Two of the U.S. Senate’s most respected voices on health care are urging the Trump administration to pump the brakes on allowing step therapy by Medicare Advantage plans. Sen. Rand Paul, R-Ky., Congress’ only ophthalmologist, and Sen. Sherrod Brown, D-Ill., last week sent a letter urging Centers for Medicare & Medicaid Services head Seema Verma to halt this new policy, which began Jan. 1. They also implore the Trump administration to “establish a clear set of guardrails to reduce any potential barriers to care prior to moving forward with the proposed policy change.”
Medicare Advantage plans are now allowed to force step therapy for beneficiaries, a change that took effect at the beginning of the month. 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.
The Academy and other organizations throughout medicine continue to believe there are two prevailing reasons why CMS’ step therapy policy may run afoul with statute. First, CMS does not have the authority to grant Medicare Advantage plans the ability to limit coverage for Part B drugs. Secondly, we believe that the plan interferes with beneficiaries’ access to the same services provided under original Medicare, which is inappropriate.
In opposing the policy, the senators cite the new policy’s lack of a requirement to ensure proper clinical review for step-therapy cases, along with the absence of clarity regarding the number of times beneficiaries’ care must fail if their coverage changes during treatment.
This is a major, positive development in the Academy’s efforts to ensure continued access to needed treatments for our patients. We’re pushing to compel the agency to reverse its policy, which will place patients at risk by delaying care based on physicians’ recommended treatments.
This development is especially important since Paul and Brown are both nationally known figures, particularly on the issue of health care. Their opposition to step therapy will help give this issue more prominence as the Academy continues to lay out the legal case for halting its implementation.
Last week, the Academy, along with a new step-therapy coalition, including rheumatology, the American Society of Retina Specialists and the American Society of Cataract and Refractive Surgery, revealed the findings of an independent legal review that indicates that the agency and its Medicare Advantage program are at risk of litigation. The American Glaucoma Society and the Retina Society are also supporting this effort.
In our coalition letter to CMS, we 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.”
https://www.aao.org/Assets/72902f00-8206-4b6f-bafc-15258acfdc1c/636821273093800000/joint-a-p-letter-to-cms-on-step-therapy-12-31-2018-pdf