CMS Rule Reflects ACR’s Advocacy, but More Patient Protections Needed

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

“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.

The Part D Requirement
The same CMS final rule also includes a requirement, effective Jan. 1, 2021, that Part D Explanations of Benefits sent to Medicare beneficiaries include information about drug price increases and lower cost alternatives.

“The ACR agrees that this information is helpful and beneficiaries should have access to any possible ways to lower their out-of-pocket costs,” Angus Worthing, chair of the ACR’s Government Affairs Committee, said in a statement.⁴ “However, we would not support this information being used to force a stable patient to switch to another biologic medication for the sake of cost control. This switch would needlessly disrupt continuity of care and put patients at significant risk [of losing disease control and experiencing] potentially life-threatening complications.”

This is especially true of rheumatology patients, says Dr. Phillips: “The disease control of our rheumatic patients is fragile, and the drug choices we make may be nuanced by patient-specific factors that are not captured in these cost analyses. Moreover, at least until we have access to a wider range of biosimilar options, many of our treatments do not have a cheaper alternative, or the patient may have already passed through and failed one or several of those cheaper alternatives.”

Kelly April Tyrrell writes about health, science and health policy. She lives in Madison, Wis.

References

1. Centers for Medicare & Medicaid Services. Medicare Advantage prior authorization and step therapy for Part B drugs. [Fact sheet.] 2018 Aug 7. https://www.cms.gov/newsroom/fact-sheets/medicare-advantage-prior-authorization-and-step-therapy-part-b-drugs.
2. Centers for Medicare and Medicaid Services. Medicare Advantage and Part D drug pricing final rule (CMS-4180-F). [Fact sheet.] 2019 May 16. https://www.cms.gov/newsroom/fact-sheets/medicare-advantage-and-part-d-drug-pricing-final-rule-cms-4180-f.
3. American College of Rheumatology. American College of Rheumatology Targets Step Therapy and Drug Pricing in New Position Statements. 2019 April 1. https://www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/1012
4. American College of Rheumatology. American College of Rheumatology statement on CMS Medicare Advantage final rule. 2019 May 20. https://www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/1019.