Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more
The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised FDA labeling guidance for...more
This post continues our investigation of proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA) issued by the US Departments of Labor, Health and Human Services and the Treasury (the...more
The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more
Could Help to Streamline Development and Approval - On May 25, 2023, the Food and Drug Administration (“FDA” or the “Agency”) announced the availability of a new Draft Guidance for Industry, Generally Accepted Scientific...more
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
This opinion regards a proposed restructuring of financial relationships, which includes the forgiveness of debt, between a health system and a nearby clinic. ...more
The Center for Disease Control’s (CDC) “Mask Mandate” was recently vacated by a Florida district court on the grounds that it exceeded CDC’s statutory authority and violated the procedures for executive branch rulemaking set...more
On October 15, 2021, the U.S. Food and Drug Administration (“FDA”) approved Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm), the first interchangeable biosimilar to AbbVie’s blockbuster immunosuppressant Humira®...more
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic and help restore normal social and economic life, even as variant threats loom. ...more
As detailed in a recent alert, U.S. District Judge Dabney L. Friedrich, in Alabama Association of Realtors v. U.S. Department Of Health And Human Services, found that the Centers for Disease Control and Prevention (CDC) did...more
A federal judge in Washington, D.C. has ruled that the Centers for Disease Control and Prevention (CDC) exceeded its authority in issuing a nationwide eviction moratorium aimed at protecting renters facing hardship in the...more
CMS Hospital Price Transparency Rule - After years of policy debate on health care price transparency, the Centers for Medicare & Medicaid Services (CMS) has issued a game-changing hospital price transparency regulation....more
Effective January 1, 2022, the “No Surprises Act” signed into U.S. law as part of H.R. 133, “Consolidated Appropriations Act, 2021,” implicates (1) emergency services provided by non-participating providers at participating...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
Beginning in 2022, employer-sponsored health plans will be required to pay providers certain emergency and out-of-network charges that would have otherwise been balance billed to participants. That is the centerpiece of...more
The Consolidated Appropriations Act (CAA), 2021, which was signed into law December 27, 2020, includes provisions designed to increase transparency in employee health benefit plans in four key areas. Removal of Gag Clauses...more
On April 21, 2020, the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG) issued a Proposed Rule amending civil money penalty (CMP) regulations. This Proposed Rule seeks to address three...more
Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
Key Points - In February, the U.S. Food and Drug Administration issued a "bright-line rule" redefining "biological products" under the Biologics Price Competition and Innovation Act (BPCIA) to include insulin and other...more
The Situation: Though not universal, Electronic Health Records ("EHR") technology adoption is now widespread in the health care industry. And, while an existing safe harbor under the federal Anti-Kickback Statute ("AKS") and...more
On November 15, the Centers for Medicare and Medicaid Services (CMS) issued a final rule requiring public disclosure of hospital charges. Along with the Departments of Health and Human Services, Labor and the Treasury, CMS...more
Our Health Care Group explains new rules (final and proposed) from the Centers for Medicare & Medicaid Services on pricing transparency for hospitals and cost-sharing information for health plans....more
FDA authority to crack down on illegally marketed stem cell treatments confirmed - On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug...more