[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]


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

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.

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

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

[[Page 32398]]

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

[[Page 32399]]

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]
BILLING CODE 4120-01-P