation described in paragraph
                (a)(4)(ii) may count as one of the face-to-face visits.
                 In Sec. 412.29(e), we are revising this paragraph to state that a
                procedure must be in effect to ensure that patients receive close
                medical supervision, as evidenced by at least 3 face-to-face visits per
                week by a licensed physician with specialized training and experience
                in inpatient rehabilitation to assess the patient both medically and
                functionally, as well as to modify the course of treatment as needed to
                maximize the patient's capacity to benefit from the rehabilitation
                process, except that during the PHE, as defined in Sec. 400.200, such
                visits may be conducted using telehealth services (as defined in
                section 1834(m)(4)(F) of the Act).
                 We welcome feedback on these revisions to the regulations at
                Sec. Sec. 412.622(a)(3)(iv) and 412.29(e) for the duration of the PHE.
                K. Removal of the IRF Post-Admission Physician Evaluation Requirement
                for the PHE for the COVID-19 Pandemic and Clarification Regarding the
                ``3-Hour'' Rule
                 IRF care is only considered by Medicare to be reasonable and
                necessary under section 1862(a)(1) of the Act if the patient meets all
                of the IRF coverage requirements outlined in Sec. 412.622(a)(3), (4),
                and (5). Failure to meet the IRF coverage criteria in a particular case
                results in denial of the IRF claim. Under Sec. 412.622(a)(4)(ii), to
                document that each patient for whom the IRF seeks payment is reasonably
                expected to meet all of the requirements in Sec. 412.622(a)(3) at the
                time of admission, the patient's medical record at the IRF must contain
                a post-admission physician evaluation that meets ALL of the following
                requirements:
                 It is completed by the rehabilitation physician within 24
                hours of the patient's admission to the IRF.
                 It documents the patient's status on admission to the IRF,
                includes a comparison with the information noted in the preadmission
                screening documentation, and serves as the basis for the development of
                the overall individualized plan of care.
                 It is retained in the patient's medical record at the IRF.
                 In an effort to provide rehabilitation physicians with as much
                flexibility as possible, we are removing the post-admission physician
                evaluation requirement at Sec. 412.622(a)(4)(ii) for all IRFs during
                the PHE for the COVID-19 pandemic. We believe that removal of this
                requirement will greatly reduce the amount of time rehabilitation
                physicians in IRFs spend on completing paperwork requirements when a
                patient is admitted to the IRF, and will free up their time to focus
                instead on caring for patients and helping where they may be needed
                with the PHE for the COVID-19 pandemic. Accordingly, we are amending
                Sec. 412.622(a)(4)(ii) to note that the post-admission physician
                evaluation is not required during the PHE for the COVID-19 pandemic. To
                effectuate this change, on an interim basis, we are revising Sec.
                412.622(a)(4)(ii) to specify that the post-admission physician
                evaluation is not required during the PHE for the COVID-19 pandemic.
                 We note that this does not preclude an IRF patient from being
                evaluated by a rehabilitation physician within the first 24 hours of
                admission if the IRF believes that the patient's condition warrants
                such an evaluation.
                 We invite feedback on our removal of the post-admission physician
                evaluation
                [[Page 19253]]
                documentation requirement at Sec. 412.622(a)(4)(ii) for all IRFs
                during the PHE for the COVID-19 pandemic.
                 In addition, we are providing clarity for all IRFs during the PHE
                for the COVID-19 pandemic with regard to the intensive rehabilitation
                therapy requirements for IRF coverage at Sec. 412.622(a)(3)(ii),
                commonly known as the ``3-hour'' rule. Section 412.622(a)(3)(ii)
                generally requires that a beneficiary be reasonably expected to
                actively participate in, and benefit from, an intensive rehabilitation
                therapy program on admission to the IRF. Under current industry
                standards, this intensive rehabilitation therapy program generally
                consists of at least 3 hours of therapy (physical therapy, occupational
                therapy, speech-language pathology, or prosthetics/orthotics therapy)
                per day at least 5 days per week. In certain well-documented cases,
                this intensive rehabilitation therapy program might instead consist of
                at least 15 hours of intensive rehabilitation therapy within a 7-
                consecutive day period, beginning with the date of admission to the
                IRF. Benefit from this intensive rehabilitation therapy program is
                demonstrated by measurable improvement that will be of practical value
                to the patient in improving the patient's functional capacity or
                adaptation to impairments. The required therapy treatments must begin
                within 36 hours from midnight of the day of admission to the IRF.
                 We recognize that IRFs may have difficulties in meeting these
                requirements because normal staffing shifts may be disrupted as staff
                who would conduct the therapy program may have COVID-19, be self-
                isolated, or be unavailable for other reasons related to the PHE. As
                such, while these requirements remain in place, we are clarifying that
                in cases where an IRF's intensive rehabilitation therapy program is
                impacted by the PHE for the COVID-19 pandemic (for example, due to
                staffing disruptions resulting from self-isolation, infection, or other
                circumstances related to the PHE), the IRF should not feel obligated to
                meet the industry standards referenced in Sec. 412.622(a)(3)(ii), but
                should instead make a note to this effect in the medical record.
                L. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
                (FQHCs)
                1. Expansion of Virtual Communication Services Furnished by RHCs and
                FQHCs
                a. Background
                 RHC and FQHC visits are face-to-face (in-person) encounters between
                a patient and an RHC or FQHC practitioner during which time one or more
                RHC or FQHC qualifying services are furnished. RHC and FQHC
                practitioners are physicians, NPs, PAs, certified nurse midwives,
                clinical psychologists, and clinical social workers, and under certain
                conditions, a registered nurse (RN) or licensed practical nurse
                furnishing care to a homebound RHC or FQHC patient. A Transitional Care
                Management service can also be an RHC or FQHC visit. A Diabetes Self-
                Management Training (DSMT) service or a Medical Nutrition Therapy (MNT)
                service furnished by a certified DSMT or MNT provider may also be an
                FQHC visit.
                 RHCs are paid an all-inclusive rate (AIR) for medically-necessary,
                face-to-face visits with an RHC practitioner. The rate is subject to a
                payment limit, except for those RHCs that have an exception to the
                payment limit for being ``provider-based'' (see Sec. 413.65). FQHCs
                are paid the lesser of their actual charges or the FQHC PPS rate for
                medically-necessary, face-to-face visits with an FQHC practitioner.
                Only medically-necessary medical, mental health, or qualified
                preventive health services that require the skill level of an RHC or
                FQHC practitioner can be RHC or FQHC billable visits.
                 The RHC and FQHC payment rates reflect the cost of all services and
                supplies that an RHC or FQHC furnishes to a patient in a single day,
                and are not adjusted for the complexity of the patient health care
                needs, the length of the visit, or the number or type of practitioners
                involved in the patient's care. Services furnished by auxiliary
                personnel (such as nurses, medical assistants, or other clinical
                personnel acting under the supervision of the RHC or FQHC practitioner)
                are considered to be incident to the visit and are included in the per-
                visit payment. This may include services furnished prior to or after
                the billable visit that occur within a medically appropriate time
                period, which is usually 30 days or less.
                 RHCs and FQHCs are also paid for care management services,
                including chronic care management services, general behavioral health
                integration services, and psychiatric Collaborative Care Model
                services. These are typically non-face-to-face services that do not
                require the skill level of an RHC or FQHC practitioner and are not
                included in the RHC or FQHC payment methodologies.
                 In the CY 2019 PFS proposed rule (83 FR 35863), we proposed
                separate payments to RHCs and FQHCs for certain CTBS referred to as
                ``Brief Communication Technology-Based Services'' for a ``virtual
                check-in'' and separate payment for remote evaluation of recorded video
                and/or images. ``Virtual check-ins'' are brief (5 to 10 minutes), non-
                face-to-face check ins with a patient via communication technology to
                assess whether the patient's condition necessitates an office visit.
                This service could be billed only in situations where the medical
                discussion was for a condition not related to an RHC or FQHC visit
                furnished within the previous 7 days, and does not lead to an RHC or
                FQHC visit within the next 24 hours or at the soonest available
                appointment. We also proposed payment for remote evaluation of patient-
                transmitted information conducted via pre-recorded ``store and
                forward'' video or image technology, including interpretation with
                verbal follow-up with the patient within 24 business hours. We had
                proposed that payment would be made if the remote evaluation did not
                originate from a related RHC or FQHC visit furnished within the
                previous 7 days, or lead to an RHC or FQHC visit within the next 24
                hours or soonest available appointment.
                 In the CY 2019 PFS final rule (83 FR 59683), we finalized
                requirements and payment for RHCs and FQHCs furnishing Virtual
                Communication Services. Effective January 1, 2019, RHCs and FQHCs are
                paid for Virtual Communication Services HCPCS code G0071 (Payment for
                communication technology-based services for 5 minutes or more of a
                virtual (non-face-to-face) communication between an RHC or FQHC
                practitioner and RHC or FQHC patient, or 5 minutes or more of remote
                evaluation of recorded video and/or images by an RHC or FQHC
                practitioner, occurring in lieu of an office visit; RHC or FQHC only).
                HCPCS code G0071 is on an RHC or FQHC claim, either alone or with other
                payable services, and at least 5 minutes of communication technology-
                based or remote evaluation services are furnished by an RHC or FQHC
                practitioner to a patient who has had an RHC or FQHC billable visit
                within the previous year, and the medical discussion or remote
                evaluation is for a condition not related to an RHC or FQHC service
                provided within the previous 7 days, and does not lead to an RHC or
                FQHC visit within the next 24 hours or at the soonest available
                appointment. We added a new paragraph (e) to 42 CFR 405.2464 to reflect
                this payment.
                 HCPCS code G0071 is set at the average of the national non-facility
                PFS payment rates for HCPCS code G2012 (communication technology-based
                services) and HCPCS code G2010
                [[Page 19254]]
                (remote evaluation services) and is updated annually based on the PFS
                national non-facility payment rate for these codes. RHC and FQHC face-
                to-face requirements are waived when these services are furnished to an
                RHC or FQHC patient. Coinsurance and deductibles apply to RHC claims
                for HCPCS code G0071 and coinsurance applies to FQHC claims for HCPCS
                code G0071.
                b. Improving Access to Care Management and Virtual Communication
                Services Furnished by RHCs and FQHCs
                 RHCs and FQHCs furnish services in rural and urban areas that have
                been determined to be medically underserved areas or health
                professional shortage areas. They are an integral component of the
                Nation's health care safety net, and we want to ensure that Medicare
                patients who are served by RHCs and FQHCs are able to communicate with
                their RHC or FQHC practitioner in a manner that enhances access to
                care, consistent with evolving medical care.
                 Particularly in rural areas where transportation is limited and
                distances may be far, we believe the use of CTBS may help some patients
                to determine if they need to schedule a visit at the RHC or FQHC. If it
                is determined that a visit is not necessary, the RHC or FQHC
                practitioner would be available for other patients who need their care.
                 In the CY 2019 PFS final rule (83 FR 59452), we finalized payment
                for new online digital assessment services, also referred to as ``E-
                Visits,'' for practitioners billing under the PFS. These are non-face-
                to face, patient-initiated communications using online patient portals.
                An online patient portal is a secure online website that gives patients
                24-hour access to personal health information from anywhere with an
                internet connection by using a secure username and password. These
                digital assessment services are for established patients who require a
                clinical decision that otherwise typically would have been provided in
                the office. To minimize risks associated with exposure to COVID-19, and
                to provide the best care possible during the PHE for the COVID-19
                pandemic, we believe that RHCs and FQHC practitioners, like many other
                health care providers, should explore the use of interactive
                communications technology in the place of services that would have
                otherwise been furnished in person and reported and paid under the
                established methodologies.
                 To facilitate the ability of RHCs and FQHCs to take such measures
                when appropriate, on an interim basis, we are expanding the services
                that can be included in the payment for HCPCS code G0071, and update
                the payment rate to reflect the addition of these services.
                Specifically, we are adding the following three CPT codes:
                 99421 (Online digital evaluation and management service,
                for an established patient, for up to 7 days, cumulative time during
                the 7 days; 5-10 minutes)
                 99422 (Online digital evaluation and management service,
                for an established patient, for up to 7 days, cumulative time during
                the 7 days; 11-20 minutes)
                 99423 (Online digital evaluation and management service,
                for an established patient, for up to 7 days, cumulative time during
                the 7 days; 21 or more minutes)
                 We are revising the payment rate for HCPCS code G0071 to include
                the national non-facility payment rates for these three new codes.
                Effective for services furnished on or after March 1, 2020 and
                throughout the PHE for the COVID pandemic, the payment rate for HCPCS
                code G0071 will be the average of the PFS national non-facility payment
                rate for HCPCS code G2012 (communication technology-based services),
                HCPCS code G2010 (remote evaluation services), CPT code 99421, CPT code
                99422, and CPT code 99423. The RHC and FQHC face-to-face requirements
                are be waived for these services. Section 405.2464(e) establishes
                payment for communication technology-based and remote evaluation
                services, and no regulatory changes are required.
                 The services that are payable using HCPCS code G0071 require that
                the beneficiary has been seen by an RHC or FQHC practitioner during the
                previous 12 months. Under the current PHE for the COVID-19 pandemic, we
                believe that it is necessary to make these services available to
                beneficiaries who would otherwise not have access to clinically
                appropriate in-person treatment. Therefore, during the PHE for the
                COVID-19 pandemic, we are finalizing that all virtual communication
                services that are billable using HCPCS code G0071 will also be
                available to new patients that have not been seen in the RHC or FQHC
                within the previous 12 months. Also, in situations where obtaining
                prior beneficiary consent would interfere with the timely provision of
                these services, or the timely provision of the monthly care management
                services, during the PHE for the COVID-19 pandemic consent can obtained
                when the services are furnished instead of prior to the service being
                furnished, but must be obtained before the services are billed. We will
                also allow patient consent to be acquired by staff under the general
                supervision of the RHC or FQHC practitioner for the virtual
                communication and monthly care management codes during the PHE for the
                COVID-19 pandemic. These changes are consistent with the flexibilities
                were are establishing for similar services paid under the PFS as
                described in section II.D. of this IFC.
                2. Revision of Home Health Agency Shortage Area Requirements for
                Furnishing Visiting Nursing Services
                a. Background
                 Sections 1861(aa)(1)(A) and (B) of the Act describes RHC and FQHC
                services as services and supplies furnished by a physician, PA, NP,
                clinical psychologist clinical social worker; and items and services
                furnished incident to these services, and specifies requirements for
                these practitioners and services.
                 In the case of an RHC or FQHC that is located in an area in which
                there exists a shortage of HHAs, part-time or intermittent nursing care
                and related medical supplies (other than drugs and biologicals) are
                authorized under section 1861(aa)(1)(C) of the Act. These services can
                be furnished by a registered professional nurse or licensed practical
                nurse to a homebound individual under a written plan of treatment that
                is established and periodically reviewed by an RHC or FQHC physician,
                or established by a NP or PA and periodically reviewed and approved by
                the RHC or FQHC physician.
                 In Sec. 405.2416, we specify that visiting nurse services are
                covered if all of the following are met:
                 The RHC or FQHC is located in an area in which the
                Secretary has determined that there is a shortage of HHAs;
                 The services are rendered to a homebound individual;
                 The services are furnished by a registered professional
                nurse or licensed practical nurse that is employed by, or receives
                compensation for the services from the RHC or FQHC;
                 The services are furnished under a written plan of
                treatment that is established and reviewed at least every 60 days by a
                supervising physician of the RHC or FQHC; or established by an NP, PA
                or certified nurse midwife (CNM); and reviewed at least every 60 days
                by a supervising physician. The written plan of treatment must be
                signed by the supervising physician, NP, PA or CNM of the RHC or FQHC.
                 Nursing care that is covered by this section includes services that
                must be
                [[Page 19255]]
                performed by a registered professional nurse or licensed practical
                nurse if the safety of the patient is to be assured and the medically
                desired results achieved; and personal care services, to the extent
                covered under Medicare as home health services. These services include
                helping the patient to bathe, to get in and out of bed, to exercise and
                to take medications. Household and housekeeping services or other
                services that would constitute custodial care are not covered.
                 Section 405.2416 also defines ``homebound'' as an individual who is
                permanently or temporarily confined to his or her place of residence
                because of a medical or health condition, or if the individual leaves
                the place of residence infrequently. It does not include a hospital or
                long term care facility.
                 In Pub. 100-02, Medicare Benefit Policy Manual, Chapter 13, section
                190, we further describe RHC and FQHC visiting nursing services as
                skilled nursing services that require the skills of a nurse based on
                the complexity of the service (for example, intravenous and
                intramuscular injections or insertion of catheters), the condition of
                the patient (for example, a non-skilled service that, because of the
                patient's condition, can only be safely and effectively provided by a
                nurse), and accepted standards of medical and nursing practice. All
                services must be reasonable and necessary to the diagnosis and
                treatment of the patient's illness or injury within the context of the
                patient's unique medical condition, and a service that can be safely
                and effectively self-administered or performed by a nonmedical person
                without the direct supervision of a nurse, is not considered a skilled
                nursing service, even if provided by a nurse. A service which, by its
                nature, requires the skills of a nurse to be provided safely and
                effectively continues to be a skilled service even if it is taught to
                the patient, the patient's family, or other caregivers. If a patient
                needs skilled nursing care and there is no one trained or able and
                willing to provide it, the services of a nurse would be reasonable and
                necessary to the treatment of the illness or injury. We also specify
                that the determination of whether visiting nurse services are
                reasonable and necessary is made by the physician based on the
                condition of the patient when the services were ordered and what is
                reasonably expected to be appropriate treatment for the illness or
                injury throughout the certification period.
                 The requirements for furnishing visiting nursing services include
                that the patient is considered to be ``confined to the home'' as
                defined in section 1835(a) of the Act and that the RHC or FQHC is
                located in an area that has a shortage of HHAs. The services and
                supplies must be provided under a written plan of treatment; are
                furnished on a part-time or intermittent basis only; and drugs and
                biological products are not provided.
                 Chapter 13 of the Medicare Benefit Policy Manual, section 190,
                specifies the requirements for HHA shortage areas for purposes of
                visiting nursing services furnished by RHCs and FQHCs. The RHC or FQHC
                must be currently located in a county, parish or similar geographic
                area in which the Secretary has determined that there is no
                participating HHA under Medicare; or adequate home health services are
                not available to RHC or FQHC patients even though a participating HHA
                is in the area; or, there are patients whose homes are not within the
                area serviced by a participating HHA; or considering the area's climate
                and terrain, whose homes are not within a reasonable traveling distance
                to a participating HHA. RHCs and FQHCs that are located in an area that
                has not been determined to have a current HHA shortage and are seeking
                to provide visiting nurse services must make a written request to the
                appropriate CMS Regional Office along with written justification that
                the area it serves meets the required conditions.
                b. Revision of Home Health Agency Shortage Area Requirements for
                Furnishing Visiting Nursing Services
                 To address the PHE for the COVID-19 pandemic and its impact on
                underserved rural and urban communities, we are implementing, on an
                interim basis, changes to the requirements for visiting nursing
                services furnished in the home by RHCs and FQHCs.
                 Section 405.2416(a)(1) states that visiting nurse services are
                covered if the RHC or FQHC is located in an area in which the Secretary
                has determined that there is a shortage of HHAs, and Sec. 405.2417
                provides additional requirements for an area to be determined to have a
                shortage of HHAs. During the PHE for the COVID-19 pandemic, we believe
                the need for visiting nursing services furnished by RHCs or FQHCs may
                increase. Therefore, for the duration of the PHE for the COVID-19
                pandemic, we are determining that any area typically served by the RHC,
                and any area that is included in the FQHCs service area plan, is
                determined to have a shortage of HHAs, and no request for this
                determination is required.
                 We believe this flexibility is important for patient access to
                nursing services in the home and the potential for HHAs to be
                overwhelmed during PHE for the COVID-19 pandemic. However, RHCs and
                FQHCs should check the HIPAA Eligibility Transaction System (HETS)
                before providing visiting nurse services to ensure that the patient is
                not already under a home health plan of care. If a patient is under a
                home health plan of care, the HHA must provide optimal care to achieve
                the goals and outcomes identified in the patient's plan of care, for
                each patient's medical, nursing, and rehabilitative needs (Sec.
                484.105). Therefore, RHC/FQHC visiting nurse services would not be
                covered by Medicare if such services are found to overlap with a 30-day
                period of home health care. We note that an RHC/FQHC visiting nurse
                service solely to obtain a nasal or throat culture would not be
                considered a nursing service because it would not require the skills of
                a nurse to obtain the culture as the specimen could be obtained by an
                appropriately-trained medical assistant or laboratory technician.
                However, during an otherwise covered RHC/FQHC visiting nurse service,
                the nurse could obtain the nasal or throat culture to send to the
                laboratory for testing.
                 Section 405.2416(a)(2) states that visiting nursing services are
                rendered to a homebound individual, and Sec. 405.2416(d) states that
                homebound means an individual who is permanently or temporarily
                confined to his or her place of residence because of a medical or
                health condition, and that the individual may be considered homebound
                if he or she leaves the place of residence infrequently. We refer the
                reader to the definition of ``homebound'' as it pertains the PHE for
                the COVID-19 pandemic in section II.F. of this IFC, Clarification of
                Homebound Status under the Medicare Home Health Benefit.
                c. Regulatory Changes
                 To make available additional visiting nursing services during the
                PHE for the COVID-19 pandemic in areas served by RHCs and FQHCs, we are
                revising, on an interim basis, Sec. 405.2416 to add paragraph (a)(5),
                to state that during the PHE for the COVID-19 pandemic, an area
                typically served by the RHC, and an area that is included in the FQHC's
                service area plan, is determined to have a shortage of HHAs, and no
                request for this determination is required.
                [[Page 19256]]
                M. Medicare Clinical Laboratory Fee Schedule: Payment for Specimen
                Collection for Purposes of COVID-19 Testing
                 In response to the PHE for the COVID-19 pandemic and in an effort
                to be as expansive as possible within the current authorities to have
                testing available to Medicare beneficiaries who need it, we are
                changing Medicare payment policies during the PHE for the COVID-19
                pandemic to provide payment to independent laboratories for specimen
                collection for COVID-19 testing under certain circumstances.
                 In general, section 1833(h)(3) of the Act requires the Secretary to
                provide for and establish a nominal fee for specimen collection for
                laboratory testing and a fee to cover transportation and personnel
                expenses for trained personnel to collect specimens from homebound
                patients and inpatients (not in a hospital), in addition to the amounts
                provided under the Medicare Clinical Laboratory Fee Schedule (CLFS).
                Section 1833(h)(3)(A) of the Act provides that the Secretary must
                establish a nominal fee to cover the appropriate costs in collecting
                the sample on which a clinical diagnostic laboratory test was performed
                and for which payment is made under Medicare Part B, except that not
                more than one such fee may be provided with respect to samples
                collected in the same encounter. The HCPCS codes for the nominal
                specimen fees currently listed on the CLFS (HCPCS codes 36415, P9612,
                and P9615) have a payment rate of $3. Section 216(a) of the Protecting
                Access to Medicare Act of 2014 (Pub. L. 113-93, enacted April 1, 2014)
                added section 1834A(b)(5) to the Act which increases by $2 the nominal
                fee that would otherwise apply under section 1833(h)(3)(A) of the Act
                for a sample collected from an individual in a skilled nursing facility
                (SNF) or by a laboratory on behalf of an HHA. Therefore, effective
                April 1, 2014, the nominal fee that would otherwise apply for a sample
                collected from an individual in a SNF or by a laboratory on behalf of a
                HHA is $5 (see Sec. 414.507(f)), and the relevant HCPCS code is G0471.
                 In addition, section 1833(h)(3)(B) of the Act requires the
                Secretary to provide for and establish a fee to cover the
                transportation and personnel expenses for trained personnel to travel
                to the location of an individual to collect the sample, except that
                such a fee may be provided only with respect to an individual who is
                homebound or an inpatient in an inpatient facility (other than a
                hospital). In accordance with this provision, Medicare established a
                travel allowance for a laboratory technician to draw a specimen from
                homebound patients and non-hospital inpatients. Under current guidance,
                the travel allowance is intended to cover the estimated travel costs of
                collecting a specimen from a Medicare beneficiary and to reflect the
                technician's salary and travel costs. It is paid only when the nominal
                specimen collection is also payable and is not available if the
                technician is merely performing a messenger service to pick a specimen
                drawn by a physician or nursing home personnel. The methodology for
                determining the travel allowance varies depending on the round trip
                mileage to patients' homes. For instance, a per mile travel allowance
                methodology applies when the round trip to patients' homes is greater
                than 20 miles and a flat rate travel allowance methodology applies when
                the round trip to patients' homes is less than 20 miles. Medicare Part
                B MACs calculate the travel allowance for each claim. We have heard
                from stakeholders that in some cases the MAC requires them to maintain
                paper logs of miles traveled to receive the travel allowance.
                 CMS' current policies for payment of the nominal specimen
                collection fee and the fee to cover transportation and expenses for
                trained personnel to collect specimens from homebound patients and non-
                hospital inpatients are set forth in Pub. 100-04, Medicare Claims
                Processing Manual, chapter 16, section 60. We also implemented the
                increased nominal specimen collection fee under section 1834A(b)(5) of
                the Act in our regulations at Sec. 414.507(f). The manual instructions
                regarding payment of these fees are available on the CMS website at
                https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c16.pdf. Neither the annual cash deductible nor the 20
                percent coinsurance for Medicare apply to the specimen collection fees
                or travel allowance for laboratory tests.
                 This IFC is establishing the following changes to the specimen
                collection fee policy for the duration of the PHE for the COVID-19
                pandemic. We will provide for Medicare payment of a nominal specimen
                collection fee and associated travel allowance to independent
                laboratories for collection of specimens related to COVID-19 clinical
                diagnostic laboratory testing for homebound and non-hospital
                inpatients. Stakeholders have informed us that access to COVID-19
                testing in facilities especially is limited due to the resource costs
                associated with acquiring the samples in a manner that prevents
                exposure for patients and health care workers. With patients confined
                to their homes for their own safety or the safety of others, there is
                an additional need to have patients tested in their homes and minimize
                exposure to others. We believe that providing a specimen collection fee
                for COVID-19 testing during the PHE will provide independent
                laboratories with additional resources to provide this testing and at
                the same time help with efforts to limit patients' exposure to the
                general population and alleviate patients' unease with leaving the
                home.
                 Under this policy, the nominal specimen collection fee for COVID-19
                testing for homebound and non-hospital inpatients generally will be
                $23.46 and for individuals in a SNF or individuals whose samples will
                be collected by laboratory on behalf of an HHA will be $25.46.
                Medicare-enrolled independent laboratories can bill Medicare for the
                specimen collection fee using one of two new HCPCS codes for specimen
                collection for COVID-19 testing and bill for the travel allowance with
                the current HCPCS codes set forth in section 60.2 of the Medicare
                Claims Processing Manual (P9603 and P9604). Our policy will also
                incorporate the clarification in the definition of homebound as
                discussed in section II.F. of this IFC, relating to the clarification
                of homebound status under the Medicare home health benefit.
                 In establishing a nominal fee for COVID-19 specimen collection, we
                considered the type of trained laboratory personnel required to collect
                the specimen and the resources this type of collection could require.
                As noted previously, the current specimen collection fee HCPCS codes on
                the CLFS for homebound and non-hospital inpatients are $3 and $5, but
                we recognize that these fees are not intended to address additional
                resources needed during the PHE for the COVID-19 pandemic. Absent
                concrete information regarding the costs associated with independent
                laboratories collecting such specimens for COVID-19 tests in the
                context of the PHE, we looked to similar services in other settings of
                care as a potential benchmark. In looking at other Medicare payment
                systems, we believe the PFS is the best source for a potential payment
                amount since physicians and other practitioners often bill for services
                that involve specimen collection by trained, non-institutional staff.
                 Under the PFS, a Level 1 office visit (CPT code 99211) typically
                does not require the presence of a physician or other qualified health
                care professional and the usual presenting problem(s) are minimal. This
                code is what is typically reported by physician practices when the
                patient only sees clinical office staff
                [[Page 19257]]
                for services like acquiring a routine specimen sample. CPT code 99211,
                describes an:
                 Office visit for E/M of an established patient that may be
                performed by clinical staff under supervision (may not require a
                physician's presence). Usually the presenting problem(s) are minimal
                and typically 5 minutes are spent supervising or performing the
                service.
                 The CY 2020 national PFS payment amount for Level 1 established
                patient office visits is $23.46 on the PFS. We also considered
                establishing a higher payment amount that considered the Level 1 E/M
                visit plus the payment amount for CPT code 89220, Sputum obtaining
                specimen aerosol induced technique, for a specimen collection fee of
                $40.06, but we believe there is likely overlapping costs in staff time
                for these two services and the Level 1 office visit payment rate is
                adequate.
                 For initial diagnostic testing for COVID-19, the CDC issued interim
                guidelines that recommend collecting and testing for the virus using an
                upper respiratory nasopharyngeal swab (NP). The CDC guidance also
                states that collection of oropharyngeal swabs (OP) is a lower priority
                and if collected should be combined in the same tube as the NP. The CDC
                guidance advises that collection of sputum should only be done for
                those patients with productive coughs. See https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html. Similar
                collection method types, that is, NP or OP swabs are also used in other
                laboratory developed tests for COVID-19.
                 Section 1833(h)(3) of the Act does not specifically describe the
                types of specimen collection methods that are eligible for the nominal
                fee and transportation and personnel expenses. However, section
                1833(h)(3)(B) of the Act does refer to ``trained personnel'' that would
                collect the sample from homebound individuals and inpatients in non-
                hospital inpatient facilities. This suggests that to be medically
                necessary and for payment to be made for sample collection, the method
                of sample collection must require some training or skill on the part of
                the laboratory technician and cannot be conducted by the beneficiary,
                the beneficiary's caregiver, or facility staff if the facility does not
                have a laboratory, and therefore, is using an outside laboratory to
                perform its testing of patients. The Medicare Claims Processing Manual
                provides additional guidance on the medical necessity requirements for
                specimen collection. Specifically, the manual states that ``Medicare
                allows payment for a specimen collection fee when it is medically
                necessary for a laboratory technician to draw a specimen from either a
                nursing home patient or homebound patient'' and that ``the technician
                must personally draw the specimen.'' It also states that ``[t]his fee
                will not be paid to anyone who has not extracted the specimen'' and
                lists ``venipuncture or urine sample by catheterization'' as examples
                of a technician personally drawing the specimen. The manual further
                clarifies what it means for a specimen collection to be medically
                necessary stating that ``. . .where the specimen is a type that would
                require only the services of a messenger and would not require the
                skills of a laboratory technician, for example, urine or sputum, a
                specimen pickup service would not be considered medically necessary.''
