First in a series.

Like it or not, the 2020 presidential election campaign is well underway. With it comes the latest in public policy ideas, including more attempts to overhaul health care in the U.S.

The phrase “Medicare for All” has captured the minds, if not the hearts, of several candidates and an impressive portion of the voting public. It has shifted the conversation about health care in politics, at least temporarily, away from both “repeal and replace” and “protect the Affordable Care Act.”

This year’s National Home Infusion Association (NHIA) conference kicked off with the 2nd Annual Sterile Compounding Forum. The well-attended track provided an overview of the state of sterile compounding, insight into the most common citations confronting sterile compounders, considerations for compliance and risks relating to compounding, background on how states and the FDA are implementing rules and regulations, including those involved in the delivery of home infusion products.

We are pleased to sponsor the NHIA conference and participate in the following activities:

For decades, pundits, policymakers and consumer groups have called for better tools to make health care purchasing decisions easier.  Greater cost transparency and clear indicators of quality, they say, would help consumers make the right choices, which would lead to lower costs and better quality care.

If only it were as easy as using Angie’s List:  describe the need and up pops the names of local providers, along with comparative information on their performance.

Increasingly, such information and tools are available.  But their impact is unclear.

Since 2010, Medicare consumers have had an “Angie’s List” type of resource in Physician Compare, an online service produced by the Centers for Medicare and Medicaid Services (CMS).  The website was mandated by the Patient Protection and Affordable Care Act (ACA).  It serves a two-fold purpose, according to CMS:

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.