Too Big a Step? Medicine Urges CMS to Reverse New Step Therapy Policy



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Step therapy is commonly known as “fail-first.” But to many in medicine, step therapy itself invites failure from the start.

In step therapy, insurers require physicians and patients to prove certain drugs don’t work for them before the health plan will pay for the next “step” up: that is, a potentially more effective medication that also can be more expensive. 

The Texas Medical Association has worked hard to eliminate barriers between patients and the treatments they need, which is why TMA backed legislation in 2017 to check step therapy protocols in state-regulated private plans.

In a reversal at the federal level, the Centers for Medicare & Medicaid Services (CMS) will allow step therapy in commercially run Medicare Advantage (MA) health plans. In August, CMS announced that beginning in 2019, it would lift a prohibition on step therapy for physician-administered drugs in MA that had been in place since 2012. 

TMA and many of its friends in organized medicine are emphatically urging CMS to reconsider, warning of harmful impacts on patients, especially those with life-threatening conditions such as cancer.

Keller family physician Gregory Fuller, MD, deals with plenty of step therapy protocols in private plans. He often runs into problems with patients who change health plans and as a result discover a medication that’s been working for them isn’t available. 

Dr. Fuller is blunt about health plans’ intentions when they implement step therapy.

“It doesn’t have anything to do with providing good medical care,” he said. “It’s just the insurance [company’s] way to control money.”

Bad for patients

In its Aug. 7 announcement, CMS said allowing MA plans to use step therapy for Part B drugs would “help achieve the goal of lower drug prices while maintaining access to covered services and drugs for beneficiaries.” It said plans could use step therapy only for new prescriptions or when administering Part B drugs, “for enrollees that are not actively receiving the affected medication.”

The restriction to new prescriptions is of little comfort to the American Medical Association (AMA), TMA, and dozens of state medical societies and specialty societies. They urged CMS Administrator Seema Verma to reconsider the decision in a September letter. Step therapy “can both harm patients and undercut the physician-patient decision-making process,” they wrote, noting that a patient’s unique clinical situation dictates the appropriate course of treatment.

Step therapy protocols are particularly concerning for physician-administered drugs, the letter says, noting many of these patients have serious or life-threatening conditions.

“For cancer patients, selecting the proper personalized treatment as quickly as possible can be critical to survival. For others, such as those suffering from conditions like autoimmune disorders and progressive blinding eye diseases, delays in getting appropriate treatments can mean prolonged symptomatic periods and irreversible damage, making a ‘fail first’ approach to treatment inappropriate,” the letter said. “Although the notification states that step therapy can only be applied to new prescriptions and administrations of outpatient drugs, we have serious concerns about patients who will change Medicare Advantage plans being required to disrupt their current treatment to retry previously failed therapeutic regimens to meet step therapy requirements for a new plan.”

Austin oncologist Debra Patt, MD, a breast cancer specialist, says therapeutic interventions in cancer often aren’t interchangeable. She often has more than 20 treatment options she offers patients with metastatic breast cancer, each with different levels of toxicity and efficacy. 

And Dr. Patt personalizes those treatment decisions: For example, she’ll avoid chemotherapy if the patient’s clinical situation is appropriate for doing so, and it’s what the patient prefers. 

“I might be able to keep them on pill-based therapy for many years … and they come and see me once a month, or maybe even every other month, and that leads to a much better quality of life for them, because their toxicity is so minimal,” she said. 

That personalization is often lost in step therapy protocols, medicine’s letter says.

“While a particular drug or therapy might be generally considered appropriate for a condition, the presence of comorbidities, potential drug-drug interactions, or patient intolerances, for example, may necessitate the selection of an alternative drug as the first course of treatment,” it said. “Step therapy requirements often fail to allow for such considerations, resulting in delays in getting patients the right treatments at the right time and unnecessary complications in the physician-patient decision-making process.”

Bad for physicians

Step therapy also creates an administrative burden for physicians, the letter notes. For example, physicians sometimes have no ready access to a patient’s benefits and formulary information.

“This lack of transparency makes it exceedingly difficult to determine what treatments are preferred by a particular [payer] at the point of care and places practices at financial risk for the cost of administered drugs if claims are later denied for unmet (yet unknown) step therapy requirements. Furthermore, [payer] exemption and appeals processes can be complicated and lengthy, making them burdensome for both busy physician practices and patients awaiting treatment.”

