In this short recording, Healthcare attorneys Wakaba Tessier and Erica Ash discuss a recent Department of Justice (DOJ) settlement involving a specialty pharmacy and its private equity owner. This case is significant because – not only did the DOJ name the compounding pharmacy and its two executives – but it also named the private equity
On June 1, 2019, the United States Pharmacopeia (“USP”) published the final revisions to its pharmaceutical sterile compounding standards (“chapter <797>”). Chapter <797> sets forth standards for the preparation of compounded sterile medications to help ensure products are safe and effective and reduce risks such as contamination or incorrect dosing. The most recent revisions implement new standards and revise existing ones based on recent scientific and technological developments. The chapter <797> revisions also incorporate stakeholder input raised during the July 2018 to November 2018 public comment period, much of which concerned allergens, beyond-use dating, and the general ambiguity throughout the chapter.
The USP’s most recent revisions to chapter <797> are extensive and those who prepare compounded sterile products (“CSPs”) are advised to familiarize themselves with the new standards. Significant changes include:
Continue Reading USP Finalizes Revisions to Sterile Compounding Standards
On Tuesday, June 18, 2019, our team of legal professionals and industry experts hosted a Compliance Considerations for Pharmacy Sale or Acquisition Webinar that took a look at the regulatory pitfalls and problems that can arise in a pharmacy transaction.
The free on-demand recording will provide real-life examples of what to do – and not
In January of 2019, the Centers for Medicare and Medicaid Services (“CMS”) implemented a helpful change to the signature exception to the Stark Law. In particular, the exception may now be used more than once during a 3-year period for compensation arrangements with the same referring physician.
History of Signature Exception
The signature exception to the Stark Law has undergone several revisions within the past few years. The original version of the exception was implemented by CMS effective October 1, 2008 in response to concerns regarding the potential for significant Stark Law penalties for mere “technical” violations of the statute. The original language in the signature exception provided for a grace period for noncompliance with the signature requirement of many of the compensation arrangement exceptions to the Stark Law, such as the personal service arrangements exception and fair market value exception. In particular, a 90-day grace period was permitted for late signatures that were inadvertent, and a 30-day grace period was permitted for late signatures that were “not inadvertent.” In addition, the exception could only be used once for the same referring physician during a 3-year period. In other words, after the exception was used once by a DHS entity for a late signature on a compensation agreement with a referring physician, any late signatures on other agreements entered into by the DHS entity and the same referring physician during the following 3-year period would trigger a violation of the Stark Law.
Continue Reading CMS Finalizes Helpful Change to Stark Law Signature Exception
Recently enacted federal law expanding criminal liability for kickbacks related to all payors, and increased government enforcement activity in behavioral health (see press release), has heightened the importance of clinical due diligence for private equity investors targeting deals and acquisitions in the emerging behavioral health space. PE firms continue to target behavioral health opportunities as federal and commercial insurance coverage expands for mental health, including substance abuse treatment and telehealth services. Such commercial coverage will only become more commonplace after a federal court this month found United Behavioral Health improperly denied benefits for treatment of mental health and substance use disorders to plan participants because United’s guidelines did not comply with the terms of its own insurance plans and state law.[1] PE firms entering the behavioral health market, though, particularly opportunities related to substance abuse treatment and laboratory services, should carefully review a company’s compliance with the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”).
Continue Reading Private Equity in Behavioral Health: Clinical Due Diligence Requires Consideration of EKRA, the New Anti-Kickback Law Applicable to All Payors
When Title IX of the Education Amendments of 1972, 20 U.S.C. § 1681, et seq. (“Title IX”), which prohibits many forms of discrimination on the basis of sex, appears in the news or on social media, we typically associate it with traditional colleges and universities. But recent case law suggests that Title IX likely applies to a broader set of institutions, including, under certain circumstances, some hospitals.
Over the years, an extensive body of federal case law and regulation has arisen around Title IX, imposing detailed requirements on institutions concerning how they must respond to and investigate complaints, how complaints must be adjudicated and the nature of appropriate remedies. Moreover, these regulations also have recently been in flux. As a result, Title IX compliance often requires significant institutional resources and constant vigilance.
Because compliance with Title IX requires significant attention from the institution, it is critical that hospitals determine whether they meet the developing criteria to be subject to the requirements of Title IX and, if so, whether they have in place the proper policies, procedures and personnel to ensure compliance. In this article, we describe those criteria and provide a brief summary of the broader legal context.
Continue Reading Do the Detailed Federal Requirements for Addressing Sex Discrimination Apply to Your Hospital?
Last August, the Healthcare Worker Violence Protection Act was signed into law by Illinois Governor Rauner. This law creates a new set of employee rights and obligations for healthcare providers in Illinois. Generally, this law is designed to provide personal safety to frontline healthcare providers, such as doctors and nurses, and protect the rights of those who would raise or report safety concerns and assaults by expanding the Illinois Whistleblower Act.
Continue Reading Workplace Violence Protection Act: Illinois Hospitals and Healthcare Providers Face New Challenge
The Rape, Abuse and Incest National Network (“RAINN”) reports that sexual assault and abuse of people with disabilities often goes unnoticed, and, according to the National Crime Victimization Survey, people with disabilities are victimized by crime at higher rates than the rest of the population. Too often, it is the caregivers who are the perpetrators. While one with a disability may give consent to sexual activity, there can never be consent between one who is disabled and receiving care and a member of the caregiving staff.
Continue Reading Sexual Abuse of People with Disabilities
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.
Continue Reading HHS proposes moving up the enforcement of 340B penalties to January 1, 2019
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.
Continue Reading DOJ Adds Private Equity Firm to False Claims Act Complaint