ADAMS AND ASSOCIATES GOVERNMENT RELATIONS
1706 Rangecrest Road, Raleigh, NC 27612
(919) 841-0964 (919) 801-1837 Cell
Legislative Report
July 11, 2017
by Tony Adams
On June 22, the 2017-18 budget was ratified by the NC House and Senate and was sent to Governor Roy Cooper for him to either sign or veto. The appointed budget conference committee of Senate and House members had been working behind the scenes for weeks on coming to an agreement on the different versions of the budget originally passed by both chambers. Governor Cooper, as expected, vetoed the budget bill, H257, but his veto was overridden by both the House and Senate on June 28, thus becoming law.
2017 Ratified Legislation of Importance to NCAP
House Bill 243,the Strengthen Opioid Misuse Prevention Act (STOP Act), passed both the House and Senate in overwhelming and bipartisan votes, and has been signed into law by Gov. Cooper. The bill extends the statewide standing order for opioid antagonists to allow practitioners to prescribe an opioid antagonist to any governmental or nongovernmental agency (ii) designates certain Schedule II and III drugs as "targeted controlled substances and makes changes to the laws governing the prescribing of those targeted controlled substances, (iii) clarifies the allowable funds for syringe exchange programs, (iv) makes changes to the statutes governing the Controlled Substance Reporting System (CSRS) database, and (v) amends language in the 2015 budget to facilitate the interstate connectivity of the CSRS database.
Prescriptions for targeted controlled substances will be limited to no more than a 5 day supply upon the initial consultation and treatment of a patient for acute pain, unless the prescription is for post-operative acute pain relief immediately following a surgical procedure, in which case the practitioner may not prescribe more than a 7-day supply. Upon any subsequent consultation for the same pain, the practitioner may issue any appropriate renewal, refill, or new prescription for a targeted controlled substance. The terms "acute pain," "chronic pain," and "surgical procedure" are defined. Dispensers are not required to verify that a practitioner falls within one of the exceptions from the requirement that all targeted controlled substances be e-prescribed and dispensers may continue to dispense targeted controlled substances from valid written, oral, or facsimile prescriptions that are otherwise consistent with applicable laws. Dispensers are further immune from civil or criminal liability or disciplinary action from the Board of Pharmacy for dispensing a prescription written by a prescriber in violation of G.S. 90-106.
Dispensers are required to report certain information on prescriptions they fill within 3 days after the prescription is delivered, but are encouraged to report such information within 24 hours, to the Controlled Substances Reporting System(SRS).The bill also requires dispensers to report required information by the close of the next business day after filling a prescription unless the system is temporarily not operational and the inability to report is documented in the dispenser's records. The Department of Health and Human Services would be required to assess civil penalties of up to $100 for a first violation, up to $250 for a second violation, and up to $500 for each subsequent violation, not to exceed $5,000 per pharmacy in a calendar year to pharmacies found to have failed to report required information within a reasonable period of time after being informed that such information is missing or incomplete; however pharmacies who, in good faith, attempt to report, will not be assessed a civil penalty.
H243 also allows the Department to notify practitioners and their respective licensing boards of prescribing behavior that increases risk of diversion of controlled substances, increases risk of harm to the patient, or is an outlier among other practitioner behavior.It also requires recipients of new or renewed pharmacist licenses to demonstrate to the NC Board of Pharmacy registration for access to the CSRS within 30 days of licensure.
Practitioners will now be required to review a patient's 12-month history in the CSRS prior to prescribing "targeted controlled substance" and review the patient's 12-month history in the CSRS every three months while the targeted controlled substance remains part of the patient's medical care plan. These reviews would have to be documented in the patient's medical records, along with the occasion of any CSRS outage that prevents such a review; the practitioner would be required to review the 12-month history upon restoration of the CSRS after an outage. In addition, a practitioner would be able to, but not required to, review a patient's CSRS history if: (1) the controlled substance is to be administered to the patient in a health care setting, hospital, nursing home, outpatient dialysis facility, or residential care facility; (2) the controlled substance is for the treatment of cancer or a cancer-associated condition; or (3) the controlled substance is prescribed to a patient in hospice or palliative care. H243 also requires a dispenser to review an individual's 12-month history in the CSRS prior to dispensing a targeted controlled substance whenever: 1) the dispenser believes the individual is seeking controlled substances for reasons other than treatment of a medical condition; 2) the prescriber is located outside of the usual area the dispenser serves; 3) the individual lives outside the usual area the dispenser serves; 4) the individual pays with cash when there is an insurance plan on file with the dispenser; or 5) the individual demonstrates potential misuse of a controlled substance. A dispenser would be required to withhold delivery of a prescription until verified if the dispenser believes it to be duplicative or fraudulent. Dispensers would be immune from civil or criminal liability for actions authorized by this section and failure to review the system prior to dispensing a controlled substance would not constitute medical negligence.
