By Jeremy Koff, senior consulting editor
November 10, 2026 | For neurotechnology companies, FDA authorization is only one step toward commercial adoption. Medicare coverage and adequate payment remain separate hurdles. Two federal initiatives address different parts of that challenge: CMS’s proposed Regulatory Alignment for Predictable and Immediate Device coverage pathway, or RAPID, would bring coverage considerations into clinical development earlier, while the NOPAIN Act provides temporary additional payments for qualifying non-opioid pain treatments. RAPID is a proposed administrative pathway; NOPAIN is enacted legislation. Together, they illustrate both the opportunities and the remaining gaps in translating regulatory success into patient access.
The distinction matters. A favorable coverage decision establishes the circumstances under which Medicare will cover a treatment. It does not necessarily provide payment sufficient to make that treatment practical for a hospital or physician to deliver. RAPID and NOPAIN approach these issues through separate mechanisms, with different eligibility requirements. Participation in one does not establish eligibility for the other. Their relationship is a commercial one: manufacturers need both a credible route to coverage and an economic case for adoption.
Both initiatives are welcome, but they leave another reimbursement gap unresolved: the differences between Medicare and commercial insurance coverage. Progress at CMS does not assure comparable coverage or payment from commercial health plans, which may apply different evidence requirements and reach different conclusions about the same technology. For manufacturers, earlier Medicare engagement is a meaningful advance, but a broader reimbursement strategy remains essential.
Neurotech Reports editor James Cavuoto raised these concerns in our January 2019 publisher’s letter, calling for stronger FDA–CMS coordination and incentives for private insurers to support promising therapies based on their longer-term clinical and economic value. The current initiatives offer an opportunity to advance those goals, but considerable unfinished business remains.
RAPID’s premise deserves the industry’s attention. Manufacturers would engage FDA and CMS at the investigational device exemption (IDE) pre-submission stage, allowing them to address Medicare’s evidence expectations while trial design and enrollment criteria can still be adjusted. For qualifying devices that successfully complete the pathway, CMS suggests issuing a proposed national coverage determination on the day of FDA authorization, contingent on publication of the relevant FDA review summary. Final decisions would be targeted approximately 60 days later for Class II devices and 90 days later for Class III devices. Those are coverage-decision targets, not guaranteed reimbursement dates.
There is a cautionary precedent. FDA–CMS Parallel Review began as a pilot in 2011 and became permanent in 2016. It also offered early advice on trial design and concurrent regulatory and coverage reviews. Yet FDA reports 97 formal requests to participate through December 2024 and lists only two devices that completed Parallel Review.
When this editor previously asked manufacturers about their reluctance to participate in the program, a recurring concern was the risk of an unfavorable national coverage decision. Some preferred pursuing coverage through individual Medicare Administrative Contractors, where an adverse decision in one region would not necessarily foreclose opportunities elsewhere. Designing a study to satisfy both agencies could also increase expense or extend development without resolving coding and payment.
RAPID must therefore offer a stronger commercial proposition. Its proposed structure ties collaboration to the IDE process, establishes explicit decision targets, and gives participating cases priority when CMS cannot accommodate all pending national reviews. Manufacturers could withdraw before CMS publishes a proposed national coverage determination. These features could make participation more attractive, although they cannot remove the consequences of an unfavorable coverage decision.
We believe this approach has a better chance of attracting eligible manufacturers than Parallel Review did. For a company already planning a substantial clinical study, incorporating Medicare-relevant outcomes before enrollment could be less expensive than assembling another evidence package after FDA authorization. The benefit will depend on whether CMS delivers useful guidance and meets its proposed timelines.
Eligibility, however, remains narrow. RAPID principally targets certain Class II Breakthrough Devices pursuing de novo authorization and participating in FDA’s Total Product Life Cycle Advisory Program, along with Class III Breakthrough Devices pursuing premarket approval. TAP participation is not required for the latter. A limited exception accommodates some 510(k) devices. Entry would occur at the IDE pre-submission stage, and a controlling national coverage determination would preclude participation. CMS could also require further research through coverage with evidence development, delaying the start of associated coverage until the required study receives approval.
Meanwhile, the payment environment is becoming more demanding. CMS’s FY 2027 inpatient final rule repealed the special Breakthrough Device alternatives for inpatient New Technology Add-On Payments and outpatient device transitional pass-through payments, with transition protections. Traditional pathways remain, but manufacturers outside the exceptions must satisfy the standard requirements, including substantial clinical improvement. The outpatient change generally applies to applications received from October 1, 2026; the inpatient change begins with FY 2028 applications.
Those transition protections are consequential. Certain devices designated Breakthrough by September 30, 2026, retain access to the alternative pathways, subject to authorization deadlines and other requirements. Manufacturers should assess their position carefully. Neither Breakthrough designation nor a faster coverage decision, by itself, assures supplemental payment.
NOPAIN addresses the payment side more directly. Section 4135 of the Consolidated Appropriations Act, 2023, establishes additional Medicare payments for eligible non-opioid pain treatments furnished in hospital outpatient departments and ambulatory surgery centers during 2025–2027. By allowing payment beyond the amount bundled into a procedure, the law could make qualifying products more practical for providers to adopt. It does not guarantee full recovery of a product’s cost.
For devices, eligibility requires more than an absence of opioids. A product must meet the statute’s FDA-related requirements and deliver therapy for postoperative pain or postsurgical or regional analgesia. Clinical trial results or peer-reviewed data must demonstrate an ability to displace opioids, lower their use during or after surgery, or reduce prescribing quantities. Payment must otherwise be bundled, and products receiving transitional pass-through payments are excluded. These conditions make opioid-related outcomes relevant to clinical development, but they do not create a general reimbursement pathway for chronic-pain neurotechnology.
The SPRINT Peripheral Nerve Stimulator System provides a relevant industry example. CMS lists it among qualifying products under code C9807. The agency’s payment table also demonstrates why eligibility and payment stability are separate concerns: the current limit is $2,525.62, compared with a proposed CY 2027 limit of $1,510.84. The proposed figure is not final; neither amount guarantees payment on every claim, and qualification does not extend automatically to every use of the system. The complete list of qualifying products appears on the CMS non-opioid treatments page.
Together, RAPID and NOPAIN point toward a more coordinated approach to reimbursement, although neither provides a complete solution. CMS should broaden appropriate access to early coverage coordination while addressing coding and payment during that process. Manufacturers, in turn, should design studies that establish meaningful patient benefit and help providers evaluate the cost of delivering treatment.
Hopefully, these programs will help bring needed, novel products to market sooner, particularly for early-stage companies that often struggle to raise capital. Ultimately, their success should be measured by how many patients receive effective care. Faster coverage decisions are valuable. A reimbursement system that enables clinicians to act on those decisions would be more valuable still. The gap between Medicare and commercial insurers remains unfinished business.
