[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)]
[Notices]
[Pages 53474-53476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23027]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-224-14, CMS-10684, CMS-10524, CMS-10572, 
CMS-10433 and CMS-10657]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid 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 24, 2018.

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. 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) 786-1326.

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-224-14 Federal Qualified Health Center Cost Report
CMS-10684 21st Century Cures Act Section 12002 IMD Study
CMS-10524 Medicare Program; Prior Authorization Process for Certain 
Durable Medical Equipment, Prosthetic, Orthotics, and Supplies (DMEPOS)

[[Page 53475]]

CMS-10572 Transparency in Coverage Reporting by Qualified Health Plan 
Issuers
CMS-10433 Data Collection to Support QHP Certification and other 
Financial Management and Exchange Operations
CMS-10657 The State Flexibility to Stabilize the Market Grant Program
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. Title of Information Collection: Federal Qualified Health Center 
Cost Report; Type of Information Collection Request: Extension of a 
currently approved collection; Use: Under the authority of sections 
1815(a) and 1833(e) of the Act, CMS requires that providers of services 
participating in the Medicare program submit information to determine 
costs for health care services rendered to Medicare beneficiaries. 
Furthermore, these sections of the Act provide that no Medicare 
payments will be made to a provider unless it furnishes the 
information. CMS requires that providers follow reasonable cost 
principles under 1861(v)(1)(A) of the Act when completing the Medicare 
cost report. Under the regulations at 42 CFR 413.20 and 413.24, CMS 
defines adequate cost data and requires cost reports from providers on 
an annual basis. The Form CMS-224-14 cost report is needed to determine 
a provider's reasonable cost incurred in furnishing medical services to 
Medicare beneficiaries and to calculate the FQHC settlement amount. 
These providers, paid under the FQHC prospective payment system (PPS), 
may receive reimbursement outside of the PPS for Medicare reimbursable 
bad debts and pneumococcal and influenza vaccines. The FQHC cost report 
is also used for rate setting and payment refinement activities, 
including developing a FQHC market basket. Additionally, the Medicare 
Payment Advisory Commission (MedPAC) uses the FQHC Medicare cost report 
data to calculate Medicare margins, to formulate recommendations to 
Congress regarding the FQHC PPS, and to conduct additional analysis of 
the FQHC PPS. Form Number: CMS-224-14 (OMB control number: 0938-1298); 
Frequency: Yearly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 2,240; Number of Responses: 2,240; 
Total Annual Hours: 129,920. (For questions regarding this collection 
contact Julie Stankivic at (410) 786-5725.)
    2. Title of Information Collection: 21st Century Cures Act Section 
12002 IMD Study; Type of Information Collection Request: New collection 
(request for a new OMB control number); Use: The Act requires that HHS 
conduct a study of the effects of the 2016 Medicaid Managed Care final 
rule's provisions that clarified policy on coverage of IMD services in 
lieu of other covered services. The survey is needed to help answer the 
5 mandated study questions. The collected data will be used by CMS 
develop a Report to Congress as required by the Act. Form Number: CMS-
10684 (OMB Control Number: 0938-TBD); Frequency: Yearly; Affected 
