Posted: 26 Jul 2016 08:37 PM PDT
By John A. Gilbert Jr. & Alan M. Kirschenbaum –
On Friday, July 22, 2016, President Obama signed into law the Comprehensive Addiction and Recovery Act (“CARA” or “Act”) of 2016, which is intended to help reverse the serious prescription drug abuse trend in the United States. Although the Act’s primary objective is to address the serious problem of prescription drug abuse, CARA also includes several provisions related to pain management that reflect a recognition of the important need to treat pain. We hope that the implementation of CARA will strike the right balance between these two objectives so as to ensure a successful outcome on both fronts.
The following are some notable elements of the new law:
The Act requires the Department of Health and Human Services (“HHS”) to convene a Pain Management Best Practices Inter-Agency Task Force. The goals of the Task Force are to update the best practices for pain management and prescribing pain drugs and to review medical alternatives to opioids. The Task Force is to include representatives of HHS, the Department of Defense (“DOD”), the Department of Veterans Affairs (“VA”), and the Office of National Drug Control Policy (“ONDCP”) as well as practitioners, pharmacists, and other experts. The Act also requires HHS, along with other agencies, to advance education and awareness of prescription drug abuse among providers and the public. The Act identifies specific issues to be addressed, including the link between heroin and prescription opioids and the dangers of mixing fentanyl and heroin.
A significant part of the law is directed at addressing the issue of opioid abuse at VA facilities by improving the Opioid Therapy Risk Report tool and generally improving the education and training on pain management and safe opioid prescribing practices. For example, the VA is required to designate a pain management team at each facility to coordinate pain management therapy for patients.
The Act also authorizes HHS to establish a grant program to support prescribing of opioid overdose reversal drugs such as naloxone. This program would be available to Federally qualified health centers, opioid treatment programs or other practitioners authorized to dispense narcotic drugs for office based treatment. HHS is also authorized to make grants available to states to implement programs for pharmacists to dispense an FDA approved drug or device for “emergency treatment of known or suspected opioid overdose, as appropriate, pursuant to a standing order.” CARA also provides for grants to states to allow first-responders to administer such drugs and for a GAO review of so-called state “Good Samaritan” laws that allow individuals to administer overdose drugs in emergency situations.
Section 705 of the Act removes a financial disincentive that currently discourages drug manufacturers from developing new abuse-deterrent formulations of pain medications. Under the Medicaid Drug Rebate Program, line extensions of existing oral dosage form innovator drugs may be subject to a higher Medicaid rebate than other newly introduced innovator drugs. (See p. 21 of our summary of CMS’s implementing regulation here.) The Act amends the Medicaid Rebate statute to specifically exclude a new abuse deterrent formulation from the definition of a “line extension” that may be subject to higher rebates.
CARA also amends the federal Controlled Substances Act to allow a pharmacist to partially fill a Schedule II controlled substance prescription based on the request of the prescriber or patient. The prior law and regulations allowed a partial fill of a Schedule II drug only where the pharmacy did not have enough to dispense the entire quantity prescribed. Under the new provisions, either the prescriber or patient can request that the prescription be partially filled at first. The remainder can then be dispensed within 30 days of the original prescription. The objective of this provision appears to be an attempt to limit the amount of pain medicine received by the patient to no more than necessary. However, the new provisions will also require more diligence on the part of pharmacists to ensure that they monitor dispensing, especially if the partial filling is directed by the practitioner rather than requested by the patient. In this case, the pharmacist may need to consult with the practitioner should the patient request to fill the remainder of the prescription.
The Act also authorizes nurse practitioners and physician’s assistants to administer, prescribe, and dispense narcotics in office-based opioid treatment programs. Previously, this practice was limited to physicians. It also authorizes HHS to increase the patient limit for office-based treatment from 30 to 100.
Finally, the Act contains provisions to expand the reporting requirements and access to state prescription drug monitoring programs by practitioners as well as law enforcement. This will likely not only increase access by practitioners to assist in treating patients, but also expand the use of monitoring programs as tool for law enforcement to investigate practitioners, pharmacies, and patients.
