Bill Summary for H 243 (2017-2018)

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Summary date: 

Mar 30 2017

Bill Information:

View NCGA Bill Details2017-2018 Session
House Bill 243 (Public) Filed Thursday, March 2, 2017
AN ACT STRENGTHENING OPIOID MISUSE PREVENTION BY EXTENDING STANDING ORDERS FOR OPIOID ANTAGONIST TO COMMUNITY HEALTH GROUPS; REQUIRING SUPERVISING PHYSICIANS TO PERSONALLY CONSULT WITH PHYSICIAN ASSISTANTS AND NURSE PRACTITIONERS WHO PRESCRIBE CERTAIN SCHEDULE II OR III CONTROLLED SUBSTANCES FOR LONG-TERM USE; REQUIRING ELECTRONIC PRESCRIBING OF CERTAIN SCHEDULE II AND III CONTROLLED SUBSTANCES; ESTABLISHING MAXIMUM LIMITS FOR INITIAL PRESCRIPTIONS OF SCHEDULE II AND III CONTROLLED SUBSTANCES; REQUIRING HOSPICE AND PALLIATIVE CARE PROVIDERS TO PROVIDE EDUCATION REGARDING PROPER DISPOSAL OF CERTAIN UNUSED CONTROLLED SUBSTANCES; CLARIFYING ALLOWABLE FUNDS FOR SYRINGE EXCHANGE PROGRAMS; REQUIRING VETERINARIAN PARTICIPATION IN THE CONTROLLED SUBSTANCES REPORTING SYSTEM; ESTABLISHING CIVIL PENALTIES FOR PHARMACIES THAT EMPLOY DISPENSERS WHO IMPROPERLY REPORT INFORMATION TO THE CONTROLLED SUBSTANCES REPORTING SYSTEM (CSRS); EXPANDING THE ROLE OF THE DEPARTMENTS OF HEALTH AND HUMAN SERVICES (DHHS) IN USING CSRS DATA TO DETECT AND PREVENT FRAUD AND MISUSE; MANDATING DISPENSER REGISTRATION FOR ACCESS TO THE CSRS; MANDATING DISPENSER AND PRACTITIONER USE OF THE CSRS; REQUIRING DHHS TO REPORT PRACTITIONERS WHO FAIL TO PROPERLY USE THE CSRS; CREATING A SPECIAL REVENUE FUND TO SUPPORT THE CSRS; AND REQUIRING AN ANNUAL REPORT FROM DHHS ON THE CSRS.
Intro. by Murphy, Davis, Malone, Horn.

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Bill summary

House committee substitute makes the following changes to the 1st edition.

Changes the act's long title.

Adds the term targeted controlled substance to GS 90-87, defining the term to mean any controlled substance included in GS 90-90(1), (2), or (3), or GS 90-91(d). Effective July 1, 2017. Makes changes to refer to targeted controlled substance instead of controlled substance throughout the proposed language of GS 90-18.1(b), GS 90-18.2(j), GS 90-106, and proposed GS 90-106.3. Makes conforming changes.

Adds descriptors to each new subsection of GS 90-106, concerning prescriptions and labeling. Changes the effective date of the proposed changes, providing subsections (a), (a1), and (a2) become effective January 1, 2020, and subsections (a3) and (a4) become effective January 1, 2018 (previously, provided an effective date of July 1, 2018, to the entire statute).

Amends proposed subsection (a1), requiring a practitioner to electronically prescribe all targeted controlled substances. Provides that a practitioner who experiences temporary technological or electric failure or other extenuating circumstances (currently does not include other extenuating circumstances) that prevent the prescription from being transmitted electronically is exempt from the requirement.

