Agency Information Collection Activities: Proposed Collection; Comment Request

Published date31 January 2019
Citation84 FR 731
Record Number2019-00433
SectionNotices
CourtCenters For Medicare & Medicaid Services
Federal Register, Volume 84 Issue 21 (Thursday, January 31, 2019)
[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
                [Notices]
                [Pages 731-734]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2019-00433]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Centers for Medicare & Medicaid Services
                [Document Identifier: CMS-10330, CMS-10673, CMS-906, CMS-10433, CMS-276
                and CMS-10694 and CMS-P-0015A]
                Agency Information Collection Activities: Proposed Collection;
                Comment Request
                AGENCY: Centers for Medicare & Medicaid Services, Department of Health
                and Human Services.
                ACTION: Notice.
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                SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
                announcing an opportunity for the public to comment on CMS' intention
                to collect information from the public. Under the Paperwork Reduction
                Act of 1995 (the PRA), federal agencies are required to publish notice
                in the Federal Register concerning each proposed collection of
                information (including each proposed extension or reinstatement of an
                existing collection of information) and to allow 60 days for public
                comment on the proposed action. Interested persons are invited to send
                comments regarding our burden estimates or any other aspect of this
                collection of information, including the necessity and utility of the
                proposed information collection for the proper performance of the
                agency's functions, the accuracy of the estimated burden, ways to
                enhance the quality, utility, and clarity of the information to be
                collected, and the use of automated collection techniques or other
                forms of information technology to minimize the information collection
                burden.
                DATES: Comments must be received by April 1, 2019.
                ADDRESSES: When commenting, please reference the document identifier or
                OMB control number. To be assured consideration, comments and
                recommendations must be submitted in any one of the following ways:
                 1. Electronically. You may send your comments electronically to
                http://www.regulations.gov. Follow the instructions for ``Comment or
                Submission'' or ``More Search Options'' to find the information
                collection document(s) that are accepting comments.
                 2. By regular mail. You may mail written comments to the following
                address: CMS, Office of Strategic Operations and Regulatory Affairs,
                Division of Regulations Development, Attention: Document Identifier/OMB
                Control Number ___, Room C4-26-05, 7500 Security Boulevard, Baltimore,
                Maryland 21244-1850.
                 To obtain copies of a supporting statement and any related forms
                for the proposed collection(s) summarized in this notice, you may make
                your request using one of following:
                 1. Access CMS' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
                 2. Email your request, including your address, phone number, OMB
                number, and CMS document identifier, to Paperwork@cms.hhs.gov.
                 3. Call the Reports Clearance Office at (410) 786-1326.
                FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.
                SUPPLEMENTARY INFORMATION:
                Contents
                 This notice sets out a summary of the use and burden associated
                with the following information collections. More detailed information
                can be found in each collection's supporting statement and associated
                materials (see ADDRESSES).
                CMS-10330 Enrollment Opportunity Notice Relating to Lifetime Limits;
                Required Notice of Rescission of Coverage; and Disclosure Requirements
                for Patient Protection under the Affordable Care Act
                CMS-10379 Rate Increase Disclosure and Review Requirements (45 CFR part
                154)
                CMS-10673 Medicare Advantage Qualifying Payment Arrangement Incentive
                (MAQI) Demonstration
                CMS-906 The Fiscal Soundness Reporting Requirements
                CMS-276 Prepaid Health Plan Cost Report
                CMS-10694 Testing of Web Survey Design and Administration for CMS
                Experience of Care Surveys
                CMS-P-0015A Medicare Current Beneficiary Survey
                 Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain
                approval from the Office of Management and Budget (OMB) for each
                collection of information they conduct or sponsor. The term
                ``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
                1320.3(c) and includes agency requests or requirements that members of
                the public submit reports, keep records, or provide information to a
                third party. Section 3506(c)(2)(A) of the PRA requires federal agencies
                to publish a 60-day notice in the Federal Register concerning each
                proposed collection of information, including each proposed extension
                or reinstatement of an existing
                [[Page 732]]
                collection of information, before submitting the collection to OMB for
                approval. To comply with this requirement, CMS is publishing this
                notice.
