United States Attorney General Merrick Garland, giving remarks about the lawsuit, highlighted public criticism over Live Nation-Ticketmaster’s “exorbitant fees and technological failures” and stated that this lawsuit is “what...more
8/7/2024
/ Anticompetitive Behavior ,
Antitrust Division ,
Antitrust Litigation ,
Antitrust Violations ,
Competition ,
Department of Justice (DOJ) ,
Injunctive Relief ,
Sherman Act ,
State and Local Government ,
State Attorneys General ,
The Clayton Act
Since 1984, the “Chevron doctrine” had served as the bedrock of many regulatory actions by the U.S. Department of Health and Human Services (HHS) and other federal agencies. Under the doctrine, courts followed a two-step...more
State Attorneys General play a significant role in shaping health care policy across the country. While the national debates over health care policy in Congress and the federal government receive significant media attention,...more
On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more
5/24/2024
/ Appeals ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
While State Attorneys General are limited to enforcing laws within their respective states, their enforcement activities often implicate businesses located elsewhere but whose business activity crosses state lines. One area...more
The U.S. Court of Appeals for the 10th Circuit issued a sweeping decision that (1) maintains long-standing federal protections for employer and union-sponsored health plans to design their health benefit plans, including...more
On January 30, 2023, the United States Court of Appeals for the Third Circuit issued its decision in Sanofi Aventis U.S. LLC v. United States Department of Health and Human Services, enjoining the United States Department of...more
On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...more
12/7/2022
/ Comment Period ,
Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Rules ,
Section 340B
The 340B program requires drug manufacturers to offer outpatient pharmaceuticals to statutorily defined covered entities (including certain hospitals and certain federal grantees, such as federally qualified health centers)...more
June 27, 2022 Key Takeaways: Late last week, the Supreme Court released its opinion in Becerra v. Empire Health Foundation, a case that involves the complex but important question regarding how to calculate the Medicare and...more
Earlier this week, the Supreme Court released its opinion in American Hospital Association et al. v. Becerra et al., a case that involves the proper method for the Medicare program to reimburse hospitals for outpatient drugs...more
6/17/2022
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drugs ,
Remand ,
Remedies ,
Reversal ,
SCOTUS ,
Section 340B
For the third time since its passage, the United States Supreme Court has saved the Affordable Care Act (“ACA”) from a legal challenge. In a 7-2 decision in California v. Texas, the Court held that several Republican-led...more
On November 10, 2020, the United States Supreme Court is scheduled to hold oral argument in California v. Texas (Dkt. No. 19-840), a case in which the Trump administration and several Republican-led states have asked the...more
On December 18, 2019, in a reversal of historic and substantive reservations, the U.S. Food and Drug Administration (FDA or Agency) issued a notice of proposed rulemaking (Proposed Rule) that, if finalized, would allow for...more
In October 2018, Mayor Marty Walsh signed the Lobbyist Registration and Regulation Ordinance for the City of Boston. The Ordinance, which is largely modeled after the Massachusetts State Lobbying Law (M.G.L. c. 3, §§39-50),...more
In 2009, the United States Supreme Court in Wyeth v. Levine affirmed a judgment rejecting a prescription drug manufacturer’s contention that plaintiff’s claim that the manufacturer should have strengthened its U.S. Food and...more
What Do They Mean for Providers? -
Both California and New York have recently enacted so-called “Surprise Bills Laws” that require out-of-network providers to give notice to patients that a particular item or service...more
The Massachusetts Legislature is currently considering Senate Bill 1048, “An Act to Promote Transparency and Cost Control of Pharmaceutical Drug Prices.” The bill, sponsored by State Senator Mark Montigny, Vice Chair of the...more