CMS Final Rule Maintains Protections for Part D Beneficiaries with Cancer; Safeguards Still Needed Under Medicare Advantage and Part B

May 22, 2019

On May 16, the Centers for Medicare & Medicaid Services (CMS) released a final rule on drug coverage policies. After receiving feedback from the American Society of Clinical Oncology (ASCO) and other stakeholders, CMS did not finalize a proposal that would have impeded access to drugs within Medicare Part D’s Six Protected Classes. The agency did, however, finalize a proposal to allow the use of step therapy for protected class prescription drugs under Medicare Advantage and Part B—despite stakeholder concerns.

“ASCO applauds CMS for listening to ASCO and other stakeholders by not finalizing a proposal that would have significantly impacted access to drugs within the Six Protected Classes,” said ASCO President Monica M. Bertagnolli, MD, FACS, FASCO, in a statement released May 17. “We are disappointed, however, that CMS finalized its proposal to allow the use of step therapy for protected class prescription drugs under Medicare Advantage and Medicare Part B.”

ASCO has long opposed step therapy, which requires patients to try and fail to have a desired clinical outcome on a lower cost medication before they can access the medication prescribed by their health care provider. ASCO asserts that the practice delays patient access to proper treatments and potentially leads to irreversible disease progression and other significant patient health risks.

CMS also proposed using “negotiated price” as the lowest possible payment pharmacies can receive. This would have removed the risk of reimbursement “claw backs” related to provider performance and shifted fees associated with quality metrics to a bonus structure. These fees are imposed on Oncology providers as Direct and Indirect Remuneration (DIR) fees. ASCO supported this proposal asserting that it would would reduce beneficiary out-of-pocket costs and improve price transparency. While CMS decided not to implement the policy for 2020, the agency is still considering policies to improve drug pricing transparency.

ASCO will continue to work with policymakers on solutions to ensure access to high-quality, affordable prescription drugs for all patients with cancer.