                Information Collection
                 1. Type of Information Collection Request: Extension; Title of
                Information Collection: Enrollment Opportunity Notice Relating to
                Lifetime Limits; Required Notice of Rescission of Coverage; and
                Disclosure Requirements for Patient Protection under the Affordable
                Care Act; Use: Sections 2712 and 2719A of the Public Health Service
                Act, as added by the Affordable Care Act, and the interim final
                regulations titled ``Patient Protection and Affordable Care Act:
                Preexisting Condition Exclusions, Lifetime and Annual Limits,
                Rescissions, and Patient Protections'' (75 FR 37188, June 28, 2010)
                contain rescission notice, and patient protection disclosure
                requirements that are subject to the Paperwork Reduction Act of 1995.
                The rescission notice will be used by health plans to provide advance
                notice to certain individuals that their coverage may be rescinded as a
                result of fraud or intentional misrepresentation of material fact. The
                patient protection notification will be used by health plans to inform
                certain individuals of their right to choose a primary care provider or
                pediatrician and to use obstetrical/gynecological services without
                prior authorization.
                 The related provisions are finalized in the final regulations
                titled ``Final Rules under the Affordable Care Act for Grandfathered
                Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits,
                Rescissions, Dependent Coverage, Appeals, and Patient Protections''.
                The final regulations also require that, if State law prohibits balance
                billing, or a plan or issuer is contractually responsible for any
                amounts balanced billed by an out-of-network emergency services
                provider, a plan or issuer must provide a participant, beneficiary or
                enrollee adequate and prominent notice of their lack of financial
                responsibility with respect to amounts balanced billed in order to
                prevent inadvertent payment by the individual. Form Number: CMS-10330
                (OMB control number: 0938-1094); Frequency: Occasionally; Affected
                Public: Private Sector, State, Local, or Tribal Governments; Number of
                Respondents: 920; Total Annual Responses: 71,268; Total Annual Hours:
                524. (For policy questions regarding this collection contact Usree
                Bandyopadhyay at 410-786-6650.)
                 2. Type of Information Collection Request: Revision of a currently
                approved collection; Title of Information Collection: Medicare
                Advantage Qualifying Payment Arrangement Incentive (MAQI)
                Demonstration; Use: The Centers for Medicare & Medicaid Services (CMS)
                is testing a demonstration, under Section 402 of the Social Security
                Amendments of 1967 (as amended), entitled the Medicare Advantage
                Qualifying Payment Arrangement Incentive (MAQI) Demonstration (``the
                Demonstration''). The MAQI demonstration tests whether providing
                exclusions from the Merit-based Incentive Payment System (MIPS)
                reporting requirements, payment adjustments, and performance feedback
                (collectively, the ``MIPS exclusions'') for eligible clinicians who
                participate to a sufficient degree in certain payment arrangements with
                Medicare Advantage Organizations (MAOs) (combined with participation,
                if any, in Advanced Alternative Payment Models (APMs) with Medicare
                Fee-for-Service (FFS)) will increase or maintain participation in
                payment arrangements with MAOs similar to Advanced APMs and change the
                manner in which clinicians deliver care.
                 Clinicians may currently participate in one of two paths of the
                Quality Payment Program (QPP): (1) MIPS, which adjusts Medicare
                payments based on combined performance on measures of quality, cost,
                improvement activities, and advancing care information, or (2) Advanced
                Alternative Payment Models with Medicare (Advanced APMs), under which
                eligible clinicians may earn an incentive payment for sufficient
                participation in certain payment arrangements with Medicare fee-for-
                service (FFS) and other payers, and starting in the 2019 performance
                period, with other payers such as Medicare Advantage, commercial
                payers, and Medicaid managed care. To participate in the Advanced APM
                path of QPP for a given year and earn an incentive payment, eligible
                clinicians must meet the criteria of Qualifying APM Participants (QPs);
                in addition to earning an APM incentive payment, QPs are excluded from
                the MIPS reporting requirements and payment adjustment.
                 An eligible clinician that does not meet the criteria to be a QP
                for a given year will be subject to MIPS for that year unless the
                clinician meets certain other MIPS exclusion criteria, such as being
                newly enrolled in Medicare or meeting the low volume threshold for
                Medicare FFS patients, payments and services. The MAQI Demonstration
                allows participating eligible clinicians to have the opportunity to
                receive the MIPS exclusions for a given year if they participate to a
                sufficient degree in certain Qualifying Payment Arrangements with MAOs
                (and Advanced APMs with Medicare FFS) during the performance period for
                that year, without requiring them to be QPs or otherwise meet the MIPS
                exclusion criteria of QPP. Under this Demonstration, clinicians are not
                required to have a minimum amount of participation in an Advanced APM
                with Medicare FFS in order to receive the MIPS exclusions for a year,
                but if they did have participation in Advanced APMs with Medicare FFS,
                that participation will also be counted towards the thresholds that
                trigger the provision of MIPS exclusions under the demonstration.