Amends proposed subsection (a3), concerning limitations on prescriptions upon initial consultation for acute pain. Prohibits a practitioner from prescribing more than a five-day supply of any targeted controlled substance upon the initial consultation and treatment of a patient for acute pain, unless the prescription is for post-operative acute pain relief (previously not clarified) for use immediately following a surgical procedure. Adds provision prohibiting a practitioner from prescribing more than a seven-day supply of any targeted controlled substance for post-operative acute pain relief immediately following a surgical procedure. Further, adds that subsection (a3) does not apply to prescriptions for controlled substances issued by a practitioner who orders a controlled substance to be wholly administered in a hospital, nursing home licensed under GS Chapter 131E, hospice facility, or residential care facility as defined in GS 14-32.2(c1).

Adds surgical procedure to the defined terms in proposed subsection (a4).

Adds new subsection (a5) to grant a dispenser immunity from any civil or criminal liability or disciplinary action from the Board of Pharmacy for dispensing a prescription written by a prescriber in violation of GS 90-106, as amended.

Deletes and replaces the previous language of proposed GS 90-106.3. Now directs any hospice or palliative care provider who prescribes a targeted controlled substance to be administered to a patient in his or her home for the treatment of pain as part of in-home hospice or palliative care to, at the commencement of treatment, provide oral and written information to the patient and his or her family regarding the proper disposal of the targeted controlled substances. Requires the information to include the availability of permanent drop-boxes or periodic drug take-back events that allow for the safe disposal of controlled substances such as those permanent drop boxes and events that may be identified through NC Operation Medicine Drop. 

Deletes proposed GS 58-51-56, which directs health benefit plans to charge a co-payment for a limited, initial prescription of a Schedule II through V controlled substance in an amount that is either proportional between the co-payment charged for a 30-day supply of the controlled substance and the amount prescribed to the beneficiary, or equal to the co-payment charged for a 30-day supply, provided that the beneficiary will not be charged any additional co-payments for subsequent prescriptions for the remainder of the 30-day supply.

Amends the proposed changes to GS 90-113.73. Amends the Schedule II through V prescription reporting deadline for dispensers to require a report no later than the close of the next business day after the prescription is delivered, but encourages dispensers to report the information no later than 24 hours after the prescription is delivered (previously, proposed no later than 24 hours after a prescription is delivered; currently required at close of business three days after the date of delivery). Further, adds new provision providing that, in the event the dispenser is unable to report the information within the time frame required by the statute because the system is not operational or there is some other temporary electrical or technological failure, the inability must be documented in the dispenser's records, and the dispenser must promptly report the information once the electrical or technological failure has been resolved. Amends the information a dispenser is required to report, as specified in subsection (b), to now include (1) if the controlled substance is dispensed for an animal, the name of the owner of the animal and the specified contact information and date of birth of the owner and (2) if the prescriber is a physician assistant or a nurse practitioner, the name of that individual's supervising physician. Amends the directive in proposed subsection (e) to require the Department of Health and Human Services (DHHS) to assess a civil penalty of up to $100 for a first violation and up to $250 for a second violation, and up to $500 for each subsequent violation (currently up to $250 for a first violation and up to $500 for subsequent violations) against a pharmacy that employs a dispenser who fails to comply with the reporting requirements within a reasonable period of time after being informed by DHHS that required information is missing or incomplete for a first violation, up to a maximum of $5,000 (previously, $10,000) per pharmacy per calendar year.

Provides that the proposed changes to GS 90-113.73, except for subsection (b), which is effective when the act becomes law, are effective 30 days after the date the Chief Information Officer notifies the Revisor of Statutes that the Controlled Substance Reporting System database has the capability to record the information described in the statute as amended. Directs the Chief Information Officer to notify the Revisor of Statutes once the CSRS database has the capability to record the information described in the statute as amended.

Amends proposed GS 90-113.74(b1)(1a) to authorize DHHS to notify practitioners and their respective licensing boards (previously only practitioners) of prescribing behavior that increases risk of diversion of controlled substances, increases risk of patient harm, or is an outlier among other practitioner behavior. Adds an effective date of July 1, 2017.

Deletes proposed GS 90-113.74(c)(11), which authorizes DHHS to release Controlled Substances Reporting System (CSRS) data to third-party payers and their agents, for the purposes of claimant case management, detection of inappropriate prescriptions of controlled substances to a claimant, or detection of misuse or diversion of a controlled substance by a claimant.

