Archives: Fraud and Abuse

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Lawyer Misconduct Dooms FCA Suit

A fraudulent survey of doctors sponsored by attorneys for a qui tam relator doomed a False Claims Act (FCA) complaint against a pharmaceutical company. In a forceful opinion, United States District Judge Dennis Saylor IV, District of Massachusetts, found violation of ethical rules, excised more than 100 paragraphs of the complaint as a sanction, and … Continue Reading

Can DOJ Impose False Claims Act on States?

The immense power wielded by the Department of Justice (DOJ) under the False Claims Act (FCA) has limits according to United States District Judge Anna J. Brown in the District of Oregon. This month the court decided DOJ cannot force the Act to apply to an “arm of the state” simply by intervening in the suit. Although … Continue Reading

OIG Expands Anti-Kickback Statute and Civil Monetary Penalties Protections (Part 2)

As we discussed in a previous post, the Department of Health and Human Services Office of Inspector General (OIG) published a final rule (Final Rule) amending the safe harbors to the Anti-Kickback Statue (AKS) and also amending exceptions to the Civil Monetary Penalties rule (CMP), providing greater protection for certain arrangements with beneficiaries. In this second … Continue Reading

OIG Expands Anti-Kickback Statute and Civil Monetary Penalties Protections

Late last year, the Department of Health and Human Services Office of the Inspector General (OIG) published a final rule (Final Rule) that amends the safe harbors to the federal Anti-Kickback Statute (AKS) by modifying an existing safe harbor, adding new safe harbors and codifying existing statutory provisions that provide further protections from sanctions under the … Continue Reading

Will Verdict Encourage Counsel To Become Healthcare Relators?

Last week a jury awarded millions of dollars to a former General Counsel who brought a whistleblower retaliation lawsuit against a life sciences company. (Verdict form here.) Does that verdict warn the health care industry to brace for a wave of False Claims Act (FCA) litigation brought by in house counsel who have turned relators? Certainly not. General Counsel … Continue Reading

HHS OIG Issues Another Regulation On Eve of Inauguration

On January 11, 2017, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued a final rule explaining new policies for excluding individuals and entities from participation in federal health care programs.  The final rule reflects amendments to the agency’s exclusion authorities made by the Affordable Care Act in 2010 and … Continue Reading

DOJ Juggernaut Will Continue To Rack in $$$$

The Department of Justice (DOJ) announced this week that it collected another $4.7 billion during FY 2016 under the False Claims Act (FCA). This was the third largest haul in history, bringing total recoveries since FY 2009 up to $31.3 billion. Although DOJ did not say it directly, there seems no end in sight to … Continue Reading

Supreme Court Approves Implied False Certification Theory but Imposes “Demanding” Materiality Limitation

In a decision that will impact every provider who supplies goods and services to the federal government, the Supreme Court today approved the implied false certification theory as a basis for liability under the False Claims Act (FCA). Specifically, in Universal Health Services v. Escobar, the Court ruled that the FCA is violated whenever a … Continue Reading

Billions at Stake for Providers in Argument Before US Supreme Court

This week, the United States Supreme Court heard oral arguments in Universal Health Services v. United States ex rel. Escobar, a case destined to influence the scope of False Claims Act (FCA) liability for anyone who receives payments from Medicare, Medicaid or any other federal government-funded health care program. As Justice Breyer acknowledged during oral … Continue Reading

Task Forces in 10 States Target Providers of Services to Elderly

On March 30, 2016, the US Department of Justice (DOJ) announced that healthcare providers who serve the elderly in the following 10 states will have task forces looking over their shoulders: California, Georgia, Kansas, Kentucky, Iowa, Maryland, Ohio, Pennsylvania, Tennessee and Washington. Known as the Elder Justice Task Forces (Task Forces), these partnerships combine the … Continue Reading

Settlement With DOJ Opens a New Chapter For Tuomey

The cautionary tale of Tuomey (summaries can be found here and here), which illustrated the risks for hospitals structuring arrangements with physicians, is finally coming to a close. When the U.S. District Court for the District of South Carolina first ordered Tuomey Healthcare System, Inc. (“Tuomey”) to pay $237 million for violations of the Stark … Continue Reading

Largest National Health Care Fraud Take-Down in History Focuses on Medicare Part D

