More Important COVID-19 Updates for ACG Members and GI Practices
From ACG Legislative and Public Policy Council Chair, Whitfield L. Knapple, MD, FACG
In an effort to keep ACG members and GI practices up to date on important updates for patients and members in the wake of the 2019 Novel Coronavirus (COVID-19) outbreak, please find below the latest information tailored for GI practices from the Centers for Medicare and Medicaid (CMS), the U.S. Centers for Disease Control (CDC), and the U.S. Food and Drug Administration (FDA):
CMS is posting a fact sheet relating to the Medicare Administrative Contractors’ (MACs) pricing of both the CDC and non-CDC tests.
CMS issued key protective mask guidance for health care workers. CMS also sent a memorandum to State Survey Agencies clarifying the types of facemasks health care workers may use in situations involving COVID-19 and other respiratory infections.
For Medicare Beneficiaries and Patients
CMS updated its fact sheet on coverage and payment related to COVID-19.
CMS also issued FAQs relating to essential health benefits and COVID-19.
CDC updated its clinical guidance for management of patients with confirmed COVID-19.
The FDA authorized the third emergency use test granted for the COVID-19 outbreak.
The FDA set up a 24/7 hotline to help labs with diagnostic test issues.
The FDA released a letter to health care providers on surgical mask and gown conservation strategies.
FDA Safety Alert: Risk of Infections and Serious Adverse Events in FMT
From ACG FDA Related Matters Committee Chair Stephen Hanauer, MD, FACG
On Thursday, the U.S. Food and Drug Administration (FDA) released a safety alert announcing serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT). According to the FDA, there have been infections caused by enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producing Escherichia coli (STEC). The FDA also suspects these pathogenic organisms were transmitted from FMT products supplied by a stool bank company based in the United States. Read the full safety alert here.
As background, in July 2013, the FDA issued a guidance document stating that it intends to exercise enforcement discretion under limited conditions discretion regarding the IND requirements for the use of FMT products to treat C. difficile infection in patients that have not responded to standard therapies, provided that the patient has given consent. The consent should include, at a minimum, a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks.
ACG will continue to monitor and notify members of important FDA safety alerts impacting patients and GI practices.
Practice Management Toolbox Article: Developing an Infection Control Plan for Your Office
Reminder: Your Medicare MIPS/QPP 2019 Reporting is Due March 31
Please note that the 2019 Medicare Merit-based Incentive Payment System (MIPS) submissions are due on March 31. According to CMS, the data submission window closes March 31, 2020, 8pm (Eastern). Make sure you sign-in to submit or review your 2019 performance year data. Final feedback will be available summer 2020. Click here to sign-in and report your data.
Guidance for ACG members: Are you a small or solo practice? New to Medicare? Not sure if you even have to report MIPS data? Or looking for last minute help to avoid a Medicare payment cut in 2021? Click here to read ACG’s “Making $ense of MACRA” guidance for the 2019 reporting year.
Remember to contact your ACG Governor on important state and local issues impacting you and your practice.
The ACG Board of Governors is one of the most unique aspects of the American College of Gastroenterology. Governors are ACG Fellows that are elected from the membership of a particular state or region. There are currently 77 Governors across seven different regions in the U.S. and abroad. The Board of Governors acts as a two-way conduit between College leadership and the membership at-large. This helps the College make certain it is meeting the evolving needs of the membership.