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The US Centers for Medicare and Medicaid Services (CMS) is evaluating two innovative new medtech technologies for special additional payments in 2020 under its 29 July proposed Outpatient Prospective Payment System (OPPS) rule, and says it wants to see more data on clinical improvements for both.

For new technology items and services, the agency under its OPPS regulations sometimes provides special, temporary additional payments for a two- to three-year period under its “transitional pass-through payments” process, the CMS explained in its proposed rule.

Among the group of devices for which applications for pass-through payments were filed for the 2020 coverage year was Procept BioRobotic Corp.’s Aquabeam System to remove and resect prostate tissue.  And Boston Scientific applied for a pass-through payment under the proposed OPPS for its Eluvia drug-eluting stent to treat peripheral artery disease (PAD). The proposed New Technology Add-On Payment (NTAP) for the stent was endorsed by several commenters on the proposed IPPS rule. (Also see "Despite Paclitaxel Warnings, Physicians Endorse Boston Sci’s Eluvia Stent For NTAP In CMS Pay Proposal Comments" - Medtech Insight, 10 Jul, 2019.)

The CMS has to evaluate each new device it reviews for a pass-through payment by three criteria: first, that it is not being appropriately described by any already existing category of device; second, that it will substantially improve the diagnosis or treatment of an illness or injury compared to other devices used to treat that disease; and third, that the cost of the device is “not insignificant,” and exceeds 25% of the costs for that category of devices.

While sponsors of both the Aquabeam System and Eluvia DES have submitted voluminous trial data supporting the products, the CMS said it “lacked sufficient evidence” of clinical improvement for both products and is asking for further comment from the public.

PROCEPT BioRobotic Aquabeam System To Relieve LUTS

Procept first submitted an application for transitional pass-through payment status for Aquabeam for 2019 coverage, and special payment for the product is being considered again, for the 2020 coverage year. The Aquabeam System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS), due to benign prostatic hyperplasia.

The Aquabeam system works by robotically emitting a high-velocity, nonheated sterile saline water jet in a procedure called “aquablation” to resect the prostate to relieve symptoms of urethral compression that are indicative of LUTS. The system also uses real-time intra-operative ultrasound guidance to allow the surgeon to precisely plan and resect the obstructive prostate tissue. The entire Aquabeam system includes a disposable, single-use handpiece, as well as components considered to be capital equipment.

Procept founder and CEO Nikolai Aljuri told Medtech Insight in mid-2018 after a comparison trial between his product and traditional surgical options that he was confident that the AquaBeam System would become popular. “I can imagine that the urologists of the future in the next five to 10 years will really only know aquablation and nothing else,” Aljuri said at the time. (Also see "Procept BioRobotics Believes Aquablation Could Dominate BPH Treatment…If It Gets Coverage" - Medtech Insight, 12 Jun, 2018.)  

But in its proposed OPPS rule review, the CMS was not as enthusiastic, and asked for further comment. AquaBeam met the agency’s first criteria (not fitting any other category of device for indication) and third criteria for cost (at $2,500 for the handpiece, and $69,662 for the average aquablation case, the costs were 25% higher than the ambulatory payment classification the CMS might assign). But the device stumbled on the second, substantial clinical improvement criteria.

“Based on the evidence submitted with the application, we are concerned that there is a lack of sufficient evidence that the AquaBeam System provides a substantial clinical improvement over other similar products, particularly in an outpatient setting where large prostates are less likely to be treated,” the agency said in its OPPS proposal.

Procept had submitted clinical data from a double-blind trial that compared 184 men with two different prostate treatments (117 treated with AquaBeam, and 67 treated by Transurethal Resection of the Prostate, or “TURP”). Efficacy data showed the equivalency of the two procedures, while the safety data were reported as showing superiority of the AquaBeam System over TURP.

However, the CMS faulted Procept’s application for the product because there are other treatment modalities available for LUTS, and “No studies comparing other treatment modalities were cited to show that the AquaBeam System is a significant improvement over other available procedures,” the agency said.

Mortality Risks Seen With Eluvia Drug-Eluting Stents

Meanwhile, Boston Scientific applied for a pass-through payment for its Eluvia stent system under the proposed 2020 OPPS rule, and for an NTAPunder the agency’s inpatient prospective payment system (IPPS) rule for next year that was proposed in May. NTAPs are associated with the IPPS regulations.

In the comments on the Eluvia stent for the IPPS proposal, several cardiologists and radiologists praised the pluses of the device, despite warnings issued by the US Food and Drug Administration over the past year about stents such as Eluvia that are coated with the problematic drug paclitaxel.

For example, William Grey, system chief of cardiovascular services at Mainline Health, commented that Eluvia is a “best-in-class” device and is capable of long-term, controlled release of paclitaxel for more than a year. And diagnostic radiologist Derek Mittleider said the stent had the ability to avoid fracture and maintain radial force, unlike other stents he used. Mittleider is a specialist with Spectrum Health Partners in Maine. (Also see "Despite Paclitaxel Warnings, Physicians Endorse Boston Sci’s Eluvia Stent For NTAP In CMS Pay Proposal Comments" - Medtech Insight, 10 Jul, 2019.)

The Eluvia stent is indicated for improving luminal diameter in the treatment of peripheral artery disease (PAD) with symptomatic de novo or restenotic lesions in the native superficial femoral artery or proximal popliteal artery. It is made of a self-expanding, nickel titanium alloy (nitinol) mesh that has a unique polymeric coating that allows for slow release of paclitaxel, which is frequently used in drug-eluting stents. 

Based on a lengthy meta-analysis that found the paclitaxel used in stents and balloons was causing more deaths than use of bare-metal stents, the FDA in March urged providers to consider alternatives. (Also see "FDA Tells Providers To Limit Use Of Paclitaxel-Coated Stents" - Medtech Insight, 20 Mar, 2019.)

Like the FDA, the CMS stated in its OPPS proposal itsconcerns about the use of paclitaxel-coated stents, noting: “There is an increased risk of death following application of the coated balloons and stents in the femoropopliteal artery of the lower limbs, and further investigations are warranted.”

In its review of the sponsor’s application, the agency also questioned the “lack of sufficient evidence that the Eluvia stent provides a substantial clinical improvement over similar products,” noting that they had not been presented with any longer-term (two-year or five-year) data on the performance and safety of the stent.

The Medicare agency also asked for public comments on whether the Eluvia stent meets specific payment criteria for pass-through payments, saying its average costs of $5,768 “did not exceed the [required] 10% of the APC (ambulatory payment classification) payment amount for the device of $4,996.”

Rule To Take Effect Next Year

The proposed CMS OPPS rule would take effect on 1 January 2020. Comments on the proposal are due on 27 September under docket No. CMS-1717-P.


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