                 We note that venipuncture and urine sample by catheterization are
                currently provided in the Medicare Claims Processing Manual as examples
                of a technician personally drawing a specimen, however, they are not an
                exhaustive list of all possible scenarios that require trained
                personnel to collect a specimen. In the case of collecting a specimen
                for COVID-19 testing, we believe that in the context of and for the
                duration of the PHE for the COVID-19 pandemic, collecting specimens
                using NP or OP swabs or collection of sputum will require a trained
                laboratory professional, as well as additional precautions that must be
                taken to minimize exposure risks in handling specimens that are
                suspected or confirmed for COVID-19. Thus, we believe that collecting a
                specimen for COVID-19 testing will incur higher costs than similar
                specimen collection services which require a trained laboratory
                professional but not additional precautions, to minimize exposure
                risks. The CDC advises that specimen collection must be performed
                correctly the first time the specimen is collected. A focus of the
                response to the PHE for the COVID-19 pandemic is to quickly identify
                individuals who are infected so that appropriate treatment for the
                patients being tested is provided in a timely manner. At the same time,
                another goal is to appropriately isolate those patients and quarantine
                those exposed to the patients to prevent further spread of the virus.
                We believe laboratory personnel will need to be trained on how to
                handle the specimen to maximize accurate test results for COVID-19.
                Laboratory personnel also will need to be trained on how to minimize
                risks for spreading the virus to themselves and/or others in the chain
                of handling the specimen before it arrives at the laboratory for
                analysis. The CDC guidance states that specimens should be collected as
                soon as possible once a person under investigation (PUI) is identified,
                regardless of the time of symptom onset, and that proper infection
                control must be maintained when collecting specimens. We believe that
                specimens for COVID-19 testing using NP, OP, or sputum must be
                collected by trained laboratory personnel, and the specimens are a type
                that would not require only the services of a messenger or specimen
                pick up service. The manual currently lists collection of sputum as a
                type that would require only the services of a messenger, and
                therefore, is not considered medically necessary. However, for the PHE
                for the COVID-19 pandemic only, we believe a specimen collection fee
                for sputum collection would be warranted and medically necessary due to
                the reasons discussed previously. If in the future other types of
                COVID-19 tests are available, such as serological tests or point of
                care tests, we note that the specimen collection fee would apply if the
                specimen collection method must be performed by trained laboratory
                personnel. However, COVID-19 tests that allow patients to collect the
                specimen themselves would not be eligible for the specimen collection
                fee.
                 To identify specimen collection for COVID-19 testing, we are
                establishing two new level II HCPCS codes. Independent laboratories
                must use one of these HCPCS codes when billing Medicare for the nominal
                specimen collection fee for COVID-19 testing for the duration of the
                PHE for the COVID-19 pandemic. These new HCPCS codes are:
                 G2023, specimen collection for severe acute respiratory
                syndrome coronavirus [hairsp]2 (SARS-CoV-2) (Coronavirus disease
                [COVID-19]), any specimen source.
                 G2024, specimen collection for severe acute respiratory
                syndrome coronavirus [hairsp]2 (SARS-CoV-2) (Coronavirus disease
                [COVID-19]), from an individual in a SNF or by a laboratory on behalf
                of a HHA, any specimen source.
                 We created the second Level II HCPCS code, G2024, because section
                1834A(b)(5) of the Act and our regulations at Sec. 414.507(f) require
                a higher fee for collecting a specimen from an individual in a SNF or
                by a laboratory on behalf of an HHA, as described previously in this
                section of the IFC. We will issue guidance when the PHE for the COVID-
                19 pandemic is over and when these codes are no longer valid and
                terminated in the HCPCS file and/or the CLFS as appropriate.
                [[Page 19258]]
                 In addition, Medicare payment for transportation and expenses for
                trained personnel to collect specimens from homebound patients (as
                discussed in section II.F. of this IFC, relating to the clarification
                of homebound status under the Medicare home health benefit) and
                inpatients (not in a hospital) for purposes of COVID-19 testing will be
                made in accordance with existing instructions found in the Medicare
                Claims Processing Manual. Independent laboratories must use the
                existing level II HCPCS codes when billing for the travel allowance,
                that is, the per mile travel allowance as described by HCPCS code P9603
                and the flat rate travel allowance as described by HCPCS code P9604.
                Additionally, we are clarifying that paper documentation of miles
                traveled is not required and laboratories can maintain electronic logs
                with that information. However, laboratories will need to be able to
                produce these electronic logs in a form and manner that can be shared
                with MACs. As stated previously, we have heard from stakeholders that
                maintaining paper logs of miles is burdensome, especially with the
                development of GPS systems and various applications for cellular phones
                in recent years that can track miles traveled. Thus, we are clarifying
                that there is no requirement that laboratories maintain logs on paper
                to document travel, and that laboratories may use digital documentation
                of this information if preferred. The MACs may provide more information
                on acceptable formats.
                 In defining an individual who is homebound for purposes of the
                specimen collection fee and the travel allowance under section
                1833(h)(3) of the Act, the manual refers to Chapters 7 and 15 of Pub.
                100-02, the Medicare Benefit Policy Manual. The definition of
                ``homebound'' in Chapters 7 and 15 of Pub. 100-02 originate from the
                statutory definition of ``confined to the home'' (that is,
                ``homebound'') under sections 1814(a) and 1835(a) of the Act. As
                discussed in section II.F. of this IFC, relating to the clarification
                of homebound status under the Medicare home health benefit patients are
                considered ``confined to the home'' (that is, ``homebound'') if it is
                medically contraindicated for the patient to leave the home. When it is
                medically contraindicated for a patient to leave the home, there exists
                a normal inability for an individual to leave home and leaving home
                safely would require a considerable and taxing effort.
                 As an example for the PHE for COVID-19 pandemic, this would apply
                for those patients: (1) Where a physician has determined that it is
                medically contraindicated for a beneficiary to leave the home because
                he or she has a confirmed or suspected diagnosis of COVID-19; or (2)
                where a physician has determined that it is medically contraindicated
                for a beneficiary to leave the home because the patient has a condition
                that may make the patient more susceptible to contracting COVID-19. A
                patient who is exercising ``self-quarantine'' for his or her own
                safety, would not be considered ``homebound'' unless it is also
                medically contraindicated for the patient to leave the home.
                Determinations of whether the patient is homebound must be based on an
                assessment of each beneficiary's individual condition. For the PHE for
                the COVID-19 pandemic, the CDC is currently advising that older adults
                and individuals with serious underlying health conditions stay home
                (CDC's guidance is interim and is expected to continue to be updated as
                warranted).\14\ As such, during the PHE for the COVID-19 pandemic, we
                expect that many Medicare beneficiaries could be considered
                ``homebound''. In light of this clarification regarding the definition
                of homebound, we are noting this clarification pertains to the specimen
                collection fee and travel allowance in the PHE for COVID-19 pandemic
                testing for homebound patients; that is, a patient is considered
                homebound for purposes of the fees under sections 1833(h)(3) and
                1834A(b)(5) of the Act if it is medically contraindicated for the
                patient to leave home.
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                 \14\ https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/high-risk-complications.html.
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                 In summary, to address the PHE for the COVID-19 pandemic, we are
                using this IFC as a vehicle to provide additional payment during the
                PHE in the form of a specimen collection fee of $23.46 generally, and
                $25.46 for an individual in a SNF or by a laboratory on behalf of a
                HHA, for COVID-19 testing and to provide a travel allowance for a
                laboratory technician to collect a specimen for COVID-19 testing from a
                non-hospital inpatients or homebound patients under section 1833(h)(3)
                of the Act.
                N. Requirements for Opioid Treatment Programs (OTP)
                 In the CY 2020 PFS final rule (84 FR 62645 and 62646), we finalized
                allowing the use of interactive two-way audio/video communication
                technology to furnish the counseling and therapy portions of the weekly
                bundle of services furnished by OTPs. In light of the PHE for the
                COVID-19 pandemic, during which the public has been instructed to
                practice self-isolation or social distancing, and because interactive
                audio-video communication technology may not be available to all
                beneficiaries, we are revising Sec. 410.67(b)(3) and (4) to allow the
                therapy and counseling portions of the weekly bundles, as well as the
                add-on code for additional counseling or therapy, to be furnished using
                audio-only telephone calls rather than via two-way interactive audio-
                video communication technology during the PHE for the COVID-19 pandemic
                if beneficiaries do not have access to two-way audio/video
                communications technology, provided all other applicable requirements
                are met. We believe this change is necessary to ensure that
                beneficiaries with opioid use disorders are able to continue to receive
                these important services during the current PHE.
                O. Application of Teaching Physician and Moonlighting Regulations
                During the PHE for the COVID-19 Pandemic
                a. Background
                 In context of the PHE for the COVID-19 pandemic, we have been asked
                by stakeholders to relax supervision requirements related to the
                provision of teaching physician services under the PFS. For teaching
                physicians, section 1842(b) of the Act specifies that in the case of
                physicians' services furnished to a patient in a hospital with a
                teaching program, the Secretary shall not provide payment for such
                services unless the physician renders sufficient personal and
                identifiable physicians' services to the patient to exercise full,
                personal control over the management of the portion of the case for
                which payment is sought. We have also been asked to allow residents to
                independently furnish services in their capacity as fully licensed
                physicians outside of the scope of their approved GME residency in the
                inpatient setting of the hospital at which they provide services.
                b. Revisions to Teaching Physician Regulations During a PHE for the
                COVID-19 Pandemic
                 Regulations regarding PFS payment for teaching physician services
                and moonlighting are codified in 42 CFR part 415. Under Sec. 415.172,
                if a resident participates in a service furnished in a teaching
                setting, PFS payment is made only if the teaching physician is present
                during the key portion of any service or procedure for which payment is
                sought. The provisions in Sec. 415.174 exempt certain office/
                outpatient E/M services provided in the outpatient department of a
                hospital or another ambulatory care
                [[Page 19259]]
                entity (that is, primary care centers) from the physical presence
                requirement for the key portion of the service, pending all provisions
                of the regulation are met. The regulations in Sec. 415.180 state that
                for the interpretation of diagnostic radiology and other diagnostic
                tests, PFS payment is made if the interpretation is performed or
                reviewed by a physician other than a resident. For Sec. 415.184, the
                requirement for the presence of the teaching physician during
                psychiatric services in which a resident is involved may be met by
                observation of the service by use of a one-way mirror, video equipment,
                or similar device.
                 In context of the PHE for the COVID-19 pandemic, teaching hospitals
                have expressed a need to increase their capacity to respond to the PHE
                for the COVID-19 pandemic because there has been increased demand for
                physicians to respond to patient needs. For example, we have been asked
                by stakeholders to allow Medicare to make payment under the PFS for
                services billed by teaching physicians when residents have furnished
                the entirety of a service in the inpatient setting in the area of their
                approved GME program and have a teaching physician review and sign off
                on the service, rather than requiring the teaching physician be
                physically present for the key portion of the service.
                 Given the circumstances of the PHE for the COVID-19 pandemic, we
                believe that the requirements for the physical presence of the teaching
                physician during the key portion of the service would necessarily limit
                access to services paid under the PFS. We recognize that in some cases,
                the physical proximity of the physician might present additional
                exposure risks, especially for high risk patients isolated for their
                own protection or in cases where the teaching physician and/or the
                resident has been exposed to the virus and must be under quarantine, or
                who may be at home caring for family members or providing childcare. If
                the teaching physician and/or the resident is under quarantine or at
                home, it could unintentionally limit the number of licensed
                practitioners available to furnish services to Medicare patients and
                could have the unintended consequence of limiting access to services
                paid under the PFS.
                 To increase the capacity of teaching settings to respond to the PHE
                for the COVID-19 pandemic as more practitioners are increasingly being
                asked to assist with the COVID-19 response, on an interim basis, for
                the duration of the PHE for the COVID-19 pandemic, we are amending the
                teaching physician regulations to allow that as a general rule under
                Sec. 415.172, the requirement for the presence of a teaching physician
                can be met, at a minimum, through direct supervision by interactive
                telecommunications technology, as described in section II.E. of this
                IFC. In other words, the teaching physician must provide supervision
                either with physical presence or be present through interactive
                telecommunications technology during the key portion of the service.
                Specifically, we believe that when use of such real-time, audio and
                video telecommunications technology allows for the teaching physician
                to interact with the resident through virtual means, their ability to
                furnish assistance and direction could be met without requiring the
                teaching physician's physical presence for the key portion of the
                service.
                 Currently, under the primary care exception in Sec. 415.174,
                certain lower and mid-level office/outpatient E/M services provided in
                primary care centers are exempt from the physical presence requirement
                for the key portion of the service. The teaching physician must direct
                the care from such proximity as to constitute immediate availability
                (that is, provide direct supervision). In context of the PHE for the
                COVID-19 pandemic, the teaching physician may be under quarantine or
                otherwise at home, or the physical proximity of the teaching physician
                might present additional exposure risks. Additionally, during the PHE
                for the COVID-19 pandemic, more patients may present with more complex
                needs, such as an underlying condition that places them at high risk
                for COVID-19 and that necessitate a high level office/outpatient E/M
                service (that is, level 4 or 5 visit). Consequently, on an interim
                basis, for the duration of the PHE for the COVID-19 pandemic, we are
                amending Sec. 415.174 to allow that all levels of an office/outpatient
                E/M service provided in primary care centers may be provided under
                direct supervision of the teaching physician by interactive
                telecommunications technology. We believe use of real-time, audio and
                video telecommunications technology allows for the teaching physician
                to interact with the resident through virtual means, and thus would
                meet the requirement for teaching physician presence for office/
                outpatient E/M services furnished in primary care centers. For Sec.
                415.180, for the duration of the PHE for the COVID-19 pandemic, we will
                allow PFS payment to be made for the interpretation of diagnostic
                radiology and other diagnostic tests when the interpretation is
                performed by a resident under direct supervision of the teaching
                physician by interactive telecommunications technology. The teaching
                physician must still review the resident's interpretation. For Sec.
                415.184, for the duration of the PHE for the COVID-19 pandemic, the
                requirement for the presence of the teaching physician during the
                psychiatric service in which a resident is involved may be met by the
                teaching physician's direct supervision by interactive
                telecommunications technology. For both Sec. Sec. 415.180 and 415.184,
                allowing residents to furnish these services under direct supervision
                of the teaching physician by interactive telecommunications technology
                would allow for the presence requirement to be met. These diagnostic
                radiology, diagnostic tests, and psychiatry services could continue to
                be provided to patients that need them in the event the teaching
                physician is in quarantine or otherwise at home, or where the physical
                proximity of the teaching physical might present additional exposure
                risk.
                 The regulations describing PFS payment for teaching physician
                services do have additional exceptions for specific policies. For
                example, as described in Sec. 415.172, in the case of surgical, high-
                risk, or other complex procedures, the teaching physician must be
                present during all critical portions of the procedure and immediately
                available to furnish services during the entire service or procedure.
                In the case of procedures performed through an endoscope, the teaching
                physician must be present during the entire viewing. As described in
                Sec. 415.178 for anesthesia services, the teaching anesthesiologist
                must be present during all critical or key portions of the anesthesia
                service or procedure involved and the teaching anesthesiologist must be
                immediately available to furnish anesthesia services during the entire
                procedure. Given the complex nature of these procedures and the
                potential danger to the patient, even in the context of the PHE for the
                COVID-19 pandemic and the inherent exposure risks for patients and
                physicians, we believe that the requirements for physical presence for
                either the entire procedure or the key portions of the service,
                whichever are applicable, are necessary for patient safety. Thus, the
                PHE for the COVID-19 pandemic exceptions previously described will not
                apply in the case of surgical, high risk, interventional, or other
                complex procedures, services performed through an endoscope, and
                anesthesia services. We seek comment
                [[Page 19260]]
                on whether other procedures should also be exempt from this policy
                given the complex nature or potential danger to the patient.
                 Collectively, the flexibilities described for Sec. Sec. 415.172,
                415.174, 415.180, and 415.184 are intended to ensure there are as many
                qualified practitioners as possible. They are also intended to minimize
                the number of people coming into contact with one another by removing
                the need for in-person direct supervision. We view direct supervision
                by interactive telecommunications technology as the minimum requirement
                for provision of the service for purposes of Medicare payment. However,
                teaching physicians may continue to exercise their clinical judgment to
                decide whether it is appropriate to utilize these flexibilities in
                furnishing their services involving residents. We also seek comment on
                our belief that direct supervision by interactive telecommunications
                technology is appropriate in the context of this PHE, as well as
                whether any guardrails should be included, and how it balances risks
                that might be introduced for beneficiaries with reducing exposure risk
                and the increased spread of the disease, in the context of this PHE.
                c. Application of the Expansion of Telehealth Services to Teaching
                Physician Services
                 On March 17, 2020, we announced the expansion of telehealth
                services on a temporary and emergency basis pursuant to waiver
                authority added under section 1135(b)(8) by the Coronavirus
                Preparedness and Response Supplemental Appropriations Act.\15\ Starting
                on March 1, 2020, Medicare can pay for telehealth services, including
                office, hospital, and other visits furnished by physicians and other
                practitioners to patients located anywhere across the country including
                in a patient's place of residence. We have been asked by stakeholders
                to clarify whether this expansion applies to teaching physician
                services, including those furnished under the primary care exception.
                We believe that allowing Medicare payment for services billed by the
                teaching physician when the resident is furnishing services, including
                office/outpatient E/M services provided in primary care centers, via
                telehealth under direct supervision by interactive telecommunications
                technology would allow residents to furnish services remotely to
                patients who may need to be isolated for purposes of exposure risk
                based on presumed or confirmed COVID-19 infection, and as a result,
                would increase access to services for patients. To increase the
                capacity of teaching settings to respond to the PHE for the COVID-19
                pandemic as more practitioners are increasingly being asked to assist
                with the COVID-19 response, we believe that, for telehealth services
                involving residents, the requirement that a teaching physician be
                present for key portions of the service can be met through virtual
                means. We also believe same is true for telehealth services furnished
                by the resident in primary care centers. The use of real-time, audio
                and video telecommunications technology allows for the teaching
                physician to interact with the resident through virtual means while the
                resident is furnishing services via telecommunications technology, and
                thus, in the circumstances of the PHE, would meet the requirement for
                teaching physician presence for office/outpatient E/M services
                furnished in primary care centers. Consequently, on an interim basis
                for the duration of the PHE for the COVID-19 pandemic, we are revising
                our regulations to specify that Medicare may make payment under the PFS
                for teaching physician services when a resident furnishes telehealth
                services to beneficiaries under direct supervision of the teaching
                physician which is provided by interactive telecommunications
                technology. Additionally, on an interim basis, for the duration of the
                PHE for the COVID-19 pandemic, Medicare may make payment under the PFS
                for services billed under the primary care exception by the teaching
                physician when a resident furnishes telehealth services to
                beneficiaries under the direct supervision of the teaching physician by
                interactive telecommunications technology. We also seek comment on our
                belief that direct supervision by interactive telecommunications
                technology is appropriate in the context of this PHE, as well as
                whether and how it balances risks that might be introduced for
                beneficiaries with reducing exposure risk and the increased spread of
                the disease, in the context of this PHE.
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                 \15\ https://www.cms.gov/newsroom/press-releases/president-trump-expands-telehealth-benefits-medicare-beneficiaries-during-covid-19-outbreak.
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                d. Payment Under the PFS for Teaching Physician Services When Resident
                Under Quarantine
                 There also may be circumstances in which the resident may need to
                furnish services while under quarantine (for example, while at home).
                We have been asked by stakeholders if residents who have been exposed
                to COVID-19 and are under quarantine, and otherwise well and able to
                work, are able to furnish services that do not require face-to-face
                patient care, such as reading the results of tests and other imaging
                studies. Because current regulations require the physical presence of
                the teaching physician during the key portion of the service, residents
                would not be able to furnish services from quarantine, which could
                limit the number of licensed practitioners available to furnish
                services to Medicare patients and could have the unintended consequence
                of limiting access to services paid under the PFS. Because we are
                amending the teaching physician regulations to allow that as a general
                rule under Sec. 415.172, the requirement for the presence of a
                teaching physician can be met through direct supervision by interactive
                telecommunications technology, on an interim basis, for the duration of
                the PHE for the COVID-19 pandemic, Medicare may also make payment under
                the PFS for teaching physician services when the resident is furnishing
                these services while in quarantine under direct supervision of the
                teaching physician by interactive telecommunications technology. We
                believe this policy will limit exposure to COVID-19 and to allow for
                the continued access to physicians' services of residents while in
                quarantine.
                e. Revisions to Moonlighting Regulations During a PHE for the COVID-19
                Pandemic
                 A licensed resident physician is considered to be ``moonlighting''
                when they furnish physicians' services to outpatients outside the scope
                of an approved graduate medical education (GME) program. Under current
                regulations, the services of residents in hospitals in which the
                residents have their approved GME program are not considered separately
                billable as physicians' services and instead are payable under
                Sec. Sec. 413.75 through 413.83 regarding direct GME payments, whether
                or not the services are related to the approved GME training program.
                When a resident furnishes services that are not related to their
                approved GME programs in an outpatient department or emergency
                department of a hospital in which they have their training program,
                those services can be billed separately as physicians' services and
                payable under the PFS if they meet the criteria described in our
                regulation at Sec. 415.208(b)(2).
                 In light of the PHE for the COVID-19 pandemic, teaching hospitals
                need to secure as much physician coverage as possible because there has
                been increased demand for physicians to
                [[Page 19261]]
                respond to patient needs, such as furnishing services to patients in
                inpatient settings who have either a presumed or confirmed COVID-19
                infection. Stakeholders have requested that residents be able to
                furnish physicians' services to patients in the inpatient setting
                outside of the scope of their approved GME programs in the hospital
                where they have their training.
                 We believe that our regulation at Sec. 415.208(b), which limits
                the scope of services that can be separately billable by moonlighting
                residents when furnished outside their approved GME programs to
                patients in an outpatient department or emergency department of a
                hospital in which they have their training program, does not adequately
                meet the needs of teaching hospitals to ensure there are as many
                qualified practitioners available as possible given the circumstances
                of the PHE for the COVID-19 pandemic. Under current policy, for
                example, a resident in a hospital's approved GME program for anesthesia
                who typically furnishes only anesthesia-related services in an
                operating room would not be able to provide separately billable
                physicians' services when treating inpatients in the intensive care
                unit for COVID-19 infection, even if these services were not part of
                the resident's approved GME program. As a result, this regulation could
                unintentionally limit the number of licensed practitioners available to
                furnish services to Medicare patients and could have the unintended
                consequence of limiting access to critically needed care. Consequently,
                on an interim basis, for the duration of the PHE for the COVID-19
                pandemic, we are amending our regulation in Sec. 415.208 to state that
                the services of residents that are not related to their approved GME
                programs and are performed in the inpatient setting of a hospital in
                which they have their training program are separately billable
                physicians' services for which payment can be made under the PFS
                provided that the services are identifiable physicians' services and
                meet the conditions of payment for physicians' services to
                beneficiaries in providers in Sec. 415.102(a), the resident is fully
                licensed to practice medicine, osteopathy, dentistry, or podiatry by
                the State in which the services are performed, and the services are not
                performed as part of the approved GME program.
                P. Special Requirements for Psychiatric Hospitals (Sec. 482.61(d))
                 In the June 16, 2016 Federal Register, we published the ``Medicare
                and Medicaid Programs; Hospital and Critical Access Hospital (CAH)
                Changes To Promote Innovation, Flexibility, and Improvement in Patient
                Care'' proposed rule (81 FR 39447), which outlined a number of proposed
                hospital and CAH Condition of Participation (CoP) requirements,
                including those focused on infection control, antibiotic use, and scope
                of practice for NPPs (that is, advanced practice providers (APPs) such
                as PAs, NPs, psychologists, and CNSs, as well as other qualified,
                licensed practitioners to whom this revision might also be applicable).
                 Subsequently, in the September 30, 2019 Federal Register, we
                published the ``Medicare and Medicaid Programs; Hospital and Critical
                Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and
                Improvement in Patient Care'' final rule (84 FR 51775) that finalized
                several of these proposed changes to modernize the hospital and CAH
                requirements, improve quality of care, and support HHS and CMS
                priorities. In that final rule, we deleted the modifying term
                ``independent'' from the Patient's Rights CoP at 42 CFR 482.13(e)(5)
                and (e)(8)(ii) regarding which practitioners may order the use of
                restraints and seclusion. These revisions to the regulatory text were
                intended to finally make the language of the hospital CoPs consistent
                with the language of the Children's Health Act of 2000 (CHA) (Pub. L.
                106-310, enacted October 17, 2000) regarding restraint and seclusion
                orders and licensed practitioners, and upon which the CoP language was
                originally intended to be based. Additionally, and to remain consistent
                throughout this CoP, we revised Sec. 482.13(e)(10) and (11),
                (e)(12)(i)(A), (e)(14), and (g)(4)(ii) that contained the term
                ``licensed independent practitioner'' by changing the term from
                ``licensed independent practitioner'' to simply ``licensed
                practitioner.''
                 In the final rule, we stated that the revision reflected our goal
                to have health professionals operate within the scope of practice
                allowed by state law, and that it also recognized the need to fully
                utilize the healthcare workforce. We also stated that we believe that
                this change will reduce unnecessary burden for hospitals and remove
                obstacles APPs face when ordering seclusion and restraints. However, we
                stated that we disagreed with the commenters who stated that the
                removal of the term ``independent'' will cause confusion over the
                applicability of this requirement. Our removal of the term
                ``independent'' is consistent with the language used in the CHA, which
                utilizes the term ``other licensed practitioner,'' without the
                independent modifying term. In addition, the order of restraint or
                seclusion must be ordered by a licensed practitioner who is authorized
                by hospital policy in accordance with State law to do so.
                 In the September 30, 2019 final rule, we made additional revisions
                to address other areas of the hospital CoPs that we viewed as being
                either conflicting with, or more stringent than, existing state scope-
                of-practice laws and licensing requirements, and which, if
                appropriately revised, would give APPs greater flexibility to practice
                more broadly in the current healthcare system while still being in
                accordance with respective state scope-of-practice laws.
                 Therefore, in our review of the Hospital CoPs for the proposed
                rule, we discovered that there were several provisions that incorrectly
                reference Sec. 482.12(c)(1), which lists the types of physicians and
                applies only to patients who are Medicare beneficiaries. Section
                482.12(c) states that the governing body of the hospital must ensure
                that every Medicare patient is under the care of one of the following
                practitioners:
                 A doctor of medicine or osteopathy;
                 A doctor of dental surgery or dental medicine who is
                legally authorized to practice dentistry by the State and who is acting
                within the scope of his or her license;
                 A doctor of podiatric medicine, but only with respect to
                functions which he or she is legally authorized by the State to
                perform;
                 A doctor of optometry who is legally authorized to
                practice optometry by the State in which he or she practices;
                 A chiropractor who is licensed by the State or legally
                authorized to perform the services of a chiropractor, but only with
                respect to treatment by means of manual manipulation of the spine to
                correct a subluxation demonstrated by X-ray to exist; and
                 A clinical psychologist as defined in Sec. 410.71, but
                only for a clinical psychologist services as defined in Sec. 410.71
                and only to the extent permitted by State law.
                 The reference of this ``Medicare beneficiary-only'' requirement in
                certain other provisions of the hospital CoPs (which we have listed
                below) inappropriately links it to all patients and not Medicare
                beneficiaries exclusively. In fact, per section 1861(e)(4) of the Act,
                every patient with respect to whom payment may be made under this title
                must be under the care of a physician except that a patient receiving
                qualified psychologist services (as defined in subsection (ii)) may be
                under the care of a clinical psychologist with respect to such services
                to the extent permitted under State law. In
                [[Page 19262]]
                accordance with that provision, we have chosen to apply Sec. 482.12(c)
                to Medicare patients. With the exception of a few provisions in the
                CoPs such as those directly related to Sec. 482.12(c) described here,
                the remainder of the CoPs apply to all patients, regardless of payment
                source, and not just Medicare beneficiaries. For example, the Nursing
                Services CoP, at Sec. 482.23(c)(1), requires that all drugs and
                biologicals must be prepared and administered in accordance with
                Federal and State laws, the orders of the practitioner or practitioners
                responsible for the patient's care as specified under Sec. 482.12(c),
                and accepted standards of practice. Since the CoPs clearly allow
                hospitals to determine which categories of practitioners would be
                responsible for the care of other patients, outside the narrow Medicare
                beneficiary restrictions of Sec. 482.12(c), this reference is
                inappropriate and unnecessarily restrictive of hospitals and their
                medical staffs to make these determinations based on State law and
                practitioner scope of practice.
                 To clarify that these provisions apply to all patients and not only
                Medicare beneficiaries, we deleted any inappropriate references to
                Sec. 482.12(c) in the final rule. Therefore, we deleted references to
                Sec. 482.12(c) found in the following provisions: Sec. 482.13(e)(5),
                (e)(8)(ii), (e)(14), and (g)(4)(ii) in the Patients' Rights CoP; and
                Sec. 482.23(c)(1) and (3) in the Nursing Services CoP. We note here
                that we did not receive any comments on these changes as they proposed
                in the June 2016 proposed rule, and therefore, we finalized them
                without change.
                 In performing our most recent review of the hospital CoPs,
                including the Requirements for Specialty Hospitals at subpart E of 42
                CFR part 482, we discovered that we inadvertently failed to propose to
                delete another inappropriate reference to Sec. 482.12(c), which is
                contained in the current provision at Sec. 482.61(d) in the Special
                Medical Record Requirements for Psychiatric Hospitals CoP (pertaining
                to which hospital personnel may complete progress notes for patients).
                The current provision also contains the term ``licensed independent
                practitioner.'' Therefore, in the interests of consistency with the
                other recent revisions we have noted here, we are now deleting the
                reference to Sec. 482.12(c) along with the modifier ``independent'' in
                this IFC.
                 We believe that as currently written and implemented, this
                requirement requires some clarification for the reasons that we have
                discussed. As we have already stated and made clear through our recent
                revisions to the hospital CoPs, we believe that APPs, including PAs,
                NPs, psychologists, and CNSs (as well as other qualified, licensed
                practitioners to whom this revision might also be applicable), when
                acting in accordance with State law, their scope of practice, and
                hospital policy, should have the authority to practice more broadly and
                to the highest level of their education, training, and qualifications
                as allowed under their respective state requirements and laws in this
                area.
                 We believe that NPPs practicing in the psychiatric hospital setting
                should be able to record progress notes of psychiatric patients for
                whom they are responsible. Therefore, we will allow the use of NPPs, or
                APPs, to document progress notes of patients receiving services in
                psychiatric hospitals, in addition to MDs/DOs as is currently allowed.
