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Washington Healthcare Update

On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more

DOJ Takes Aim at Responsible Individuals in Corporate Investigations

U.S. Deputy Attorney General Sally Quillian Yates recently announced new instructions for attorneys at the U.S. Department of Justice (DOJ), outlining in a memorandum the DOJ’s policies with respect to civil and criminal...more

Bristol-Myers Squibb Pays $14 Million to SEC to Resolve China FCPA Offenses

On October 5, the SEC announced a settlement with Bristol-Myers Squibb to resolve allegations that the pharmaceutical company’s Chinese joint venture, BMS China, gave cash, jewelry, and other benefits to health care providers...more

FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public

Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more

OIG Reports Insufficient Oversight Of HIPAA Compliance

The HHS Office for Civil Rights (OCR) must improve its oversight and enforcement of patient information privacy and security rules by “covered entities” and their business associates under the Health Information Portability...more

Is Your HIPAA Compliance Program Ready for the FTC?

Everyone in healthcare knows that the next round of HIPAA audits is coming. Covered entities and business associates have long been advised to review and update their HIPAA security risk analyses, have business associate...more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

Some Useful Insights from Steris-Synergy Merger Case

The Federal Trade Commission suffered a rare loss when, on Sept. 24, the U.S. District Court for the Northern District of Ohio denied its request for a preliminary injunction, despite having accepted the FTC’s “actual...more

NC Legislative Update for October 2015

This Week - The North Carolina General Assembly has finally ADJOURNED! And they did so just after 4:00 in the morning on Wednesday September 30th, 2015. The close of the nine-month long 2015 session was met with a round...more

Suing the Hand that Feeds You

Jeffrey Jacobs alleges that Idaho’s Pocatello Hospital violated the False Claims Act because of physician recruitment contracts that were overly generous to his practice group. Jeff should know because he was recruited under...more

Uncovering the mysteries behind GME payments for Medicare Advantage patients: Carve-outs and shadow bills

Medicare makes graduate medical education (GME) payments to teaching hospitals to pay Medicare's share of the teaching and patient care costs associated with Medicare Advantage (MA) patients. Under the Balanced Budget Act...more

King v. Burwell & Beyond: ACA Litigation Continues

The Supreme Court’s ruling in King v. Burwell resolved what may be the last existential legal threat to Obamacare. The case upheld the extension of premium tax credits in states operating under federally created insurance...more

Market Allocation = Antitrust Consequences

The U.S. Department of Justice and the State of Michigan recently initiated a civil antitrust action to enjoin certain marketing agreements between four south-central Michigan hospital systems alleging that the agreements...more

Health care consolidations: Complex maneuvers in a high-stakes environment

In today’s shifting health care landscape, providers are consolidating and forming strategic partnerships that position them to offer comprehensive, high-quality services at reasonable costs....more

Bristol-Myers Squibb FCPA Enforcement Action

Yesterday, the Securities and Exchange Commission (SEC) announced a Foreign Corrupt Practices Act (FCPA) enforcement action against Bristol-Myers Squibb Company (BMS) for the actions of the company’s joint venture (JV) in...more

OMB Reviewing New Final Rule on ACO Waivers

Joint waivers issued by the Centers for Medicare and Medicaid Services (CMS) and HHS Office of Inspector General (OIG) relating the application of the physician self-referral law, the Federal anti-kickback statute, and...more

West Coast States Bolster Momentum for Pharmacist Provider Status Reforms

In recent years, legislative reforms have been introduced that recognize pharmacists as reimbursement-eligible providers under government-funded health care programs. While these efforts have attracted significant media and...more

Arbitration of Nursing Home Suits: Take Two

Quasi Tort Reform in Nursing Home Litigation Is on the Way! Last fall, I posted a blog about the national trend of including arbitration provisions in nursing home admission agreements. This trend peaked following the...more

OCR announces launch of Phase 2 of HIPAA audits

Although the Office for Civil Rights (OCR) has indicated in the past that it would start its next round of HIPAA audits, apparently it means business now. In the wake of an Inspector General report that the OCR was merely...more

Ky. Ruling Casts Doubt on Health Care Arbitration Agreements

Health care institutions in Kentucky may want to take a fresh look at their patient arbitration provisions, in light of a September 24 decision by the Kentucky Supreme Court. Out-of-state institutions may want to take a...more

When a Violation of a Rule or Regulation Becomes an FCA Violation: Understanding the Distinction Between Conditions of Payment and...

If you read one thing… - The False Claims Act’s (FCA) language, structure, court precedent and purpose limit its application to only regulatory breaches that are conditions of payment and not conditions of...more

CMS Releases Proposed Rule Reforming Medicare CLFS Payment Rates

The Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule [CMS-1621-P] in accordance with Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which establishes a new payment methodology...more

Health Systems Alert: Corporate Practice of Dentistry Prohibitions Have Teeth: New York AG Takes a Bite – 8 Key Takeaways

When contemplating a healthcare transaction between licensed healthcare professionals and non-professionals, a key issue is whether the state in question has a prohibition on the corporate practice of medicine, dentistry or...more

Blog: HHS To Launch New HIPAA Audits in Early 2016 in Response to OIG Reports

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued two reports yesterday calling for the HHS Office of Civil Rights (OCR) to strengthen its Health Insurance Portability and...more

UnitedHealthcare Services Denied Injunction Against Out-of-Network Physician Seeking to Bar Balance Billing of the Patient

In UnitedHealthcare Servs., Inc. v Asprinio (2015 NY Slip Op 25298), decided on August 31, 2015, in the Supreme Court of Westchester County, UnitedHealthcare suffered a set-back against attempts to prevent balance billing by...more

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