Health Advocacy Groups React to CMS Step Therapy Guidance


In response to the CMS’ step therapy approach to lowering drug costs, many advocacy groups expressed concern that the move will harm patient access to treatments for chronic conditions.

Following an announcement by the Centers for Medicare and Medicaid Services (CMS) of its new step therapy policy, several health advocacy groups expressed concern that the decision could compromise access to treatment for patients with chronic conditions.

As part of the Trump administration’s ongoing efforts to reduce drug prices, the Department of Health and Human Services (HHS) recently announced the new federal policy, which takes effect on January 1, 2019. The policy arms Medicare Advantage (MA) plans with the option of applying step therapy across physician-administered and self-administered medications under Medicare Part B and Part D, with the intention to control prescription drug costs.1

In a statement, Health and Human Services Secretary Alex Azar said, “By allowing Medicare Advantage plans to negotiate for physician-administered drugs like private-sector insurers already do, we can drive down prices for some of the most expensive drugs seniors use.”2

According to CMS, step therapy is a type of prior authorization for drugs that begins treatment for a medical condition with the most preferred drug therapy, which is frequently older and less expensive, and progresses to other therapies only if necessary. The CMS states that implementing this method, along with care coordination and drug adherence programs, can lower costs and improve the quality of care for Medicare beneficiaries.

Although intended to produce savings for patients, health groups argue that the requirements can be detrimental to patients with chronic conditions. Over the past few days, several advocates fired off statements speaking out against the new guidance. The Community Oncology Alliance (COA) called the policy a “nightmare” for patients with cancer.3

“Cancer treatment is becoming more personalized and not all therapies produce the identical result from patient to patient. Having therapy options is imperative to successful treatment,” Jeff Vacirca, MD, FACP, president of COA and CEO of New York Cancer Specialists, said in a press release. “CMS’ action is the anthesis of where personalized cancer treatment is going—it’s old school, cookbook medicine that treats every patient as one size fits all. It’s telling me to effectively sit back and let some middleman make treatment decisions for my patients.”

The American Society of Clinical Oncology (ASCO) released a statement urging the CMS to reverse its decision.4

“In modern cancer care there is frequently a lack of interchangeable treatment options, and optimal care requires patient access to the most medically appropriate drug at the most opportune time based on the highest quality evidence,” ASCO President Monica M Bertagnolli, MD, FACS, FASCO, said in the statement.

Most recently, the American College of Rheumatology (ACR) echoed concerns that the policy change threatens patient access to treatment, citing its long opposition to utilization management techniques.

“Utilization management techniques like step therapy prevent and delay important treatments for rheumatic disease patients, which can result in irreversible joint or organ damage,” ACR President David Daikh, PhD, MD, said in the statement.5

Conversely, Patients for Affordable Drugs President and Founder David Mitchell voiced support for the policy change, given that patient protection is ensured.

“As a patient, I understand the concerns about the potential misuse of step therapy, but as long as patients are protected with a timely and workable appeals process, allowing step therapy in Medicare Advantage is a step I can support,” Mitchell said in a statement.6

Under the guidance, beneficiaries enrolled in a plan offering step therapy can request an expedited exception if they believe they need direct access to a drug that would otherwise only be available after trying an alternative, according to CMS. MA plans will also be required to pass on more than half of any savings to patients.

There are currently more than 20 million beneficiaries enrolled in MA plans who could be affected by the changes, CMS reported. However, under the policy, step therapy can only be applied to new prescriptions or administrations of Part B drugs for patients.


1. Medicare Advantage Prior Authorization and Step Therapy for Part B Drugs [Fact Sheet]. CMS’ website. Accessed August 9, 2018.

2. Trump Administration Gives Medicare New Tools to Negotiate Lower Drug Prices for Patients [statement]. HHS’ website. Accessed August 9, 2018.

3. COA Statement on CMS Guidance Allowing Step Therapy in Medicare Advantage Plans [statement]. COA’s website. Accessed August 9, 2018.

4. Step Therapy Creates Barriers to Care for Medicare Advantage Beneficiaries with Cancer [statement]. ASCO’s website. Accessed August 9, 2018.

American College of Rheumatology: New CMS Decision an Affront to America’s Sickest Medicare Patients [statement]. ACR’s website. Accessed August 9, 2018

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