Health Care

In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor. 

Yesterday both chambers of the Illinois legislature voted to override the Governor's amendatory veto and passed Public Act 098-1127, which prohibits a physician from charging a markup on anatomic pathology services if the physician orders but does not supervise or perform the service.

Last week, the Government Accountability Office (GAO) released a report examining group purchasing organization (GPO) practices. 

On November 24, 2014, the New Jersey Appellate Division affirmed a lower court’s decision to dismiss a physician’s lawsuit against a hospital based on federal and state statutory immunity provisions that shield hospitals and their peer review participants from monetary damages.

Our Health Care Enforcement Defense Practice has published its most recent Qui Tam Update analyzing 68 recently unsealed health care related whistleblower cases. In this issue, the team analyzes overall trends in the 68 cases, and looks more closely at three notable cases. 

The United States District Court for the Western District of Washington ruled recently that the state’s corporate practice of medicine doctrine does not provide a private right of action, either express or implied, and dismissed claims brought by State Farm Mutual Automobile Insurance Company and State Farm Fire and Casualty Company.

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”).

On November 19, 2014, a panel of the United States Court of Appeals for the Ninth Circuit heard oral arguments in one of the most significant antitrust health care cases in years.

Last week, a unanimous three-judge panel of the D.C. Circuit upheld the religious accommodation to the Affordable Care Act’s (“ACA”) contraceptive coverage mandate (Priests for Life v. HHS, D.C. Cir. No. 13-5368, Nov. 14, 2014). 

The health care industry remains an enforcement priority for the Federal Trade Commission ("FTC"). In a recent interview, the Director of the FTC’s Bureau of Competition, Debbie Feinstein, stated that the Bureau’s top three priorities for health care antitrust enforcement.

Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food and Drug Administration (FDA); and (2) conspiring to defraud the U.S. government by concealing their illegal activities.

With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.”  And to quote one of my favorite sports commentators, Tony Kornheiser, “I believe I had that.”

The United States Court of Appeals for the Seventh Circuit affirmed the dismissal of a False Claims Act (“FCA”) case against Shopko Operating Stores, LLC, in which a former Shopko pharmacist asserted Medicaid billing violations.

This week, the HHS Office of Civil Rights (OCR) issued a bulletin (Bulletin) to remind covered entities and business associates that "the protections of the Privacy Rule are not set aside during an emergency."

On October 21, 2014, the U.S. District Court for the Southern District of Ohio granted Defendants’ motion for summary judgment, holding that Premier Health Partners (“Premier”) and its affiliate hospitals, Atrium Health Systems, Catholic Health Initiatives, MedAmerica Health Systems, Samaritan Health Partners, and Upper Valley Medical Center (collectively, “Defendants”), operating under a joint operating agreement (“JOA”), constituted a single entity incapable of conspiring in violation of Section 1 of the Sherman Act.

On October 21, 2014, the U.S. District Court for the Southern District of Ohio granted Defendants’ motion for summary judgment, holding that Premier Health Partners and its affiliate hospitals were operating under a joint operating agreement, constituted a single entity incapable of conspiring in violation of Section 1 of the Sherman Act. 

On October 24, 2014, the Internal Revenue Service issued Notice 2014-67 (the “Notice”), which provides important guidance and increased flexibility for issuers and conduit borrowers of tax-exempt bonds regarding contracting with private parties in a manner that avoids “private use” by such parties of bond-financed facilities.

As part of the Outpatient Prospective Payment System (OPPS) Rule issued last week, the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to conditionally package certain ancillary services assigned to APCs with a “geographic mean cost” of $100 or less.  

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to HHS programs and operations during the current fiscal year and beyond.

The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”).