Department of Health and Human Services May 26, 2023 – Federal Register Recent Federal Regulation Documents

This proposed rule would seek to implement policies in the Medicaid Drug Rebate Program (MDRP) related to the new legislative requirements in the Medicaid Services Investment and Accountability Act of 2019 (MSIAA), which are needed to address drug misclassification, as well as drug pricing and product data misreporting by manufacturers. Additionally, we are proposing several other program integrity and program administration provisions or modifications in this proposed rule including revising and proposing key definitions used in the MDRP. This proposed rule also designates a time limitation on manufacturers initiating audits with States; clarifies and establishes requirements for State fee-for-service (FFS) pharmacy reimbursement; codifies conditions relating to States claiming FFP for physician-administered drugs (PADs); clarifies the requirement of accumulating price concessions when determining best price; designates drug price verification and transparency through data collection; and proposes two new contracting requirements between States and their Medicaid managed care plans. In addition, this rule includes a proposal unrelated to MDRP that would make revisions to the third-party liability regulation due to Bipartisan Budget Act (BBA) of 2018. Finally, we are proposing to rescind revisions made by the December 31, 2020 final rule ``Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements'' to the Determination of Best Price and Determination of Average Manufacturer Price (AMP) sections.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.'' The guidance represents the current thinking of FDA on adjusting for covariates in randomized clinical trials for drugs and biological products. The guidance discusses general recommendations for performing covariate adjustment, recommendations for performing covariate adjustment using linear models, and recommendations for performing covariate adjusting using nonlinear models. The guidance is intended to facilitate covariate adjustment in the analysis of randomized clinical trials of drugs and biological products and to clarify recommendations for its use. The guidance finalizes the revised draft guidance entitled ``Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products'' issued on May 21, 2021.

The Children's Bureau (CB), the Administration for Children and Families (ACF) is requesting a three-year extension of the data information collection for the Adoption and Foster Care Analysis and Reporting System (AFCARS) that was implemented as part of the AFCARS final rule published in May 2020 (85 FR 28410). There are no proposed changes to the data information collection published as the regulation in May 2020. The estimated time per response related to record keeping has been revised since the previous published notice (88 FR 16449) due to feedback from the State and Tribal reporting agencies.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Measures for Primary Healthcare Spending, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), plans to request review and approval by the Office of Management and Budget (OMB) of the information collection listed below.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP-STAC). This virtual meeting is open to the public. Time will be available for public comment.