2021-10260. Agency Information Collection Activities: Submission for OMB Review; Comment Request

AGENCY:

Centers for Medicare & Medicaid Services, Health and Human 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 on the collection(s) of information must be received by the OMB desk officer by June 14, 2021.

ADDRESSES:

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

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: https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html.

FOR FURTHER INFORMATION CONTACT:

William Parham at [phone].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: New Technology Services for Ambulatory Payment Classifications under the Outpatient Prospective Payment System; Use: Section 1833(t)(6) of the Social Security Act (the Act) states, “The Secretary shall provide for an additional payment under this paragraph for any of the following that are provided as part of a covered OPD service (or group of services).” In accordance with the Act, CMS needs to keep pace with emerging new technologies and make them accessible to Medicare beneficiaries in a timely manner. It is necessary that we continue to collect appropriate information from interested parties such as hospitals, medical device manufacturers, pharmaceutical companies and others that bring to our attention specific services that they wish us to evaluate for New Technology APC payment.

The information that we seek to continue to collect is necessary to determine whether certain new services are eligible for payment in New Technology APCs, to determine appropriate coding and to set an appropriate payment rate for the new technology service. The intent of these provisions is to ensure timely beneficiary access to new and appropriate technologies.

Both the New Technology APC provision and the transitional pass-through provisions provide ways for ensuring appropriate payment for new technologies for which the use and costs are not adequately represented in the base year claims data on which the outpatient PPS is constructed. Although individual drugs and biologicals and categories of medical devices will receive transitional pass-through payments for 2 to 3 years from the date payment is initiated for the specific item or category, the underlying statutory provision is permanent and provides an on-going mechanism for reflecting the introduction of new items into the payment structure in a timely manner. New Technology APCs are designed to allow appropriate payment for new technology services that are not covered by the transitional pass-through provisions. Form Number: CMS-10054 (OMB control number: 0938-0272); Frequency: Yearly; Affected Public: Private Sector, Business or other for-profits; Number of Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 160. (For policy questions regarding this collection contact Allison Bramlett at 410-786-6556.)

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medication Therapy Management Program Improvements; Use: Information collected by Part D MTM programs as required by the Standardized Format for the CMR summary is used by beneficiaries or their authorized representatives, caregivers, and their healthcare providers to improve medication use and achieve better healthcare outcomes. Members in a Part D sponsors' plan who are eligible are enrolled in the sponsors' MTM program and offered a CMR which is a consultation between the MTM provider (such as a pharmacist) with the beneficiary to review their medications. After a CMR is performed, the sponsor creates and sends a summary of the CMR to the beneficiary that includes a medication action plan and personal medication list using the Standardized Format; Form Number: CMS-10396 (OMB control number 0938-1154); Frequency: Occasionally; Affected Public: Business or other for-profits; Number of Respondents: 807; Total Annual Responses: 2,386,955; Total Annual Hours: 1,591,383. (For policy questions regarding this collection contact Victoria Dang at 410-786-3991.)

Dated: May 11, 2021.

William N. Parham, III,

Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.