Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more
Our Health Care and Health Care Litigation Groups examine a policy move by the Department of Health and Human Services (HHS) that will allow the department to forgo notice and comment procedures for many of its regulations....more
The U.S. Department of Health and Human Services (HHS) on Feb. 28, 2025, issued a policy statement limiting the circumstances under which HHS agencies must publish proposed rules for public comment before the rules are...more
Effective March 3, 2025, the US Department of Health and Human Services (HHS) rescinded its long-standing policy that had waived a statutory exemption under the Administrative Procedure Act (APA) from notice and comment...more
The policy statement aims to bring more rapid action on personnel and management decisions and empowers HHS and each of its offices and subagencies to promulgate or rescind certain rules without a period of notice and comment...more
On March 3, the Federal Register published a policy statement from the Department of Health and Human Services (HHS) titled “Policy on Adhering to the Text of the Administrative Procedure Act” (the Policy Statement)....more
On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more
Various smaller health insurance issuers have challenged the risk-adjustment program under the Patient Protection and Affordable Care Act (ACA), alleging, among other things, that its underlying methodology favors larger...more
While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more
After a drawn-out drafting-and-review process, the hotly contested No Surprises Act (Act) has made its way into law after being tucked into the 5,500+ pages of the Consolidated Appropriations Act, 2021, signed into law on...more
On August 20, 2020, the Department of Health & Human Services (HHS) released a statement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, which announced that...more
In this week’s episode, Adam Cooper discusses the Supreme Court’s decision in Azar v. Allina Health Services, as well as a related memorandum issued in late 2019 by the Centers for Medicare and Medicaid Services (“CMS”) that...more
On January 23, 2020, the United States District Court for the District of Columbia declared sections of the 2013 Omnibus Rule unlawful. The Court found that the Department of Health and Human Services (HHS) impermissibly...more
In response to the disruptive Supreme Court decision on the impact and effect of administrative guidance, HHS has issued a memorandum suggesting that CMS's ability to enforce some of its payment policies may be limited by the...more
The US Department of Health and Human Services (HHS) Office of General Counsel (OGC) offered the healthcare industry the benefit of its legal analysis of the recent US Supreme Court opinion in Azar v. Allina Health Services...more
A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...more
On October 31, 2019, the Office of General Counsel for the U.S. Department of Health and Human Services (HHS) issued an important memo from Kelly M. Cleary, CMS Chief Legal Officer, and Brenna E. Jenny, Deputy General...more
On September 4, 2019, following remand from the Supreme Court’s decision in Azar v. Alina Health Services, No. 17-1484 (U.S. June 3, 2019), the United States District Court for the District of Columbia declined plaintiff...more
On June 3, 2019, the Supreme Court issued an eagerly anticipated opinion in Azar v. Allina Health Services, a decision with far-reaching implications both for the calculation of disproportionate share payments and provider...more
The Medicare Program, established in 1965, initially seemed simple: provide health care for senior citizens by paying hospitals and doctors directly for the care the seniors required. Initially, there were two parts to...more
On June 3, 2019, the U.S. Supreme Court issued its decision in Azar v. Allina Health Services, et al., Case No. 17-1484. The Court ruled in favor of a group of hospitals in a dispute over Medicare disproportionate share...more
On June 3, 2019, the Supreme Court of the United States (SCOTUS) issued an opinion in Azar v. Allina Health Services whereby it ruled that the United States Department of Health and Human Services (HHS) violated the Medicare...more
In a 7-to-1 decision, the U.S. Supreme Court on June 3, 2019, held that “Because the Department of Health and Human Services neglected its statutory notice-and-comment obligations when it revealed a new policy that...more
In a landmark decision on June 3, 2019, the Supreme Court held that the Department of Health and Human Services (HHS) was required to engage in notice and comment rulemaking before publishing methodology (Medicare Fractions)...more
On June 3, 2019, the United States Supreme Court issued its decision in Azar v. Allina Health Services, delivering a multi-billion dollar victory for hospitals that serve a disproportionate share of low-income patients by...more