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# CMS Eyes End of Alternative NTAPs in Inpatient Draft And Looks Forward to RAPID
- URL: https://www.themedtechscribe.com/cms-eyes-end-of-alternative-ntaps-in-inpatient-draft-and-looks-forward-to-rapid/
- Published: 2026-10-25T16:31:19.000Z
- Updated: 2026-10-25T16:38:50.000Z
- Author: Mark McCarty
- Tags: CMS, Medicare

*(*[*Posted*](https://www.linkedin.com/pulse/medicare-churn-ntaps-rapid-program-mark-mccarty-ytfbf/?ref=themedtechscribe.com) *May 6, 2026, on LinkedIn)*

CMS has proposed to terminate the alternative pathway for the new technology add-on payment (NTAP) mechanism, and [Judy Rosenbloom](https://www.linkedin.com/in/judyrosenbloom/?lipi=urn%3Ali%3Apage%3Ad%5Fflagship3%5Fpeople%5Fconnections%3BU8%2FVyZGdQfWgULXV4lluoQ%3D%3D&ref=themedtechscribe.com) and [Jo Ellen Slurzberg](https://www.linkedin.com/in/jo-ellen-slurzberg-2611464/?lipi=urn%3Ali%3Apage%3Ad%5Fflagship3%5Fpeople%5Fconnections%3BU8%2FVyZGdQfWgULXV4lluoQ%3D%3D&ref=themedtechscribe.com) of JR Associates Inc. told me that the sheer volume of breakthrough devices might be a source of congestion for the NTAP program. However, they also stated that the newly proposed Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway might also be a factor in the proposal to do away with the alternative NTAP mechanism.

CMS proposed to drop the alternative NTAP pathway in its draft rule for the inpatient prospective payment system (IPPS) for fiscal 2027, hinting that the transitional pass-through program for outpatient care might also be on the line. In the fiscal 2020 and 2021 inpatient final rules, CMS established an alternative NTAP pathway for FDA-designated breakthrough devices along with a subset of antimicrobial agents characterized as qualified infectious disease products.

One of the attractions of the alternative NTAP pathway relative to the traditional pathway is that CMS does not evaluate the application for the substantial clinical improvement criteria. However, CMS also said in the proposed IPPS rule that it assumes by default that these breakthrough technologies are not substantially similar to existing technologies for the stated indication for use.

**Prudence, experience prove hazardous to NTAP**

The agency stated further that it brought the alternative NTAP program along with the understanding that it would be “prudent to gain experience” with this mechanism prior to expanding it to other technologies. That experience has led CMS to the conclusion that it may be better to subject the candidate device to the substantial clinical improvement test as well as the newness test for NTAP coverage after all.

Slurzberg, vice president for global health policy at Reseda, Calif.-based JR Associates, said “it’s hard to say what CMS is really thinking, but certainly there are a lot of breakthrough devices, and many have raised questions about how FDA is making those decisions relative to coverage and payment.” MCIT was withdrawn due to pushback by AHIP (formerly known as America’s Health Insurance Plans) and CMS’s own concerns, as well as clinical thought leaders. CMS’s proposal to scrap the alternative pathway might be seen as a response to the question of whether a breakthrough device is necessarily fit for purpose, as it were, for the alternative NTAP pathway.

Slurzberg remarked that the high number of breakthrough device applications has greatly increased the number of applicants in the alternative NTAP and the hospital outpatient transitional pass-through (TPT) programs. By removing the alternative pathways, the volume of applications that must be reviewed for clinical improvement may increase. In either case, it is unclear whether requiring the clinical criteria will affect the number of applicants or the CMS workload because more analysis is required.

Still, industry believes there is a need for an alternative to the traditional NTAP and TPT routes to give manufacturers a shot at reimbursement levels that make the product adoptable in a timely fashion, given that these products can generally meet the cost criteria.

Rosenbloom, founder and president of JR Associates, added that CMS may be grappling with a sensitivity for fiscal restraint as well. While the NTAP program is not subject to budget neutrality requirements, the increased number of applications may lead CMS to believe that the alternative pathway is boosting the related spending to a higher level than anticipated. The IPPS rule provides information about the expected NTAP spending but there is no data about actual spending or information specific to devices with breakthrough designation.

Slurzberg pointed out that CMS can limit or alter the NTAP program at its discretion. “I think we have to see where CMS may be open to some form of compromise to acknowledge devices that meet some of the criteria, so we don’t just throw the whole alternative pathway without some consideration,” she remarked.

**Dueling acronyms offer a possible explanation**

Rosenbloom also mused that the emergence of the RAPID coverage pathway might reflect somewhat on the proposal to do away with the alternative NTAP pathway in a serving of government acronym soup. “I can’t imagine it’s entirely incidental when we think about the timing,” she stated, given that CMS and FDA announced the RAPID program a mere 13 days after CMS posted the draft inpatient rule.

RAPID is designed to bring breakthrough devices to market in a manner that seems to strike a resemblance to the Transitional Coverage for Emerging Technologies (TCET) program. Rosenbloom said TCET “is a little bit of a mystery because they’re accepting so few products into that program” relative to the number of devices that have received an FDA breakthrough device designation. A CMS official noted that about 40 devices with breakthrough designation would potentially qualify for the RAPID program now. This is far more than the roughly five per year CMS will consider with the TCET program and far less than the 1,200-plus applications accepted to date in the FDA breakthrough device program and its antecedent. This suggests that the RAPID criteria will not apply to all breakthrough devices.

Still, Rosenbloom pointed out that many, perhaps most of the products in the breakthrough devices program require no national coverage determination (NCD), but that doesn’t mean industry has a clear idea of exactly what CMS has in mind for RAPID. “We don’t have any details right now, so we have to wait and see what kinds of criteria are going to be married with the RAPID program, and whether there will be some complementary payment program for inpatient and outpatient care that will travel with it,” she stated.

Though information about the RAPID program is limited at this time, a national coverage decision (NCD) will not address the payment gap left if the alternative pathways are removed. Many devices eligible for NTAP and TPT may not require or would be appropriate for an NCD. Frequently payment rate, rather than coverage, is the barrier to access for these technologies.

Perhaps predictably, there are also questions about CMS bandwidth when it comes to the RAPID program, Rosenbloom said, noting that CMS has traditionally had a difficult time keeping up with the demand for national coverage analyses. She expressed skepticism that CMS’s Coverage and Analysis Group will be able to handle more than a handful of applications under RAPID per year, given the need to interact with applicants at early stages of device development.

Rosenbloom and Slurzberg summarized that for manufacturers, pursuing an NCD is a strategic decision because it has long term implications. Manufacturers must consider any potential positive and unintended consequences. Ultimately, stakeholders will need to see the details related to which devices will be eligible for the RAPID program and how payment will be addressed in order to evaluate this program.