[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Pages 59165-59166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23284]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10137, CMS-10141, 10773 and 10494]


Agency Information Collection Activities: Submission for OMB 
Review; 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 a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate 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 on the collection(s) of information must be received by 
the OMB desk officer by November 26, 2021.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    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.

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-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 approval. To 
comply with this requirement, CMS is publishing this notice that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Solicitation for 
Applications for Medicare Prescription Drug Plan 2023 Contracts; Use: 
Coverage for the prescription drug benefit is provided through 
contracted prescription drug plans (PDPs) or through Medicare Advantage 
(MA) plans that offer integrated prescription drug and health care 
coverage (MA-PD plans). Cost Plans that are regulated under Section 
1876 of the Social Security Act, and Employer Group Waiver Plans (EGWP) 
may also provide a Part D benefit. Organizations wishing to provide 
services under the Prescription Drug Benefit Program must complete an 
application, negotiate rates, and receive final approval from CMS. 
Existing Part D Sponsors may also expand their contracted service area 
by completing the Service Area Expansion (SAE) application.
    Collection of this information is mandated in Part D of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
(MMA) in Subpart 3. The application requirements

[[Page 59166]]

are codified in Subpart K of 42 CFR 423 entitled ``Application 
Procedures and Contracts with PDP Sponsors.''
    The information will be collected under the solicitation of 
proposals from PDP, MA-PD, Cost Plan, Program of All Inclusive Care for 
the Elderly (PACE), and EGWP applicants. The collected information will 
be used by CMS to: (1) Ensure that applicants meet CMS requirements for 
offering Part D plans (including network adequacy, contracting 
requirements, and compliance program requirements, as described in the 
application), (2) support the determination of contract awards. Form 
Number: CMS-10137 (OMB control number: 0938-0936); Frequency: Yearly; 
Affected Public: Businesses or other for-profits, Not-for-profit 
institutions; Number of Respondents: 716; Total Annual Responses: 382; 
Total Annual Hours: 1,716. (For policy questions regarding this 
collection contact Arianne Spaccarelli at 410-786-5715.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Prescription Drug Benefit Program; Use: Plan sponsor and State 
information is used by CMS to approve contract applications, monitor 
compliance with contract requirements, make proper payment to plans, 
and ensure that correct information is disclosed to potential and 
current enrollees. Form Number: CMS-10141 (OMB control number: 0938-
0964); Frequency: Once; Affected Public: Private sector (Business or 
other for-profit and Not-for-profit institutions); Number of 
Respondents: 11,771,497; Total Annual Responses: 675,231,213; Total 
Annual Hours: 9,312,314. (For policy questions regarding this 
collection contact Maureen Connors at 410-786-4132.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Non-Quantitative 
Treatment Limitation Analyses and Compliance Under MHPAEA; Use: The 
Paul Wellstone and Pete Domenici Mental Health Parity and Addiction 
Equity Act of 2008 (MHPAEA) (Pub. L. 110-343) generally requires that 
group health plans and group health insurance issuers offering mental 
health or substance use disorder (MH/SUD) benefits in addition to 
medical and surgical (med/surg) benefits do not apply any more 
restrictive financial requirements (e.g., co-pays, deductibles) and/or 
treatment limitations (e.g., visit limits, prior authorizations) to MH/
SUD benefits than those requirements and/or limitations applied to 
substantially all med/surg benefits. The Patient Protection and 
Affordable Care Act, Public Law 111-148, was enacted on March 23, 2010, 
and the Health Care and Education Reconciliation Act of 2010, Public 
Law 111-152, was enacted on March 30, 2010. These statutes are 
collectively known as the ``Affordable Care Act.'' The Affordable Care 
Act extended MHPAEA to apply to the individual health insurance market. 
MHPAEA does not apply directly to small group health plans, although 
its requirements are applied indirectly in connection with the 
Affordable Care Act's essential health benefit requirements. The 
Consolidated Appropriations Act, 2021 (the Appropriations Act) was 
enacted on December 27, 2020. The Appropriations Act amended MHPAEA, in 
part, by expressly requiring group health plans and health insurance 
issuers offering group or individual health insurance coverage that 
offer both med/surg benefits and MH/SUD benefits and that impose non-
quantitative treatment limitations (NQTLs) on MH/SUD benefits to 
perform and document their comparative analyses of the design and 
application of NQTLs. Further, beginning 45 days after the date of 
enactment of the Appropriations Act, group health plans and health 
insurance issuers offering group or individual health insurance 
coverage must make their comparative analyses available to the 
Departments of Labor, Health and Human Services (HHS), and the Treasury 
or applicable state authorities, upon request. The Secretary of HHS is 
required to request the comparative analyses for plans that involve 
potential violations of MHPAEA or complaints regarding noncompliance 
with MHPAEA that concern NQTLs and any other instances in which the 
Secretary determines appropriate. The Appropriations Act also requires 
the Secretary of HHS to submit to Congress, and make publicly 
available, an annual report on the conclusions of the reviews. Form 
Number: CMS-10773 (OMB control number: 0938-1393); Frequency: On 
Occasion; Affected Public: State, Local, or Tribal Governments, Private 
Sector; Number of Respondents: 250,137; Total Annual Responses: 36,461; 
Total Annual Hours: 1,013,184. (For policy questions regarding this 
collection, contact Usree Bandyopadhyay at 410-786-6650.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Exchange 
Functions: Standards for Navigators and Non-Navigator Assistance 
Personnel-CAC; Use: Section 1321(a)(1) of the Affordable Care Act 
directs and authorizes the Secretary to issue regulations setting 
standards for meeting the requirements under title I of the Affordable 
Care Act, with respect to, among other things, the establishment and 
operation of Exchanges. Pursuant to this authority, regulations 
establishing the certified application counselor program have been 
finalized at 45 CFR 155.225. In accordance with 155.225(d)(1) and (7), 
certified application counselors in all Exchanges are required to be 
initially certified and recertified on at least an annual basis and 
successfully complete Exchange required training. Form Number: CMS-
10494 (OMB control number: 0938-1205); Frequency: On Occasion; Affected 
Public: State, Local, or Tribal Governments, Private Sector (not-for-
profit institutions); individuals or households; Number of Respondents: 
278,072; Total Annual Responses: 278,072; Total Annual Hours: 918,024. 
(For policy questions regarding this collection contact Evonne Muoneke 
at 301-492-4402.)

    Dated: October 21, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-23284 Filed 10-25-21; 8:45 am]
BILLING CODE 4120-01-P