Agency Information Collection Activities: Proposed Collection; Comment Request
| Published date | 25 March 2024 |
| Record Number | 2024-06239 |
| Citation | 89 FR 20658 |
| Court | Centers For Medicare & Medicaid Services,Health And Human Services Department |
| Section | Notices |
Federal Register, Volume 89 Issue 58 (Monday, March 25, 2024)
[Federal Register Volume 89, Number 58 (Monday, March 25, 2024)]
[Notices]
[Pages 20658-20660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06239]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-381, CMS-10279, CMS-10774 and CMS-10636]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
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 (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 May 24, 2024.
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, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.
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-381 Identification of Extension Units of Medicare Approved
Outpatient Physical Therapy/Outpatient Speech Pathology (OPT/OSP)
Providers and Supporting Regulations
CMS-10752 Submission of 1135 Waiver Request Automated Process
CMS-10774 The International Classification of Diseases, 10th Revision,
Procedure Coding System (ICD-10-PCS)
CMS-10636 Triennial Network Adequacy Review for Medicare Advantage
Organizations and 1876 Cost Plans
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 collection of information, before
submitting the collection to OMB for
[[Page 20659]]
approval. To comply with this requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Identification of
Extension Units of Medicare Approved Outpatient Physical Therapy/
Outpatient Speech Pathology (OPT/OSP) Providers and Supporting
Regulations; Use: Form CMS-381 was developed to ensure that each OPT/
OSP extension location at which OPT/OSP providers furnish services,
must be reported by the providers to the State Survey Agencies (SAs).
Form CMS-381 is completed when: (1) new OPT/OSP providers enter the
Medicare program; (2) when existing OPT/OPS providers delete or add a
service, or close or add an extension location; or, (3) when existing
OPT/OSP providers are recertified by the State Survey Agency every 6
years.
In 2022, CMS transitioned some of the certification processes to
the Center for Program Integrity (CPI) and the Medicare Administrative
Contractor (MAC). Prior to the transition, the CMS Survey Operations
Group was involved in the processing of the extension location
requests. As a result of the new processing instructions, CMS is now
reconciling the Form CMS-381 with updates to the instructions.
Additionally, CMS has revised the Form CMS-381 to incorporate the
initial enrollment of OPT/OSPs which was previously completed on the
Form CMS-1856 (0938-0065). CMS has combined the forms into one form in
order to further align with the transitioned processes and streamline
the requests from the provider community. This change will decrease the
burden on both the provider community as well as CMS. Furthermore, this
change will also allow for OPTs who wish to initially enroll in the
Medicare program to submit an extension location request with the
initial enrollment. The State Survey Agency or Accrediting Organization
(for those OPTs requesting deemed status) will survey the extension
location during the initial survey to verify compliance with the
Medicare conditions. Form Number: CMS-381 (OMB control number: 0938-
0273); Frequency: Occasionally; Affected Public: Private Sector;
Business or other for-profit and not-for-profit institutions; Number of
Respondents: 506; Total Annual Responses: 506; Total Annual Hours: 253.
(For policy questions regarding this collection contact Caecilia
Andrews at 410-786-2190.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Submission of
1135 Waiver Request Automated Process; Use: Waivers under section 1135
of the Social Security Act (the Act) and certain flexibilities allow
the CMS to relax certain requirements, known as the Conditions of
Participation (CoPs) or Conditions of Coverage to promote the health
and safety of beneficiaries. Under section 1135 of the Act, the
Secretary may temporarily waive or modify certain Medicare, Medicaid,
and Children's Health Insurance Program (CHIP) requirements to ensure
that sufficient health care services are available to meet the needs of
individuals enrolled in Social Security Act programs in the emergency
area and time periods. These waivers ensure that healthcare entities/
caregivers who provide such services in good faith can be reimbursed
and exempted from sanctions.