                 Given the changes made to the requirements under Sec. 482.13
                regarding the removal of the word ``independent'' from the phrase
                ``licensed independent practitioner'' when referencing NPPs that we
                have previously discussed, we are making the same change for this
                provision. We believe that the regulatory language should be as
                consistent as possible throughout the hospital CoPs and, in addition,
                as was the case with the requirement under Sec. 482.13, using the term
                ``licensed independent practitioner'' may inadvertently exacerbate
                workforce shortage concerns, might unnecessarily impose regulatory
                burden on hospitals by restricting a hospital's ability to allow APPs
                and other NPPs to operate within the scope of practice allowed by state
                law, and does not recognize the benefits to patient care that might be
                derived from fully utilizing APPs and their clinical skills to the
                highest levels of their training, education, and experience as allowed
                by hospital policy in accordance with state law. We believe that this
                change permits a greater scope of practice for these professionals in
                the psychiatric hospital context.
                Q. Innovation Center Models
                1. Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency
                Policy
                 Through this IFC, we are amending the Medicare Diabetes Prevention
                Program (MDPP) expanded model to modify certain MDPP policies during
                the PHE. Specifically, this IFC will permit certain beneficiaries to
                obtain the set of MDPP services more than once per lifetime, increase
                the number of virtual make-up sessions, and allow certain MDPP
                suppliers to deliver virtual MDPP sessions on a temporary basis. These
                changes are in response to COVID-19, which resulted in an interruption
                to expanded model services delivered by MDPP suppliers and/or prevented
                MDPP beneficiaries from attending sessions. Throughout the rulemaking
                for the MDPP expanded model, we sought to ensure that the MDPP set of
                services would be delivered in-person, in a classroom based setting,
                within an established timeline. At the time, the priority was placed on
                establishing a structured service that, when delivered within the
                confines of the rule, would create the least risk of fraud and abuse,
                increase the likelihood of success, and maintain the integrity of the
                data collected for evaluation purposes. However, the COVID-19 pandemic
                has led to suspension of in-person class sessions and guidance from CDC
                that Medicare-age beneficiaries stay home. In response, we will
                implement provisions that allow for temporary flexibilities that
                prioritize availability and continuity of services for MDPP suppliers
                and MDPP beneficiaries impacted by extreme and uncontrollable
                circumstances during the COVID-19 PHE. The changes in this IFC are
                applicable to MDPP suppliers, as defined in Sec. 410.79(b), that are
                enrolled in MDPP as March 1, 2020, and MDPP beneficiaries as defined in
                Sec. 410.79(b) who were receiving MDPP set of services as of March 1,
                2020. Under these temporary flexibilities, the requirement for in-
                person attendance at the first core-session will remain in effect. As a
                result, if beneficiaries are prohibited from attending the first core
                session in person, suppliers will be unable to start any new cohorts
                with MDPP beneficiaries. All flexibilities described in this IFC will
                cease to be available at the conclusion of the PHE. The CDC issued
                guidance to all National Diabetes Prevention Program suppliers on or
                about March 12, 2020, providing alternative delivery options during the
                COVID-19 national emergency, including encouraging organizations to use
                virtual make-up sessions as necessary, regardless of usual delivery
                mode; if virtual make-up sessions are not possible, organizations may
                pause offering classes. When classes resume, the CDC is allowing
                suppliers to pick up where they left off, or to restart the expanded
                model program from week one. It is our intent to conform with the CDC
                guidance where feasible, with the overall intent to minimize disruption
                of services for MDPP suppliers and MDPP beneficiaries; by allowing MDPP
                beneficiaries to maintain their
                [[Page 19263]]
                eligibility. We are amending the MDPP regulations to provide for
                certain changes, including allowing MDPP suppliers to either deliver
                MDPP services virtually or suspend in-person services and resume
                services at a later date. The limit to the number of virtual make-up
                sessions is waived for MDPP suppliers with existing capabilities to
                provide services virtually, so long as the virtual services are
                furnished in a manner that is consistent with the CDC Diabetes
                Prevention Recognition Program (DPRP) standards for virtual sessions,
                follow the CDC-approved DPP curriculum requirements, and are provided
                upon the individual MDPP beneficiary's request. In addition, the MDPP
                supplier may only furnish to the MDPP beneficiary a maximum of one
                session on the same day as a regularly scheduled session and a maximum
                of one virtual make-up session per week. Virtual make-up sessions may
                only be furnished to achieve attendance goals and may not be furnished
                to achieve weight-loss goals. An MDPP supplier may offer to an MDPP
                beneficiary no more than: 15 virtual make-up sessions offered weekly
                during the core session period; 6 virtual make-up sessions offered
                monthly during the core maintenance session interval periods; and 12
                virtual make-up sessions offered monthly during the ongoing maintenance
                session interval periods.
                 In addition, these changes permit certain MDPP beneficiaries to
                obtain the set of MDPP services more than once per lifetime, for the
                limited purposes of allowing a pause in service and to provide the
                flexibilities that will allow MDPP beneficiaries to maintain
                eligibility for MDPP services despite a break in service, attendance,
                or weight loss achievement.
                 We are amending our provisions at Sec. 410.79 by adding paragraph
                (e).
                2. Changes to the Comprehensive Care for Joint Replacement (CJR) Model
                To Extend the Length of Performance Year 5 by Three Additional Months
                and To Change the Extreme and Uncontrollable Circumstances Policy To
                Account for the COVID-19 Pandemic
                 Through this IFC, we are implementing two changes to the
                Comprehensive Care for Joint Replacement (CJR) model to support the
                continuity of model operations and to ensure that CJR participants do
                not unfairly suffer financial consequences from the impact of COVID-19
                due to their participation in CJR. Specifically, we are implementing a
                3-month extension to CJR performance year (PY) 5 such that the model
                will now end on March 31, 2021, rather than ending on December 31,
                2020. On February 24, 2020, we published a proposed rule titled
                ``Medicare Program: Comprehensive Care for Joint Replacement Model
                Three-Year Extension and Changes to Episode Definition and Pricing''
                (85 FR 10516; CMS-5529-P). We wish to ensure continuity of CJR model
                operations in participant hospitals during this PHE for the COVID-19
                pandemic so that we do not create any additional disruptions to the
                standard care procedures hospitals have in place during this
                challenging time. Therefore, we are implementing a 3-month extension of
                CJR PY 5 and amending the provisions at 42 CFR 510.2 and 510.200(a) to
                reflect that extension.
                 Further, recognizing that the current CJR model policy for extreme
                and uncontrollable circumstances policy is not applicable to the PHE
                for the COVID-19 pandemic, we also are implementing a change to that
                policy in this IFC such that it will be applicable to episodes impacted
                by the COVID-19 pandemic. Currently, the CJR extreme and uncontrollable
                circumstances policy, which is codified at Sec. 510.305(k), applies
                only during major disaster declarations where a participant hospital
                and its beneficiaries are affected by natural disasters, such as,
                hurricanes, earthquakes, wildfires.\16\ Although the COVID-19 outbreak
                in the United States was declared as a national emergency on March 13,
                2020,\17\ the current CJR extreme and uncontrollable circumstances
                policy does not apply to this national emergency. Although we do not
                expect many new CJR episodes to initiate as we have recently issued
                guidance \18\ stressing the need to avoid elective surgeries in light
                of the COVID-19 virus, we recognize that a number of beneficiaries are
                in active CJR episodes that initiated prior to March 2020. Further, we
                acknowledge that CJR hip fracture episodes, which generally result from
                emergent accidents and are not necessarily avoidable, will continue to
                occur. Given the challenges to the health care delivery system in
                responding to COVID-19 cases and the expenses associated with treating
                this highly contagious virus, we want to avoid inadvertently creating
                incentives to place cost considerations above patient safety within the
                CJR model during this COVID-19 pandemic. Therefore, to enable the CJR
                model to adjust for the effect of COVID-19, we are broadening the
                extreme and uncontrollable circumstances policy by applying certain
                financial safeguards to participant hospitals that have a CCN primary
                address that is located in an emergency area for episodes that overlap
                with the emergency period, as those terms are defined in section
                1135(g) of the Act, for which the Secretary issued a waiver or
                modification of requirements under section 1135 of the Act on March 13,
                2020, which applies nationwide.\19\ Accordingly, all participant
                hospitals are located in the emergency area and qualify for applicable
                financial safeguards during the emergency period.
                ---------------------------------------------------------------------------
                 \16\ 82 FR 57066.
                 \17\ See: https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
                 \18\ See: https://www.cms.gov/files/document/31820-cms-adult-elective-surgery-and-procedures-recommendations.pdf.
                 \19\ See https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
                ---------------------------------------------------------------------------
                 Amending the extreme and uncontrollable circumstances policy to
                account for all participant hospitals affected by the COVID-19 pandemic
                allows participant hospitals to concentrate on patient care and ensures
                that participant hospitals are not held financially liable for episode
                costs that escalate due to effects from the COVID-19 pandemic. While
                this amendment greatly broadens the extreme and uncontrollable
                circumstances policy, the significant impact the health care delivery
                system faces in responding to COVID-19 cases and the expenses
                associated with treating this highly-contagious virus justifies
                modifying the extreme and uncontrollable circumstances policy and
                increasing the financial safeguards. Specifically, we are stating that
                for a fracture or non-fracture episode with a date of admission to the
                anchor hospitalization that is on or within 30 days before the date
                that the emergency period (as defined in section 1135(g) of the Act)
                begins or that occurs through the termination of the emergency period
                (as described in section 1135(e) of the Act), actual episode payments
                are capped at the target price determined for that episode under Sec.
                [thinsp]510.300. Though different financial safeguards apply for
                fracture and non-fracture episodes when a major disaster declaration is
                declared, we believe applying equal financial safeguards for both
                episodes during the COVID-19 pandemic is more appropriate due to its
                nationwide impact on hospitals and post-acute care facilities ability
                to provide care for beneficiaries during this PHE.
                 We are codifying these provisions at Sec. 510.305 (k)(3) and (4).
                [[Page 19264]]
                3. Alternative Payment Model Treatment Under the Quality Payment
                Program
                 As has been described previously in this IFC, we are seeking to
                give entities and individuals that provide services to Medicare
                beneficiaries needed flexibilities to respond effectively to the
                serious public health threats posed by the spread of the COVID-19, and
                to address the needs of health care providers specific to this declared
                national emergency. We further recognize that flexibilities may be
                necessary and appropriate in the context of Alternative Payment Models
                (APMs), including applicable model tests conducted under section 1115A
                of the Act by the CMS Center for Medicare and Medicaid Innovation
                (Innovation Center), as well as the Medicare Shared Savings Program. We
                note that aspects of APM policies under the Quality Payment Program are
                designed to follow on from the specific designs, policies, and
                operations of individual APMs. We recognize that our current
                regulations may be insufficient for purposes of adequately responding
                to the still-emerging COVID-19 national emergency and that additional
                action may be necessary and appropriate to prevent APM participants
                from facing undue burden in or negative consequences through the
                Quality Payment Program.
                 We acknowledge that possible changes might be needed to address
                issues that may arise for APM participants in light of the current
                emergency. We will consider undertaking additional rulemaking,
                including possibly another interim final rule, to amend or suspend APM
                QPP policies as necessary to ensure accurate and appropriate
                application of Quality Payment Program policies in light of the PHE due
                to COVID-19.
                R. Remote Physiologic Monitoring
                 In recent years, we have finalized payment for seven CPT codes in
                the Remote Physiologic Monitoring (RPM) code family. We finalized
                payment in the CY 2018 PFS final rule for CPT code 99091 (Collection
                and interpretation of physiologic data digitally stored and/or
                transmitted by the patient and/or caregiver to the physician or other
                qualified health care professional, qualified by education, training,
                licensure/regulation requiring a minimum of 30 minutes of time). The
                following year, we finalized payment for CPT codes 99453 (Remote
                monitoring of physiologic parameter(s)(e.g., weight, blood pressure,
                pulse oximetry, respiratory flow rate), initial; set-up and patient
                education on use of equipment), 99454 (Remote monitoring of physiologic
                parameter(s)(e.g., weight, blood pressure, pulse oximetry, respiratory
                flow rate), initial; device(s) supply with daily recording(s) or
                programmed alert(s) transmission, each 30 days), and 99457 (Remote
                physiologic monitoring treatment management services, clinical staff/
                physician/other qualified health care professional time in a calendar
                month requiring interactive communication with the patient/caregiver
                during the month; first 20 minutes)). Most recently, for the CY 2020
                PFS final rule (84 FR 62645 and 62646), we finalized a treatment
                management add-on code CPT code 99458 (Remote physiologic monitoring
                treatment management services, clinical staff/physician/other qualified
                health care professional time in a calendar month requiring interactive
                communication with the patient/caregiver during the month; each
                additional 20 minutes) and two self-measured blood pressure monitoring
                codes, CPT code 99473 (Self-measured blood pressure using a device
                validated for clinical accuracy; patient education/training and device
                calibration) and CPT code 99474 (Separate self-measurements of two
                readings one minute apart, twice daily over a 30-day period (minimum of
                12 readings), collection of data reported by the patient and/or
                caregiver to the physician or other qualified health care professional,
                with report of average systolic and diastolic pressures and subsequent
                communication of a treatment plan to the patient).
                 We are concerned that under the PHE for the COVID-19 pandemic,
                physicians and other health care professionals are faced with
                challenges regarding potential exposure risks for themselves and their
                patients. In response, the CDC has urged health care professionals to
                make every effort to interview patients by telephone, text monitoring,
                or video conferencing instead of in-person. We believe that RPM
                services support the CDC's goal of reducing human exposure to the novel
                coronavirus while also increasing access to care and improving patient
                outcomes.
                 RPM services are considered to be CTBS and, as such, would be
                billable only for established patients. Our goal during the PHE for the
                COVID-19 pandemic is to reduce exposure risks to the novel coronavirus
                for practitioners and patients and to increase access to services by
                eliminating as many obstacles as possible to delivering necessary
                services. Allowing RPM services to be furnished only to established
                patients could be an obstacle to delivery of reasonable and necessary
                care particularly during current conditions. Thus, in response to the
                PHE for the COVID-19 pandemic, we are finalizing on an interim basis,
                that RPM services can be furnished to new patients, as well as to
                established patients.
                 In addition to current policy that there be an established patient-
                practitioner relationship, we require for CTBS at least verbal consent
                from a Medicare beneficiary to receive the services. We finalized this
                requirement to avoid scenarios where beneficiaries are unexpectedly
                responsible for copays for services that do not involve the typical in-
                person, face-to-face service that a patient receives during an office
                visit. We continue to believe that patient consent is important.
                However, we also believe that acquiring patient consent should not
                interfere with the provision of RPM services during the PHE for the
                COVID-19 pandemic. Therefore, we are finalizing on an interim basis
                that consent to receive RPM services can be obtained once annually,
                including at the time services are furnished, during the duration of
                the PHE for the COVID-19 pandemic. However, to enhance beneficiary
                protection, for both new and established patients, we suggest that the
                physician or other health care practitioner review consent information
                with a beneficiary, obtain the beneficiary's verbal consent, and
                document in the medical record that consent was obtained.
                 Finally, we are clarifying that RPM codes can be used for
                physiologic monitoring of patients with acute and/or chronic
                conditions. The typical patient needing RPM services may have a chronic
                condition (for example, high blood pressure, diabetes, COPD). However,
                RPM can be used for other conditions. For example, RPM services allow a
                patient with an acute respiratory virus to monitor pulse and oxygen
                saturation levels using pulse oximetry. Nurses, working with
                physicians, can check-in with the patient and then using patient data,
                determine whether home treatment is safe, all the while reducing
                exposure risk and eliminating potentially unnecessary emergency
                department and hospital visits.
                S. Telephone Evaluation and Management (E/M) Services
                 For CY 2008, the CPT Editorial Panel created CPT codes to describe
                E/M services furnished by a physician or qualified healthcare
                professional via telephone or online, including CPT codes 98966
                (Telephone assessment and management service provided by a qualified
                nonphysician health care professional to an established patient,
                [[Page 19265]]
                parent, or guardian not originating from a related assessment and
                management service provided within the previous 7 days nor leading to
                an assessment and management service or procedure within the next 24
                hours or soonest available appointment; 5-10 minutes of medical
                discussion), 98967 (Telephone assessment and management service
                provided by a qualified nonphysician health care professional to an
                established patient, parent, or guardian not originating from a related
                assessment and management service provided within the previous 7 days
                nor leading to an assessment and management service or procedure within
                the next 24 hours or soonest available appointment; 11-20 minutes of
                medical discussion), 98968 (Telephone assessment and management service
                provided by a qualified nonphysician health care professional to an
                established patient, parent, or guardian not originating from a related
                assessment and management service provided within the previous 7 days
                nor leading to an assessment and management service or procedure within
                the next 24 hours or soonest available appointment; 21-30 minutes of
                medical discussion), 99441 (Telephone evaluation and management service
                by a physician or other qualified health care professional who may
                report evaluation and management services provided to an established
                patient, parent, or guardian not originating from a related E/M service
                provided within the previous 7 days nor leading to an E/M service or
                procedure within the next 24 hours or soonest available appointment; 5-
                10 minutes of medical discussion), 99442 (Telephone evaluation and
                management service by a physician or other qualified health care
                professional who may report evaluation and management services provided
                to an established patient, parent, or guardian not originating from a
                related E/M service provided within the previous 7 days nor leading to
                an E/M service or procedure within the next 24 hours or soonest
                available appointment; 11-20 minutes of medical discussion), and 99443
                (Telephone evaluation and management service by a physician or other
                qualified health care professional who may report evaluation and
                management services provided to an established patient, parent, or
                guardian not originating from a related E/M service provided within the
                previous 7 days nor leading to an E/M service or procedure within the
                next 24 hours or soonest available appointment; 21-30 minutes of
                medical discussion). We assigned a status indicator of ``N''
                (Noncovered) to these services because: (1) These services are non-
                face-to-face; and (2) the code descriptors include language that
                recognizes the provision of services to parties other than the
                beneficiary for whom Medicare does not provide coverage (for example, a
                guardian).
                 We do not believe that we should continue to consider these to be
                categorically non-covered services. In PFS rulemaking subsequent to CY
                2008, we established separate payment for numerous non-face-to-face
                services, including care management services and prolonged non-face-to-
                face E/M services. We have also noted, for example in CY 2017, that we
                recognize that in current medical practice, practitioner interaction
                with caregivers is an integral part of treatment for some patients.
                Accordingly, the descriptions for several payable codes under the PFS
                include direct interactions between practitioners and caregivers (81 FR
                80331).
                 When we established separate payment for services like virtual
                check-ins and e-visits, we recognized that non-face-to-face services
                had become an important part of overall physician care of Medicare
                beneficiaries, especially relative to care for chronic conditions. The
                current Medicare policy regarding the CPT codes that describe telephone
                E/M services predated our ongoing recognition of the need to pay
                separately for these kinds of services. Despite the fact that these are
                classified as E/M services in the coding, we do not believe that these
                codes describe full E/M services, but rather are closely analogous to
                the virtual check-in services. Although we assigned a ``Noncovered''
                status indicator for the telephone E/M codes, we still established the
                American Medical Association's RUC-recommended RVUs for them. To
                establish the payment rate for the virtual check-in service, we used
                the RUC-recommended valuation for the lowest level telephone E/M code.
                However, the telephone E/M codes provide additional stratification by
                time for circumstances when a practitioner spends more than a brief
                amount of time in direct communication with the patient. We believe
                that under ordinary circumstances outside of the PHE, if the needs of
                the patient are significant enough to require the amount of time and
                attention from the practitioner specified in the codes for higher level
                telephone evaluations or assessments, either an in-person visit or a
                telehealth visit would be required. Alternatively, if the needs of the
                patient are less acute and lengthy, a virtual check-in would suffice.
                However, in the context of the goal of reducing exposure risks
                associated with the PHE for the COVID-19 pandemic, especially in the
                case that two-way, audio and video technology required to furnish a
                Medicare telehealth service might not be available, we believe there
                are many circumstances where prolonged, audio-only communication
                between the practitioner and the patient could be clinically
                appropriate yet not fully replace a face-to-face visit. We believe that
                the existing telephone E/M codes, in both description and valuation,
                are the best way to recognize the relative resource costs of these
                kinds of services. Therefore, we are finalizing, on an interim basis
                for the duration of the PHE for the COVID-19 pandemic, separate payment
                for CPT codes 98966-98968 and CPT codes 99441-99443. For these codes,
                we are finalizing on an interim basis for the duration of the PHE for
                the COVID-19 pandemic, work RVUs as recommended by the AMA Health Care
                Professionals Advisory Committee (HCPAC) for CY PFS 2008 rulemaking as
                discussed in the CY 2008 PFS final rule (72 CFR 66371) of 0.25 for CPT
                code 98966, 0.50 work RVUs for CPT code 98967, and 0.75 for CPT code
                98968, and work RVUs as recommended by the AMA Relative Value Scale
                Update Committee (RUC) of 0.25 for CPT code 99441, 0.50 for CPT code
                99442, and 0.75 for CPT code 99443. We are finalizing the HCPAC and
                RUC-recommended direct PE inputs which consist of 3 minutes of post-
                service RN/LPN/MTA clinical labor time for each code.
                 Similar to the CTBS described in section II.D. of this IFC, we
                believe it is important during the PHE to extend these services to both
                new and established patients. While some of the code descriptors refer
                to ``established patient,'' during the PHE we are exercising
                enforcement discretion on an interim basis to relax enforcement of this
                aspect of the code descriptors. Specifically, we will not conduct
                review to consider whether those services were furnished to established
                patients. CPT codes 98966-98968 described assessment and management
                services performed by practitioners who cannot separately bill for E/
                Ms. We are noting that these services may be furnished by, among
                others, LCSWs, clinical psychologists, and physical therapists,
                occupational therapists, and speech language pathologists when the
                visit pertains to a service that falls within the benefit category of
                those practitioners.
                 To facilitate billing of these services by therapists, we are
                designating CPT codes 98966-98968 as CTBS ``sometimes therapy''
                services that
                [[Page 19266]]
                would require the private practice occupational therapist, physical
                therapist, and speech-language pathologist to include the corresponding
                GO, GP, or GN therapy modifier on claims for these services.
                T. Physician Supervision Flexibility for Outpatient Hospitals--
                Outpatient Hospital Therapeutic Services Assigned to the Non-Surgical
                Extended Duration Therapeutic Services (NSEDTS) Level of Supervision
                 Non-surgical extended duration therapeutic services (NSEDTS)
                describe services that have a significant monitoring component that can
                extend for a sizable period of time, that are not surgical, and that
                typically have a low risk of complications after the assessment at the
                beginning of the service. The minimum default supervision level of
                NSEDTS was established in the CY 2011 OPPS/ASC final rule with comment
                period (75 FR 72003 through 72013) as being direct supervision during
                the initiation of the service, which may be followed by general
                supervision at the discretion of the supervising physician or the
                appropriate NPP (Sec. 410.27(a)(1)(iv)(E)). In this case, initiation
                means the beginning portion of the NSEDTS which ends when the patient
                is stable and the supervising physician or the appropriate NPP
                determines that the remainder of the service can be delivered safely
                under general supervision. We established general supervision as the
                appropriate level of supervision after the initiation of the service
                because it is challenging for hospitals to ensure direct supervision
                for services with an extended duration and a significant monitoring
                component, particularly for CAHs and small rural hospitals.
                 In the CY 2020 OPPS/ASC final rule with comment period (84 FR 61359
                through 61363), we changed the generally applicable minimum required
                level of supervision for most hospital outpatient therapeutic services
                from direct supervision to general supervision for hospitals and CAHs.
                Given the circumstances of the PHE for the COVID-19 pandemic, we
                believe it is critical that hospitals have the most flexibility as
                possible to provide the services Medicare beneficiaries need during
                this challenging time. Changing the minimum default level of
                supervision to general supervision for NSEDTS during the initiation of
                the service will give providers additional flexibility they will need
                to handle the burdens created by the PHE for the COVID-19 pandemic.
                 Therefore, we are assigning, on an interim basis, all outpatient
                hospital therapeutic services that fall under Sec.
                410.27(a)(1)(iv)(E), a minimum level of general supervision to be
                consistent with the minimum default level of general supervision that
                applies for most outpatient hospital therapeutic services, and we are
                revising Sec. 410.27(a)(1)(iv)(E) to reflect this change in the
                minimum level of supervision. General supervision, as defined in our
                regulation at Sec. 410.32(b)(3)(i) means that the procedure is
                furnished under the physician's overall direction and control, but that
                the physician's presence is not required during the performance of the
                procedure.
                U. Application of Certain National Coverage Determination and Local
                Coverage Determination Requirements During the PHE for the COVID-19
                Pandemic
                 National Coverage Determinations (NCDs) are determinations by the
                Secretary with respect to whether or not a particular item or service
                is covered nationally under Title XVIII. Local Coverage Determinations
                (LCDs) are determinations by a Medicare Administrative Contractor (MAC)
                with respect to whether or not a particular item or service is covered
                under section 1862(a)(1)(A) of the Act in the particular MAC's
                geographical areas. Articles are often published alongside LCDs and
                contain coding or other guidelines that complement an LCD. NCDs and
                LCDs contain clinical conditions a patient must meet to qualify for
                coverage of the item or service. Some NCDs and LCDs may also contain
                requirements for face-to-face, timely evaluations or re-evaluations for
                a patient to initially qualify for coverage or to qualify for
                continuing coverage of the item or service. These requirements are more
                often present in NCDs and LCDs for durable medical equipment than for
                other items and services.
                1. Face-to-Face and In-Person Requirements
                 For the duration of this PHE for the COVID-19 pandemic, it is in
                the best interest of patients, health care professionals and suppliers
                to limit face-to-face encounters and avoid exposure of vulnerable
                Medicare beneficiaries to COVID-19. Therefore, on an interim basis, we
                are finalizing that to the extent an NCD or LCD (including articles)
                would otherwise require a face-to-face or in-person encounter for
                evaluations, assessments, certifications or other implied face-to-face
                services, those requirements would not apply during the PHE for the
                COVID-19 pandemic.
                 We note that some face-to-face encounter requirements for DMEPOS
                Power Mobility Devices (PMDs) are mandated by statute for program
                integrity purposes. This IFC does not apply to those statutory
                requirements. For example, PMD face-to-face encounter requirements are
                found in section 1834(a)(1)(E)(iv) of the Act, as codified in Sec.
                410.38, and our regulation already permits the use of telehealth in
                accordance with Medicare guidelines. We have extended flexibilities to
                permit a broader use of telehealth services during the PHE for the
                COVID-19 pandemic. It should be noted that this does not confer changes
                to the clinical indications of coverage for any LCD or NCD unless
                specifically indicated below.
                2. Clinical Indications for Certain Respiratory, Home Anticoagulation
                Management and Infusion Pump Policies
                 During the PHE for the COVID-19 pandemic, it is possible that
                patients receiving services for respiratory related indications will be
                required to receive care in unexpected settings, including the home.
                This may be necessary as COVID-19 and other patients are shifted across
                healthcare settings to accommodate an increase in patient volume.
                 Therefore, we are finalizing on an interim basis that we will not
                enforce the clinical indications for coverage across respiratory, home
                anticoagulation management and infusion pump NCDs and LCDs (including
                articles) allowing for maximum flexibility for practitioners to care
                for their patients. This enforcement discretion will only apply during
                the PHE for the COVID-19 pandemic. These policies include, but are not
                limited to:
                 NCD 240.2 Home Oxygen.
                 NCD 240.4 Continuous Positive Airway Pressure for
                Obstructive Sleep Apnea.
                 LCD L33800 Respiratory Assist Devices (ventilators for
                home use).
                 NCD 240.5 Intrapulmonary Percussive Ventilator.
                 LCD L33797 Oxygen and Oxygen Equipment (for home use).
                 NCD 190.11 Home Prothrombin Time/International Normalized
                Ratio (PT/INR) Monitoring for Anticoagulation Management.
                 NCD 280.14 Infusion Pumps.
                 LCD L33794 External Infusion Pumps.
                 At the conclusion of the PHE for the COVID-19 pandemic, we will
                return to enforcement of these clinical indications for coverage.
                [[Page 19267]]
                3. Requirements for Consultations or Services Furnished by or With the
                Supervision of a Particular Medical Practitioner or Specialist
                 Staffing is being adjusted in both facility and non-facility
                settings to accommodate for the needs of patients during the PHE for
                the COVID-19 pandemic. These staffing decisions may impact the
                availability of physicians and physician specialists to furnish
                evaluations, consultations and procedures or to supervise others. To
                the extent NCDs and LCDs require a specific practitioner type or
                physician specialty to furnish a service, procedure or any portion
                thereof, we are finalizing on an interim basis the chief medical
                officer or equivalent of the facility can authorize another physician
                specialty or other practitioner type to meet those requirements during
                the PHE for the COVID-19 pandemic. Additionally, to the extent NCDs and
                LCDs require a physician or physician specialty to supervise other
                practitioners, professionals or qualified personnel, the chief medical
                officer of the facility can authorize that such supervision
                requirements do not apply during the PHE for the COVID-19 pandemic.
                V. Change to Medicare Shared Savings Program Extreme and Uncontrollable
                Circumstances Policy
                 In December 2017, we issued an interim final rule with comment
                period, titled ``Medicare Shared Savings Program: Extreme and
                Uncontrollable Circumstances Policies for Performance Year 2017''
                (hereinafter referred to as the ``December 2017 interim final rule with
                comment period''), which appeared in the Federal Register on December
                26, 2017 (82 FR 60912 through 60919). The December 2017 interim final
                rule with comment period established a policy for determining quality
                performance scores for accountable care organizations (ACOs)
                participating in the Medicare Shared Savings Program (Shared Savings
                Program), when the ACO, its participating ACO providers and suppliers,
                and assigned beneficiaries were located in geographic areas that were
                impacted by extreme and uncontrollable circumstances, such as
                hurricanes, wildfires, or other triggering events, during performance
                year (PY) 2017, including the applicable quality data reporting period
                for the performance year if the quality reporting period was not
                extended. In the CY 2019 PFS final rule we extended the extreme and
                uncontrollable circumstances policy finalized for PY 2017 to PY 2018
                and subsequent performance years. Under the policy adopted in that
                final rule, for a given performance year, including the applicable
                quality data reporting period for the performance year if the quality
                reporting period is not extended, we will use an alternative approach
                to calculating the quality score for ACOs affected by extreme and
                uncontrollable circumstances (42 CFR 425.502(f)).
