Topic: Enforcement

CMS Withdraws Proposed Medicaid Fiscal Accountability Rule

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 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 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

The Supreme Court resolves circuit split on FCA statute of limitations period

By Maxwell Karasek (US), Carol Poindexter (US) and Zach Smith (US) on May 14, 2019 Posted in Enforcement

On May 13, the U.S. Supreme Court unanimously affirmed a decision by the U.S. Court of Appeals for the 11th Circuit, holding that the False Claims Act’s (“FCA”) limitations period in 31 U.S.C.(b)(2) applies to “relator-initiated actions” in which the Government declines to intervene and that a relator in a nonintervened suit is not “the … Continue reading

DOJ issues guidance on cooperation credit in FCA investigations

By Michael Koon (US), Carol Poindexter (US) and Zach Smith (US) on May 9, 2019 Posted in Enforcement

On May 7, the Department of Justice (“DOJ”) released an update to its previous 2017 guidance (“Updated Guidance”) outlining when the government will award cooperation credit to defendants in False Claims Act (“FCA”) investigations. Under the Updated Guidance, set forth at Justice Manual Section 4-4.112, defendants can earn cooperation credit in FCA cases in three … Continue reading

OIG publishes Medicaid Fraud Control Units Fiscal Year 2018 Annual Report

By Savannah Wiseman (US) on March 27, 2019 Posted in Enforcement

On March 25, 2019, the Office of Inspector General (OIG) published its Medicaid Fraud Control Units Fiscal Year 2018 Annual Report. Forty-nine states and the District of Columbia have a Medicaid Fraud Control Unit (MFCU) which is responsible for investigating and prosecuting Medicaid provider fraud and patient neglect and abuse. The report notes that it … Continue reading

Anthem to pay US$115M to settle lawsuit relating to 2015 data breach

By Jeewon Kim Serrato (US) and Savannah Wiseman (US) on September 12, 2018 Posted in Enforcement

Anthem Inc. has agreed to a US$115 million settlement to resolve a class action lawsuit relating to a 2015 cyberattack that compromised data on 79 million individuals. Anthem has denied any wrongdoing. In February of 2015, Anthem reported that hackers stole personally identifiable information from millions of current and former customers, including names, addresses, social … Continue reading

DOJ announces Market Integrity and Consumer Fraud Task Force

By Yvonne Puig (US) and Jeff Wurzburg (US) on July 12, 2018 Posted in Enforcement

On July 11 the U.S. Department of Justice (DOJ) announced a new Task Force on Market Integrity and Consumer Fraud. The wide-ranging Task Force will be chaired by the Deputy Attorney General and work towards: [T]he investigation and prosecution of cases involving fraud on the government, the financial markets, and consumers, including cyber-fraud and other … Continue reading

US DOJ charges 601 individuals in nation’s largest healthcare fraud takedown

By Benjamin Wallfisch (US) on July 10, 2018 Posted in Enforcement

Last week, the U.S. Department of Justice announced charges against 601 individuals for their alleged participation in healthcare fraud schemes. According to the announcement, the alleged fraud is estimated to have resulted in more than $2 billion in losses to federal healthcare programs. This national healthcare fraud takedown is the largest in U.S. history, surpassing … Continue reading

Recent effort to regulate pharmaceutical pricing deemed unconstitutional by Fourth Circuit

By Robin Adelstein (US) on April 17, 2018 Posted in Enforcement, FDA & Food Safety, News from DC, Regulatory

In the absence of federal action, states have attempted to rein in high pharmaceutical pricing by enacting laws aimed at regulating drug pricing. Following what now has become a trend, on March 13, 2018, Oregon became the newest state to enact such legislation, The Prescription Drug Price Transparency Act, H.B. 4005. But many of these … Continue reading