[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 57984-57986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26524]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-718-721 and CMS-10307]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

ACTION: Notice.

-----------------------------------------------------------------------

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

[[Page 57985]]

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 January 8, 2018.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-5806, OR, Email: 
[email protected].
    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' Web site address at Web site address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

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: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Business Proposal Forms for Quality Improvement Organizations (QIOs); 
Use: The submission of proposal information by current quality 
improvement associations (QIOs) and other bidders, on the appropriate 
forms, will satisfy our need for meaningful, consistent, and verifiable 
data with which to evaluate contract proposals. We use the data 
collected on the forms associated with this information collection 
request to negotiate QIO contracts. We will be able to compare the 
costs reported by the QIOs on the cost reports to the proposed costs 
noted on the business proposal forms. Subsequent contract and 
modification negotiations will be based on historic cost data. The 
business proposal forms will be one element of the historical cost data 
from which we can analyze future proposed costs. In addition, the 
business proposal format will standardize the cost proposing and 
pricing process among all QIOs. With well-defined cost centers and line 
items, proposals can be compared among QIOs for reasonableness and 
appropriateness. Form Number: CMS-718-721 (OMB control number: 0938-
0579); Frequency: Annually; Affected Public: Business or other for-
profits and Not-for-profit institutions; Number of Respondents: 20; 
Total Annual Responses: 20; Total Annual Hours: 1,000. (For policy 
questions regarding this collection contact Benjamin Bernstein at 410-
786-6570.)
    2. Type of Information Collection Request: Reinstatement with 
change of a previous approved information 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) (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. These statutes are 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).

Medical Necessity Disclosure Under MHPAEA

    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.

Claims Denial Disclosure Under MHPAEA

    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

[[Page 57986]]

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.

Disclosure Request Form

    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: 267,538; Number of Responses: 1,081,929; Total 
Annual Hours: 43,327. (For policy questions regarding this collection, 
contact Usree Bandyopadhyay at 410-786-6650.)

    Dated: December 5, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2017-26524 Filed 12-7-17; 8:45 am]
 BILLING CODE 4120-01-P