Important FDA Safety Alert: Xeljanz, Xeljanz XR (tofacitinib) and Increased Risk of Blood Clots and Death with Higher Dose

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

This week the U.S. Food and Drug Administration (FDA) approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of Xeljanz, Xeljanz XR (tofacitinib), which is used in patients with ulcerative colitis. In addition, the approved use of tofacitinib for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines. The FDA added its most prominent Boxed Warning, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis.

ACG and the ACG FDA Related Matters Committee will continue to update membership on important FDA safety alerts impacting gastroenterology and our patients.

Congress Will Not Take Up Surprise Billing Before August Recess

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

Congress will not take up surprise billing before August recess
Congressional leaders confirmed this week that the “surprise billing” legislation currently making its way through the legislative process will be put on hold until after the August recess. The legislation is designed to curb balanced billing and help settle disputes between out-of-network providers and insurers.

The U.S. Senate's Health, Education, Labor, and Pensions (HELP) Committee cleared a bill last month that 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 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 HELP committee's bill.

What are the risks of a “benchmark” resolution?
Since the benchmark would save the federal government costs over the next decade, it should come as no surprise that savings may be from lower provider reimbursement. A median-rate benchmark for out-of-network providers provides little incentive for insurers to agree to rates above the median-rate when negotiating contracts with participating or in-network providers. This ultimately makes the median-rate lower and lower.

What is ACG Doing for You?

ACG and a coalition of national and state medical societies are advocating for a system modeled after New York’s state law, which includes an independent dispute resolution (IDR) process should providers and insurers fail to agree on a payment rate. A recent report on the NY 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 health care service performed by a provider in the same or similar specialty within the same geographic area.

Urge Your Members of Congress to Support a Bill Modeled After This New York Law

Last week, the U.S. House Energy and Commerce Committee cleared their version of “surprise billing” legislation, which includes an IDR amendment offered by Rep. Raul Ruiz, MD (D-CA) and Rep. Larry Bucshon, MD (R-IN). However, IDR appeals would be restricted to cases with a claims threshold of $1,250 (indexed to inflation). The mediator must consider the contracted rate for services provided in the same geographic area when resolving a payment dispute, the complexity of the patient's treatment, quality measures, and the provider's training, education and experience.

The "Protecting People from Surprise Medical Bills Act of 2019" (HR 3502) requires insurers to reimburse providers the commercially reasonable rate for such out-of-network services, as well as establishes an independent dispute resolution process in the event the parties cannot agree on a payment.

Next Steps

ACG continues to work with policymakers and this coalition of medical societies on your behalf. The proposals are fluid and can certainly change as Congress heads home for its August recess. ACG is fighting on your behalf. Stay tuned!

New Practice Management Tools: Indispensable and Practical Guidance for ACG Members

The latest edition of the ACG Magazine is out! Click here to check it out. Among these insightful articles, the ACG Practice Management Committee offers tips in improving the informed consent process in your GI practice, and Anne Bittinger discuss ways to improve your ancillary income via clinical research.

"Reviewing and Updating the Informed Consent Process in your Practice" by Stephen T. Amann, MD, FACG and Brian B. Baggott, MD

"Trials Without Tribulations: Pursuing Clinical Research from Ancillary Income" by Ann M. Bittinger, Esq.

Interested in learning more about how to incorporate clinical research? Attend the ACG Annual Meeting and the "Roadmap for a Successful Community or Academic GI Practice Course: Ramp-Up Your Practice, Super-Charge Your Staff."

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 private practice 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.