FDA Safety Alert: NDMA Found in Zantac/Ranitidine Samples

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

FDA Safety Alert: NDMA Found in Zantac/Ranitidine Samples

On Friday, the U.S. Food and Drug Administration (FDA) announced that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

The FDA is not calling for individuals to stop taking ranitidine at this time. According to the FDA, you can discuss other treatment with patients should they wish to discontinue taking prescription ranitidine.

Read the FDA safety alert here. ACG will continue to update membership on important safety alerts impacting clinical GI and our patients.

House Committee Holds Hearing on Barriers to Care and Burdens on Small Medical Practices

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

On Wednesday, the House Committee on Small Business held a hearing on “Barriers to Care and Burdens on Small Medical Practices." The hearing reviewed the effects that step therapy, prior authorization, and burnout have on patient care and physician practices. Step therapy, of course, creates unnecessary obstacles for a patient to receive the best possible care. Burnout reduces the number of physicians available to patients and puts additional operational and administrative stress on the physicians that continue to serve their communities. Lastly, prior authorization drives up the cost of running a practice, increases burnout, and increases time for a patient to receive the medication they need. One interesting statistic that came out of the hearing—two-thirds of patients will receive a delay in treatment because of prior authorization.

On behalf of your patients, tell Congress to pass H.R. 2279, the Safe Step Act, and H.R. 3107, the Improving Seniors' Timely Access to Care Act of 2019!

Rep. Brad Wenstrup, MD (R-OH) at the 2019 ACG Washington D.C. fly-in. Rep. Wenstrup has introduced the Safe Step Act, or H.R. 2279. Click on the picture above to tell Congress to pass H.R. 2279!

From ACG Massachusetts Governor Anthony Lembo, MD, FACG

ACG Governors are also active on step therapy legislation at the state and local level too!

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.

Learn how to get your patients the medication you prescribed without unnecessary steps! Attend the ACG Annual Meeting and register for the "Roadmap for a Successful Community or Academic GI Practice" course. You will learn invaluable tips and tricks on approaches to obtaining pre-authorizations and appealing denials for pharmaceutical therapies.

It's Back! Apply to be a Part of the Joint ACG-FDA Fellowship Program

Current first and second-year fellows are invited to submit their application for a one-month rotation at the U.S. Food and Drug Administration (FDA), sponsored by ACG. Third-year fellows who are taking a 4th year of advanced fellowship may apply as well.

Awardees will have the opportunity to participate in daily FDA activities and will gain firsthand knowledge of the drug and device approval process. The College will provide a stipend for travel and daily living expenses.

Eligible applicants must complete an online application which must include two recommendations: one from the fellow's current Program Director and one from a Fellow of the American College of Gastroenterology (FACG).

All applications must be submitted to ACG and will be reviewed by the ACG FDA Related Matters Committee along with staff at the FDA. The candidate will be chosen and notified of acceptance by November 2019.

The application deadline is Friday, September 27, 2019.

For complete details regarding the FDA-ACG Fellowship Program, click HERE.

Will ACG Members be Subject to Additional Documentation Requirements? CMS and Congress Can Easily Fix This Issue

CMS recently released the CY 2020 proposed regulation on the Medicare physician fee schedule payment changes. In this rule, CMS seeks comment on whether ACG members should be required to notify patients of the cost-sharing implications prior to performing a lonoscopy, and then document these notifications in the medical record. CMS also seeks comment on how to monitor and audit compliance. ACG and the GI societies oppose this proposal. ACG members would be subject to additional audit and compliance requirements due to a problem that CMS and Congress can easily resolve.

ACG, AGA, and ASGE recently met with CMS officials to discuss CMS’ recent proposal on whether gastroenterologists should be required to educate patients on the Medicare cost-sharing quirk with patients prior to performing a screening colonoscopy.

This is a policy solution that should not be borne by ACG members: Urge U.S. House Leadership to Take Up H.R. 1570 Now!

The Removing Barriers to Colorectal Screening Act of 2019, (H.R. 1570 and S. 668) achieved an important milestone of securing over 290 supporters in the U.S. House of Representatives (currently, H.R. 1570 has 294 cosponsors). Thank you for lending your voice to support this bill!