Dr. Fuller says some step therapy procedures actually require two failures on a drug before the patient can move to the next-best one. Fortunately, many electronic health records (EHRs), including his, include drug formulary information so physicians know what medication choices are available. Dr. Fuller’s EHR includes a pop-up that describes what drugs will be options in a step therapy plan. 

But what happens when patients change plans and can’t access the medication that’s been working? 

“If there’s something very specific that they need to be on, especially some type of brand-name product, then that can become an issue,” Dr. Fuller said. “Especially when you’re dealing with cardiac drugs, neurologic medications, especially seizure medications, and then some of the auto-immune conditions [where] a lot of them require biologics, which are much more expensive.

“If you’re required to take somebody off of those and put them on something that’s in a completely different therapeutic class, that could have health ramifications. So guess what we end up doing? We go through an appeal process, which again puts the burden on physicians and their staff, and actually can put a burden on a patient if we’re having to appeal it and their current medication’s not available.”

John Flores, MD, chair of TMA’s Council on Socioeconomics, encounters step therapy barriers with his diabetic patients. For instance, health plans typically require those patients to try Metformin — which he says is often not effective — for a few months before they’ll pay for a more effective expensive treatment.

In some instances, Dr. Flores says, if a particular illness isn’t progressing very fast, it may be appropriate for physicians to prescribe a less expensive medicine.

“But that should be up to the physician,” he said. “CMS is allowing clerks and nonphysicians to make these medical decisions for our patients, and that’s where they’re going to come to harm. I think it needs to be up to the physician and the clinician to make those decisions in most cases.”

Follow the evidence

Representatives for commercial carriers contracted to run Medicare Advantage plans did not make anyone available for interviews for this story. A spokesperson for Humana, one of Texas’ largest MA plans, said the insurer declined to comment. The Texas Association of Health Plans said its executive director, Jamie Dudensing, was not available for an interview at the time this article was written. 

In an email to Texas Medicine, a CMS spokesperson says the new step therapy policy includes several safeguards to ensure patients receive the medications they need.

“First, step therapy may only be applied to new prescriptions or administrations of Part B drugs for enrollees that are not actively receiving the affected medication,” CMS said. “Second, MA plans will still be required to cover all medically necessary [outpatient] drugs. Third, the beneficiary can ask for an exception if they believe that they need direct access to a drug that would otherwise only be available after trying an alternative drug. MA plans will approve these exception requests based on medical necessity criteria. Fourth, if a plan denies a beneficiary’s request, the beneficiary has the right to appeal, and CMS will be monitoring appeals activity to ensure beneficiaries’ requests are appropriately evaluated. Plans are strongly encouraged to adhere to timelines for [self-administered drug] appeals, which require a decision within 72 hours.”

Also, CMS says, MA plans that implement step therapy on outpatient medications will be required to tell their beneficiaries. To read CMS’ policy on step therapy in MA, visit tma.tips/masteptherapy.

Step therapy hasn’t been widespread in Texas cancer care, Dr. Patt says, because of state policies against step therapy mandates and restrictive formularies. One of the biggest blows to step therapy in state-regulated plans came with the passage of TMA-backed Senate Bill 680 during the 2017 legislative session. That measure helps physicians override insurers’ step therapy protocols significantly faster. (See “State Step Therapy Measure a Key Win for TMA,” page 32.)


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While she understands both government and commercial payers’ focus on controlling costs, Dr. Patt says there’s a better solution: The use of evidence-based clinical pathways, which apply science while keeping the decision in the exam room — between the doctor and patient. Dr. Patt serves as the breast cancer chair for The U.S. Oncology Network’s Pathways Task Force.

“We review the evidence and we decide given certain clinical scenarios, what’s the most efficacious choice, what’s the least toxic choice, and what is the highest-value choice,” she said. The higher-value treatment refers to the one that strikes the best balance between efficacy, low toxicity, and cost. Physicians will select that one, Dr. Patt adds, if they and the patient narrow it down to treatment options that are relatively interchangeable.

“We would like to see us move forward with CMS in a more collaborative way toward that end,” she said, “because it’s just better patient care.” 

Tex Med. 2018;114(11):30-33
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