A bipartisan group of 73 House lawmakers — led by Reps. Barbara Lee (D-CA) and Will Hurd (R-TX) — penned a letter to Department of Health and Human Services (HHS) Secretary Alex Azar opposing changes to Medicare’s six protected classes policy. The lawmakers stressed that adding additional prior authorization and step therapy requirements could have detrimental effects to beneficiaries who deal with HIV, cancer, mental illness, and other serious health conditions. “…We are concerned that these provisions of the proposed rule will have reverberating effects for patients suffering from multiple conditions that are currently covered and exacerbate health disparities among poor and minority communities,” the letter states. “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 portions of the rule.”  

​In a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma, a bipartisan group of 14 Senators — led by Sens. Marco Rubio (R-FL) and Kyrsten Sinema (D-AZ) — penned a letter urging the agency to reconsider its proposed changes to Medicare’s six protected classes policy. The Senators emphasized that the protected classes serve as an essential patient safeguard for beneficiaries with complex medical conditions, noting that the policy has long enjoyed bipartisan support among lawmakers. “The proposed rule would allow Part D plans to limit access to critical medicines to patients in need of immunosuppressants, antidepressants, antipsychotics, anticonvulsants, antiretrovirals, and antineoplastic medicines, by permitting prior authorization or step therapy,” the letter states. “We urge CMS to reconsider this proposal that would risk the health of our most vulnerable beneficiaries.

A series of recent news articles in dozens of publications across the country highlight a myriad of concerns raised by patient advocates over a new proposal that would weaken Medicare Part D's six protected classes policy.  As over 140 individual advocacy organizations are noted, it would be extremely dangerous to risk limiting access to medications for patients with the most complex chronic conditions, such as cancer, HIV, mental health conditions, Epilepsy, and others. This new one-pager from the Partnership for Part D Access provides a visual overview of some of the many articles that detail these concerns. 

​In a February 12 speech before the American Medical Association (AMA), HHS Secretary Alex Azar acknowledged the dangers inherent in requiring step therapy for patients who are already stabilized on an effective regimen of medications. Interestingly, his remarks seemed to run counter to his agency’s current proposal to weaken Medicare’s successful “six protected classes” policy. A new fact sheet from the Partnership sheds light on these comments and provides background on their application to the six protected classes policy. 

In a letter to Department of Health and Human Services (HHS) Secretary Alex Azar, House Mental Health Caucus Co-chairs Grace Napolitano (D-NY) and John Katko (R-NY) urged HHS not to move forward with harmful changes to Medicare’s Six Protected Classes Policy. The bipartisan letter — signed by 39 House members — states that the proposed changes are “particularly worrisome” for Medicare beneficiaries living with mental illness, noting that the change “directly targets” some of the program’s most vulnerable populations. “CMS has stated that patients will be able to use the lengthy appeals and exceptions processes to gain coverage for medicines if plans deny access to needed medicines,” the letter states. “However, those processes are difficult for patients to navigate and are likely to become overwhelmed with patients desperate to stay on the medicines they have been using to successfully manage complex conditions.” 

A group of more than 140 leading patient advocacy organizations sent a letter today to the Centers for Medicare and Medicaid Services (CMS) in opposition to a recent proposal that would establish broad exceptions to Medicare Part D’s protected classes policy. As the letter explains, these changes to the protected classes policy threaten the well-being of Medicare beneficiaries with chronic conditions, cognitive impairments, and limitations in their activities of daily living.  Meanwhile, the groups point out that potential savings CMS could realize from allowing plans to add new, more expansive restrictions on access to drugs in the protected classes would be reversed by increases in costs in other areas of Medicare and lead to undesirable patient outcomes. Specifically, CMS’s analysis overlooks the importance of the costs that could be incurred from disrupting treatment for stabilized patients and restricting access for those patients starting treatment. 

​Today, Partnership for Part D Access (Partnership) submitted a comment letter to the Centers for Medicare and Medicaid (CMS) expressing concern that the agency’s recent Medicare proposal to weaken Medicare’s six protected classes will ultimately harm patients with the most complex conditions. In the letter, the Partnership highlights several concerns with CMS’ proposed rule, arguing that the agency misunderstands both the congressional intent of the policy and the reality of how it is appropriately working for Medicare patients today. The letter provides ample evidence highlighting the effectiveness of the current protected classes policy, which was created to ensure patients with the most challenging medical conditions have access to the full range of treatment options under Medicare Part D. “The flaws in the proposed approach and the potential for significant harm to patients lead us to respectfully request the agency withdraw each of the three proposed exceptions,” the letter states. 

​The most popular type of Medicare drug coverage is through a stand-alone prescription drug plan (PDP). A stand-alone plan never has to pay for hospital or physician visits — those are covered by traditional Medicare. Another way to get drug benefits from Medicare is through Medicare Advantage (MA) plans, which are private insurance plans subsidized by the government to manage prescription drug benefits alongside other medical benefits. ​Because of this difference, stand-alone drug plans have less incentive than MA plans to keep people healthy enough to avoid some hospital visits.