Whistleblowers remain a steady source of False Claim Act (FCA) suits against health care and life science companies each year. Join our upcoming webinar – “Qui Tam Relators: What You Need to Know” on July 12 at 1pm ET. Colleagues in our Health Care Enforcement Defense Practice Group will help companies better understand how to deal with FCA cases, which result in billions of dollars of recovery for the government each year. Hope Foster, Larry Freedman, Karen Lovitch and Ellyn Sternfield will share insights to the relator process, help companies understand how to react if it is named in a whistleblower suit, and provide tips for how to prevent them.
In this final installment of our Health Care Enforcement Review and 2017 Outlook series, we analyze health care enforcement trends gathered from 2016 civil settlements and criminal resolutions of health care fraud and abuse cases. Behind the headlines covering enormous recoveries in 2016, several themes are apparent.
The False Claims Act continued to generate large civil settlements.
Continuing the trend from recent years, the False Claims Act (“FCA”) remained the primary civil enforcement tool against health care providers as well as pharmaceutical, life sciences, and medical device companies, predominantly driven by qui tam FCA complaints filed by relators. In fiscal year 2016, the Department of Justice obtained more than $4.7 billion in settlements and judgments from FCA cases, $2.5 billion of which it obtained from the health care industry. Continue Reading Health Care Enforcement Review and 2017 Outlook: Significant Health Care Fraud and Abuse Civil Settlements and Criminal Resolutions
Please join Mintz Levin for a webinar discussing health care fraud enforcement in the pharmacy and pharmaceutical industry on October 26, 2016 at 1 pm (ET). My colleagues Theresa Carnegie, Larry Freedman, and Ellyn Sternfield, members of Mintz Levin’s Health Law and Health Care Enforcement Defense practices, will discuss enforcement trends facing the industry.
The webinar will cover topics relevant to virtually all sectors of the health care and life sciences industries, especially pharmaceutical manufacturers, pharmacies, pharmacy benefit managers (PBMs), and health insurers as well as those who invest in the health care and life sciences industries.
During the webinar, my colleagues will discuss:
- Litigation, investigations, and settlements involving pharmaceutical manufacturers, PBMs, specialty pharmacies, and health care providers;
- Federal (including the Department of Justice and the Office of Inspector General) and state enforcement focus on the financial relationships among the companies and providers involved in the pharmaceutical supply chain; and
- Emerging trends in government enforcement and what is fueling them.
The webinar is approved for CLE credit in California and New York.
You can register for the webinar here.
Earlier today, my colleagues Tom Crane and Larry Freedman released a Health Care Enforcement Defense Advisory regarding the Supreme Court’s long-awaited, unanimous decision in Universal Health Services v. United States ex rel. Escobar (“Escobar”). As they discuss in detail, the Court ruled that under certain circumstances the theory of “implied false certification” can give rise to liability under the False Claims Act (“FCA”).
The Court explained that FCA liability can attach when (1) “the claim does not merely request payment, but also makes specific representations about the goods or services provided,” and (2) the defendant’s “failure to disclose noncompliance with material statutory, regulatory, or contractual requirements makes those representations misleading half-truths.” However, the Court also limited the scope of the FCA by imposing a “rigorous” and “demanding” standard of materiality.
For more information and a discussion on what this decision might mean for health care enforcement defense, please click here.
Last week the Supreme Court heard oral argument in a False Claims Act (“FCA”) case in which the Court is considering the validity of the so-called implied false certification theory. This theory attaches FCA liability when a person submits a claim for payment notwithstanding a violation of an underlying law or regulation, but without a factually false claim form. Because of the massive volume of Medicare and Medicaid regulations that a provider could potentially violate, the case is significant. More than two dozen stakeholders weighed in with amici briefs. Here we discuss some of the important questions raised in the oral argument. Continue Reading Justices Grapple with Limits of False Claims Act Liability in Implied Certification Cases
As 2015 comes to a close and you look ahead to the New Year, we hope that you will consider joining us for an informative webinar on health care enforcement trends for 2016. On Wednesday, January 13, 2016, my colleagues Hope Foster, Laurence Freedman, and Bridget Rohde will host “Health Care Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead.” The webinar will highlight key enforcement activities from 2015 and the trends we expect to see in 2016. Continue Reading Upcoming Webinar and Report – Health Care Enforcement in 2016
The former CFO of Shelby Regional Medical Center, Joe White, pleaded guilty to knowingly making a false statement related to the hospital’s meaningful use of electronic health records (“EHR”). Shelby Regional had received $785,655 in meaningful use incentive payments from Medicare for fiscal year 2012. White faces sentencing of up to five years in prison.
