Healthcare professionals, entrepreneurs and investors once again descended on San Francisco this past January for the J.P. Morgan Healthcare Conference (JPM). While the invitation-only JPM conference is the headline event, most people who come to San Francisco for the week are focused on what’s happening outside of the JPM, with learning and network opportunities literally around every corner.

With JPM in the backdrop, nearly two dozen healthcare and life science conferences and events occur simultaneously, nearly all of them within a four-block radius of JPM itself. These events cover a wide range of perspectives and topics, with innovation being the permeating theme. In a 24-hour period, an investor can take in presentations from a dozen private companies developing new therapies, seminars on disruptive technologies like artificial intelligence, and global perspectives on industry trends across multiple continents.

If you happen to miss our NHIA Talk Infusion Webinar on Compliance and Risk Considerations for Compounding Pharmacies, please click on the link to enjoy a free on-demand recording.

Our program guides you through the current landscape and common compliance concerns in compounding. We will help you understand the focus of FDA and state…

The Trump Administration’s latest effort to limit the power of pharmacy benefit managers (“PBMs”) is marred by economic uncertainty and looming legal scrutiny.  The Office of Inspector General (“OIG”) within the Department of Health and Human Services (“HHS”) recently released a proposed rule (“proposed rule”) removing safe harbor protection under the Anti-Kickback Statute (“AKS”) for prescription drug rebates (“drug rebates) paid by a manufacturer to Medicare Part D plan sponsors and Medicaid managed care organizations (“MCOs”) or their PBMs.  The rule also creates new safe harbor protections for point-of-sale reductions in price and certain PBM services fees.[1]   The long-awaited proposed rule follows months of anticipation after the Trump Administration released its May 2018 Blueprint to reduce prescription drug costs.[2]

PBMs in Brief

PBMs, on behalf of health plans, employers, and other entities, negotiate and contract with drug manufacturers to obtain rebates on prescription drugs dispensed to health plan members.  By aggregating their collective scale and purchasing power of all health plan or employer group clients, PBMs can negotiate better deals with the manufacturer than any one plan or group operating independently.  Rebates are typically negotiated on brand-name drugs that compete with therapeutically-similar brands and generics. These retroactive rebates (after point-of-sale) are based on a multitude of factors, including a drug’s placement in a plan formulary designed by the PBM, and the PBM’s power to increase a manufacturer’s market share for specific drugs by inclusion on a formulary.  A manufacturer may provide a greater rebate if its product is included in a “preferred” position on the PBM formulary.

Courts recognize the complication that exists when determining what constitutes actionable harassment where a healthcare employee is a caretaker for a patient with diminished capacity. The Fifth Circuit Court of Appeals recently reviewed this issue in a Title VII case that highlights the risks posed to employers in the healthcare and social assistance industries by patient harassment and violence: Gardner v. CLC of Pascagoula, LLC, No. 17-60072 (February 6, 2019). In Gardner, the Fifth Circuit explained the risks to healthcare employers when it reversed summary judgment on a nurse assistant’s claim for hostile work environment and retaliation, holding that a genuine dispute of material fact existed as to whether an assisted living facility took reasonable precautions to prevent sexual harassment and physical violence by a resident.

Background

Gardner was a Certified Nursing Assistant employed at the Plaza Community Living Center, an assisted living facility, and “often worked with patients who were either physically combative or sexually aggressive.” Gardner had been assigned to work with a patient who had been diagnosed with multiple “physical and mental illnesses,” and had a reputation for groping female employees, as well as a history of violent and sexual behavior toward both patients and staff at the facility. Gardner alleged that she put up with propositioning and sexual assault by the patient on a regular basis, but that when she complained to the administrator at the facility, she was told to “put [her] big girl panties on and go back to work.”

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.

Under Texas law, physicians that will be called upon to complete and sign a death certificate in Texas are required to register to file the certificate electronically with the Texas Department of State Health Services. The Texas Medical Board is authorized to take action against providers who do not register for electronic filing of death certificates under Tex. Health and Safety Code §193.005. Until recently, registration and filing of death certificates was made through the Texas Electronic Registrar (“TER”).

On January 1, 2019, the Texas Department of State Health Services replaced TER with a new platform, the Texas Electronic Vital Events Registrar (“TxEver”). TxEver supports all vital events operations, including reporting, registration, and amendments of birth and death records, and represents one of the first fully integrated vital records systems nationwide. TxEver will additionally support the Texas remote birth issuance system, which allows users to obtain copies of birth certificates without having to visit the vital records offices in their county of birth.

Hospitals are not happy with CMS’ recent changes to hospital outpatient payments.  Two hospital associations and three hospitals claim in a federal lawsuit filed December 4, 2018, that CMS had no authority to change the payment scheme for off-campus provider-based departments (PBDs).  The change took effect January 1, 2019, and is estimated to reduce payments to hospitals by $380 million in the first year of a two-year phase-in period.

The plaintiffs, including the American Hospital Association and the Association of American Medical Colleges, are seeking judgment that the payment change is unenforceable as well as preliminary and permanent injunctive relief.  The complaint against US Department of Health and Human Services Secretary Alex Azar was filed in the U.S. District Court for the District of Columbia.

The plaintiffs’ assert that the reduced payments threaten patient access to care and harm the providers’ ability to meet the health care needs of their patients, including some of the most vulnerable populations. 

The regulation of pharmacies at the state level might not be what Justice Louis Brandeis had in mind as an example of a “laboratory of democracy,” but for pharmacists and consumers, state-level policy-making can have important real-world effects and encourage efforts on the federal stage. Over the past twelve months a number of regulatory trends have played out that define the current operating environment for pharmacies, many of which are anticipated to continue in 2019.