December 2, 2014 EXECUTIVE SUMMARY. Table of Contents. I. Introduction... 2 II. Key Insights... 2

Transcription

1 December 2, 2014 EXECUTIVE SUMMARY Table of Contents I. Introduction... 2 II. Key Insights... 2 A. Access to Care Medications Interventions and Treatment for Substance Use... 2 B. Preserving Core Values Legal Clarity Compassion Federal Supremacy Privacy... 4 III. Policy Priorities... 4 A. Access to Care Medications Interventions and Treatment for Substance Use... 4 B. Core Values Legal Clarity Compassion Federal Supremacy Privacy... 5 IV. Participants and Agenda Potomac Street NW, Suite 150-A Washington, D.C (202)

2 I. Introduction As the prescription drug abuse epidemic continues to evolve, unintended consequences of well-intentioned policy approaches are beginning to emerge. Although efforts to reduce the supply of opioid medications available for abuse are proving to be successful, the pendulum has swung back, resulting in unintended consequences. These include inadequate reduction in demand, contributing to increased heroin use and buprenorphine misuse. Additionally, with many policies falling short by addressing opioids only, as opposed to all controlled substances, benzodiazepine and stimulant abuse continue to increase. Counterfeit and analog drugs are readily available through sophisticated supply chains and manufacturing processes, while dirty doctors have shifted tactics from pill mills to black market novel biologics and fraud and abuse in testing for substance use. The objectives of the seventh annual National Prescription Drug Abuse Prevention Policy Meeting ( Policy Meeting ) of the (CLAAD) were to share unique perspectives, discuss policy, provide contextual analysis, and build consensus; and maximize the use of limited resources by harmonizing efforts. The event fostered coordination among multiple sectors of society to advance two vitally important common goals: to reduce prescription drug abuse and improve consumer access to high quality health care. The participants largely agreed that it is necessary to evaluate and refine policy strategies to address their unintended consequences, refocusing on access to care and protecting core values. II. Key Insights A. Access to Care 1. Medications Currently, there are no clear or consistent enforcement standards on which controlled substance registrants may rely in preventing controlled substance diversion. Rather than providing clear notice of its expectations of controlled substance registrants, the Drug Enforcement Administration ( DEA ) has used law enforcement tactics to fulfill its regulatory role. As a result, patients with legitimate needs for controlled substances have experienced increased challenges in accessing their prescriptions, some health care practitioners fear prescribing controlled substances, and pharmacists have been placed in the difficult situation of having to deny access to medications to individuals with legitimate needs. 2. Interventions and Treatment for Substance Use The Drug Addiction Treatment Act of 2000 ( DATA 2000 ), which imposes patient limits on controlled substance registrants who prescribe buprenorphine for the treatment of opioid dependence in office-based settings, has hindered access to treatment by relegating patients to waiting lists, compelling prescribers to abandon patients, and forcing some individuals to seek relief from diverted and illicit substances available on the black market. 2

3 Individuals with substance use disorders ( SUDs ) are often caught in a cycle of arrest and incarceration; however, drug courts have been shown to reduce criminal justice costs and recidivism by taking a rehabilitative approach. Although a high number of incarcerated individuals have SUDs, jails and prisons often do not provide sufficient treatment services. Payer policies enable waste, fraud, and abuse in substance use testing by encouraging the use of outmoded, inaccurate technology and the duplication of services. Payer responses to waste, fraud, and abuse have yielded further limits on access, by excessively restricting coverage26.8 percent of individuals who died from a drug overdose had experienced a prior overdose with a hospital visit, and 82.3 percent of overdose decedents had a known substance abuse history. Naloxone can save the lives of individuals who have overdosed on opioids. State legislation related to dispensing naloxone to first responders and loved ones with a prescription varies from state to state. Good Samaritan laws provide immunity from liability to individuals who assist an individual who has overdosed in getting medical help. These laws also vary greatly from state to state. B. Preserving Core Values 1. Legal Clarity Drug-impaired driving cases are increasing, especially among individuals who use marijuana. Yet, officials have difficulties measuring non-alcoholic substance-related impairment. State prosecutors have troubles proving impairment due to the subjectivity of impairment determinations making drug-impaired driving difficult to prosecute fairly and effectively. Laws that punish driving after prescribed medication use, rather than under impairment, provide a clearer legal standard but make it even more difficult for patients who need controlled substances to lead productive lives. 2. Compassion States have implemented punitive laws and policies in efforts to reduce substance use among pregnant women and the resulting risk of Neonatal Abstinence Syndrome ( NAS ). State laws that criminalize substance use during pregnancy further perpetuate stigma and do not deter harm to the child or the mother. Such laws cause distrust of health care providers and yield a strong disincentive to seek prenatal care. 3. Federal Supremacy Banning a single medication is an unconstitutional violation of the Equal Protection Clause because it involves applying a state law in a discriminatory manner by allowing products of essentially the same composition of the banned product to be used and sold in interstate commerce. 3

