ACCC Policy Update, Part 1

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:

• Require Part D plans to offer real-time drug price comparison tools to beneficiaries starting Jan. 1, 2022, to allow consumers to shop for lower-cost alternative therapies under their prescription drug benefit plan
• Allow a second, “preferred” specialty tier in Part D with a lower cost-sharing amount
• Require Part D plans to disclose the measures they use to evaluate pharmacy performance in their network agreements. This would enable CMS to publicly track and report how plans are measuring and applying pharmacy performance measures.
• Strengthen network adequacy rules for Medicare Advantage (MA) plans by codifying CMS’ existing network adequacy methodology. The proposed rule has provisions addressing access to care in rural areas and encouraging the use of telehealth in all areas. For rural areas, the agency proposes to lower the percentage of beneficiaries required to live within the maximum time and distances standards from 90 percent to 85 percent. For telehealth providers in MA contracted networks, CMS proposes to decrease by 10 percent the percentage of beneficiaries required to live within the maximum time and distance standards when the plan contracts with telehealth providers for Dermatology, Psychiatry, Cardiology, Otolaryngology, and Neurology. The agency asks for comments on whether to expand this credit to other specialties.

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.