The Centers for Medicare & Medicaid Services is providing more information on its plan to allow step therapy in Medicare Advantage for physician-administered drugs. CMS announced the change earlier this month, prompting the Academy to voice our opposition to any policy that removes physicians’ and patients’ treatment choices from care. This week, the agency confirmed that it will permit Medicare Advantage plans to require that patients’ treatment start with an off-label option, which would include ophthalmic treatments like Avastin.
Step therapy is a type of prior authorization for drug treatments. Treatment is required to begin with Medicare Advantage plans' most-preferred drug therapy, and physicians are allowed to select alternatives to the preferred drug only under defined circumstances.
In addressing this issue, CMS notes that plans can require enrollees “to try and fail drugs supported only by an off-label indication” before giving access to a drug based on its U.S. Food and Drug Administration-approved indication, if certain criteria are met. These criteria include off-label indication that is supported by widely used treatment guidelines or clinical literature that CMS considers representative of best practices.
CMS attempted to clarify this issue and others that surfaced in the agency’s initial announcement with a new FAQ document. That document:
- Indicates that Medicare Advantage plans may implement mandatory step-therapy programs
- Notes that plans have flexibility in calculating and administering enrollee rewards
- Describes the elements of drug management care coordination programs, requirements for step-therapy notifications in certain plan documents and requirements for exception requests
- Clarifies that enrollees currently receiving a “particular” Part B drug “cannot be required under a step-therapy policy to change their medication”
- Indicates that plans are not required to submit step-therapy requirements to CMS
The document provides additional guidance on utilization management tools for other Part B covered services.
The Academy continues to believe that step therapy in Medicare Advantage for physician-administered drugs is a legally questionable policy with a potentially dangerous effect on eye care.
This policy has the potential to deny patients access to proven FDA-approved treatments, while removing physicians’ and patients’ treatment choices from care. It could even pit us against health plan representatives who would have the final say on treatment.
CMS’ authority on this issue comes with some limitations. Under the policy, Medicare Advantage plans would share half of the savings netted from step therapy with individual patients in the form of a payment or gift card.
Medicare Advantage plans would also need to couple such a policy with a drug management care coordinator program. Additionally, ongoing Part B therapy could not be disrupted. No beneficiary currently receiving drugs would be required to change their medication.
The policy change would take effect Jan. 1, 2019 as part of a Medicare Advantage patient-centered care program. However, the Academy believes that the challenges of implementing such a program before Medicare Advantage enrollment begins means few plans will be able to implement step therapy for 2019.
Private payers already use step therapy – with questionable patient outcomes. To adopt such a policy for nearly a third of Medicare’s patients is a major move that the Academy opposes.
The Academy in 2014 argued successfully against step therapy’s legality and continues to question it on these grounds. The 2014 challenge was based on a 2012 CMS memo that concurred with our legal assessment. This announcement rescinded the 2012 memo, leaving patients and physicians to challenge the legal authority for allowing step therapy under Medicare Advantage.