Why Your Help Matters Now: According to the U.S. House of Representatives Rules Committee, Speaker Pelosi and the U.S. House must consider one bill (at a minimum) from the “Consensus Calendar” each session week. For a bill to be eligible for the Consensus Calendar, a measure must accumulate 290 cosponsors for at least 25 legislative days. While a vote is not guaranteed just for meeting the criteria, not many bills will meet this threshold, thus improving the likelihood of consideration.

A Recent Review of Medicare Fee-for-Service Claims Emphasizes the Need for Congress to Pass H.R. 1570 and S. 668

ACG and the Moran Company recently reviewed Medicare claims data from 2011 to 2017 and found that the incidence of polypectomy during screening colonoscopy is increasing dramatically. This is good news. For each percent increase in pre-cancerous polyp detection, there is a 3 percent reduction in CRC incidence and a 4 percent reduction in CRC death.

Thanks to the improved quality of CRC screening procedures, gastroenterologists have improved adenoma detection rates. At the same time, CRC incidence rates in the Medicare-age population have been declining as well.

Quality is Improving!

... But Medicare Beneficiary Liability is Increasing with the “Post-Polypectomy Surprise”
Due to a quirk in federal law, Medicare will cover the full cost of a "screening" colonoscopy. However, when a polyp is detected and removed, this "therapeutic" procedure is no longer considered a "screening" for coding and reimbursement purposes. Thus:

  • Medicare beneficiaries incur surprise out-of-pocket medical costs.
  • This is counter to the U.S. public healthcare goal of removing barriers to increasing CRC screening rates.

In April 2019, 100 ACG Governors and member of the ACG Leadership advocated for the Removing Barriers bill and other important issues impacting your GI practice and patients.

CDC: Viral Hepatitis Cases Continue to Increase

On Tuesday, September 10th, the U.S. Centers for Disease Control and Prevention (CDC) released official viral hepatitis surveillance data for the year 2017. Some highlights:

Hepatitis A: Incidence rates decreased more than 95% from 1995 to 2011, then increased by 140% from 2011 to 2017. Until 2017, US incidence rates were influenced by occasional outbreaks, often linked to imported food, and from time-to-time among non-immune persons. In 2017, large person-to-person outbreaks began occurring among persons who use drugs and persons experiencing homelessness. Rates of acute hepatitis A infection remain low in children and adolescents due to childhood vaccination recommendations for hepatitis A starting in 1996. In 2017, rates of reported acute hepatitis A cases increased more markedly for males than for females, consistent with higher rates of drug use among men compared to women. The incidence among Asian/Pacific Islanders returned to the 2015 rate following an uptick in 2016 that was likely due to the ending of a large foodborne outbreak that occurred in Hawaii.

Hepatitis B: Injection drug use is a major risk factor associated with acute hepatitis B cases in the U.S. Chronic hepatitis B infections primarily occur among persons born outside the US in countries with intermediate or high rates of hepatitis B prevalence. For the first time between 2002 and 2017, adults aged 40–49 had the highest rate of acute hepatitis B in 2017. Males have historically experienced higher rates of reported hepatitis B compared to females, consistent with risk factors being more common in males.

Hepatitis C: New cases of acute hepatitis C have increased rapidly in the U.S. since 2010, and have most often been associated with injection drug use. Rates rapidly increased for young adults aged 20–29 years and aged 30–39 years from 2009 to 2017. These age groups have been most affected by the nation’s opioid crisis. For the first time since 2014, adults aged 40–49 years experienced a decrease in infection rates from 2016 to 2017. Rates increased among adults aged 50–59 years and aged ≥60 years from 2015 to 2017 to the highest rate reported from 2002 through 2017. Both males and females experienced an increased rate of reported acute hepatitis C from 2010 to 2017, although the increase for males was more pronounced.

Number of Reported New Infections by Year
2015 2016 2017
Hepatitis A 1,390 2,077 3,366
Hepatitis B 3,370 3,218 3,407
Hepatitis C 2,436 2,967 3,186

Click here to access the 2017 report and here access the updated tables/figures. ACG will continue to update membership on the latest findings from CDC and other health agencies.