Topic: Enforcement

COVID-19 Update: Federal Mask Mandate Struck Down by Florida Court

On April 19, 2022, a federal district court in Florida determined the federal mask mandate from the Biden Administration was unlawful and therefore void. The mandate required patrons to wear a mask on public transportation, like airplanes, trains, and buses. The federal judge presiding over the case determined the mandate exceeded statutory authority created under … Continue reading

Lundbeck v Sandoz – High Court decision

By Jackie O'Brien (AU) and Louise Connell on March 14, 2022 Posted in Enforcement, General

1. Introduction The High Court has delivered the latest instalment in Lundbeck and Sandoz’s lengthy saga concerning escitalopram. The particular circumstances giving rise to this dispute are unique, however, the High Court’s approach to interpreting a patent licence granted by Lundbeck to Sandoz should be considered when preparing patent licences. The High Court’s decision may … Continue reading

Australia – TGA updates the Therapeutic Goods Advertising Code

By Bernard O'Shea (AU) and Louise Connell on March 6, 2022 Posted in Enforcement, General, Regulatory

The TGA has issued an updated Therapeutic Goods Advertising Code (New Code). The New Code regulates advertising of therapeutic goods to consumers. Only certain therapeutic goods can be advertised to the public. The New Code seeks to ensure that permitted advertising provides consumers with accurate and balanced information concerning the quality, safety and efficacy of … Continue reading

US 5th Cir. grants a nationwide stay of OSHA’s vaccine-or-test mandate

By Kevin Mayer (US) on November 9, 2021 Posted in Coronavirus, Enforcement, General

On November 6, 2021, the Fifth Circuit Court of Appeals granted a nationwide stay of the Occupational Health and Safety Administration (OSHA)‘s Emergency Temporary Standard (ETS) vaccine-or-test mandate that was issued on November 5, 2021. The court granted the nationwide stay due to “grave statutory and constitutional issues” with the mandate. The emergency stay was requested by numerous … Continue reading

OSHA Updates Its COVID Interim Enforcement Response Plan

By Kevin Mayer (US) on July 12, 2021 Posted in Coronavirus, Enforcement, General

Based on an evaluation of current inspection and illness data, federal OSHA has revised its March 21, 2021 National Emphasis Program (NEP), adjusting the targeted industries to those most at risk for COVID-19 exposure. The revised NEP still includes healthcare and non-healthcare industries, including meat and poultry processing, but eliminates a prior appendix that provided … Continue reading

ACA Survives “[T]hird Installment in [U.S. Supreme Court’s] epic Affordable Care Act [T]rilogy”

By Yvonne Puig (US), Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on June 17, 2021 Posted in Enforcement, General, News from DC

On Thursday, June 17, 2021, in a 7-2 opinion, the U.S. Supreme Court upheld the Affordable Care Act (“ACA”) in the case California v. Texas. The Court held that Texas, the other plaintiff states, and the two individual plaintiffs did not have standing to challenge as unconstitutional the ACA’s minimum essential coverage provision. The plaintiffs … Continue reading

Healthcare Regulatory Landscape Transformed by Stark, AKS Final Rules

By Joseph Keillor (US) and Jeff Wurzburg (US) on November 23, 2020 Posted in Enforcement, General, News from DC, Regulatory

In what may prove to be the most substantial fraud and abuse rulemaking in over a decade, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) published on November 20, 2020 long-awaited final rules changing the regulations addressing the Anti-Kickback Statute (“AKS”) and … Continue reading

CMS Withdraws Proposed Medicaid Fiscal Accountability Rule

By Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on September 15, 2020 Posted in Coronavirus, Enforcement, General, Regulatory

On Monday, September 14, 2020, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Seema Verma announced on Twitter that CMS was withdrawing the proposed Medicaid Fiscal Accountability Rule (“MFAR”) from its regulatory agenda. The MFAR, which was proposed in November of 2019, would have added new reporting requirements for state governments to receive state … Continue reading

