Pharmacy benefit managers (PBMs) influence access to prescription drugs by negotiating rebates from manufacturers in exchange for formulary placement. While insurers benefit from these rebates, they often disadvantage GI practices by restricting access to biosimilars, impacting patient care. The Federal Trade Commission has acknowledged the significant power PBMs hold, and the medical community is advocating for change.
Author: Abhay Panchal
The FDA has approved ustekinumab-aauz (Otulfi), a biosimilar to Stelara by Johnson & Johnson, for treating conditions like Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. This marks the fourth biosimilar approval for ustekinumab. Otulfi, from Formycon and Fresenius Kabi, will launch in February 2025 due to a settlement agreement. Clinical trials have shown that Otulfi’s efficacy and safety are comparable to Stelara.
UnitedHealthcare’s national prior authorization gold-card program went into effect on Oct. 1, offering reduced pre-certification requirements for providers who meet specific eligibility criteria. Providers must maintain a high prior authorization approval rate and be in-network with UnitedHealthcare plans to qualify. The program aims to streamline the approval process, though it has drawn criticism from the American Gastroenterological Association and American College of Gastroenterology. Some physicians are cautiously optimistic about its potential benefits for patients and providers.
The American Society of Anesthesiologists (ASA) filed a trademark complaint against the American Association of Nurse Anesthesiology (AANA) over the latter’s use of the term “anesthesiology,” claiming it could confuse patients. AANA argues that nurse anesthetists have a long history of safely administering anesthesia. The case reflects broader tensions around professional titles and scope of practice between physicians and nurse practitioners. The decision will be made by the Trademark Trial and Appeal Board but could escalate to federal court.
In this episode of the MGC podcast, Dr. Laurie Keefer discusses her work in brain-gut behavior therapies for GI conditions like Crohn’s disease, ulcerative colitis, IBS, and GERD. She highlights the resistance within the medical community toward nonpharmacological treatments and explores how she selects appropriate behavioral interventions for individual patients. As a key figure in the Rome Foundation and with over 250 peer-reviewed publications, Dr. Keefer shares insights on the growing role of psychological therapies in managing GI disorders.
GI Alliance, the largest U.S. network of gastroenterology practices, has partnered with Medtronic to implement the AI-powered GI Genius™ endoscopy module across its 400 locations. This technology improves polyp detection during colonoscopies, reducing missed polyps by up to 50%, which is critical in early colorectal cancer detection. This collaboration underscores GI Alliance’s commitment to integrating innovative AI solutions to enhance patient care and outcomes, especially in the fight against colorectal cancer.
A new study suggests that patients taking GLP-1 medications like Ozempic, Wegovy, Mounjaro, or Zepbound may have inadequate bowel or stomach preparation before endoscopic procedures. The research found that these patients had higher instances of food remaining in the stomach or stool in the bowel, potentially impacting the effectiveness of endoscopies or colonoscopies. However, no serious complications such as aspiration occurred. More research is needed to assess if updated guidelines for GLP-1 use before these procedures are necessary.
A bariatric surgeon has agreed to pay $45,000 to settle allegations of submitting false claims to Medicare and Medicaid. The settlement follows claims that the surgeon billed for procedures not supported by the necessary medical documentation. The case underscores the ongoing efforts to enforce healthcare fraud regulations and ensure compliance with proper billing practices in the medical field.
The NordICC trial on colorectal cancer (CRC) screening might have underestimated 10-year risk reductions due to delays in cancer registration, affecting study outcomes. Researchers estimate that delays of up to 3 years could have reduced the accuracy of risk reduction by as much as 75%. While screening colonoscopy’s impact appears weaker than anticipated, experts urge caution in interpreting results until full 10- and 15-year follow-up data are available to assess true reductions in CRC risk and mortality.
The FDA has granted breakthrough therapy designation to Sagimet Biosciences’ denifanstat for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced fibrosis. The designation is based on positive results from the phase 2b FASCINATE-2 trial, showing significant improvements in MASH resolution, liver fibrosis, and fat reduction.