[Federal Register Volume 86, Number 28 (Friday, February 12, 2021)]
[Notices]
[Pages 9349-9351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02941]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-18F5, CMS-10307, CMS-10495 and CMS-10454]


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 March 15, 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: 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: Application for 
Enrollment in Medicare Part A internet Claim (iClaim) Application 
Screen Modernized Claims System and Consolidated Claim Experience 
Screens; Use: Individuals who are already entitled to retirement or 
disability benefits under Social Security or Railroad Retirement Board 
(RRB) benefits are automatically entitled to premium-free Medicare 
Hospital Insurance (Part A) when they attain age 65 or reach the 25th 
month of disability benefit entitlement. These individuals do not file 
a separate application for Medicare Part A because their application 
for Social Security or RRB benefits is also an application for Part A. 
The form is for individuals who are not eligible for Social Security 
for RRB benefits, but may qualify for premium-free Medicare Part A 
based on certain requirements outlined in Sec.  406.11 and 406.15 or 
for certain disabled individuals who may enroll in premium Medicare 
Part A based on certain requirements outlined in Sec.  406.20. 
Individuals may also choose to enroll in

[[Page 9350]]

Medicare Part B at the same time they apply for Medicare Part A.
    The Application for Enrollment in Medicare Part A (CMS-18F5 and 
CMS-18F5-SP) was designed to capture all the information needed to make 
a determination of an individual's entitlement to Part A. This 
Information Collection Request (ICR) adds the collection instruments 
SSA uses to collect information from individuals who are filing an 
Application for Hospital Insurance, updates the burden information. CMS 
will begin reporting for additional collection instruments, including 
the internet Claim System (iClaim), Modernized Claims System (MCS), and 
the Consolidated Claims Experience (CCE). Form Number: CMS-18F5 (OMB 
control number: 0938-0251); Frequency: Annually; Affected Public: 
State, Local, or Tribal Governments; Number of Respondents: 1,394,264; 
Total Annual Responses: 1,394,264; Total Annual Hours: 348,566. (For 
policy questions regarding this collection contact Carla Patterson at 
410-786-1000.)
    2. Type of Information Collection Request: Extension; Title of 
Information Collection: Medical Necessity and Claims Denial Disclosures 
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 ensure 
that they do not apply any more restrictive financial requirements 
(e.g., co-pays, deductibles) and/or treatment limitations (e.g., visit 
limits) 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, collectively known as the ``Affordable Care Act.'' The 
Affordable Care Act extended MHPAEA to apply to the individual health 
insurance market. Additionally, the Department of Health and Human 
Services (HHS) final regulation regarding essential health benefits 
(EHB) requires health insurance issuers offering non-grandfathered 
health insurance coverage in the individual and small group markets, 
through an Exchange or outside of an Exchange, to comply with the 
requirements of the MHPAEA regulations in order to satisfy the 
requirement to cover EHB (45 CFR 147.150 and 156.115).
    MHPAEA section 512(b) specifically amends the Public Health Service 
(PHS) Act to require plan administrators or health insurance issuers to 
provide, upon request, the criteria for medical necessity 
determinations made with respect to MH/SUD benefits to current or 
potential participants, beneficiaries, or contracting providers. The 
Interim Final Rules Under the Paul Wellstone and Pete Domenici Mental 
Health Parity and Addiction Equity Act of 2008 (75 FR 5410, February 2, 
2010) and the Final Rules under the Paul Wellstone and Pete Domenici 
Mental Health Parity and Addiction Equity Act of 2008 set forth rules 
for providing criteria for medical necessity determinations. CMS 
oversees non-Federal governmental plans and health insurance issuers.
    MHPAEA section 512(b) specifically amends the PHS Act to require 
plan administrators or health insurance issuers to supply, upon 
request, the reason for any denial or reimbursement of payment for MH/
SUD services to the participant or beneficiary involved in the case. 
The Interim Final Rules Under the Paul Wellstone and Pete Domenici 
Mental Health Parity and Addiction Equity Act of 2008 (75 FR 5410, 
February 2, 2010) and the Final Rules under the Paul Wellstone and Pete 
Domenici Mental Health Parity and Addiction Equity Act of 2008 
implement 45 CFR 146.136(d)(2), which sets forth rules for providing 
reasons for claims denial. CMS oversees non-Federal governmental plans 
and health insurance issuers, and the regulation provides a safe harbor 
such that non-Federal governmental plans (and issuers offering coverage 
in connection with such plans) are deemed to comply with requirements 
of paragraph (d)(2) of 45 CFR 146.136 if they provide the reason for 
claims denial in a form and manner consistent with ERISA requirements 
found in 29 CFR 2560.503-1. Section 146.136(d)(3) of the final rule 
clarifies that PHS Act section 2719 governing internal claims and 
appeals and external review as implemented by 45 CFR 147.136, covers 
MHPAEA claims denials and requires that, when a non-quantitative 
treatment limitation (NQTL) is the basis for a claims denial, that a 
non-grandfathered plan or issuer must provide the processes, 
strategies, evidentiary standard, and other factors used in developing 
and applying the NQTL with respect to med/surg benefits and MH/SUD 
benefits.
    Group health plan participants, beneficiaries, covered individuals 
in the individual market, or persons acting on their behalf, may use 
this optional model form to request information from plans regarding 
NQTLs that may affect patients' MH/SUD benefits or that may have 
resulted in their coverage being denied. Form Number: CMS-10307 (OMB 
control number: 0938-1080); Frequency: On Occasion; Affected Public: 
State, Local, or Tribal Governments, Private Sector, Individuals; 
Number of Respondents: 250,137; Total Annual Responses: 987,714; Total 
Annual Hours: 35,475. (For policy questions regarding this collection 
contact Usree Bandyopadhyay at 410-786-6650.)
    3. Type of Information Collection Request: Extension; Title of 
Information Collection: Data Collection and Submission, Registration, 
Attestation, Dispute and Resolution, Record Retention, and Assumptions 
Document Submission, for Open Payments; Use: Section 6002 of the 
Affordable Care Act added section 1128G to the Social Security Act (the 
Act), which requires applicable manufacturers of covered drugs, 
devices, biologicals, or medical supplies (as defined at 42 CFR 
403.902) to report annually to the Secretary certain payments or other 
transfers of value to covered recipients. Section 1128G of the Act also 
requires applicable manufacturers and applicable group purchasing 
organizations (GPOs) to report certain information regarding the 
ownership or investment interests held by physicians or the immediate 
family members of physicians in such entities.
    Specifically, manufacturers of covered drugs, devices, biologicals, 
and medical supplies (applicable manufacturers) are required to submit 
on an annual basis the information required in section 1128G(a)(1) of 
the Act about certain payments or other transfers of value made to 
covered recipients during the course of the preceding calendar year. 
Similarly, section 1128G(a)(2) of the Act requires applicable 
manufacturers and applicable GPOs to disclose any ownership or 
investment interests in such entities held by physicians or their 
immediate family members, as well as information on any payments or 
other transfers of value provided to such physician owners or 
investors. Form Number: CMS-10495 (OMB control number: 0938-1237); 
Frequency: Once; Affected Public: Private sector; Business or other 
for-profits; Number of Respondents: 34,616; Total Annual Responses: 
78,812; Total Annual Hours: 1,897,790. (For policy questions regarding 
this collection contact Kathleen Ott 410-786-4246.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of