COVID-19 Update: CMS Updates Conditions of Participation for Hospitals and CAHs to Require COVID-19 Reporting

By Yvonne Puig (US), Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on August 28, 2020 Posted in Coronavirus, Enforcement, Regulatory

On Tuesday, August 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an interim final rule that updates the Medicare Conditions of Participation to require all hospitals to which 42 CFR Part 482 applies, as well as critical access hospitals (“CAHs”), to electronically report information including the number of confirmed or suspected COVID-19 … Continue reading

COVID-19 Update: CMS Announces Resumption of Survey Activities

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on August 19, 2020 Posted in Coronavirus, Enforcement, General, Regulatory

On August 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced it was resuming inspections of Medicare and Medicaid certified providers and suppliers, which had been suspended in late March in response to the COVID-19 public health emergency. More specifically, CMS will be resuming onsite revisit surveys for surveys with end dates on, … Continue reading

CMS Publishes CY 2021 Proposed Policy, Payment, and Quality Provision Changes to Medicare Physician Fee Schedule

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Rachel Park (US) on August 5, 2020 Posted in Coronavirus, Enforcement, Regulatory

On Monday, August 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the CY 2021 Physician Fee Schedule (PFS) proposed rule. We describe certain material provisions from the proposed rule below. Telehealth CMS proposes to add services to the Medicare telehealth list on a Category 1 basis. The additional services include group psychotherapy, … Continue reading

COVID-19 update: Trump issues Telehealth Executive Order

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on August 4, 2020 Posted in Coronavirus, Enforcement, News from DC

President Trump issued an Executive Order on August 3, 2020 that will continue the momentum for telehealth in rural areas.… Continue reading

CMS publishes FY 2021 Skilled Nursing Facility, Inpatient Psychiatric Hospital, and Hospice Medicare Payment final rules

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on August 4, 2020 Posted in Enforcement, News from DC, Regulatory

All three of these Medicare payment final rules will become effective on October 1, 2020.… Continue reading

President Trump unveils executive orders on lowering drug prices

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on July 30, 2020 Posted in Coronavirus, Enforcement, General, News from DC

On Friday, July 24, 2020, President Trump issued three executive orders, and announced a potential fourth executive order, with the stated intention of lowering the cost of prescription drugs in the United States. The general consensus among legal commentators is that the executive orders are not self-executing and implementation of the policies therein will, therefore, … Continue reading

Court of Appeals Upholds HHS Site-Neutral Payment Cuts to Off-Campus Provider Based Departments

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on July 20, 2020 Posted in Coronavirus, Enforcement, General

On Friday, July 17, 2020, the Court of Appeals for the District of Columbia found in favor of the U.S. Department of Health and Human Services (“HHS”) by holding that Medicare Part B payment cuts to certain services provided to Medicare beneficiaries in off-campus provider-based departments (“PBDs”) are within the agency’s statutory authority. More specifically, … Continue reading

U.S. Supreme Court Rules that the Federal Government “Shall” Pay Health Insurers $12 Billion Under the Risk Corridors Program

By Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on May 6, 2020 Posted in Enforcement, General, News from DC

On Monday, April 27, 2020, the U.S. Supreme Court ruled, in an 8-1 decision, that the federal government is required to pay health insurers $12 billion under the Patient Protection and Affordable Care Act’s (ACA) risk corridors program. Background of the Case Congress in the ACA created three premium stabilization programs to support insurers during … Continue reading

Deputy Associate Attorney General Stephen Cox Addresses DOJ’s False Claims Act Enforcement Priorities and Regulatory Reforms

By Chandra Westergaard (US), Keith M. Rosen (US) and Rachel Park (US) on February 19, 2020 Posted in Enforcement, General

On January 27, Deputy Associate Attorney General Stephen Cox delivered keynote remarks on the False Claims Act (FCA) at the 2020 Advanced Forum on False Claims and Qui Tam Enforcement. Mr. Cox’s remarks described the Department of Justice’s (“DOJ”) ongoing enforcement efforts and priorities, as well as outlined DOJ’s regulatory reform agenda and some of its … Continue reading

