[Federal Register Volume 85, Number 104 (Friday, May 29, 2020)]
[Notices]
[Pages 32397-32399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11387]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10110, CMS-10156, CMS-10728, and CMS-R-21]
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 July 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. 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 N. Parham at (410) 786-4669.
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-10110 Manufacturer Submission of Average Sales Price (ASP) Data for
Medicare Part B Drugs and Biologicals
CMS-10156 Retiree Drug Subsidy (RDS) Application and Instructions
CMS-10728 Value in Opioid Use Disorder Treatment Demonstration
CMS-R-21 Withholding Medicare Payments to Recover Medicaid Overpayments
and Supporting Regulations in 42 CFR 447.31
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
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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: Revision with change of
a currently approved collection; Title of Information Collection:
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare
Part B Drugs and Biologicals; Use: Section 1847A of the Act requires
that the Medicare Part B payment amounts for covered drugs and
biologicals not paid on a cost or prospective payment basis be based
upon manufacturers' average sales price data submitted quarterly to the
Centers for Medicare & Medicaid Services (CMS). The reporting
requirements are specified in 42 CFR part 414 Subpart J.
The Division of Ambulatory Services (DAS), will utilize the ASP
data (ASP and number of units sold as specific in section 1847A of the
Act) to determine the Medicare Part B drug payment amounts for CY 2005
and beyond. The manufacturers submit their ASP data for all of their
NDCs for Part B drugs. DAS compiles the data, analyzes the data and
runs the data through software to calculate the volume-weighted ASP for
all of the NDCs that are grouped within a given HCPCS code. The formula
to calculate the volume-weighted ASP is the Sum (ASP * units) for all
NDCs/Sum (units * bill units per pkg) for all NDCs. DAS provides ASP
payment amounts for several components within CMS that utilize 1847(A)
payment methodologies to implement various payment policies including,
but not limited to, ESRD, OPPS, OTP and payment models. The Department
of Health and Human Services' Office of the Inspector General also uses
the ASP data in conducting statutorily mandated studies. Form Number:
CMS-10110 (OMB control number: 0938-0921); Frequency: Quarterly;
Affected Public: State, Local, or Tribal Governments; Number of
Respondents: 300; Total Annual Responses: 1,200; Total Annual Hours:
15,600. (For policy questions regarding this collection contact Felicia
Eggleston at 410 786-9287.)
2. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Retiree Drug Subsidy (RDS) Application and Instructions; Use: Under the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
and implementing regulations at 42 CFR part 423 subpart R plan sponsors
(e.g., employers, unions) who offer prescription drug coverage to their
qualified covered retirees are eligible to receive a 28% subsidy for
allowable drug costs. In order to qualify, plan sponsors must submit a
complete application to the Centers for Medicare & Medicaid Services
(CMS) with a list of retirees for whom it intends to collect the
subsidy. Once CMS reviews and analyzes the information on the
application and the retiree list, notification will be sent to the plan
sponsor about its eligibility to participate in the Retiree Drug
Subsidy (RDS) Program.
CMS has contracted with an outside vendor to assist in the
administration of the RDS program; this effort is called the RDS
Center. Plan Sponsors will apply on-line for the retiree drug subsidy
by logging on to the RDS Secure website. 42 CFR 423.844 describes the
requirement for qualified retiree prescription drug plans who want to
receive the retiree drug subsidy. Once the Plan Sponsor submits the RDS
application via the RDS Secure website (and a valid initial retiree
list) CMS, through the use of its contractor, will analyze the
application to determine whether the Plan Sponsor qualifies for the
RDS. To qualify for the subsidy, the Plan Sponsor must show that its
coverage is as generous as, or more generous than, the defined standard
coverage under the Medicare Part D prescription drug benefit. Form
Number: CMS-10156 (OMB control number: 0938-0957); Frequency: Yearly;
Affected Public: Private Sector, Business or other for-profits, Not-
for-profits institutions; Number of Respondents: 1,803; Total Annual
Responses: 1,803; Total Annual Hours: 115,392. (For policy questions
regarding this collection contact Ivan Iveljic at 410-786-3312.)
3. Type of Information Collection Request: New Collection; Title of
Information Collection: Value in Opioid Use Disorder Treatment
Demonstration; Use: Value in Opioid Use Disorder Treatment (Value in
Treatment) is a 4-year demonstration program authorized under section
1866F of the Social Security Act (Act), which was added by section 6042
of the Substance Use-Disorder Prevention that Promotes Opioid Recovery
and Treatment for Patients and Communities Act (SUPPORT Act). The
purpose of Value in Treatment, as stated in the statute, is to
``increase access of applicable beneficiaries to opioid use disorder
treatment services, improve physical and mental health outcomes for
such beneficiaries, and to the extent possible, reduce Medicare program
expenditures.'' As required by statute, Value in Treatment will be
implemented no later than January 1, 2021.
Section 1866F(c)(1)(A)(ii) specifies that individuals and entities
must apply for and be selected to participate in the Value in Treatment
demonstration pursuant to an application and selection process
established by the Secretary.
Section 1866F(c)(2)(B)(iii) specifies that in order to receive CMF
and performance-based incentive payments under the Value in Treatment
program, each participant shall report data necessary to: monitor and
evaluate the Value in Treatment program; determine if criteria are met;
and determine the performance-based incentive payment. Form Number:
CMS-10728 (OMB control number: 0938-New); Frequency: Yearly; Affected
Public: Individuals and Households; Number of Respondents: 12,096;
Total Annual Responses: 12,096; Total Annual Hours: 1,285. (For policy
questions regarding this collection contact Rebecca VanAmburg at 410-
786-0524.)
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Withholding
Medicare Payments to Recover Medicaid Overpayments and Supporting
Regulations in 42 CFR 447.31; Use: Certain Medicaid providers that are
subject to offsets for the collection of Medicaid overpayments may
terminate or substantially reduce their participation in Medicaid,
leaving the state Medicaid agency unable to recover the amounts due.
Recovery procedures allow for determining the amount of overpayments
and offsetting the overpayments by withholding the provider's Medicare
payments. To effectuate the withholding, the state agency must provide
their respective CMS regional office with certain documentation that
identifies the provider and the Medicaid overpayment amount. The agency
must also demonstrate that the provider was notified of the overpayment
and that demand for the overpayment was made. An opportunity to appeal
the overpayment determination must be afforded to the provider by the
Medicaid state agency. Lastly, Medicaid state agencies must notify CMS
when to terminate the withholding; Form Number: CMS-R-21 (OMB control
number: 0938-0287); Frequency: Occasionally; Affected Public: State,
Local, or Tribal Governments; Number of Respondents: 54; Total Annual
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Responses: 27; Total Annual Hours: 81. (For policy questions regarding
this collection contact Stuart Goldstein at 410-786-0694.)
Dated: May 21, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2020-11387 Filed 5-28-20; 8:45 am]
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