CMS should reconsider and withdraw the potentially harmful step therapy guidance

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Recently, The Centers for Medicare & Medicaid Services (CMS) issued a guidance allowing step therapy under Part B in Medicare Advantage Plans. Step therapy, appropriately labeled “Fail First,” is an approach that too many health-care providers and companies impose on patients in an attempt to save money on costs. However, it can also be harmful to patients, potentially leading to extended periods of illness, significant unnecessary follow-up visits and time waiting for this and all too often more complicated downstream medical issues. 

Under step therapy, a patient must try a less expensive, usually older medication — which is frequently a less effective medicine or one with more potential side-effects or less convenient dosing — before allowing that patient to access the drug their health-care provider recommended.

{mosads}As a practicing clinical pharmacist, I have seen firsthand the potential problems step therapy has on patients, the lost productivity it leads to, and how it not so subtly undermines the health-care provider-patient relationship and puts an organization, in this case, federal bureaucrats, at the center of decision making. 

Picture a single parent. Their child has been diagnosed with diabetes. Their health-care provider assesses the child’s specific needs, prescribes an appropriate treatment plan and recommends the best medication to lower their glucose levels. However, the family’s health insurance won’t cover the drug that the health-care provider prescribed, instead insisting on only paying for a different, older and less expensive option.

The parent must then wait for that drug to fail to improve their child’s condition before they are permitted to try a new drug. This cycle could happen many times over several weeks months or even years before the family is finally able to access the originally prescribed medication. The refusal of insurance companies to provide the originally prescribed drug feeds into this Fail First cycle and ultimately leads to a patient receiving less efficient care and suffering longer than they need to.

The health-care provider-patient relationship is one that takes time and effort to cultivate and implementing step therapy only disrupts that connection and undermines trusted professional recommendations and best judgment.

Health-care providers know how to properly assess and prescribe the most appropriate treatments for their patients — the ones that give them the best chance of being optimally cared for.  

It doesn’t matter if this is for a simple ear infection, a manageable chronic lifelong disease, or an aggressive form of cancer — the health-care provider knows the patient, knows the circumstances and knows the best way to approach each individual situation. 

Imagine if we applied a fail-first step therapy approach to other areas of our lives? On airplanes, we expect the safest, most effective instruments to guide the pilots that have our lives in their hands at 37,000 feet.

But, rather than using the most appropriate and technologically optimum instruments, companies were directed to use older, less effective instruments and wait for them to fail before using the originally recommended parts. The outrage that would ensue from a situation like this would be overwhelming and yet, we are expected to be comfortable with that same practice being applied to our health-care system. 

Put simply, fail-first is a fundamentally flawed policy that values cost-cutting over the expertise and advice of the prescriber. But if optimized, efficient and effective care — first time — and the overall health and wellbeing of patients is the ultimate goal, then CMS should fully withdraw its step therapy guidance.

Additionally, any future efforts to implement this potentially harmful practice should include the creation and implementation of appropriate patient safeguards.

Patients deserve the best chance of success from the very beginning of their treatment. Health-care stakeholders must work together to make changes that improve our programs while also ensuring that patients have access to the best quality care available, without having to wait while their condition gets worse.

Dr. Salvatore Giorgianni Jr. is a pharmacist currently serving as the senior science adviser to Men’s Health Network. He also serves as Chair-Emeritus for the American Public Health Association Men’s Health Caucus.


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