Working Together to Prevent Prescription Drug Abuse
November 5th, 2016

Legislative Concepts

I. Public Health Approach The Alliance supports a broad public health approach to preventing the abuse of medicines and its associated consequences by placing a premium on early identification and treatment. This is accomplished through promotion of public health tools such as the widespread adoption of drug courts, Medicaid coverage adoption of prescription drug abuse screening tools, such as SBIRT, and other patient intervention and treatment approaches which utilize evidence-based treatment of prescription drug abuse.

  • Expansion of national and community-based prescription drug abuse prevention programs in schools, communities and the workplace.
  • Ensure and evaluate access to coverage of prescription drug abuse treatment by insurers, exchanges, Medicaid and Medicare to cover treatment for prescription drug abuse and addiction per Mental Health Parity Act and Affordable Care Act requirements.
  • Target and expand funding and resources to prescription drug abuse prevention and treatment.
  • Department of Justice to conduct an analysis of states where drug courts have been successful in decreasing prescription drug abuse and lowering costs associated with prosecution and incarceration, and then establish a federal plan, which implements identified best practices nationwide so states can adopt.
  • Coordinate the law enforcement associated with drug courts with federal and state prescription drug treatment programs and public health agencies to improve likelihood of early intervention and rehabilitation.
  • Encourage the U.S. Department of Health and Human Services (HHS), National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), and Substance Abuse and Mental Health Services Administration (SAMHSA), to conduct research regarding the effectiveness of applying the SBIRT model to prescription drug abuse (currently utilized predominantly for alcohol and tobacco).
  • HHS to provide grants to states to ensure national coverage of Screening, Brief Intervention, and Referral to Treatment Coverage (SBIRT), or similar patient treatment approach, as an intervention protocol for early prevention and treatment at all places of patient care. HHS to provide communication to providers of the availability of non-Medicaid reimbursement for SBIRT, and require Medicaid coverage of treatment for patients referred through SBIRT or similar patient intervention program, including access to specialty care.
  • HHS to target seven states where prescription drug abuse is prevalent and to provide grant dollars to those states to train health care professionals in early detection and treatment of prescription drug abuse.
  • Support the broad adoption of policies recommending increased access to naloxone (an opioid antagonist) to combat the most feared consequence of abuse, overdose. This includes recommendations by the Substance Abuse and Mental Health Services Administration (SAMHSA) in their Opioid Overdose Toolkit that suggests certain patients on long-term opioid therapy, including some patients on certain preparations such as extended release/long acting opioids and some others at an elevated risk for opioid overdose may benefit from a prescription of naloxone. Additionally, support the U.S. Office of National Drug Control Policy (ONDCP) recommendations to reduce perceived naloxone access barriers by passing prescriber and lay administrator immunity laws as well as policies that support third party prescribing to family members, bystanders and caregivers.

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II. Improve the Effectiveness of Prescription Drug Monitoring Programs (PDMPs) The Alliance believes that each state should operate an effective, interoperable and up-to-date PDMP that is integrated into prescriber and pharmacist workflow, and provide for prescriber notification and education in outlier cases.

  • The Alliance supports a Government Accountability Office (GAO) study to evaluate research-based evidence that demonstrates PDMP effectiveness, relating to the various characteristics of PDMPs (timely data collection/reporting and accessibility of this information by prescribers, pharmacists and their respective designees and information sharing among states, doctor shopping thresholds, PMP staff size, etc.) to outcomes
  • Advocate for solutions that provide prescribers, their proxies where allowed under state law, and pharmacists with patient-specific, timely updated information at the point-of-care for the purpose of improving public health.
  • Support full funding and staffing for up-to-date, and interoperable prescription drug monitoring programs at the point-of-care that are integrated into a prescriber’s and pharmacist’s workflow.
  • Require each state to have an effective interoperable and timely updated Prescription Drug Monitoring Program, which should ideally include integration of PDMP data into electronic health records (EHRs). The PDMP should identify the patient and the prescriber.
  • Encourage adoption of National Association of Boards of Pharmacy (NABP) Interconnect program to apply nation-wide and to allow uniform access guidelines for PDMP programs across state lines.

