From payment issues to new technology and superbugs to company news, here are 10 of the biggest stories to break in the gastroenterology and endoscopy field this year.
1. Colonoscopy and lower GI/endoscopy reimbursement cuts. In July, CMS released the 2016 Medicare Physician Fee Schedule proposed rule, which includes cuts for colonoscopy and other lower GI/endoscopy procedures. The reimbursement cuts for the colonoscopy family procedures could be up to 19 percent. Proposed changes for 11 lower GI/endoscopy procedures, by RVU percent change, include:
• Colonoscopy with biopsy (45380): -19 percent
• Colonoscopy with snare polypectomy (45385): -12 percent
• Colonoscopy (45378): -11 percent
• Colorectal cancer screen, high risk (G0105): -2 percent
• Colorectal cancer screen, low risk (G0121): -2 percent
• Colonoscopy with hot biopsy (45384): -11 percent
• Colonoscopy with submucosal injection (45381): -14 percent
• Colonoscopy, flexible with ablation (45388): -15 percent
• Flexible sigmoidoscopy with biopsy (45331): -7 percent
• Flexible sigmoidoscopy (45330): -20 percent
• Colonoscopy with control of bleeding (45382): -16 percent
The American College of Gastroenterology, American Gastroenterological Association and American Society for Gastrointestinal Endoscopy are working with their members and lawmakers to advocate for the specialty and fight against the proposed payment cuts.
CMS will issue its final rule by Nov. 1.
2. Colonoscopy quality measure. CMS tested a new outpatient colonoscopy quality measure for ASCs and hospital outpatient departments through July 31. The "7-day risk-standardized hospital visit after outpatient colonoscopy" measure is new to the CMS ASC Quality Reporting Program. ASCs and HOPDs will be required to collect this data on this measure in CY 2016. CY 2018 payments will be impacted by the data collection. CMS offered the "dry run" period in July to allow ASCs and HOPDs to a chance to measure results and ask any questions.
4. Superbug outbreaks. Duodenoscopes used during ERCP made national headlines this year, following several high profile "superbug" outbreaks. Ronald Reagan UCLA Medical Center in Los Angeles discovered an outbreak of Carbapenem-resistant Enterobacteria in January and began to notify 179 patients who could have been exposed to CRE from October to January. Of seven patients infected, two died.
Shortly after the UCLA Medical Center news broke, Cedars-Sinai Medical Center in Los Angles reported four patients had contracted CRE. Both the UCLA and Cedars-Sinai outbreaks were linked to duodenoscopes used to perform ERCPs. The same scope was used on the four Cedars-Sinai patients between August 2014 and January 2015.
Three major manufacturers – FUJIFILM, Olympus and PENTAX – all manufacture duodenoscopes. Closely following the outbreaks, the FDA released a safety communication addressing concerns over the scope's design and reprocessing. In August, the FDA sent warning letters to all three companies regarding their scopes and a number of violations.
5. MOC recertification. The majority of gastroenterologists, 93 percent, think the current maintenance of certification process is burdensome and irrelevant to their practice, according to the AGA. In light of frustration with the current MOC process, the AGA proposed an alternative to recertification with the American Board of Internal Medicine. The proposed alternative is called The Gastroenterologist: Accountable Professionalism in Practice. Shortly after the AGA's proposed alternative was released, the ABIM released proposed changes to its own certification process in the report A Vision for Certification in Internal Medicine in 2020.
6. Colonoscopy alternatives. Colonoscopy remains the gold standard for colorectal cancer screening, and a key diagnostic and therapeutic tool for other GI conditions, but alternatives to GI's mainstay procedure are gaining traction. For example, the global market for capsule endoscopy is expected to generate revenues of $399.7 million by 2020. The market is expected to grow at a compound annual growth rate of 14.8 percent from 2015 to 2020.
Additionally, Cologuard, the noninvasive stool DNA colorectal cancer screening test developed by Exact Sciences, made strides in the market. CMS voted to uphold the test's $492.72 Medicare reimbursement. The test has also gained coverage from several commercial insurers.
7. HCV drugs. New hepatitis C drugs have been making headlines for more than a year, for both high efficacy rates and prices. Researchers at the University of Pittsburgh estimate that HCV could become a rare disease as early as 2036. The researchers based their prediction on the combination of HCV screening at birth and the use of new, direct-acting antiviral drugs.
This year, the FDA approved two new oral HCV drugs. Technivie, from AbbVie, is a combination of ombitasvir, paritaprevir and ritonavir. The drug is designed for use with ribavarin for adult HCV patients with genotype 4. Daklinza, from Bristol-Myers Squibb, was cleared for use with Sovaldi from Gilead Sciences for the treatment of HCV genotype 3.
Gilead Sciences is also in the process of evaluating Sovaldi with its experimental NS5A inhibitor velpatasvir. The once-daily, fixed dose combination of drugs is showing promise for treating all forms of hepatitis C. Gilead is testing the treatment in four late-stage studies.
Though drugs such as these continue to make strides in eliminating HCV, their high price tags remain a hot topic of conversation. The American Association for the Study of Liver Diseases, Infectious Disease Society-USA and International Antiviral Society-USA are collaborating to update hepatitis C treatment guidelines to include a section on cost-effective treatment. The updated guideline, still in draft form, is being designed to inform physicians of the economics of HCV treatment.
Early this year, Gilead Sciences announced plans to allow generic drug makers develop a new version of its Sovaldi. This new iteration of the drug is undergoing clinical trials, but Gilead contends that it will be more effective at treating HCV. Clinical trials are expected to finish this year.
8. CalPERS cost savings. Colonoscopy is a value tool for colorectal cancer screening and has the potential to result in significant cost savings. Two years ago, the California Public Employees' Retirement System began offering patients full coverage for colonoscopy screenings. Under the CalPERS’ reference system, colonoscopies performed at ASCs would be covered in full, while colonoscopies performed at hospital outpatient departments would only be covered up to $1,500. Researchers from the University of California-Berkeley conducted a study of savings generated from the CalPERS initiative. During the study period, the percentage of CalPERS patients who selected ASCs for their colonoscopies increased from 70 percent to 90 percent. Over the two year span, CalPERS saved approximately $7 million,
9. EndoChoice IPO. EndoChoice had a busy year. In January, the company launched its second generation Fuse endoscopy system. Then in May, EndoChoice launched its initial public officer. The IPO yielded $94.9 million. The proceeds will be used for the continued commercialization of its Fuse system.
10. GERD treatment. Gastroesophageal reflux disease continues to be one of the most common conditions gastroenterologists encounter. There are approximately 7 million GERD diagnoses in the ambulatory setting in a year period, according to the AGA. In August, a new study confirmed Stretta, a non-abalative radiofrequency treatment for GERD, as safe, effective and durable. In May, Mederi Therapeutics announced its Stretta Therapy had been used in 18,000 cases of GERD.