4 Maine s prescription drug importation law permits consumer importation of drugs from foreign pharmacies (i.e., Canada, United Kingdom, Australia, and New Zealand); however, the majority of online pharmacies do not comply with U.S. regulations and many of these pharmacies distribute counterfeit or diverted medications. There is concern that this model may proliferate to other states, following the medical marijuana political model. In contrast to Maine s law, California s Senate Bill 600 ( SB 600 ) prohibits the distribution, purchase, and sale of counterfeit and diverted medications. Municipalities with self-funded health plans are encouraging employees to use foreign, unapproved medications, which can be counterfeits or diverted. 4. Privacy Some states employ an active investigation standard that allows law enforcement to access information from the states Prescription Monitoring Programs ( PMPs ) without adequate safeguards to protect patient and prescriber privacy. An Oregon U.S. district judge ruled that patients and physicians have a reasonable expectation of privacy of PMP data. III. Policy Priorities A. Access to Care 1. Medications To preserve access to medications and reduce fear of liability among prescribers and pharmacists, clarity must be provided regarding the DEA s regulatory expectations and processes. This goal can be achieved by enacting legislation that clarifies existing authorities under the Controlled Substances Act, including defining imminent danger, establishing enforcement escalation processes (i.e., a corrective action plan), and requiring a report to Congress on the impact of enforcement activities and opportunities for agency and stakeholder collaboration. Greater regulatory clarity will enable prescribers, pharmacists, and other controlled substance registrants to fulfill their professional obligations to prevent diversion, misuse, and abuse with fewer negative outcomes for people with legitimate medication needs. 2. Interventions and Treatment for Substance Use To improve access to substance use treatment, the Department of Health and Human Services ( HHS ) or Congress must increase the patient limit under DATA 2000 through the rulemaking process or legislation. Additional physicians must be encouraged to obtain training in addiction medicine and to register with the Center for Substance Abuse Treatment ( CSAT ) to prescribe buprenorphine under DATA 2000 and increase availability of office-based addiction treatment. DATA 2000 must be expanded to allow for advanced practice nurses to prescribe addiction treatment medications if they obtain certification in addiction. Drug courts must be expanded and utilized in a consistent and meaningful manner. 4

5 Substance use treatment must also be provided in a consistent and meaningful manner to individuals in jails and prisons. These individuals must have post-release access to treatment. The Centers for Medicare and Medicaid Services ( CMS ) must enact payer policies that favor modern technology and reduce waste and duplication of services in testing for substance use. Medicare contractors should be encouraged to bundle testing for multiple substances for a flat fee. B. Core Values 1. Legal Clarity Sober homes must be subject to greater oversight to prevent abuse and diversion. Education about safe storage and disposal of all medications must be prioritized. The U.S. Food and Drug Administration ( FDA ) must finalize guidance regarding abuse-deterrent formulations of opioids ( ADFs ). 2. Compassion States must overturn punitive laws in favor of policies that encourage pregnant women to seek substance use treatment and recovery services and give pregnant women priority access to treatment. States must adopt the Overdose Death Prevention Act or similar legislation that would establish specific rules that apply to an emergency care practitioner when a patient suffers a non-fatal unintentional overdose. States must authorize pharmacies to distribute naloxone without a prescription to first responders and family members who receive intervention training and a prescription. Model state legislation should be drafted regarding access to naloxone and Good Samaritan laws. 3. Federal Supremacy It is essential that the federal government defend its authority to determine which medications may be marketed and sold in the United States. States must refrain from banning select medications. Maine s importation law must be repealed and other states must be discouraged from enacting similar legislation. States should be encouraged to enact legislation similar to California SB 600. Policy makers and consumers must be educated about the dangers of foreign, nonapproved medications. In cases where state law conflicts with federal law, federal law prevails pursuant to the U.S. Constitution. 4. Privacy Safeguards must be put into place to prevent the violation of patient and prescriber privacy. PMPs should be optimized through a system of red flags to alert PMP operators regarding abnormal data access patterns. 5

