FDA Requests Withdrawal of Weight-Loss Drug
From ACG FDA Related Matters Committee Chair Stephen Hanauer, MD, FACG
On Thursday, the U.S. Food & Drug Administration (FDA) requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw its weight-loss drug from the U.S. market because of an increased occurrence of cancer. The drug manufacturer, Eisai, has submitted a request to voluntarily withdraw the drug from the market. In January 2020, ACG alerted members that the FDA was reviewing clinical trial data about a possible risk of cancer associated with lorcaserin.
According to the FDA, ACG members should stop prescribing and dispensing lorcaserin to patients. Contact patients currently taking lorcaserin, inform them of the increased occurrence of cancer seen in the clinical trial, and ask them to stop taking the medicine. Discuss alternative weight-loss medicines or strategies with your patients.
FDA is not recommending special screening for patients who have taken lorcaserin.
Read the full FDA safety alert here.
ACG will continue to work with the FDA on important safety issues impacting our patients and practices.
Movement on "Surprise Billing" Legislation in the U.S. House of Representatives
From ACG Legislative and Public Policy Council Chair, Whitfield L. Knapple, MD, FACG
The U.S. House Ways and Means Committee on Wednesday advanced its version of legislation to end "surprise" medical bills. On Tuesday, the U.S. House Education and Labor Committee approved its proposal. As ACG has updated you in the past, there is bipartisan support to address out-of-network and “surprise” medical bills in the both the U.S. House and Senate. However, there are various competing proposals within each chamber of Congress and disagreements on how payment disputes will be resolved between providers and insurers. Specifically, whether there should be a simple benchmark and/or have an independent dispute resolution (IDR) process when insurers and providers are unable to agree on an acceptable payment for services.
The House Education and Labor Committee proposal that was approved on Tuesday is similar to an agreement struck last year by U.S. House Energy and Commerce and the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee. The HELP Committee’s proposal on “surprise billing” resolves payment disputes by paying plans and providers at a federal benchmark set to the median in-network rate for each area of the country. The Energy & Commerce Committee agreement established the option to go to arbitration for bills over $750.
The Congressional Budget Office (CBO) is tasked with “scoring” a bill, or estimating the costs/savings to the federal government if the bill were enacted. The provision ending surprise medical bills by instituting a federal benchmark payment would save nearly $24.8 billion over 10 years (offsetting other federal spending contained in the committee's bill).
The Ways & Means Committee bill resolves disputes via an independent mediator. The Ways & Means proposal was concerned about benchmarks that may ultimately favor health plans in payment disputes. The CBO estimates that the Ways & Means proposal would save the government $17.77 billion over 10 years.
Congressional leaders are hoping to negotiate an agreement and pass a bill by the end of May 2020, as part of a package reauthorizing funding for a set of federal health programs. The Trump Administration this week also urged the committees to come to an agreement and pass a bill.
What is ACG Doing for You?
While “surprise medical bills” may impact GI less than other specialties, ACG is concerned about the downstream effects of any “surprise billing” legislation on GI non-emergency and outpatient services, out-of-network disputes on ancillary services such as pathology and anesthesia, as well as the impact on future contract negotiations. According to policy experts, a statutory benchmark to settle any out-of-network payment dispute set at the median rate, for example, provides little incentive for insurers to agree to a rate above the median when negotiating new contracts with participating or in-network providers. This may ultimately drive the median rate lower.
ACG will be on Capitol Hill next week, working with the U.S. House Ways & Means Committee members and others in helping to advance a "surprise billing" proposal that is equitable for ACG members and physician practices. A recent report on New York’s law suggested that the IDR process is an equitable process: "As of October 2018, IDR decisions have been roughly evenly split between providers and payers, with 618 disputes decided in favor of the health plan and 561 decided in favor of the provider. However, insurers have tended to win the majority of out-of-network emergency services disputes (534-289), while providers have won the majority of surprise bill disputes (272-84)." The NY law advises mediators to consider the “usual and customary rate” for a service, defined as the 80th percentile of all (non-discounted) charges for a particular healthcare service performed by a provider in the same or similar specialty within the same geographic area. At least 25 states have laws protecting patients from surprise out-of-network bills, usually for emergency care.
New Program This Year: ACG's Meet Your Governor Initiative
From ACG Governors James Hobley, MD, MSc, FACG, and Alison Schneider, MD, FACG
We want to remind ACG members of two exciting upcoming ACG regional courses:
Meet Your ACG Governor!
We appreciate the opportunity to meet you and learn more about important issues in our states and regions. Dr. Hobley will be at the welcome reception for registered attendees on Friday, March 6th (ACG/LGS Course). Dr. Schneider will be at the registration desk each morning on March 13-15 (ACG/FGS Course).
We hope to see you there!
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 Practice Management Toolbox E-Book
The ACG Practice Management Committee is proud to announce a digital compendium of articles in the Practice Management Toolbox series as well as "Law Mind" articles published in ACG MAGAZINE.
The Practice Management Committee is confident this series and the e-Book compendium will provide a valuable resource for members striving to optimize their practices.
What is the Practice Management Toolbox?
Gastroenterologists in private practice find themselves working in a time of unprecedented transformation. Pressures are high as they make important management decisions that profoundly affect their business future, their private lives, and their ability to provide care to patients. The ACG Practice Management Committee has a mission to bring practicing colleagues together to explore solutions to overcome management challenges, to improve operations, enhance productivity, and support physician leadership. It was in this spirit that the Practice Management Toolbox was created.
The Toolbox is a series of short articles, written by practicing gastroenterologists, that provide members with easily accessible information to improve their practices. Each article covers an issue important to gastroenterologists and physician-lead clinical practices. They include a brief introduction, a topic overview, specific suggestions, helpful examples and a list of resources or references. Each month a new edition of the Toolbox will be released and will then remain available here along with all previous editions. The Practice Management Committee is confident this series will a provide valuable resource for members striving to optimize their practices.