[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)]
[Notices]
[Pages 27450-27452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10705]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10185 and CMS-10328]


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 require; 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 any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.

DATES: Comments must be received by July 5, 2016.

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

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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' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    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: Reports Clearance Office 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-10185 Medicare Part D Reporting Requirements and Supporting 
Regulations

CMS-10328 Medicare Self-Referral Disclosure Protocol

    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.
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Part D 
Reporting Requirements and Supporting Regulations; Use: Data collected 
via Medicare Part D Reporting Requirements will be an integral resource 
for oversight, monitoring, compliance and auditing activities necessary 
to ensure quality provision of the Medicare Prescription Drug Benefit 
to beneficiaries. For all reporting sections, data are reported 
electronically to CMS. Each reporting section is reported at one of the 
following levels: Contract (data should be entered at the H#, S#, R#, 
or E# level) or Plan (data should be entered at the Plan Benefit 
Package (PBP level, e.g., Plan 001 for contract H#, R#, S#, or E). 
Sponsors should retain documentation and data records related to their 
data submissions. Data will be validated, analyzed, and utilized for 
trend reporting by the Division of Clinical and Operational Performance 
(DCOP) within the Medicare Drug Benefit and C & D Data Group. If 
outliers or other data anomalies are detected, DCOP will work in 
collaboration with other Divisions within CMS for follow-up and 
resolution. For CY2017 Reporting Requirements, the following 7 
reporting sections will be reported and collected at the Contract-level 
or Plan-level: Enrollment and Disenrollment, Retail, Home Infusion, and 
Long-Term Care Pharmacy Access, Medication Therapy Management (MTM) 
Programs, Grievances, Improving Drug Utilization Review Controls, 
Coverage Determinations and Redeterminations, and Employer/Union 
Sponsored Sponsors. Form Number: CMS-10185 (OMB control number: 0938-
0992); Frequency: Annually and semi-annually; Affected Public: Private 
sector (Business or other for-profits); Number of Respondents: 561; 
Total Annual Responses: 11,438; Total Annual Hours: 14,750. (For policy 
questions regarding this collection contact Chanelle Jones at 410-786-
8008).
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Self-
Referral Disclosure Protocol; Use: The Affordable Care Act (``ACA'') 
was enacted on March 23, 2010. Section 6409 of the ACA requires the 
Secretary of the Department of Health and Human Services (the 
``Secretary''), in cooperation with the Office of Inspector General of 
the Department of Health and Human Services, to establish a Medicare 
self-referral disclosure protocol (``SRDP''). The SRDP enables 
providers of services and suppliers to self-disclose actual or 
potential violations of the physician self-referral statute, section 
1877 of the Social Security Act (the ``Act''). Section 6409(b) of the 
ACA gives the Secretary the authority to reduce the amount due and 
owing for all violations of section 1877 of the Act. In establishing 
the amount by which an overpayment may be reduced, the Secretary may 
consider: The nature and extent of the improper or illegal practice; 
the timeliness of the self-disclosure; the cooperation in providing 
additional information related to the disclosure; and such other 
factors as the Secretary considers appropriate.
    In accordance with the ACA, CMS established the SRDP on September 
23, 2010, and information concerning how to disclose an actual or 
potential violation of section 1877 of the Act was posted on the CMS 
Web site. The most recent approval of this information collection 
request (``ICR'') was issued by the Office of Management and Budget on 
August 26, 2014.
    We are now seeking approval to revise the currently approved ICR. 
Under the currently approved collection, a party must provide a 
financial analysis of overpayments arising from actual or potential 
violations of section 1877 of the Act based on a 4-year lookback 
period. On February 12, 2016, CMS published a final rule on the 
reporting and returning of overpayments. See CMS-6037-F, Medicare 
Program; Reporting and Returning of Overpayments, 81 FR 7654 (Feb. 12, 
2016) (the ``final overpayment rule''). The final overpayment rule 
establishes a 6-year lookback period for reporting and returning 
overpayments. We are revising the information collection for the SRDP 
to reflect the 6-year lookback period established by the final 
overpayment rule. The re vision is necessary to ensure that parties 
submitting self-disclosures to the SRDP report overpayments for the 
entire 6-year lookback period. The 6-year lookback period applies only 
to submissions to the SRDP received on or after March 14, 2016, the 
effective date of the final overpayment rule; parties submitting self-
disclosures to the SRDP prior to March 14, 2016 need only provide a 
financial analysis of potential overpayments based on a 4-year lookback 
period.
    We are also taking the opportunity to streamline and simplify the 
SRDP by issuing a required form for SRDP submissions. The SRDP Form 
will reduce the burden on disclosing parties by reducing the amount of 
information

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that is required for submissions to the SRDP and providing a 
streamlined and standardized format for the presentation of the 
required information. Form Number: CMS-10328 (OMB control number: 0938-
1106); Frequency: Annually and semi-annually; Affected Public: Private 
sector (Business or other for-profits and Not-for-profits); Number of 
Respondents: 200; Total Annual Responses: 200; Total Annual Hours: 
5,000. (For policy questions regarding this collection contact Matt 
Edgar at 410-786-0698.)

    Dated: May 3, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-10705 Filed 5-5-16; 8:45 am]
 BILLING CODE 4120-01-P