The HHS Office of Inspector General allows nursing facilities to give discounts to private insurers. OIG Advisory Opinion 17-08 describes a startup company planning to develop a network of nursing facilities (the Network). The company wants nursing facilities in the Network to provide discounts on daily rates charged to a long-term care insurer (Participating Payor) and its Policyholders. Qualifying nursing … Continue Reading
In a settlement this week, the government rewards prompt action of a biopharma company by declining a penalty. Although an enforcement action by the Securities and Exchange Commission, the approach corresponds to a recent announcement by the Department of Justice. Companies that self-report, cooperate, and remediate will receive lenient treatment. This settlement makes clear just how valuable those efforts can … Continue Reading
A federal judge rejects healthcare company’s “C” plea as not good enough. Lessons from this decision apply to any healthcare provider trying to negotiate a specific sentence with the federal government. A summary of the judge’s criticism follows a short background about a C plea. Types of Guilty Pleas Federal Criminal Rule 11(c)(1) governs plea agreement procedure. It … Continue Reading
Effective training prepares healthcare providers to recognize violations of the anti-kickback and false claims statutes. However, a violation may seem just a straightforward business arrangement to those not familiar with the statutes. This article on the Squire Patton Boggs Anti-Corruption blog uses an example to explain that training must focus on remuneration, not just kickbacks.… Continue Reading
Rejecting a contrary holding in the Fourth Circuit, the Sixth Circuit decided a healthcare provider has no “fundamental right to participate in federal health care programs.” Accordingly, the Department of Health and Human Services (HHS) was correct to exclude a pharmacist from federal healthcare programs simply because he was convicted of misdemeanor misbranding.… Continue Reading
June 16, 2017, marks the one-year anniversary of the precedent-setting U.S. Supreme Court decision in Universal Health Services v. United States ex rel. Escobar (Escobar), which approved the implied false certification theory as a basis for liability under the False Claims Act (FCA). Because the decision impacts every provider who supplies goods and services to … Continue Reading
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
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
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
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
Last week a jury awarded millions of dollars to a former General Counsel who brought a whistleblower retaliation lawsuit against a life sciences company. 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 brought the … Continue Reading
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
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
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
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
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
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
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. The OIG’s “national sweep” yielded prosecution of $712 million in false billings and led to charges against 46 … Continue Reading
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
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
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
Just before the ball dropped to start the new year, the Centers for Medicare & Medicaid Services approved the Recovery Audit Contractor (RAC) to identify and recoup improper payments for durable medical equipment, home health and hospice care on a national basis (known as region 5). The contract, dated December 30, 2014, is the first … Continue Reading
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
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