[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
[[Page 27451]]
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
[[Page 27452]]
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