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From Health Law Daily, February 24, 2016

Committee hearing focuses on strategies to prevent, treat, and fight opioid abuse

By Harold Bishop, J.D.

On February 23, 2016, the Senate Finance Committee conducted a hearing to examine the opioid epidemic in America. The goal of the hearing was to help the Committee gain a better understanding of why opioid abuse has dramatically risen in the past 15 years and how this abuse can best be curtailed. The hearing was focused on a bipartisan bill to provide Medicare with an important tool to fight opioid abuse. At the hearing, the Committee heard from three witnesses that described the challenges faced and offered strategies for more prevention, better treatment, and tougher enforcement.

Bipartisan legislation. The Stopping Medication Abuse and Protecting Seniors Act of 2015 (S.1913), introduced by Senator Toomey (R-Pa) on July 30, 2015, is a bipartisan bill that would allow Medicare Part D plans to work with at-risk beneficiaries to identify one physician to prescribe opioids and one pharmacy to fill all their opioid prescriptions. It is hoped that having opioids prescribed by one physician instead of multiple physicians will improve care coordination and prevent inappropriate access to medications that are susceptible to abuse.

Most Medicaid programs and private commercial plans already have this one-physician, one-pharmacy restriction or “lock-in” program, also referred to as patient review and restriction (PRR) programs. It is hoped that this bill will have a similar impact in Medicare. Establishing a lock-in program in Medicare was also proposed by President Obama in the Administration’s 2017 budget proposal.

Allan Coukell. Allan Coukell, Senior Director of Health Programs at The Pew Charitable Trusts, testified that the opioid epidemic requires a multi-faceted response, including strategies to prevent drug abuse and addiction, identify patients who are at risk, prevent overdoses, educate providers about how to prescribe opioids responsibly, and to ensure that people who do become addicted get the help they need. In implementing these strategies, however, he stressed that we must not lose sight of the importance of providing adequate pain management to people who need it. Coukell also stressed his support for S. 193, which would extend PRR programs to Medicare.

David Hart. David Hart, Assistant Attorney-in-Charge of the Health Fraud Unit/Consumer Protection Section of the Oregon Department of Justice, testified about the need for tougher enforcement by highlighting two investigations.

The first was Oregon’s 2007 investigation of Purdue Pharma for the off-label promotion of OxyContin®, an extended release formulation of oxycodone, first introduced in 1995. According to Hart, the inhibition against prescribing opioids long-term “was already breaking down before OxyContin was introduced, [but] after its introduction, this breakdown accelerated, fueled in part by Purdue Pharma’s aggressive marketing and promotion of the drug.” Hart further testified that at the time of the 2007 settlement with Purdue Pharma, which merely required cessation of unlawful promotion, he did not “fully appreciate the severity of the opioid epidemic and the long lasting effects of Purdue’s OxyContin promotion.” Had I so known, I would have advocated for a settlement which would have required more extensive remedial action by Purdue to correct the inappropriate prescribing patterns for opioids that Purdue’s marketing helped create.”

Hart also discussed Oregon’s investigation of the marketing and promotion of Subsys®, a sub-lingual fentanyl spray that is more than 50 times more powerful than heroin and is only approved for breakthrough cancer pain. In that investigation, Oregon issued investigative demands to Insys, the manufacturer of Subsys. According to Hart, Oregon’s “comprehensive investigation revealed several patterns of alleged misconduct, including reports that the company provided improper financial incentives to doctors to increase prescriptions, aggressively promoted Subsys to doctors not qualified to prescribe the drug, and deceptively promoted Subsys for treatment of mild pain.” To avoid a lawsuit, Insys agreed to an Assurance of Voluntary Compliance which prohibited the identified misconduct and required Insys to pay Oregon more than two times the total Subsys sales in the state.

Nancy K. Young. Nancy K. Young, Ph.D., Director of Children and Family Futures, Inc., emphasized three primary points in her testimony:

  • The increase of opioid misuse has been described by long-time child welfare professionals as having the worst effects on child welfare systems that they have seen.
  • The current environment has at least two major differences from our prior experiences, first that young people are dying at astonishing rates and many states report that infants are coming into protective custody at alarming rates.
  • Federal investments over the past decade testing strategies to improve outcomes for families in child welfare affected by substance use disorders have generated a knowledge base that allows us to clearly state that we can no longer say we don’t know what to do.

According to Young, in addition to key programmatic strategies needed to prevent child placement into families where substance abuse disorders are present, the following system changes are also needed to: (1) effectively monitor effects over time; (2) ensure state agency staff are prepared to work effectively with these families; (3) develop state-specific financing strategies to maximize recent changes in substance use disorder treatment; (4) fill gaps in treatment access for these families; and (5) build collaborative efforts that cross agency boundaries and support communities.

Companies: The Pew Charitable Trusts; Purdue Pharma; Insys; Children and Family Futures, Inc.

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