Enacts proposed GS 90-113.74A as GS 90-113.74B. Makes organizational changes and adds new subsection providing that the statute does not apply to a licensee employed in a pharmacy practice setting where a Schedule II, III, or IV controlled substance will not be dispensed. Makes conforming changes to the statute's proposed title.

Enacts proposed GS 90-113.74B as GS 90-113.74C. Adds clarification that in the event the practitioner is unable to review the information in the controlled substances reporting system pertaining to the patient because the system is not operational or there is some other temporary electrical or technological failure (previously temporary nature was not specified), this inability must be documented in the patient's medical record. Makes conforming changes to refer to targeted controlled substance. Deletes the provision in subsection (b), subdivision (4), allowing a practitioner to review the information in the controlled substances reporting system pertaining to a patient prior to prescribing a targeted controlled substance to the patient when the controlled substance is prescribed in an amount indicated for a period not to exceed five days and does not allow a refill, or for a period not to exceed seven days if the prescription indicates the controlled substance is for immediate post-operative pain relief. 

Enacts proposed GS 90-113.74C as GS 90-113.74D. Makes clarifying change. Makes conforming changes to refer to targeted controlled substance. Adds new provision to subsection (b) establishing that failure to review the controlled substance reporting system in accordance with subsection (a) of the statute does not constitute medical negligence. 

Makes technical changes to proposed GS 90-113.75A, establishing the Controlled Substances Reporting System Fund.

Deletes proposed GS 90-113.75B, which directs practitioners, prior to prescribing Schedule II through V controlled substances, to review information in CSRS regarding the patient for the 12 months preceding the initial prescription; to consult CSRS information for the 12 months preceding each subsequent three-month period that the substance remains part of the patient’s medical care; and to document each instance of review in the patient’s medical record, as well as instances in which review is not possible due to the unavailability of CSRS due to some technological failure. Directs the practitioner to review the information when the CSRS becomes available again, and to document that review in the patient’s medical record. 

Enacts proposed GS 90-113.75C as GS 90-113.75B, directing the annual report by DHHS be submitted by February 1, beginning February 1, 2019 (previously annually on November 1, beginning November 1, 2019). Adds the NC Board of Podiatry Examiners to the entities to which the report must be submitted. Makes conforming change to refer to "targeted controlled substances." Changes the requirements of the report, requiring the specified practitioners be treated as distinct categories of practitioners for categorizing the practitioners prescribing controlled substances and the number of prescriptions authorized by each category of practitioners. Deletes the requirement that the report include the prescribing behavior of practitioners that increases the risk of diversion of controlled substances, increases the risk of harm to the patient, or is an outlier among other practitioner behavior.

Adds new section to amend SL 2015-241, Section 12F.16(h), to direct DHHS, Division of Mental Health, Developmental Disabilities, and Substance Abuse Services, to continue to work toward establishing interstate connectivity for the Controlled Substances Reporting System established under GS 90-113.73. Makes conforming changes to replace references to the PMP InterConnect with references to the Controlled Substances Reporting System (CSRS). Further, amends Section 12F.16(i)(3), providing that the $40,035 appropriation is to be used to establish interstate connectivity for CSRS. Directs DHHS, upon receipt of any grant funding for that purpose or upon identification of other allowable receipts for that purpose, to reimburse the General Fund for the costs associated with establishing interstate connectivity for the CSRS. Limits the reimbursement amount to the amount of any grant funding received by DHHS for the purpose plus the amount of any allowable receipts used by DHHS for the purpose, not to exceed the amount of the nonrecurring funds appropriated in Section 12F.16(i)(3). Effective July 1, 2017.

Deletes the previous appropriation provision, which appropriated $10 million each for 2017-18 and 2018-19 from the General Fund to DHHS, Division of Mental Health, Developmental Disabilities, and Substance Abuse Services, to be used for increasing the availability of community-based treatment and recovery services for substance use disorders.