New Opioid Law Promises Sweeping Changes
On July 22, 2016, President Obama signed the Comprehensive Addiction and Recovery Act (CARA) into law. This is the first major federal addiction legislative package in decades and is designed to tackle the opioid epidemic through a six-part initiative: prevention, treatment, recovery, law enforcement, criminal justice reform and overdose reversal.1 In a rare sign of bipartisanship, Congressional Republicans and Democrats worked cooperatively for much of the first half of 2016 on the legislation. The U.S. Senate was first to act by passing an earlier version of CARA in March 2016, with a 94-1 vote.2 The U.S. House followed by passing a package of 18 separate opioid-related bills by a vote of 400-5, in May 2016.3 Leaders from both parties came together in July 2016 to hammer out compromise language before it easily passed both chambers and was sent to President Obama.
Despite near universal support in Congress, determining the funding for CARA has been tabled for now. The new law authorizes over $181 million each year in new funding to fight the opioid epidemic, but monies must be appropriated every year through the regular appropriations process. Republican leaders in Congress have signaled funding will be considered during fiscal year 2017 appropriations deliberations later this year. While we wait for Congress to settle on funding, there are a number of key provisions in the new law with a direct impact on pharmacists and pharmacies that will be implemented by various federal agencies in the coming weeks and months.
The new law aims to address unused medications by allowing for the partial fill of prescriptions and supporting the efficient disposal of medications no longer needed by patients. The law amends the Controlled Substances Act to allow for partial fills of prescriptions of Schedule II controlled substances, “if not prohibited by state law subject to the following requirements: the prescription is written and filled in accordance with this section [Title VII section 702 of CARA] and Drug Enforcement Administration regulations; a partial fill is requested by the patient or practitioner; and, the total quantity dispensed does not exceed the total quantity prescribed. Any remaining portion of a partially filled prescription may be filled but must be filled not later than 30 days after the prescription was written.”4 In emergency situations, the remaining portions of a partially filled prescription for a controlled substance in schedule II shall not be filled later than 72 hours after the prescription is issued.5
Pharmacy and Prescriber Lock-In Provisions
Policymakers considered a number of approaches to address prescription medication abuse, with specific attention given to polypharmacy – the simultaneous use of several medications to treat a single medical condition. As a result, the new law initiates lock-in provisions designed to prevent prescription drug abuse under Medicare Part C and D. Beginning January 1, 2019, prescription drug plan (PDP) sponsors are permitted to establish drug management programs (DMPs) for at-risk beneficiaries. Under these voluntary programs, PDP sponsors may limit a beneficiary’s access to coverage for frequently- abused drugs to one prescriber and pharmacy.
Many pharmacy and prescriber stakeholders opposed the lock-in provisions because they argued it limits beneficiary choice and gives unchecked power to PDP sponsors. As a partial compromise, CARA includes a specific exemption from the lock-in provision for beneficiaries who reside in long-term care facilities (LTCFs), including skilled nursing facilities and intermediate care facilities for individuals with intellectual disabilities or other facilities that contract with a single pharmacy. The exemption recognizes the population served by LTCFs is at low risk for drug abuse, as well as the controls already in place to maintain a single point of accountability for all medication-related issues. The law also gives the U.S. Department of Health and Human Services (HHS) Secretary discretion to exempt other beneficiaries, which means the exemption language may be applied more broadly to include those in assisted living, correctional facilities and other settings. HHS is currently working on regulations to implement CARA and will reveal the scope of the lock-in exemption in proposed rulemaking.
Support for State Monitoring Programs
The law reauthorizes the National All Schedules Prescription Electronic Reporting (NASPER) Act that provides grants to state prescription drug monitoring programs (PDMPs). Theses grants must support state efforts to improve their PDMPs by increasing interoperability and the use of health information technology (HIT), e-health records, health information exchanges and e-Prescribing. According to CARA, these state-administered controlled substance monitoring systems must be enhanced to “ensure that health care providers have access to the accurate, timely prescription history information that they may use as a tool for the early identification of patients at risk for addiction.” 6
CARA also includes provisions to combat overdoses by expanding access to reversal agents, including naloxone. The law makes federal grants available to states to fund programs that allow pharmacists to dispense naloxone without a prescription. It also encourages healthcare providers who prescribe opioids to simultaneously prescribe opioid overdose reversal drugs and expands access to opioid overdose antidote medications for caregivers of at-risk individuals.
FDA Opioid Action Plan
CARA imposes a number of reforms for the U.S. Food & Drug Administration (FDA). The FDA is required to refer all new drug applications for opioids to an FDA advisory committee. The law also requires the Secretary of HHS to convene the FDA Pediatric Advisory Committee to seek recommendations regarding a framework for the inclusion of information in the labeling of drugs that are opioids before the approval of any labeling or change to labeling for any drug that is an opioid intended for use in a pediatric population.7 The Secretary of HHS is also required to examine an Extended Release/Long Acting Opioids Risk Evaluation and Mitigation Strategy and recommend education programs for prescribers on opioids. Lastly, the FDA is required to release a final version of guidance on General Principles for Evaluating the Abuse Deterrence of Generic Solid Opioid Drug Products.
The Road Ahead
CARA marks a significant achievement for the typically gridlocked policymaking process in Washington, DC. The new law is expected to ignite action at the federal, state and local levels to combat the opioid epidemic through a six-part initiative: prevention, treatment, recovery, law enforcement, criminal-justice reform and overdose reversal. However, there are significant implementation challenges on the horizon due to the uncertainty of funding for many of the CARA provisions. Pharmacists and pharmacies are positioned to help address the opioid epidemic and a new set of initiatives from CARA will require pharmacists and pharmacies to adapt to the changes.
Brad Kile is president of the Dumbarton Group, LLC, an advocacy and policy firm.
1 “Comprehensive Addiction and Recovery Act (CARA)”. Community Anti-Drug Coalitions of America (CADCA). Web. 25 August 2016. http://www.cadca.org/comprehensive-addiction-and-recovery-act-cara
2, 3 “S. 524 Comprehensive Addiction and Recovery Act of 2016.” GovTrack. Web. 25 August 2016. https://www.govtrack.us/congress/votes/114-2016/s34
4 “S. 524 Comprehensive Addiction and Recovery Act if 2016.” GovTrack. Web. 25 August 2016. https://www.govtrack.us/congress/votes/114-2016/h193
5 S. 524 “Comprehensive Addiction and Recovery Act of 2016.” Title VII, Section 702, (a). Congress.gov. Web. 13 September 2016. https://www.congress.gov/bill/114th-congress/senate-bill/524/text
6 S. 524 “Comprehensive Addiction and Recovery Act of 2016.” Title I, Section 106, (a) (2). Congress.gov. Web. 13 September 2016. https://www.congress.gov/bill/114th-congress/senate-bill/524/text
7 S. 524 “Comprehensive Addiction and Recovery Act of 2016.” Title I, Section 109, (a). Congress.gov. Web. 13 September 2016. https://www.congress.gov/bill/114th-congress/senate-bill/524/text