On May 15, 2023, the Fifth Circuit temporarily stayed a district-court ruling that struck down a key part of the Affordable Care Act (ACA). As a result of the stay, the ACA’s health insurance coverage requirements for...more
On December 29, 2020, the United States Court of Appeals for the District of Columbia issued its opinion in American Hospital Association v. Azar (the Opinion) upholding the Hospital Transparency Regulation (the Rule) issued...more
On December 29, 2020, the U.S. Court of Appeals for the District of Columbia Circuit upheld a CMS final rule promulgated in November 2019 that requires hospitals to disclose various forms of pricing information related to the...more
In recent weeks, the Trump Administration has been considering allowing health insurance to be purchased across state lines and expanding access to “Association Health Plans” (AHPs) that could take economic advantage of...more
The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more
Earlier this month, the Court of Appeals for the D.C. Circuit issued its decision in Central United Life Insurance Co., v. Burwell, striking down a Department of Health and Human Services (HHS) rule prohibiting the sale and...more
This is the 54th in a series of WorkCite articles concerning the Patient Protection and Affordable Care Act and its companion statute, the Health Care and Education Reconciliation Act of 2010 (referred to collectively as the...more
Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more
On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more
The Departments issued FAQs clarifying prior guidance on the ACA’s cost-sharing limitations applicable to non-grandfathered plans, and restating their enforcement approach with respect to the ACA’s provider nondiscrimination...more
Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more
On December 19, 2014, various federal agencies issued proposed regulations (“Proposed Regulations”) to amend the definition of “excepted benefits” to include certain limited wraparound health insurance coverage. “Excepted...more
The Departments of the Treasury/IRS, Labor and Health and Human Services (the “Departments”) recently issued a final regulation under the 90-day waiting period limitation, which is included among the Affordable Care Act’s...more