PA 16-43—sHB 5053

Public Health Committee

Planning and Development Committee

Judiciary Committee

AN ACT CONCERNING OPIOIDS AND ACCESS TO OVERDOSE REVERSAL DRUGS

SUMMARY: This act contains various provisions on opioid abuse prevention and treatment and related issues. It:

1. prohibits, with certain exceptions, a prescribing practitioner authorized to prescribe an opioid drug from issuing a prescription for more than a seven-day supply to (a) a minor or (b) an adult for the first time for outpatient use ( 7);

2. makes various changes to the electronic prescription drug monitoring program, such as (a) expanding who may serve as a prescriber's authorized agent, (b) modifying reporting deadlines, and (c) decreasing required prescriber reviews for prolonged treatment with schedule V nonnarcotic drugs ( 8 & 9);

3. allows any licensed health care professional to administer an opioid antagonist (e. g. , Narcan) to treat or prevent a drug overdose without civil or criminal liability ( 1);

4. requires municipalities, by October 1, 2016, to amend their local emergency medical services (EMS) plans to ensure that specified first responders are equipped with an opioid antagonist and trained in administering it ( 1);

5. prohibits certain health insurance policies that provide prescription drug coverage for opioid antagonists from requiring prior authorization for these drugs ( 2 & 3); and

6. requires the Public Health Committee chairpersons to establish a working group on the issuance of opioid drug prescriptions by prescribing practitioners ( 11).

The act also makes changes affecting the (1) Alcohol and Drug Policy Council ( 4), (2) practice of auricular acupuncture ( 5), (3) scope of practice of alcohol and drug counseling ( 6), and (4) disciplining of controlled substance registrants ( 10).

Lastly, the act makes technical and conforming changes.

EFFECTIVE DATE: Various, see below.

7 — OPIOID DRUG PRESCRIPTIONS

Seven-Day Supply

The act prohibits a prescribing practitioner authorized to prescribe an opioid drug from issuing a prescription for more than a seven-day supply to (1) a minor at any time or (2) an adult for the first time for outpatient use.

When prescribing an opioid drug to a minor for less than seven days, the act requires the practitioner to discuss with the minor and if present when the prescription is issued, the minor's custodial parent, guardian, or legal custodian:

1. the associated risks of addiction and overdose;

2. the dangers of taking opioid drugs with alcohol, benzodiazepines, and other central nervous system depressants; and

3. why the prescription is necessary.

The act defines an “opioid drug” as any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.

Exceptions

The act allows the practitioners to prescribe more than a seven-day supply of an opioid drug to an adult or minor if, in their professional judgment, the drug is required (1) for palliative care or (2) to treat the person's acute medical condition, chronic pain, or cancer-associated pain. The practitioners must document the patient's condition in their medical record and indicate that an alternative to the opioid drug was not appropriate to treat the patient's condition.

The act's provisions on opioid drug prescriptions do not apply to medications that treat opioid drug dependence or abuse, including opioid antagonists and agonists (e. g. , medications such as morphine that activate the same areas of the brain as other opioids).

EFFECTIVE DATE: July 1, 2016

8 & 9 — ELECTRONIC PRESCRIPTION DRUG MONITORING PROGRAM

Under the electronic prescription drug monitoring program, the Department of Consumer Protection (DCP) collects information on controlled substance prescriptions to prevent improper or illegal drug use or improper prescribing. The act makes various changes affecting the program.

EFFECTIVE DATE: July 1, 2016, except a conforming change is effective October 1, 2016.

Reporting Deadline

The act extends, from 24 hours to the end of the following business day, the deadline for pharmacists and other controlled substance dispensers to report specified prescription information to DCP under the program. (PA 15-5, June Special Session, shortened the deadline, starting July 1, 2016, from at least weekly to immediately but not later than 24 hours after dispensing the prescription. )

For veterinarians dispensing controlled substance prescriptions, the act continues the less frequent reporting schedule that applied to all dispensers until July 1, 2016. Thus, the act requires them to report at least weekly. It also allows veterinarians who do not maintain records electronically to report in other formats approved by the DCP commissioner.

The act also provides that if the program is not operational, the pharmacy or dispenser must report by the next business day after regaining access to the program (i. e. , the next day during which the pharmacy is open to the public).

