The ACG Legislative Action Center: Quick and Easy Advocacy
From ACG Legislative and Public Policy Council Chair, James C. Hobley, MD, MSc, FACG
ACG remains busy on Capitol Hill advocating for important policies impacting our patients and practices. As you know, “step therapy” insurance policies require a certain drug to be used first without success before we can prescribe other treatments. This cost-control measure is bad for our patients, interferes with the patient-physician relationship, and creates significant burdens for our practices.
The Safe Step Act of 2021: The Safe Step Act (S. 464; H.R. 2163) requires group health plans regulated by the Employee Retirement Income Security Act (ERISA) to implement a clear and transparent exceptions process to any step therapy protocol.
The ACG Legislative Action Center: Please urge your leaders in Washington D.C. to support this important bill. The ACG Legislative Action Centers makes "on-the-go advocacy" very simple and easy!
U.S. Senator Bill Cassidy, MD, FACG (R-LA) and U.S. Representative Kim Schrier, MD (D-WA) participated in the 2021 ACG Advocacy Day. Sen. Cassidy and colleagues introduced the Safe Step Act (S.464) in the U.S. Senate.
U.S. Representative Raul Ruiz, MD (D-CA) participated in the 2021 ACG Advocacy Day. Rep. Ruiz and colleagues introduced the House version of the Safe Step Act (H.R. 2163). Not shown: U.S. Representative Larry Bucshon, MD (R-IN) also participated in the 2021 ACG Advocacy Day and is an original cosponsor of H.R. 2163.
The Centers for Medicare and Medicaid Services (CMS) announced this week that Medicare Administrative Contractors (MACs) may now begin conducting post-payment medical reviews for services after March 2020. The Targeted Probe and Educate Program (intensive education to assess provider compliance through up to 3 rounds of review) will restart later. According to CMS, the MACs will continue to offer detailed review decisions and education as appropriate.
CMS also notified Medicare contractors that a blood-based biomarker test is now an appropriate colorectal cancer screening test once every 3 years for Medicare beneficiaries when performed certified laboratory, the patient is age 50-85 years, asymptomatic, and at average risk of developing colorectal cancer. The blood-based biomarker screening test must have other conditions prior to coverage, as outlined in the notification.
ACG, FDA, and Medical Societies Co-Hosting Events in July - Register Today!
From FDA Related Matters Committee Chair, Eric D. Shah, MD, MBA, FACG
Register today for the upcoming "Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI)" Workshops. The U.S. Food and Drug Administration (FDA) is partnering with ACG and other medical societies on two important GI workshops on July 21 and July 22.
The first workshop will be on eosinophilic gastrointestinal disorders. Discussions will focus on the following:
- The diagnosis and natural history of eosinophilic gastrointestinal disorders.
- Assessing clinical benefit in eosinophilic gastrointestinal disorders.
The second workshop will focus on celiac disease. Discussions will focus on the approach to drug development in celiac disease and include the following topic areas:
- The histologic endpoints to assess treatment benefit in patients with celiac disease.
- Regulatory framework for pediatric drug development in celiac disease.
- The role of gluten challenge in clinical trials
Other FDA News:
On Thursday, May 27th, the FDA approved Zeposia (ozanimod) for the treatment of moderately to severely active ulcerative colitis (UC) in adults. This is the first-in-class, sphingosine-1phopate (S1P) receptor modulator approved for use in patients with UC. The recommended dosage is 0.92 mg taken orally daily after a 7-day titration (same dosing as the approved indication for relapsing forms of multiple sclerosis). The FDA hopes to initiate studies in the pediatric population in the near future.
The ACG Practice Management Toolbox: "Better Practices Make Better Lives"
The ACG Practice Management Toolbox is a series of short articles that provide members with easily accessible information to improve their practices.
The ACG Practice Management Committee provide solutions to overcome management challenges, to improve operations, enhance productivity, and support leadership. Committee Chair Stephen T. Amann, MD, FACG and members continue to work under the motto instilled by former Chair, Louis J. Wilson, MD, FACG: "Better Practices Make Better Lives." Check out some recent articles below.