Azar Meets With Stakeholders re Step Therapy

ASCO press release, August 8 here.

Trade press - 

CMS To Create Separate Appeals Process For MA Step Therapy

August 16, 2018

CMS officials plan to create a separate process for patients to appeal Medicare Advantage plans’ use of step therapy for Part B drugs, HHS Secretary Alex Azar told doctor and patient representatives at a meeting Wednesday (Aug. 15).

The meeting was called in response to criticism from provider and patient groups over CMS’ announcement that it will let Medicare Advantage plans make beneficiaries use less expensive doctor-administered drugs before getting more expensive therapies. MA plans will be able to use step therapy across doctor-administered drugs and retail drugs, but plans also must share half of savings from step therapy with beneficiaries.

The meeting was attended by American Academy of Ophthalmology, the American Cancer Society’s Cancer Action Network, the American College of Rheumatology, the American Society of Clinical Oncologists, and Patients for Affordable Drugs, according to an HHS release. The release states that most attendees said they are worried about the step therapy policy, and that Azar is open to “solutions that may alleviate the burden that could be imposed on physicians by the new negotiation tools.”

David Glasser, associate secretary for health policy for the American Academy of Ophthalmology, said Medicare has a poor track record of policing MA plans, and he worries that MA plans will abuse step therapy, just as some already abuse prior authorization. Glasser said he has heard complaints about MA plans using prior authorization to routinely deny access to treatments, only to reverse those denials nearly every time they’re challenged. He said the tactic slows treatment, which can lead to avoidable, permanent damage in patients.

To help avoid unnecessary treatment delays, Azar said CMS plans to create a separate appeals process for MA step therapy decisions. Glasser said it is encouraging that CMS is trying to reduce the potential burden of the step therapy policy, but he said the separate appeals process would have to be well staffed to avoid the same backlogs that exist with other appeals processes. He added that although a new process wouldn’t have a backlog, there often are kinks to work out in new systems that could cause delays all the same.

Azar also urged doctors to work with MA plans on incorporating their medical societies’ clinical pathways and prefered practice patterns into step therapy processes, Glasser said. That’s a laudable goal, Glasser said, but the problem is there are many MA plans, each with their own process for prior authorization. Doctors want a uniform process, but Azar wants plans to develop their own protocols because that is part of the way they compete for enrollees.

Doctors are in favor of using clinical pathways and prefered practice pattern. However, Glasser said, doctors are wary of letting plans, which are not as familiar with the nuances of therapies as ophthalmologists, make those decisions.

The American Cancer Society Cancer Action Network said step therapy policy should be accompanied by a set of patient protections including:

·         Evidence-based treatment guidelines that avoid making patients use medically inappropriate therapies.

·         A simple, fast waiver processes that avoids treatment delays. Also, CMS should monitor exception requests to determine whether categories of drugs should be exempted from step therapy.

·         Full transparency so Medicare beneficiaries who are shopping for plans can tell whether Part D plans use restrictive step therapy. While CMS intends to require plans to notify beneficiaries through the Annual Notice of Coverage, new MA beneficiaries may not be given advance notice of this policy.The cancer group says it also isn’t clear to what extent the Medicare.gov plan finder will convey this information.