On February 18, 2025, the U.S. Court of Appeals for the 1st Circuit issued a highly anticipated ruling interpreting the relationship between the False Claims Act ("FCA") and the federal Anti-Kickback Statute ("AKS"), holding...more
2/26/2025
/ Anti-Kickback Statute ,
Appellate Courts ,
But For Causation ,
Causation ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Pharmaceutical Industry
On November 17, 2023, the U.S. Department of Health and Human Services ("HHS") Centers for Medicare and Medicaid Services ("CMS") published a final rule (the "Final Rule") requiring Medicare skilled nursing facilities...more
12/27/2023
/ Business Ownership ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Federal Trade Commission (FTC) ,
Final Rules ,
Hart-Scott-Rodino Act ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
Premerger Notifications ,
Private Equity ,
REIT ,
Skilled Nursing Facility ,
Transparency
Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance. This year’s seminar will take place virtually on March 15, March 17, March 22, and...more
2/14/2022
/ Antitrust Violations ,
Business Development ,
CEOs ,
CFOs ,
Chief Compliance Officers ,
Clinical Laboratories ,
Continuing Legal Education ,
COOs ,
Coronavirus/COVID-19 ,
Enforcement Actions ,
Fraud and Abuse ,
Government Investigations ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Healthcare Workers ,
Hospitals ,
Nurses ,
PHI ,
Physicians ,
Risk Management ,
Surprise Medical Bills ,
Telehealth ,
Webinars
Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance. This year’s seminar will take place virtually on March 15, March 17, March 22, and...more
2/11/2022
/ Antitrust Violations ,
Business Development ,
CEOs ,
CFOs ,
Chief Compliance Officers ,
Clinical Laboratories ,
Continuing Legal Education ,
COOs ,
Coronavirus/COVID-19 ,
Enforcement Actions ,
Fraud and Abuse ,
Government Investigations ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Healthcare Workers ,
Hospitals ,
Nurses ,
PHI ,
Physicians ,
Risk Management ,
Surprise Medical Bills ,
Telehealth ,
Webinars
Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance. This year’s seminar will take place virtually on March 15, March 17, March 22, and...more
2/10/2022
/ Antitrust Violations ,
Business Development ,
CEOs ,
CFOs ,
Chief Compliance Officers ,
Clinical Laboratories ,
Continuing Legal Education ,
COOs ,
Coronavirus/COVID-19 ,
Enforcement Actions ,
Fraud and Abuse ,
Government Investigations ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Healthcare Workers ,
Hospitals ,
Nurses ,
PHI ,
Physicians ,
Risk Management ,
Surprise Medical Bills ,
Telehealth ,
Webinars
Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance. This year’s seminar will take place virtually on March 15, March 17, March 22, and...more
2/9/2022
/ Antitrust Violations ,
Business Development ,
CEOs ,
CFOs ,
Chief Compliance Officers ,
Clinical Laboratories ,
Continuing Legal Education ,
COOs ,
Coronavirus/COVID-19 ,
Enforcement Actions ,
Fraud and Abuse ,
Government Investigations ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Healthcare Workers ,
Hospitals ,
Nurses ,
PHI ,
Physicians ,
Risk Management ,
Surprise Medical Bills ,
Telehealth ,
Webinars
On December 2, 2020, the Centers for Medicare & Medicaid Services (CMS) published the final "Sprint Regulations," reinterpreting key aspects of the federal physician self-referral or "Stark" law. Most of the Sprint...more
There are three things that cannot be stopped: time, gravity, and the increasing complexity of the Stark Law. To be fair, complexity has not been the goal of the Centers for Medicare & Medicaid Services (CMS). Rather, Stark's...more
On December 2, 2020, the Centers for Medicare & Medicaid Services (CMS) released the calendar year 2021 Final Rule implementing changes to the Medicare hospital Outpatient Prospective Payment System (OPPS) and Ambulatory...more
With the benefit of more than three decades of rulemaking and hundreds of submissions under the Self-Referral Disclosure Protocol, CMS has seized the opportunity in the final Sprint Regulations to adopt a number of...more
The Coronavirus Aid, Relief, and Economic Security (CARES) Act will make available an initial $2.2 trillion in government funds to mitigate the economic effects of COVID-19. Government agencies have been immediately tasked...more
The Sprint Regulations’ value-based exceptions and related amendments have attracted much well-deserved attention. However, value-based matters aside, the Sprint Regulations portend significant positive changes to the Stark...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
6/12/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Department of Health and Human Services (HHS) ,
Hospitals ,
Low-Income Issues ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part C ,
Notice and Comment ,
Pay Reductions ,
Provider Payments ,
Reaffirmation ,
Retroactive Application ,
SCOTUS ,
Substantive Rule ,
Vacated
Starting January 1, 2020, hospitals, health systems, and many other healthcare providers must give notice to the Attorney General 60 days in advance of closing certain transactions. ...more
On January 12, 2017, the Department of Health and Human Services Office of Inspector General (“OIG”) published a final rule which provides guidance on its new and expanded bases for permissive exclusion from federal health...more
The Office of Inspector General (“OIG”) of the Department of Health and Human Services has issued a final rule (“Final Rule”) adding new safe harbors to the federal anti-kickback statute, amending existing safe harbors, and...more
1/16/2017
/ Anti-Kickback Statute ,
Civil Monetary Penalty ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
FQHC ,
Generic Drugs ,
Health Care Providers ,
Medicare ,
OIG ,
Pharmacies ,
Remuneration ,
Rural Areas ,
Safe Harbors
In a unanimous decision issued on June 16, 2016, in Universal Health Inc. v. U.S. et al. ex rel. Escobar et al. the United States Supreme Court resolved a circuit split and held that an “implied certification” theory can...more
On Feb. 12, 2016, CMS published the much anticipated final regulations implementing the so-called “60-Day Rule.” Congress adopted the 60-Day Rule as part of the Affordable Care Act (ACA). The Rule requires health care...more
Please join Davis Wright Tremaine partners Bob Homchick and Adam Romney, and associate Kyle Gotchy for a briefing regarding the final rule for the Comprehensive Care Joint Replacement (CJR) Program.
They will discuss the...more
On Nov. 24, the Centers for Medicare & Medicaid Services will publish in the Federal Register the final rule for the Comprehensive Care Joint Replacement (CJR) Program. The CJR Program is a new payment model that requires...more
The federal physician self-referral ban or Stark law has been a part of the legal landscape for almost 25 years. The breadth of the law’s prohibitions, its strict liability formulation and draconian remedies have made it the...more
7/28/2015
/ BPCI ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Healthcare ,
Hospitals ,
Medicaid ,
Medicare ,
Medicare Shared Savings Program ,
Physician Fee Schedule ,
Physicians ,
Qui Tam ,
Relators ,
Stark Law ,
Tuomey
On June 9, 2015, the Department of Health and Human Services Office of Inspector General (OIG) issued a Fraud Alert focused on physician relationships. The Alert cautions physicians who enter into compensation arrangements...more
Last week, the Centers for Medicare & Medicaid Services (CMS) released its Final Rule on the Medicare Shared Savings Program (MSSP). The Final Rule provides additional flexibility to accountable care organizations...more
On April 20, 2015, four organizations (including OIG, American Health Lawyers Association, the Association of Healthcare Internal Auditors and the Health Care Compliance Association) issued “Practical Guidance for Health Care...more
On April 20, 2015, the Inspector General of the Department of Health and Human Services (OIG), the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA) and the Health Care...more