Topic: Enforcement

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

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

Rumors of sea change in DOJ policy potentially confirmed by two recent memos

By Carol Poindexter (US) on January 31, 2018 Posted in Enforcement

Rumors of a significant shift in U.S. Department of Justice (DOJ) policy were confirmed last week when a privileged and confidential internal DOJ memo was leaked to the press. The memo outlines seven factors government attorneys should use for evaluating whether the government should seek dismissal of qui tam actions filed under the federal False Claims … Continue reading

New tax law may have significant consequences for defendants settling False Claims Act suits

By on January 31, 2018 Posted in Enforcement

The Tax Cuts and Jobs Act may significantly limit the deductibility of False Claims Act settlements for defendants going forward. … Continue reading

Relator’s pharmacy allegations dismissed; government’s U&C allegations survive

By on January 30, 2018 Posted in Enforcement

Although a Florida compounding pharmacy has scored a win against a whistleblower’s allegations, it continues to defend against the government’s allegations of improper inflation of its Usual & Customary charges submitted to TRICARE. The U.S. District Court for the Middle District of Florida granted motions to dismiss with prejudice in favor of the pharmacy RS … Continue reading

FDA releases 2017 enforcement statistics and recall draft guidance

By on January 22, 2018 Posted in Enforcement

On January 17, 2018, the U.S. Food and Drug Administration (“FDA”) released its 2017 enforcement statistics. Overall, the statistics showed that there were no food importation debarment enforcement actions in the past year. Notably, there were 15,318 warning letters issued, 9,199 products recalled, and 2,945 recall events. There were 12 injunctions, 5 drug product debarments, … Continue reading

Court applies Escobar, overturns $350M False Claims Act verdict

By on January 16, 2018 Posted in Enforcement

In Universal Health Services v. U.S. ex rel Escobar, the United States Supreme Court emphasized the importance of the materiality standard in False Claims Act cases. Since that decision, litigants have anxiously awaited further guidance on how Escobar’s instructions would be applied by lower courts. In U.S. ex rel Ruckh v. Salus Rehabilitation, LLC et … Continue reading

OIG rescinds advisory opinion to charity

By Carol Poindexter (US) on November 30, 2017 Posted in Enforcement

For the first time, the OIG has rescinded an advisory opinion issued to a charity. According to the OIG, the advisory opinion – issued in 2006 and modified in 2015 – was revoked because the charity “failed to comply with certain factual certifications” about independence from donors, potentially steering Medicare beneficiaries toward certain prescription drugs. … Continue reading

Third and Fifth circuits accept materiality arguments in throwing out qui tam cases

By on November 27, 2017 Posted in Enforcement

On November 16, 2017, the Third Circuit Court of Appeals affirmed the grant of summary judgment in favor of CVS Caremark, Corp. (“CVS Caremark”), finding that although the lower court’s reasoning was flawed, the whistleblower Anthony Spay failed to establish the requisite materiality element of a False Claims Act (“FCA”) lawsuit. In making its decision, … Continue reading

DOJ policy shift in qui tam litigation?

By Callan Edquist (US) on November 17, 2017 Posted in Enforcement

Last week, a senior US Department of Justice official appeared to announce a surprising, and potentially significant, shift in policy regarding qui tam litigation. Michael Granston, director of the commercial litigation branch of the fraud section in the DOJ’s civil division, said during a speech that the DOJ will be moving to dismiss False Claims … Continue reading

Bakery receives Warning Letter for listing “love” as an ingredient

By Benjamin Wallfisch (US) on October 4, 2017 Posted in Enforcement

The US Food & Drug Administration does not have much of a sense of humor when it comes to the mandatory ingredient list on packaged food products. Last month, FDA issued a Warning Letter to the Nashoba Brook Bakery in Concord, Massachusetts, for, among other violations, listing “love” as an ingredient in its granola and … Continue reading

Judge doubles down on finding of materiality in FCA case

By Joseph Keillor (US) and Sarah Jean Kilker (US) on September 26, 2017 Posted in Enforcement

Federal courts continue to grapple with applying the “materiality” standard that is needed to cause a Stark Law violation or other underlying compliance matter to trigger False Claims Act liability. Although we have recently begun to gain a clearer view of what contractual requirements will not likely be viewed as material, at least one federal … Continue reading

Government audits shift to high error rates and significant variances

By on August 18, 2017 Posted in Enforcement

CMS has revamped its approach to pursuing alleged improper payments. Its new audit strategy with Medicare Administrative Contractors (MACs) will target providers and suppliers with the highest error rates or the most significant deviations. This is a significant shift in strategy to focus on outliers when seeking recoupment. Under the new audit process, through a process of … Continue reading

Ambulance and telehealth services among 14 new inquiries announced by HHS OIG

By Benjamin Wallfisch (US) on July 19, 2017 Posted in Enforcement

On Monday, July 17, the Office of Inspector General for the U.S. Department of Health and Human Services announced 14 new inquiries into potentially fraudulent billing of Medicare and Medicaid. The OIG announcement is part of a new policy to update its investigative Work Plan every month rather than once or twice per year. The … Continue reading