DOJ Recovers More than $2.6 Billion from Health Care False Claims Act Cases in FY 2019

By Keith M. Rosen (US) and Chandra Westergaard (US) on January 21, 2020 Posted in Enforcement, General

On January 9, the United States Department of Justice (“DOJ”) announced its statistics on federal False Claims Act cases for FY 2019. In a lengthy press release, the DOJ reported more than $3 billion in settlements and judgments from civil cases involving fraud and false claims against the government. Of this total, the DOJ reported … Continue reading

U.S. Fifth Circuit Court of Appeals affirms the ACA’s individual mandate penalty is unconstitutional and remands the case to the lower court to examine severability

By Jeff Wurzburg (US) on December 19, 2019 Posted in Enforcement, General

On Wednesday, December 18, 2019, the U.S. Court of Appeals for the Fifth Circuit held in Texas v. Azar that the Affordable Care Act’s (ACA) individual mandate is unconstitutional and remanded the case to the lower court for further review. In a split 2-1 panel decision, the Fifth Circuit held that the individual mandate is … Continue reading

CMS Releases Final Rule on CY 2020 Physician Fee Schedule Updates and Implements Opioid Use Disorder Treatment Programs

By Jeff Wurzburg (US), Thomas Dowdell (US) and Mark Faccenda (US) on November 12, 2019 Posted in Enforcement, News from DC, Regulatory

On November 1, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates the Medicare Physician Fee Schedule (PFS) rates and policies for calendar year (CY) 2020 and expands Medicare coverage to opioid treatment programs (OTPs) that treat beneficiaries with opioid use disorder (OUD). In a fact sheet accompanying the … Continue reading

U.S. District Court Upholds Ruling that CMS Exceeded Its Statutory Authority in Reducing Medicare Payments for Clinic Visit Evaluation and Management Services Furnished in Hospital Excepted Off-Campus Provider-Based Departments

By Mark Faccenda (US) and Jeff Wurzburg (US) on October 25, 2019 Posted in Enforcement, News from DC, Regulatory

On October 21, 2019, U.S. District Judge Rosemary M. Collyer denied the government’s request to modify the Court’s previous ruling on September 17, 2019, that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory authority when it reduced Medicare payment rates for clinic visit evaluation and management (E&M) services provided to Medicare patients … Continue reading

DOJ intervenes in FCA lawsuit against Life Spine for an illegal kickback scheme

By Savannah Wiseman (US) and Benjamin Wallfisch (US) on July 29, 2019 Posted in Enforcement

This week, the Department of Justice (DOJ) intervened in a False Claims Act (FCA) lawsuit against Life Spine and two of its executives, filed in the U.S. District Court for the Southern District of New York. The lawsuit alleges that Life Spine violated the Anti-Kickback Statute by paying more than $7 million in consulting fees, … Continue reading

New entity added to OIG “high risk – heightened scrutiny” list

By Savannah Wiseman (US) and Benjamin Wallfisch (US) on July 26, 2019 Posted in Enforcement

The Office of Inspector General (OIG) has added a new entity, Ridgeview Rehab & Nursing Center, LLC (Ridgeview), to its list of individuals and entities designated as “high risk – heightened scrutiny.” The “high risk – heightened scrutiny” list is part of the OIG’s fraud risk indicator tool, which the OIG made public last year. … Continue reading

OIG Publishes Guidance on Grant Self-Disclosure Program

By Carol Poindexter (US), Savannah Wiseman (US) and Benjamin Wallfisch (US) on July 18, 2019 Posted in Enforcement

Recently, the Office of Inspector General (OIG) published newly-issued guidance on the HHS OIG Grant Self-Disclosure Program (“Program”), which creates a formal framework for recipients, sub-recipients, and applicants for federal grant money to disclose potential violations of federal criminal, civil, or administrative law that may impact federally-awarded grants. Similar to the OIG’s Provider Self-Disclosure Protocol, … Continue reading