House Bill 466, the Pharmacy Patient Fair Practice Act, passed the House and Senate with little opposition and has been sent to the Governor for his signature. The bill permits pharmacists to discuss lower-cost alternative drugs with, and sell lower-cost alternative drugs to, consumers. It would prohibit pharmacy benefits managers from using contract terms to prevent pharmacies from providing store direct delivery services. Pharmacy benefits managers would be prohibited from charging insureds a co-pay that exceeds the total submitted charges by a network pharmacy. It would allow pharmacy benefits managers to charge pharmacies a fee for costs related to claim adjudication only if the fee was set out in a contract or reported on the remittance advice of the claim. Under current law Pharmacy benefits managers are entities who contract with pharmacies on behalf of insurers to administer prescription drug benefits. Currently, they are regulated in their placement of drugs on the maximum allowable cost price list by Article 56A of Chapter 58, but they are not subject to additional regulation. House Bill 466 would the law by adding additional requirements for pharmacy benefits managers. It would require pharmacy benefits managers to permit pharmacists to discuss an insured's cost share for a drug, disseminate information about lower-priced alternative drugs, and sell a lower-priced alternative drugs without penalty. Pharmacy benefits managers would be prohibited from using contractual terms to prevent pharmacies from providing store direct delivery services, from charging insured’s co-payments that exceed the total charges submitted by a network pharmacy, and from charging fees or otherwise holding pharmacies responsible for the costs of adjudicating a claim, unless the fee was set out in contract or reported on the remittance advice of the adjudicated claim.
Senate Bill 104 also passed the House and Senate with little opposition and is awaiting the Governor’s signature. It would make a number of technical changes to G.S. 90-85.15, which governs applications and requirements for licensure as a pharmacist, and mandate that the Board of Pharmacy require applicants for a pharmacy license to provide the Board with a criminal history report, at the applicant's expense, from a reporting service designated by the Board.
Current lawallows the Department of Public Safety (DPS) to provide a criminal record check to the Board of Pharmacy for applicants for a pharmacy license. Currently, the Board is not required to request a background check, but if it does, it must submit a request that includes the fingerprints of the applicant and any additional information required by DPS. DPS then must send the applicant's fingerprints to the State and Federal Bureaus of Investigation for criminal history checks. The Board must keep any information pursuant to this law privileged and confidential, in accordance with applicable State law and the Board may charge each applicant a fee for conducting the criminal history check.
Senate Bill 104 would make a number of technical changes to G.S. 90-85.15 and mandate that the Board of Pharmacy require applicants for a pharmacy license to provide the Board with a criminal record report from a reporting system that would be designated by the Board. Information from these reports would remain privileged and confidential in accordance with State law and federal guideline
INCREASE IN PERSONAL CARE SERVICES RATE: Directs that beginning January 1, 2018, the Department of Health and Human Services, Division of Medical Assistance, shall increase to $3.90 the rate paid per 15-minute billing unit for personal care services provided pursuant to Clinical Coverage Policy 3L and for in-home aide, respite care in-home aide, and personal care assistance services provided under the Community Alternatives Program for Children (CAP-C) waiver pursuant to Clinical Coverage Policy 3K-1. This equates to an hourly rate of $15.60.
RETROACTIVE PERSONAL CARE SERVICES PAYMENT: Directs the Department of Health and Human Services, Division of Medical Assistance, to amend Section 5.5, Retroactive Prior Approval for PCS, of Clinical Coverage Policy 3L, State Plan Personal Care Services (PCS), to extend the allowable retroactive period for prior approvals for personal care services from 10 days to 30 days upon the same conditions that are currently required for retroactive prior approval of personal care services.
Regarding our effort to introduce a collaborative pharmacy practice agreement bill, we were unable to secure introduction of proposed legislation in the 2017 session of the General Assembly due to the opposition of key members of the House and the NC Medical Society and the NC Family Physicians. Since the deadline for introducing a bill this session occurred we have been making significant progress on securing legislative support for our proposal, with several powerful members of both the House and Senate agreeing to work with us on introducing legislation in the 2018 short session. In the interim we will be organizing a grassroots campaign to have our members and other supportive providers contact their local representatives and arrange in-district meetings to garner support for our efforts.
We have been following two other bills that during this year’s session of the General Assembly had a negative impact on our efforts to gain support for our collaborative practice proposal. One, H88, and its companion bill, S73, the Modernize Nursing Practice Act, seeks to expand the scope of practice for Advanced Practice Registered Nurses. Neither bill passed during the 2017 session due to vigorous opposition from the NC Medical Society and other physician groups. The bills are technically still alive for the 2018 short session since they have a financial component in them.
The other bill, S342, Enact Enhanced Access to Eye Care Act, seeks to amend the scope of practice of optometry. S342 was strongly opposed by ophthalmologists throughout the state and the bill was assigned to the Senate Rules Committee, with no action taken on the bill. This was despite the fact that the NC Optometric Society contracted with 15 lobbyists, including some of the most influential ones in the state.