Health Care Counsel Blog

The Health Resources and Services Administration, as administrator of the 340B Drug Pricing Program on behalf of the Department of Health and Human Services (HHS), published its proposed 340B Drug Pricing Program Omnibus Guidance on August 28, 2015.

Earlier this summer, Los Angeles hosted the Special Olympics World Summer Games at venues throughout the city. The games featured more than 6,400 athletes from 177 countries who competed in 27 sports, including aquatics, gymnastics, track and field, basketball, football, tennis, and volleyball.

David S. Greenberg co-authored an article published in Bloomberg BNA’s Medicare Report on the implications of the Centers for Medicare & Medicaid Services’ proposed revisions affecting long-term care facilities participating in Medicare and Medicaid programs.

On August 7, 2015, the US District Court for the Southern District of New York issued a significant decision concerning FDA’s regulation of off-label promotion of approved drugs.

On August 5, 2015, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 15-11.

On Monday, a federal district court judge in New York issued a ruling that, if adopted broadly, will have a significant – and potentially nightmarish – impact on any provider who receives an overpayment from Medicare or Medicaid.  Kane v. Healthfirst, Inc. and U.S. v. Continuum Health Partners Inc. 

A recent court ruling is a good reminder to health care providers that bankruptcy may not (as is sometimes suggested) be a safe harbor for providers in danger of being forced out of business by the loss of their Medicare and Medicaid provider agreements.

In an unexpected development, the Centers for Medicare and Medicaid Services recently proposed several changes that will generally add greater flexibility to Stark Law regulations in the proposed physician fee schedule for calendar year 2016, which was published on July 15, 2015.

In an unexpected development, the Centers for Medicare and Medicaid Services recently proposed several changes that will generally add greater flexibility to Stark Law regulations in the proposed physician fee schedule for calendar year 2016, which was published on July 15, 2015.

Earlier today, the Senate Finance Committee approved legislation which would resurrect roughly 50 expired tax incentive provisions that lapsed on December 31, 2014. 

On July 7, 2015, the US Court of Appeals for the Ninth Circuit overruled a 23-year-old False Claims Act precedent, relaxing its test for deciding when a whistleblower can overcome a motion to dismiss because the allegations in the complaint were publicly disclosed. 

On June 10, 2015, the U.S. Department of Health and Human Services, Office for Civil Rights, announced that it had entered into a resolution agreement with St. Elizabeth’s Medical Center, a Massachusetts hospital, to resolve potential HIPAA violations.

Last week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced the creation of a new litigation team focused solely on using the OIG’s authority to impose civil monetary penalties and exclude individuals and businesses from Medicare and Medicaid.

King v. Burwell understandably took the attention of the health care industry a couple of weeks ago when it upheld a key component of the ACA. A day later, the Supreme Court released another decision that may have a more significant going-forward impact on the health care industry: Obergefell.

The United States Court of Appeals for the District of Columbia Circuit released a decision requiring the Department of Health and Human Services to reconsider a 2008 rule prohibiting certain per-click leasing arrangements under the Stark Law.

Who can make healthcare decisions for an incompetent patient when there is no person available to give consent?  

In the long awaited decision in King v. Burwell, the Supreme Court ruled this morning in a 6-to-3 decision that the Affordable Care Act (ACA) permits tax credits for individuals who purchase their health insurance through a Federal health insurance marketplace (Federal Exchange), not just for indivi

The US Attorney General announced a “takedown” of 243 defendants over the last three days, representing the largest health care fraud enforcement effort in the Medicare Fraud Strike Force’s eight-year history and the largest criminal health care fraud action in the history of the Justice Department.

On June 17, 2015, the Health Resources and Services Administration (HRSA) published a long-awaited proposed rule setting forth revisions to the current regulations governing the 340B Drug Discount Program (340B Program) as set forth in 42 C.F.R. part 10 (Proposed Rule).

The Department of Health and Human Services Office of the Inspector General issued a Fraud Alert, reminding physicians that they will be held liable under the anti-kickback statute for compensation arrangements that do not reflect fair market value compensation for bona fide services they provide.

Charitable organizations that want to provide financial assistance to patients for the costs of health care are challenged with ensuring that their programs do not run afoul of federal fraud and abuse laws.

The United States Department of Justice (DOJ) announced that pharmacy benefits manager Medco Health Solutions Inc. (Medco) agreed to pay the government $7.9 million to resolve allegations that Medco’s arrangements with pharmaceutical manufacturer AstraZeneca violated the False Claim Act.

The US Supreme Court on Tuesday decided a closely watched False Claims Act (FCA) case, Kellogg Brown & Root Services, Inc. v. United States ex rel. Carter, with important implications for companies confronting FCA claims.

Pharmaceutical manufacturers could face a new line of attack related to Hatch-Waxman reverse payment settlement agreements (so-called, “pay-for-delay” settlements).

The Chairman of the U.S. Senate Committee on Health, Education, Labor, and Pensions recently started an investigation into whether agency “guidance” is being used as a means to impose obligations on the public while circumventing the formal rule making process.