2024-05712. 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 April 17, 2024.

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, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.

FOR FURTHER INFORMATION CONTACT:

William Parham at (410) 786–4669.

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: Revision of a currently approved collection; Title of Information Collection: Collection of Encounter Data from MA Organizations, Section 1876 Cost HMOs/CMPs, MMPs, and PACE Organizations; Use: Section 1853(a)(3)(B) of the Act directs CMS to require MA organizations and eligible organizations with risk-sharing contracts under 1876 to “submit data regarding inpatient hospital services . . . and data regarding other services and other information as the Secretary deems necessary” in order to implement a methodology for “risk adjusting” payments made to MA organizations and other entities. Risk adjustments to enrollee monthly payments are made in order to take into account “variations in per capita costs based on [the] health status” of the Medicare beneficiaries enrolled in an MA plan.

CMS uses encounter data to develop individual risk scores for risk adjusted payment to MA organizations, PACE organizations, and MMPs. Starting with Payment Year (PY) 2016, CMS began to blend risk scores calculated with Risk Adjustment Processing Data and Medicare Fee-For-Service (FFS) data with risk scores calculated with encounter data and FFS data, for risk scores calculated under both the CMS–HCC and the RxHCC models. In PY 2022, we will move to calculating risk scores under both the CMS–HCC and the RxHCC models using 100 percent of the risk score calculated using encounter data and FFS data.

All organizations required to submit encounter data use an electronic connection between the organization and CMS to submit encounter data and to receive information in return. CMS collects the data from MA organizations, 1876 Cost Plans, MMPs and PACE organizations in the X12N 837 5010 format for professional, DME, and institutional, and dental services or items provided to MA enrollees. Form Number: CMS–10340 (OMB control number: 0938–1152); Frequency: Daily; Affected Public: Private Sector, Business or other for-profits and Not-for-profits institutions; Number of Respondents: 284; Total Annual Responses: 1,467,645,179; Total Annual Hours: 48,936,279. (For policy questions regarding this collection contact Raymond Mierwald at 410 446–5449).

2. Type of Information Collection Request: Reinstatement without change of previously approved collection; Title of Information Collection: Medication Therapy Management Program Improvements—Standardized Format; Use: Section 1860D–4(c)(2)(C)(i) of the Act requires plan sponsors to offer MTM services that include an annual CMR with a written summary and action plan provided in a standardized format developed in consultation with stakeholders. This requirement is codified at § 423.153(d)(1)(vii)(D), which requires that the standardized action plan and summary comply with requirements specified by CMS for the standardized format. Components of the CMR summary in Standardized Format should include a cover letter, personalized medication list, and action plan if applicable.

Users include members in a Part D sponsors' plan who are eligible are enrolled in the sponsors' MTM program and offered a CMR. The CMR is a consultation between the MTM provider (such as a pharmacist) with the beneficiary to review their medications. The MTM provider is either an employee/contractor of the plan itself or of a downstream entity contracted by the plan to provide MTM services. 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.

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. Form Number: CMS–10396 (OMB control number: 0938–1154); Frequency: Yearly; Affected Public: Private Sector and Business or other for-profits; Number of Respondents: 849; Total Annual Responses: 2,382,774; Total Annual Hours: 1,588,595. (For policy questions regarding this collection contact Victoria Dang at 410–786–3991 or [e-mail].)

William N. Parham, III,

Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.