6 Congress must enact legislation to reauthorize the National All-Schedules Prescription Electronic Reporting ( NASPER ) program that provides funding to state PMPs so they can operate effectively and more efficiently. Furthermore, to have a meaningful impact on prescription drug abuse, all states must implement a PMP and establish interoperability among PMPs to exchange data across state lines. IV. Participants and Agenda The individuals listed below attended the Policy Meeting. The positions set forth in this Executive Summary are CLAAD s and do not necessarily reflect the priorities or policy recommendations of the individuals or the organizations with which they are affiliated. Dave Aronberg State Attorney, 15th Judicial Circuit of Florida Michael Barnes Aubrey Briggman Two Dreams Outer Banks Todd Brown Northeastern University Nelson Bunn National District Attorneys Association Renan Castillo Johns Hopkins Bloomberg School of Public Health Kathy Egan City Millennium Health Wade Delk American Society for Pain Management Nursing Calvina Fay Drug Free America Foundation Katherine Fornili International Nurses Society on Addictions Alex Lewis Alliance for Safe Online Pharmacies J. Kevin Massey Jared McClain National Association of Attorneys General Penny McElroy Watauga Recovery Center Jeff McLeod National Governors Association Penny Mills American Society of Addiction Medicine Lisa Pearlstein American Society of Anesthesiologists Karen Perry NOPE Task Force Burt Rosen Purdue Pharma, L.P. Halle Schweikert Community Anti-Drug Coalitions of America 6

7 Kristen LaRose Freitas Healthcare Distribution Management Association Alicia Georges National Family Partnership Michael Ghobrial American Pharmacists Association Nancy Glick Allergan Shari Hicks Edward Hutchison National Sheriffs Association Sarah Kelsey National Alliance for Model State Drug Laws Dominique Simon Allies in Recovery Kyle Simon Marsha Stanton Zogenix Wes Sterman Ashley Walton American Society of Anesthesiologists Susan Weinstein National Alliance for Model State Drug Laws Stacey Worthy DCBA Law & Policy AGENDA 7:30 a.m. Registration and Breakfast 8:30 a.m. Meeting Objectives and Themes Michael Barnes, CLAAD 8:45 a.m. Building on Progress: Accomplishments and Priorities All Participants 10:00 a.m. Updating the National Strategy Kyle Simon, CLAAD 10:15 a.m. Break 10:30 a.m. 11:30 a.m. Evaluating Policy Therapeutic Approach Mitigating Unintended Consequences Federal Policy Update H.R. 4709: Protecting Consumer Access Omnibus Draft Legislation 12:00 p.m. Networking Lunch 1:00 p.m. State Policy Update Stacey Worthy, DCBA Law & Policy Michael Barnes, CLAAD Kristen LaRose Freitas, Healthcare Distribution Management Association Kyle Simon, CLAAD 7

8 Overdose Death Prevention Act Florida s Approach to Pill Mills and Opioid Abuse Drug Policy and Federal Supremacy Karen Perry, NOPE Task Force Dave Aronberg, State of Florida Michael Barnes, CLAAD 2:15 p.m. Break 2:30 p.m. Prescription Monitoring Programs: Protecting Patient and Prescriber Privacy 3:15 p.m. Preview of 2015 Activities All Participants 3:30 p.m. Conclusion Sarah Kelsey, National Alliance for Model State Drug Laws 8