On August 19, the U.S. Departments of Health and Human Services, Labor, and the Treasury (the Departments) issued final rules implementing the No Surprises Act, known as the “Requirements Related to Surprise Billing: Final...more
As states begin to pivot away from the emergency health measures implemented at the beginning of the COVID-19 pandemic, state governments are now grappling with addressing traditional health care concerns, while...more
On February 23, a Texas federal court vacated several key portions of an interim final rule (Rule) governing the No Surprises Act's (Act) independent dispute resolution (IDR) process. The court's decision has been lauded by...more
On December 9, the American Medical Association (AMA) and the American Hospital Association (AHA) (the Associations) filed a lawsuit in the U.S. District Court for the District of Columbia challenging the proposed regulations...more
On October 28, the Texas Medical Association (TMA), a trade association that represents more than 55,000 physicians and medical students, filed a lawsuit in the Eastern District of Texas challenging key portions of CMS’s...more
On September 30, U.S. Departments of Health and Human Services (HHS), Labor, and Treasury, as well as the Office of Personnel Management, issued another interim final rule — “Requirements Related to Surprise Billing: Part II”...more
On July 1, U.S. Departments of Health and Human Services (HHS), Labor, and Treasury, as well as the Office of Personnel Management, issued an interim final rule implementing the No Surprises Act (Act) and requesting...more
In its latest effort to provide direction and clarity to regulated industry and stakeholders, on September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule and preamble amending its medical product...more
10/1/2020
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First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
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Off-Label Use ,
Pharmaceutical Industry ,
Preamble ,
Proposed Rules ,
Repeal ,
Totality of Circumstances Test