Federal Regulatory Update: New Quarantine and Medicare Advantage Regulations

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85 FR 7874 – Interim Final Rule - The CDC issued this interim final rule to amend its Foreign Quarantine regulations, to enable CDC to require airlines to collect, and provide to CDC, certain data regarding passengers and crew arriving from foreign countries for the purposes of health education, treatment, prophylaxis, or other appropriate public health interventions, including travel restrictions. Although the rule was not published until February 12, 2020, it became effective on February 7, 2020. 

85 FR 7500 – Proposed Rule - This proposed rule proposes the methodology and data sources necessary to determine federal payment amounts to be made for program year 2021 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges. Comments must be received by March 11, 2020.

85 FR 9002:  CMS released a proposed rule and the Advance Notice Part II to update Medicare Advantage and Part D programs.  According to CMS,  the changes proposed would lower beneficiary cost sharing on some of the most expensive prescription drugs, promote the use of generic drugs, and allow beneficiaries to know in advance and compare their out-of-pocket payments for different prescription drugs. The proposed rule would implement changes stemming from recent federal laws, including the Bipartisan Budget Act of 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, and the 21st Century Cures Act. The proposed rule also seeks to codify many existing policies that have been implemented through sub-regulatory guidance.  CMS has summarized the proposed rule in this Fact Sheet and the Advance Notice in this Fact Sheet . CMS will accept comments on all proposals in the Advance Notice through March 6, 2020 and CMS expects to publish the final Rate Announcement by April 6, 2020.

Gene Therapy:  The FDA issued six final guidances on gene therapy manufacturing and clinical development of products and a draft guidance, Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations. The six final guidances provide the agency’s recommendations for product developers on manufacturing issues and recommendations for those focusing on gene therapy products to address specific disease areas. The agency is issuing this suite of documents to help advance the field of gene therapy while providing recommendations to help ensure that these innovative products meet the FDA’s standards for safety and effectiveness. The draft guidance on interpreting sameness of gene therapy products under the orphan drug regulations provides the FDA’s proposed current thinking on an interpretation of sameness between gene therapy products for the purposes of obtaining orphan-drug designation and eligibility for orphan-drug exclusivity. The draft guidance focuses on how the FDA will evaluate differences between gene therapy products when they are intended to treat the same disease.