Step Therapy

The Academy opposes the adoption of step therapy in Medicare Advantage, which now covers over half of all Medicare beneficiaries, and commercial payer policies.

Step therapy can have harmful consequences on patient care, including:

• Delays in timely access to medically necessary care
• Increased administrative burdens on physician practices
• Payer-driven restrictions on the patient-physician relationship

The Academy works directly with state ophthalmological and subspecialty societies to protect physicians' rights to treat patients as they see fit. We are educating legislators and regulators on the dangers of fail-first care for eye disease.

The Academy has written to the Centers for Medicare & Medicaid Services (CMS) urging the agency to rescind the policy allowing MA plans to implement step therapy requirements. We have also written to and met with CMS and the Office of the Inspector General (OIG) about the need for an investigation into the impact of MA plans’ use of step therapy on beneficiary access to Part B drugs. We continue to monitor and respond to Medicare Advantage and commercial plans, where step therapy policies affecting ophthalmic drugs have been implemented.

We are also supporting the Safe Step Act (H.R. 5509/S.2903), federal legislation that would establish important patient protections for step therapy used by group health plans under the Employee Retirement Income Security Act (ERISA). 

Your experiences with step therapy are urgently needed to demonstrate how "fail first" policies are affecting ophthalmic care. The Academy is calling on ophthalmologists to share stories of how step therapy burdens impact patient access to care.

You can bolster our advocacy efforts by submitting your stories through the Academy's step therapy survey or by emailing healthpolicy@aao.org. We are interested in cases from both Medicare Advantage and commercial plans. These stories are critical to informing federal policymakers that step therapy may interfere with the patient-physician relationship and negatively affect patient outcomes in ophthalmic care.

Step therapy — also known as "fail first" therapy — requires patients to begin treatment with a health plan's most-preferred drug. Physicians may only prescribe alternatives under defined circumstances, typically after the preferred drug has been tried and deemed ineffective.

Step therapy has long been used by private payers. Its adoption in Medicare Advantage became possible following a 2018 CMS memo authorizing Medicare Advantage plans to apply step therapy to certain Medicare Part B drugs, with the policy change taking effect January 1, 2019.

For ophthalmologists, this is particularly concerning. Many sight-threatening conditions — including wet age-related macular degeneration and diabetic macular edema — require timely, individualized treatment. Requiring patients to "fail first" on a less-preferred drug before accessing the physician's recommended therapy can result in delays that lead to permanent vision loss.