On January 19, 2021 – the last full day of the Trump administration – CMS released a Part D Payment Modernization Model Request for Applications (RFA) for calendar year 2022. This model would provide “formulary flexibility” by exempting participating Part D plans from some of Part D’s formulary coverage requirements. These requirements include rules for the six “protected classes” and the two drugs per class requirements.
The six protected classes are unique because the correct treatment is often patient-specific, so options are needed to ensure access to effective medicine. These changes would ultimately impact the most vulnerable patients, including those with cancer, mental health conditions, and HIV. Since the proposed model was released, patient groups and advocates – particularly those representing patients with the diseases and conditions treated by medicines in these classes – have come out against the changes.
Now, a bipartisan group of 67 Members of Congress have written to the Acting Secretary of HHS and the Acting Administrator of CMS to express their “strong opposition” to this new model.
The members write, “This new model does not fairly take into account the public health implications for patients that utilize drugs under the six protected classes, especially during the COVID-19 pandemic, and we urge the Biden Administration to use their readily available authorities to pull back these changes to the PDM model immediately.”
The members go on to say that, “We do not believe these…changes to the model would result in significant cost savings but will instead push access to essential medications out of reach for vulnerable patients. Part D plans are already equipped with tools to manage spending and encourage the use of generics when possible for the six protected classes.”
The members end by noting that, “We are troubled that for the third time in seven years, CMS is again considering changes to Part D that would strip these critical medicines of their protected status, especially in the middle of a deadly pandemic. Potential changes to the six protected classes have been twice rejected during both the Obama and Trump Administrations after receiving significant opposition from Congress, patient groups, providers, and other stakeholders.”
PhRMA remains strongly opposed to these changes. Since the inception of the Part D program, PhRMA has supported the Part D policy of protecting certain drug categories or classes in which patients require access to a broad range of treatments without unreasonable delay.
Learn more about the critical importance of the six protected classes policy here.