2014-05-30 20:24:33 UTC

Lingering Reimbursement Concerns About Recent Advances

June 6, 2014

Over the last year, innovation in GI technology has surged forward. Pivotal studies bring new devices toward clinical adoption, but reimbursement issues can impede clinical progress.

The crosscurrents of innovation and reimbursement in 2013 emerged as a key theme during the 2014 AGA Technology Summit, sponsored by AGA’s Center for GI Innovation and Technology (CGIT). Complacency is as much a disease as colorectal cancer. Without intervention, both can be fatal.

Fortunately, innovation in GI technology surged forward in 2013. New colonoscopy instrumentation showed dramatic improvement in polyp detection, peroral endoscopic myotomy (POEM) emerged as a key minimally invasive technology for achalasia, and fecal transplants gained approval for treatment of Clostridium difficile. Whether reimbursement keeps pace with these and other new emerging technologies remains an open question.

Pivotal studies bring new devices toward clinical adoption, but reimbursement issues can impede clinical progress.

“It’s easy to become complacent about colonoscopy,” said Michael Kochman, MD, AGAF, CGIT chair and Wilmott family professor of medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia. The aging baby boomer population and the Affordable Care Act bring more older adults into the health-care system.

The latest innovation in colonoscopy, full spectrum endoscopy (FUSE) offers a 330-degree view and a potential improvement in polyp detection rates. The combination of innovative technology, an expanding patient base, and assured reimbursement offers little incentive for legacy practitioners to shift away from colonoscopy in the short-term. Long-term, however, colonoscopy cannot endure as the primary support for most GI practices.

Many expect CMS to cut colonoscopy reimbursement rates in the coming years. Competing technologies for colorectal cancer screening have improved, and at some point will likely equal the polyp detection rates demonstrated by the best gastroenterologists, and potentially at a lower overall cost to the system. GIs who want to adopt new technologies such as FUSE must invest in equipment and training without any assurance that reimbursement will increase as their outcomes improve. The interplay of innovation and reimbursement means GIs must diversify their practice beyond colonoscopy.

New data, new practices
Equally significant changes in the treatment of Barrett’s esophagus are on the way. New outcomes data question the need for frequent endoscopic surveillance of nondysplastic Barrett’s. These new data could affect guidelines on both the surveillance interval for patients with Barrett’s and the use of ablation.

Emerging evidence in gastroesophageal reflux disease (GERD) suggest more opportunities for non-pharmacologic intervention. Recent studies show clinical benefit from endoscopic barriers, surgical barriers and pacer/electrical stimulation. There are no clearly superior technologies at this point, but clinical changes are likely.

Natural orifice surgery is showing clear signs of success. The U.S. NOSCAR cholecystectomy study has been completed, but the results are still sealed. Trials have shown very strong early evidence for POEM, and the procedure may be able to replace laparoscopic Heller myotomy; but the lack of a clear coverage and reimbursement pathway could hinder adoption as the Heller procedures have established reimbursement.

The past year also brought progress in fecal microbiome transplantation as the FDA reversed initial objections and accepted FMT for select C. difficile infections. The agency is developing FMT regulations, but reimbursement remains an issue. (More about FMT: fmt.gastro.org)

New codes for endoscopic mucosal resection may allow for physician reimbursement, but the reimbursement amount remains poor in comparison to the time and risk incurred. The current CMS reimbursement structure gives far greater weight to costs incurred than to costs avoided; a selective focus that disadvantages new technologies and procedures that carry higher initial costs but lower overall expenditures to the health system.

New investment climate
The long drought in medtech investment is easing, which made 2013 positive for investors.

The continuing record-low interest rates encourage all varieties of investors. A sharp spike in the number of adults turning 30 will foster investment just as a similar spike fed the investment boom of the 1990s, predicts Jason Mills, managing director and equity research analyst for Canaccord Genuity, San Francisco, CA.

That positive investment climate favors technologies with strong growth. But the most sought-after technologies will be those that offer strong growth plus strong gross margins. Strong margins require appropriate reimbursement. Medical societies can help to bring new technologies to market with an assured reimbursement pathway by acting as impartial intermediaries between industry, payors, regulatory authorities and patients.

Cardiology built a highly successful model using patient registries in transcatheter valves (TVT registry) and left ventricular assist devices (INTERMACS). CGIT has launched a similar initiative with the STAR registry. STAR will collect real-world data comparing laparoscopic fundoplication versus transoral fundoplication for GERD. Evidence from both the clinical and cost perspectives will be key to winning the marketing and reimbursement approval that clinicians need to bring innovation into clinical practice.

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