Prescribers and Agents

Under existing law, before prescribing more than a 72-hour supply of a controlled substance, the prescribing practitioner or his or her authorized agent must review the patient's records in the prescription drug monitoring program. The prescribing practitioner or agent must also periodically review a patient's records in the program when the practitioner prescribes controlled substances for continuous or prolonged treatment.

The act eliminates the requirement that the authorized agent be a licensed health care professional. It also reduces the required frequency of reviewing records for continuous or prolonged treatment of schedule V nonnarcotic controlled substances. It requires these reviews annually, rather than every 90 days as under prior law. The act continues to require these reviews every 90 days for other controlled substances.

Under the act, a prescribing practitioner may designate an authorized agent to review the program and patient controlled substance prescription information on the practitioner's behalf. A practitioner must ensure that his or her agent's access is limited to the program's statutory purposes and occurs in a manner that protects the confidentiality of information accessed through the program.

The act specifies that prescribers and their authorized agents are subject to the federal Health Insurance Portability and Accountability Act's (HIPAA) regulations on administrative safeguards for protecting electronic protected health information. It also provides that DCP may take disciplinary action against a prescribing practitioner for acts of his or her authorized agent.

The act makes corresponding changes by expanding when the DCP commissioner must release controlled substance prescription information, on request, to prescribing practitioners' authorized agents. It requires him to release information to agents in the same situations as for requests by prescribers themselves (instead of only certain situations as under prior law), and specifies that the agents need not be licensed health care professionals.

Specific Requirements for Prescribers in Hospitals

Under the act, prescribing practitioners who work for or provide professional services to hospitals must receive the DCP commissioner's approval before designating authorized agents to review the program and patient controlled substance prescription information on the practitioner's behalf. Along with the request to designate agents, practitioners must submit for approval a written protocol for oversight of the agents on a commissioner-approved form. The protocol must designate the hospital's medical director, a hospital department head, or another prescribing practitioner as the person responsible for ensuring that the agents' access is limited to the program's statutory purposes and occurs in a manner that protects confidentiality.

The act allows DCP to (1) take disciplinary action against such designated responsible parties for the agents' acts and (2) inspect hospital records to determine compliance with approved protocols.

1 — ADMINISTRATION OF OPIOID ANTAGONISTS BY LICENSED HEALTH CARE PROFESSIONALS

The act allows any licensed health care professional to administer an opioid antagonist to treat or prevent a drug overdose without being (1) civilly or criminally liable for such action or (2) deemed as violating his or her professional standard of care. Prior law limited such immunity to health care professionals authorized to prescribe an opioid antagonist (see BACKGROUND).

By law, an “opioid antagonist” is naloxone hydrochloride (e. g. , Narcan) or any other similarly acting and equally safe drug that the U. S. Food and Drug Administration has approved for treating a drug overdose.

EFFECTIVE DATE: Upon passage

1 — LOCAL EMS PLANS

 The act requires each municipality, by October 1, 2016, to amend its local EMS plan to ensure that the EMS responder (e. g. , EMS personnel or resident state trooper) likely to be the first person to arrive on the scene of a medical emergency is equipped with an opioid antagonist and has received Department of Public Health (DPH)-approved training in administering it.

Under the act, “EMS personnel” includes an individual certified as an emergency medical responder, emergency medical technician, advanced emergency medical technician, EMS instructor, or paramedic.

EFFECTIVE DATE: Upon passage

2 & 3 — PRIOR AUTHORIZATION FOR OPIOID ANTAGONISTS

The act prohibits certain health insurance policies that provide prescription drug coverage for opioid antagonists from requiring prior authorization for these drugs. It applies to individual and group health insurance policies delivered, issued, renewed, amended, or continued in Connecticut that cover (1) basic hospital expenses; (2) basic medical-surgical expenses; (3) major medical expenses; (4) hospital or medical services, including those provided under an HMO plan; or (5) single ancillary services (e. g. , prescription drugs).

Because of the federal Employee Retirement Income Security Act (ERISA), state insurance benefit mandates do not apply to self-insured benefit plans.

EFFECTIVE DATE: January 1, 2017

4 — ALCOHOL AND DRUG POLICY COUNCIL

Under existing law, the council is charged with (1) reviewing state policies and practices on substance abuse treatment and prevention programs, referrals to such programs, and criminal sanctions and programs and (2) developing and coordinating a statewide, interagency, integrated plan for these matters. The act requires the council to amend this plan by January 1, 2017 to contain measurable goals, including reducing the number of opioid-induced deaths in the state.

