In this first installment of Mintz Levin’s Health Care Fraud Enforcement Defense Group’s periodic updates on health care enforcement activities in 2012,Brian Dunphy, Hope Foster, Samantha Kingsbury, Tracy Miner, and Stephanie Willis focus on significant civil settlements, criminal prosecutions, and regulatory developments that occurred in the first quarter of 2012. This update follows our Year in Review series focusing on… Continue Reading
Category Archives: State & Federal Audits, Investigations & Litigation
Subscribe to State & Federal Audits, Investigations & Litigation RSS FeedAbbott Labs to Pay $1.6 Billion to Settle Consumer Protection and Misbranding Claims
Posted in Fraud & Abuse, Pharma & Medical Devices, State & Federal Audits, Investigations & LitigationAbbott Laboratories (Abbott), an Illinois company, will pay over $1.6 billion in penalties to the federal government and several states related to its alleged illegal promotion of the prescription drug Depakote for off-label uses, as announced by the settling parties on May 7, 2012. Specifically, the government has alleged that the Company: marketed Depakote, in nursing… Continue Reading
Press Coverage Triggers HIPAA-Related Inquiry
Posted in Hospitals & Health Systems, Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & LitigationWritten by Kimberly Gold Most state and federal health care investigations are prompted by audits or claims brought by whistleblowers. But a recent newspaper article about a debt collection company’s tactics has prompted Congressional ire and potentially a federal investigation. On April 24th, a New York Times article highlighted Accretive Health’s alleged debt collection practices after… Continue Reading
Medicare Fraud Strike Force Bust Involves Highest Amount of False Billings in a Single Takedown
Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation2012 is already a record-breaking year in health care fraud enforcement. This week Attorney General Eric Holder and Secretary of the Department of Health and Human Services (HHS) Kathleen Sebelius announced the biggest takedown in the history of the Medicare Fraud Strike Force (Strike Force) in terms of Medicare dollars at stake. The Strike Force… Continue Reading
Open Letter from Senate Finance Committee Seeks Fraud-Fighting Input
Posted in Fraud & Abuse, Health Care Reform, State & Federal Audits, Investigations & LitigationYesterday the Senate Finance Committee posted an open letter on its website to the health care sector soliciting industry stakeholder insights on ways to combat fraud, waste, and abuse in the Medicare and Medicaid programs. This letter comes on the heels of an April 25th hearing at which the members questioned government officials from the Department of Health and… Continue Reading
Senate Committee Holds Hearing on Health Care Fraud Enforcement
Posted in Fraud & Abuse, Health Care Reform, State & Federal Audits, Investigations & LitigationWritten by: Stephanie Willis and John Custer, ML Strategies Intern A hearing titled Anatomy of a Fraud Bust: From Investigation to Conviction held by the Senate Committee on Finance (Committee) on April 24th allowed federal health care agencies to both tout their fraud-fighting successes, and defend their failure to implement all of the fraud-fighting initiatives created by… Continue Reading
The Rising Cost of HIPAA Violations
Posted in Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & LitigationAs detailed by Kimberly Gold in a recent Privacy & Security Matters post, a physician group recently agreed to pay a six-figure fine and implement a corrective action plan under a Resolution Agreement with the U.S. Department of Health and Human Services Office for Civil Rights after a lengthy investigation into potential HIPAA violations. I encourage you to… Continue Reading
CMS To Pay Hospitals Over $3 Billion for CMS’ Miscalculation
Posted in Hospitals & Health Systems, Reimbursement, State & Federal Audits, Investigations & Litigation, UncategorizedHospital chains Hospital Corporation of America (HCA) and Tenet Healthcare Corporation (Tenet) announced on April 12th that the Centers for Medicare & Medicaid Services (CMS) has admitted that it erroneously calculated the rural floor provision established by the Balanced Budget Act of 1997. According to the HCA press release: [T]he rural floor provision establishes that a]… Continue Reading
Industry Trends in Criminal Health Care Fraud Enforcement
