Agency Information Collection Activities: Proposed Collection; Comment Request
| Citation | 85 FR 68330 |
| Record Number | 2020-23893 |
| Published date | 28 October 2020 |
| Section | Notices |
| Court | Centers For Medicare & Medicaid Services,Health And Human Services Department |
Federal Register, Volume 85 Issue 209 (Wednesday, October 28, 2020)
[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.
[[Page 68331]]
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
[[Page 68332]]
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