The act also allows the council's co-chairpersons (the departments of Mental Health and Addiction Services (DMHAS) and Children and Families commissioners) to establish subcommittees and working groups and appoint individuals who are not council members to serve on them. These include licensed alcohol and drug counselors; pharmacists; municipal police chiefs; EMS personnel; and representatives of organizations that provide education, prevention, intervention, referrals, rehabilitation, or support services to individuals with substance use disorder or chemical dependency.

EFFECTIVE DATE: October 1, 2016

5 — AURICULAR ACUPUNCTURE

Under existing law, certain certified, unlicensed individuals may practice auricular acupuncture to treat alcohol and drug abuse, under a physician's supervision, in DPH-licensed freestanding substance abuse facilities or DMHAS-operated settings.

The act specifies that these individuals must be certified by the National Acupuncture Detoxification Association; prior law required that they be certified by a DPH-approved organization. The act allows them to practice the five-point auricular acupuncture protocol specified as part of the association's certification program, as an adjunct therapy to treat alcohol and drug abuse and other behavioral interventions covered by the protocol.

The act expands the settings in which these individuals may practice, by allowing them to do so in any other setting where the protocol is an appropriate adjunct therapy for such treatment. As under existing law, they must practice under a physician's supervision.

The act also makes a conforming change to the DPH commissioner's duty to adopt regulations on this practice.

EFFECTIVE DATE: October 1, 2016

6 — ALCOHOL AND DRUG COUNSELING

By law, alcohol and drug counselors must be licensed or certified by DPH. Existing law defines the practice of alcohol and drug counseling as the professional application of methods that assist individuals or groups to understand alcohol and drug dependency problems, define goals, and plan actions reflecting their interests, abilities, and needs as affected by such dependency. The act specifies that this may include, as appropriate:

1. conducting a substance use disorder screening or psychosocial history evaluation to document an individual's use of pain medications, other prescribed drugs, illegal drugs, and alcohol, to determine the person's risk for substance abuse;

2. developing a preliminary diagnosis based on this screening or evaluation;

3. determining the person's risk of abusing pain medications, other prescribed drugs, illegal drugs, and alcohol;

4. developing a treatment plan and referral options to ensure that the person receives needed recovery supports; and

5. developing an opioid use consultation report and submitting it to the person's primary care provider for that provider to review and include in the patient's medical record.

EFFECTIVE DATE: October 1, 2016

10 — DCP DISCIPLINARY ACTION AGAINST CONTROLLED SUBSTANCE REGISTRANTS

The act adds the following to the list of reasons the DCP commissioner may take disciplinary action against a controlled substance registrant:

1. failing to establish and implement administrative safeguards for protecting electronic protected health information required by HIPAA and

2. breaching any such safeguards by a prescribing practitioner's authorized agent.

By law, the commissioner may, for sufficient cause, suspend, revoke, or refuse to renew a registration; place a registration on probation or put conditions on it; and assess a civil penalty of up to $1,000 for each violation.

EFFECTIVE DATE: October 1, 2016

11 — WORKING GROUP ON OPIOID DRUG PRESCRIPTIONS

The act requires the Public Health Committee chairpersons, by October 1, 2016, to convene a working group to address the issuance of opioid drug prescriptions by prescribing practitioners. The working group must study whether it is a best practice for prescribing practitioners to limit prescriptions to minors to no more than a three-day supply to treat an acute medical condition.

The act requires the working group to report the study results to the Public Health Committee by February 1, 2017.

EFFECTIVE DATE: Upon passage

BACKGROUND

Opioid Antagonist Good Samaritan Law

Existing law allows licensed health care practitioners authorized to prescribe an opioid antagonist to prescribe, dispense, or administer it to treat or prevent a drug overdose without being civilly or criminally liable for the action or for its subsequent use.

The law also allows anyone, if acting with reasonable care, to administer an opioid antagonist to a person he or she believes, in good faith, is experiencing an opioid-related drug overdose. It generally gives civil and criminal immunity to such a person regarding the administration of the opioid antagonist (CGS 17a-714a).

Prescribing Practitioner

Under existing law, the following health providers may prescribe medication within the scope of their practice: physicians, dentists, podiatrists, optometrists, physician assistants, advanced practice registered nurses, nurse-midwives, and veterinarians (CGS 20-14c).

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