The Alliance supports the components of a strong prescription drug-monitoring program.  Certain effective PDMP components, as set forth by the National Association of Model State Drug Laws (NAMSDL), should be as follows:

  • The PDMP would monitor federal controlled substances, additional specified controlled substances regulated by the state, and drugs of concern documented to demonstrate a potential for abuse, particularly those identified by law enforcement and addiction treatment professionals.
  • The PDMP would improve patient care by proactively providing reports to educate prescribers and dispensers on instances of overuse by patients.
  • The PDMP would support the safe practice of medicine by generating reports to prescribers in instances where prescribing patterns fall outside of expected norms (controlled for practice specialty or patient populations).  PDMP programs should provide these prescribers with data identifying their prescribing patterns and, if necessary, direct those physicians to educational resources on the appropriate prescribing of controlled substances. Prescribers who are not responsive to program efforts or who continue an unexplained pattern of prescribing after being contacted by the program will be referred to the appropriate state medical licensing authority for further investigation.
  • The PDMP statute should allow the Administrator to disclose de-identified data for statistical, public research, public policy or educational purposes. Prior to disclosure, the Administrator should remove all information, which identifies, or could reasonably be used to identify, the patient, prescriber, dispenser or other person who is the subject of the information.
  • The individuals or officials allowed to request specific data from the program should include prescribers, dispensers and health care licensing boards that regulate prescribers and dispensers.
  • Requestors of PDMP information are required to prove that they have the education, training and instruction necessary to responsibly and properly use the data, as well as prove they fall within a designated category of authorized requestors. Health licensing agencies must establish a uniform standard for designating authorized requestors of PDMP.
  • State officials, by statute, regulation, rule or policy, or in practice, should establish an appropriate linkage from the PDMP to addiction treatment professionals to help individuals identified through the PDMP as potentially impaired or potentially addicted to a substance monitored by the PDMP.
  • Each state should provide for appropriate interstate sharing of PDMP data by statute, regulation or interstate agreement. Recipients of PDMP data from other states may include prescribers, dispensers, health care licensing boards that regulate prescribers and dispensers,  PDMP officials or other specified authorities, subject to privacy and other standards of the supplying state.
  • PDMP data should not be subject to public or open records law.
  • The PDMP should include: an evaluation component that identifies the cost benefits of the PDMP; impacts of the use of the data on the practices of authorized users; and, any recommended operational improvements and other information relevant to policy, research and education involving controlled substances and other drugs of concern monitored by the PDMP.  As part of the ongoing assessment process, an advisory committee or designated individuals should provide advice and input regarding the development and operation of the PDMP.

III. Abuse Deterrent Technology The Alliance supports the Food and Drug Administration (FDA) to require generic versions of extended-release, long acting opioids to have abuse-deterrent properties that are equal in effectiveness, but not necessarily identical to the brand . Abuse deterrent technology is an important and effective tool that should be used to help address prescription drug abuse, and should be incentivized for manufacturers to advance the development of this technology.

  • Require FDA to be the arbiter of what is an effective deterrent.
  • FDA to take into account the continued evolution of abuse deterrence technology, and the need for these products to prove abuse deterrence by increasing the safe use of a product and to prevent abusers from being able to “easily circumvent” the protective measures of a product.
  • FDA to establish parameters for approval of generic abuse deterrent formulations.
  • Require abuse deterrent technology for generic products to be as effective as, but not necessarily identical to, the brand reference product.

IV. Eliminating Pill Mills The Alliance supports enforcement actions to halt “pill mill” activities through legislation that develops standards for pain management clinics and assists prescribers with guidelines on how to prescribe painkillers safely and effectively.

