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Boston Scientific and Stryker Get Another NTAP Year Because of COVID-19

Image by fizkes - Adobe Stock NTAP extension rule
CMS also served up final opinions on new NTAP applications, including Medtronic's Harmony transcatheter pulmonary valve.

The Centers for Medicare & Medicaid Services (CMS) is finalizing a one-year extension new technology add-on payments for 13 technologies for which the new technology add-on payment (NTAP) would otherwise be discontinued beginning fiscal year 2022.

These 13 products include Boston Scientific's Eluvia drug-eluting stent, Cook Medical's Hemospray, and Stryker's SpineJack system.

The NTAP extension is part of a final rule CMS issued Monday for the FY 2022 Medicare hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS). Specifically, the NTAP extension is connected to CMS’ decision to use FY 2019 data instead of FY 2020 data for the FY 2022 IPPS rate setting.

The final rule updates Medicare payment policies and rates for operating and capital-related costs of acute care hospitals and for certain hospitals and hospital units excluded from the IPPS for FY 2022. Because IPPS payments are generally based on the most recently available Medicare claims and cost report data, which tends to have a lag of two years to three years, the statute provides temporary additional payments for cases with high costs under the NTAP policy.

Under this policy, Medicare pays the applicable Medicare severity diagnosis related group payment rate and up to an additional 65% (75% for certain antimicrobials) of the cost of the approved new technology. The NTAP is not budget neutral and is generally limited to the two-year to three-year period following the date the product is launched.

"For the IPPS and LTCH PPS rate setting, our long-standing goal is always to use the best available data overall," the authors of the final rule noted.

Medical devices impacted by the NTAP extension

The extra year of NTAP reimbursement will apply to Boston Scientific's Eluvia drug-eluting vascular stent system, which was developed for the treatment of peripheral artery disease. The Eluvia stent is designed to re-open the blocked artery and restore blood flow, while also utilizing a drug-polymer combination to offer a sustained, low-dose release of drug to prevent tissue regrowth within the stented artery. FDA approved the Eluvia stent system in September 2018 based on findings from the IMPERIAL trial.

Another device granted a NTAP last year, which will benefit from the one-year extension, is Cook Medical's Hemospray. Cook's Hemospray product is an endoscopic hemostat, meaning that it helps stop bleeding in the gastrointestinal tract. This product is a single-use device that sprays an inorganic powder toward the source of a bleed. When the powder comes in contact with blood, it absorbs water and forms a gel. The gel creates a stable barrier that covers the bleeding site.

Stryker's SpineJack also won a NTAP last year, so it too will benefit from Monday's final rule. The SpineJack is designed to treat osteoporotic vertebral compression fractures, and data suggests the technology may be superior to balloon kyphoplasty.

Final opinions on new NTAP applications

CMS granted a NTAP for single-use duodenoscopes, which applies to Boston Scientific's Exalt Model D single-use duodenoscope, as part of the FY 2022 hospital IPPS. This means that beginning Oct. 1, 2021, CMS will give hospitals additional device reimbursement when single-use duodenoscopes are used for eligible cases in the hospital inpatient setting.

Cleared by FDA in December 2019, the Exalt Model D is designed to eliminate the risk of infection due to ineffective reprocessing of traditional reusable duodenoscopes. Duodenoscopes are used to diagnose and treat various pancreatic and biliary conditions during endoscopic retrograde cholangiopancreatography (ERCP) procedures. Every year, more than 700,000 ERCP procedures are performed in the United States and roughly 1.5 million are completed worldwide. In 2019 FDA recommended that providers use duodenoscopes with disposable components or fully disposable devices, when available.

The Exalt Model D previously received a breakthrough device designation from FDA as well as transitional pass-through (TPT) payment by CMS, the latter of which allows for incremental device reimbursement for Medicare cases performed in the hospital outpatient setting. Also, in response to a Boston Scientific request, CMS created two unique ICD-10 procedure codes for hospitals to facilitate reporting the use of single-use duodenoscopes when used in the hospital inpatient setting beginning in October.

"Securing NTAP, in addition to TPT, for the Exalt Model D duodenoscope will support healthcare providers in accessing this device for Medicare patients – a group that represents over 40% of all ERCPs performed in the U.S. each year," said Dave Pierce, a Boston Scientific executive vice president and president of the company's MedSurg and endoscopy businnesses. "Adequate reimbursement is key for the adoption of any new technology, and this decision from CMS will help provide hospitals with the means to treat Medicare patients with this device."

Cerus also won a new technology add-on payment for its Intercept Fibrinogen Complex (IFC). The NTAP for patients receiving IFC for control of massive bleeding associated with fibrinogen deficiency is in addition to existing Medicare payment corresponding to the Medicare severity diagnosis-related group (MS-DRG) assigned for each inpatient stay. CMS indicated that the NTAP will apply when the patient's cost of care exceeds the MS-DRG payment.

“CMS’ issuance of an NTAP for IFC will support Medicare beneficiary and provider access to this innovative new blood product designed to address urgent, life-threatening bleeding events in the inpatient setting,” said Jessica Hanover, PhD, Cerus’ vice president of corporate affairs. “We applaud CMS for their decision to provide this incremental payment for IFC. The need for effective tools to help clinicians manage bleeding events is critical. When minutes matter in the life-saving care of a bleeding patient, having the convenience of IFC with its five-day post-thaw shelf will enable many hospitals to have improved access.”

CMS also granted a NTAP for Medtronic's Harmony transcatheter pulmonary valve system. FDA approved the Harmony system earlier this year, marking the world's first non-surgical heart valve to treat pediatric and adult patients with a congenital heart disease. The Harmony system offers a less invasive option to treat patients with a native or surgically-repaired right ventricular outflow tract, the part of the heart that carries blood out of the right ventricle to the lungs. The device is designed for patients who have severe pulmonary valve regurgitation (blood leaking backward into the right lower chamber of the heart), a condition that often results from congenital heart disease.

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