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Category Archives: State & Federal Audits, Investigations & Litigation

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OMB Finalizes Review of 60-Day Overpayment Rule

Posted in Fraud & Abuse, Health Care Fraud Enforcement, Health Care Reform, Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, State & Federal Audits, Investigations & Litigation

The Office of Management and Budget completed its review of the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days (the “60-day rule”).  As a result, the final 60-day rule will likely be published soon. The 60-day rule will implement Section… Continue Reading

Upcoming Webinar and Report – Health Care Enforcement in 2016

Posted in Enforcement, Fraud & Abuse, Health Care Fraud Enforcement, State & Federal Audits, Investigations & Litigation

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… Continue Reading

Laboratories – 2015 Year in Review [VIDEO]

Posted in Clinical Laboratories, Enforcement, Food and Drug Administration (FDA), Fraud & Abuse, Health Care Fraud Enforcement, State & Federal Audits, Investigations & Litigation, Uncategorized

Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory developed tests (LDTs) in late 2014, the Food and Drug Administration (FDA) made clear in 2015 that it intends to move forward… Continue Reading

A Return to Evanston: FTC Revisits Old Ground in Yet Another Hospital Merger Challenge

Posted in Accountable Care Organizations, Antitrust, Hospitals & Health Systems, Mergers, Acquisitions & Other Transactions, Payors & PBMs, Physicians, Reimbursement, State & Federal Audits, Investigations & Litigation

Last week, the Federal Trade Commission (“FTC” or “Commission”) authorized staff to file an administrative complaint and to seek in federal court a temporary restraining order and a preliminary injunction to block the proposed merger of Advocate Health Care Network (Advocate) and NorthShore University HealthSystem (NorthShore) in the Chicago area.  In the Matter of Advocate… Continue Reading

Mintz Levin Advisory Analyzes Health Care Qui Tam Litigation Trends

Posted in Enforcement, Fraud & Abuse, Health Care Fraud Enforcement, State & Federal Audits, Investigations & Litigation, Uncategorized

Last week, my colleague Kevin McGinty published a fascinating advisory that provides a detailed analysis of data recently released by the Department of Justice (“DOJ”) in its annual report on False Claims Act (“FCA”) filings. This data spans 28 years (from October 1, 1987 through September 30, 2015) and tracks annual recoveries and investigations for various… Continue Reading

HIPAA and Health Care Data Privacy – 2015 Year in Review

Posted in Enforcement, Hospitals & Health Systems, Payors & PBMs, Pharmacies, Physicians, Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & Litigation

As the year winds down, we look back with a mixture of nostalgia and queasiness on the major Health Insurance Portability and Accountability Act (HIPAA) events that defined 2015.    Incredibly large data breaches became disturbingly routine, calling into question the ability of insurers and providers to protect their increasingly large troves of sensitive health information. … Continue Reading

DOJ Recovers $3.5 Billion in False Claims Act Cases in FY2015 and Pays Record Amount to Qui Tam Relators

Posted in Fraud & Abuse, Health Care Fraud Enforcement, State & Federal Audits, Investigations & Litigation

Late last week, the Department of Justice (DOJ) announced that in FY2015 it obtained more than $3.5 billion in settlements and judgments from civil cases involving allegations of false claims against the government. Once again, health care fraud recoveries led the pack, driven by qui tam (whistleblower) filings, including notable recoveries in qui tam cases… Continue Reading

HIPAA Lessons from the Warner Chilcott Settlement

Posted in Enforcement, Fraud & Abuse, Health Care Fraud Enforcement, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & Litigation

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations involving the promotion of the company’s drugs.  Continuing its focus on individuals, the former President of the Company has… Continue Reading

Skeletons in the Closet? Beware of Potential Enforcement Actions

Posted in Enforcement, Fraud & Abuse, Health Care Fraud Enforcement, State & Federal Audits, Investigations & Litigation

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement Defense Group, have discussed a wide variety of state and federal health care fraud investigations and qui… Continue Reading

Yates Memo Discussed at Pharmaceutical Compliance Congress

Posted in Clinical Laboratories, Enforcement, Fraud & Abuse, Health Care Fraud Enforcement, Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices, Pharmacies, State & Federal Audits, Investigations & Litigation

As readers of Health Law and Policy Matters know, we have covered recent developments in the Department of Justice’s (DOJ’s) commitment to prosecuting individuals involved in corporate misconduct.  A flurry of activity on this issue erupted after a Deputy Attorney General (DAG) in the DOJ named Sally Quinlan Yates published a memorandum in September. Known as the… Continue Reading

FTC-DOJ Join Forces: Encourage Repeal/Retrenchment of Virginia CON Laws

Posted in Antitrust, Home Health & Hospice, Hospitals & Health Systems, Long-term Care/Skilled Nursing Facilities, Reimbursement, State & Federal Audits, Investigations & Litigation

The Federal Trade Commission (“FTC”) and Department of Justice Antitrust Division (“DOJ”) (collectively, “agencies”) issued a joint statement to Virginia’s Certificate of Public Need (“COPN”) Work Group, which was recently charged with reviewing Virginia’s certificate of public need process and its impact on health care services in Virginia, including the development of “specific recommendations for… Continue Reading

Mintz Levin’s October Health Care Qui Tam Update

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Mintz Levin’s Health Care Enforcement Defense Group has published the latest edition of its Qui Tam Update. The October Qui Tam Update reviews 15 health-related False Claims Act cases that were recently unsealed. Over half of the cases involved both state and federal claims, and over 85% of the relators in the cases were current or… Continue Reading

