FDA Safety Alert: Voluntary Recalls of Ranitidine Hydrochloride Capsules
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.
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
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.
CMS Releases "Omnibus Burden Reduction" Rule: How Does this Impact You?
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.
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
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.