On July 22, 2016, the President signed the Comprehensive Addiction and Recovery Act of 2016 (Pub. L. No. 114-198) (CARA), an expansive law intended to address the prescription opioid abuse and heroin use crisis. The law is an important milestone in the federal government’s efforts to address the opioid abuse epidemic.
CARA authorizes the Attorney General and the Secretary of the Department of Health and Human Services (HHS) to provide grants to state and local governments, providers, community recovery organizations, and others to enhance prevention and education, improve access to medication-assisted treatment, recovery, and overdose rescue medication, and incentivize state comprehensive initiatives to prevent and address prescription opioid abuse.
The law includes extensive amendments to several existing laws, including the Public Health Services Act (PHSA) and Social Security Act (SSA), The Omnibus Crime Control and Safe Streets Act of 1968, and the federal Controlled Substances Act (CSA). Here, we highlight provisions that are most relevant to our clients that manufacture, distribute, or dispense opioids.
First, the law requires the U.S. Food and Drug Administration (FDA) to undertake additional regulatory actions related to opioid drugs. FDA must refer an application filed under 21 U.S.C. § 505(b) for “a new drug that is an opioid” to an advisory committee for consideration and recommendations unless the agency finds that: (i) a referral is not in the interest of protecting and promoting public health; (ii) it is not necessary based on a review of the relevant scientific information; and (iii) a notice containing the rationale for such findings is provided to Congress. Further, FDA must convene a Pediatric Advisory Committee to seek recommendations on a framework for pediatric use labeling before approving a proposed change to an opioid’s labeling to permit use in a pediatric population. Both of these requirements sunset on October 1, 2022. CARA also requires FDA to make recommendations regarding prescriber education programs, including which providers should participate in such programs and how often. Lastly, FDA must finalize its March 2016 draft guidance on the evaluation of abuse deterrence of generic solid oral opioid drug products by November 2017.
Second, the law amends the CSA to include nurse practitioners and physician assistants among providers eligible to prescribe and dispense medication assisted treatment outside of a federally-licensed narcotic treatment program. This change follows closely HHS’ recent final regulations increasing the patient limit under the Drug Addiction Treatment Act of 2000 (DATA 2000) from 100 to 275. Because the HHS regulation was issued under the previous statutory language it only applies to physicians. Thus, it appears that the patient cap for mid-level practitioners will remain at 100.
CARA also amends the CSA to clarify the rules regarding partially filling Schedule II controlled substance prescriptions to allow patients to decline to receive a full prescription and assess need before receiving a 30 or 60 day supply. This change attempts to solve an unintended result of the rescheduling of hydrocodone combination products to Schedule II, which caused physicians to write larger prescriptions to avoid the necessity of an office visit to refill a prescription. The law does not change the existing regulations governing partial fills of Schedule III-V controlled substance prescriptions.
Third, through amendments to the Social Security Act, the law revises the Medicare Part D prescription drug program to permit drug management programs for at-risk beneficiaries by Prescription Drug Plans (PDPs), requires a utilization management tool to prevent drug abuse, and expands activities of Medicare drug integrity contractors (MEDICs). With regard to calculating Medicaid rebates, the law amends the statutory definition of “line extension,” found at 42 U.S.C. § 1396r-8(c)(2)(C), to clarify that a line extension “does not include an abuse-deterrent formulation of the drug (as determined by the [HHS] Secretary), regardless of whether such abuse-deterrent formulation is an extended release formulation.”
Fourth, within 180 days of enactment, the Secretary of Veterans Affairs and the Secretary of Defense must issue an update to the VA/DOD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain. The update must address specific elements stated in the law, including, but not limited to “the co-administration of an opioid and other drugs, including benzodiazepines, that may result in life-limiting drug interaction.” This requirement dovetails with the new law’s creation of a task force to address any gaps and inconsistencies existing in practices for pain management developed or adopted by the federal agencies.