CLSA Opposes Trump Administration’s Proposal to Restrict Patient Access to Medicines in “Six Protected Classes” in Medicare Part D

By Jenny Nieto 
March 21, 2019

In November 2018, the Trump Administration proposed a rule that would weaken patient protections within Medicare’s Part D prescription drug benefit. Currently, Medicare Part D drug plans are required to comply with the “protected drug classes” policy, which ensure that beneficiaries have access to “all or substantially all” drugs in six specific classes of medicines (like antiretrovirals, antidepressants, antipsychotics, and anticonvulsant agents).

This intentional policy ensures that patients with certain diseases and conditions – like cancer, HIV/AIDS, epilepsy, mental illnesses as well as organ transplant recipients – have access to multiple medication options due to the complex nature of these conditions.  The Administration’s proposal would allow Part D 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.

This new rule is being proposed in the name of controlling drug costs – while the anticipated “savings” from the proposal are estimated to be rather small, the expected impact on patients will be significant, and in fact may put the lives of patients at risk. If enacted, patients could no longer have access to the innovative treatments they need most, and doctors may be forced to follow a policy that makes them prescribe cheaper treatments first rather than the therapy they believe is the most effective for a given patient’s situation.

CLSA is strongly opposed to this proposal and we firmly believe, if enacted, it will restrict patient access to life-saving medicines and disincentivize future investment in new therapies to address challenging diseases. Our concerns are aligned with multiple external stakeholders who are opposed to the proposal, including 145 patient groups and nearly 100 bipartisan Members of Congress, as demonstrated through their support of separate but complementary letters led by, respectively, California’s own Rep. Barbara Lee (D-Oakland) and Rep. Grace Napolitano (D-El Monte).

In opposition to this proposal, CLSA has launched a grassroots advocacy campaign to connect Californians with their Member of Congress to express their concern and disapproval with the proposed rule. More information about the campaign and how to get involved is available here.

Questions? Please contact Jenny Nieto, CLSA’s Vice President of Federal Government Relations & Alliance Development (