During emergencies, CMS must be able to apply program waivers and
flexibilities under section 1135 of the Social Security Act, in a
timely manner to respond quickly to unfolding events. In a disaster or
emergency, waivers and flexibilities assist health care providers/
suppliers in providing timely healthcare and services to people who
have been affected and enables States, Federal districts, and U.S.
Territories to ensure Medicare and/or Medicaid beneficiaries have
continued access to care. During disasters and emergencies, it is not
uncommon to evacuate patients in health care facilities to other
provider settings or across State lines, especially, during hurricane,
wildfire, and tornado events. CMS must collect relevant information for
which a provider is requesting a waiver or flexibility to make proper
decisions about approving or denying such requests. Collection of this
data aids in the prevention of gaps in access to care and services
before, during, and after an emergency. CMS must also respond to
inquiries related to a Public Health Emergency (PHE) from providers.
CMS is not collecting information from these inquiries; we are merely
responding to them.
The collection of the information surrounding 1135 Waiver requests/
inquiries is based on a case-by-case basis and not regularly scheduled
(e.g., quarterly, annually, by all providers/suppliers). The collection
of information only occurs when the healthcare entity, impacted by an
emergency, is requesting waivers/flexibilities under Section 1135 of
the Act or inquiring about PHEs. The collection of information is also
dependent on provider types; therefore, it is not a collection for all
Medicare-participating facilities. In 2021, we implemented a
streamlined, automated process to standardize the 1135 waiver requests
and inquiries submitted based on lessons learned during the COVID-19
PHE.
Furthermore, the normal operations of a healthcare provider are
disrupted by emergencies or disasters occasionally. When this occurs,
State Survey Agencies (SA) deliver a provider/beneficiary tracking
report regarding the current status of all affected healthcare
providers and their beneficiaries. We are revising this information
collection streamlined automated process to update for clarity during
emergencies. To quickly identify patient risks/needs, CMS added fields
to assess sufficient staffing, equipment and supplies as well as added
an assessment of a cyber security attack on the care and services
provided to patients (if applicable). Moreover, to decrease the time/
effort of stakeholders (State Survey Agencies (SAs)/Providers)
submitting this data during emergencies, CMS also added a feature to
autofill multiple fields when the stakeholder documents a valid CMS
Certification Number (CCN). This streamlined automated process will
consist of a public facing web form as well as a process for SAs/
Providers to submit data using extracts (CSV or Excel) on emergent
events impacting Health Care Facilities via automated mail handler
system. Both processes (public facing web form and extracts via an
automated mail handler system) are known as the Health Care Facility
(HCF) Operational Status. Finally, Acute Hospital Care at Home waiver
is granted at the individual hospital/CMS Certification Number (CCN)
level and waives Sec. 482.23(b) and (b)(1) of the Hospital Conditions
of Participation (CoPs) which require nursing services to be provided
on premises 24 hours a day, 7 days a week and the immediate
availability of a registered nurse for care of any patient (This waiver
allows hospitals to utilize models of at-home hospital care). This
Acute Hospital Care at Home web form was revised to add questions for
the respondents to meet requirements for all hospitals for (1) the
Patient Rights CoP at 42 CFR 482.13, (2) the Consolidated
Appropriations Act of 2023 and (3) for emergency response. Form Number:
CMS-10752 (OMB control number: 0938-1384); Frequency: Occasionally;
Affected Public: Private Sector: Business or other for-profits and Not-
for-profit institutions and State, Local or Tribal Governments; Number
of Respondents: 1,020; Total Annual Responses: 11,916; Total Annual
Hours:
[[Page 20660]]
11,916. (For policy questions regarding this collection, contact
Adriane Saunders at 404-562-7484.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: The International
Classification of Diseases, 10th Revision, Procedure Coding System
(ICD-10-PCS); Use: The HIPAA Act of 1996 required CMS to adopt
standards for coding systems that are used for reporting health care
transactions. The Transactions and Code Sets final rule (65 FR 50312)
published in the Federal Register on August 17, 2000 adopted the
International Classification of Diseases, 9th Revision, Clinical
Modification (ICD-9-CM) Volumes 1 and 2 for diagnosis codes and ICD-9-
CM Volume 3 for inpatient hospital services and procedures as standard
code sets for use by covered entities (health plans, health care
clearinghouses, and those health care providers who transmit any health
information in electronic form in connection with a transaction for
which the Secretary has adopted a standard). ICD-9-CM Volumes 1 and 2,
and ICD-9-CM Volume 3 were already widely used in administrative
transactions when we promulgated the August 17, 2000 final rule, and we
decided that adopting these existing code sets would be less disruptive
for covered entities than modified or new code sets.
