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

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. Continue Reading In healthcare worker safety, California leads the way

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. Continue Reading What Health Care Providers Need to Know About Patient Rideshare

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, breaches involving less than 500 individuals can be documented throughout the course of the year and submitted 60 days after the end of the calendar year.[1] This means that covered entities have until February 28, 2018 to complete their annual breach reporting obligations.

If you need assistance completing or filing your breach reports, please contact Julie Sullivan at 303.749.7255 or your usual Husch Blackwell attorney.

[1] 45 C.F.R. §§ 164.408(b),(c), available at https://www.law.cornell.edu/cfr/text/45/164.408.

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] Continue Reading Revised SRDP Process Begins June 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 held that family members with powers of attorney may enter into arbitration agreements on behalf of nursing home residents.

In Kindred Nursing Centers, two separate families admitted their elderly family members, (hereafter “the residents”) to a Nursing Home. In both cases, the family members completed admission paperwork on behalf of the residents, pursuant to powers of attorneys. The admission paperwork included an arbitration agreement, which provided that “any and all claims or controversies arising out of or in any way relating to…the Resident’s stay at the Facility” would be resolved through binding arbitration. When the residents subsequently died, their estates brought lawsuits against the Nursing Home. The Nursing Home moved to compel arbitration.

The Kentucky Supreme Court held that the arbitration agreements were invalid. In so holding, the Kentucky Supreme Court purported to create a “clear statement rule.” Under the “clear statement rule,” the Kentucky Supreme Court held that the family members could only enter into arbitration agreements on behalf of the residents, if the powers of attorney expressly gave them the right to enter into arbitration agreements. Because neither power of attorney expressly addressed arbitration agreements, the Kentucky Supreme Court found them insufficient to authorize the family member to waive the residents’ right to a jury. The United States Supreme Court reversed.

On appeal, the United States Supreme Court explained that the Federal Arbitration Act (FAA) makes arbitration agreements valid, irrevocable, and enforceable.  While arbitration agreements are subject to generally applicable contract defenses, they cannot be invalidated pursuant to rules that apply only to arbitration agreements. The Supreme Court then held that Kentucky’s “clear statement rule” ran afoul of the FAA because it required arbitration agreements to be expressly authorized by powers of attorney when other contracts did not require such express authorization. This violates the FAA because the FAA requires that arbitration agreements be on equal footing as all other contracts.

The United States Supreme Court then analyzed the specific powers of attorney at issue. The first power of attorney authorized the family member to (among other things) “institute legal proceedings” and “make contracts of every nature in relation to both real and personal property.” On remand, the United States Supreme Court instructed the Kentucky Supreme Court to evaluate whether the forgoing language encompassed the ability to execute arbitration agreements. The second power of attorney authorized the family member to “transact, handle, and dispose of all matters affecting [the resident] and/or [the resident’s] estate in any possible way” including the power to “draw, make, and sign in [the resident’s] name any and all … contracts, deeds or agreements.” The Supreme Court held that this second power of attorney was broad enough to encompass the execution of an arbitration agreement. Thus, the second resident’s arbitration agreement must be enforced.

Kindred Nursing Centers removes any doubt that nursing homes may enforce arbitration agreements executed on a resident’s behalf by their attorney-in-fact, provided that the underlying power-of-attorney provides sufficient contracting authority.

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 discrimination (including sexual harassment) by resident physicians and necessitate that hospitals comply with federal Title IX regulations and guidance. The ruling also opens the door for residents who experience sex discrimination to sue under Title IX, thereby avoiding the complex administrative exhaustion process required to file a similar claim under Title VII of the Civil Rights Act of 1964, which generally governs sex discrimination in the workplace. For more information on this new development, visit the legal alert authored by Derek Teeter and Lorinda Holloway.