Compliance

On Wednesday, the Department of Health and Human Services (“HHS”) reversed course in its delay of implementing fines against drug manufacturers that intentionally overcharge 340B providers. In a notice of proposed rulemaking, HHS intends to advance the effective date of its final rule on the 340B drug price ceiling and civil monetary penalties to January 1, 2019, rather than July 1, 2019, as previously proposed.

The United States Department of Justice (“DOJ”) has intervened in a False Claims Act (“FCA”) case against a Florida compounding pharmacy, Diabetic Care Rx, LLC d/b/a Patient Care America (“PCA”), and, in an unexpected move, named PCA’s private equity sponsor and controlling shareholder, Riordan, Lewis & Haden, Inc. (“RLH”), as a co-defendant. The DOJ complaint accuses PCA, RLH and two PCA officers/directors (who were also RLH partners) of overseeing a kickback scheme which DOJ alleges induced referrals that resulted in TRICARE paying over $68 million for medically unnecessary compound drug prescriptions. DOJ alleges the illegal scheme was designed by RLH.

In the last two months, the healthcare industry has seen both federal and state efforts to further regulate healthcare worker safety. Stakeholders and other jurisdictions are keeping an eye on these developments, which could spread to other states, as well.

While the federal legislation is focused on reducing workplace violence at healthcare facilities, an initiative in California will decide what additional regulations should be imposed to remove surgical plume and limit the exposure of healthcare professionals to surgical smoke in the state’s operating rooms.

The debate over providing transportation to patients is nothing new. Hospitals, doctors and other providers have long struggled with whether they can provide free or discounted taxis, shuttles, metro cards or other transportation means to patients to come to appointments and receive care. On one hand, there is evidence that without reliable transportation options, patients are more likely to miss preventative, primary care appointments, increasing the risk of more costly and unnecessary medical services down the road. On the other hand, certain federal laws like the Anti-Kickback Statute (AKS) and Civil Monetary Penalty (CMP) law have given providers serious concerns that such transportation services might be considered an illegal “kickback” to gain patients, or an illegal inducement to receive care.

With the New Year underway, the deadline is quickly approaching for HIPAA covered entities to file their annual breach reports with the U.S. Department of Health & Human Services Office for Civil Rights (“OCR”).

While breaches involving 500 or more individuals must be reported no later than 60 calendar days from the date of discovery,…

Beginning on June 1, 2017, health care providers of services and suppliers must submit all information necessary for the Centers for Medicare and Medicaid Services (“CMS”) to analyze actual or potential violations of the federal physician self-referral law (the “Stark Law”) using approved forms designed to streamline the CMS Voluntary Self-Referral Disclosure Protocol (the “SRDP”).  If you are currently working on a self-disclosure filing for CMS, you must convert that disclosure to this new format or risk CMS rejecting the disclosure in its entirety. The new forms, contained within Form CMS-10328 available here, must be used for all voluntary Stark Law self-disclosures submitted on or after June 1, 2017, except disclosures by physician-owned hospitals and rural providers regarding a failure to disclose physician ownership on the provider’s website or in any public advertisement.[1]

The United States Supreme Court has long upheld the validity and enforceability of arbitration agreements. Thus, it was no surprise when the Court reversed a decision from the Kentucky Supreme Court that declined to recognize arbitration agreements executed by individuals pursuant to powers of attorney. In Kindred Nursing Centers LP. v. Clark, the Court…

The U.S. Court of Appeals for the Third Circuit held recently that Title IX of the Education Amendments of 1972 (“Title IX”)—which prohibits sex discrimination in the “education programs or activit[ies]” of entities receiving federal financial assistance—can apply to residency programs at hospitals. The ruling may profoundly impact how hospitals respond to complaints of sex…

Emerging Issues in Healthcare Law is coming to the Big Easy. The American Bar Association’s 18th annual conference is slated for New Orleans March 8-11.

Husch Blackwell is a platinum sponsor of this event featuring the most emergent topics facing the healthcare bar. As the industry faces changes and continues to grow under healthcare reform and enforcement, this conference allows attendees a perfect opportunity to stay ahead of the developments.