Becker's ASC Review

15 GASTROENTEROLOGY GI's changing regulatory landscape By Claire Wallace T he last 12 months saw major regulatory changes for the field of gastroenterology, from new FDA approvals to sweeping statewide and national legislation. Here is what to know about a handful of recent regulatory changes. FDA approvals In July, the FDA approved a new screening test for colorectal cancer that only requires a sample of blood. While met with mixed reviews from physicians and GI groups, the blood test, created by Palo Alto, Calif.-based Guardant Health, was able to detect 83% of colorectal cancers in studies, but only 13% of dangerous polyps. In October, the FDA also approved the Cologuard Plus test, a next- generation, multitarget stool DNA test approved for patients at an average risk for colorectal cancer. e FDA's approval was based on findings from the Blue-C study, one of the largest prospective, head- to-head studies ever conducted in colorectal cancer screening. Among the 19,000 study participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity. State legislation On Jan. 1, legislation went into effect in four states providing patients full insurance coverage for their colonoscopy procedures. Nebraska, Illinois, Vermont and Kentucky have expanded access for patients. "is is great legislative advocacy for patients and I applaud the efforts and initiative of the Illinois General Assembly," Omar Khokhar, MD, partner at Illinois GastroHealth in Bloomington, told Becker's. "Colon cancer is preventable with early detection and anything that increases access will improve CRC-related morbidity, mortality and associated costs." Drug approvals In 2024, the FDA approved 50 new drugs. One of those drugs, Vyloy, approved on Oct. 18, falls under the umbrella of gastroenterology. Vyloy is used to treat gastric or gastroesophageal junction adenocarcinoma. It is used in combination with fluoropyrimidine- and platinum-containing chemotherapy. n Where do independent GIs stand in 2025? By Francesca Mathewes R ising practice costs and increased consolidation across healthcare have made it more difficult for gastroenterologists to maintain independent practices. According to a November 2024 report by Medicus, independent, Medicare-billing gastroenterologists dropped by 58% between 2019 and 2022. Reimbursement rates may play a key role in the decline of independent gastroenterologists — between 2007 and 2022, average GI reimbursements fell by 33%, when adjusted for inflation. In November, CMS also finalized a 94-cent (2.83%) conversion factor decrease from 2024. e physician fee schedule conversion factor for 2025 is $32.35, down from $33.29 in 2024. Physicians and medical groups have expressed concern over the decrease in reimbursements, saying that year-over-year decreases are proving unsustainable for many. e Digestive Health Physicians Association released a statement July 16, when the rule was proposed, opposing the cut, saying it "follows years of negligible increases, freezes and a payment cut in 2024." "is is unsustainable for our nation's medical groups, physicians and other health care providers," the statement said. "e effects of these cuts will be exacerbated in rural and underserved areas, which continue to face significant healthcare access challenges." e disparity between sites of service for gastroenterology procedures may be pushing gastroenterologists toward employed settings. In an ASC setting, the average colonoscopy costs $925, compared to $1,224 in a hospital outpatient department. Additionally, screening colonoscopies in the U.S. cost a total of $23.7 billion in 2021, the most recent available data for nationwide cancer screening costs. Number of female GIs grows 219% in 18 years By Claire Wallace F rom 2004 to 2022, the number of women in the active physician workforce increased 97%, while the number of men increased 13%. This was a major stride for women in the medical workforce, as female physicians are still majorly underrepresented, especially in certain specialties. Among the 20 largest physician specialties, women's representation between 2004 and 2022 grew the second most in gastroenterology, led only by critical care medicine, according to a May news release from the Association of American Medical Colleges. In 2004, women made up 9% of the GI workforce, while in 2022, they made up 21% of the workforce. That is a growth of 219%. Meanwhile, female physicians see the least representation in orthopedics (6%) and urology (11%). n

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