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Information Collection: Disclosure of State Rating Requirements; Use: 
The final rule ``Patient Protection and Affordable Care Act; Health 
Insurance Market Rules; Rate Review'' implements sections 2701, 2702, 
and 2703 of the Public Health Service Act (PHS Act), as added and 
amended by the Affordable Care Act, and sections 1302(e) and 1312(c) of 
the Affordable Care Act. The rule directs that states submit to CMS 
certain information about state rating and risk pooling requirements 
for their individual, small group, and large group markets, as 
applicable. Specifically, states will inform CMS of age rating ratios 
that are narrower than 3:1 for adults; tobacco use rating ratios that 
are narrower than 1.5:1; a state-established uniform age curve; 
geographic rating areas; whether premiums in the small and large group 
market are required to be based on average enrollee amounts (also known 
as composite premiums); and, in states that do not permit any rating 
variation based on age or tobacco use, uniform family tier structures 
and corresponding multipliers. In addition, states that elect to merge 
their individual and small group market risk pools into a combined pool 
will notify CMS of such election. This information will allow CMS to 
determine whether state-specific rules apply or Federal default rules 
apply. It will also support the accuracy of the federal risk adjustment 
methodology. Form Number: CMS-10454 (OMB control number: 0938-1258); 
Frequency: Occasionally; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 3; Total Annual Responses: 3; Total 
Annual Hours: 17. (For policy questions regarding this collection 
contact Russell Tipps at 301-869-3502.)

    Dated: February 9, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-02941 Filed 2-11-21; 8:45 am]
BILLING CODE 4120-01-P