A federal district court recently dismissed a qui tam relator’s complaint in a declined case against the Hospital for Special Surgery (“Hospital”), its former CEO, and an outside billing company alleging that they violated the federal False Claims Act (FCA) and the New York FCA resulting from alleged violations of the Anti-Kickback Statute (AKS) and the Stark Law. Relator, Corporate Compliance Associates (CCA), asserted nine claims apparently based in part on information obtained from the Hospital’s former Chief Compliance Officer and former Associate Vice President of Physician Services. CCA alleged, among other things, that the Hospital sought to induce patient referrals to the hospital by purportedly paying kickbacks to its contract physicians in the form of (1) compensation arrangements that included salary payments tied to referral volumes, and (2) payments for allegedly sham administrative and teaching responsibilities. The court’s wide-ranging and thorough decision to dismiss is notable for at least two reasons, as discussed below. Continue Reading Another Court Weighs in on Rule 9(b)’s Requirements Under the False Claims Act
Written by: Ellyn L. Sternfield
The increasing availability of health care claims and payment data may portend the future of government and private health care enforcement and litigation.
Data is the lifeblood of health care fraud enforcement efforts. For many years, Medicare enforcement was hampered by CMS’s use of multiple Medicare contractors to pay and process Medicare claims. In late 2010, I wrote about how this could change with the allocation of more than $350 million to create integrated Medicare and Medicaid databases designed to enhance government health care fraud detection and enforcement efforts. It now appears that the future is here.
OIG Report on Medicare Part D Data
Last week, the OIG issued a Report analyzing 2009 Medicare Part D data. The Report finds that of 1.1 million individual medical practitioners who had prescribed drugs paid for through Part D, 736 general practitioners were “extreme outliers” in terms of five key measures:
- The average number of prescriptions written per beneficiary;
- The number of pharmacies filling that provider’s prescriptions;
- The percentage of prescriptions for Schedule II drugs;
- The percentage of prescriptions for Schedule III drugs; and
- The percentage of prescriptions for brand name drugs.
The data analysis uncovered some eye-popping statistics. One physician was responsible for prescriptions filled by 872 different pharmacies located in 47 states and Guam, another averaged more than 71 prescriptions per individual beneficiary, and another ordered more than 400 prescriptions for each of 16 beneficiaries. In 2009, Medicare paid more than $352 million on prescriptions written by the 736 physicians identified as extreme outliers.
The Report provides government prosecutors with a roadmap for potential enforcement. It also illustrates what may be the future of public and private health care fraud enforcement as more and more health care payment data becomes publicly available. Not only government prosecutors, but also individuals with their own agendas, will be able to analyze the data for aberrations and outliers.
CMS Release of Medicare Claims Processing Data
In recent months, CMS has begun publicly releasing Medicare claims processing data, including hospital charge data for specified outpatient and inpatient treatments. Multiple media reports have already pointed out discrepancies in the hospital prices reflected in the data. CMS promises that more health care data will be forthcoming.
Injunction on Release of Physician Payment Information Overturned
On May 31, 2013, a federal judge overturned an injunction that had been in place for 33 years, which had prevented the release of information on what Medicare pays individual physicians. The injunction was initially issued at the request of the Florida Medical Association, which argued that release of information on what Medicare paid the physicians constituted an unwarranted invasion of personal privacy, reasoning the judge found “no longer equitable.”
Medicare Data Access Bill Introduced
After this injunction was lifted, legislation was introduced in the Senate to make Medicare payment data publicly available in a free, searchable database. The Medicare Data Access for Transparency and Accountability Act would also affirm that data on Medicare payments to physicians and suppliers is public information, not exempt from disclosure under the Freedom of Information Act. The bill does not address whether publication of the data constitutes public disclosure for purposes of qui tams brought under the federal or state false claims acts.
It is clear that through integrated databases, government investigators are gaining enhanced access to Medicaid and Medicare data that will be mined and analyzed to develop future health care enforcement cases. It is also clear that insurers, the media, class action counsel, and potential qui tam whistleblowers also may soon be mining this newly available data to identify potential outliers and develop their own health care based litigation efforts.
What’s at stake for states that fail to bring their false claims laws in line with new federal standards by the August 31 deadline? A 10% share from settlements of Medicaid fraud lawsuits which, considering the $4.2 billion the federal government recovered in fiscal year 2012, could mean big money. But is it a big enough incentive for states?
Ellyn Sternfield, an attorney in Mintz Levin’s Health Care Fraud Enforcement Defense Practice, weighs in on what some states are thinking in, States Pressured to Match Their False Claims Acts to Federal Law, an article published last week in Thomson Reuters. Many state lawmakers, she says, are reluctant to change their state false claims laws, fearing the resources required to investigate Medicaid false claims and having to share recoveries with whistleblowers may not make it cost-effective.