[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