Biden Administration Rescinds Trump ... - Policy & Medicine
Oct 26, 2021 · One of the final healthcare actions made by the Trump Administration has been rescinded by the Biden Administration. On December 23, 2020, the Trump Administration finalized a rule that directed the Department of Health and Human Services (HHS) to take action to require that federally qualified health centers (FQHCs) make insulin and injectable epinephrine available to certain patients at 340B ...
DOJ Announces $345 Million Settlement with Community Health …
Jan 25, 2024 · The United States Department of Justice (DOJ) recently reached a $345 million settlement with Community Health Network, Inc., a health care network headquartered in Indianapolis, Indiana, over allegations that the company violated the False Claims Act by knowingly submitting claims to Medicare for services that were Stark Law referral violations.. The claim was initially brought in 2014 by a ...
DaVita Reaches $34 Million False Claims Act Settlement
Sep 12, 2024 · DaVita has agreed to pay more than $34 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce referrals to DaVita Rx, a former subsidiary that provided pharmacy services for dialysis patients, and by paying kickbacks to nephrologists and vascular access physicians to induce …
Tenet Healthcare Corporation Resolves False Claims Act …
Jul 20, 2023 · Recently, VHS of Michigan – doing business as The Detroit Medical Center Inc (DMC), Vanguard Health Systems Inc. (Vanguard), and Tenet Healthcare Corporation (Tenet) – agreed to pay $29,744,065 to resolve allegations that they violated the False Claims Act by providing kickbacks to referring physicians. DMC operates multiple hospitals in the Detroit region, including Sinai-Grace Hospital ...
DEA and HHS Extend Telehealth Flexibilities for Controlled …
Jan 10, 2024 · The Drug Enforcement Administration (DEA) and the HHS announced they will extend pandemic-era telehealth prescribing flexibilities for controlled substances through 2024. The temporary extension marks the second time regulators have prolonged the relaxed prescribing rules for drugs like opioid use disorder medications or stimulants for ADHD ...
FDA Issues Enforcement Letter Regarding Eskata Risks Omitted …
Aug 2, 2019 · The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) recently issued an enforcement letter to Aclaris Therapeutics, Inc., regarding direct-to-consumer (“DTC”) advertising for its Eskata product. Eskata is a hydrogen peroxide topical solution used to treat seborrheic keratoses (“SK”).
Novartis Settlements and Corporate Integrity ... - Policy & Medicine
Jul 9, 2020 · The $642 million sum is for two different settlements – the first over the company’s alleged illegal use of three foundations as conduits to pay copayments for Medicare patients taking Novartis’ drugs Gilenya and Afinitor and the second over the company’s alleged payments of kickbacks to doctors. First Settlement – Illegal Foundations.
HHS OIG Issues Report on Two Midnight Rule in Medicare
Sep 10, 2024 · On June 13, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a report identifying weaknesses in Medicare billing practices that contribute to these overpayments. Two-Midnight Rule. The two-midnight rule is CMS’s method for distinguishing inpatient hospital stays from outpatient hospital stays.
FDA and Disease Awareness Programs – Policy & Medicine
Aug 5, 2010 · FDA’s defines disease awareness communications as those “that discuss a particular disease or health condition, but does not mention any specific drug and does not make any representation or suggestion concerning a particular drug. While the first requirement is clear, FDA has not given specific instruction about what any “representation ...
Physician Payments Sunshine Act Final Rule: Quick Reference Guide
Feb 13, 2013 · 35,887. We posted several stories analyzing the various aspects of the Final Rule to implement the Physician Payments Sunshine Act—Section 6002 of the Patient Protection and Affordable Care Act (PPACA). In light of the significant complexity the rule presents to many stakeholders, we decided to provide a condensed chart or quick reference ...