Important FDA Safety Alerts in GI: What you need to know

Boxed warning for Ocaliva (obeticholic acid)

The U.S. Food and Drug Administration (FDA) issued a warning this week stating that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC). To ensure correct dosing and to reduce the risk of liver problems, the FDA clarified the current recommendations for screening, dosing, monitoring, and managing PBC patients. The FDA also added a new Boxed Warning, FDA’s most prominent warning, to highlight this labeling information.

As a condition of approval, the FDA required the manufacturer of Ocaliva, Intercept Pharmaceuticals, to continue studying the medicine in patients with advanced PBC. These clinical trials are currently ongoing, and FDA expects to receive results in 2023. The FDA is adding the additional warnings to the drug label after receiving reports that Ocaliva is being given to PBC patients more often than is recommended in the prescribing information, resulting in liver decompensation, liver failure, and sometimes death.  The FDA recommends that providers should follow the Ocaliva dosing regimen in the drug label, which is based on calculating a Child-Pugh score in PBC patients with suspected liver cirrhosis before treatment to determine their specific classification and starting dosage.  Dosing higher than recommended in the drug label can increase the risk for liver decompensation, liver failure, and sometimes death.

FDA encourages safe use of Imodium (loperamide)

Click here to read the full blog.

CMS updates to 2017 “Extreme and Uncontrollable Circumstances” Policy for MIPS: Important for ACG members in recent natural disaster areas

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

CMS updates to 2017 "Extreme and Uncontrollable Circumstances" Policy for MIPS Clinicians: Important for ACG members in recent natural disaster areas

This week, the Centers for Medicare & Medicaid Services (CMS) has updated its Extreme and Uncontrollable Circumstances policy for the 2017 Merit-based Incentive Payment System (MIPS) transition year to include counties affected by Hurricane Nate and additional counties affected by the California wildfires.

The data submission period for the 2017 transition year of MIPS is January 2 through March 31, 2018. MIPS-eligible clinicians in Federal Emergency Management Agency (FEMA) designated areas affected by Northern California wildfires and Hurricanes Harvey, Irma, Maria and Nate will be automatically identified. No action is required.  MIPS-eligible clinicians in these newly identified designated areas for Hurricane Nate and the California Wildfires are now covered by the Extreme and Uncontrollable Circumstances policy:

  • Alabama: Autauga, Baldwin, Choctaw, Clarke, Dallas, Macon, Mobile, and Washington
  • Mississippi: George, Greene, Hancock, Harrison, Jackson, and Stone
  • California: Butte, Lake, Mendocino, Napa, Nevada, Orange, Santa Barbara, Solano, Sonoma, Ventura, and Yuba

To learn more, please see CMS’ Extreme and Uncontrollable Circumstances Policy for MIPS in 2017 Fact Sheet.

Important Note: If you are automatically identified but still choose to submit data on two or more MIPS performance categories and your MIPS payment adjustment will be based on your final score.

ACG Advocacy Paying Off

This is welcomed news, as ACG has been urging CMS to grant these exemptions for ACG members impacted by these natural disasters.  ACG also championed a resolution at the recent American Medical Association (AMA) House of Delegates meeting to urge the AMA and others to advocate for more regulatory waivers for providers impacted by recent hurricanes.

From the ACG Governors: Update on Saline Shortages

The ACG Board of Governors meets regularly throughout the year to discuss important clinical and practice management issues impacting ACG members and our patients.  The ACG Governors recently met in Las Vegas during the 2018 ACG IBD School & Board of Governors/ASGE Best Practices Course.  Of note, the ACG Governors conveyed the continued concerns of many of our colleagues across the country regarding saline shortages.  As ACG members are aware, saline shortages have been a significant issue over the past several months.  The ACG Governors continue to represent your interests and advocate on your behalf.  Thus, saline shortages have been an important priority for ACG leadership.

This week, the FDA provided an update on saline shortages:

We recognize that managing the thousands of flu-related hospitalizations has increased the demand for certain saline products – which are commonly used to both hydrate and deliver medications via intravenous routes. As we’ve shared over the past several months, across the country, there remains a shortage of IV saline bags, which have long faced supply issues. These supply issues were worsened by the impact of Hurricane Maria on the medical products manufacturing sector in Puerto Rico, which impacted small volume IV bags. Although the saline shortage is improving, this year’s worse-than-normal flu season and workarounds deployed by health care providers in the wake of this shortage have increased demand for saline and other products.

The products include large volume saline bags typically used to hydrate patients; small volume IV saline bags (generally in 50 and 100 ml sizes) that are often used to deliver other medicines; as well as empty IV containers of varying sizes that are being used by many health care providers to compound their own IV saline solutions by filling these empty containers. As such, we’re actively working to improve the large and small IV bag shortage and tracking potential shortages of critical medical products, such as the empty IV containers.

The FDA also provided an update on when ACG members may expect an increased availability of supply: Click here to read the full blog.