Posted in Fraud & Abuse, Health Care Reform, State & Federal Audits, Investigations & Litigation, UncategorizedMintz Levin’s Health Care Enforcement Defense Group has issued a new Client Advisory: Industry Trends in Criminal Health Care Fraud Enforcement – Part III in a Continuing Series on Health Care Enforcement. Written by Hope Foster, Tracy Miner, Stephanie Willis, Samantha Kingsbury, and Brian Dunphy, this third and final installment reviewing criminal health care fraud enforcement activities in 2011 and… Continue Reading
DOJ’s Strategies – FCPA and Health Care Fraud
Posted in Pharma & Medical Devices, State & Federal Audits, Investigations & LitigationFor insights into how Foreign Corrupt Practices Act (FCPA) enforcement is creeping into the pharmaceutical and medical device manufacturer arena, see this article, which I co-authored with Paul Pelletier, former principal deputy chief of the Criminal Division’s Fraud Section at the Department of Justice (DOJ). It discusses how DOJ is now using “letters of inquiry” and other informal practices to… Continue Reading
HHS Issues Report to Congress on the Self-Referral Disclosure Protocol
Posted in Clinical Laboratories, Fraud & Abuse, Health Care Reform, Hospitals & Health Systems, Physicians, State & Federal Audits, Investigations & LitigationWritten by Tom Crane and Brian Dunphy On March 23, 2012, the Department of Health and Human Services (HHS) issued its statutorily required report to Congress (Report) describing the implementation of the Medicare Physician Self-Referral Disclosure Protocol (SRDP) and the status of disclosures under the SRDP to date. The SRDP was authorized by the Affordable Care… Continue Reading
FTC Petitions for Rare Supreme Court Review of Hospital Acquisition
Posted in Antitrust, Hospitals & Health Systems, Mergers, Acquisitions & Other Transactions, State & Federal Audits, Investigations & LitigationWritten by Christi Braun, Matthew Cohen, and Bruce Sokler Last week, the Solicitor General, at the request of the Federal Trade Commission (FTC), petitioned the U.S. Supreme Court to review a ruling of the Eleventh Circuit regarding the acquisition of Palmyra Park Hospital (Palmyra) in Albany, Georgia by Phoebe Putney Health System (PPHS). In December 2010,… Continue Reading
Client Alert – The False Claims Act: The Impact in 2012
Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation, UncategorizedMintz Levin has issued a Client Alert: The False Claims Act: The Impact in 2012 - Part II in a Continuing Series on Health Care Enforcement. Written by Hope Foster, Tracy Miner and Brian Dunphy, this second part in our ongoing series reviewing health care fraud enforcement activities in 2011 and monitoring enforcement in 2012, expands… Continue Reading
CMS Issues Final Payment Error Calculation Methodology for Medicare Advantage RADV Audits
Posted in Payors & PBMs, State & Federal Audits, Investigations & LitigationWritten by Roy Albert and Susan Berson Thirteen months after over 500 comments were submitted in response to a CMS proposal, Medicare Part C (“Medicare Advantage”) plan sponsors and other stakeholders now know the methodology CMS will use in calculating payment errors through extrapolated estimates in audits based on risk adjustment data validation (“RADV”). On February… Continue Reading
Government Health Care Enforcement: How 2011 Actions Are Impacting 2012 Priorities
Posted in Fraud & Abuse, Pharma & Medical Devices, State & Federal Audits, Investigations & LitigationHealth care providers and pharmaceutical and medical device manufacturers are operating in an environment of intense scrutiny. As discussed in a Mintz Levin client advisory, in 2011, the federal government directed extraordinary resources and attention to detecting and prosecuting health care fraud and abuse. Numerous law enforcement agencies are casting a wide net and are… Continue Reading
Another Attempt to Curb the Sale of Prescription Data Comes Up Empty
Posted in Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & Litigation, UncategorizedWritten by: Ellyn Sternfield and Stephanie Willis Last year, the Supreme Court limited the ability of states to regulate the sale of prescription data. In Sorrell v. IMS Health, the Supreme Court determined that a 2007 Vermont law that effectively banned the sale of prescription data for commercial marketing purposes unless the prescriber consented was an… Continue Reading
The Best and Worst of HIPAA Compliance