Public: State, Local, or Tribal Governments; Number of Respondents: 43; 
Number of Responses: 43; Total Annual Hours: 86. (For questions 
regarding this collection contact Laura Snyder at (410) 786-3198.)
    3. Title of Information Collection: Medicare Program; Prior 
Authorization Process for Certain Durable Medical Equipment, 
Prosthetic, Orthotics, and Supplies (DMEPOS); Type of Information 
Collection Request: Revision of a currently approved collection; Use: 
The CMS has had longstanding concerns about the improper payments 
related to DMEPOS items. The Department of Health and Human Services' 
Office of the Inspector General and the U.S. Government Accountability 
Office have published multiple reports indicating questionable billing 
practices by suppliers, inappropriate Medicare payments, and 
questionable utilization of DMEPOS items. The fiscal year (FY) 2017 
Medicare FFS program improper payment rate for the Durable Medical 
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) was 44.6%, 
accounting for over $3.7 billion in projected improper payments. The 
CMS has implemented several initiatives in recent years to address 
these issues, such as the DMEPOS Competitive Bidding Program, as well 
as heightened screening of suppliers, as authorized by the Affordable 
Care Act.
    In addition to those actions, CMS is continuing the use of prior 
authorization in fee for service Medicare. Prior authorization is a 
process through which a request for provisional affirmation of coverage 
is submitted for review before an item is rendered to a Medicare 
patient and before a claim is submitted for payment. Prior 
authorization helps make sure that applicable Medicare coverage, 
payment, and coding rules are met before item(s) are rendered. Prior to 
furnishing the item to the beneficiary and prior to submitting the 
claim for processing, a requester must submit a prior authorization 
request that includes evidence that the item complies with all 
applicable Medicare coverage, coding, and payment rules. Consistent 
with Sec.  [thinsp]414.234(d), such evidence must include the order, 
relevant information from the beneficiary's medical record, and 
relevant supplier-produced documentation. After receipt of all 
applicable required Medicare documentation, CMS or one of its review 
contractors will conduct a medical review and communicate a decision 
that provisionally affirms or non-affirms the request. A provisional 
affirmative decision is a preliminary finding that a future claim 
submitted to Medicare for the DMEPOS item likely meets Medicare's 
coverage, coding, and payment requirements. Suppliers who receive a 
non-affirmative decision have unlimited resubmission opportunities. 
Form Number: CMS-10524 (OMB control number: 0938-1293); Frequency: 
Occasionally; Affected Public: Private Sector (Business or other for-
profits, Not-for-Profit Institutions); Number of Respondents: 321,551; 
Total Annual Responses: 321,551; Total Annual Hours: 160,775.68 (For 
policy questions regarding this collection contact Yuliya Cook at (410) 
786-0157.)
    4. Title of Information Collection: Information Collection for 
Transparency in Coverage Reporting by Qualified Health Plan Issuers; 
Type of Information Collection Request: Extension of a currently 
approved information collection request; Use: Section 1311(e)(3) of the 
Affordable Care Act requires issuers of Qualified Health Plans (QHPs), 
to make available and submit transparency in coverage data. This data 
collection would collect certain information from QHP issuers in 
Federally-facilitated Exchanges and State-based Exchanges that rely on 
the

