Department of Health and Human Services December 31, 2020 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC), a component of the U.S. Department of Health and Human Services (HHS), announces an Agency Order requiring negative pre-departure COVID-19 test results for all airline passengers arriving into the United States from the United Kingdom (UK). This Order is issued to preserve human life; prevent the further introduction, transmission, and spread of the virus that causes COVID-19 into the United States, including new virus variants; preserve the health and safety of airline crew members, passengers, airport personnel, and communities; and preserve hospital, healthcare, and emergency response resources within the United States.

Notice is provided that the Director of the Indian Health Service has approved the rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2021.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Consumer Antiseptic Rub Final Rule Questions and Answers.'' We are issuing this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act to help small businesses understand and comply with the Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph (Consumer Antiseptic Rub FR). In the Consumer Antiseptic Rub FR, FDA established that 28 active ingredients used in nonprescription (also known as over-the-counter (OTC)) consumer antiseptic products intended for use without water (consumer antiseptic rubs) are not eligible for evaluation under FDA's OTC Drug Review, which was used to evaluate the safety and effectiveness of OTC drug products marketed in the United States on or before May 1972. The Consumer Antiseptic Rub FR also established that three active ingredients used in consumer antiseptic rubs are eligible for evaluation under the OTC Drug Review and granted requests to temporarily defer further rulemaking on these three eligible ingredients to allow for the development and submission of new safety and effectiveness data.

In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD) will hold public meetings for the 2021 calendar year (CY). Information about ACTPCMD, agendas, and materials for these meetings can be found on the ACTPCMD website at https://www.hrsa.gov/advisory-committees/primarycare-dentist/ index.html.

This final rule will advance CMS' efforts to support state flexibility to enter into innovative value-based purchasing arrangements (VBPs) with manufacturers, and to provide manufacturers with regulatory support to enter into VBPs with payers, including Medicaid. To ensure that the regulatory framework is sufficient to support such arrangements and to promote transparency, flexibility, and innovation in drug pricing without undue administrative burden, we are finalizing new regulatory policies and clarifying certain already established policies to assist manufacturers and states in participating in VBPs in a manner that is consistent with the law and maintains the integrity of the Medicaid Drug Rebate Program (MDRP). This final rule also revises regulations regarding: Authorized generic sales when manufacturers calculate average manufacturer price (AMP) for the brand name drug; pharmacy benefit managers (PBM) accumulator programs and their impact on AMP and best price when manufacturer- sponsored assistance is not passed through to the patient; state and manufacturer reporting requirements to the MDRP; new Medicaid Drug Utilization Review (DUR) provisions designed to reduce opioid related fraud, misuse and abuse; the definitions of CMS-authorized supplemental rebate agreement, line extension, new formulation, oral solid dosage form, single source drug, multiple source drug, innovator multiple source drug for purposes of the MDRP; payments for prescription drugs under the Medicaid program; and coordination of benefits (COB) and third party liability (TPL) rules related to the special treatment of certain types of care and payment in Medicaid and Children's Health Insurance Program (CHIP).