Agency Information Collection Activities: Proposed Collection; 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 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 September 3, 2024.

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, 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 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-179 Medicaid State Plan Base Plan Pages

CMS-10536 Medicaid Eligibility and Enrollment (EE) Implementation Advanced Planning Document (IAPD) Template

CMS-R-153 Medicaid Drug Use Review (DUR) Program

CMS-10326 Electronic Submission of Medicare Graduate Medical Education (GME) Affiliation Agreements

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.

Information Collections

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicaid State Plan Base Plan Pages; Use: State Medicaid agencies complete the plan pages while we review the information to determine if the state has met all of the requirements of the provisions the states choose to implement. If the requirements are met, we will approve the amendments to the state's Medicaid plan giving the state the authority to implement the flexibilities. For a state to receive Medicaid Title XIX funding, there must be an approved Title XIX state plan. Form Number: CMS-179 (OMB control number 0938-0193); Frequency: Occasionally; Affected Public: State, Local, and Tribal Governments; Number of Respondents: 56; Total Annual Responses: 1,120; Total Annual Hours: 22,400. (For policy questions regarding this collection contact Gary Knight at 304-347-5723.)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicaid Eligibility and Enrollment (EE) Implementation Advanced Planning Document (IAPD) Template; Use: To assess the appropriateness of states' requests for enhanced federal financial participation for expenditures related to Medicaid eligibility determination systems, we will review the submitted information and documentation to make an approval determination for the advanced planning document. Form Number: CMS-10536 (OMB control number: 0938-1268); Frequency: Yearly, once, and occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 168; Total Annual Hours: 2,688. (For policy questions regarding this collection contact Loren Palestino at 410-786-8842.)

3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicaid Drug Use Review (DUR) Program; Use: States must provide for a review of drug therapy before each prescription is filled or delivered to a Medicaid patient. This review includes screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse. Pharmacists must make a reasonable effort to obtain, record, and maintain Medicaid patient profiles. These profiles must reflect at least the patient's name, address, telephone number, date of birth/age, gender, history, e.g., allergies, drug reactions, list of medications, and pharmacist's comments relevant to the individual's drug therapy. The State must conduct retrospective drug use review which provides for the ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, inappropriate or medically unnecessary care. Patterns or trends of drug therapy problems are identified and reviewed to determine the need for intervention activity with pharmacists and/or physicians. States may conduct interventions via telephone, correspondence, or face-to-face contact. The states and managed care organizations (MCOs) are provided the reporting instrument (a survey) by CMS, and by responding to the survey, the states generate annual reports which are submitted to CMS for the purposes of monitoring compliance and evaluating the progress of states' DUR programs. The survey and the annual recordkeeping and reporting requirements under the pertinent regulations, are completed by pharmacists employed by, or contracted with the various state Medicaid programs and their MCOs. The annual reports submitted by states are reviewed and results are compiled by CMS in a format intended to provide information, comparisons and trends related to states' experiences with DUR. The states benefit from the information and may enhance their programs each year based on state reported innovative practices that are compiled by CMS from the annual reports. A comparison/summary of the data from the annual reports is published on Medicaid.gov annually, and serves as a resource for stakeholders, including but not limited to states, manufacturers, researchers, congress, CMS, the Office of Inspector General, non-governmental payers and clinicians on the topic of DUR in state Medicaid programs. Form Number: CMS-R-153 (OMB control number: 0938-0659); Frequency: Yearly, quarterly, and occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 52; Total Annual Responses: 676; Total Annual Hours: 41,860. (For policy questions regarding this collection contact Mike Forman at 410-786-2666.)

4. Type of Information Collection Request: Reinstatement without change of a currently approved collection; Title of Information Collection: Electronic Submission of Medicare Graduate Medical Education (GME) Affiliation Agreements; Use: Existing regulations at § 413.75(b) permit hospitals that share residents to elect to form a Medicare GME affiliated group if they are in the same or contiguous urban or rural areas, if they are under common ownership, or if they are jointly listed as program sponsors or major participating institutions in the same program by the accrediting agency. The purpose of a Medicare GME affiliated group is to provide flexibility to hospitals in structuring rotations under an aggregate full time equivalent (FTE) resident cap when they share residents. The existing regulations at § 413.79(f)(1) specify that each hospital in a Medicare GME affiliated group must submit a Medicare GME affiliation agreement (as defined under § 413.75(b)) to the Medicare Administrative Contractor (MAC) servicing the hospital and send a copy to the Centers for Medicare and Medicaid Services' (CMS) Central Office, no later than July 1 of the residency program year during which the Medicare GME affiliation agreement will be in effect.

CMS will use the information contained in electronic affiliation agreements as documentation of the existence of Medicare GME affiliations, and to verify that the affiliations being formed by teaching hospitals for the purposes of sharing their Medicare GME FTE cap slots are valid according to CMS regulations. CMS will also use these affiliation agreements as reference materials when potential issues involving specific affiliations arise. While we have used hard copies of affiliation agreements for those same purposes in the past, we implemented this electronic submission process in order to expedite and ease the process of retrieving, analyzing and evaluating affiliation agreements. Form Number: CMS-10326 (OMB control number: 0938-1111); Frequency: Annually; Affected Public: Private Sector, Business or other for profits, Not for profit institutions; Number of Respondents: 125; Total Annual Responses: 125; Total Annual Hours: 166. (For policy questions regarding this collection contact Shevi Marciano at 410-786-2874.)