In August 2018, the Centers for Medicare and Medicaid Services (CMS) announced it would permit Medicare Advantage plans to use step therapy for Part B drugs, with a lookback period of just 108 days.1 On May 16, 2019, however, the CMS issued a final rule that extends the lookback period for Part B therapies to 365 days, grandfathering in treatments begun in that timeframe. It’s one of several changes the ACR has actively advocated for since the initial announcement.2
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“When the ruling came out, we saw the lookback period had been changed to 365 days,” says Chris Phillips, MD, chair of the ACR’s Insurance Subcommittee. “We saw the ruling language was reflective of what we told [the CMS], and it’s encouraging they read and took our feedback.”
What Is Step Therapy?
Step therapy (or fail-first therapy) refers to a practice in which insurers require patients to try and fail preferred, formulary-covered (and often cheaper) drugs before they are granted coverage for non-formulary or more expensive medications. The ACR opposes step therapy when implemented solely on the basis of cost to insurers and has actively advocated for exceptions and regulations that protect patient access to life-saving drugs, including many biologics.3
“The 108-day lookback period raised obvious concerns, because many of the drugs we prescribe may have longer treatment intervals than that, or patients go off of them and then it’s a shorter window,” says Dr. Phillips, a solo practitioner in Paducah, Ky.
Additional Safeguards Needed
Although the ACR is encouraged by this and the CMS’ decision to require plans to respond to step therapy appeals within 72 hours, rheumatologists remain concerned about the lack of additional safeguards to protect patients.
For example, says Dr. Phillips, the Part B rule will begin in 2020, but the CMS has not yet allowed for exceptions to step therapy, particularly “if a treating physician thinks there are contraindications, or a drug is likely to be ineffective or cause harm.”
“We have been advocating for this, but the CMS has not been willing to codify the exceptions we ask for,” he adds.
Other safeguards the ACR has requested include:
- Requiring Medicare Advantage plans to make the step therapy exception process easily accessible on websites for providers, patients and caregivers;
- Providing more details about Medicare Advantage plans’ accountability to these rules; and
- Increasing the level of monitoring by the CMS.
Additionally, denied requests should provide a sufficient level of detail, including whether missing information led to the denial.