On the heels of its announcement that it is “hiring additional lawyers to look into taking more administrative actions against” physicians, the Office of Inspector General (OIG) recently filed 75 indictments and 14 complaints against various parties.  See the Fact Sheet.  The OIG’s “national sweep” yielded prosecution of $712 million in false billings and led … Continue Reading

OIG Puts Muscle Behind Its Alert

Only two days after releasing its latest fraud alert, a deputy director from HHS’s Office of Inspector General announced that the OIG will be hiring additional attorneys to look into taking more administrative actions against physicians in their individual capacity. This announcement emphasizes that the OIG means serious business – not only is the OIG … Continue Reading

OIG Warns Physicians Regarding Noncompliant Agreements

Tuesday, the OIG released a fraud alert advising physicians to ensure their compensation arrangements, such as medical director agreements, reflect fair market value for bona fide services the physicians actually provide, or they could potentially face liability under the Anti-Kickback Statute.  As part of the fraud alert, the OIG encouraged physicians “to carefully consider the … Continue Reading

CMS delays identifying overpayments. Can you?

The Centers for Medicare and Medicaid Services (CMS) continues to mull over the knotty problem of what it means to identify an overpayment from the government.  Healthcare providers do not have the same luxury. Five  years ago, the Affordable Care Act required a provider that received an overpayment from the government to report and repay it within 60 days of identifying the … Continue Reading

Release of the 2015 OIG Work Plan

Happy Halloween!  In addition to costumes and candy, October 31 saw the release of the 2015 Work Plan by the Office of Inspector General for Health and Human Services.  Always a lengthy document, the Work Plan can indicate areas that providers and suppliers want to monitor closely, as they are areas receiving attention from the government.  In … Continue Reading

DOJ Criminal Division Increasing Attention on Health Care False Claims

There may be more criminal cases involving healthcare fraud in the near future, as the U.S. Department of Justice has announced it will be ramping up its review of whistleblower cases involving alleged health care fraud.  In a recent speech Leslie R. Caldwell, Assistant Attorney General for the DOJ’s Criminal Division, announced that the U.S. Department of Justice was … Continue Reading

CMS Finalizes Medicare Part C and Part D Program Changes for Contract Year 2015: Moderate Deviations from Proposed Rule

On January 8, 2014, we noted several proposed changes to the Medicare Part C and D programs as delineated in CMS’ January 8th proposed rule (hereinafter “Proposed Rule”). On Monday, May 19, 2014, CMS issued the final rule, titled Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare … Continue Reading

Is Your Name on the List?

Given the 880,000 names of physicians released by Medicare Wednesday, physicians who treat Medicare patients can expect their names to be on the list.  The list, searchable here, contains the name of the provider, the specialty area, the city, county and state as well as the total payments made to the provider by Medicare for … Continue Reading

Florida Proposes Pharmacy Audit Rights Legislation

The Florida legislature is currently considering proposed legislation that may affect the way in which managed care organizations, insurers, third-party payors, pharmacy benefit managers and other entities audit pharmacies in Florida.  The Florida House of Representatives, Health Innovation Subcommittee, is reviewing HB 745, which proposes to create a “Pharmacy audit bill of rights.”  The Health … Continue Reading

Is CMS Prepared for Evolving Medical Records Technology?

Health care fraud accounts for billions of the US health expenditure each year. This week HHS published a study addressing possible deficiencies in CMS’ capability to address fraud vulnerabilities and ensure the integrity of electronic health records (“EHR”) systems which CMS and its contractors use to pay Medicare claims. Concerns about whether CMS’ oversight and … Continue Reading

CMS and OIG Ring in the New Year with Final Rules on EHR Donations

On December 27, 2013, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General of the Department of Health and Human Services (“OIG”) published final rules (“Final Rules”) regarding the electronic health records (“EHR”) donations Stark Law Exception (42 C.F.R. 411.357(w)) and Anti-Kickback Statute Safe Harbor (“AKS Safe Harbor”) (42 C.F.R. … Continue Reading

Fourth Circuit Requires Penalties for FCA Violations, Even Where No Government Economic Damage Found

Author: Rebecca A. Worthington, Esquire In a decision sure to generate comment during the new year, the Fourth Circuit ruled in United States ex rel. Bunk v. Gosselin World Wide Moving, No. 12-1369, 2013 U.S. App. LEXIS 25225 (Dec. 19, 2013), that penalties of some amount must be awarded for violations of the civil False … Continue Reading
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