                 The first performance period for the Demonstration was 2018 and the
                Demonstration will last up to five years. Clinicians who meet the
                definition of an eligible clinician under QPP, as defined under 42 CFR
                414.1305, are eligible to participate in the MAQI Demonstration.
                Participation will last the duration of the Demonstration, unless
                participation is voluntarily or involuntarily terminated under the
                terms and conditions of the Demonstration. Demonstration participants
                will have the opportunity to submit the required documentation and be
                evaluated for the MIPS exclusions each year. If Demonstration
                participants submit information, but do not meet the conditions of the
                Demonstration, their participation in the Demonstration will not be
                terminated, but they will not receive the MIPS exclusions. Therefore,
                unless they become QPs or are excluded from MIPS for other reasons, the
                participating clinicians will be subject to MIPS and will face the MIPS
                payment adjustments for the applicable year.
                 In order to conduct an evaluation and effectively implement the
                MAQI Demonstration, CMS must collect information from Demonstration
                participants on (a) payment arrangements with MAOs and (b) Medicare
                Advantage (MA) payments and patient counts. CMS requires a new
                collection of this information as this information is not already
                available through other sources. The information collected in these
                forms will allow CMS to evaluate whether the payment arrangement(s)
                that clinicians have with MAOs meet the Qualifying Payment Arrangement
                criteria, and determine whether a clinician's MAO and FFS APM patient
                population or payments meet demonstration thresholds. Both of these
                areas are also requirements for review and data collection under QPP
                (i.e. the Eligible Clinician-Initiated Other Payer Advanced APM
                Determination form and All-Payer QP
                [[Page 733]]
                Submission form), and therefore similar forms have been prepared and
                reviewed under the QPP.
                 Given these similarities in forms, burden estimates for the MAQI
                Demonstration PRA package were derived from burden analyses and
                formulation done in conjunction with the QPP forms; more specifically
                the estimated burden associated with the submission of payment
                arrangement information for Other Payer Advanced APM Determinations.
                CMS estimates the total hour burden per respondent for the MAQI
                demonstration to be 15 hours or less, to match the hours listed in the
                equivalent QPP forms. Full detail of how these estimates were derived
                can be found in the published (83 FR 59452).
                 Based on public comments, we have revised the collection
                instruments to include modifications to allow Taxpayer Identification
                Numbers (TIN) level participation and greater functionality for
                organization/authorized representatives to submit on behalf of their
                clinicians. Form Number: CMS-10673 (OMB control number: 0938-1354;
                Frequency: Annually; Affected Public: Business or other for-profit and
                Not-for-profit institutions; Number of Respondents: 100,000; Total
                Annual Responses: 100,000; Total Annual Hours: 1,500,000. (For policy
                questions regarding this collection contact John Amoh at
                john.amoh@cms.hhs.gov.)
                 3. Type of Information Collection Request: Extension of a currently
                approved collection; Title of Information Collection: The Fiscal
                Soundness Reporting Requirements; Use: All contracting organizations
                must submit audited annual financial statements one time per year. In
                addition, to the audited annual submission, Health Plans with a
                negative net worth and/or a net loss and the amount of that loss is
                greater than one-half of the organization's total net worth must file
                quarterly financial statements for fiscal soundness monitoring. Part D
                organizations are required to submit three (3) quarterly financial
                statements. Lastly, PACE organizations are required to file four (4)
                quarterly financial statements for the first three (3) years in the
                program. After the first three (3) years, PACE organizations with a
                negative net worth and/or a net loss and the amount of that loss is
                greater than one-half of the organization's total net worth must submit
                quarterly financial statements for fiscal soundness monitoring. CMS is
                responsible for overseeing the ongoing financial performance for all
                Medicare Health Plans, PDPs, and PACE organizations. Specifically, CMS
                needs the requested information collected in order to establish that
                contracting entities within those programs maintain fiscally sound
                operations. Form Number: CMS-906 (OMB control number: 0938-0469);
                Frequency: Yearly; Affected Public: Business or other for-profits, Not-
                for profits institutions; Number of Respondents: 767; Total Annual
                Responses: 1589; Total Annual Hours: 530. (For policy questions
                regarding this collection contact Christa Zalewski at 410-786-1971.)