When a request is submitted in MEARISTM, the Diagnosis
Related Groups (DRGs) and Coding Team in the Division of Coding and
DRGs (DCDRG) have instant access to the request and accompanying
materials to facilitate a more-timely review of the proposed updates or
changes. Upon receipt of a procedure code request, CMS immediately
acknowledges receipt of the request and communicates to the requestor
that additional follow up will occur once an analyst has been assigned.
In addition, CMS provides information via email communication in a
letter to each requestor outlining the meeting process. CMS holds
standard pre-meeting conference calls with requestors to discuss their
procedure code topic request in more detail in advance of the ICD-10
C&M Committee Meetings. Also, prior to the committee meeting, we make
the procedure code topic meeting materials publicly available, commonly
referred to as the ``Agenda packet'' on our website at: https://www.cms.gov/medicare/coding-billing/icd-10-codes/icd-10-coordination-maintenance-committee-materials. Lastly, once the meeting has
concluded, CMS sends a follow-up letter to the requestor informing them
of next steps in the process so they can anticipate what to expect.
Form Number: CMS-10774 (OMB control number: 0938-1409); Frequency:
Yearly; Affected Public: Private Sector; Business or other for-profit
and not-for-profit institutions; Number of Respondents: 80; Total
Annual Responses: 80; Total Annual Hours: 800. (For policy questions
regarding this collection contact Andrea Hazeley at 410-786-3543.)
4. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Triennial Network
Adequacy Review for Medicare Advantage Organizations and 1876 Cost
Plans; Use: This collection of information request is authorized under
section 1852(d)(1) of the Social Security Act which permits an MA
organization to select the providers from which an enrollee may receive
covered benefits, provided that the MA organization makes such benefits
available and accessible in the service area with promptness and in a
manner which assures continuity in the provision of benefits as defined
in Sec. Sec. 422.112(a)(1)(i) and 422.114(a)(3)(ii) (under Part 422,
Subpart C--benefits and beneficiary protections) and Sec. Sec.
417.414(b) and 417.416(a) and (e) (under Part 417, Subpart J--
Qualifying Conditions for Medicare Contracts).
The information will be collected by CMS through HPMS. CMS measures
access to covered services through the establishment of quantitative
standards for a predefined list of provider and facility specialty
types. These quantitative standards are collectively referred to as the
network adequacy criteria. Network adequacy is assessed at the county
level and CMS requires that organizations contract with a sufficient
number of providers and facilities to ensure that at least 90 percent
of enrollees within a county can access care within specific travel
time and distance maximums for Large Metro and Metro county types and
that at least 85 percent of enrollees within a county can access care
within specific travel time and distance maximums for Micro, Rural and
CEAC (Counties with Extreme Access Considerations county types. Form
Number: CMS-10636 (OMB control number: 0938-1346); Frequency: Yearly;
Affected Public: Private Sector; Business or other for-profit; Number
of Respondents: 502; Total Annual Responses: 2,753; Total Annual Hours:
27,470. (For policy questions regarding this collection contact Amber
Casserly at 410-786-5530.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-06239 Filed 3-22-24; 8:45 am]
BILLING CODE 4120-01-P