                 Under this current policy at Sec. 425.502(f), the Shared Savings
                Program extreme and uncontrollable circumstances policy does not apply
                for a performance year if an extreme and uncontrollable circumstance
                occurs during the quality reporting period for that performance year
                and the quality reporting period is extended. For all performance years
                starting in 2019, the original quality reporting period was January 2,
                2020, through March 31, 2020. In response to the PHE for the COVID-19
                pandemic, we have determined that the 2019 MIPS data submission
                deadline will be extended by 30 days until April 30, 2020, to give
                eligible clinicians more time to report quality and other data for
                purposes of MIPS. This extended timeline also applies to Shared Savings
                Program ACOs because they are required to report quality data via the
                CMS Web Interface and we align the Shared Savings Program data
                submission timeline with the timeline for MIPS data submission. While
                the extended timeframe for data submission is intended to give eligible
                clinicians sufficient time to complete all the elements of MIPS
                reporting during the PHE for the COVID-19 pandemic, we realize that
                this extension alone may not be sufficient to ease the burden of
                reporting given the increased burden of providing care to all patients
                during this time. For this reason, under the Quality Payment Program,
                we have determined that the MIPS automatic extreme and uncontrollable
                circumstances policy will apply to MIPS eligible clinicians, who do not
                submit their MIPS data by the extended timeline. Under this automatic
                extreme and uncontrollable circumstances policy, MIPS eligible
                clinicians, who are not participants in APMs, who do not submit any
                MIPS data will have all performance categories reweighted to zero
                percent, resulting in a score equal to the performance threshold, and a
                neutral MIPS payment adjustment. However, under the policy, if a MIPS
                eligible clinician submits data on two or more MIPS performance
                categories, they will be scored and receive a 2021 MIPS payment
                adjustment based on their final score.
                 The automatic extreme and uncontrollable circumstances policy
                described above does not apply to MIPS eligible clinicians who are
                subject to the APM scoring standard (82 FR 53899), such as MIPS
                eligible clinicians participating in Shared Savings Program ACOs.
                Instead, these MIPS eligible clinicians will continue to be scored
                under the existing APM scoring standard. Generally, if no MIPS eligible
                clinicians in an APM Entity submit data by the extended deadline for
                the Quality and Promoting Interoperability performance categories due
                to extreme and uncontrollable circumstances, the APM scoring standard
                would apply as follows. The Cost performance category will be weighted
                at zero percent, as usual. The Improvement Activities performance
                category will be scored as usual. The Quality performance category will
                be reweighted to zero percent where the APM has waived quality
                reporting for purposes of the APM as in these circumstances CMS
                determines that there are not sufficient measures or activities
                applicable and available to MIPS eligible clinicians, consistent with
                Sec. 414.1370(h). Finally, if all MIPS eligible clinicians in an APM
                Entity have been excepted from reporting the Promoting Interoperability
                performance category, then the Promoting Interoperability performance
                category weight will be reweighted to zero for the APM Entity for that
                MIPS performance period (Sec. 414.1370(g)(4)(iii)(A)). As a result, in
                these circumstances, the Quality, Cost, and Promoting Interoperability
                categories would all be weighted at zero percent. And as only one
                performance category will be scored, the Improvement Activities
                performance category, such MIPS eligible clinicians would receive a
                neutral MIPS payment adjustment.
                 For MIPS eligible clinicians participating in Shared Savings
                Program ACOs that do not report quality and obtain a neutral payment
                adjustment under MIPS, according to the existing APM scoring standard
                described above, the Shared Savings Program must determine that the
                ACOs are impacted by an extreme and uncontrollable circumstance and
                waive the quality reporting requirement under the Shared Savings
                Program. As currently written, the Shared Savings Program extreme and
                uncontrollable circumstances policy does not allow for the
                determination that an ACO has been impacted by an extreme and
                uncontrollable circumstance that occurs during the quality reporting
                period if quality reporting period is extended, as
                [[Page 19268]]
                it has been for performance years starting in 2019.
                 In addition, under the Shared Savings Program, if an ACO fails to
                report quality data by the submission deadline, the ACO will not have
                met the quality performance standard and will receive a quality score
                of zero, unless the extreme and uncontrollable circumstances policy
                under Sec. 425.502(f) applies. In the event an ACO receives a quality
                performance score of zero, the ACO would be ineligible to share in
                savings, if earned and would owe maximum losses if participating under
                Track 2 or the ENHANCED track. The current Medicare Shared Savings
                Program extreme and uncontrollable circumstances policy for purposes of
                determining an ACO's quality score for use in determining shared
                savings or losses applies if twenty percent or more of an ACO's
                assigned beneficiaries or its legal business entity are located in an
                area identified under the Quality Payment Program as being affected by
                an extreme and uncontrollable circumstance for the performance year,
                including the quality reporting period if the quality reporting period
                is not extended.
                 The effect of the MIPS quality reporting period extension is that
                the current Shared Savings Program extreme and uncontrollable
                circumstance policy does not apply, because the current extreme and
                uncontrollable circumstances policy is only available for extreme and
                uncontrollable circumstances that occur during the quality reporting
                period, such as the current PHE for the COVID-19 pandemic, if the
                quality reporting period is not extended. The inability to apply the
                extreme and uncontrollable circumstances policy to waive the quality
                reporting requirements under the Shared Savings Program during the PHE
                may adversely impact ACOs and their participating ACO providers and
                suppliers, because the extended timeline to submit data alone may not
                be sufficient to support ACOs and their participating ACO providers and
                suppliers, who are focused on care delivery during the national
                emergency.
                 The intent of the Shared Savings Program extreme and uncontrollable
                circumstance policy is to mitigate any impact on quality performance
                and the resultant effect on financial reconciliation due to emergency
                circumstances outside of the ACO's control. Accordingly, we believe it
                is necessary to revise the policies governing the availability of the
                Shared Savings Program extreme and uncontrollable circumstances
                policies to extend the protection to ACOs that may not be able to
                completely and accurately report their quality data for 2019, despite
                the extension of the quality reporting period. To provide relief to all
                ACOs participating in the Shared Savings Program during 2019, we need
                to modify the extreme and uncontrollable circumstances policy as it
                applies to disasters that occur during the reporting period to
                eliminate the restriction that the extreme and uncontrollable
                circumstances policy applies only if the reporting period is not
                extended.
                 As explained above, the PHE for the COVID-19 pandemic was declared
                during the quality reporting period for performance years starting in
                2019. The PHE for the COVID-19 pandemic applies to all counties in the
                United States, and we believe it is appropriate to offer relief under
                the Shared Savings Program extreme and uncontrollable circumstances
                policy to all Shared Savings Program ACOs that are unable to completely
                and accurately report quality for 2019 by the extended deadline due to
                the PHE for the COVID-19 pandemic. Due to the PHE for the COVID-19
                pandemic and our desire to provide relief for Shared Savings ACOs who
                need to focus resources on patient care at this time, we believe that
                this policy must be effective starting with the quality reporting
                period for performance years starting in 2019. Further, as illustrated
                by the current PHE for the COVID-19 pandemic, there may be
                unanticipated situations in the future, during which extension of a
                quality reporting window alone would not provide sufficient relief from
                reporting burden at a time when ACOs and their ACO providers and
                suppliers need to focus on patient care. Accordingly, in this IFC, we
                are revising the regulation at Sec. 425.502(f) to remove the
                restriction which prevents the application of the Shared Savings
                Program extreme and uncontrollable circumstances policy for disasters
                that occur during the quality reporting period if the reporting period
                is extended, to offer relief under the Shared Savings Program to all
                ACOs that may be unable to completely and accurately report quality
                data for 2019 due to the PHE for the COVID-19 pandemic. Specifically,
                we are amending the regulation at Sec. 425.502(f) to remove the phrase
                ``if the quality reporting period is not extended,'' effective with
                quality reporting for PY 2019.
                 We are considering whether the current policy, which assigns an ACO
                the higher of the mean quality score across all ACOs and the ACO's own
                quality score, in the event the ACO is determined to be impacted by an
                extreme and uncontrollable circumstances, will continue to be
                appropriate for PY 2020 and beyond. Any change to that current policy
                would be made through future notice and comment rulemaking.
                 Regarding Shared Savings Program financial reconciliations for
                performance years starting in 2019, we note that because the PHE for
                the COVID-19 pandemic was declared during the reporting period for
                those performance years, the provisions that allow for an adjustment to
                the amount of shared losses for ACOs found to be affected by an extreme
                and uncontrollable circumstance during a performance year would not
                apply for performance years starting in 2019. However, for PY 2020
                financial reconciliation, we will reduce the amount of an ACO's shared
                losses by an amount determined by multiplying the shared losses by the
                percentage of the total months in the performance year affected by an
                extreme and uncontrollable circumstance, and the percentage of the
                ACO's assigned beneficiaries who reside in an area affected by an
                extreme and uncontrollable circumstance. At this time, the PHE for the
                COVID-19 pandemic applies to all counties in the country; therefore,
                100 percent of assigned beneficiaries for all Shared Savings Program
                ACOs reside in an affected area and the total months affected by an
                extreme and uncontrollable circumstance will begin with March and
                continue through the end of the current PHE, as defined in Sec.
                400.200.
                 Additionally, the Medicare Shared Savings Program financial
                methodology includes updating each ACO's benchmark at the end of each
                performance year based on the performance year expenditure trend. The
                factors used to update ACOs' benchmarks will reflect the national and
                regional trends related to spending and utilization changes during
                2020, including any changes arising from the PHE for the COVID-19
                pandemic.
                W. Level Selection for Office/Outpatient E/M Visits When Furnished Via
                Medicare Telehealth
                 In the CY 2020 PFS final rule (84 FR 62847 and 62848), we finalized
                a number of changes to the framework of the office/outpatient E/M
                requirements for CY 2021. Beginning January 1, 2021 for office/
                outpatient E/M visits, the code level will be selected based on either
                the level of MDM or the total time personally spent by the reporting
                practitioner on the day of the visit
                [[Page 19269]]
                (including face-to-face and non-face-to-face time). We noted that there
                was broad support for these changes from the AMA and other specialty
                societies. Currently, telehealth office/outpatient E/Ms can be
                furnished to beneficiaries in their homes only when they are for
                individuals with a substance use disorder (SUD) diagnosis for purposes
                of treatment of such disorder or co-occurring mental health disorder.
                For these services, the primary factor in selecting the appropriate
                level of E/M service to bill would be time spent counseling the
                patient. Under the waiver issued by the Secretary pursuant to section
                1135(b)(8) of the Act, telehealth office/outpatient E/Ms can be
                furnished to any patient in their home regardless of their diagnosis or
                medical condition. However, the current E/M coding guidelines would
                preclude the billing practitioner from selecting the office/outpatient
                E/M code level based on time in circumstances where the practitioner is
                not engaged in counseling and/or care coordination.
                 On an interim basis, we are revising our policy to specify that the
                office/outpatient E/M level selection for these services when furnished
                via telehealth can be based on MDM or time, with time defined as all of
                the time associated with the E/M on the day of the encounter; and to
                remove any requirements regarding documentation of history and/or
                physical exam in the medical record. This policy is similar to the
                policy that will apply to all office/outpatient E/Ms beginning in 2021
                under policies finalized in the CY 2020 PFS final rule. It remains our
                expectation that practitioners will document E/M visits as necessary to
                ensure quality and continuity of care. To reduce the potential for
                confusion, we are maintaining the current definition of MDM. We note
                that currently there are typical times associated with the office/
                outpatient E/Ms, and we are finalizing those times as what should be
                met for purposes of level selection. The typical times associated with
                the office/outpatient E/Ms are available as a public use file at
                https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1715-F. This
                policy only applies to office/outpatient visits furnished via Medicare
                telehealth, and only during the PHE for the COVID-19 pandemic.
                X. Counting of Resident Time During the PHE for the COVID-19 Pandemic
                 In section II.O. of this IFC, ``Application of the Teaching
                Physician Regulations During the PHE for the COVID-19 pandemic,'' we
                state that the teaching supervision requirement can be met in certain
                circumstances through direct supervision using interactive
                telecommunications technology, including when a medical resident is
                quarantined at home. Regarding claiming of the residents for indirect
                medical education (IME) and Direct graduate medical education (DGME)
                purposes, under current regulations, if a resident is training in a
                hospital, that hospital claims the resident for IME and DGME (per Sec.
                413.78(a)), and if a resident is training in a nonprovider site such as
                a doctor's office or clinic, the hospital or hospitals that pays the
                resident's salaries and fringe benefits claims the resident for IME and
                DGME (per Sec. 413.78(g)). Currently, there is no provision in the
                regulations for a hospital to claim a resident for IME or DGME if the
                resident is performing patient care activities within the scope of his
                or her approved program in his or her own home, or in a patient's home.
                For the duration of this emergency situation, we are permitting the
                hospital that is paying the resident's salary and fringe benefits for
                the time that the resident is at home or in the home of a patient that
                is already a patient of the physician or hospital, but performing
                patient care duties within the scope of the approved residency program
                (and meets appropriate physician supervision requirements as stated in
                section II.O. of this IFC) to claim that resident for IME and DGME
                purposes.
                Y. Addressing the Impact of COVID-19 on Part C and Part D Quality
                Rating Systems
                1. Background
                a. Legislative Authority for Star Ratings
                 Based on its authority to disseminate comparative information,
                including about quality, to beneficiaries under sections 1851(d) and
                1860D-1(c) of the Act and authority to collect various types of quality
                data under section 1852(e) of the Act, CMS develops and publicly posts
                a 5-star ratings system for MA and Part D plans. That system is also
                the basis for determining quality bonus payment (QBP) status for MA
                plans under section 1853(o) of the Act. Section 1876 cost plans are
                also included in the MA and Part D Star Rating system as codified at 42
                CFR 417.472(k) and are also required by Sec. 417.472(j) to make CAHPS
                survey data available to CMS. In a final rule, ``Medicare Program;
                Contract Year 2019 Policy and Technical Changes to the Medicare
                Advantage, Medicare Cost Plans, Medicare Fee-for-Service, the Medicare
                Prescription Drug Benefit Programs, and the PACE Program,'' published
                on April 16, 2018 (83 FR 16519 through 16589), we adopted regulations
                to govern this quality rating system for cost MA and Part D plans,
                which are generally rated at the contract level. In a final rule,
                ``Medicare and Medicaid Program; Policy and Technical Changes to the
                Medicare Advantage, Medicare Prescription Drug Benefit, Programs of
                All-Inclusive Care for the Elderly (PACE), Medicaid Fee-for-Service,
                and Medicaid Managed Care Programs for Years 2020 and 2021,'' published
                April 16, 2019 (84 FR 15830 and 15831), we amended the regulations
                governing the quality rating program for MA and Part D plans. Those
                final rules contain a more detailed discussion of CMS' authority in
                this area and we encourage readers to refer to those final rules.
                 In the CY 2020 Final Call Letter and the CY 2020 final rule,
                published in the Federal Register on April 16, 2019 (84 FR 15830 and
                15831), we finalized a set of rules for adjusting the calculation of
                Star Ratings for the cost and Parts C and D organizations that are
                impacted by extreme and uncontrollable circumstances. We provided in
                the 2021 Advance Notice that the same policy as used for adjustments to
                2020 Star Ratings based on extreme and uncontrollable circumstances
                would be continued for CY 2021 Star Ratings. We did not envision the
                unprecedented circumstances surrounding the PHE for the COVID-19
                pandemic when we developed the adjustments for extreme and
                uncontrollable circumstances for the Part C and D Star Ratings program;
                as they exist currently, they are not sufficient in the case of the PHE
                for the COVID-19 pandemic.
                b. Overview of Star Ratings
                 The Star Ratings are generally based on measures of performance
                during a period that is 2 calendar years before the year for which the
                Star Ratings are issued; 2021 Star Ratings will generally be based on
                performance during 2019 and the 2022 Star Ratings will similarly be
                based on performance in 2020. We use multiple data sources to measure
                quality and performance of contracts. Various regulations require plans
                to report on quality improvement and quality assurance and to provide
                data which we can use to help beneficiaries compare plans (for example,
                Sec. Sec. 417.472(j) and (k), 422.152(b), 423.153(c), and 423.156). In
                addition, we may require plans to report statistics and other
                information in specific categories (Sec. Sec. 422.516 and 423.514).
                Data from these sources and other sources are used to calculate
                measures
                [[Page 19270]]
                of plan sponsor performance each year, as provided in Sec. Sec.
                422.162 and 423.182. The Star Ratings serve an important purpose in
                providing comparative information to enrollees and are also used to
                identify whether an MA plan is eligible for a QBP under section 1853(o)
                of the Act. The Patient Protection and Affordable Care Act (Pub. L.
                111-148), as amended by the Healthcare and Education Reconciliation Act
                (Pub. L. 111-152), provides for quality ratings, based on a 5-star
                rating system and the information collected under section 1852(e) of
                the Act, to be used in calculating payment to MA organizations
                beginning in 2012. Specifically, sections 1853(o) and 1854(b)(1)(c) of
                the Act were added and amended to provide, respectively, for an
                increase in the benchmark against which MA organizations bid and in the
                portion of the savings between the bid and the benchmark available to
                the MA organization to use as a rebate. We assign both low and high
                performing icons that are displayed on www.Medicare.gov to help
                Medicare beneficiaries make plan decisions based on either consistently
                low performance for 3 or more years or receiving 5 stars for the
                highest rating, respectively. Additionally, plans that demonstrate
                exceptional performance due to achieving a 5 Star Rating for their
                highest rating can market year round and beneficiaries receive a
                special election period that allows the eligible beneficiary to enroll
                in a 5-star plan during the contract year. We also have the authority
                to terminate plans that have below a 3-star rating for 3 or more years.
                The Star Ratings therefore serve a number of important purposes for
                cost, MA and Part D plans; we believe that plans engage in behavior
                during the performance measurement period to improve their Star Ratings
                and to achieve higher Star Ratings.
                 Healthcare Effectiveness Data and Information Set (HEDIS) and
                Consumer Assessment of Healthcare Providers and Systems (CAHPS) data
                are the basis for the calculation of the majority of measures for both
                the Part C and Part D Star Ratings. HEDIS measures include clinical
                measures assessing the effectiveness of care, access/availability
                measures, and service use measures and are calculated by CMS through a
                contract with the National Committee for Quality Assurance (NCQA). Many
                of the HEDIS measures require plans to perform reviews of patients'
                medical records or to obtain information directly from physician
                offices, which is a time-intensive activity.
                 CAHPS refers to a comprehensive family of surveys that ask
                consumers and patients to evaluate experiences of care. Cost plans,
                Part C plans, and Part D plans are all required by regulation
                (Sec. Sec. 417.472, 422.152, and 423.156, respectively) to contract
                with approved Medicare CAHPS survey vendors to conduct the Medicare
                CAHPS satisfaction survey of Medicare plan enrollees in accordance with
                CMS specifications and submit the survey data to CMS. The Star Ratings
                system uses measures from HEDIS and CAHPS extensively, and there are
                negative consequences for a plan's Star Ratings (overall and on
                specific measures) if the necessary data for the HEDIS and CAHPS
                measures are not reported or validated. Although the 2021 Star Ratings
                reflect performance in 2019 for most of the measures, data collection
                for HEDIS and CAHPS is conducted in the first half of CY 2020 to feed
                into the 2021 Star Ratings that are finalized by October 2020.
                Similarly, the Health Outcomes Survey will occur in 2020 to collect
                data used for the 2022 Star Ratings and the same concerns about survey
                activities apply to that survey.
                2. Impact of COVID-19 on Star Ratings Data Collection
                 The World Health Organization (WHO) has characterized COVID-19 as a
                pandemic, and there are alarming levels of spread and severity of
                COVID-19 across the United States. The CDC and medical professionals
                recommend that the best way to prevent the spread of the virus is to
                avoid contact with infected individuals. Social distancing is a method
                that public health officials use to curb the transmission and spread of
                infectious illnesses like COVID-19. Prior research has shown that these
                measures help mitigate the spread of contagious viruses in the absence
                of vaccines (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3372334/), as
                is the case with COVID-19.
                 To help curb the spread of COVID-19, governors around the country
                are putting in place actions to protect public health and safety and
                help mitigate the spread of the virus, including school closures,
                limiting the size of gatherings and events, and restaurant closures.
                Employers are moving to mandatory telework when feasible. The intent of
                these actions is to save lives, keep people safe, and slow the rate of
                infection. As of March 28, 2020, all 50 states were under a State of
                Emergency. Additionally, areas of the country are being put under
                shelter-in-place orders to further curtail the spread of the virus. CDC
                has provided guidance to health care facilities (for example, https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/guidance-hcf.html) that range from rescheduling non-urgent outpatient visits and
                elective surgeries, promoting telehealth visits, and managing mildly
                ill COVID-19 patients at home. Also, on March 16, 2020, CDC issued
                interim guidance (https://www.cdc.gov/coronavirus/2019-ncov/community/large-events/index.html) advising the public against holding gatherings
                of more than 10 individuals. On March 18, 2020, we released
                recommendations related to delaying adult elective surgeries, non-
                essential medical, surgical, and dental procedures during the COVID-19
                outbreak to be able to focus health care professionals on those most in
                need of healthcare (https://www.cms.gov/newsroom/press-releases/cms-releases-recommendations-adult-elective-surgeries-non-essential-medical-surgical-and-dental).
                 On March 13, 2020, President Trump declared a national emergency as
                a result of the COVID-19 pandemic. The declaration of the PHE for the
                COVID-19 pandemic allows certain Medicare requirements and conditions
                of participation to be waived under section 1135 of the Act providing
                more flexibility to providers in furnishing medically necessary health
                care to beneficiaries.
                 Currently, data collection for HEDIS measures is ongoing for
                services and performance during the 2019 measurement period. MA
                contracts are required to submit their HEDIS summary-level data to the
                NCQA by June 15, 2020, as well as to submit their HEDIS patient-level
                data to CMS the same day. Currently, data collection activities are
                underway to meet the June deadlines. Some of the HEDIS measures require
                medical record review or obtaining information directly from physician
                offices. We recognize that obtaining medical records from physician
                offices and the necessary documentation from physician offices needed
                for the plan to meet HEDIS requirements, and requiring plans to
                participate in HEDIS audits will put a strain on the limited resources
                available to these health care providers. Some of these activities are
                generally done in person so compliance with social distancing efforts,
                travel bans and quarantines raise additional challenges, as well as
                risks to staff. CMS' top priority is to ensure public health and
                safety, including that of beneficiaries, health and drug plan staff,
                and providers, and to allow health and drug plans, providers, and
                physician offices to focus on what is most important at this time: The
                provision of care.
                 Under Sec. Sec. 417.472(i) and (j), 422.152(b)(5), and 423.156,
                all
                [[Page 19271]]
                coordinated care MA plans, section 1876 contracts, and Part D sponsors,
                respectively, are required to contract with a CMS-approved CAHPS survey
                vendor to conduct the Medicare CAHPS satisfaction survey in accordance
                CMS specifications and to submit the data to CMS. The administration of
                the surveys and data collection are currently ongoing until the end of
                May 2020 for the CAHPS survey data that would be used for the 2021 Star
                Ratings. We are concerned that the COVID-19 pandemic will pose
                significant challenges and safety concerns in successfully completing
                the current CAHPS data collection. Most of the survey administration
                protocols cannot be completed remotely, requiring staff to work in mail
                facilities and call centers where telephone interviewers assemble in
                close quarters to perform the telephone administration of the survey.
                We are concerned that cost plans, MA organizations, and Part D plan
                sponsors will not be able to complete this year's data collection
                without jeopardizing the health and safety of survey vendor staff. We
                have similar concerns about the Health Outcomes Survey (HOS) data
                collection scheduled for later in 2020.
                 This IFC amends, as necessary, the calculations for the 2021 and
                2022 Part C and D Star Ratings to incorporate changes to address the
                expected impact of the PHE for the COVID-19 pandemic on data collection
                and performance. Plans urgently need to know these changes so as not to
                further exacerbate the PHE for the COVID-19 pandemic by continuing
                efforts to complete the HEDIS and CAHPS data collection activities. The
                HEDIS data collection diverts physicians' offices and health plans from
                handling the day-to-day emergencies as a result of the PHE for the
                COVID-19 pandemic. Additionally, we are concerned it is not possible to
                safely continue the HEDIS and CAHPS data collection activities while
                complying with the CDC recommendation for social distancing.
                 Under normal circumstances, if Part C and section 1876 plans do not
                fully complete their HEDIS data collection activities and successfully
                meet NCQA's HEDIS audit requirements, we assign each of the HEDIS Star
                Ratings measures 1 star. Similarly, if the CAHPS data cannot be
                completed and submitted on time by Part C, section 1876 cost, and Part
                D plans, we historically have assigned each of the CAHPS Star Ratings
                measures 1 star. Furthermore, unreliable CAHPS measure scores are
                excluded from the Part C and D Star Ratings calculations. Without
                knowing the changes made by this IFC to the methodology for calculating
                the 2021 and 2022 Star Rating, plans could have conflicting incentives,
                needing physician offices and plan staff to focus on caring for those
                impacted by COVID-19 and keeping Medicare beneficiaries and those
                involved in data collection activities safe, while at the same time
                wanting to ensure that future Star Ratings and QBP ratings are not
                impacted by the PHE for the COVID-19 pandemic which could negatively
                impact future benefits offered by MA organizations. The changes to the
                calculations for 2021 and 2022 Star Ratings are designed to avoid
                inadvertently creating incentives for plans to place cost and Star
                Rating considerations above efforts to address the COVID-19 pandemic.
                3. Provisions of IFC
                 This IFC is modifying the calculation of the 2021 and 2022 Part C
                and D Star Ratings to address the expected disruption to data
                collection posed by the PHE for the COVID-19 pandemic. Specifically,
                this IFC: (1) Replaces the 2021 Star Ratings measures calculated based
                on HEDIS and Medicare CAHPS data collections with earlier values from
                the 2020 Star Ratings (which are not affected by the public health
                threats posed by COVID-19); (2) establishes how we will calculate or
                assign Star Ratings for 2021 in the event that CMS' functions become
                focused on only continued performance of essential Agency functions and
                the Agency and/or its contractors do not have the ability to calculate
                the 2021 Star Ratings; (3) modifies the current rules for the 2021 Star
                Ratings to replace any measure that has a data quality issue for all
                plans due to the COVID-19 outbreak with the measure-level Star Ratings
                and scores from the 2020 Star Ratings; (4) in the event that we are
                unable to complete HOS data collection in 2020 (for the 2022 Star
                Ratings), replaces the measures calculated based on HOS data
                collections with earlier values that are not affected by the public
                health threats posed by COVID-19 for the 2022 Star Ratings; (5) removes
                guardrails for the 2022 Star Ratings; and (6) expands the existing hold
                harmless provision for the Part C and D Improvement measures to include
                all contracts for the 2022 Star Ratings.
                a. HEDIS, CAHPS, and HOS Data Collection and Submission for 2021 Star
                Ratings and 2022 Star Ratings
                 We issued a Health Plan Management System (HPMS) memo, entitled
                ``Reporting Requirements for 2020 HEDIS[supreg], HOS, and CAHPS[supreg]
                Measures,'' on September 9, 2019 to establish the due date for the 2019
                measurement year for HEDIS. In light of the public safety issues in
                continuing to require the submission of HEDIS data for the 2019
                measurement year, we are eliminating the HEDIS 2020 submission
                requirement that covers the 2019 measurement year and we are requesting
                that Medicare health plans, including MA and section 1876
                organizations, curtail HEDIS data collection work immediately. This
                will allow health plans, providers, and physician offices to focus on
                caring for Medicare beneficiaries during this PHE for the COVID-19
                pandemic and will minimize risk of the spread of infection by
                eliminating travel and in-person work for the collection of HEDIS data.
                Our goal is to ensure that offices of health care providers remain
                focused on patients needing care. Medicare health plans can use any
                HEDIS data that they have collected for their internal quality
                improvement efforts.
                 We are also amending the regulations requiring the submission of
                the CAHPS survey data to CMS for Medicare health and drug plans to
                relieve them of the requirement as it applies to the 2020 survey data
                collection to ensure the safety of survey vendor staff and align with
                the CDC's social distancing guidance. Both Part C and D plans can use
                any CAHPS survey data already collected for their internal quality
                improvement efforts. Accordingly, we are modifying regulations in parts
                417, 422, and 423 to eliminate requirements for the collection of HEDIS
                and CAHPS data that would otherwise occur in 2020. Specifically, we are
                revising the Part C regulation at Sec. 422.152 by adding a new
                paragraph (b)(6), which provides that MA organizations are not required
                to submit HEDIS and CAHPS data that would otherwise be required for the
                calculation of the 2021 Star Ratings. In addition, we are revising the
                cost plan regulation at Sec. 417.472(i) and (j) in two ways: In
                paragraph (i), to add a requirement for cost plans to comply with Sec.
                422.152(b)(6) and in paragraph (j), to make the obligation for cost
                plans to conduct CAHPS surveys subject to paragraph (i). Finally, we
                are revising the Part D regulations at Sec. Sec. 423.156 and 423.182.
                We are revising Sec. 423.156 to not require Part D sponsors to submit
                CAHPS data that would otherwise be required for the calculation of the
                2021 Star Ratings. We are also adding Sec. 423.182(c)(3) so that for
                2021 Star Ratings only, Part D sponsors are not required to submit
                CAHPS data that would otherwise be required for the calculation of the
                2021 Star Ratings. While our revisions do not outright prohibit cost
                plans, MA plans, and Part D plans from continuing efforts to
                [[Page 19272]]
                collect HEDIS data or conduct CAHPS surveys during 2020, such as to use
                that data about plan performance in 2019 for the plan's own internal
                quality initiatives, we do not expect plans to do so. An additional
                component of the HEDIS data collection is the HOS that NCQA administers
                in partnership with CMS. This year's HOS survey administration was
                scheduled to be from April through July 2020. Given the significant
                safety concerns, similar to the ones related to the administration of
                the CAHPS survey, we are moving the HOS survey administration to late
                summer and will provide MA plans more information in the upcoming
                months. We will continue to monitor the situation to see if any further
                adjustments are needed. To prepare for the possibility that the PHE for
                the COVID-19 pandemic continues and the HOS survey data cannot be
                collected starting in late summer for the 2022 Star Ratings, we are
                amending the regulations for the Part C 2022 Star Ratings (by adding
                new Sec. 422.166(j)(2)) to allow us to use the Star Ratings and
                measure scores for the 2021 Star Ratings for any measures that come
                from the HOS survey; this will address any gaps in the necessary HOS
                data if the HOS survey cannot be administered in 2020. The measures
                from the HOS survey include the following: Improving or Maintaining
                Physical Health; Improving or Maintaining Mental Health; Reducing the
                Risk of Falling; Improving Bladder Control; and Monitoring Physical
                Activity.
                b. Adjustments to the 2021 Star Ratings Methodology Due To Lack of
                HEDIS and CAHPS Data
                 In response to the PHE for the COVID-19 pandemic and its impact on
                health care delivery and data collection, we are making a series of
                adjustments to the Star Ratings methodology to protect the health and
                safety of individuals who would collect the HEDIS and CAHPS data; to
                allow health and drug plans and their providers to focus on caring for
                Medicare beneficiaries during the PHE for the COVID-19 pandemic; and to
                address the unusual, unexpected, and uncontrollable changes that this
                pandemic is likely to have on the Part C and D Star Ratings. Because of
                the short time frame during which information is collected, analyzed,
                and used in the calculation of the Star Ratings published in October
                each year, immediate action is necessary to amend the methodology as a
                result of the extraordinary circumstances created by the PHE for the
                COVID-19 pandemic. Data collection is currently underway for both the
                HEDIS and CAHPS data, and the data are due to CMS in June 2020. A
                series of adjustments to the 2021 Star Ratings are being made to
                account for eliminating the need to collect and submit HEDIS and CAHPS
                data for the 2021 Star Ratings.
