Patient Access

AGA POSITION: Patients must have access to the drugs, devices, diagnostics and therapies that can improve their quality of life.

 

AGA supports ensuring that patients have access to new drugs, devices, diagnostics and therapies that can improve their quality of life. Through the AGA Center for GI Innovation and Technology, we support innovation and the development of new technology in gastroenterology, hepatology, nutrition and obesity by guiding innovators, companies, private equity and venture capital through the technology development and adoption process. It is the goal of AGA and the center to help assess the value of new technologies on patient care, and support the approval, coverage and adoption of technologies that demonstrate promise and merit.

AGA appreciates efforts in the House and Senate on the 21st Century Cures initiative to modernize and accelerate the process of developing and delivering new treatments and technologies for patients. We look forward to working with Congress on developing a mechanism that encourages innovation, while also helping us determine which treatments work best for patients.

Coverage of New Treatments and Technologies

Approval of a new device or technology does not always translate into coverage for patients. When providers are not reimbursed for new technologies and patients are not covered, providers are less likely to use the new treatment, which can harm patients who might not be receiving access to potentially life-saving treatments. Specifically, AGA is concerned that Medicare Administrative Contractors (MACs) automatically put Category III codes on their non-covered lists, because they are categorized as “new technology.” AGA suggests that rather than a blanket policy to not cover Category III codes or “new technologies,” MACs should review all reference studies and literature considered by the AMA CPT Editorial Panel when the Category III code is approved, in addition to any peer-reviewed, published data and data from observational research. This change in policy and additional independent review will provide greater consideration of the effectiveness of the treatment for a potential patient.

Use of Observational Registries

Over the last decade, several technologies that could have improved gastroenterology care failed due to a lack of guidance and support. AGA offers a unique blend of clinical, research, regulatory and payment knowledge to companies that are working on GI, nutrition and hepatology devices, therapeutics, and diagnostics. As a neutral objective broker, the AGA Center for GI Innovation and Technology works with device, diagnostic and other life science companies in the GI space to identify and gather the data needed by key stakeholders in the health-care system. These stakeholders include providers, payors, purchasers, accountable care organizations and regulatory agencies.

  • STAR Registry. A partnership of the AGA Center for GI Innovation and Technology and EndoGastric Solutions®, the registry compares laparoscopic surgery to an incisionless procedure to treat gastroesophageal reflux disease (GERD).

The “STAR Registry” (Laparoscopic Nissen Fundoplication [LNF] Surgery Versus Transoral Incisionless Fundoplication [TIF®]: Anti-Reflux Treatment Registry) will provide the first real-world data observing patient outcomes following traditional laparoscopic surgery and TIF with the EsophyX® device. The goal of the STAR registry is to gather important data about the benefits of surgery in patients with GERD, a condition that affects millions of people.

  • Fecal Microbiota Transplantation (FMT). The leadership of AGA, the Infectious Diseases Society of America, the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, and the Crohn’s & Colitis Foundation of America, supported by the American College of Gastroenterology, and together with the FDA and CDC, have submitted an NIH proposal to develop and manage a protocol to examine the long term safety, efficacy and outcomes of the fecal microbiota transplant (FMT) procedure. A national FMT registry will assess short- and long-term safety and effectiveness, help standardize best practices for FMT, and gauge the potential consequences of manipulating the gut microbiome on human health and disease.
Collaboration with FDA
  • Reducing Regulatory Barriers to Physicians to Offer FMT to Patients. AGA worked very closely with FDA urging them to streamline the process of providing FMT to patients in need. FDA announced that physicians will not be required to apply for an investigational new drug (IND) for the use of FMT to treat patients with C. difficile infection who do not respond to standard therapies. This policy, which still encourages physicians to submit an IND and to receive informed consent as to the potential risks from the patient, was a victory for both physicians and for some of our sickest patients who will now have access to a life-saving treatment.
  • Ensuring Patient Safety with Endoscopic Procedures. AGA is working with FDA, CDC, and manufacturers to ensure patient safety from the use of endoscopic procedures, such as endoscopic retrograde cholangiopancreatography (ERCP), which was recently linked to the spread of carbapenem-resistant Enterobacteriaceae (CRE). Some have referred to this germ as a “superbug,” because it has become resistant to most available antibiotics. Patient safety of endoscopic procedures is a primary concern for gastrointestinal endoscopists and we continue to educate gastroenterologists and surgeons who perform ERCP to be aware of the potential for infection by CRE bacteria through ERCP. AGA urges increased vigilance around cleaning these highly specialized instruments and strict adherence to manufacturers’ guidelines and infection control guidelines. We encourage hospitals and other facilities to conduct periodic assessments of their disinfection procedures and practices. Additionally, we urge these facilities to ensure the competency of all staff involved in disinfecting these devices. We will continue to work with FDA and other agencies to ensure a proper resolution that ensures the safety of our patients who undergo this procedure.

 February 2015