Regulatory Editor

The Centers for Medicare & Medicaid Services said it will sustain coverage of percutaneous image-guided lumbar decompression (PILD) procedures under the coverage with evidence development framework. While the agency continues to demonstrate reluctance to cover the procedure outright, CMS indicated it is amenable to studies other than randomized, controlled trials in order to establish the clinical value of PILD. However, one of the sponsors of the affected devices indicated its enthusiasm for that device is waning.

CMS initially offered coverage with evidence development (CED) in a January 2014 decision memo that was followed by approval of studies by two manufacturers in pursuit of further evidence. Vertiflex Inc. of San Clemente, Calif., maker of the Totalis system, won the agency's nod for approval of a CED study in May 2014, the same month the agency gave the nod to a study by Vertos Medical Inc. of Aliso Viejo, Calif., with its "mild" device. CMS had initially proposed non-coverage in its prior review of the procedure. (See Medical Device Daily, Jan. 13, 2014.)

CMS reopened the discussion earlier this year, although at least one Medicare administrative contractor had previously covered the procedure. Consolidation of the MACs had the effect of narrowing the geographic area of coverage, but Jacksonville, Fla.-based First Coast Service Options, the MAC responsible for the retiree-rich state of Florida, was never on board. (See MDD, April 18, 2016).

The agency had proposed an extension of CED in its draft coverage update, adding a few more details about the data collection points. Some clinicians are of the view that the jury remains out on the procedure, but one clinician told Medical Device Daily that the universe of surgeons who are experienced in this procedure is small. (See MDD, Sept. 12, 2016.)

In the latest final decision memo, CMS said it will "continue CED and expand" the terms of the January 2014 coverage determination, stating that it will cover the procedure "through a prospective longitudinal study" for any FDA-approved/cleared device that has successfully completed a CMS-approved randomized, controlled trial.

Later in the memo, CMS noted that the sample sizes seen in RCTs of the procedure were "relatively small compared to the large number of potentially eligible patients." Thus, the agency explained, the procedure ought to be tested in routine clinical practice in order to establish whether the findings in the controlled studies will hold up in broad clinical implementation.

CMS remarked that the September coverage proposal had expressed a preference for prospective cohort studies, but that some of the comments led the agency to abandon that requirement in favor of "a broader prospective longitudinal study to increase patient access." The memo noted that such a study will provide data on "duration of benefit and avoidance of harm," and that such a change is "consistent with the broader concept to incorporate real world evidence and data that provide important information for beneficiaries as they make treatment decisions."

Earl Fender, president and CEO of Vertiflex, said, "we understand and support the decision by CMS to extend coverage for PILD under the auspices of CED," adding that the company will "continue to collaborate with CMS as we consider conducting the additional studies requested." However, Fender added that the company "will continue to focus on its flagship product, Superion, which has broader applicability for treating spinal stenosis."

Vertiflex won a PMA for the Superion interspinous spacer in May 2015 with an indication for moderate degenerative stenosis of the lumbar spine. The company announced in November 2015 that the American Medical Association's CPT editorial panel had moved the code for this device type from category III, a designation for experimental devices, to category I, effective Jan. 1, 2017. The company noted that CMS had added interspinous spacers to the list of approved procedures in ambulatory settings with an effective date of Jan. 1, 2016. The company insisted it is not dropping the Totalis, however.


The FDA reported it is dropping its previous requirement that consumers seeking hearing aids will have to go through a medical evaluation prior to purchasing class I and some class II hearing aids. The move was prompted in part by reports by other federal agencies, but the Obama administration was prompted by the news to laud the agency's decision.

The FDA's Dec. 12 immediately-in-effect guidance, which the agency posted to its website Dec. 7, said that only about 20 percent of those who could benefit from the use of hearing aids ever seek professional help, partly because of the cost of such devices. However, the agency also observed that consumers often see a value problem in comparisons of the costs and benefits of these devices.

The President's Council of Advisors on Science and Technology (PCAST) said in an October 2015 report that the FDA medical evaluation requirement adds little benefit and serves as a barrier to access for many in need of hearing assistance, but the National Academies of Sciences, Engineering and Medicine also filed a report citing issues with the policy. A statement published with the June 2016 National Academies report noted that the risk of a missed diagnosis of other diseases due to a relaxation of the FDA policy was low. The Obama administration said in a Dec. 7 post at the White House blog that hearing aids cost an average of $2,300 and that 10,000 Americans reach the age of 65 every day. The blog said the FDA's move could increase competition and drive down prices.

The scope of the guidance covers class I air-conduction hearing aids and class II hearing aids that employ wireless air conduction technology. Bone-conduction devices and those requiring insertion by a medical professional are not included, and the agency said this guidance does not pertain to anyone younger than the age of 18 years.

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