On Friday, July 22, 2016, President Obama signed into law the Comprehensive Addiction and Recovery Act (“CARA” or “Act”) of 2016, which is intended to help reverse the serious prescription drug abuse trend in the United States. Although the Act’s primary objective is to address the serious problem of prescription drug abuse, CARA also includes several provisions related to pain management that reflect a recognition of the important need to treat pain. We hope that the implementation of CARA will strike the right balance between these two objectives so as to ensure a successful outcome on both fronts.
The following are some notable elements of the new law:
The Act requires the Department of Health and Human Services (“HHS”) to convene a Pain Management Best Practices Inter-Agency Task Force. The goals of the Task Force are to update the best practices for pain management and prescribing pain drugs and to review medical alternatives to opioids. The Task Force is to include representatives of HHS, the Department of Defense (“DOD”), the Department of Veterans Affairs (“VA”), and the Office of National Drug Control Policy (“ONDCP”) as well as practitioners, pharmacists, and other experts. The Act also requires HHS, along with other agencies, to advance education and awareness of prescription drug abuse among providers and the public. The Act identifies specific issues to be addressed, including the link between heroin and prescription opioids and the dangers of mixing fentanyl and heroin.
A significant part of the law is directed at addressing the issue of opioid abuse at VA facilities by improving the Opioid Therapy Risk Report tool and generally improving the education and training on pain management and safe opioid prescribing practices. For example, the VA is required to designate a pain management team at each facility to coordinate pain management therapy for patients.
The Act also authorizes HHS to establish a grant program to support prescribing of opioid overdose reversal drugs such as naloxone. This program would be available to Federally qualified health centers, opioid treatment programs or other practitioners authorized to dispense narcotic drugs for office based treatment. HHS is also authorized to make grants available to states to implement programs for pharmacists to dispense an FDA approved drug or device for “emergency treatment of known or suspected opioid overdose, as appropriate, pursuant to a standing order.” CARA also provides for grants to states to allow first-responders to administer such drugs and for a GAO review of so-called state “Good Samaritan” laws that allow individuals to administer overdose drugs in emergency situations.
Section 705 of the Act removes a financial disincentive that currently discourages drug manufacturers from developing new abuse-deterrent formulations of pain medications. Under the Medicaid Drug Rebate Program, line extensions of existing oral dosage form innovator drugs may be subject to a higher Medicaid rebate than other newly introduced innovator drugs. (See p. 21 of our summary of CMS’s implementing regulation here.) The Act amends the Medicaid Rebate statute to specifically exclude a new abuse deterrent formulation from the definition of a “line extension” that may be subject to higher rebates.
CARA also amends the federal Controlled Substances Act to allow a pharmacist to partially fill a Schedule II controlled substance prescription based on the request of the prescriber or patient. The prior law and regulations allowed a partial fill of a Schedule II drug only where the pharmacy did not have enough to dispense the entire quantity prescribed. Under the new provisions, either the prescriber or patient can request that the prescription be partially filled at first. The remainder can then be dispensed within 30 days of the original prescription. The objective of this provision appears to be an attempt to limit the amount of pain medicine received by the patient to no more than necessary. However, the new provisions will also require more diligence on the part of pharmacists to ensure that they monitor dispensing, especially if the partial filling is directed by the practitioner rather than requested by the patient. In this case, the pharmacist may need to consult with the practitioner should the patient request to fill the remainder of the prescription.
The Act also authorizes nurse practitioners and physician’s assistants to administer, prescribe, and dispense narcotics in office-based opioid treatment programs. Previously, this practice was limited to physicians. It also authorizes HHS to increase the patient limit for office-based treatment from 30 to 100.
Finally, the Act contains provisions to expand the reporting requirements and access to state prescription drug monitoring programs by practitioners as well as law enforcement. This will likely not only increase access by practitioners to assist in treating patients, but also expand the use of monitoring programs as tool for law enforcement to investigate practitioners, pharmacies, and patients.
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