                 The April 2018 final rule (83 FR 16538 through 16546) included the
                measures finalized for the 2021 Star Ratings. Included in those
                measures are many that use HEDIS or CAHPS as the data source. In the
                2020 Star Ratings, 14 measures had HEDIS as their data source, and nine
                measures had CAHPS as their data source. The measurement period for
                most of the Star Ratings measures is 2019; for many of those measures,
                we (or the plans) already have the data necessary to calculate a
                measure score and assign a 2021 measure-level rating but validation and
                analysis of those data remain to be done. For the HEDIS data source,
                the measurement period finalized in the April 2018 final rule is the
                calendar year 2 years prior to the Star Ratings year so for the 2021
                Star Ratings, the HEDIS measurement period is the 2019 measurement
                year. However, those data are collected in 2020.
                 Similarly, for the CAHPS data source, the measurement period
                finalized for the 2021 Star Ratings is the most recent data submitted
                for the survey of enrollees. In general, the most recent data would be
                the survey conducted from March through the end of May each year, which
                for the 2021 Star Ratings would have corresponded to March through May
                2020 data collection. However, these data will not be available for
                HEDIS and CAHPS measures. CMS considered if we could remove all of the
                HEDIS and CAHPS measures from the 2021 Star Ratings. If we removed
                these measures from the Star Ratings, we would not have enough measures
                to rate plans and to have a complete picture of performance given
                approximately half of the Star Ratings measures come from HEDIS and
                CAHPS. Removing all of these measures would severely compromise the
                integrity of the Part C and D Star Ratings and would have significant
                impact on payment for MA organizations. Given measure scores and stars
                do not fluctuate significantly year to year, we believe using the 2020
                measure-level stars and scores for the missing HEDIS and CAHPS data
                provides the best approximation of performance in 2019. This
                substitution addresses the lack of HEDIS and CAHPS data that would
                otherwise be used for 2021 Star Ratings while permitting us to
                calculate and use reliable Star Ratings for 2021 enrollment and 2022
                QBP status determinations. Given the issues related to PHE for the
                COVID-19 pandemic associated with completing the HEDIS data collection
                for the 2019 measurement year, we will use the HEDIS measure scores and
                Star Ratings based on the 2018 measurement year (that is, the data used
                for the 2020 Star Ratings) for the 2021 Star Ratings. For the 2021 Star
                Ratings, given the safety concerns related to completing the CAHPS
                surveys and data collection and the inability of survey vendors to
                fully complete data collection for 2020, we will use the CAHPS data
                submitted to CMS in June 2019. To accomplish this, we are revising
                Sec. Sec. 422.166 and 423.186 to add new regulation text that the
                measures calculated based on HEDIS data are calculated based on data
                for the 2018 performance period and the measures calculated based on
                CAHPS data are calculated based on survey data collected from March
                through May 2019. Specifically, we are adding a new paragraph (j) to
                each of these regulations and are codifying these specific rules about
                HEDIS and CAHPS data at Sec. Sec. 422.166(j)(1)(i) and (ii) and
                423.186(j)(1)(i).
                 The measurement period for all other measures will not change from
                what was finalized in the April 2018 final rule. For both HEDIS and
                CAHPS measures, we will use 2020 measure-level Star Ratings (and
                associated measure-level scores) in all the Star Ratings calculations
                codified at Sec. Sec. 422.160, 422.162, 422.164, 422.166, 423.180,
                423.182, 423.184, and 423.186 in calculating the 2021 Star Ratings. For
                the 2021 Star Ratings, there will be no changes from the prior year in
                the measure-level cut points for any of the HEDIS and CAHPS measures.
                We had previously announced in the April 2019 final rule that the Plan
                All-Cause Readmissions measure would be moved to display for the 2021
                Star Ratings due to the substantive specification change. We will
                continue to exclude this measure for the 2021 Star Ratings as provided
                in that final rule, so the data associated with it for the 2018
                performance period (collected in spring 2019) will be posted on the
                display page for 2021 ratings.
                 Since we will be using the 2020 Star Ratings data for the HEDIS and
                CAHPS measures, we will carry forward the measure-level improvement
                change score as described at Sec. Sec. 422.164(f)(4)(i) and
                423.184(f)(4)(i) from the 2020 Star Ratings for all HEDIS or CAHPS
                measures for the 2021 Star Ratings Part C and D improvement measure
                calculations. We are codifying this at Sec. Sec. 422.166(j)(1)(iii)
                and 423.186(j)(1)(ii).
                 Under Sec. Sec. 422.164(g)(1) and (2) and 423.184(g)(2), we reduce
                HEDIS and CAHPS measures to 1 star when either
                [[Page 19273]]
                HEDIS measures used to populate the Star Ratings are not reported or
                for failure to adhere to CAHPS reporting requirements. For the 2021
                Star Ratings, we will not reduce these measures to 1 star for failure
                to report the 2020 HEDIS or CAHPS data and is codifying that approach
                at Sec. Sec. 422.166(j)(1)(iv) and 423.186(j)(1)(iii). We are amending
                Sec. Sec. 422.166 and 423.186 by adding paragraph (j) to codify these
                various special rules for the 2021 Star Ratings.
                c. Use of 2020 Star Ratings To Substitute for 2021 Star Ratings in the
                Event of Extraordinarily Compromised CMS Capabilities or Systemic Data
                Issues
                 There is great uncertainty about how the COVID-19 pandemic will
                evolve over the next 6 to 9 months, and the impact on the American
                population and institutions resulting from the pandemic. We have
                considered the normal activities required to prepare, calculate, and
                publish the Star Ratings, as well as finalize the ratings to be used as
                the basis for MA QBPs in the event that CMS' functions to calculate the
                2021 Star Ratings are significantly impacted. The operational timelines
                for calculating the Star Ratings each year are extremely tight. For
                example, when we receive all of the measure-level data in early August,
                we have approximately 1 month to: Review the Star Ratings measure data
                for accuracy; prepare data and supportive material to provide plans
                with a preview period so they can review their numeric measure scores
                and raise issues to CMS; work with contractors to calculate the Star
                Ratings; prepare for a second preview period for plans to see their
                preliminary measure level and overall star ratings. This work must be
                completed in the months of August and September so that the Star
                Ratings are ready for public display on Medicare Plan Finder in early
                October for the Annual Enrollment Period. If the COVID-19 pandemic or
                actions necessary in connection with the PHE impact the ability of CMS
                and its contractors to complete these steps to calculate the 2021 Star
                Ratings, it would be impracticable and contrary to the public interest
                to begin rulemaking in August to adopt a policy for how to address such
                an unprecedented situation. The normal notice and comment rulemaking
                process would also prevent CMS from providing quality ratings to
                Medicare beneficiaries choosing a 2021 plan during the Annual
                Enrollment Period beginning in October and conflict with CMS providing
                MA organizations the opportunity to appeal their QBP ratings for 2022
                payment in time for 2022 bid submissions. There would be insufficient
                time to engage in notice and comment rulemaking to make changes to the
                2021 Star Ratings methodology in time to issue the Star Ratings on
                Medicare Plan Finder.
                 Star Ratings are used to identify which MA plans are eligible for a
                QBP and for a greater percentage of the amount by which the benchmark
                for the plan's service area exceeds the plan's bid for covering Part A
                and Part B benefits; the quality bonus results in an increase to the
                benchmark for an MA plan's service area and the percentage that
                determines the amount of the beneficiary rebate. See Sec. Sec.
                422.258(d)(7) and 422.260. Together, these financial consequences for a
                high Star Rating, can result in higher beneficiary rebates, which are
                used to pay for supplemental benefits and reductions in the Part B or
                Part D premium for enrollees in the plan. Given the impact the Star
                Ratings have on payment and the benefits offered to Medicare
                beneficiaries, it is critical that MA organizations have certainty in
                terms of how the ratings would be calculated if this situation should
                occur.
                 Adopting a provision to address such extraordinary circumstances
                before they come to pass in connection with the COVID-19 pandemic will
                ensure that Medicare health and drug plans and Medicare beneficiaries
                are aware of the steps CMS will take before those actions become
                necessary. This advance notice will alleviate uncertainty and provide
                stability for cost plans, MA organizations, and Part D sponsors so they
                can focus on continuing to ensure Medicare beneficiaries have access to
                needed medical care. In case the PHE for the COVID-19 pandemic gets to
                a point that CMS' functions become focused on only continued
                performance of essential agency functions or the agency and its
                contractors do not have the ability to calculate the 2021 Star Ratings,
                as part of this IFC, we are establishing rules for this circumstance.
                These rules would only be implemented for the 2021 Star Ratings if the
                impact of the PHE for the COVID-19 pandemic reaches a point where CMS
                and its contractors are compromised to the point the 2021 Star Ratings
                cannot be calculated using the methodology set forth in the April 2018
                final rule and this IFC. Calculating the Star Ratings requires a full
                team of staff and contractors with specialized skill sets. If the PHE
                for the COVID-19 pandemic escalates, we will need to devote more
                resources to activities to address essential Agency functions so that
                adding staff or resources to calculate the Star Ratings would not be
                appropriate.
                 If CMS' resources become extraordinarily compromised, we will use
                the 2020 Star Ratings as the 2021 Star Ratings. This authority is
                codified at Sec. Sec. 422.166(j)(1)(v) and 423.186(j)(1)(iv) and
                limited specifically to the COVID-19 pandemic.
                 We are also concerned, given the uncertainties ahead, whether CMS
                and plans will be able to safeguard against data quality issues for
                non-CAHPS and non-HEDIS measures for which CMS does not already have
                data for the 2021 Star Ratings. As an example, sponsors report Special
                Needs Plan (SNP) Care Management and Medication Therapy Management
                (MTM) data to CMS by March 2020, and these data undergo independent
                data validation beginning in April. While validation activities can be
                conducted remotely between the plans' staff and data validation
                reviewers, there may be other difficulties in completing the work this
                year on time and consistent with CMS requirements due to the
                significant impact of the PHE for the COVID-19 pandemic. Normally, as
                codified at Sec. Sec. 422.164(b) and 423.184(b), we review the quality
                of the data before making a final determination about inclusion of the
                measures in each year's Star Ratings. Given the potential for multiple
                measures to have data quality issues across many plans as a result of
                COVID-19, we are addressing this possibility by adopting a rule to
                permit replacing the 2021 Star Ratings measure scores and stars with
                the 2020 Star Ratings measures scores and stars for the impacted
                measures for all plans rather than excluding multiple measures from the
                2021 Star Ratings calculations. Removing multiple measures from the
                Star Ratings can cause unanticipated changes in the ratings which would
                create more instability for Medicare health and drug plan sponsors and
                could have significant impacts on MA QBPs at a time where MA
                organizations need stability in the ratings when they need to focus on
                caring for those impacted by COVID-19.
                 To be prepared if we have data quality issues for any non-HEDIS or
                non-CAHPS 2021 Star Ratings measures, we are adopting a specific rule
                limited to the PHE for the COVID-19 pandemic. At Sec. Sec. 422.164(i)
                and 423.184(i), we are adopting authority for CMS to substitute the
                score and star for the measure used in the 2020 Star Ratings in the
                calculation of the 2021 Star Ratings when there is a systemic data
                quality issue for all plans as a result of the PHE for the COVID-19
                pandemic. Therefore, in the above example, we would use sponsors' SNP
                Care Management and MTM Program Completion Rate for Comprehensive
                Medication Review measures' scores and stars from the
                [[Page 19274]]
                2020 Star Ratings as the sponsors' 2021 Star Ratings on those measures.
                 We are making these adjustments to the Star Ratings methodology
                since our inability to make calculations at a late stage in the annual
                Star Ratings publication process would severely jeopardize our ability
                to calculate 2022 MA payments accurately and consistent with the
                statutory QBP provision particularly since our ability to change other
                deadlines based on availability of the Star Ratings (for example, the
                bid deadline, Annual Election Period, and the start of the new plan
                benefit year) is limited but the Star Ratings are an integral part of
                those other activities. In extreme situations like the ones described
                above, the solicitation and consideration of public comments to
                establish how CMS should proceed would be impracticable since the
                process could not be completed in time to issue new Star Ratings that
                could be used to inform beneficiary choice during the Annual Election
                Period. The MA statute, at section 1851(d) of the Act, requires that
                information about plan quality and performance indicators be provided
                to Medicare beneficiaries to help them make informed plan choices. In
                addition, MA plans need to know their eligibility for QBPs in advance
                of the bid deadline to develop their bids; the bid deadline is also set
                by the statute, as the first Monday in the June prior to the coverage
                year. The 2021 Star Ratings will be the basis for 2022 QBPs so
                definitive Star Ratings need to be available to plans in advance of
                June 2021, to accommodate bid planning and to ensure that plans have
                the ability to appeal their QBP status if necessary. We understand that
                MA organizations begin developing and pricing their plan benefit
                packages well before the June bid deadline and depend on the release of
                Star Ratings in the preceding October as a critical milestone in their
                planning for an upcoming plan year. Adopting the new rule at Sec. Sec.
                422.164(i) and 423.184(i) to address measure-level substitutions of
                2020 scores for data quality issues that impact the availability,
                accuracy, reliability and validity of the measure-level data that would
                otherwise be used for 2021 ratings will provide stability and certainty
                for the program. This approach will allow CMS and MA organizations to
                move seamlessly to a new basis for calculating QBPs in the event that
                the original one (that is, using the data about 2019 performance) is
                unavailable. It will also allow MA organizations to incorporate into
                their planning the possibility that they will be required to use the
                2020 Star Ratings for some or all measures in developing their 2022
                bids.
                 To codify these provisions, we are amending Sec. Sec. 422.164 and
                423.184 by adding a new paragraph (i) to each section, as well as by
                amending Sec. 422.166 by adding a new paragraph (j)(1)(v) and amending
                Sec. 423.186 by adding a new paragraph (j)(1)(iv).
                d. 2022 Star Ratings
                 For the 2022 Star Ratings, we expect plans to submit HEDIS data in
                June 2021 and to administer the CAHPS survey in 2021 as usual. The
                majority of measures for the 2022 Star Ratings are based on the 2020
                measurement year, which is ongoing during the PHE for the COVID-19
                pandemic. We are using the IFC to make immediate changes to the
                methodology for the 2022 Star Ratings so as not to inappropriately
                incentivize actions by plans and healthcare providers that are not
                directly related to the PHE for the COVID-19 pandemic. By adopting
                these changes immediately, Medicare health and drug plans will be
                assured as quickly as possible about how performance changes driven or
                caused by the COVID-19 pandemic will be addressed in the Star Ratings
                that use this performance period. Except as addressed in this IFC, we
                anticipate that the 2022 Star Ratings will be implemented as codified
                at Sec. Sec. 422.160, 422.162, 422.164, 422.166, 423.180, 423.182,
                423.184, and 423.186.
                i. Guardrails
                 We recognize that health and drug plans and their providers are
                needing to adapt their current care practices in light of the PHE for
                the COVID-19 pandemic and the need to care for the most vulnerable
                patients, such as the elderly and those with chronic health conditions;
                these changes in how plans and providers care for Medicare
                beneficiaries as a result of COVID-19 will impact performance for the
                2020 measurement period which feeds into the 2022 Star Ratings. On
                March 18, 2020, we issued guidance (available on the CMS website at
                https://www.cms.gov/files/document/31820-cms-adult-elective-surgery-and-procedures-recommendations.pdf) to delay all non-essential planned
                surgeries and procedures, including dental, until further notice.
                Healthcare providers are being asked to encourage patients to remain at
                home, except for emergencies, to help curb the spread of COVID-19 and
                to help limit the exposure to the virus. Plans and their providers are
                focused primarily on providing urgent care to Medicare beneficiaries
                who may be infected by COVID-19. We realize that this will impact the
                data collected during the 2020 measurement year which will impact the
                2022 Part C and D Star Ratings. Thus, as part of this IFC, we are
                making some adjustments to account for the potential decreases in
                measure-level scores so health plans can have some degree of certainty
                knowing that the Star Ratings will be adjusted and can focus right now
                on patients who are most in need.
                 To increase the predictability of the cut points used for measure-
                level ratings, we previously finalized that, starting with the 2022
                Star Ratings, guardrails would be implemented for measures that have
                been in the program for more than 3 years. As specified at Sec. Sec.
                422.166(a)(2)(i) and 423.186(a)(2)(i), the guardrails ensure that the
                measure-threshold-specific cut points for non-CAHPS measures do not
                increase or decrease more than 5 percentage points from one year to the
                next. As noted in the April 2019 final rule, the trade-off for the
                predictability provided by the bi-directional cap is the inability to
                fully keep pace with changes in performance across the industry. While
                cut points that change less than the cap would be unbiased and keep
                pace with changes in the measure score trends, changes in the overall
                performance that are greater than the cap would not be reflected in the
                new cut points. The performance that will be used for the 2022 Star
                Ratings is performance in 2020, that is, during the PHE for the COVID-
                19 pandemic. We anticipate that most, if not all, plans could have
                performance changes on certain measures as they deal with the demands
                the PHE for the COVID-19 pandemic will place on the health care system
                in the United States. Guardrails that prevent the cut points for
                measures from lowering, even when performance scores are lower across
                the board, will result in plans having similar low measure-level
                ratings even if their performance is relatively distinguishable.
                 Since the Star Ratings are used to calculate the payment to MA
                organizations by providing an increase in the benchmark against which
                MA organizations bid and in the portion of the savings between the bid
                and benchmark available to MA organizations to use as rebates,
                unanticipated significant declines in the Star Ratings would create
                significant uncertainty in the program and potential beneficiary access
                issues if ratings significantly decline across the cost plan, MA and
                Part D programs. Given the enormity of this situation we believe it is
                important for plans to be able to focus on patients that are in the
                most need during the outbreak, and our
                [[Page 19275]]
                guardrails, as currently constructed, could have unintended incentives
                to the contrary. In addition, adopting this policy as soon as possible
                will minimize incentives for plans and providers to focus on non-urgent
                care or administrative efforts, even if those issues are tied to
                existing Star Ratings measures, and focus their attention on urgent
                care issues. As such, in response to the PHE for the COVID-19 pandemic,
                we are delaying implementation of the guardrails so that cut points can
                change by more than 5 percentage points if national performance
                declines as a result of the PHE for the COVID-19 pandemic. We are
                modifying Sec. Sec. 422.166(a)(2)(i) and 423.186(a)(2)(i) to delay the
                application of the guardrails beginning with the 2023 Star Ratings
                produced in October 2022. No other aspect of the guardrails policies
                finalized in the April 2019 final rule is changing with this
                modification.
                ii. Improvement Measure
                 The existing Star Ratings system and regulations include a well-
                developed improvement measure and methodology for calculating and using
                it. However, because we anticipate that performance during the 2020
                measurement period may decline for plans across the nation, we believe
                that it is appropriate to adopt a provision to minimize the negative
                effect of the improvement measure and improvement scores. As with the
                guardrails policy, this amendment to the existing regulations is
                designed to minimize or eliminate incentives in the Star Ratings that
                might be inconsistent with the steps necessary to address the COVID-19
                pandemic. We are revising the methodology for the Part C and D
                improvement measure for the 2022 Star Ratings to expand the hold
                harmless rule to include all contracts at the overall and summary
                rating levels recognizing that the PHE for the COVID-19 pandemic may
                result in a decline in industry performance. Currently, for MA-PD
                contracts with an overall rating of 4 or more stars, if the inclusion
                of the improvement measure(s) reduces a contract's overall Star Rating,
                the Part C and D improvement measures are excluded from the overall
                Star Ratings calculations for that contract. Similarly, for MA-only
                contracts with 4 or more stars, if the inclusion of the Part C
                improvement measure reduces the Part C summary Star Rating, it is
                excluded from the calculations for that contract. Our revision will
                expand the current hold harmless rule and how it works to all contracts
                regardless of their ratings and also apply it to the Part C and D
                summary ratings for the 2022 Star Ratings only.
                 We are codifying a new paragraph (g)(3) at Sec. Sec. 422.166 and
                423.186 and adding text at the end of the existing text in Sec. Sec.
                422.166(f)(1)(i) and 423.186(f)(1)(i) to implement this new hold
                harmless provision for the 2022 Star Ratings only.
                iii. Categorical Adjustment Index
                 Beginning with the 2017 Star Ratings, we implemented the
                Categorical Adjustment Index (CAI) that adjusts for the average within-
                contract disparity in performance associated with the percentages of
                enrollees who receive a low-income subsidy and/or are dual eligible
                (LIS/DE) and/or have disability status. For the 2022 Star Ratings, we
                will calculate the CAI as codified at Sec. Sec. 422.166(f)(2) and
                423.186(f)(2). The CAI values will be calculated based on the 2021 Star
                Ratings data which will use the older HEDIS and CAHPS data from the
                2020 Star Ratings. For each measure, adjusted measure scores which are
                used to construct the CAI values will be calculated using the
                enrollment year associated with the year of data being used for that
                measure (that is, 2018 enrollment year data for HEDIS and CAHPS
                measures, 2019 enrollment year data for all other measures). Given we
                are following the rules codified in regulation, there are no changes to
                the regulatory text. We are providing this explanation to avoid
                uncertainty on this point for Medicare health and drugs plans.
                iv. QBP Calculations for New Contracts
                 Under Sec. 422.252, a new MA plan means an MA contract offered by
                a parent organization that has not had another MA contract in the
                previous 3 years. For just the 2022 QBP ratings that are based on 2021
                Star Ratings, we are modifying this definition to treat an MA plan as a
                new MA plan if it is offered by a parent organization that has not had
                another MA contract for the previous 4 years. This change would account
                for how new plans that started in 2019 would have reported HEDIS and
                CAHPS data to CMS for the first time in 2020 for the 2021 Star Ratings;
                because of our elimination of the HEDIS and CAHPS data submissions to
                CMS, these plans will not have enough measures to calculate the 2021
                Star Ratings and, consequently, the 2022 QBP rating. A new contract
                with an effective date of January 1, 2019 would normally be treated as
                new for purposes of QBPs for 2019, 2020, and 2021. The 2022 QBP rating
                would be based on the 2021 Star Ratings which these contracts will not
                have due to the elimination of HEDIS and CAHPS data.
                Z. Changes To Expand Workforce Capacity for Ordering Medicaid Home
                Health Nursing and Aide Services, Medical Equipment, Supplies and
                Appliances and Physical Therapy, Occupational Therapy or Speech
                Pathology and Audiology Services
                 Title XIX of the Act requires that, to receive Federal Medicaid
                matching funds, a State must offer certain basic services to the
                categorically needy populations specified in the Act. Home health
                services for Medicaid-eligible individuals who are entitled to nursing
                facility services is one of these mandatory services. Individuals
                ``entitled to'' nursing facility services include the basic
                categorically needy populations that receive the standard Medicaid
                benefit package, and can include medically needy populations if nursing
                facility services are offered to the medically needy within a State.
                Home health services include part-time or intermittent nursing, home
                health aide services, medical supplies, equipment, and appliances, and
                may include therapeutic services. Current Medicaid regulations require
                an individual's physician to order home health services as part of a
                written plan of care. The plan of care must be reviewed every 60 days,
                except for medical supplies, equipment and appliances which must be
                reviewed by a physician annually.
                 We recognize that increased demand on the direct care services
                provided by physicians during the PHE for the COVID-19 pandemic could
                cause a delay in the availability of physicians to order home health
                services in the normal timeframe. In recognition of the critical need
                to expand workforce capacity, we are amending 42 CFR 440.70 to allow
                licensed practitioners practicing within their scope of practice, such
                as, but not limited to, NPs and PAs, to order Medicaid home health
                services during the existence of the PHE for the COVID-19 pandemic.
                 This change to Sec. 440.70 will expand the workforce and is also a
                continuation of CMS' efforts to align with Medicare on who can order
                medical supplies, equipment, and appliances, and allowing smoother
                access to services for Medicaid beneficiaries, including those who are
                dually eligible. This alignment will also eliminate administrative
                burden to states and providers when dealing with inconsistencies in the
                practitioners who may order these items between the Medicare and
                Medicaid programs.
                [[Page 19276]]
                 This change applies to who can order Medicaid home health nursing
                and aide services, medical supplies, equipment and appliances and
                physical therapy, occupational therapy or speech pathology and
                audiology services covered under Sec. 440.70(b)(1), (2), (3), and (4).
                 This change does not expand the benefit categories where these
                items can be covered. States must continue to cover and claim home
                health nursing and aide services, medical supplies, equipment and
                appliances, and physical therapy, occupational therapy or speech
                pathology and audiology services (that are covered under the home
                health benefit) under the home health benefit, unless otherwise allowed
                by federal regulations.
                AA. Origin and Destination Requirements Under the Ambulance Fee
                Schedule
                 Section 1861(s)(7) of the Act establishes an ambulance service as a
                Medicare Part B service where the use of other methods of
                transportation is contraindicated by the individual's condition, but
                only to the extent provided in regulations. We have established
                regulations at Sec. 410.40 that govern Medicare coverage of ambulance
                services. Under Sec. 410.40(e)(1), Medicare Part B covers ground (land
                and water) and air ambulance transport services only if they are
                furnished to a Medicare beneficiary whose medical condition is such
                that other means of transportation are contraindicated. The
                beneficiary's condition must require both the ambulance transportation
                itself and the level of service provided for the billed services to be
                considered medically necessary.
                 Under Sec. 410.40(e)(1), nonemergency transportation by ambulance
                is appropriate if either the beneficiary is bed-confined, and it is
                documented that the beneficiary's condition is such that other methods
                of transportation are contraindicated; or, if his or her medical
                condition, regardless of bed confinement, is such that transportation
                by ambulance is medically required. That section further provides that
                bed confinement is not the sole criterion in determining the medical
                necessity of ambulance transportation but is one factor that is
                considered in medical necessity determinations. For a beneficiary to be
                considered bed-confined, Sec. 410.40 (e)(1) states that all of the
                following criteria must be met: (1) The beneficiary is unable to get up
                from bed without assistance, (2) the beneficiary is unable to ambulate,
                and (3) the beneficiary is unable to sit in a chair or wheelchair.
                 The origin and destination requirements for coverage of ambulance
                services are addressed in our regulations at Sec. 410.40(f). As
                provided in that section, Medicare covers the following ambulance
                transportation:
                 From any point of origin to the nearest hospital, critical
                access hospital (CAH), or skilled nursing facility (SNF) that is
                capable of furnishing the required level and type of care for the
                beneficiary's illness or injury. The hospital or CAH must have
                available the type of physician or physician specialist needed to treat
                the beneficiary's condition;
                 From a hospital, CAH, or SNF to the beneficiary's home;
                 From a SNF to the nearest supplier of medically necessary
                services not available at the SNF where the beneficiary is a resident,
                including the return trip; and
                 For a beneficiary who is receiving renal dialysis for
                treatment of ESRD, from the beneficiary's home to the nearest facility
                that furnishes renal dialysis, including the return trip.
                 We continue to believe that our current regulatory requirements
                governing coverage of ambulance services are appropriate under normal
                circumstances. However, in the context of the PHE for the COVID-19
                pandemic, we recognize that providers and suppliers furnishing ground
                ambulance services and other health care professionals are faced with
                new challenges regarding potential exposure risks, for Medicare
                beneficiaries and for members of the community at large.
                 Therefore, on an interim basis, we will expand the list of
                destinations at Sec. 410.40(f) for which Medicare covers ambulance
                transportation to include all destinations, from any point of origin,
                that are equipped to treat the condition of the patient consistent with
                Emergency Medical Services (EMS) protocols established by state and/or
                local laws where the services will be furnished. The EMS protocols are
                recognized operating procedures that all emergency service
                professionals such as emergency medical technicians (EMTs) and
                paramedics must follow for patient assessment, treatment,
                transportation and delivery to definitive care. These protocols are
                designed by national, state and/or local medical authorities and
                institutions. Based on these protocols, a patient suspected of having
                COVID-19 that requires a medically necessary transport may be
                transported to a testing facility to get tested for COVID-19 instead of
                a hospital in an effort to prevent possible exposure to other patients
                and medical staff.
                 These destinations may include, but are not limited to: Any
                location that is an alternative site determined to be part of a
                hospital, CAH or SNF, community mental health centers, FQHCs, RHCs,
                physicians' offices, urgent care facilities, ambulatory surgery centers
                (ASCs), any location furnishing dialysis services outside of an ESRD
                facility when an ESRD facility is not available, and the beneficiary's
                home. This expanded list of destinations will apply to medically
                necessary emergency and non-emergency ground ambulance transports of
                beneficiaries during the PHE for the COVID-19 pandemic. Consistent with
                section 1861(s)(7) of the Act, there must be a medically necessary
                ground ambulance transport of a patient in order for an ambulance
                service to be covered.
                 We are revising, on an interim basis, Sec. 410.40 to add a new
                paragraph (f)(5), to state that during the PHE for the COVID-19
                pandemic only, a covered destination includes a ground ambulance
                transport from any point of origin to a destination that is equipped to
                treat the condition of the patient consistent with state and local EMS
                protocols where the services will be furnished. These destinations
                include, but are not limited to, any location that is an alternative
                site determined to be part of a hospital, CAH or SNF, community mental
                health centers, FQHCs, RHCs, physician offices, urgent care facilities,
                ASCs, any location furnishing dialysis services outside of an ESRD
                facility when an ESRD facility is not available, and the beneficiary's
                home. Home may be an appropriate destination for a COVID-19 patient who
                is discharged from the hospital to home to be under quarantine (as
                noted above, there must be a medically necessary ground ambulance
                transport of a patient in order for an ambulance service to be
                covered).
                BB. Merit-Based Incentive Payment System (MIPS) Updates
                1. MIPS Improvement Activities Inventory Update
                 The CY 2018 Quality Payment Program final rule (82 FR 53660)
                finalized that we would add new improvement activities or make
                modifications to existing improvement activities in the Improvement
                Activities Inventory through notice-and-comment rulemaking. An
                improvement activity means an activity that relevant MIPS eligible
                clinician, organizations and other relevant stakeholders identify as
                improving clinical practice or care delivery and that the Secretary
                determines, when effectively executed,
                [[Page 19277]]
                is likely to result in improved outcomes. We refer readers to Table H
                in the Appendix of the CY 2017 Quality Payment Program final rule (81
                FR 77177 through 77199), Tables F and G in the Appendix of the CY 2018
                Quality Payment Program final rule (82 FR 54175 through 54229), Tables
                A and B in the Appendix 2 of the CY 2019 PFS final rule (83 FR 60286
                through 60303), and Tables A, B, and C in the Appendix 2 of the CY 2020
                PFS final rule (84 FR 63514 through 63538) for our previously finalized
                Improvement Activities Inventory. We also refer readers to the Quality
                Payment Program website at https://qpp.cms.gov/ for a complete list of
                the most current list of improvement activities.
