President Biden Executive Order on Non-Compete Clauses, Hospital Mergers, and More on Surprise Billing

From ACG Legislative and Public Policy Council Chair, James C. Hobley, MD, MSc, FACG

On Friday, July 9th, the Biden Administration released an Executive Order (EO) to “promote competition in the American economy.” The EO includes over 70 directives for federal agencies to develop policies that “promptly tackle some of the most pressing competition problems across our economy.” Among the initiatives notable for ACG members, the EO:

  • Encourages the U.S. Federal Trade Commission (FTC) to ban or restrict non-compete employment agreements.
  • Underscores that "hospital mergers can be harmful to patients" and encourages the U.S. Justice Department and FTC to review and revise their merger guidelines to ensure patients are not harmed by such mergers.
  • Directs Health and Human Services (HHS) to support existing hospital price transparency rules (see ACG alert on the U.S. Supreme Court's decision not to hear hospital pricing case) and to finish implementing federal legislation to address surprise hospital billing (more below).
  • Directs the U.S. Food and Drug Administration to work with states and tribes to safely import prescription drugs from Canada.
  • Directs HHS to increase support for generic and biosimilar drugs and issue a comprehensive plan within 45 days to "combat high prescription drug prices and price gouging," and encourages the FTC to ban “pay for delay” and similar agreements.
  • Directs HHS to standardize plan options in the National Health Insurance Marketplace.

ACG will be monitoring these forthcoming federal regulations and will continue to advocate on behalf of the clinical GI and our patients.

More information on Surprise Billing Regulation: Last week, ACG alerted membership that the first regulation on “surprise billing” was released. The "No Surprises Act" was signed into law last year and prohibits surprise billing (also referred to as "balance billing"), where a patient receives an unexpected out-of-network medical bill. The law applies to both emergency and non-emergency situations. This is the first regulation in an expected series of rules implementing the law. Some highlights for ACG members:

  • The rule clarifies that it applies to health plans offering group or individual health insurance coverage, with respect to plan years beginning on or after January 1, 2022. The term “group health plan” also includes self-insured health plans.
  • Except for certain states with an “All-Payer Model Agreement” (e.g. Maryland), the reimbursement rate or Qualifying Payment Amount (QPA) is the median contracted rate for the same service, by the same provider, in the same insurance market across all of an issuer’s health plans as of January 31, 2019 (increased for inflation).
  • The cost-sharing requirement for non-emergency items and services provided by an out-of-network provider at an in-network facility cannot be greater than the cost-sharing requirement that would apply had the items or services been furnished by an in-network provider (unless various notice and consent criteria are satisfied).
  • The rule defines the term “same or similar item or service” as a health care item or service billed under the same or comparable code, including  the Current Procedural Terminology (CPT), Healthcare Common Procedure Coding System (HCPCS), or Diagnosis-Related Group (DRG) codes.
  • The term “provider in the same or similar specialty” is defined as the practice specialty of a provider, as identified by the plan and consistent with the plan or issuer’s usual business practice.

ACG will continue to educate members on the impact to GI practices and patients. Please contact ACG staff if you have any questions. Click here for CMS’ fact sheet.

Register Today for Upcoming FDA/ACG Public Workshops

From FDA Related Matters Committee Chair, Eric D. Shah, MD, MBA, FACG

Register today for the upcoming "Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI)" Workshops. The U.S. Food and Drug Administration (FDA) is partnering with ACG and other medical societies on two important GI workshops on July 21 and July 22.

The first workshop will be on eosinophilic gastrointestinal disorders. Discussions will focus on the following:

  • The diagnosis and natural history of eosinophilic gastrointestinal disorders.
  • Assessing clinical benefit in eosinophilic gastrointestinal disorders.

The second workshop will focus on celiac disease. Discussions will focus on the approach to drug development in celiac disease and include the following topic areas:

  • The histologic endpoints to assess treatment benefit in patients with celiac disease.
  • Regulatory framework for pediatric drug development in celiac disease.
  • The role of gluten challenge in clinical trials

Information Blocking Rules: Are You Prepared?

HHS finalized regulations designed to promote EHR interoperability and to enhance patients’ ability to control their medical information. The goal is to prevent information blocking among software developers and insurers, removing the current “silos” and opening various health IT closed “ecosystems.” Of note, many of these provisions go into effect July 2021.

What does it mean for me?
ACG members must understand that the information blocking prohibition applies to physicians, and that rules placed on software developers, insurers, and hospitals impact your clinical notes and patient care management.

Hear from the legal expertsClick here for ACG's webinar on the legal implications and impact to GI practices.

ACG will continue to educate members and provide guidance on important issues facing GI practices and clinicians.

New ACG Practice Management Committee Toolbox Articles!

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.