CARA's assault on opioid addiction

In 2016, over 33,000 Americans died as a result of an accidental overdose related to prescription pain relievers or heroin, and over two million people had an opioid use disorder. In August 2017, President Donald Trump announced plans to declare the opioid epidemic a national emergency. While it remains unclear when Trump will take any formal action or what new resources will be allocated to address the opioid epidemic as a result, it is important to examine the modern baseline for addressing the crisis: the Comprehensive Addiction and Recovery Act of 2016 (CARA), which President Obama signed into law in July of 2016. ----- Background and funding After nearly 40 years without much action at the federal level, CARA attempts to provide a multi-faceted, coordinated response to the opioid crisis by framing the problem as primarily a medical issue. The law provides funding for prevention, treatment, and recovery efforts, while also encouraging criminal justice reform. This article will focus on provisions that most directly impact doctors and drug treatment facilities, though there are numerous other sections that address other matters, such as addiction research, pharmaceutical regulation, and law enforcement. CARA called for $181 million dollars in grant funding to various stakeholders, including agencies, states and physicians to provide more services to people dealing with an addiction. The law also requires annual appropriations of funds through the broader budget process which may lead to political battles in the future. For the moment, however, Congress appears interested in implementing the programs outlined in CARA, because subsequent legislation directed a billion dollars, far in excess of what CARA originally called for, towards the opioid epidemic. ----- Opioid overdose Several sections in CARA focus on increasing access to both overdose reversal drugs and addiction treatment through a variety of measures. CARA allows the secretary of the Department of Health and Human Services to give providers information about prescribing a drug for emergency treatment of a suspected overdose, and authorizes HHS to support both providers and programs financially. Under the law, HHS can grant up to $200,000 annually to federally qualified health centers, opioid treatment programs, or practitioners who are already working in the addiction treatment field. These funds can be used for a variety of things, such as establishing a naloxone co-prescription program, training providers on co-prescribing, purchasing naloxone, and establishing protocols to connect patients with additional services. Naloxone is a drug that can effectively reverse an opioid overdose. Co-prescribing means that patients receiving an opioid for long-term chronic pain, or patients in treatment for an opioid use disorder, are also given a prescription for naloxone. Studies show co-prescribing dramatically reduces opioid-related emergency department visits over time. ----- Dispensing and disposing Other parts of CARA focus on controlling the flow of prescription opioids in use in the community. First, more types of entities, including pharmacies (both stand-alone retail and locations at hospitals and clinics), narcotic treatment programs, and long-term care facilities can apply for grants either to create or to expand disposal sites for unwanted prescription medications. Second, CARA amends the Controlled Substances Act to allow pharmacists to partially fill schedule II prescriptions if requested by the patient or the prescriber. Remaining portions of prescriptions may be filled within thirty days after the prescription was written. ----- Expanded access Several sections of the law allow for the expansion of programs managed by the Substance Abuse and Mental Health Services Administration, an agency within HHS. It also directs funds to states to expand access to addiction treatment services, particularly those that use evidence-based medication assisted treatment programs. CARA amends the Controlled Substances Act to allow nurse practitioners and physician assistants to prescribe and dispense buprenorphine, a narcotic that can treat opioid addiction. With this change, nurse practitioners and physician assistant can now provide this service outside of a federally-licensed narcotic treatment program after they undergo 24 hours of training. State laws outlining the requirements for physician supervision of nurse practitioners and physician assistants still apply. CARA also changes the way physicians dispense buprenorphine. To dispense the drug physicians apply for a waiver through SAMHSA. Now, physicians that have been treating up to 100 patients with this drug for at least a year can apply to treat 275 patients. This, in combination with the new prescribing rights for nurse practitioners and physician assistants, should improve patients' ability to access addiction treatment. ----- Limitations While CARA earned widespread bipartisan support, some critics maintain that the bill failed to go far enough because the law does not contain a mandate requiring prescription drug monitoring programs. PDMPs are databases maintained by individual states that physicians can check before writing an opioid prescription to flag patients that are potentially overusing prescription drugs. While almost every state has a PDMP, not all states require physicians to check it before prescribing. An early version of CARA tied some grant money to states requiring that physicians check their local PDMP. However, some physicians lobbied against the requirement, arguing that searching the PDMP was onerous and not very effective because the databases are not always kept current. The final version of CARA allows HHS to award grants to states to develop their own response plans to the opioid epidemic, which could include establishing, maintaining or improving a PDMP, but does not mandate that practitioners use it. ----- Conclusion CARA represents a congressional attempt to tackle the opioid epidemic from a variety of angles to match the large scale of the problem. Time will tell if Congress continues to make funding the law a priority and how successful the law is at reducing the number of people dealing with an addiction. For the moment, providers and addiction treatment programs should consider applying for grants applicable to their practice that might enhance the care their patients receive. ----- Barry F. Rosen is the chairman & CEO of the law firm of Gordon Feinblatt LLC, heads the firm's health care practice group, and can be reached at 410-576-4224 or brosen@gfrlaw.com. Alexandria K. Montanio is an associate in Gordon Feinblatt's litigation and health care practice groups, and can be reached at 410-576-4278 or amontanio@gfrlaw.com. Published: Mon, Sep 25, 2017