Insights on Health Care

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

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 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. 

Arent Fox proudly supported the 2015 Special Olympics World Summer Games, held in Los Angeles from July 5 to August 2, 2015, by contributing pro bono legal services for the 2015 Special Olympics World Summer Games Organizing Committee.

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.

Health care partner Tom Jeffry was interviewed by Law360 to discuss the implications of the Ninth Circuit’s recent ruling in a False Claims Act litigation against Kinetic Concepts Inc.

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?  

Partner Lowell Brown, the leader of the Health Care Practice Group, was featured in a recent Law360 article, “Attorneys React To Supreme Court’s ACA Save.”

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 2015 edition of Legal 500 US has rated 50 Arent Fox LLP attorneys as national leaders in their field. In addition, 15 of the firm’s practice areas were ranked among the best in the country.

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.

Partner Linda Baumann was quoted extensively in Bloomberg BNA’s Health Law Resource Center’s article on the landmark False Claims Act case decided by the Supreme Court on May 26, 2015, Kellogg Brown & Root Svcs., Inc. v. United States ex rel. Carter.