The Academy has informed the Centers for Medicare & Medicaid Services that an independent legal review secured by the Academy and our coalition partners indicates potential grounds for litigation following the Jan. 1 start to step therapy in Medicare Advantage. Following an extensive legal review, the Academy, along with an anti-step-therapy coalition that includes the American Society of Retina Specialists and the American Society of Cataract and Refractive Surgery, argue that CMS’ reliance on an Aug. 8, 2018, policy memorandum “does not provide a legally sufficient basis for [Medicare Advantage] plans to implement such programs.”
If CMS proceeds, the Academy believes it immediately exposes its Medicare Advantage program and plans to litigation on behalf of physicians and patients.
This latest action was fueled by a CMS decision in November to use its rulemaking process to expand health plans’ authority to use prior authorization and step therapy for self-administered drugs covered under the Part D program. By codifying its Part D policy via rulemaking, CMS tacitly acknowledged that it erred when it said step therapy is permissible, based in a policy memorandum.
There is compelling evidence that shows how CMS’ step therapy initiative will put the agency in jeopardy on a number of fronts. In spite of the mounting evidence against step therapy, the agency opted to proceed with implementation on Jan. 1.
The Academy and others continue to believe that the following arguments justify the illegality of CMS’ step therapy policy:
- CMS does not have the authority to grant Medicare Advantage plans the ability to limit coverage for Part B drugs.
- The plan interferes with beneficiaries’ access to the same services provided under Original Medicare, which is inappropriate.
CMS is permitting Medicare Advantage plans to require that patients’ treatment start with an off-label option, which would include ophthalmic treatments, such as Avastin.
The agency says the policy allows Medicare Advantage plans the ability to negotiate drug prices, which could lower costs. However, the Academy believes that it instead inserts substantial obstacles between patients and their physicians’ recommended treatment options.
