19 Leading Patient Groups Urge CMS for Continuous Oversight of the Six Protected Classes Policy during Part D Benefit Redesign
On September 11, 2023, 19 patient groups sent a letter to the Centers for Medicare and Medicaid Services (CMS) calling on them to reinvigorate their enforcement efforts around the Six Protected Classes. In 2025, the Inflation Reduction Act’s provisions around the redesign of the Part D program will go into effect, and we expect Part D plans to change their approaches in how they structure their plan designs. CMS has been collecting input on this redesign, and is currently drafting a rule to help implement it. At this critical juncture, these groups urged the agency to be even more rigorous in their reviews of Part D plan formularies, and be more transparent about the results of this oversight.
The Part D benefit, and specifically the drugs in Part D’s six protected classes, is a lifeline for over 50 million Americans. While Congress and CMS is in the process of changing the program, we must ensure that the parts that are working for Medicare beneficiaries are not unnecessarily interrupted. The Six Protected Classes policy exists because patients on these drugs risk extreme health consequences if they were to lose access. The Partnership commends this wide range of patient groups for bringing this issue to the attention of CMS.
Click here to view the full letter.
Today, the Co-Chairs of the House Mental Health and HIV/AIDS Caucuses introduced a resolution expressing support for Medicare Part D’s six protected classes policy, which is an essential safeguard that ensures that beneficiaries have access to needed medications.
The Partnership for Part D Access, which represents a wide variety of healthcare stakeholders including patient advocacy groups, thanks the Co-Chairs, Reps. Grace Napolitano, John Katko, Barbara Lee, and Jenniffer González Colón for introducing this resolution which demonstrates bipartisan support for maintaining this important patient access policy.
Medicare’s six-protected classes policy, which has been in place since the Medicare Part D program was implemented, requires that plans cover all or substantially all medications within those classes, which include: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals, and antineoplastics. The six-protected classes policy ensures that those living with mental illness, HIV/AIDS, epilepsy, cancer, Parkinson’s, and those receiving organ transplantation have access to needed medications. The policy exists to protect patients from risks, complications, and negative outcomes from not having access to these medications. Congress has repeatedly stood up against attempts to weaken these patient protections and this resolution will go a long way to reaffirm that commitment.
We urge members of the House of Representatives to co-sponsor this important resolution.
Contact: Jakara Eason
November 29, 2021
Today, 36 leading health advocacy organizations sent a letter to Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) underscoring the value to patients of Medicare’s 6 protected classes policy.
The letter was signed by leading health advocacy organizations, including the National Council for Mental Wellbeing, the Cancer Support Community, Epilepsy Foundation, HIV+Hepatits Policy Institute, the American Kidney Fund, Depression and Bipolar Support Alliance, The Kennedy Forum, and Mental Health America. The letter states,
“This policy has been a vital protection for patients and restricting access to these therapies would have major, life-threatening consequences for patients and increase the likelihood of costly hospitalizations and emergency room visits…”
The letter was sent in response to a request for information sent by Senate Finance Committee leadership on September 22, 2021.
For more information, or to download the letter in its entirety, please click here.
Patient Advocates Applaud Biden Administration for Maintaining Medicare's Six Protected Classes Policy
Washington D.C. — The Partnership for Part D Access, a broad-based coalition of health care stakeholders including diverse patient advocacy organizations that represent patients who benefit from treatments covered under each of Medicare’s “six protected classes,” commended the Centers for Medicare and Medicaid Services (CMS) for rejecting a proposal that would have substantially weakened Medicare’s six protected classes policy.
Members of the Congressional Mental Health and HIV Caucuses recently urged the Biden administration to revoke a final-hour request by the last administration to weaken Medicare protected class drug coverage. The lawmakers implored the Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) to reconsider the changes to the Medicare Part D Payment Modernization (PDM) model, noting the new model doesn’t fairly take into account the public health implications for patients that utilize drugs under the six protected classes.
The letter advocates for the Acting HHS Secretary and Acting CMS Administrator to pull back new allowances under the PDM model that would allow participating plans to weaken coverage requirements to one drug per class, as well as limit coverage of medication in all six protected classes by CY 2023. The lawmakers note that Pat D plans are already equipped with the necessary tools to manage spending and encourage the use of generics when possible for the six protected classes.
“These proposed changes fail to consider the unique needs of patients who need the treatment that is best for their condition, or patients who must try different treatments before finding the right treatment for their needs,” the letter explains. “we do not believe these formulary flexibility changes to the model would result in significant cost savings but will instead push access to essential medications out of reach for vulnerable patients.”
The bipartisan group of 67 members joined “significant opposition from Congress, patient groups, providers, and other stakeholders” to the potential changes to protections for the six protected classes.
The letter in its entirety can be read here.
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