  • Establish guidelines for prescribers and pharmacists to help them identify potential abusers and diverters of controlled substances to help ensure the safe and effective prescribing and dispensing of opioids and other controlled substances.
  • HHS to conduct a study of best practices in states regarding statutes and guidelines on regulating pain management clinics.  Develop state model laws/guidelines based on study findings of best practices and encourage states to adopt state model.

V. Education on Prescription Drug Abuse The Alliance supports education for the public – consumers, patients and all stakeholders – to stop this public health epidemic and help prevent new cases of abuse.

  • Authorize Department of Health and Human Services to conduct nationwide public education campaign on prescription drug abuse.

VI. Medicaid Pharmacy Lock-In Program The Alliance recommends improving State Medicaid pharmacy “Lock-In” programs as an avenue for States to prevent and fight the abuse of prescription medicines by Medicaid beneficiaries.

  • Require Medicaid programs to establish a “Lock-In” program under which procedures are designed to prevent fraud and abuse in the dispensing and prescribing of certain controlled substances to high users, including restricting the beneficiary to obtain prescriptions from only one pharmacy.
  • Establish exceptions to Medicaid beneficiaries in areas such as rural regions where access to pharmacies is limited.

VII. Medicare Pharmacy Lock-In Program The Alliance is currently evaluating prescription drug abuse within the Medicare program and is determining how to curb abuse in Medicare Part D plans. The Alliance is reviewing how to appropriately implement a Medicare Lock-In program.

  • Restrict beneficiaries who are suspected of abusing certain medications to obtain prescriptions from only one pharmacy.
  • CMS should establish protections for beneficiaries to ensure that access to needed medications is not disrupted.

VIII. Enhance Oversight of Controlled Substances and Establish Prescription Drug Abuse Working Group The Alliance supports bringing greater clarity to the requirements for the safe and secure distribution and dispensing of controlled substances and establishment of a prescription drug abuse working group to report to Congress.

  • Clarify existing authorities under the Controlled Substances Act (CSA).  Implement a process to identify and mitigate concerns pertaining to the distribution and dispensing of controlled substances.
  • Ensure that any imposed restrictions regarding the continued distribution of controlled substances are not performed in an overly broad manner such that they adversely affect patient care and access.
  • Require registrants to obtain criminal background checks and drug tests on each non-licensed health care professional , such as warehouse workers of distributors or manufacturers, who has or will have access to controlled substances.   Licensed healthcare professionals such as prescribers and dispensers would be exempted from this section’s requirements.
  • The bill requires the Attorney General to give the registrant an opportunity to submit a corrective action plan that demonstrates how the registrant plans to correct the grounds for revocation or suspension and for the Attorney General to then determine whether, in light of the plan, revocation or suspension proceedings should be discontinued or deferred.
  • The President to establish a Working Group comprised of governmental sector leaders, industry sector leaders and advocates to review and report to Congress on federal policies to reduce prescription drug diversion and abuse and make recommendations on specific ways to address the epidemic.

IX. Take Back Program Proposal – The Alliance seeks to decrease the supply of diverted prescription drugs, and, to that end, supports the appropriate removal of unused, unneeded or expired prescription drugs, including controlled substances, from medicine cabinets and out of the reach of potential abusers, and federal funding for a national framework to support accessible state-level Take Back locations. The Alliance puts forth the following guidance to ensure an effective Take Back program under the DEA proposed rule:

  • The requirements of voluntary participation in Take Back should not be prohibitively burdensome with respect to cost, liability, or compliance hurdles, so as to deter participation and therefore limit the usefulness of the program.
  • Any proposed rule offered by DEA implementing the drug disposal statute should be harmonized with other federal agency rules (see EPA, OSHA, FDA, DOT), as well as state requirements.
  • A proposed DEA rule should ensure expansion of the program to allow for additional federal agencies, e.g., DOD, VA, to participate in the program.
  • DEA, in conjunction with other federal agencies participating in the Take Back program, should from time to time study the effectiveness of the program comparative to the prescription drug epidemic to evaluate whether the program is having a mitigating effect.  Such evaluation should ensure that the economic and environmental impacts of the program remain minimal.