COA Statement: CMS Proposal Effectively Unprotects Six Protected Classes

November 26, 2018 8:14 PM EST

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CMS Proposal a Potential Nightmare for Vulnerable Medicare Patients with Cancer and Other Serious Diseases

Washington, DC, Nov. 26, 2018 (GLOBE NEWSWIRE) -- The Centers for Medicare & Medicaid Services (CMS) proposal to allow Medicare Part D and Medicare Advantage plans to dictate access to drugs in the “six protected classes” is a potential nightmare for vulnerable patients with cancer.

For the first time ever, Medicare patients with cancer and other serious diseases that rely on drugs in these protected therapeutic categories, will no longer have guaranteed access to potentially life-saving drugs. Instead, they will be subjected to “fail first” step therapy and formulary restrictions that potentially restrict them from receiving the evidence-based therapies that their trained physicians prescribe as first line cancer treatment.

“Fail first” step therapy forces patients and their physicians to try cheaper, often older, treatments before they are allowed access to state-of-the art, newer therapies, which are often more expensive. This is despite the recommendation of the treating physician who understands the patient’s individual case and believes the other treatments available would not work.

Step therapy requirements are driven by financial interests to save money and not by what is in the best medical interest of patients. Patients are left at the whim of insurance and pharmacy benefit manager (PBM) middlemen who are more concerned with their profit margins than patient outcomes, side effects, and wellbeing.  Treatment decisions are made by nameless and faceless corporate bureaucrats who are often not board certified in the diseases they are making coverage decisions over.

What is the point of having protected therapeutic classes if they are not truly protected? CMS created the six protected therapeutic classes because the diseases they treated, such as cancer, were serious and life-threatening. In oncology there are few therapeutic and generic-to-brand equivalents that can be substituted when formularies are restricted, so patients need uninhibited access to the therapies their oncologists prescribe.

Although CMS claims this proposal includes patient safeguards, navigating those hurdles while dealing with cancer is cumbersome, agonizing, and an unnecessary burden. Additionally, delays in starting cancer treatment can have grave consequences and are inexcusable.

While COA commends and supports the Administration’s ongoing efforts to lower drug prices and costs for Medicare and its beneficiaries, weakening or dismantling protected classes is a step too far. Medicare patients facing cancer pay for and deserve a health care system that allows them access to the latest, evidence-based treatments that they and their oncologists decide are best for them.

Jeff Vacirca, MD, FACP
Community Oncology Alliance


About the Community Oncology Alliance: The majority of Americans battling cancer receive treatment in the community oncology setting. Keeping patients close to their homes, families, and support networks lessens the impact of this devastating disease. Community oncology practices do this while delivering high-quality, cutting-edge cancer care at a fraction of the cost of the hospital setting. The Community Oncology Alliance (COA) advocates for community oncology and smart public policy that ensures the community cancer care system remains healthy and able to provide all Americans with access to local, quality, affordable cancer care. Learn more at

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