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In this election year, U.S. healthcare policy is center stage. ACCC is monitoring proposed rules and policy changes to gauge their impact on cancer care access and delivery.
Recent policy actions include the Centers for Medicare & Medicaid Services (CMS) release on Feb. 5 of CY 2021/2022 Medicare Advantage and Part D Proposed Rule that would:
The comment deadline on this proposed rule is 5 pm, April 6, 2020.
Together with the Medicare Advantage and Part D proposed rule, CMS also released 2021 Medicare Advantage and Part D Advance Notice Part II, in which the agency solicits comments on potentially developing measures of generic and biosimilar utilization in Medicare Part D as part of a plan’s star rating. The comment deadline on Advance Notice Part I and Part II proposals is Friday, March 6, 2020.
Coverage for Diagnostic Tests Using NGS
On Jan. 27, 2020, CMS issued a National Coverage Determination (NCD) that expands the coverage of FDA-approved laboratory diagnostic tests that use next-generation sequencing (NGS) for patients with germline, or inherited, ovarian or breast cancer. CMS also gave Medicare Administrative Contractors (MACs) the ability to determine coverage of NGS laboratory tests for other inherited cancers.
Importation of Prescription Drugs
As part of the Administration’s push to lower prescription drug prices, the Food and Drug Administration (FDA) released a proposed rule and draft guidance on drug importation into the U.S. The proposed rule would authorize states, wholesalers, and pharmacists to submit proposals to import prescription drugs from Canada into the U.S. The rule excludes the importation of biologics and infused drugs.
The FDA issued draft guidance that describes the pathways drug manufacturers would be able to use to import prescription drugs (including biologics) into the U.S. that are FDA-approved, manufactured abroad, and originally intended for sale in a foreign country.
The proposed rule comes after the Dec. 28, 2019 Administration release of a notice of proposed rulemaking on drug importation and draft guidance. These actions follow the administration’s “Safe Importation Action Plan,” released in July 2019, which laid out pathways for importing certain prescription drugs into the U.S.
Stay tuned for Part 2 of ACCC’s Policy Update, in which we address the spotlight on 340B, the potential impact of Medicaid block grants, and more.