American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

CMS Finalizes Medicare Advantage and Part D Drug Pricing Rules

The Centers for Medicare & Medicaid Services (CMS) May 23 published its final rule Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, which amends Medicare Advantage (MA) and Prescription Drug Benefit program (Part D) polices that affect drug prices and out-of-pocket costs for patients. This rule finalizes regulatory provisions that require Part D insurers to include on their formularies all drugs in six protected classes—anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants. The agency had initially proposed to expand the use of prior authorization and other utilization management tools to enable Part D insurers to exclude or limit access to certain medications that were otherwise required to be included on insurers’ formularies because of their protected class status. CMS chose not enact its proposal in this final rule after the American College of Surgeons (ACS) expressed strong concerns that such coverage restrictions could disrupt care, impede patient access to medically necessary therapies, and threaten the safety of beneficiaries who were prescribed immunosuppressants to prevent organ rejection after a transplant operation.

Under this rule, CMS will also require all Part D insurers to adopt digital Real Time Benefit Tools (RTBTs) that can effectively integrate with clinicians’ electronic health records (EHRs) and electronic prescribing systems. When properly implemented, RTBTs have the capability to inform prescribers when lower-cost or more appropriate alternative treatments are available under a patient’s prescription drug benefit. The ACS has supported the agency’s efforts to make beneficiary-specific drug coverage and cost information more available to physicians at the point-of-care. Part D insurers must begin using at least one fully integrated RTBT by January 1, 2021.

For more information about the final rule, contact Lauren Foe, Senior Regulatory Associate, ACS Division of Advocacy and Health Policy, at