                 4. Type of Information Collection Request: Revision of a currently
                approved collection; Title of Information Collection: Information
                Collection Requirements for Compliance with Individual and Group Market
                Reforms under Title XXVII of the Public Health Service Act; Use:
                Sections 2723 and 2761 of the Public Health Service Act (PHS Act)
                direct the Centers for Medicare and Medicaid Services (CMS) to enforce
                a provision (or provisions) of title XXVII of the PHS Act (including
                the implementing regulations in parts 144, 146, 147, and 148 of title
                45 of the Code of Federal Regulations) with respect to health insurance
                issuers when a state has notified CMS that it has not enacted
                legislation to enforce or that it is not otherwise enforcing a
                provision (or provisions) of the group and individual market reforms
                with respect to health insurance issuers, or when CMS has determined
                that a state is not substantially enforcing one or more of those
                provisions. Section 2723 of the PHS Act directs CMS to enforce an
                applicable provision (or applicable provisions) of title XXVII of the
                PHS Act (including the implementing regulations in parts 146 and 147 of
                title 45 of the Code of Federal Regulations) with respect to group
                health plans that are non-Federal governmental plans. This collection
                of information includes requirements that are necessary for CMS to
                conduct compliance review activities.
                 The Department of the Treasury, the Department of Labor, and the
                Department of Health and Human Services (collectively, the Departments)
                issued proposed regulations titled ``Health Reimbursement Arrangements
                and Other Account-Based Group Health Plans'' under section 2711 of the
                PHS Act and the health nondiscrimination provisions of HIPAA, Public
                Law 104-191 (HIPAA nondiscrimination provisions.) The proposed
                regulations are intended to expand the usability of health
                reimbursement arrangements and other account-based group health plans
                (collectively referred to as HRAs). In general, the proposed
                regulations would expand the usability of HRAs by eliminating the
                current prohibition on integrating HRAs with individual health
                insurance coverage, thereby permitting employers to offer HRAs to
                employees enrolled in individual health insurance coverage. Under the
                proposed regulations employees would be permitted to use amounts in an
                HRA integrated with individual health insurance coverage to pay
                expenses for medical care (including premiums for individual health
                insurance coverage), subject to certain requirements. This collection
                includes the requirements related to substantiation of individual
                health insurance coverage by an HRA prior to making reimbursements and
                the notice that HRAs would be required to provide to each participant.
                Form Number: CMS-10430 (OMB control number: 0938-0702); Frequency:
                Annually; Affected Public: State Governments, Private Sector, State or
                local governments; Number of Respondents: 2,785; Total Annual
                Responses: 298,175; Total Annual Hours: 7,737. (For policy questions
                regarding this collection contact Usree Bandyopadhyay at 410-786-6650.)
                 5. Type of Information Collection Request: Revision of a currently
                approved information collection; Title of Information Collection:
                Prepaid Health Plan Cost Report; Use: Health Maintenance Organizations
                and Competitive Medical Plans (HMO/CMPs) contracting with the Secretary
                under Section 1876 of the Social Security Act are required to submit a
                budget and enrollment forecast, semi-annual interim report, 4th Quarter
                interim report (CMS has waived this annual submission), and a final
                certified cost report in accordance with 42 CFR 417.572-417.576. The
                submission, receipt and processing of the cost reports is imperative to
                determine if MCOs are paid on a reasonable basis for the covered
                services furnished to Medicare enrollees. CMS reviews the data
                submitted within the cost reports to establish monthly payment rates,
                monitor interim rates, and determine the final reimbursement. Health
                Care Prepayment Plans (HCPPs) contracting with the Secretary under
                Section 1833 of the Social Security Act are required to submit a budget
                and enrollment forecast, semi-annual interim report, and final cost
                report in accordance with 42 CFR 417.808 and 42 CFR 417.810. Form
                Number: CMS-276 (OMB control number: 0938-0165); Frequency: Quarterly;
                Affected Public: Businesses or other for-profits, Not-for-profit
                institutions; Number of Respondents: 57; Total Annual Responses: 67;
                Total Annual Hours: 1,800. (For policy
                [[Page 734]]
                questions regarding this collection, contact Bilal Farrakh at 410-786-
                4456.)
