In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of...more
4/7/2023
/ Anti-Kickback Statute ,
Appeals ,
But For Causation ,
Causation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare ,
OIG ,
Regulatory Standards ,
Remuneration
On February 6, 2023, a judge for the United States District Court for the Eastern District of Texas (“Texas District Court”) ruled in favor of the Texas Medical Association (“TMA”) and against the United States Departments of...more
After multiple extensions over the past three years, on Monday, January 30, 2023, President Biden announced that the COVID-19 national emergency and public health emergency (“PHE”) will officially end on May 11, 2023....more
We previously noted that the regulations implementing the No Surprises Act (“NSA”) appeared to be inconsistent with the NSA because they seemed to establish the qualifying payment amount (“QPA”) as the appropriate payment...more
8/31/2022
/ Billing ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Dispute Resolution ,
Health Care Providers ,
Health Insurance ,
Healthcare Facilities ,
Hospitals ,
Interim Final Rules (IFR) ,
No Surprises Act (NSA) ,
U.S. Treasury
As part of the Fiscal Year 2023 New York state Executive Budget legislation, $1.2 billion in funding has been allocated for the payment of bonuses for certain “frontline” healthcare workers.
With the stated goals to...more
5/11/2022
/ Audits ,
Bonuses ,
Essential Workers ,
Healthcare ,
Healthcare Workers ,
Home and Community Based Services (HCBS) ,
Medicaid ,
New York ,
State Budgets ,
State Funding ,
Wage and Hour
We previously noted that the No Surprises Act (NSA) regulation’s establishment of the presumption that the qualifying payment amount (QPA)—generally, the median payment by the plan to providers in the region—is the...more
Recently, in Siegel v. Snyder, Slip.Op. 07624, New York’s Appellate Division, Second Department interpreted New York’s peer review/quality assurance confidentiality statute in a manner that may require modifications to the...more
On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued its Calendar Year (CY) 2022 Physician Fee Schedule (“PFS”) Final Rule. In this post, we sample some key highlights from the Final Rule. ...more
12/23/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
FQHC ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Medicare ,
MPFS ,
Physician Fee Schedule ,
Rural Health Care Program ,
Self-Referral ,
Stark Law ,
Telehealth ,
Telemedicine
In a November 12, 2021 revision of its prior draft guidelines for hospital co-location compliance with Medicare conditions of participation (COP) for hospitals (QSO-19-13), CMS has apparently softened its approach to...more
In an advisory opinion posted November 10, 2021 (AO 21-15), the Office of the Inspector General of the United States Department of Health and Human Services (OIG) appeared to soften a disturbing position that it had taken in...more
11/30/2021
/ Advisory Opinions ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
OIG ,
Physicians ,
Safe Harbors ,
Self-Referral ,
Stark Law
This post reviews Part II of the federal No Surprises Act regulations. In previous publications, we have commented upon the No Surprises Act, and Part I of the regulations.
The “Requirements Related to Surprise Billing;...more
Although the COVID-19 pandemic is still active worldwide, health care industry leaders and regulators have already begun to think about how to implement post-pandemic changes to health care delivery based on lessons learned...more
10/27/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Disaster Preparedness ,
Emergency Management Plans ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Infectious Diseases ,
Patient Access ,
Personal Protective Equipment ,
Public Health Emergency ,
Telehealth
On August 12, 2021, a panel of the Seventh Circuit voting 2-1 endorsed the existence of an “objective reasonableness” defense under the FCA. United States ex rel. Schutte v. SuperValu, Inc., No. 11-cv-3290, 2021 WL 3560894...more
In July 2021, Senator Chuck Grassley led a bipartisan group of senators in introducing S.B. 2428, the “False Claims Amendments Act of 2021,” which aims to address legal developments in FCA doctrine that, according to the...more
9/13/2021
/ Burden-Shifting ,
Discovery ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Legislative Agendas ,
Materiality ,
Qui Tam ,
Regulatory Agenda ,
Regulatory Reform ,
Whistleblower Protection Policies
In a FAQ published on August 20, 2021, the Departments of Labor, Health and Human Services, and the Treasury (collectively, the “Departments”) significantly delayed implementation of statutory requirements on surprise billing...more
9/3/2021
/ Affordable Care Act ,
Consolidated Appropriations Act (CAA) ,
Delays ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
Hospitals ,
Price Transparency ,
Public Disclosure ,
Regulatory Agenda ,
Regulatory Requirements ,
Rulemaking Process ,
Statutory Requirements ,
Surprise Medical Bills
As discussed in a prior post, the Hospital Price Transparency Rule at 45 C.F.R. § 180.10 et. seq. (the “Rule”), requires all hospitals to provide clear, accessible pricing information about the items and services they provide...more
This post provides an update to our previous publication summarizing the federal No Surprises Act and is part two of two in a series on new interim regulations implementing certain requirements of the No Surprises Act.
In...more
This post provides an update to our previous publication summarizing the federal No Surprises Act and is part one of two in a series on new interim regulations implementing certain requirements of the No Surprises Act....more
On June 24, 2021, New York Governor Andrew Cuomo issued Executive Order 210, which officially declared the end of the New York State of Emergency caused by the COVID-19 pandemic effective June 25, 2021. The issuance of the...more
On June 10, 2021, the U.S. Department of Labor Occupational Safety and Health Administration (“OSHA”) announced “an emergency temporary standard to protect healthcare workers from contracting coronavirus.” The standard...more
The U.S. Department of Justice (the “DOJ”) recently settled whistleblower False Claims Act (“FCA”) allegations against The University of Miami (“UMiami”) for $22 million, which resolves claims from three separate lawsuits...more
The COVID-19 pandemic has seen a wave of telehealth policy changes across the nation at both federal and state levels. Such changes have expanded access to health care and addressed underutilization in chronic disease...more
In a prior blog post, we discussed CMS’ Hospital Price Transparency Rule at 45 C.F.R. § 180.10 et. seq., effective January 1, 2021 (the “Rule”), which requires hospitals to make public “a machine-readable file containing a...more
In a report issued by the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) on March 23, 2021 (the “2021 Report”), representatives from 320 hospitals in 45 states, the District of...more
The latest COVID-19 stimulus bill, the American Rescue Plan of 2021 (the “Act”), enacted on March 11, 2021, provides $1.9 trillion in funding for various COVID-19 relief measures. However, while the Act includes many funding...more
4/22/2021
/ American Rescue Plan Act of 2021 ,
CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicaid ,
Provider Relief Fund ,
Public Health ,
Relief Measures ,
Rural Health Care Providers ,
Skilled Nursing Facility