[[Page 53476]]

federal IT platform (i.e., HealthCare.gov). HHS anticipates that 
consumers may use this information to inform plan selection.
    As stated in the final rule Patient Protection and Affordable Care 
Act; Establishment of Exchanges and Qualified Health Plans; Exchange 
Standards for Employers (77 FR 18310; March 27, 2012), broader 
implementation will continue to be addressed in separate rulemaking 
issued by HHS, and the Departments of Labor and the Treasury (the 
Departments).
    Consistent with Public Health Service Act (PHS Act) \1\ section 
2715A, which largely extends the transparency reporting provisions set 
forth in section 1311(e)(3) to non-grandfathered group health plans 
(including large group and self-insured health plans) and health 
insurance issuers offering group and individual health insurance 
coverage (non-QHP issuers), the Departments intend to propose other 
transparency reporting requirements at a later time, through a separate 
rulemaking conducted by the Departments, for non-QHP issuers and non-
grandfathered group health plans. Those proposed reporting requirements 
may differ from those prescribed in the HHS proposal under section 
1311(e)(3), and will take into account differences in markets, 
reporting requirements already in existence for non-QHPs (including 
group health plans), and other relevant factors. The Departments also 
intend to streamline reporting under multiple reporting provisions and 
reduce unnecessary duplication. The Departments intend to implement any 
transparency reporting requirements applicable to non-QHP issuers and 
non-grandfathered group health plans only after notice and comment, and 
after giving those issuers and plans sufficient time, following the 
publication of final rules, to come into compliance with those 
requirements. Form Number: CMS-10572 (OMB control number: 0938-1310); 
Frequency: Annually; Affected Public: Private Sector (Business or other 
for-profits); Number of Respondents: 160; Number of Responses: 160; 
Total Annual Hours: 10,880. (For questions regarding this collection 
contact Valisha Jackson at (301) 492-5145.)
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    \1\ PHS Act section 2715A also is incorporated into section 
715(a)(1) of the Employee Retirement Income Security Act and section 
9815(a)(1) of the Internal Revenue Code.
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    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Data Collection 
to Support QHP Certification and other Financial Management and 
Exchange Operations; Use: As directed by the rule Establishment of 
Exchanges and Qualified Health Plans; Exchange Standards for Employers 
(77 FR 18310) (Exchange rule), each Exchange is responsible for the 
certification and offering of Qualified Health Plans (QHPs). To offer 
insurance through an Exchange, a health insurance issuer must have its 
health plans certified as QHPs by the Exchange. A QHP must meet certain 
minimum certification standards, such as network adequacy, inclusion of 
Essential Community Providers (ECPs), and non-discrimination. The 
Exchange is responsible for ensuring that QHPs meet these minimum 
certification standards as described in the Exchange rule under 45 CFR 
155 and 156, based on the Patient Protection and Affordable Care Act 
(PPACA), as well as other standards determined by the Exchange. Issuers 
can offer individual and small group market plans outside of the 
Exchanges that are not QHPs.
    The instruments in this information collection will be used for the 
2020 certification process and beyond. Providing these instruments now 
will give issuers and other stakeholders more opportunity to 
familiarize themselves with the instruments before releasing the 2020 
application. Form Number: CMS-10433 (OMB control number: 0938-1187); 
Frequency: Annually; Affected Public: State, Local, or Tribal 
Governments, Private Sector (Business or other for-profits); Number of 
Respondents: 2,892 Number of Responses: 2,892; Total Annual Hours: 
68,666. (For questions regarding this collection contact Joshua Annas 
at (301) 492-4407).
    6. Type of Information Collection Request: Request for a new OMB 
control number; Title of Information Collection: The State Flexibility 
to Stabilize the Market Grant Program Reporting; Use: Section 1003 of 
the Affordable Care Act (ACA) adds a new section 2794 to the PHS Act 
entitled, ``Ensuring That Consumers Get Value for Their Dollars.'' 
Specifically, section 2794(a) requires the Secretary of the Department 
of Health and Human Services (the Secretary) (HHS), in conjunction with 
the States, to establish a process for the annual review of health 
insurance premiums to protect consumers from unreasonable rate 
increases. Section 2794(c) directs the Secretary to carry out a program 
to award grants to States. Section 2794(c)(2)(B) specifies that any 
appropriated Rate Review Grant funds that are not fully obligated by 
the end of FY 2014 shall remain available to the Secretary for grants 
to States for planning and implementing the insurance market reforms 
and consumer protections under Part A of title XXVII of the Public 
Health Service Act (PHS Act). States that are awarded funds under this 
funding opportunity are required to provide CMS with four quarterly 
reports and one annual report (except for the last year of the grant) 
until the end of the grant period detailing the state's progression 
towards planning and/or implementing the pre-selected market reforms 
under Part A of Title XXVII of the PHS Act. A final report is due at 
the end of the grant period. Form Number: CMS-10657 (OMB control 
number: 0938-NEW); Frequency: Annually and Quarterly; Affected Public: 
State, Local or Tribal Governments; Number of Respondents: 31; Total 
Annual Responses: 5; Total Annual Hours: 2,108. (For policy questions 
regarding this collection contact Jim Taing at (301) 492-4182.)

    Dated: October 17, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff. Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-23027 Filed 10-22-18; 8:45 am]
 BILLING CODE 4120-01-P