FDA Safety Alert: Voluntary Recalls of Ranitidine Hydrochloride Capsules

From ACG FDA Related Matters Committee Chair Stephen Hanauer, MD, FACG

This week, the U.S. Food and Drug Administration (FDA) announced that Sandoz Inc. and Apotex Corp. are voluntarily recalling Ranitidine Hydrochloride Capsules in the U.S. to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA. Please note, according to the FDA, Sandoz and Apotex have not received any reports of adverse events related to use of the product as part of this recall.

Read the FDA safety alert on Sandoz’s recall here.
Read the FDA safety alert on Apotex’s recall here.

ACG will continue to work with the FDA and update you on important safety alerts impacting clinical GI.

The ACG Board of Governors Urge Speaker Nancy Pelosi to Pass H.R. 1570: ACG Governors Continue to Represent You in Washington D.C.

From Neil Stollman, MD, FACG and Patrick Young, MD, FACG, Chair and Vice Chair of the ACG Board of Governors:

ACG Board of Governors Chair Neil Stollman, MD, FACG

ACG Board of Governors Vice Chair Patrick Young, MD, FACG

In a letter to Speaker Nancy Pelosi this week, the ACG Board of Governors requested U.S. House leadership to pass the Removing Barriers to Colorectal Cancer Screening Act of 2019 (H.R. 1570). H.R. 1570 resolves an unanticipated flaw in the Affordable Care Act that results in a "surprise medical bill" when a polyp is removed during a screening colonoscopy. According to the American Cancer Society, 145,600 Americans will be diagnosed with colorectal cancer and over 51,000 will die from this disease in 2019. It is crucial that Congress corrects this significant lapse in Medicare beneficiary cost-sharing protections. Congress is currently considering "surprise medical bill" legislation. H.R. 1570 resolves one example of a surprise bill, the "post-polypectomy surprise bill" when a screening turns therapeutic.

Read the ACG Board of Governors letter to Speaker Pelosi here.

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.

New in the ACG Magazine: Practice-Friendly Private Equity – What to Look for When Selling Your Practice

The new edition of the ACG Magazine is out, covering hot topics for ACG members and GI practices. Private equity continues to be one such topic in GI. In the “law mind” section of the ACG Magazine, frequent contributor Ann Bittinger, Esq. outlines some issues on private equity in GI and offers guidance for those GI practices considering partnering with private equity firms. Check out the article here.

Want More Guidance on Private Equity and GI Practices?

Learn the important issues when considering the private equity option! Attend the ACG Annual Meeting and register for the "Roadmap for a Successful Community or Academic GI Practice" course.

CMS Releases "Omnibus Burden Reduction" Rule: How Does this Impact You?

From ACG Legislative and Public Policy Council Chair, Whitfield L. Knapple, MD, FACG

On Thursday, September 26th, the Centers for Medicare & Medicaid Services (CMS) released the Omnibus Burden Reduction (Conditions of Participation) Final Rule. According to CMS, the rule is designed to “cut the red tape, bringing relief to America’s healthcare providers by reducing unnecessary burden, allowing them to focus on their top priority – patients.” While the rule largely focuses on hospitals and facilities, here are some important issues impacting ambulatory surgical centers (ASCs) and ACG members:

  • Removes the provisions requiring ASCs to have a written transfer agreement with a hospital that meets certain Medicare requirements, or that all physicians performing surgery in the ASC have admitting privileges in a hospital. Instead, ASCs will be required to periodically provide the local hospital with written notice that outlines the ASC operation and patient population served by the ASC facility. All ASCs must continue to have an effective procedure for immediate transfers to a hospital for patients requiring emergency medical care beyond the capabilities of the ASC.
  • Removes the current requirements that a physician or other qualified practitioner conduct a complete comprehensive medical history and physical assessment on each patient not more than 30 days before the date of the scheduled surgery. Additionally, CMS is finalizing the requirement that each ASC establish and implement a policy that identifies patients who require an history and physical (H&P) prior to surgery.

Please click here for a fact sheet. Please click here to view the final rule.

ACG will continue to advocate on your behalf in reducing unnecessary burdens for GI clinicians.

New ACG Guidance! Accessing FDA Resources in Clinical Practice: A Primer for the Practicing Gastroenterologist

From Eric D. Shah, MD (pictured), Dawn B. Beaulieu, MD, Bruce Yacyshyn, MD, FACG, and the FDA Related Matters Committee

The inner workings of the Food and Drug Administration (FDA) can seem elusive from the realities of the day-to-day clinical practice. For the FDA to accomplish its mission, they have exclusive access to comprehensive and historical clinical trial data and a wealth of outcomes data. These data include the largest claims dataset covering over 227 million Americans, including patient-level data. Staying up-to-date with FDA communications is important as gastroenterologists and their patients look for guidance in areas of rapid innovation such as biosimilars, fecal microbiota for transplantation, and endoscopic bariatric treatments.

Click here for a summary of useful datasets and resources published on the FDA website which can enable gastroenterologists to stay current with regulatory guidance and access valuable FDA resources.