CLSA & Allied Stakeholders Succeed in Halting Administration’s Final Rule on Six Protected Classes in Medicare Part D

May 18, 2019
By Molly Fishman

A strong healthcare system delivers the care patients need, when they need it. That’s why Congress created Medicare Part D, the prescription drug benefit, and required insurance plans to cover at least two drugs in each therapeutic class. Nobody should be denied care because they cannot afford their medications, and Part D helps ensure patients have access to the therapies they need.

To drive the point home, the Centers for Medicare & Medicaid Services (CMS) created six protected classes. These include medications for cancer, mental illness, HIV/AIDS and other conditions. Part D plans must cover “all or substantially all drugs” for these patients.

Last fall, the Trump Administration proposed a rule that would have weakened these patient protections within Medicare Part D by allowing plans to limit coverage of drugs in the six protected classes, either by refusing coverage of certain products or by imposing utilization management tools like “fail first” or “step therapy” protocols.

CLSA actively opposed the proposed rule, and supported bipartisan congressional sign-on letters in opposition to the proposed rule, both led by members of the California Congressional delegation: a January 2019 letter, led by Reps. Grace Napolitano (D-San Dimas) and John Katko (R-N.Y.), and a March 2019 letter, led by Reps. Barbara Lee (D-Oakland) and Will Hurd (R-Texas). CLSA also launched a grassroots advocacy campaign inviting individual constituents to weigh in with legislators in opposition to the proposal. Our grassroots advocacy network reached approximately 30,000-40,000 individuals in California.

On Thursday, May 16, CLSA’s advocacy paid off when CMS released its final rule and fact sheet. In the final rule, CMS decided to not adopt two proposals which would have allowed Part D plans to exclude a protected class drug from their formularies for multiple years if price-growth exceeded an inflation index as well as if the drug represented a new formulation that is not a significant innovation over the original product.

Additionally, CMS prohibited the use of step therapy and prior authorization for patients with Part D already on a stable treatment plan, and instead codified current policy (since 2006) that would only allow the use of these utilization management tools for new enrollees initiating therapy starting January 1, 2020, and only for drugs in five of the six protected classes (notably, antiretrovirals are excluded). CMS also adopted a shorter timeframe for Medicare Advantage (MA) plans – where these utilization management tools are already allowed – to respond to a patient’s request for coverage of, or appeal of a denial of, a drug.

While more is work is needed to ensure that patients are able to access the medications they need in an affordable and timely manner, CLSA is pleased the Administration did not implement the utilization management provisions as described in the proposed rule that would have been detrimental to patient care. Questions? Please contact Molly Fishman, CLSA’s Director of Federal Government Relations (