                 The COVID-19 pandemic has been deemed a PHE by the Secretary of the
                Department of Health and Human Services. Information regarding the PHE
                for the COVID-19 pandemic may be found at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. In this IFC, we
                are adding one new improvement activity to the Improvement Activities
                Inventory for the CY 2020 performance period in response to this PHE.
                We refer readers to Table 1 for a full description which includes the
                type of action that would qualify for this improvement activity. This
                improvement activity promotes clinician participation in a COVID-19
                clinical trial utilizing a drug or biological product to treat a
                patient with a COVID-19 infection.\20\ To receive credit for this
                clinical improvement, clinicians must report their findings through an
                open source clinical data repository or clinical data registry. When
                utilizing the term ``open source'' we mean making available to the
                public the results of research, including publications and scientific
                data, which enables reuse, increases transparency, and facilitates
                reproductibility of research results.\21\
                ---------------------------------------------------------------------------
                 \20\ For more information on the COVID-19 clinical trials we
                refer readers to the U.S. National Library of Medicine website at
                https://clinicaltrials.gov/ct2/results?cond=COVID-19.
                 \21\ More information on open source is available at https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html; https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
                ---------------------------------------------------------------------------
                 We believe that participation in this activity is likely to result
                in improved outcomes by improving the collection of data clinicians use
                for the care of their patients as they monitor and manage COVID-19 and
                drive care improvements. We believe that encouraging clinicians to
                utilize an open source clinical data repository or clinical data
                registry for data reporting will bring the results of their research to
                the forefront of healthcare far quicker than if it goes through the
                cycle of peer review and publishing. In addition, we believe that this
                could improve clinical practice and care delivery, a relevant
                stakeholder donated a database for the pandemic so that health
                officials/clinicians/the public could track patients and drugs that
                work to better improve outcomes of COVID-19 patients.
                 In the CY 2019 PFS (83 FR 59778 through 59782), we provided details
                regarding the Annual Call for Activities and how stakeholders submit
                potential improvement activities. In general, to nominate a new
                activity or request a modification to an existing improvement activity,
                a stakeholder must submit a nomination form available at
                www.qpp.cms.gov during the Annual Call for Activities. For this new
                improvement activity, we are making a one-time exception from our
                established Annual Call for Activities timeframe and processes due to
                this PHE.
                 New improvement activities should meet one or more criteria to be
                included in the Improvement Activities Inventory (82 FR 53660). We
                believe that this activity meets the improvement activities submission
                criteria of a ``public health emergency as determined by the
                Secretary,'' which was finalized in the 2019 PFS final rule (83 FR
                59779). As noted in the CY 2017 Quality Payment Program final rule, we
                use the criteria for nominating new improvement activities in selecting
                improvement activities for inclusion in the program (82 FR 53659). We
                also clarified that those criteria are but one factor in determining
                which improvement activities we ultimately proposed (83 FR 59780). For
                MIPS eligible clinicians who wish to submit this new improvement
                activity, we refer readers to the CY 2019 PFS final rule (83 FR 59778
                through 59782) for our previously finalized improvement activities
                submission requirements. Table 1 displays the new improvement activity.
                 Table 1--New Improvement Activity for the MIPS CY 2020 Performance
                 Period
                ------------------------------------------------------------------------
                
                ------------------------------------------------------------------------
                 Improvement activity
                ------------------------------------------------------------------------
                Activity ID:...................... IA_ERP_XX.
                Subcategory:...................... Emergency Response And Preparedness.
                Activity Title:................... COVID-19 Clinical Trials.
                Activity Description:............. To receive credit for this activity,
                 a MIPS-eligible clinician must
                 participate in a COVID-19 clinical
                 trial utilizing a drug or
                 biological product to treat a
                 patient with a COVID-19 infection
                 and report their findings through a
                 clinical data repository or
                 clinical data registry for the
                 duration of their study. For more
                 information on the COVID-19
                 clinical trials we refer readers to
                 the U.S. National Library of
                 Medicine website at https://clinicaltrials.gov/ct2/results?cond=COVID-19.
                Weighting:........................ High.
                ------------------------------------------------------------------------
                2. MIPS Applications for Reweighting Based on Extreme and
                Uncontrollable Circumstances
                 As a result of the PHE for the COVID-19 pandemic, we are applying
                the MIPS automatic extreme and uncontrollable circumstances policy at
                Sec. 414.1380(c)(2)(i)(A)(8) and (c)(2)(i)(C)(3) to MIPS eligible
                clinicians for the 2019 MIPS performance period/2021 MIPS payment year.
                We believe that this application of the policy is appropriate given the
                impact COVID-19 will likely have on the ability of many MIPS eligible
                clinicians to complete data submission for the MIPS program for the
                2019 MIPS performance period because most of those submissions will
                occur during CY 2020.
                 Due to the timing of the PHE, we realize that there may be
                scenarios where MIPS-eligible clinicians are not covered by the
                automatic extreme and uncontrollable circumstances policy. For example,
                as we stated in the CY 2019 PFS final rule, the automatic extreme and
                uncontrollable circumstances policy does not apply to groups or virtual
                groups (83 FR 59874
                [[Page 19278]]
                and 59875); however, under Sec. 414.1380(c)(2)(i), individual
                clinicians, groups and virtual groups could submit an application for
                reweighting the performance categories based on extreme and
                uncontrollable circumstances. To provide additional relief to
                individual clinicians, groups, and virtual groups for whom sufficient
                MIPS measures and activities may not be available for the 2019 MIPS
                performance period due to the PHE for the COVID-19 pandemic, we are
                extending the deadline to submit an application for reweighting the
                quality, cost, and improvement activities performance categories based
                on extreme and uncontrollable circumstances (Sec.
                414.1380(c)(2)(i)(A)(6)) and the Promoting Interoperability performance
                category based on extreme and uncontrollable circumstances (Sec.
                414.1380(c)(2)(i)(C)(2)) from December 31, 2019 to April 30, 2020, or a
                later date that we may specify. This extended deadline of April 30,
                2020 mirrors the MIPS data submission deadline extension. The extended
                deadline is available only for applications that demonstrate the
                clinician has been adversely affected by the PHE for the COVID-19
                pandemic.
                 We are also modifying our existing policy for the 2019 performance
                period/2021 MIPS payment year so that if a MIPS eligible clinician,
                group, or virtual group submits an application for reweighting based on
                the PHE for the COVID-19 pandemic by the extended deadline, any MIPS
                data they have submitted or will submit would not effectively void
                their application. Under Sec. 414.1380(c)(2)(i)(A)(6) and
                (c)(2)(i)(C), if an application for reweighting the performance
                categories based on extreme and uncontrollable circumstances is
                submitted, but data on measures or activities for a performance
                category are also submitted, a MIPS eligible clinician will be scored
                on the submitted data, and the performance categories for which data
                are submitted will not be reweighted. However, for the 2019 performance
                period we believe it is appropriate to modify this policy, because we
                believe it is possible that a MIPS eligible clinician, group, or
                virtual group could have submitted some MIPS data prior to the PHE for
                the COVID-19 pandemic, but due to circumstances related to the PHE for
                the COVID-19 pandemic, are not able to complete their submission such
                that the data they submitted may not reflect their actual performance
                on the measures and activities. As a result, we are modifying the
                policy at Sec. 414.1380(c)(2)(i)(A)(6) to create an exception for the
                2019 performance period/2021 MIPS payment year only, such that if a
                MIPS eligible clinician demonstrates through an application submitted
                to CMS that they have been adversely affected by the PHE for the COVID-
                19 pandemic, but also submits data for the quality, cost, or
                improvement activities performance categories, the performance
                categories for which data are submitted would still be reweighted
                (subject to CMS' approval of the application), and the data submission
                would not effectively void the application for reweighting. We are also
                modifying the policy at Sec. 414.1380(c)(2)(i)(C) to create a similar
                exception for the Promoting Interoperability performance category for
                the 2019 performance period/2021 MIPS payment year only.
                CC. Inpatient Hospital Services Furnished Under Arrangements Outside
                the Hospital During the Public Health Emergency (PHE) for the COVID-19
                Pandemic
                1. Overview for Inpatient Hospital Services
                 For purposes of Medicare payment, section 1861(b) of the Act
                defines inpatient hospital services in part as the following items and
                services furnished to an inpatient of a hospital and (except as
                provided in paragraph (3)) by the hospital: (1) Bed and board; (2) such
                nursing services and other related services, such use of hospital
                facilities, and such medical social services as are ordinarily
                furnished by the hospital for the care and treatment of inpatients, and
                (3) such other diagnostic or therapeutic items or services, furnished
                by the hospital or by others under arrangements with them made by the
                hospital, as are ordinarily furnished to inpatients either by such
                hospital or by others under such arrangements.
                 Routine services in the hospital setting are those described in
                sections 1861(b)(1) and (b)(2) of the Act. Under our current policy for
                hospital services furnished under arrangements that we adopted in the
                FY 2012 IPPS/LTCH PPS rulemaking (76 FR 51714), routine services cannot
                be provided under arrangement outside the hospital. Only the
                therapeutic and diagnostic services described in section 1886(b)(3) of
                the Act can be provided under arrangement outside the hospital.
                 We continue to believe that our current policy prohibiting routine
                services from being provided under arrangement outside the hospital is
                consistent with the statute and appropriate for the reasons discussed
                in the FY 2012 IPPS/LTCH PPS rulemaking. However, we wish to give
                hospitals that provide services to Medicare beneficiaries flexibility
                to respond effectively to the serious public health threats posed by
                COVID-19. Recognizing the urgency of this situation, and understanding
                that our current policy may inhibit use of capacity in settings that
                might otherwise be effective in the efforts to mitigate the impact of
                the pandemic on Medicare beneficiaries and the American public, we are
                changing our under arrangements policy during the PHE for the COVID-19
                pandemic so that hospitals are allowed broader flexibilities to furnish
                inpatient services, including routine services outside the hospital.
                2. Prior Rulemaking
                 In the FY 2012 IPPS/LTCH PPS rulemaking (76 FR 51711), we noted
                that the statute specifies that ``routine services,'' for example, bed,
                board, nursing and other related services, except those specified at
                paragraph (3) of section 1861(b) of the Act are to be provided by ``the
                hospital,'' and not just ``a hospital.'' Similarly, we noted that our
                implementing regulations at Sec. 409.12 indicate that Medicare pays
                for nursing and related services, use of hospital facilities, and
                medical social services as inpatient hospital services or inpatient CAH
                services only if those services are ordinarily furnished by the
                hospital or CAH. We pointed out that, consistent with section
                1861(b)(3) of the Act, only with regard to other diagnostic or
                therapeutic services do the regulations at Sec. 409.16 state that
                Medicare will also pay for these services if furnished ``by others
                under arrangements made by the hospital or CAH.''
                 Under our current policy adopted in the FY 2012 IPPS/LTCH PPS
                rulemaking, if routine services, that is, services described in
                sections 1861(b)(1) and (b)(2) of the Act, are provided in the
                hospital, they are considered as being provided ``by the hospital.'' We
                stated that we believe this policy is consistent with the statute
                because the statutory language specifying that the routine services
                described in sections 1861(b)(1) and (b)(2) of the Act be provided ``by
                the hospital'' suggests that the hospital is required to exercise
                professional responsibility over the services, including quality
                controls. In situations in which certain routine services are provided
                through arrangement ``in the hospital,'' for example, contracted
                nursing services, we stated that we believe the arrangement generally
                results in the hospital exercising the same level of control over those
                services as the hospital does in situations in
                [[Page 19279]]
                which the services are provided by the hospital's salaried employees.
                 Therefore, if routine services are provided in the hospital to its
                inpatients, we consider the service as being provided by the hospital.
                However, if these services are provided to its patients outside the
                hospital, the services are considered as being provided under
                arrangement, and not by the hospital. Therefore, consistent with the
                statute, we stated that only therapeutic and diagnostic services can be
                provided under arrangement outside the hospital.
                 Some commenters during the FY 2012 IPPS/LTCH PPS rulemaking stated
                that our policy to limit the services a hospital may provide under
                arrangements is not required by the statute or regulations. Some
                commenters also believed that CMS' proposed reading of the statutory
                definition of inpatient hospital services is only one possible
                interpretation of the statute.
                 In our response to these comments, we noted that we focused on
                section 1861(b) of the Act because it provides the statutory basis for
                our policy to limit the services that may be furnished under
                arrangement. As we noted in that rulemaking, the reference to
                diagnostic or therapeutic items or services in section 1861(b)(3) of
                the Act is to services furnished by the hospital or by others under
                arrangements. Therefore, we stated that we believe it is consistent
                with the statutory language to limit the services that may be furnished
                outside of a hospital under arrangement to only diagnostic and
                therapeutic services.
                 We noted that our policy does not alter the definition of inpatient
                hospital services, but instead limits the services a hospital may
                provide under arrangements outside the hospital. If a patient of
                Hospital A is in Hospital B receiving routine services, the patient
                will still be an ``inpatient,'' but the services will not be considered
                ``inpatient hospital services'' furnished by the hospital for purposes
                of payment for services defined under section 1861(b) of the Act. If
                the patient is admitted to Hospital B, then the patient would be an
                ``inpatient'' of Hospital B and the routine services furnished to that
                individual would meet the definition of ``inpatient routine services''
                under section 1861(b) of the Act.
                 We also discussed in the FY 2012 IPPS/LTCH PPS rulemaking the
                policy considerations supporting this change. We stated that we became
                aware that some hospitals were furnishing certain routine services,
                including ICU services, under arrangement. For example, under certain
                arrangements, if an inpatient of an IPPS-excluded hospital (``hospital
                A'') required ICU services, and the IPPS-excluded hospital could not
                provide these services, the patient was moved to an IPPS hospital
                (``hospital B'') that could furnish the ICU services. In these
                situations, the patient was not transferred to hospital B but was moved
                from an inpatient bed of hospital A to an inpatient bed of hospital B.
                However, the IPPS-excluded hospital treated these services as being
                provided under arrangement and included the cost of those services on
                its cost report. We found it problematic that the patient was, at all
                times, considered an inpatient of hospital A even though the patient
                occupied an inpatient bed at hospital B.
                 Because the two hospitals in the example above are under two
                different payment systems, we stated that we believe this arrangement
                can result in inappropriate and potentially excessive Medicare
                payments. The IPPS-excluded hospital, hospital A, is paid on a
                reasonable cost basis, subject to a ceiling. In most cases, this
                payment is greater than if the hospital were paid under the IPPS for
                the same patient. Furthermore, although there is a ceiling on the
                amount of Medicare payment for hospital A, there are also provisions
                that allow hospital A to receive adjustments to its ceiling in certain
                circumstances, which in the absence of our policy could allow payment
                to hospital A above those allowed by its ceiling. Therefore, in the
                absence of our policy these arrangements could allow hospital A to
                request an adjustment to its ceiling because its ICU costs had
                increased beyond what is allowed. In that case, hospital A would
                receive additional payments beyond its ceiling. We stated that we
                believe that by limiting the furnishing of routine services under
                arrangements to situations in which the services are furnished in
                hospital A, we reduce the opportunity for gaming. In these more limited
                situations, hospital A exercises sufficient control over the use of
                hospital resources when furnishing these services such that the
                services are appropriately included in hospital A's cost report.
                 Under our current policy adopted in that rulemaking, if hospital A
                did not have the resources to treat a patient, it would transfer the
                patient to hospital B for ICU services, and hospital B would bill
                Medicare consistent with the IPPS provisions. Hospital A would be paid
                for an inpatient discharge.
                3. Inpatient Hospital Services Furnished Under Arrangements Outside the
                Hospital During the PHE for the COVID-19 Pandemic
                 As noted earlier in this section, we continue to believe that our
                current policy is consistent with the statute and appropriate for the
                reasons discussed in the FY 2012 IPPS/LTCH PPS rulemaking. However, we
                wish to give hospitals that provide services to Medicare beneficiaries
                additional flexibilities to respond effectively to the serious public
                health threats posed by the spread of COVID-19. Recognizing the urgency
                of this situation, and understanding that some pre-existing Medicare
                payment rules may inhibit use of capacity that might otherwise be
                effective in the efforts to mitigate the impact of the pandemic on
                Medicare beneficiaries and the American public, we are changing our
                under arrangements policy during the PHE for the COVID-19 pandemic
                beginning March 1, 2020, so that hospitals are allowed broader
                flexibilities to furnish inpatient services, including routine services
                outside the hospital.
                 We believe that our concerns articulated in the FY 2012 rulemaking
                regarding gaming of routine services provided outside the hospital for
                payment reasons are significantly mitigated by the existence of the
                PHE. Hospitals would be treating patients in locations outside the
                hospital for a variety of reasons, including limited beds and/or
                limited specialized equipment such as ventilators, and for a limited
                time period. We do not expect that during the PHE for the COVID-19
                pandemic hospitals would be treating patients outside the hospital for
                gaming reasons.
                 As noted, we continue to believe that our current policy of
                limiting the services that may be provided under arrangements outside
                of the hospital to therapeutic and diagnostic items and services is
                consistent with the statute and supported by the policy considerations
                discussed in the FY 2012 IPPS/LTCH PPS final rule. However, we do not
                believe that the statute would preclude this change in policy to allow
                routine services to also be provided under arrangements outside the
                hospital, in light of the compelling circumstances and the need for
                additional, short-term flexibility during the current PHE for the
                COVID-19 pandemic. Consistent with this, and as previously summarized
                in section II.BB.2 of this IFC, we note that we received comments
                during the FY 2012 rulemaking that our policy to limit the services a
                hospital may provide under
                [[Page 19280]]
                arrangements is not required by the statute and that CMS' reading of
                the statutory definition of inpatient hospital services is only one
                possible interpretation of the statute.
                 While we are changing our under arrangements policy during the PHE
                for the COVID-19 pandemic to allow hospitals broader flexibilities in
                furnishing inpatient services, we emphasize that we are not changing
                our policy that a hospital needs to exercise sufficient control and
                responsibility over the use of hospital resources in treating patients,
                as discussed in the FY 2012 IPPS/LTCH PPS final rule and Section 10.3
                of Chapter 5 of the Medicare General Information, Eligibility, and
                Entitlement Manual (Pub. 100-01). Nothing in the current PHE for the
                COVID-19 pandemic has changed our policy or thinking with respect to
                this issue and we are making no modifications to this aspect of the
                policy. Hospitals need to continue to exercise sufficient control and
                responsibility over the use of hospital resources in treating patients
                regardless of whether that treatment occurs in the hospital or outside
                the hospital under arrangements. If a hospital cannot exercise
                sufficient control and responsibility over the use of hospital
                resources in treating patients outside the hospital under arrangements,
                the hospital should not provide those services outside the hospital
                under arrangements.
                 For the reasons set forth above, effective for services provided
                for discharges for patients admitted to the hospital during the PHE for
                COVID-19 beginning March 1, 2020, if routine services are provided
                under arrangements outside the hospital to its inpatients, these
                services are considered as being provided by the hospital.
                DD. Advance Payments to Suppliers Furnishing Items and Services Under
                Part B
                 In an effort to be able to be more responsive to situations in
                which Part B suppliers could request advance payments from CMS, we are
                making modifications to existing advance payments rules found in 42 CFR
                421.214. Currently, Sec. 421.214 limits CMS' ability to make advance
                payments in situations where a CMS contractor is unable to process
                claims within established time limits. In light of the PHE Declaration
                related to COVID-19 and the inability to project the impact it may have
                in the future on CMS' abilities to ensure timely payment and the
                potential challenges for suppliers to prepare and submit claims to CMS
                contractors, we are revising the definition of advance payment in Sec.
                421.214(b). Currently, paragraph (b) defines advance payment as a
                conditional partial payment made by the carrier in response to a claim
                that it is unable to process within established time limits. We are
                revising this definition to state that the conditional partial payment
                will be made by the ``contractor'' (not the carrier) except as provided
                in paragraph (j). We are also adding language to permit payments under
                an exception at Sec. 421.214(c). In addition, we are also adding
                paragraph (j) to specifically address emergency situations in which it
                will be able to make advance payments. Additionally, existing rules
                limit CMS to no more than 80 percent of the anticipated payment for
                that claim based upon the historical assigned claims payment data for
                claims paid to the supplier. Under exceptional circumstances as
                outlined in paragraph (j), we are increasing this limit to 100 percent
                of the anticipated payment for that claim based upon the historical
                assigned claims payment data for claims paid to the supplier in
                paragraph (f)(1)(i). We are also adding a criterion to Sec. 421.214
                that suppliers in bankruptcy would not be eligible to receive advance
                payments to ensure that, with such expanded authority, CMS is able to
                appropriately pay and recover advance payments made to Part B
                suppliers.
                III. Waiver of Proposed Rulemaking
                 We ordinarily publish a notice of proposed rulemaking in the
                Federal Register and invite public comment on the proposed rule before
                the provisions of the rule take effect, in accordance with 5 U.S.C.
                553(b) of the Administrative Procedure Act (APA) and section 1871 of
                the Act. Specifically, section 553(b) of the APA requires the agency to
                publish a notice of the proposed rule in the Federal Register that
                includes a reference to the legal authority under which the rule is
                proposed, and the terms and substance of the proposed rule or a
                description of the subjects and issues involved. Section 553(c) of the
                APA further requires the agency to give interested parties the
                opportunity to participate in the rulemaking through public comment
                before the provisions of the rule take effect. Similarly, section
                1871(b)(1) of the Act requires the Secretary to provide for notice of
                the proposed rule in the Federal Register and a period of not less than
                60 days for public comment. Section 553(b)(3)(B) of the APA and section
                1871(b)(2)(C) of the Act authorize the agency to waive these
                procedures, however, if the agency finds good cause that notice and
                comment procedures are impracticable, unnecessary, or contrary to the
                public interest and incorporates a statement of the finding and its
                reasons in the rule issued.
                 Section 553(d) of the APA ordinarily requires a 30-day delay in the
                effective date of a final rule from the date of its publication in the
                Federal Register. This 30-day delay in effective date can be waived,
                however, if an agency finds good cause to support an earlier effective
                date. Section 1871(e)(1)(B)(i) of the Act also prohibits a substantive
                rule from taking effect before the end of the 30-day period beginning
                on the date the rule is issued or published. Section 1871(e)(1)(B)(ii)
                of the Act permits a substantive rule to take effect before 30 days if
                the Secretary finds that a waiver of the 30-day period is necessary to
                comply with statutory requirements or that the 30-day delay would be
                contrary to the public interest. Furthermore, section 1871(e)(1)(A)(ii)
                of the Act permits a substantive change in regulations, manual
                instructions, interpretive rules, statements of policy, or guidelines
                of general applicability under Title XVIII of the Act to be applied
                retroactively to items and services furnished before the effective date
                of the change if the failure to apply the change retroactively would be
                contrary to the public interest.
                 The nation is experiencing an emergency of unprecedented magnitude.
                Ensuring the health and safety of Medicare beneficiaries, Medicaid
                recipients, and healthcare workers is of primary importance. As this
                IFC directly supports that goal by offering healthcare professionals
                flexibilities in furnishing services while combatting the COVID-19
                pandemic and ensuring that sufficient health care items and services
                are available to meet the needs of individuals enrolled in the Medicare
                and Medicaid programs, it is critically important that we implement
                this IFC as quickly as possible. As we are in the midst of a PHE, we
                find good cause to waive notice and comment rulemaking as we believe it
                would be contrary to the public interest for us to undertake normal
                notice and comment rulemaking procedures. For the same reasons, because
                we cannot afford any delay in effectuating this IFC, we find good cause
                to waive the 30-day delay in the effective date and, moreover, to make
                this IFC effective as of March 1, 2020--the date the President of the
                United States declared to be the beginning of the national emergency
                concerning the COVID-19 outbreak.
                 On January 30, 2020, the International Health Regulations Emergency
                Committee of the World Health
                [[Page 19281]]
                Organization (WHO) declared the outbreak of the 2019 Novel Coronavirus
                (COVID-19) to be a Public Health Emergency of International
                Concern.\22\ On January 31, 2020, Health and Human Services Secretary
                Alex M. Azar II declared a Public Health Emergency (PHE) \23\ under
                section 319 of the Public Health Service Act (42 U.S.C. 247d), in
                response to COVID-19. On March 11, 2020, the WHO publicly declared
                COVID-19 to be a pandemic.\24\ On March 13, 2020, the President
                declared that the COVD-19 outbreak in the United States constitutes a
                national emergency,\25\ beginning March 1, 2020. This declaration,
                along with the Secretary's January 30, 2020 declaration of a PHE,
                conferred on the Secretary certain waiver authorities under section
                1135 of the Act. On March 13, 2020, the Secretary authorized waivers
                under section 1135 of the Act, effective March 1, 2020.\26\
                ---------------------------------------------------------------------------
                 \22\ https://www.who.int/news-room/detail/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-
                (2005)-emergency-committee-regarding-the-outbreak-of-novel-
                coronavirus-(2019-ncov).
                 \23\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
                 \24\ https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020.
                 \25\ https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
                 \26\ https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
                ---------------------------------------------------------------------------
                 In support of the imperative to contain and combat the virus in the
                United States, this IFC will give health care workers and hospitals
                additional flexibility to respond to the virus and continue caring for
                patients while minimizing exposure. CDC guidelines are clear that
                public exposure greatly increases the overall risk to public health and
                they stress the importance of containment and mitigation strategies to
                minimize public exposure and the spread of COVID-19. As of March 29th,
                the CDC reports 122,653 cases of COVID-19 in the United Sates and 2,112
                deaths.\27\ Individuals such as healthcare workers who come in close
                contact with those infected with COVID-19 are at an elevated risk of
                contracting the disease. To minimize these risks, the CDC has urged
                healthcare professionals to make every effort to distance themselves
                from those who are potentially sick with COVID-19 by using modalities
                such as telephonic interviews, text monitoring systems, or video
                conference.\28\ As the healthcare community works to establish and
                implement infection prevention and control practices, CMS is also
                working to revise and implement regulations that function in concert
                with those healthcare community infection prevention and treatment
                practices.
                ---------------------------------------------------------------------------
                 \27\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html.
                 \28\ https://www.cdc.gov/coronavirus/2019-ncov/php/guidance-evaluating-pui.html.
                ---------------------------------------------------------------------------
                 This IFC offers flexibilities in certain Medicare and Medicaid
                regulations that support measures to combat the COVID-19 pandemic and
                safeguard all interests by protecting healthcare providers and
                vulnerable beneficiaries. The provisions of this IFC better enable and
                facilitate physicians and other clinicians, to focus on caring for
                these beneficiaries during this PHE for the COVID-19 pandemic and
                minimize their own risks to COVID-19 exposure. For example, by
                increasing access to telehealth and testing in a patient's home, and
                improving infection control, this IFC will provide flexibilities for
                Medicare beneficiaries to be able to receive medically necessary
                services without jeopardizing their health or the health of those who
                are providing those services, in turn minimizing public exposure and
                the overall risk to public health. Moreover, changes to Medicare
                payment rules will confer on practitioners and other healthcare
                providers the broadest flexibility to use remote communications
                technology to avoid exposure risks to themselves, their patients, and
                communities. These changes include greater flexibilities to use
                communications technology to interact with patients directly and to
                supervise care directly provided by other clinicians. This IFC alters
                the applicable payment rules to provide specimen collection fees for
                independent laboratories collecting specimens from beneficiaries who
                are homebound or inpatients (not in a hospital) for COVID-19 testing.
                Additionally, certain new model-specific requirements for Innovation
                Center Models and program-specific requirements for the Quality Payment
                Program will reduce or prevent practices that might inappropriately
                incentivize cost considerations over patient safety. Changes to the
                calculation of the 2021 and 2022 Part C and D Star Ratings will address
                the expected disruption to data collection and measure scores posed by
                the COVID-19 pandemic, and amendments to the Medicaid home health
                regulations will enable other licensed practitioners to order services,
                equipment, and therapy they otherwise could not.
                 We believe it would be contrary to the public interest for us to
                undertake normal notice and comment procedures and to delay the
                effective date of this IFC. We find good cause to waive notice of
                proposed rulemaking under section 553(b)(3)(B) of the APA and section
                1871(b)(2)(C) of the Act, and, for the reasons stated, we find that it
                would be contrary to the public interest to delay the effective date of
                this IFC, under section 553(d) of the APA and section 1871(e)(1)(B)(i)
                of the Act.
                 Furthermore, the President declared that the COVID-19 outbreak in
                the United States constituted a national emergency beginning March 1,
                2020. To ensure the consistent availability throughout the national
                emergency period of measures we are taking to address the COVID-19
                pandemic, we believe it is vital that the effective date of this IFC
                align with the first day of the national emergency. It is also
                important to ensure the health care providers that acted expeditiously
                to implement appropriate physical and operational changes to their
                practices to adapt to emergency conditions, even in the absence of
                changes in our policies to address them, are not disadvantaged relative
                to other health care providers, and will not be discouraged from taking
                similar appropriate actions in the future. March 1, 2020 precedes the
                date of publication of this IFC in the Federal Register, which means
                this rule has a retroactive effect. However, section 1872(e)(1)(A)(ii)
                of the Act permits the Secretary to issue a rule with retroactive
                effect if the failure to do so would be contrary to the public
                interest. As we have explained above, we believe it would be contrary
                to the public interest not to implement this IFC as soon as we are
                authorized to do so under the authority of section 1871(e)(1)(A)(ii) of
                the Act, that is, retroactively to March 1, 2020. We are providing a
                60-day public comment period for this IFC as specified in the DATES
                section of this document.
                IV. Collection of Information Requirements
                 For IFC changes to the MA and Part D Star Ratings program, the
                elimination of the requirement to collect and submit data for OMB
                control numbers 0938-1028 (HEDIS) and 0938-0732 (CAHPS) will reduce
                some burden. Those collections are approved for 164,200 hours and
                123,375 hours annually, respectively. Due to the ongoing nature of
                these information collections, it is difficult to determine the extent
                of the burden. However, the burden estimates for the HEDIS and CAHPS
                information collection requests are approved
                [[Page 19282]]
                through November 30, 2020 and April 30, 2021, respectively. Upon
                resubmission for OMB approval, we will revise both information
                collections to more accurately account for the burden decreases.
