[Federal Register Volume 85, Number 209 (Wednesday, October 28, 2020)]
[Notices]
[Pages 68330-68332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23893]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10307 and CMS-10495]


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 (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 December 28, 2020.

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. Call the Reports Clearance Office at (410) 786-1326.

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

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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-10307 Medical Necessity and Claims Denial Disclosures under MHPAEA
CMS-10495 Data Collection and Submission, Registration, Attestation, 
Dispute and Resolution, Record Retention, and Assumptions Document 
Submission, for Open Payments

    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 approval. To comply with this 
requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: Extension of a currently 
approved collection; 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) (P.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.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; 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

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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.)

    Dated: October 23, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-23893 Filed 10-27-20; 8:45 am]
BILLING CODE 4120-01-P