Posted in Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & LitigationIf improving your HIPAA/HITECH compliance policies and procedures is one of your organization’s 2012 goals, I encourage you to read an article written by my colleague Ellen Janos entitled The Best and Worst of HIPAA Compliance, which was published in Corporate Compliance Insights. The article provides valuable information to assist covered entities in preparing for increased monitoring and audits by… Continue Reading
District Court Allows Trial on Whether a Below Cost but Competitively Bid Arrangement Can Lead to a Kickback Violation
Posted in Fraud & Abuse, State & Federal Audits, Investigations & LitigationWritten by Kevin McGinty The recent decision by a federal court judge in Mississippi to deny defendants’ motion for summary judgment in United States ex rel. Jamison v. McKesson rejected a well-established defense to claims that competitively procured arrangements for goods and services constituted “remuneration” for purposes of the Anti-Kickback Statute (“AKS”). Where it has… Continue Reading
Case Study: Messner v. Northshore University HealthSystem
Posted in Antitrust, Hospitals & Health Systems, State & Federal Audits, Investigations & LitigationLaw360 recently published an interesting article examining the Seventh Circuit’s recent opinion in Messner v. Northshore University HealthSystem. Written by my colleagues Christi Braun, Rob Kidwell, Kevin McGinty, and Bruce Sokler, the article provides an in-depth analsyis of the Messner decision, which involves significant class certification issues as well as an important analysis of antitrust harm in the… Continue Reading
OIG Warns Physicians of Fraud Liability from Medicare Reassignments
Posted in Fraud & Abuse, Physicians, Reimbursement, State & Federal Audits, Investigations & Litigation, UncategorizedWritten by Karen S. Lovitch and Stephanie D. Willis An OIG Alert issued today reminds physicians who reassign their right to submit claims to and receive payment from Medicare may be liable for any false claims submitted to the government. The OIG linked this alert to recent settlements under the Civil Monetary Penalty Law with physicians whose Medicare payment reassignments resulted in false… Continue Reading
Sanctions Imposed For Failure to Meet Ethical Standards for Use of Privileged Documents
Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation, UncategorizedRelators and their counsel are increasingly being held accountable for the misuse of qui tam defendants’ confidential and privileged documents in connection with lawsuits alleging violations of the False Claims Act (“FCA”). In a new Health Care Enforcement Defense Group Advisory, Health Law Section Of Counsel Ellyn Sternfield and I discuss the recent decision in United States ex rel. Jerre Frazier v…. Continue Reading
D.C. Circuit Finds Physicians Can Pursue Challenge to Stark Law Regulation
Posted in Fraud & Abuse, Hospitals & Health Systems, Physicians, State & Federal Audits, Investigations & LitigationWritten by Tom Crane The D.C. Court of Appeals gave Medicare providers and suppliers a holiday gift last week with the issuance of a rare jurisdictional ruling involving a challenge to the Stark Law regulations. For years, CMS had interpreted the Stark Law as permitting physicians to act as service providers to hospitals furnishing an… Continue Reading
Most CMS Audits of Medicare Part D Prescription Drug Plans Revealed Deficiencies, Many Plans Yet to Be Audited
Posted in Payors & PBMs, State & Federal Audits, Investigations & LitigationWritten by Roy Albert and Susan Berson The HHS OIG recently issued a Report concluding that the vast majority of audited Medicare Part D Prescription Drug Plans (PDP) in existence between 2006 and 2009 had problems, many of which resulted from beneficiaries’ coverage status or payment issues. During this same time period, a number of other PDPs were never… Continue Reading
Attention HIPAA Covered Entities: Keep an Eye on Your Mailbox….
Posted in Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & LitigationWritten by Dianne Bourque The HHS Office of Civil Rights has begun notifying the 150 covered entities chosen for its first round of audits under HITECH, and it has posted a sample audit notification letter. If your organization receives one of these letters, immediate attention is critical. You may have as few as ten days to respond… Continue Reading