                V. Response to Comments
                 Because of the large number of public comments we normally receive
                on Federal Register documents, we are not able to acknowledge or
                respond to them individually. We will consider all comments we receive
                by the date and time specified in the DATES section of this preamble,
                and, when we proceed with a subsequent document, we will respond to the
                comments in the preamble to that document.
                VI. Regulatory Impact Analysis
                 Executive Order 12866 and other laws and Executive orders require
                economic analysis of the effects of proposed and final (including
                interim final) rules.\29\ The Office of Management and Budget has
                designated this rulemaking as ``economically significant'' under E.O.
                12866 and also major under the Congressional Review Act. This IFC's
                designation under Executive Order 13771, titled ``Reducing Regulation
                and Controlling Regulatory Costs'' (82 FR 9339), which was issued on
                January 30, 2017, will be informed by public comments received.
                ---------------------------------------------------------------------------
                 \29\ Section 202 of the Unfunded Mandates Reform Act of 1995
                (UMRA) (Pub. L. 104-04, enacted on March 22, 1995) also requires
                that agencies assess anticipated costs and benefits before issuing
                any rule whose mandates require spending in any 1 year of $100
                million in 1995 dollars, updated annually for inflation. In 2020,
                that amount is approximately $156 million. This IFC does not
                mandate, on an unfunded basis, any requirements for State, local, or
                tribal governments, or for the private sector.
                ---------------------------------------------------------------------------
                A. Statement of Need
                 Throughout this IFC, we discuss several changes to payment and
                coverage policies intended to allow health care providers maximum
                flexibility to minimize the spread of COVID-19 among Medicare and
                Medicaid beneficiaries, health care personnel, and the community at
                large and increase capacity to address the needs of their patients. The
                flexibilities and changes contained within this IFC are responsive to
                this developing pandemic emergency. Given the potentially catastrophic
                impact to public health, it is difficult to estimate the economic
                impact of the spread of COVID-19 under current payment rules compared
                to the rules issued in this IFC.
                 We believe that the needs of Medicare patients will likely test the
                capacity of the health care system over the coming months. Our policies
                during the PHE for the COVID-19 Pandemic will allow home health
                agencies and hospices more flexibility to furnish services via
                telecommunications technologies to minimize exposure risks to patients,
                clinicians and the general public; and there would be no change in
                Medicare payment rates or change in the types of patients treated under
                these policies compared to the absence of these policy changes.
                 Our additions to the list of Medicare telehealth services will
                allow more physicians' services to be furnished in a manner that
                reduces the exposure risk to patients and physicians. To the extent
                that physicians utilize these new flexibilities for patients that would
                have been treated in more traditional offices or hospital settings
                without this policy change, given the competing demand for physicians'
                services during the pandemic this additional flexibility would not
                result in any significant change in aggregate Medicare payments for
                physicians' services.
                 Still, it is possible that the flexibilities and changes contained
                within this IFC would increase aggregate Medicare payments. For
                example, if its protections against exposure risk are effective,
                providers may maintain their own health and thus be available to
                provide more medical treatment overall. Improvements in both provider
                and/or patient health are intended benefits of this IFC.
                 We anticipate that the change in the site of service payment amount
                for telehealth services under the PHE along with the changes that allow
                for broader flexibilities in supervision will allow physicians and
                other practitioners to better maintain overall level of needed care to
                Medicare beneficiaries in the face of exposure risks and competing
                demands for health care providers.
                 Finally, the changes to Medicaid's regulations to expand the scope
                of certain providers are anticipated to eliminate some burdens on
                providers and beneficiaries.
                 The modifications to the calculations for the 2021 and 2022 Part C
                and D Star Ratings to address the expected disruption to data
                collection and measure scores posed by the PHE for the COVID-19
                pandemic should not have a significant impact on the distribution of
                ratings across Part C and D sponsors. Consequently, there should be
                negligible impacts on payments for MA organizations from these
                modifications.
                B. Special Requirements for Psychiatric Hospitals
                 In section II.P. of this final rule, we note that existing
                requirements for psychiatric hospitals specify that progress notes must
                be recorded by the physician(s), psychologists, or other licensed
                independent practitioner(s) responsible for the care of the patient. We
                believe that this provision requires clarification and revision since
                the regulatory language is inconsistent with other recent changes
                finalized throughout the hospital CoPs as this provision applies to
                APPs, including PAs, NPs, psychologists, and CNSs.
                 Continued use of this outdated term may inadvertently exacerbate
                workforce shortage concerns, might unnecessarily impose regulatory
                burden on hospitals, especially psychiatric hospitals, by restricting a
                hospital's ability to allow APPs to operate within the scope of
                practice allowed by state law. We believe that the existing regulation
                fails to recognize the benefits to patient care that might be derived
                from fully utilizing APPs and their clinical skills to the highest
                levels of their training, education, and experience as allowed by
                hospital policy in accordance with state law.
                 Therefore, we are removing the term ``licensed independent
                practitioner(s)'' from the regulations. We believe that this revision
                is non-controversial, and that the public interest will be served by
                permitting a greater scope of practice for professionals in the
                psychiatric hospital context and further believe that these trained and
                qualified practitioners, when acting in accordance with State law,
                their scope of practice, and hospital policy, should have the authority
                to record progress notes of psychiatric patients for whose care they
                are responsible.
                 At Sec. 482.61(d), we are allowing NPPs, or APPs, to document
                progress notes in accordance with State laws and scope-of-practice
                requirements. We believe that clarification of the intent of the
                regulation is necessary and will result in NPPs (specifically PAs, NPs,
                and CNSs) documenting in the progress notes for patients receiving
                services in psychiatric hospitals.
                 We estimate that MDs/DOs currently spend approximately 30 minutes
                documenting progress notes in psychiatric hospitals, and that 33
                percent of this time would be covered by NPPs. Of the 4,823 Medicare
                participating hospitals, approximately 620 (or 13 percent) are
                psychiatric hospitals. According to AHA, there were 36,510,207
                inpatient hospital stays in 2017, and therefore, an estimated 13
                percent of these stays were at psychiatric hospitals. The change will
                result in a savings of $153.5 million (4,746,327 psychiatric hospital
                stays x 2 progress notes per stay x 0.5 hours of physician/psychiatrist
                time x $98 per
                [[Page 19283]]
                hourly wage difference between physicians/psychiatrists ($198) and NPPs
                ($100, the average wage between NPs and PAs) x 33 percent of physician
                time spent writing progress notes covered by NPPs, or APPs).
                C. Anticipated Effects of Changes to the MDPP Expanded Model
                1. Effects on Beneficiaries
                 In section II.Q. of this IFC, we are amending the MDPP expanded
                model to modify certain requirements of the model in an emergency area
                during an emergency period, as those terms are defined in section
                1135(g) of the Act, for which the Secretary has issued a waiver under
                section 1135 of the Act. Specifically, as the Secretary has issued a
                waiver under section 1135 of the Act, certain MDPP beneficiaries will
                be permitted to obtain the set of MDPP services more than once per
                lifetime, the number of virtual make-up sessions is increased, and
                certain MDPP suppliers will be permitted to deliver time limited
                virtual MDPP sessions. These changes apply only to MDPP beneficiaries
                (as defined in Sec. 410.79(b)) who were receiving the MDPP set of
                services during the emergency period, as defined under section 1135(g)
                of the Act.
                 We believe that during this COVID-19 pandemic, Medicare
                beneficiaries will not be able to attend in-person classes. Because we
                do not want to disrupt their progress and we want to promote both MDPP
                beneficiary and MDPP supplier retention, we have modified how the set
                of services can be delivered to make the program accessible to
                currently enrolled MDPP beneficiaries during this national emergency.
                Our policies during the PHE for the COVID-19 Pandemic will allow
                enrolled MDPP suppliers with active MDPP cohorts more flexibility to
                furnish virtual sessions, as described by the CDC's DPRP Standards.
                 With the exception of the requirement for in-person attendance and
                the in-person body weight measurement at the first core-session, the
                in-person attendance requirements are waived. MDPP suppliers shall not
                start any new cohorts with MDPP beneficiaries throughout the COVID-19
                PHE period in the geographic area, as defined under section 1135(g) of
                the Act, given that most beneficiaries cannot receive in-person
                services right now.
                 During the emergency period, the number of virtual make-up sessions
                is waived for MDPP suppliers, with an MDPP supplier offering MDPP
                beneficiaries no more than 15 weekly virtual make-up sessions during
                the core session period, no more than 6 monthly virtual make-up
                sessions during the core maintenance session interval period, no more
                than 12 monthly virtual make-up sessions during the ongoing maintenance
                session interval periods. All flexibilities described in this IFC will
                cease to be available as of the effective end date of the PHE. When in-
                person classes resume, the CDC is allowing suppliers to pick up where
                they left off, or to restart the program from week one. It is our
                intent to conform with the CDC guidance where feasible, with the
                overall intent to minimize disruption of services for MDPP suppliers
                and MDPP beneficiaries; by allowing MDPP beneficiaries to maintain
                their eligibility. In this IFC, we are amending the MDPP regulations to
                provide for changes as described in section II.Q.1 of this IFC,
                including allowing MDPP suppliers to either deliver MDPP services
                virtually or suspend delivery and resume services at a later date, in
                an emergency area and during this COVID-19 PHE period, as those terms
                are defined in section 1135(g) of the Act, for which the Secretary has
                authorized a waiver under section 1135 of the Act and the Secretary has
                declared a PHE. In addition, these changes permit certain MDPP
                beneficiaries to obtain the set of MDPP services more than once per
                lifetime, for the limited purposes of allowing a pause in service and
                allow MDPP beneficiaries to maintain eligibility for MDPP services
                despite a break in service, attendance, or weight loss achievement.
                These changes will have a positive impact on affected MDPP
                beneficiaries, as it will allow them to maintain eligibility for the
                expanded model, and request virtual make-up sessions if needed for
                successful completion of attendance and weight loss milestones.
                2. Effects on the Market
                 Currently, more than 196 organizations nationally are enrolled as
                MDPP suppliers. There are approximately 798 locations. We anticipate
                that of the 1,818 beneficiaries identified through our monitoring data
                and the CDC's Diabetes Prevention Recognition Program (DPRP) data,
                1,358 beneficiaries may be impacted by allowing both the once-per-
                lifetime benefit and the minimum weight loss requirement to be waived
                for those beneficiaries in the first 12 months of MDPP.
                 Table 2
                ------------------------------------------------------------------------
                 Recommended waivers Cost impact
                ------------------------------------------------------------------------
                Adjust the limit to the # Virtual Make-up sessions...... $--
                Waive the once per lifetime requirement................. 279,748.00
                Waive the minimum weight loss requirement for OM........ 53,301.50
                Waive the MDPP services time periods and intervals...... --
                Average Y1 MDPP Payments (Y1) with no COVID action...... 177,898.00
                 ---------------
                 Total cost of COVID-19 response..................... 333,049.50
                ------------------------------------------------------------------------
                Assumptions:
                --Average MDPP payments in Year 1: $412, assuming that beneficiaries
                 attended 9 sessions, and reached the 5 percent weight loss during
                 interval 1 of the core maintenance session
                --Average MDPP payments in Year 1 with no COVID-19 action: $131,
                 assuming beneficiaries attended 2 ongoing maintenance sessions
                D. Modification to the Extreme and Uncontrollable Circumstances Policy
                Under the Shared Savings Program
                 In section II.V. of this IFC, we discuss a modification to the
                extreme and uncontrollable circumstances policy under the Shared
                Savings Program. The current Medicare Shared Savings Program extreme
                and uncontrollable circumstances policy for purposes of determining an
                ACO's quality score for use in determining shared savings or shared
                losses applies if twenty percent or more of an ACO's assigned
                beneficiaries or its legal business entity are located in an area
                identified under the Quality Payment Program as being affected by an
                extreme and uncontrollable circumstance, during the performance year,
                including the applicable quality data reporting period for the
                performance year if, the quality reporting period is not extended. In
                response to the National Emergency for
                [[Page 19284]]
                the COVID-19 pandemic declared on March 13, 2020, we have determined
                that the 2019 MIPS data submission deadline will be extended by 30 days
                until April 30, 2020, to give eligible clinicians more time to report
                quality and other data for purposes of MIPS. This extended timeline
                also applies to Shared Savings Program ACOs because they are required
                to report quality data via the CMS Web Interface and we align the
                Shared Savings Program data submission timeline with the timeline for
                MIPS data submission. As currently written, our extreme and
                uncontrollable circumstances policy cannot be applied to waive the
                quality reporting requirements under the Shared Savings Program because
                the quality data submission period has been extended.
                 The PHE for the COVID-19 pandemic applies to all counties in the
                United States, and we think it is appropriate to offer relief under the
                Shared Savings Program extreme and uncontrollable circumstances policy
                to all Shared Savings Program ACOs that are unable to completely and
                accurately report quality for 2019 by the extended deadline.
                Accordingly, in this IFC, we are revising the regulation at Sec.
                425.502(f) to remove the restriction which prevents the application of
                the Shared Savings Program extreme and uncontrollable circumstances
                policy for disasters that occur during the quality period if the
                reporting period is extended, to offer relief under the Shared Savings
                Program to all ACOs that may be unable to completely and accurately
                report quality for 2019 due to the PHE for the COVID-19. As currently
                written, our extreme and uncontrollable circumstances policy cannot be
                applied to waive the quality reporting requirements under the Shared
                Savings Program because the quality data submission period has been
                extended.
                 The PHE for the COVID-19 pandemic applies to all counties in the
                United States, and we think it is appropriate to offer relief under the
                Shared Savings Program extreme and uncontrollable circumstances policy
                to all Shared Savings Program ACOs that are unable to completely and
                accurately report quality for 2019 by the extended deadline,
                Accordingly, in this interim final rule, we are revising the regulation
                at Sec. 425.502(f) to remove the restriction which prevents the
                application of the Shared Savings Program extreme and uncontrollable
                circumstances policy for disasters that occur during the quality period
                if the reporting period is extended, in order to offer relief under the
                Shared Savings Program to all ACOs that may be unable to completely and
                accurately report quality for 2019 due to the PHE for the COVID-19
                pandemic.
                 We estimate based on patterns evident in the financial
                reconciliation for performance year 2018 that this change would allow
                roughly 100 ACOs that achieve savings either to qualify to receive
                shared savings or to receive a higher effective sharing rate. We
                estimate the average resulting benefit to such ACOs ranging from
                $150,000 to $200,000 per ACO. The total impact of extending the extreme
                and uncontrollable circumstances policy despite the extension of the
                quality reporting period for 2019 is therefore estimated to be $20
                million with a range of uncertainty in such estimate spanning $15
                million to $25 million.
                E. Anticipated Effects of Changes to the Quality Payment Program
                 Since it is not possible to comprehensively predict the impact of
                the evolving PHE for the COVID-19 pandemic at this time, the Office of
                the Actuary was unable to calculate a discrete impact estimate for the
                effect of extending CJR PY 5 an additional 3 months. However, given the
                previous estimate for PY 5 in the ``Comprehensive Care for Joint
                Replacement Model Three-Year Extension and Changes to Episode
                Definition and Pricing'' proposed rule (CMS-5529-P), we anticipate the
                impact of the additional 3 months could range between $0 and $1.2
                million. We will continue to refine this analysis and will provide a
                more detailed estimate in the final rule if available. Table 3
                summarizes the financial impact of extending PY 5 an additional 3
                months. Table 3 includes the full amount of FFS episode payments and
                also includes any reconciliation payments related to the model. Table 3
                also shows costs/savings (costs are represented as positive amounts and
                savings as negative amounts) imposed on non-federal entities (that is,
                participating medical facilities), as well as net transfers of federal
                funds (that is, increases in Medicare program expenditures are
                indicated as positive amounts and decreases in Medicare program
                expenditures are indicated as negative amounts).
                 Table 3--Financial Impact of Extending PY 5 an Additional 3 Months
                ------------------------------------------------------------------------
                 Transfers
                 Scenario Costs/benefits (millions)
                ------------------------------------------------------------------------
                Net financial impact of extending CJR .............. 1.2
                 model PY 5 by 3 additional months.....
                ------------------------------------------------------------------------
                F. Overall Impact
                 The RFA requires agencies to analyze options for regulatory relief
                of small entities, if a rule has a significant impact on a substantial
                number of small entities. The great majority of hospitals and most
                other health care providers and suppliers are small entities, either by
                being nonprofit organizations or by meeting the SBA definition of a
                small business (having revenues of less than $8.0 million to $41.5
                million in any one year). Individuals and states are not included in
                the definition of a small entity. As its measure of significant
                economic impact on a substantial number of small entities, HHS uses an
                adverse change in revenue of more than 3 to 5 percent. We do not
                believe that this threshold will be reached by the provisions in this
                IFC.
                 In addition, section 1102(b) of the Act requires us to prepare a
                regulatory impact analysis if a rule may have a significant impact on
                the operations of a substantial number of small rural hospitals. This
                analysis must conform to the provisions of section 604 of the RFA. For
                purposes of section 1102(b) of the Act, we define a small rural
                hospital as a hospital that is located outside of a metropolitan
                statistical area and has fewer than 100 beds. This IFC will not have a
                significant impact on the operations of a substantial number of small
                rural hospitals.
                 Executive Order 13132 establishes certain requirements that an
                agency must meet when it issues a proposed rule that imposes
                substantial direct requirement costs on state and local governments,
                preempts state law, or otherwise has federalism implications. This IFC
                does not have a substantial direct cost impact on state or local
                governments, preempt state law, or otherwise have federalism
                implications.
                 Under the Congressional Review Act (5 U.S.C. 801 et seq.), the
                Office of Information and Regulatory Affairs designated this rule as a
                major rule, as
                [[Page 19285]]
                defined by 5 U.S.C. 804(2). As such, this rule has been transmitted to
                the Congress and the Comptroller General for review.
                List of Subjects
                42 CFR Part 400
                 Grant programs--health, Health facilities, Health maintenance
                organizations (HMO), Medicaid, Medicare, Reporting and recordkeeping
                requirements.
                42 CFR Part 405
                 Administrative practice and procedure, Diseases, Health facilities,
                Health insurance, Health professions, Medical devices, Medicare,
                Reporting and recordkeeping requirements, Rural areas, X-rays.
                42 CFR Part 409
                 Health facilities, Medicare.
                42 CFR Part 410
                 Diseases, Health facilities, Health professions, Laboratories,
                Medicare, Reporting and recordkeeping requirements, Rural areas, X-
                rays.
                42 CFR Part 412
                 Administrative practice and procedure, Health facilities, Medicare,
                Puerto Rico, Reporting and recordkeeping requirements.
                42 CFR Part 414
                 Administrative practice and procedure, Biologics, Diseases, Drugs,
                Health facilities, Health professions, Medicare, Reporting and
                recordkeeping requirements.
                42 CFR Part 415
                 Health facilities, Health professions, Medicare, Reporting and
                recordkeeping requirements.
                42 CFR Part 417
                 Administrative practice and procedure, Grant programs--health,
                Health care, Health insurance, Health maintenance organizations (HMO),
                Loan programs--health, Medicare, Reporting and recordkeeping
                requirements.
                42 CFR Part 418
                 Health facilities, Hospice care, Medicare, Reporting and
                recordkeeping requirements.
                42 CFR Part 421
                 Administrative practice and procedure, Health facilities, Health
                professions, Medicare, Reporting and recordkeeping requirements.
                42 CFR Part 422
                 Administrative practice and procedure, Health facilities, Health
                maintenance organizations (HMO), Medicare, Penalties, Privacy,
                Reporting and recordkeeping requirements.
                42 CFR Part 423
                 Administrative practice and procedure, Emergency medical services,
                Health facilities, Health maintenance organizations (HMO), Health
                professionals, Medicare, Penalties, Privacy, Reporting and
                recordkeeping requirements.
                42 CFR Part 425
                 Administrative practice and procedure, Health facilities, Health
                professions, Medicare, Reporting and recordkeeping requirements.
                42 CFR Part 440
                 Grant programs--health, Medicaid.
                42 CFR Part 482
                 Grant programs--health, Hospitals, Medicaid, Medicare, Reporting
                and recordkeeping requirements.
                42 CFR Part 510
                 Administrative practice and procedure, Health facilities.
                 For the reasons set forth in the preamble, the Centers for Medicare
                & Medicaid Services amends 42 CFR chapter IV as set forth below:
                PART 400--INTRODUCTION; DEFINITIONS
                0
                1. The authority citation part 400 is revised to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh, and 44 U.S.C. Chapter 35.
                0
                2. Section 400.200 is amended by adding the definition of ``Public
                Health Emergency'' in alphabetical order to read as follows:
                Sec. 400.200 General definitions.
                * * * * *
                 Public Health Emergency (PHE) means the Public Health Emergency
                determined to exist nationwide as of January 27, 2020, by the Secretary
                pursuant to section 319 of the Public Health Security Act on January
                31, 2020, as a result of confirmed cases of COVID-19, including any
                subsequent renewals.
                * * * * *
                PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
                0
                3. The authority citation part 405 continues to read as follows:
                 Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x,
                1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).
                0
                4. Section 405.2416 is amended by adding paragraph (a)(5) to read as
                follows:
                Sec. 405.2416 Visiting nurse services.
                 (a) * * *
                 (5) During a PHE, as defined in Sec. 400.200 of this chapter, an
                area typically served by the RHC, and an area that is included in the
                FQHC's service area plan, is determined to have a shortage of home
                health agencies, and no request for this determination is required.
                * * * * *
                PART 409--HOSPITAL INSURANCE BENEFITS
                0
                5. The authority citation for part 409 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                6. Section 409.43 is amended by revising paragraph (a)(3) to read as
                follows:
                Sec. 409.43 Plan of care requirements.
                 (a) * * *
                 (3) The plan of care must include the identification of the
                responsible discipline(s) and the frequency and duration of all visits,
                as well as those items listed in Sec. 484.60(a) of this chapter that
                establish the need for such services. All care provided must be in
                accordance with the plan of care. During a PHE, as defined in Sec.
                400.200 of this chapter, the plan of care must include any provision of
                remote patient monitoring or other services furnished via a
                telecommunications system and such services must be tied to the
                patient-specific needs as identified in the comprehensive assessment,
                cannot substitute for a home visit ordered as part of the plan of care,
                and cannot be considered a home visit for the purposes of patient
                eligibility or payment. The plan of care must include a description of
                how the use of such technology will help to achieve the goals outlined
                on the plan of care.
                * * * * *
                PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
                0
                7. The authority citation for part 410 continues to read as follows:
                 Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.
                0
                8. Section 410.27 is amended by revising paragraphs (a)(1)(iv)(D) and
                (E) to read as follows:
                [[Page 19286]]
                Sec. 410.27 Therapeutic outpatient hospital or CAH services and
                supplies incident to a physician's or nonphysician practitioner's
                service: Conditions.
                 (a) * * *
                 (1) * * *
                 (iv) * * *
                 (D) For pulmonary rehabilitation, cardiac rehabilitation, and
                intensive cardiac rehabilitation services, direct supervision must be
                furnished by a doctor of medicine or a doctor of osteopathy, as
                specified in Sec. Sec. 410.47 and 410.49, respectively. For purposes
                of this section, direct supervision means that the physician or
                nonphysician practitioner must be immediately available to furnish
                assistance and direction throughout the performance of the procedure.
                It does not mean that the physician or nonphysician practitioner must
                be present in the room when the procedure is performed. During a Public
                Health Emergency, as defined in Sec. 400.200 of this chapter, the
                presence of the physician includes virtual presence through audio/video
                real-time communications technology when use of such technology is
                indicated to reduce exposure risks for the beneficiary or health care
                provider; and
                 (E) For nonsurgical extended duration therapeutic services
                (extended duration services), which are hospital or CAH outpatient
                therapeutic services that can last a significant period of time, have a
                substantial monitoring component that is typically performed by
                auxiliary personnel, have a low risk of requiring the physician's or
                appropriate nonphysician practitioner's immediate availability after
                the initiation of the service, and are not primarily surgical in
                nature, Medicare requires a minimum of direct supervision during the
                initiation of the service which may be followed by general supervision
                at the discretion of the supervising physician or the appropriate
                nonphysician practitioner. Initiation means the beginning portion of
                the nonsurgical extended duration therapeutic service which ends when
                the patient is stable and the supervising physician or the appropriate
                nonphysician practitioner determines that the remainder of the service
                can be delivered safely under general supervision. During a Public
                Health Emergency, as defined in Sec. 400.200 of this chapter, Medicare
                requires a minimum level of general supervision for the entire service;
                and
                * * * * *
                0
                9. Section 410.28 is amended by revising paragraph (e)(1) to read as
                follows:
                Sec. 410.28 Hospital or CAH diagnostic services furnished to
                outpatients: Conditions.
                * * * * *
                 (e) * * *
                 (1) For services furnished directly or under arrangement in the
                hospital or in an on-campus or off-campus outpatient department of the
                hospital, as defined in Sec. 413.65 of this chapter, ``direct
                supervision'' means that the physician must be immediately available to
                furnish assistance and direction throughout the performance of the
                procedure. It does not mean that the physician must be present in the
                room where the procedure is performed. During a Public Health
                Emergency, as defined in Sec. 400.200 of this chapter, the presence of
                the physician includes virtual presence through audio/video real-time
                communications technology when use of such technology is indicated to
                reduce exposure risks for the beneficiary or health care provider.
                * * * * *
                0
                10. Section 410.32 is amended by revising paragraph (b)(3)(ii) to read
                as follows:
                Sec. 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and
                other diagnostic tests: Conditions.
                * * * * *
                 (b) * * *
                 (3) * * *
                 (ii) Direct supervision in the office setting means the physician
                must be present in the office suite and immediately available to
                furnish assistance and direction throughout the performance of the
                procedure. It does not mean that the physician must be present in the
                room when the procedure is performed. During a PHE, as defined in Sec.
                400.200 of this chapter, the presence of the physician includes virtual
                presence through audio/video real-time communications technology when
                use of such technology is indicated to reduce exposure risks for the
                beneficiary or health care provider.
                * * * * *
                0
                11. Section 410.40 is amended by adding paragraph (f)(5) to read as
                follows:
                Sec. 410.40 Coverage of ambulance services.
                * * * * *
                 (f) * * *
                 (5) During a Public Health Emergency, as defined in Sec. 400.200
                of this chapter, a ground ambulance transport from any point of origin
                to a destination that is equipped to treat the condition of the patient
                consistent with any applicable state or local Emergency Medical
                Services protocol that governs the destination location. Such
                destinations include, but are not limited to, alternative sites
                determined to be part of a hospital, critical access hospital or
                skilled nursing facility, community mental health centers, federally
                qualified health centers, rural health clinics, physician offices,
                urgent care facilities, ambulatory surgical centers, any location
                furnishing dialysis services outside of an ESRD facility when an ESRD
                facility is not available, and the beneficiary's home.
                * * * * *
                0
                12. Section 410.67(b) is amended in paragraphs (3) and (4) of the
                definition of ``Opioid use disorder treatment service'' by adding a
                sentence at the end of each paragraph to read as follows:
                Sec. 410.67 Medicare coverage and payment of Opioid use disorder
                treatment services furnished by Opioid treatment programs.
                * * * * *
                 (b) * * *
                 Opioid use disorder treatment service * * *
                 (3) * * * During a Public Health Emergency, as defined in Sec.
                400.200 of this chapter, where audio/video communication technology is
                not available to the beneficiary, the counseling services may be
                furnished using audio-only telephone calls if all other applicable
                requirements are met.
                 (4) * * * During a Public Health Emergency, as defined in Sec.
                400.200 of this chapter, where audio/video communication technology is
                not available to the beneficiary, the therapy services may be furnished
                using audio-only telephone calls if all other applicable requirements
                are met.
                * * * * *
                0
                13. Section 410.78 is amended by--
                0
                a. Adding paragraph (a)(3)(i) and reserved paragraph (a)(3)(ii); and
                0
                b. Revising paragraph (b) introductory text.
                 The additions and revision read as follows:
                Sec. 410.78 Telehealth services.
                 (a) * * *
                 (3) * * *
                 (i) Exception. For the duration of the Public Health Emergency as
                defined in Sec. 400.200 of this chapter, Interactive
                telecommunications system means multimedia communications equipment
                that includes, at a minimum, audio and video equipment permitting two-
                way, real-time interactive communication between the patient and
                distant site physician or practitioner.
                 (ii) [Reserved]
                * * * * *
                 (b) General rule. Medicare Part B pays for covered telehealth
                services included
                [[Page 19287]]
                on the telehealth list when furnished by an interactive
                telecommunications system if the following conditions are met, except
                that for the duration of the Public Health Emergency as defined in
                Sec. 400.200 of this chapter, Medicare Part B pays for office and
                other outpatient visits, professional consultation, psychiatric
                diagnostic interview examination, individual psychotherapy,
                pharmacologic management and end stage renal disease related services
                included in the monthly capitation payment furnished by an interactive
                telecommunications system if the following conditions are met:
                * * * * *
                0
                14. Section 410.79 is amended by adding paragraph (e) to read as
                follows:
                Sec. 410.79 Medicare Diabetes Prevention Program expanded model:
                Conditions of coverage.
                * * * * *
                 (e) MDPP expanded model emergency policy. (1) Notwithstanding
                paragraphs (a) through (d) of this section, the policies described in
                this paragraph (e) apply during the Public Health Emergency (PHE), as
                defined in Sec. 400.200 of this chapter.
                 (2) MDPP requirement changes described in paragraph (e)(1) of this
                section are applicable to:
                 (i) Organizations that are enrolled as an MDPP supplier as defined
                in paragraph (b) of this section, as of March 1, 2020; and
                 (ii) MDPP beneficiaries as defined in paragraph (b) of this
                section, who are receiving the MDPP set of services as of March 1,
                2020.
