Medicare policy for FDG PET pays for the procedure three times only after the commencement of treatment for a number of cancers, but a recent report by the Agency for Healthcare Research and Quality (AHRQ) makes a case for FDG PET/CT as a pre-treatment staging procedure for small cell lung cancer (SCLC).

The Centers for Medicare & Medicaid Services announced in 2013 that it would pay for three FDG PET scans for solid tumors, a boost from the single-scan coverage previously provided, but the agency also indicated it would drop the associated registry mandate. The agency is incurring pushback on its coverage for the use of PET with a sodium fluoride imaging agent for bone metastases, which the CMS declared in December 2015 would retain the registry mandate previously announced for that contrast agent.

The AHRQ report concluded that there are few data that allow a conclusive comparison of FDG PET/CT to two other approaches for SCLC staging (CT alone and bone scintigraphy) for locating osseous metastases, but the authors said that the evidence for several other modalities is scant. They noted that the data for endobronchial ultrasound (EBUS), MRI and PET/MRI as pre-treatment procedures is lacking even though the literature search was not limited to this particular application, but acknowledged that EBUS and endoscopic ultrasound are perhaps more routinely used for diagnosis than for staging.

The authors noted that roughly seven in 10 diagnoses of small cell lung cancer take place when the patient is already in an advanced disease stage and that five-year survival for this group is one percent. They remark that the term "standard staging" is not well defined for SCLC, but noted that multi-detector CT (MDCT) is in most instances the first procedure undertaken to generate an affirmative diagnosis.

Concordance between MDCT and FDG PET/CT was as high as 97 percent in the studies for the various stages of lung disease and metastasis to other soft tissues, the authors explained, although concordance dropped to 83 percent between these two modalities for bone metastases. There were only three studies in the analysis looking at metastases to the bone or bone marrow for CT, scintigraphy and FDG PET/CT, although the data seem to corroborate the view that the last of the three offers the greatest sensitivity. However, FDG PET/CT did not best MDCT for specificity in this area.

As might be expected, there were no comparative effectiveness studies for these three imaging modalities, and the authors gave only a low strength of evidence rating to the conclusion that FDG PET/CT is more sensitive than CT for detecting osseous metastases. The authors added that clinicians may consider eliminating the use of scintigraphy when searching for bone metastases from SCLC, and switch to "routinely using FDG PET/CT instead." The question of comparative specificity between FDG PET/CT and the other studied modalities is as yet up in the air, but the authors remarked that the elimination of scintigrapy could yield some savings inasmuch as many patients eventually undergo all three of scintigraphy, CT and FDG PET/CT.

The American College of Radiology and the American Society for Clinical Oncology were unable to provide spokespersons for comment for this story.

China's export subsidies take a hit

Beijing's many practices designed to foster local industry absorbed another hit last year in a decision to put an end to export duties, but at least one med-tech association sees an end to export subsidies for Chinese firms offering services to device makers in other nations.

Michael Froman, the U.S. Trade Representative, recently announced that Beijing had agreed to end export subsidies that were in violation of the World Trade Organization rules China had agreed to in 2001. Scott Whitaker, the newly appointed president/CEO of the Advanced Medical Technology Association (AdvaMed) lauded the news, noting that Beijing was "providing millions of dollars' worth of grants and discounted services" to local companies providing product design and testing services to device makers in other nations.

Whitaker said Froman's efforts to push back against these practices not only put a halt to the program, but "likely prevented even more Chinese government money from being poured into unfair competition" against device makers headquartered in other nations. Whitaker concluded with the observation that trade agreements are essential to the effort to flatten the impact of such barriers, but added, "enforcement is an essential element of these agreements."

Medicare Breakthrough bill surfaces

H.R. 5009, an as-yet untitled bill that recently debuted in two committees in the U.S. House of Representatives, would give the CMS a mandate to streamline its coverage and reimbursement processes for devices designated by the FDA as breakthrough medical technologies. Although the bill sports only three sponsors other than the legislation's author, two of those are Democrats, giving the proposition a bipartisan nod of credibility that could prove essential for passage.

Rep. Charles Boustany, whose home state of Louisiana is not known as a med tech-intensive area, is the author of H.R. 5009, while Rep. Gus Bilirakis (R-Fl.) is the sole Republican co-sponsor of the bill as of April 26. Boustany and Bilirakis are joined by Democrats from two med-tech intensive states in this endeavor, Reps. Richard Neal (Mass.) and Tony Cardenas (Calif.).

The legislation is assigned to the House Ways and Means and Energy and Commerce Committees. It is not clear whether the House leadership has devised any priorities with regard to H.R. 5009, but the bill's sponsors have little time to move the bill before the upcoming election swamps legislative action, given that the congressional summer recess commences in August.

Scott Whitaker, president/CEO of the Advanced Medical Technology Association (AdvaMed) said that H.R. 5009 would provide coverage for an FDA-designated and approved breakthrough for three years, during which time the CMS would provide "a predictable [level of] reimbursement." The CMS would use that time to determine whether it needs any additional data to craft a permanent coverage policy for that device or diagnostic.

Whitaker added that the bill would make unspecified improvements to the new technology add-on program (NTAP), concluding that the FDA breakthrough technology program and the potential reforms of the NTAP program in H.R. 5009 "would both stimulate development of important new devices and diagnostics and assure more rapid availability of those treatment options to patients."

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