Law360 recently quoted Husch Blackwell attorney Don Mizerk in an article about the FDA’s new request for comments.  In the announcement, the FDA established a public docket to receive suggestions for ways to improve the quality of abbreviated new drug applications (ANDAs) and for the FDA to learn about difficulties sponsors are having with…

A recent OIG Advisory Opinion (Adv. Op. 13-15) is, to a certain degree, more interesting for one of its footnotes than the body of the opinion itself. The footnote addresses a hotly debated issue, originally raised in an OIG Management Advisory Report (MAR) in 1991. That MAR took the position that an agreement between a hospital and a hospital-based physician group was a “suspect arrangement” under the Anti-Kickback Statute because the physician group was essentially required to split its revenue with the hospital–including requiring the group to provide uncompensated services to the hospital.

The OIG modified this position somewhat in the Supplement Compliance Program Guidance for Hospitals in 2005. In that compliance guidance, the OIG stated that an exclusive arrangement that required a hospital-based physician group to provide “reasonable administrative or limited clinical duties directly related to the hospital-based profession services at no or a reduced charge” would be permissible. The Compliance Guidance cautioned, however, that uncompensated or below-market-rate services would still be subject to “close scrutiny.”

Scrutiny of physician prescribing (particularly pain management) seems likely to increase in 2015 under new CMS regulations that were published on January 10, 2014. The proposed regulation makes policy and technical changes regarding the Medicare prescription drug program (Part D). Among the changes are the granting of explicit authority to deny (under 42 CFR §…

The author wishes to thank Andrew M. Hodgson for his assistance in preparing this post. Andrew is an Associate in the Firm’s Chattanooga office. 

As I approach the quarter century mark of my practice as a tort, healthcare and commercial litigator, predominately on the defense side, I reflect on some of the land mines that face the defense bar. These land mines include missing an affirmative defense, failing to join a necessary party, failing to enlist the services of all the expert witnesses needed to combat the plaintiff’s claims, and the list goes on. Even so, I would argue that none of these potential pitfalls can hold a candle to the specter of statutes of limitations and pre-suit requirements facing the plaintiff’s bar. In Tennessee, as in many states, those hurdles are magnified by pre-suit notices and other filings required of the plaintiff in making a healthcare liability claim. In November, the Supreme Court of Tennessee highlighted the importance of “crossing all your t’s and dotting all your i’s” when making such a claim in the case of Stevens v. Hickman Community Healthcare Services, Inc., No. M2012-00582-SC-S09-CV (Tenn. filed Nov. 25, 2013). Importantly, the Stevens court also made instructive rulings as to HIPAA preemption and a defendant’s right to receive records in healthcare liability actions.

Husch Blackwell attorney Joe Geraci was recently quoted in an AIS Health Reform Week article titled HHS’s Statements on Exchange QHPs Stir Confusion, Complicate Copay Assistance.  The article reports that the Obama administration is sending mixed messages on whether Qualified Health Plans (QHPs) on the insurance exchanges will be considered federal health programs.  A…

On November 13 and November 18, the federal district court handed down separate rulings on summary judgment motions in a Florida Stark Law case that many consider the new Tuomey–U.S. ex rel. Baklid-Kunz v. Halifax Medical Center. In the first decision, the Court granted the U.S. partial summary judgment on the Stark violation with respect to compensation paid to certain medical oncologists employed by the hospital. In the second decision, the Court denied the hospital’s motion for summary judgment with respect to certain neurosurgeons employed by the hospital. Both decisions tee up important hospital/physician employment issues for trial.

The case stems from a qui tam False Claims Act lawsuit filed in 2009 in which Elin Baklid-Kunz, the former compliance officer, made allegations regarding Halifax Hospital Medical Center (“Halifax Hospital”) and Halifax Staffing, Inc. (“Halifax Staffing”) (collectively, “Halifax”). The compliance officer alleged that Halifax:

  1. Had financial relationships with physicians that did not meet a Stark exception, and as a result the physicians inappropriately referred Medicare services to Halifax; and
  2. Inappropriately billed other services to Medicare.

The Department of Justice chose to intervene in the lawsuit in 2011 with respect to the Stark Law issues. Halifax filed a Motion for Summary Judgment and the U.S. filed a Motion for Partial Summary Judgment with respect to the Stark Law issues.

Ruling on the Government’s Motion for Partial Summary Judgment

Two different compensation arrangements were the subject of these decisions. In the first decision, the Court considered the Government’s motion for partial summary judgment with respect to compensation paid to the medical oncologist employed by Halifax and the resulting designated health service referrals from those physicians. The alleged Stark violations were the result of employment agreements entered into with six medical oncologists in 2005 that provided for an incentive bonus pool equal to 15% of the “operating margin for the Medial Oncology program” of the Hospital. Even though the physicians were permitted to divide that pool among themselves as they determined, which they did based on individual production, the Hospital admitted that the pool included revenue from services that were not personally performed by the medical oncologists, such as fees related to the administration of chemotherapy.

Employers should be aware of important year-end action items relating to qualified retirement plans and health and welfare plans.  Husch Blackwell attorney Uche A. Enemchukwu detailed a number of these obligations in an e-alert and noted that some require immediate attention to satisfy the December 2, 2013 deadline.  Other items must be addressed before the…

New research shows that hospitals with higher nursing levels have fewer readmissions and lower penalties for excessive readmission rates.  A new study, which appeared in the October issue of Health Affairs, found that hospitals with higher staffing levels had a 25 percent lower chance of being penalized for readmission rates when compared to hospitals with lower staffing levels.…

When was the last time you thought about your compliance program? As we know, an effective compliance program is important for healthcare companies. It’s also important to review your compliance program periodically and update it according to the latest guidance. OIG guidance and recent Corporate Integrity Agreements (CIAs) are informative about what the OIG is…

Husch Blackwell attorney Joe Geraci weighed in on recent guidance provided by HHS related to whether the federal anti-kickback statute applies to patients who purchase subsidized health insurance products on the new state or federal healthcare exchanges.  Specifically, the anti-kickback regulations apply to “federal healthcare programs” that are defined to include the following:

Any plan

…