New Federal Policy Could Limit Non-Opioid Pain Treatments

September 10, 2021

Treating pain without opioids has become possible for many patients through novel drugs approved by a regulatory process called 505(b)(2). Now, access to these treatments is in jeopardy.

The Centers for Medicare & Medicaid Services is considering changing how health care providers are reimbursed for these drugs, which are injected or infused drugs. They can, among other uses, lessen acute pain after surgical procedures or osteoarthritis-related chronic pain. The change means that, in some instances, the drugs may cost a prescribing physician more than what he or she is reimbursed. The financial disincentive, however unintentional, means physicians would be financially unable to justify prescribing 505(b)(2) drugs – even if they felt it would be in their patient’s best interest.

Reimbursement & Access Barriers

The new reimbursement method would assign 505(b)(2) drugs a “multiple source reimbursement code.” That involves lumping these drugs in with low-cost generic drugs, even though 505(b)(2) drugs are not generic.

Because reimbursement for multiple-source drugs is based primarily on the cost of generic medications, physicians face a financial loss.

And it’s not just one or two drugs that would be limited. About 80% of non-opioid pain treatments approved in the last five years have come through the 505(b)(2) regulatory pathway. Limiting access to these treatments would run counter to ongoing federal efforts to address the country’s opioid epidemic.

Impact of Reimbursement Changes

The treatments in question have a wide range of uses for pain management. Changing the payment method for these drugs could block access to safe and innovative pain management approaches for patients in the near term. Over the long term, barriers could also stifle research and investment in similar new treatments.

For the sake of patients in pain, federal policymakers would do well to reconsider proposed changes to the payment scheme for 505(b)(2) treatments. Reduced access to non-opioid pain treatment is a high price to pay for a country still fighting for safe and effective treatment options amid an ongoing opioid epidemic.

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