Medicare’s traditional approach to reimbursement makes it difficult for hospitals and physicians to use innovative medical devices for pain relief.1 Medicare generally provides only a lump-sum bundled payment for surgery, including related pain relief. As a result, hospitals and physicians often rely on opioids, which are very inexpensive but also highly addictive.
The Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which went into effect on January 1, 2025, addresses this problem. The law expands Medicare patients’ access to non-opioid postoperative pain relief. It does this by providing for separate reimbursement for pain relief, rather than just the lump-sum bundled payment for surgery. The law is set to expire on December 31, 2027, but its popularity shows that it may be extended: it had over 160 Congressional cosponsors from both political parties, including from regions hit hard by the opioid epidemic.
Under the NOPAIN Act’s implementing regulations, a medical device is eligible for separate reimbursement from Medicare in hospital outpatient and ambulatory surgical center (ASC) settings if the device meets all the following criteria:
1. Reduces postoperative pain or produces postsurgical or regional analgesia;
2. Is FDA approved (Section 515), FDA cleared (Section 510(k)), or exempt from premarket notification requirements;
3. Based on data from clinical trials or published in peer-reviewed journal articles, has the proven ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed;
4. Does not have transitional pass-through payment status under 42 C.F.R. § 419.66, which is a CMS program providing for temporary, additional payments for new medical devices under the outpatient prospective payment system; and
5. Payment would otherwise be trapped in Medicare’s bundled payment for surgery.
The Centers for Medicare and Medicaid Services (CMS) evaluates and approves non-opioid treatments for separate reimbursement under the NOPAIN Act. (Currently approved products listed here.) If a medical device is approved, Medicare will reimburse the hospital’s or ASC’s acquisition cost of the device subject to a cap of an average of approximately 18% of the hospital outpatient fee schedule amount for the surgical procedures with which the device is provided.
To obtain CMS approval of a medical device for separate reimbursement under the NOPAIN Act, device companies need to provide documentation showing the device meets the statutory criteria. This includes documentation showing the appropriate FDA status and qualifying peer-reviewed literature showing the device reduces postoperative pain or produces postsurgical or regional analgesia. CMS provides specific instructions for how to submit this information here. CMS evaluates submissions on a rolling basis. Although CMS implements these decisions through its quarterly updates to payment rates, it makes payments retroactively effective to the date that CMS approved the device.
HcFocus is a market access team built to take clients from strategy through execution, with decades of experience and deep payor and physician relationships across reimbursement, coding, coverage, and policy. Whether a product is in early-stage development, preparing for launch, or already facing a reimbursement cutback, we build the client-specific strategy and hands-on execution needed to secure and defend coverage. Reach out to schedule a strategy call.
1 The NOPAIN Act also expands patient access to non-opioid drugs and biologics, but those are beyond the scope of this article.