Bipartisan lawmakers urge Administration to rethink proposed changes to six protected classes policy

Tom Wilbur
Tom Wilbur March 22, 2019


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At the end of 2018, the Centers for Medicare & Medicaid Services (CMS) introduced a dangerous proposed rule that would weaken the Medicare Part D six protected classes policy. The six protected classes policy covers patients whose conditions – like HIV, cancer, and epilepsy among others - are treated with medicines covered under six specific drug classes. The proposed rule would weaken the six protected classes policy by allowing increased use of step therapy or utilization management, including for patients already stable on a medicine. This practice is meant to reduce drug costs by requiring patients to begin treatment with a therapy preferred by the insurer before they can access the one their doctor thinks will work best for them.

Since the proposed rule was released, patient groups and advocates — particularly those representing patients with the diseases and conditions treated by medicines in these classes— have come out strongly against the proposed rule changes. Now, Members of Congress from both sides of the aisle are expressing their concerns as well because of the potential negative impacts on patients’ health.

Last week, a bipartisan group of 73 Members of Congress, led by Congresswoman Barbara Lee and Congressman Will Hurd, sent a letter to Health and Human Services Secretary Alex Azar asking the Secretary to withdraw a proposal that would modify the Part D program protections afforded to the six classes of drugs. The Members write, “We are concerned that prior authorization and step therapy requirements could have devastating public health outcomes for those receiving treatment of HIV and the additional five protected classes. Considering the public health implications of the proposed changes to Part D protected classes related to prior authorization and step therapies – we respectfully request that you withdraw the relevant provisions of the rule.”

The bipartisan Congressional Mental Health Caucus, led by Congresswoman Grace Napolitano and Congressman John Katko, also pushed back against the rule in a letter – signed by 39 Members of Congress – to Secretary Azar. The letter states, in part, that the proposed changes are “particularly worrisome” for Medicare beneficiaries living with mental illness.

In the Senate, Senators Marco Rubio and Krysten Sinema led a bipartisan letter alongside more than a dozen Senators outlining reasons the proposed rule should be reconsidered. In the letter, they note how the rule would not just adversely affect HIV patients but also cancer patients needing “highly personalized therapies;” schizophrenia and depression patients who “often struggle to find a medicine that works for them and could risk relapse if forced to switch to alternatives;” epilepsy patients who “often find that only one treatment works for them and any disruptions in treatment could increase the likelihood of seizures;” and organ transplant patients who have “complex medical needs and should not be required to jump through hoops in order to prevent transplant rejection.”

Bipartisan lawmakers, on both sides of aisle and on both sides of the Capitol, clearly oppose this proposed rule because for over 10 years, one of the cornerstones of the Medicare Part D program has been to ensure the sickest and most vulnerable patients have access to the clinically critical medicines they rely on. Letting plans restrict access for some of the sickest and most vulnerable Part D beneficiaries would reduce adherence to those medicines, jeopardize their health, increasing their need for medical care and result in poorer health outcomes and potentially higher costs for seniors and Medicare.

Visit PrescriptionForMedicare.org to learn more.

Topics: Part D, Medicare, Prescription for Medicare