                 6. Type of Information Collection Request: New collection (Request
                for a new OMB control number); Title of Information Collection: Testing
                of Web Survey Design and Administration for CMS Experience of Care
                Surveys; Use: This collection is a new generic clearance request which
                encompasses an array of research activities to add web administration
                protocols to a series of surveys conducted by the Centers for Medicare
                & Medicaid Services (CMS). This request seeks burden hours to allow CMS
                and its contractors to conduct cognitive in-depth interviews, focus
                groups, pilot tests, and usability studies to support a variety of
                methodological studies around web modes of data collection for programs
                such as the Emergency Department Experience of Care (EDPEC), Fee-for-
                Service (FFS) Consumer Assessment of Healthcare Providers and Systems
                (CAHPS), Hospital CAHPS (HCAHPS), Medicare Advantage and Prescription
                Drug (MA & PDP) CAHPS, Home Health (HH) CAHPS, Hospice CAHPS, In-Center
                Hemodialysis (ICH) CAHPS, the Health Outcomes Survey (HOS), and the
                Medicare Advantage and Part D Plan Disenrollment Reasons surveys.
                Providers. Form Number: CMS-10694 (OMB control number: 0938-New);
                Frequency: Yearly; Affected Public: Business or other for-profits, Not-
                for-Profit Institutions; Number of Respondents: 75,250; Total Annual
                Responses: 75,250; Total Annual Hours: 17,000. (For policy, questions
                regarding this collection contact Elizabeth H. Goldstein at 410-786-
                6665.)
                 7. Type of Information Collection Request: Revision of a currently
                approved collection; Title of Information Collection: Medicare Current
                Beneficiary Survey; Use: CMS is the largest single payer of health care
                in the United States. The agency plays a direct or indirect role in
                administering health insurance coverage for more than 120 million
                people across the Medicare, Medicaid, CHIP, and Exchange populations. A
                critical aim for CMS is to be an effective steward, major force, and
                trustworthy partner in supporting innovative approaches to improving
                quality, accessibility, and affordability in healthcare. CMS also aims
                to put patients first in the delivery of their health care needs.
                 The Medicare Current Beneficiary Survey (MCBS) is the most
                comprehensive and complete survey available on the Medicare population
                and is essential in capturing data not otherwise collected through our
                operations. The MCBS is an in-person, nationally-representative,
                longitudinal survey of Medicare beneficiaries that we sponsor and is
                directed by the Office of Enterprise Data and Analytics (OEDA). The
                survey captures beneficiary information whether aged or disabled,
                living in the community or facility, or serviced by managed care or
                fee-for-service. Data produced as part of the MCBS are enhanced with
                our administrative data (e.g. fee-for-service claims, prescription drug
                event data, enrollment, etc.) to provide users with more accurate and
                complete estimates of total health care costs and utilization. The MCBS
                has been continuously fielded for more than 26 years, encompassing over
                1 million interviews and more than 100,000 survey participants.
                Respondents participate in up to 11 interviews over a four year period.
                This gives a comprehensive picture of health care costs and utilization
                over a period of time.
                 The MCBS continues to provide unique insight into the Medicare
                program and helps CMS and our external stakeholders better understand
                and evaluate the impact of existing programs and significant new policy
                initiatives. In the past, MCBS data have been used to assess potential
                changes to the Medicare program. For example, the MCBS was instrumental
                in supporting the development and implementation of the Medicare
                prescription drug benefit by providing a means to evaluate prescription
                drug costs and out-of-pocket burden for these drugs to Medicare
                beneficiaries. Beginning in 2020, this proposed revision to the
                clearance will add a few new measures to existing questionnaire
                sections. The revisions will result in a slight decrease in respondent
                burden of 4%, due to fewer projected completed cases each round. Form
                Number: CMS-P-0015A (OMB control number: 0938-0568); Frequency:
                Occasionally; Affected Public: Business or other for-profits and Not-
                for-profit institutions; Number of Respondents: 13,656; Total Annual
                Responses: 35,998; Total Annual Hours: 42,610. (For policy questions
                regarding this collection contact William Long at 410-786-7927.)
                 Dated: January 28, 2019.
                William N. Parham, III,
                Director, Paperwork Reduction Staff, Office of Strategic Operations and
                Regulatory Affairs.
                [FR Doc. 2019-00433 Filed 1-30-19; 8:45 am]
                 BILLING CODE 4120-01-P
                

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