Patient Advocates Sounding the Alarm Over Fail First

BIOtech Now
Andrew Segerman

The Centers for Medicare & Medicaid Services (CMS) has reversed a long-standing policy allowing Medicare Advantage plans to impose “step therapy” requirements for physician-administered drugs – also known as Medicare Part B.

More accurately described as “fail first,” this dangerous policy will force some patients to fail first on a medicine preferred by their insurance companies before they can receive the therapy prescribed by their doctors. Allowing insurers to stand between patients and the right treatments they need – as determined by their health care provider – threatens the health and well-being of America’s seniors. That’s why this abrupt regulatory decision has patient advocates sounding the alarm:

“Step therapy protocols that require patients to try and fail certain treatments before allowing access to other, potentially more appropriate treatments can both harm patients and undercut the physician-patient decision-making process.” — American Medical Association, the largest association of physicians and medical students in the United States

“We are not persuaded that this plan provides [cancer patients] or the health care system meaningful financial relief, while at the same time it adversely affects beneficiaries’ treatment choices and imposes on them the responsibility for pursuing exceptions to receive proper treatment.” — American Society of Clinical Oncology, CancerCare, and 14 other organizations under the Cancer Leadership Council umbrella

“When these policies interfere with the patient-physician relationship, they can result in delayed treatment, increased disease activity, loss of function, and potentially irreversible disease progression. For providers, step therapy exacerbates administrative burdens as they help patients navigate complicated and often opaque coverage determination processes.” — 40 groups including the American Academy of Neurology, the National Psoriasis Foundation, and the US Pain Foundation

“Fail first policies limit the options available for patients and their physicians to treat conditions, forcing individuals to try the treatment that is preferred by the insurance company (often an older, cheaper medicine) rather than the medicine prescribed by the physician. … Policies that sacrifice the health of patients in the hope of cutting program costs undermine the promise Medicare represents for so many individuals.” — Part B Access for Seniors and Physicians Coalition, who garnered 240 groups to sign its fail first letter

“Ensuring patients can get the right medicine at the right time is instrumental in containing long-term healthcare costs,” former Sen. Tom Coburn recently wrote in The Hill. And while this statement is true, implementing shortsighted polices like step therapy would do just the opposite. In its current form, CMS’ proposal lacks basic patient protections and should be pulled back before it harms America’s most vulnerable population.

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