Jury Sides with DOJ in First Phase of FCA Statistical Sampling Trial

Posted in Enforcement, Fraud & Abuse, Health Care Fraud Enforcement, Home Health & Hospice, State & Federal Audits, Investigations & Litigation, Uncategorized

Last week, a jury in Alabama federal court sided with the Department of Justice (DOJ) and qui tam relators in the first part of a False Claims Act (FCA) case against AseraCare Inc., a provider of hospice and palliative care services, and found that claims submitted by AseraCare for 104 patients were objectively false. In… Continue Reading

FTC Submits Public Comments to States Considering Regulations of Cooperative Agreements Between Hospitals

Posted in Antitrust, Enforcement, Hospitals & Health Systems, Physicians, State & Federal Audits, Investigations & Litigation

The Federal Trade Commission (FTC) recently submitted comments to Virginia and Tennessee regarding proposed laws in each state relating to Cooperative Agreements between hospitals and the granting of Certificates of Public Advantage (COPA). This continues the FTC’s active monitoring of state regulations potentially affecting competition in the health care market. In response to the states’… Continue Reading

FTC Provides Guidance Regarding Antitrust Compliance for State Regulatory Boards

Posted in Antitrust, Enforcement, Home Health & Hospice, Hospitals & Health Systems, Physicians, State & Federal Audits, Investigations & Litigation

In North Carolina State Board of Dental Examiners v. FTC, 135 S. Ct. 1101 (2015), the Supreme Court held that the North Carolina Board of Dental Examiners (“Board”), a state agency, was not exempt from federal antitrust laws when it prohibited non-dentists from providing teeth whitening services in competition with the state’s licensed dentists. The… Continue Reading

DOJ Clarifies Position on Individual Accountability in Corporate Investigations

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Earlier this month, we discussed a memorandum issued by Deputy Attorney General Sally Quillian Yates of the U.S. Department of Justice (DOJ).  This memorandum, referred to as the “Yates Memo,” reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to focus on individual accountability when dealing with corporate misconduct. As we discussed, the Yates Memo sets… Continue Reading

Executives Should Take a Closer Look at Insurance Coverage after New DOJ Policies

Posted in Enforcement, Fraud & Abuse, Health Care Fraud Enforcement, State & Federal Audits, Investigations & Litigation

Last week, we discussed the memorandum released by the Department of Justice emphasizing the Government’s commitment to holding individuals accountable when dealing with corporate wrongdoing. Our colleagues Heidi Lawson and Jacquelyn Burke also examined this memorandum’s impact on executives for the Mintz Levin Securities Matters blog. Executives should remember that their interests do not always match… Continue Reading

DOJ Issues Memo Directing Prosecutors to Focus on Individual Accountability

Posted in Enforcement, Fraud & Abuse, Health Care Fraud Enforcement, State & Federal Audits, Investigations & Litigation

The U.S. Department of Justice (DOJ) issued a memorandum on Wednesday from Deputy Attorney General Sally Quillian Yates that reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to focus on individual accountability when dealing with corporate misconduct. Yates delivered additional remarks yesterday on the memorandum and its expected impact on criminal and… Continue Reading

State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

Posted in Fraud & Abuse, Pharma & Medical Devices, Pharmacies, Reimbursement, State & Federal Audits, Investigations & Litigation

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing.  Multiple states have introduced bills that would require pharmaceutical manufacturers to produce information to justify the sales price for their drugs.  But the idea that pharmaceutical manufacturers are unilaterally responsible for the costs borne… Continue Reading

Court Enforces Arbitration Agreement and Requires Employees to Arbitrate FCA Claims

Posted in Fraud & Abuse, Hospitals & Health Systems, State & Federal Audits, Investigations & Litigation

On Mintz Levin’s Employment Matters blog, my colleague David Barmak recently discussed in a blog post a notable case in which a federal court compelled the arbitration of three nurses’ False Claims Act (FCA) retaliation claims against the hospital that employed them.  As described in the blog post, the court went a step further by also… Continue Reading

OIG Issues Favorable Advisory Opinion of Hospital Leasing Arrangement

Posted in Fraud & Abuse, Hospitals & Health Systems, State & Federal Audits, Investigations & Litigation

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services published Advisory Opinion 15-10 (Opinion). The Opinion addressed a hospital system’s proposal to lease non-clinician employees and provide operational and management services to a related psychiatric hospital. While finding that the Proposed Arrangement could potentially generate prohibited remuneration under the… Continue Reading

The Corporate Practice Prohibition in New York: What We Can Learn From the ADMI Settlement

Posted in Fraud & Abuse, Hospitals & Health Systems, Payors & PBMs, Physicians, State & Federal Audits, Investigations & Litigation

One of the most frequently asked questions posed to healthcare lawyers is whether State X has a prohibition on the corporate practice of medicine, nursing or other profession, and if so, whether the prohibition is enforced.  As demonstrated by last month’s well-publicized settlement between Aspen Dental Management, Inc. (ADMI) and the New York State Attorney… Continue Reading

Qui Tam Update Highlights Failed Compliance Program and Dermatology Sweetheart Deals

Posted in ACGME, Fraud & Abuse, Hospitals & Health Systems, Physicians, State & Federal Audits, Investigations & Litigation

Mintz Levin’s Health Care Enforcement Defense Practice has published its most recent Qui Tam Update, analyzing overall trends in 36 recently unsealed health care related whistleblower cases. In this issue, the team highlights a case that was filed back in 2006, with allegations that focus on a hospital’s failure to maintain a culture of compliance. United… Continue Reading