                 (3) The following changes apply under this paragraph (e):
                 (i) The in-person attendance requirements of paragraphs
                (c)(1)(ii)(A), (c)(1)(iii)(A), and (c)(3)(ii) of this section are
                waived. MDPP suppliers shall not start new cohorts with MDPP
                beneficiaries who are unable to attend the first core session in-
                person;
                 (ii) The limit described in paragraphs (d)(2) and (d)(3)(i) and
                (ii) of this section to the number of virtual make-up sessions is
                waived for MDPP suppliers with capabilities to provide services
                virtually so long as the provision of virtual services complies with
                the following:
                 (A) The curriculum furnished during the virtual make-up session
                must address the same CDC-approved DPP curriculum topic as the
                regularly scheduled session;
                 (B) The MDPP supplier furnishes to the MDPP beneficiary a maximum
                of one session on the same day as a regularly scheduled session;
                 (C) The MDPP supplier furnishes to the MDPP beneficiary a maximum
                of one virtual make-up session per week;
                 (D) Virtual make-up sessions must be furnished in a manner
                consistent with the DPRP standards for virtual sessions;
                 (E) Virtual make-up sessions can only be furnished to achieve
                attendance goals and cannot be furnished to achieve weight-loss goals;
                 (F) An MDPP supplier can only offer virtual make-up sessions upon
                an individual MDPP beneficiary's request; and
                 (G) An MDPP supplier can offer to an MDPP beneficiary:
                 (1) No more than 15 virtual make-up sessions offered weekly during
                the core session period, months 1 through 6 of the MDPP services
                period;
                 (2) No more than 6 virtual make-up sessions offered monthly during
                the core maintenance session interval periods, months 7 through 12 of
                the MDPP services period; and
                 (3) No more than 12 virtual make-up sessions offered monthly during
                the ongoing maintenance session interval periods, months 13 through 24;
                 (iii) The once per lifetime requirement as described in paragraph
                (c)(1)(i)(B) of this section is waived to permit MDPP beneficiaries
                whose sessions were paused or cancelled due to the PHE to obtain the
                set of MDPP services more than once per lifetime by electing to restart
                the MDPP set of services or resume with the most recent attendance
                session of record;
                 (iv) The minimum weight loss requirements for beneficiary
                eligibility in the ongoing maintenance session intervals described in
                paragraphs (c)(1)(ii)(B) and (c)(1)(iii)(B) of this section are waived;
                and
                 (v) MDPP suppliers may pause or delay the delivery of the MDPP set
                of services and subsequently resume services on a delayed schedule. The
                time periods and intervals must be consistent with the MDPP
                requirements as described in paragraphs (c)(1)(i)(B), (c)(1)(ii)(A),
                (c)(1)(iii)(A), (c)(2)(i)(A) and (B), and (c)(3)(i) and (ii) of this
                section.
                PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL
                SERVICES
                0
                15. The authority citation for part 412 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                16. Section 412.29 is amended by revising paragraph (e) to read as
                follows:
                Sec. 412.29 Classification criteria for payment under the inpatient
                rehabilitation facility prospective payment system.
                * * * * *
                 (e) Have in effect a procedure to ensure that patients receive
                close medical supervision, as evidenced by at least 3 face-to-face
                visits per week by a licensed physician with specialized training and
                experience in inpatient rehabilitation to assess the patient both
                medically and functionally, as well as to modify the course of
                treatment as needed to maximize the patient's capacity to benefit from
                the rehabilitation process, except that during a Public Health
                Emergency, as defined in Sec. 400.200 of this chapter, such visits may
                be conducted using telehealth services (as defined in section
                1834(m)(4)(F) of the Act).
                * * * * *
                0
                17. Section 412.622 is amended by revising paragraphs (a)(3)(iv) and
                (a)(4)(ii) introductory text to read as follows:
                Sec. 412.622 Basis of payment.
                 (a) * * *
                 (3) * * *
                 (iv) Requires physician supervision by a rehabilitation physician.
                The requirement for medical supervision means that the rehabilitation
                physician must conduct face-to-face visits with the patient at least 3
                days per week throughout the patient's stay in the IRF to assess the
                patient both medically and functionally, as well as to modify the
                course of treatment as needed to maximize the patient's capacity to
                benefit from the rehabilitation process, except that during a Public
                Health Emergency, as defined in Sec. 400.200 of this chapter, such
                visits may be conducted using telehealth services (as defined in
                section 1834(m)(4)(F) of the Act). The post-admission physician
                evaluation described in paragraph (a)(4)(ii) of this section may count
                as one of the face-to-face visits.
                 (4) * * *
                 (ii) A post-admission physician evaluation that meets all of the
                following requirements, except for the duration of the Public Health
                Emergency, as defined in Sec. 400.200 of this chapter--
                * * * * *
                PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
                0
                18. The authority citation for part 414 continues to read as follows:
                 Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).
                0
                19. Section 414.1380 is amended by--
                0
                a. Revising paragraphs (c)(2)(i)(A)(6) and (c)(2)(i)(C) introductory
                text; and
                0
                b. Adding paragraph (c)(2)(i)(C)(11).
                [[Page 19288]]
                 The revisions and addition read as follows:
                Sec. 414.1380 Scoring.
                * * * * *
                 (c) * * *
                 (2) * * *
                 (i) * * *
                 (A) * * *
                 (6) Beginning with the 2020 MIPS payment year, for the quality,
                cost, and improvement activities performance categories, the MIPS
                eligible clinician demonstrates through an application submitted to CMS
                that they were subject to extreme and uncontrollable circumstances that
                prevented the clinician from collecting information that the clinician
                would submit for a performance category or submitting information that
                would be used to score a performance category for an extended period of
                time. Beginning with the 2021 MIPS payment year, in the event that a
                MIPS eligible clinician submits data for the quality, cost, or
                improvement activities performance categories, the scoring weight
                specified in paragraph (c)(1) of this section will be applied and its
                weight will not be redistributed, unless an exception applies.
                Exception: for the 2021 MIPS payment year only, if a MIPS eligible
                clinician demonstrates through an application submitted to CMS that
                they have been adversely affected by the Public Health Emergency for
                the COVID-19 pandemic and also submits data for the quality, cost, or
                improvement activities performance categories, the preceding sentence
                will not apply.
                * * * * *
                 (C) Under section 1848(o)(2)(D) of the Act, a significant hardship
                exception or other type of exception is granted to a MIPS eligible
                clinician based on the following circumstances for the Promoting
                Interoperability performance category. Except as provided in paragraphs
                (c)(2)(i)(C)(10) and (11) of this section, in the event that a MIPS
                eligible clinician submits data for the Promoting Interoperability
                performance category, the scoring weight specified in paragraph (c)(1)
                of this section will be applied and its weight will not be
                redistributed.
                * * * * *
                 (11) For the 2021 MIPS payment year only, the MIPS eligible
                clinician demonstrates through an application submitted to CMS that
                they have been adversely affected by the Public Health Emergency for
                the COVID-19 pandemic.
                * * * * *
                PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS,
                SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN
                CERTAIN SETTINGS
                0
                20. The authority citation for part 415 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                21. Section 415.172 is amended by revising paragraphs (a) introductory
                text, (a)(2), and (b) to read as follows:
                Sec. 415.172 Physician fee schedule payment for services of teaching
                physicians.
                 (a) General rule. If a resident participates in a service furnished
                in a teaching setting, physician fee schedule payment is made only if a
                teaching physician is present during the key portion of any service or
                procedure for which payment is sought. During the Public Health
                Emergency, as defined in Sec. 400.200 of this chapter, if a resident
                participates in a service furnished in a teaching setting, physician
                fee schedule payment is made if a teaching physician is present during
                the key portion of the service using interactive telecommunications
                technology for any service or procedure for which payment is sought.
                * * * * *
                 (2) In the case of evaluation and management services, the teaching
                physician must be present during the portion of the service that
                determines the level of service billed. (However, in the case of
                evaluation and management services furnished in hospital outpatient
                departments and certain other ambulatory settings, the requirements of
                Sec. 415.174 apply.) During a Public Health Emergency, as defined in
                Sec. 400.200 of this chapter, the teaching physician may be present
                during the portion of the service that determines the level of service
                billed using interactive telecommunications technology. (However, in
                the case of evaluation and management services furnished in hospital
                outpatient departments and certain other ambulatory settings, the
                requirements of Sec. 415.174 apply.)
                 (b) Documentation. Except for services furnished as set forth in
                Sec. Sec. 415.174 (concerning an exception for services furnished in
                hospital outpatient and certain other ambulatory settings), 415.176
                (concerning renal dialysis services), and 415.184 (concerning
                psychiatric services), the medical records must document the teaching
                physician was present at the time the service is furnished. The
                presence of the teaching physician during procedures and evaluation and
                management services may be demonstrated by the notes in the medical
                records made by the physician or as provided in Sec. 410.20(e) of this
                chapter. During a Public Health Emergency, as defined in Sec. 400.200
                of this chapter, except for services furnished as set forth in
                Sec. Sec. 415.174 (concerning an exception for services furnished in
                hospital outpatient and certain other ambulatory settings), 415.176
                (concerning renal dialysis services), and 415.184 (concerning
                psychiatric services), the medical records must document if the
                teaching physician was physically present or if the teaching physician
                was present through interactive telecommunications technology at the
                time the service is furnished. The presence of the teaching physician
                during procedures and evaluation and management services may be
                demonstrated by the notes in the medical records made by the physician
                or as provided in Sec. 410.20(e) of this chapter.
                * * * * *
                0
                22. Section 415.174 is amended by adding paragraph (b) to read as
                follows:
                Sec. 415.174 Exception: Evaluation and management services furnished
                in certain centers.
                * * * * *
                 (b) During a Public Health Emergency, as defined in Sec. 400.200
                of this chapter, carriers may make physician fee schedule payment for a
                service furnished by a resident if the teaching physician is present
                through interactive telecommunications technology.
                0
                23. Section 415.180 is revised to read as follows:
                Sec. 415.180 Teaching setting requirements for the interpretation of
                diagnostic radiology and other diagnostic tests.
                 (a) General rule. Physician fee schedule payment is made for the
                interpretation of diagnostic radiology and other diagnostic tests if
                the interpretation is performed or reviewed by a physician other than a
                resident. During a Public Health Emergency, as defined in Sec. 400.200
                of this chapter, physician fee schedule payment may also be made for
                the interpretation of diagnostic radiology and other diagnostic tests
                if the interpretation is performed by a resident when the teaching
                physician is present through interactive telecommunications technology.
                 (b) [Reserved]
                0
                24. Section 415.184 is revised to read as follows:
                Sec. 415.184 Psychiatric services.
                 To qualify for physician fee schedule payment for psychiatric
                services furnished under an approved GME
                [[Page 19289]]
                program, the physician must meet the requirements of Sec. Sec. 415.170
                and 415.172, including documentation, except that the requirement for
                the presence of the teaching physician during the service in which a
                resident is involved may be met by observation of the service by use of
                a one-way mirror, video equipment, or similar device. During a Public
                Health Emergency, as defined in Sec. 400.200 of this chapter, the
                requirement for the presence of the teaching physician during the
                service in which a resident is involved may be met by direct
                supervision by interactive telecommunications technology.
                0
                25. Section 415.208 is amended by revising paragraph (b)(2)
                introductory text to read as follows:
                Sec. 415.208 Services of moonlighting residents.
                * * * * *
                 (b) * * *
                 (2) Services of residents that are not related to their approved
                GME programs and are performed in an outpatient department or emergency
                department of a hospital in which they have their training program are
                covered as physician services and payable under the physician fee
                schedule if criteria in paragraphs (b)(2)(i) through (iii) of this
                section are met. During a Public Health Emergency, as defined in Sec.
                400.200 of this chapter, the services of residents that are not related
                to their approved GME programs and are furnished to inpatients of a
                hospital in which they have their training program are covered as
                physician services and payable under the physician fee schedule if
                criteria in paragraphs (b)(2)(i) through (iii) of this section are met.
                * * * * *
                PART 417--HEALTH MAINTENANCE ORGANIZATIONS, COMPETITIVE MEDICAL
                PLANS, AND HEALTH CARE PREPAYMENT PLANS
                0
                26. The authority citation for part 417 is revised to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh, and 300e, 300e-5, and
                300e-9, and 31 U.S.C. 9701.
                0
                27. Section 417.472 is amended by revising paragraphs (i) and (j) to
                read as follows:
                Sec. 417.472 Basic contract requirements.
                * * * * *
                 (i) HMOs and CMPs. The HMO or CMP must comply with the requirements
                at Sec. 422.152(b)(5) and (6) of this chapter.
                 (j) Coordinated care and cost contracts. Subject to paragraph (i)
                of this section, all coordinated care contracts (including local and
                regional PPOs, contracts with exclusively SNP benefit packages, private
                fee-for-service contracts, and MSA contracts), and all cost contracts
                under section 1876 of the Act, with 600 or more enrollees in July of
                the prior year, must contract with approved Medicare Consumer
                Assessment of Healthcare Providers and Systems (CAHPS) survey vendors
                to conduct the Medicare CAHPS satisfaction survey of Medicare plan
                enrollees in accordance with CMS specifications and submit the survey
                data to CMS.
                * * * * *
                PART 418--HOSPICE CARE
                0
                28. The authority citation for part 418 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                29. Section 418.22 is amended by--
                0
                a. Redesignating the text of paragraph (a)(4) as paragraph (a)(4)(i);
                and
                0
                b. Adding paragraph (a)(4)(ii).
                 The addition reads as follows:
                Sec. 418.22 Certification of terminal illness.
                 (a) * * *
                 (4) * * *
                 (ii) During a Public Health Emergency, as defined in Sec. 400.200
                of this chapter, if the face-to-face encounter conducted by a hospice
                physician or hospice nurse practitioner is for the sole purpose of
                hospice recertification, such encounter may occur via a
                telecommunications technology and is considered an administrative
                expense. Telecommunications technology means the use of interactive
                multimedia communications equipment that includes, at a minimum, the
                use of audio and video equipment permitting two-way, real-time
                interactive communication between the patient and the distant site
                hospice physician or hospice nurse practitioner.
                * * * * *
                0
                30. Section 418.204 is amended by adding paragraph (d) to read as
                follows:
                Sec. 418.204 Special coverage requirements.
                * * * * *
                 (d) Use of technology in furnishing services during a Public Health
                Emergency. When a patient is receiving routine home care, during a
                Public Health Emergency as defined in Sec. 400.200 of this chapter,
                hospices may provide services via a telecommunications system if it is
                feasible and appropriate to do so to ensure that Medicare patients can
                continue receiving services that are reasonable and necessary for the
                palliation and management of a patients' terminal illness and related
                conditions. The use of such technology in furnishing services must be
                included on the plan of care, meet the requirements at Sec. 418.56,
                and must be tied to the patient-specific needs as identified in the
                comprehensive assessment and the plan of care must include a
                description of how the use of such technology will help to achieve the
                goals outlined on the plan of care.
                PART 421--MEDICARE CONTRACTING
                0
                31. The authority citation for part 421 is revised to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                32. Section 421.214 is amended by--
                0
                a. Revising paragraphs (b) and (c) introductory text;
                0
                b. Adding paragraph (d)(5);
                0
                c. Revising paragraph (f)(1)(i); and
                0
                d. Adding paragraph (j).
                 The revisions and additions read as follows:
                Sec. 421.214 Advance payments to suppliers furnishing items and
                services under Part B.
                * * * * *
                 (b) Definition. As used in this section, advance payment means a
                conditional partial payment made by the contractor in response to a
                claim that it is unable to process within established time limits
                except as provided in paragraph (j) of this section.
                 (c) When advance payments may be made. Unless otherwise qualified
                under paragraph (j) of this section, an advance payment may be made if
                all of the following conditions are met:
                * * * * *
                 (d) * * *
                 (5) Is in bankruptcy.
                * * * * *
                 (f) * * *
                 (1) * * *
                 (i) Unless otherwise qualified under paragraph (j) of this section,
                a contractor must calculate an advance payment for a particular claim
                at no more than 80 percent of the anticipated payment for that claim
                based upon the historical assigned claims payment data as defined in
                paragraph (f)(1)(ii) of this section for claims paid to the supplier.
                For suppliers qualifying and approved for advance payments under
                paragraph (j) of this section, a contractor may calculate an advance
                payment for a particular claim at up to 100 percent of the anticipated
                payment for that claim based upon the historical assigned claims
                payment data as defined in paragraph (f)(1)(ii) of this section for
                claims paid to the supplier.
                * * * * *
                [[Page 19290]]
                 (j) Advanced payments in exceptional circumstances. CMS may
                approve, in writing to the contractor, the making of advance payments
                during the period of a Public Health Emergency, as defined in Sec.
                400.200 of this chapter, or during the period under a Presidential
                Disaster Declaration, under the following exceptional conditions:
                 (1) The contractor is unable to process the claim timely, or is at
                risk of being untimely in processing the claim; or
                 (2) When the supplier has experienced a temporary delay in
                preparing and submitting bills to the contractor beyond its normal
                billing cycle.
                PART 422--MEDICARE ADVANTAGE PROGRAM
                0
                33. The authority citation for part 422 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                34. Section 422.152 is amended by adding paragraph (b)(6) to read as
                follows:
                Sec. 422.152 Quality improvement program.
                * * * * *
                 (b) * * *
                 (6) For 2021 Star Ratings only, MA organizations are not required
                to submit HEDIS and CAHPS data that would otherwise be required for the
                calculation of the 2021 Star Ratings.
                * * * * *
                0
                35. Section 422.164 is amended by adding paragraph (i) to read as
                follows:
                Sec. 422.164 Adding, updating, and removing measures.
                * * * * *
                 (i) Special rule for 2021 Star Ratings only. In the event that the
                threat to health and safety posed by the COVID-19 pandemic compromises
                the quality of the data, or ability to validate such data for all plans
                used to calculate a particular measure, CMS will substitute and use the
                2021 Star Ratings measure score and Star Rating with the 2020 Star
                Ratings measure score and Star Rating.
                0
                36. Section 422.166 is amended--
                0
                a. By revising paragraph (a)(2)(i);
                0
                b. In paragraph (f)(1)(i), by adding a sentence to the end of the
                paragraph; and
                0
                c. By adding paragraphs (g)(3) and (j).
                 The revision and additions read as follows:
                Sec. 422.166 Calculation of Star Ratings.
                 (a) * * *
                 (2) * * *
                 (i) The method maximizes differences across the star categories and
                minimizes the differences within star categories using mean resampling
                with the hierarchal clustering of the current year's data. Effective
                for the Star Ratings issued in October 2022 and subsequent years, CMS
                will add a guardrail so that the measure-threshold-specific cut points
                for non-CAHPS measures do not increase or decrease more than the value
                of the cap from one year to the next. The cap is equal to 5 percentage
                points for measures having a 0 to 100 scale (absolute percentage cap)
                or 5 percent of the restricted range for measures not having a 0 to 100
                scale (restricted range cap). New measures that have been in the Part C
                and Part D Star Rating program for 3 years or less use the hierarchal
                clustering methodology with mean resampling with no guardrail for the
                first 3 years in the program.
                * * * * *
                 (f) * * *
                 (1) * * *
                 (i) * * * For the 2022 Star Ratings only, since all contracts may
                have the improvement measure(s) excluded in the determination of their
                highest rating and summary rating(s), each contract's weighted variance
                and weighted mean are calculated both with and without the improvement
                measures.
                * * * * *
                 (g) * * *
                 (3) For 2022 Star Ratings only, CMS runs the calculations twice for
                the highest rating for each contract-type (overall rating for MA-PD
                contracts and Part C summary rating for MA-only contracts) and Part C
                summary rating for MA-PDs with all applicable adjustments (CAI and the
                reward factor), once including the improvement measure(s) and once
                without including the improvement measure(s). In deciding whether to
                include the improvement measures in a contract's highest and summary
                rating(s), CMS applies the following rules:
                 (i) For MA-PDs and MA-only contracts, a comparison of the highest
                rating with and without the improvement measure is done. The higher
                rating is used for the highest rating.
                 (ii) For MA-PDs, a comparison of the Part C summary rating with and
                without the improvement measure is done. The higher rating is used for
                the summary rating.
                * * * * *
                 (j) Special rules for 2021 and 2022 Star Ratings only. (1) For the
                2021 Star Ratings:
                 (i) The measures calculated based on HEDIS data are calculated
                based on data from the 2018 performance period.
                 (ii) The measures calculated based on CAHPS data are calculated
                based on survey data collected from March through May 2019.
                 (iii) The measure-level change score calculation described at Sec.
                422.164(f)(4)(i) is not applied for HEDIS and CAHPS measures and the
                measure-level change score used for the 2020 Star Ratings is applied in
                its place for all HEDIS and CAHPS-based measures.
                 (iv) The provisions of Sec. 422.164(g)(1) and (2) are not applied
                for the failure to submit HEDIS and CAHPS-based measures.
                 (v) In the event that there are extraordinary circumstances
                resulting from the COVID-19 pandemic that compromise CMS resources to
                the extent that CMS cannot calculate or issue 2021 Star Ratings by
                October 2020, CMS will adopt the 2020 Star Ratings as the 2021 Star
                Ratings.
                 (2) For the 2022 Star Ratings:
                 (i) In the event that the threat to health and safety posed by the
                COVID-19 pandemic compromises the ability to collect the Health
                Outcomes Survey in 2020, CMS will adopt the 2021 Star Ratings and
                measure scores for the measures that come from the Health Outcomes
                Survey as the 2022 Star Ratings and measures scores for the measures
                that come from the Health Outcomes Survey.
                 (ii) [Reserved]
                0
                37. Section 422.252 is amended by revising the definition of ``New MA
                plan'' to read as follows:
                Sec. 422.252 Terminology.
                * * * * *
                 New MA plan means a MA contract offered by a parent organization
                that has not had another MA contract in the previous 3 years. For
                purposes of 2022 quality bonus payments based on 2021 Star Ratings
                only, new MA plan means an MA contract offered by a parent organization
                that has not had another MA contract in the previous 4 years.
                * * * * *
                PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
                0
                38. The authority for part 423 continues to read as follows:
                 Authority: 42 U.S.C. 1302, 1395w-101 through 1395w-152, and
                1395hh.
                0
                39. Section 423.156 is amended by adding a sentence at the end of the
                paragraph to read as follows:
                Sec. 423.156 Consumer satisfaction surveys.
                 * * * Part D sponsors are not required to submit CAHPS data that
                would otherwise be required for the calculation of the 2021 Star
                Ratings.
                [[Page 19291]]
                0
                40. Section 423.182 is amended by adding paragraph (c)(3) to read as
                follows:
                Sec. 423.182 Part D Prescription Drug Plan Quality Rating System.
                * * * * *
                 (c) * * *
                 (3) For 2021 Star Ratings only, Part D sponsors are not required to
                submit CAHPS data that would otherwise be required for the calculation
                of the 2021 Star Ratings.
                0
                41. Section 423.184 is amended by adding paragraph (i) to read as
                follows:
                Sec. 423.184 Adding, updating, and removing measures.
                * * * * *
                 (i) Special rule for 2021 Star Ratings only. In the event that the
                threat to health and safety posed by the COVID-19 pandemic compromises
                the quality of the data, or ability to validate such data, for all
                plans, used to calculate a particular measure, CMS will substitute and
                use the 2021 Star Ratings measure score and Star Ratings with the 2020
                Star Ratings measure score and Star Rating.
                0
                42. Section 423.186 is amended--
                0
                a. By revising paragraph (a)(2)(i);
                0
                b. In paragraph (f)(1)(i), by adding a sentence to the end of the
                paragraph; and
                0
                c. By adding paragraphs (g)(3) and (j).
                 The revision and additions read as follows:
                Sec. 423.186 Calculation of Star Ratings.
                 (a) * * *
                 (2) * * *
                 (i) The method maximizes differences across the star categories and
                minimizes the differences within star categories using mean resampling
                with the hierarchal clustering of the current year's data. Effective
                for the Star Ratings issued in October 2022 and subsequent years, CMS
                will add a guardrail so that the measure-threshold-specific cut points
                for non-CAHPS measures do not increase or decrease more than the value
                of the cap from one year to the next. The cap is equal to 5 percentage
                points for measures having a 0 to 100 scale (absolute percentage cap)
                or 5 percent of the restricted range for measures not having a 0 to 100
                scale (restricted range cap). New measures that have been in the Part C
                and D Star Rating program for 3 years or less use the hierarchal
                clustering methodology with mean resampling with no guardrail for the
                first 3 years of the program.
                * * * * *
                 (f) * * *
                 (1) * * *
                 (i) * * * For the 2022 Star Ratings only, since all contracts may
                have the improvement measure(s) excluded in the determination of their
                highest rating and summary rating(s), each contract's weighted variance
                and weighted mean are calculated both with and without the improvement
                measures.
                * * * * *
                 (g) * * *
                 (3) For 2022 Star Ratings only, CMS runs the calculations twice for
                the highest rating for each contract-type (overall rating for MA-PD
                contracts and Part D summary rating for PDPs) and Part D summary rating
                for MA-PDs with all applicable adjustments (CAI and the reward factor),
                once including the improvement measure(s) and once without including
                the improvement measure(s). In deciding whether to include the
                improvement measures in a contract's highest and summary rating(s), CMS
                applies the following rules:
                 (i) For MA-PDs and PDPs, a comparison of the highest rating with
                and without the improvement measure is done. The higher rating is used
                for the highest rating.
                 (ii) For MA-PDs, a comparison of the Part D summary rating with and
                without the improvement measure is done. The higher rating is used for
                the summary rating.
                * * * * *
                 (j) Special rules for 2021 Star Ratings only. (1) For the 2021 Star
                Ratings:
                 (i) The measures calculated based on CAHPS data are calculated
                based on survey data collected from March through May 2019.
                 (ii) The measure-level change score calculation described at Sec.
                423.184(f)(4)(i) is not applied for CAHPS measures and the measure-
                level change score used for the 2020 Star Ratings is applied in its
                place for all CAHPS-based measures.
                 (iii) The provisions of Sec. 423.184(g)(2) are not applied for
                failure to submit CAHPS-based measures.
                 (iv) In the event that there are extraordinary circumstances
                resulting from the COVID-19 pandemic that compromise CMS resources to
                the extent that CMS cannot calculate or issue 2021 Star Ratings by
                October 2020, CMS will adopt the 2020 Star Ratings as the 2021 Star
                Ratings.
                 (2) [Reserved]
                PART 425--MEDICARE SHARED SAVINGS PROGRAM
                0
                43. The authority citation for part 425 continues to read as follows:
                 Authority: 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.
                Sec. 425.502 [Amended]
                0
                44. Section 425.502 is amended in paragraph (f) introductory text by
                removing the phrase ``if the quality reporting period is not
                extended''.
                PART 440--SERVICES: GENERAL PROVISIONS
                0
                45. The authority citation for part 440 is revised to read as follows:
                 Authority: 42 U.S.C. 1302.
                0
                46. Section 440.70 is amended by revising paragraphs (a)(2),
                (b)(1)(ii), and (b)(3)(iii) and (iv) to read as follows:
                Sec. 440.70 Home health services.
                 (a) * * *
                 (2) On his or her physician's orders as part of a written plan of
                care that the physician reviews every 60 days for services described in
                paragraphs (b)(1), (2), and (4) of this section, or, for the period of
                the Public Health Emergency, as defined in Sec. 400.200 of this
                chapter, orders written by an other licensed practitioner of the
                healing arts acting within the scope of practice authorized under State
                law, as part of a written plan of care that the ordering practitioner
                reviews every 60 days for services described in paragraphs (b)(1), (2),
                and (4) of this section.
                 (b) * * *
                 (1) * * *
                 (ii) Receives written orders from the patient's physician or, for
                the period of the Public Health Emergency, as defined in Sec. 400.200
                of this chapter, other licensed practitioner of the healing arts acting
                within the scope of practice authorized under State law;
                * * * * *
                 (3) * * *
                 (iii) A beneficiary's need for medical supplies, equipment, and
                appliances must be reviewed by a physician or, for the period of the
                Public Health Emergency, as defined in Sec. 400.200 of this chapter,
                an other licensed practitioner of the healing arts acting within the
                scope of practice authorized under State law, annually.
                 (iv) Frequency of further physician or, for the period of the
                Public Health Emergency, as defined in Sec. 400.200 of this chapter,
                an other licensed practitioner review of a beneficiary's continuing
                need for the items is determined on a case-by-case basis based on the
                nature of the item prescribed.
                * * * * *
                PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
                0
                47. The authority citation for part 482 continues to read as follows:
                [[Page 19292]]
                 Authority: 42 U.S.C. 1302, 1395hh, 1395rr, and 1395lll unless
                otherwise noted.
                0
                48. Section 482.61 is amended by revising paragraph (d) to read as
                follows:
                Sec. 482.61 Condition of participation: Special medical record
                requirements for psychiatric hospitals.
                * * * * *
                 (d) Standard: Recording progress. Progress notes for the patient
                must be documented, in accordance with applicable State scope-of-
                practice laws and hospital policies, by the following qualified
                practitioners: Doctor(s) of medicine or osteopathy, or other licensed
                practitioner(s), who is responsible for the care of the patient;
                nurse(s) and social worker(s) (or social service staff) involved in the
                care of the patient; and, when appropriate, others significantly
                involved in the patient's active treatment modalities.
                 The frequency of progress notes is determined by the condition of
                the patient but must be recorded at least weekly for the first 2 months
                and at least once a month thereafter and must contain recommendations
                for revisions in the treatment plan as indicated, as well as precise
                assessment of the patient's progress in accordance with the original or
                revised treatment plan.
                * * * * *
                PART 510--COMPREHENSIVE CARE FOR JOINT REPLACEMENT MODEL
                0
                49. The authority citation of part 510 is revised to read as follows:
                 Authority: 42 U.S.C. 1302, 1315a, and 1395hh.
                0
                50. Section 510.2 is amended by revising the definition of
                ``Performance year'' to read as follows:
                Sec. 510.2 Definitions.
                * * * * *
                 Performance year means one of the years in which the CJR model is
                being tested. Performance years for the model correlate to calendar
                years with the exceptions of performance year 1, which is April 1, 2016
                through December 31, 2016 and performance year 5, which is January 1,
                2020 through March 31, 2021.
                * * * * *
                Sec. 510.200 [Amended]
                0
                51. Section 510.200 is amended in paragraph (a) by removing the phrase
                ``before December 31, 2020'' and adding in its place the phrase
                ``before March 31, 2021''.
                0
                52. Section 510.305 is amended by adding paragraphs (k)(3) and (4) to
                read as follows:
                Sec. 510.305 Determination of the NPRA and reconciliation process.
                * * * * *
                 (k) * * *
                 (3) The following is an extreme and uncontrollable circumstances
                adjustment for 2019 Novel Coronavirus (previously referred to as 2019-
                nCoV, now as COVID-19):
                 (i) The episode spending adjustments specified in paragraph (k)(4)
                of this section apply for a participant hospital that has a CCN primary
                address that is located in an emergency area during an emergency
                period, as those terms are defined in section 1135(g) of the Act, for
                which the Secretary issued a waiver or modification of requirements
                under section 1135 of the Act on March 13, 2020.
                 (ii) [Reserved]
                 (4) For a fracture or non-fracture episode with a date of admission
                to the anchor hospitalization that is on or within 30 days before the
                date that the emergency period (as defined in section 1135(g) of the
                Act) begins or that occurs through the termination of the emergency
                period (as described in section 1135(e) of the Act), actual episode
                payments are capped at the target price determined for that episode
                under Sec. 510.300.
                 Dated: March 24, 2020.
                Seema Verma,
                Administrator, Centers for Medicare & Medicaid Services.
                 Dated: March 26, 2020.
                Alex M. Azar II,
                Secretary, Department of Health and Human Services.
                [FR Doc. 2020-06990 Filed 3-31-20; 4:15 pm]
                 BILLING CODE 4120-01-P