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”).
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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.
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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.
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Group of Children in a CircleOn January 6, 2017, several new regulatory exceptions to the beneficiary inducement statute went into effect. These regulations, published by the Department of Health and Human Services Office of Inspector General (OIG) in a final rule dated December 7, 2016,1 bring long awaited closure to many of the outstanding issues raised in the statutory versions of the exceptions implemented by the Affordable Care Act (ACA) and in the proposed regulations issued by the OIG on October 3, 2014.2 Several exceptions that may be of particular interest to children’s hospitals are highlighted below.
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