Life Science Compliance Update

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February 25, 2016

Senate Hearing on Opioid Epidemic Focuses on Limiting Multiple Access Points

The Senate Finance Committee held a hearing focused on the opioid abuse epidemic and its effect on the Medicare system. Senators Pat Toomey and Rob Portman have introduced a bipartisan bill Stopping Medication Abuse and Protecting Seniors Act with help from Senators Bob Casey and Sherrod Brown, that would allow Medicare Part D prescription drug plans to work with at-risk beneficiaries to identify one physician to prescribe opioids and one pharmacy to fill all the opioid prescriptions. The Senators believe that having opioids prescribed by only one physician (instead of multiple doctors) may result in better patient care and reduced abuse.

Senator Orrin Hatch, the Senate Finance Committee Chairman, recognized how important opioids are, especially for patients who suffer from severe pain following a surgical procedure or during treatment for cancer. Senator Hatch, and his colleagues on the Senate Finance Committee, are concerned that opioids also have qualities that make them addictive and prone to abuse; as such, the Senate Committee is interested in garnering a better understanding of opioid abuse and why it has risen dramatically in the past fifteen years, and ways to best curtail abuse.

Senator Ron Wyden, Ranking Member of the Senate Finance Committee, focused on the fact that in the coming years, Medicare and Medicaid may both account for over one-third of substance abuse-related spending, amounting to billions of dollars every year. Senator Wyden believes that there are three important pieces that will have to come together to make any plan in addressing the opioid "crisis": more prevention, better treatment, and tougher enforcement. Senator Wyden, for example, believes that there should be better prescribing practices and "more responsible marketing practices by opioid manufacturers."


There were three witnesses present at the hearing, representing several different organizations, positions, and viewpoints on the topic. Mr. Allan Coukell, Senior Director of Health Programs at Pew Charitable Trusts; Dr. Nancy K. Young, Director of Children and Family Futures; and Mr. David Hart, Assistant Attorney-in-Charge, Civil Enforcement, Financial Fraud and Consumer Protection Section, Oregon Department of Justice; were all present and put on testimony and answered several questions posed by the Senators.

Mr. Coukell, a pharmacist, focused on a multi-faceted response to the opioid epidemic, recommending: strategies to prevent drug abuse and addiction; identifying patients who are at risk; preventing people from overdosing; educating providers about how to prescribe opioids responsibly and ensure patients who do get addicted, get the help they need. All of those suggestions, while broad-brushed suggestions, need to be accomplished while continuing to provide adequate pain management to patients who are in dire need. Mr. Coukell's testimony focused on patient review and restriction (PRR) programs, which are in wide use in both Medicaid and commercial plans, but are prohibited in Medicare. PRRs are used to identify individuals who are at risk of overdoses or other harms and work to ensure that those patients receive coordinated care.

Dr. Young, testified on the part of the hearing that focused on the effect this epidemic is having on the children who are involved. Dr. Young stated that 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," and that "federal investments over the past decade ... have generated a knowledge base that allows us to clearly state that we can no longer say we don't know what to do."

Mr. Hart focused his testimony on the effects of opioid marketing and promotion. Specifically, Mr. Hart mentioned the $1.1 million Insys settlement, most of which is being used to fund efforts to address the opioid epidemic in Oregon. Some of the tasks Oregon is working on with that settlement money include: funding regional pain guidance groups to develop opioid prescribing practices for their communities and to facilitate coordination of care across specialties; promoting the disposal of unused and expired opioids by helping pharmacies become licensed disposal locations; and building a statewide pain guidance public education campaign web platform with regional resource pages to help providers, patients and family members make informed choices.

Questions and Further Testimony

Pharmaceutical Industry

When talking with Senator Wyden, Mr. Hart suggested policies be put in place to penalize drug companies who promote opioid prescriptions. The policies should be put in place, in part, because that way companies would be forced to "disgorge their ill-gotten gains," and force manufacturers to pay for treatment programs if they are found to be engaging in risky practices. Senator Wyden mentioned that those policies are certainly "worth exploring."

Mental Health

Another hot topic these days is mental health and mental health reform, and this hearing touched upon that subject as well. Senators Sherrod Brown and Tim Scott both emphasized the connection between opioid abuse and mental health treatment, with Senator Scott asking specifically about the coordination of care between the issues. Mr. Coukell told Senator Scott that senate bill, S. 1913, requires patients to be notified of mental health programs available, but also that mental health issues are much larger than one bill or one simple resolution.

Next Steps

There were no objections to the legislation during the hearing, though several Democrats present did mention they would like to see much more done, including Congress increasing spending for addiction services.

Senator Hatch seems eager to make some movement on one of the two bills recently introduced and focused on throughout the hearing (the Medicare Part D streamlining bill and another focused on child welfare). He has already stated that he plans to call a committee vote soon, and while we are not sure when that will be, we can feel confident that a vote will happen, given such a policy already exists in Medicaid, and according to Senator Portman, "it works in Medicaid, and it certainly should be in the Medicare program as well." Even with the Senate being gridlocked in the middle of an election year, the Medicare bill might have enough bipartisan support to justify bringing a vote.

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