AGA’s new drug affordability principles were put into action in July when AGA Chair Sheila Crowe, MD, AGAF, provided comments on the Department of Health & Human Services (HHS) recent policy statement and Request for Information, “HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs” (Blueprint). Comments were limited to four areas of the Blueprint.
Medicare Part B to Part D drug transition
Over the past decade there has been interest in consolidating Part B and Part D drug coverage and payment. AGA urges physician-administered drugs and biologics to remain under Part B due to the complexities surrounding them.
Since Part D does not allow for supplemental coverage and has higher coinsurance, this action would achieve savings by shifting costs to Medicare beneficiaries. Moving them to Part D would also increase the risk of waste leading to unnecessary Medicare spending. AGA urges the administration to avoid policy solutions that achieve Medicare program savings at the expense of Medicare beneficiaries.
The Blueprint seems to imply that off-label uses of prescription drugs are inherently less valuable than on-label uses. If the administration moves towards value-based pricing, off-label indications should not automatically be valued less, or priced lower, than on-label indications. Specifically, AGA urges the administration to ensure all medically accepted indications are appropriately valued for a drug or biologic.
Medicare Part B Competitive Acquisition Program (CAP)
AGA does not oppose the idea of a new, voluntary CAP program as it would allow interested physicians and practices to provide Part B drug administration without the burden of high acquisition costs.
AGA strongly opposes a future Part B CAP that includes vendors or Medicare carriers conducting medical reviews or utilization management. Utilization management undermines shared decision-making between physicians and patients, increases physician burden, and often puts patients at risk by delaying access to necessary care.
Reduce patient out-of-pocket spending
As out-of-pocket costs continue to rise, AGA supports the administration’s plans to increase cost transparency in the Medicare program as it increases the efficiency of the shared decision-making process between patient and physician. Drug and biologic manufacturers, health plans, and pharmacy managers should work together to lower out-of-pocket expenses for Medicare beneficiaries and for all people with digestive diseases.
Although AGA shares the Blueprint’s goal of lowering the cost of prescription drugs, lowering out-of-pocket costs for patients, increasing competition and fostering innovation, we are concerned that the recent proposal by the Trump administration to allow Medicare Advantage (MA) plans to utilize step therapy would threaten the aforementioned goals. Step therapy is a utilization management tool used by insurers that requires patients to fail one or more medications before covering the original therapy that is prescribed by the physician. AGA is concerned that the recent announcement by the Trump administration would not provide patients with the necessary protections, would increase the regulatory burden that physicians already face with step therapy and prior authorization, and could hinder innovation by preferring the lowest cost medication which may not necessarily be the most effective. AGA will continue to push for necessary patient protections to ensure that patients have the ability to appeal step therapy protocols when appropriate and are able to receive the medication that their physician thinks is the most effective to manage their condition.