A memorandum from the Office of Management and Budget (“OMB”) on January 27, 2025 notified heads of federal agencies of a temporary pause on all disbursements of federal grants and loans, effective at 5pm Eastern on January...more
Health care employers are not alone in feeling overwhelmed by the constantly changing legal status of the various federal vaccine mandates. On Thursday afternoon, the Supreme Court made its rulings on two preliminary...more
1/18/2022
/ Biden Administration ,
Biden v Missouri ,
Centers for Medicare & Medicaid Services (CMS) ,
Constitutional Challenges ,
Coronavirus/COVID-19 ,
Employer Mandates ,
Health Care Providers ,
Healthcare Facilities ,
Interim Final Rules (IFR) ,
Medicaid ,
Medicare ,
National Federation of Independent Business v Department of Labor and OSHA ,
OSHA ,
SCOTUS ,
Stays ,
Vaccinations ,
Virus Testing
Last week, the Centers for Medicare and Medicaid Services (CMS) and the Occupational Safety and Health Administration (OSHA) published their much-anticipated rules mandating COVID-19 vaccinations. ...more
11/9/2021
/ Americans with Disabilities Act (ADA) ,
Appeals ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Constitutional Challenges ,
Coronavirus/COVID-19 ,
Equal Employment Opportunity Commission (EEOC) ,
Executive Orders ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Hospitals ,
Interim Final Rules (IFR) ,
Medicaid ,
Medicare ,
New Guidance ,
Physicians ,
Popular ,
Preemption ,
Stays ,
Supremacy Clause ,
Title VII ,
Vaccinations
In 2018, the U.S. Department of Health and Human Services (“HHS”) launched what it calls a “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary...more
In 2018, the Department of Health and Human Services (the “Department”) launched what it calls a “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the health care system, with a focus on removing...more
As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug...more
9/10/2019
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Regulation ,
Safe Harbors
In a much anticipated decision, a federal judge ruled this week that the Trump Administration’s rule requiring drug manufacturers to list drug prices in television advertisements exceeds the agency’s authority.
Back in May...more
7/10/2019
/ Advertising ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Lack of Authority ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Rulemaking Process ,
Social Security Act ,
Trump Administration
On April 22, 2019, the Centers for Medicare and Medicaid Services (CMS) announced two sweeping new payment innovation models under the Primary Cares Initiatives. The models will seek to incentivize primary care and other...more
4/26/2019
/ ACOs ,
Alternative Payment Models (APM) ,
Cardiac Episode Payment Program ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Episode Payment Models (EPM) ,
Fee-for-Service ,
Health Care Providers ,
Medicaid ,
Medicare ,
Physicians ,
Request For Information ,
Value-Based Care
If the government does not take action and continues to pay for Medicare/Medicaid claims after it learns of non-compliance related to the claims, is the non-compliance material to the government’s decision to pay? This is a...more
1/24/2018
/ Conditions of Payment ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
Health Care Providers ,
Implied Certification ,
Materiality ,
Medicaid ,
Medicare ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar
On September 7, 2017, the OIG posted an advisory opinion regarding a retail pharmacy chain’s proposal to extend to federal health care program beneficiaries the option to participate in a paid membership program that includes...more
On June 16th, 2017, The Department of Justice (“DOJ”) announced a $53.6 million dollar settlement with Genesis Healthcare Inc. (“Genesis”) over six federal whistleblower lawsuits alleging that subsidiaries of the...more
On June 16, 2016, the Supreme Court issued a unanimous decision in Universal Health Services, Inc. v. United States ex rel. Escobar upholding the “implied certification” theory of liability under the False Claims Act (“FCA”)...more
6/30/2016
/ Conditions of Payment ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
Health Care Providers ,
Implied Certification ,
Material Misrepresentation ,
Materiality ,
Medicaid ,
Qui Tam ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar ,
Unlicensed Medical Providers