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From the NCAP Office
ADAMS AND ASSOCIATES GOVERNMENT RELATIONS
1706 Rangecrest Road Raleigh, NC 27612 (919) 841-0964 (919) 801-1837 Cell ta@adamsgov-relations.com
Legislative Report 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 signed by Governor Cooper. The bill permits pharmacists to discuss lower-cost alternative drugs with, and sell lower-cost alternative drugs to, consumers. It prohibits pharmacy benefits managers from using contract terms to prevent pharmacies from providing store direct delivery services. Pharmacy benefits managers will be prohibited from charging insureds a co-pay that exceeds the total submitted charges by a network pharmacy. It allows 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 will change the law by adding additional requirements for pharmacy benefits managers. It will 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 drug without penalty. Pharmacy benefits managers will 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 was signed by the the Governor. It would make a number of technical changes to G.S. 9085.15, 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 law allows 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 will make a number of technical changes to G.S. 9085.15 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 will be designated by the Board. Information from these reports will 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 Association. 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 indistrict meetings to garner support for our efforts.
We also followed two other bills during the 2017 session of the General Assembly which negatively impacted our efforts to gain support for our collaborative practice proposal. One, H88, and its companion bill, S73, the Modernize Nursing Practice Act, sought 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 these have a financial component.
The other bill, S342, Enact Enhanced Access to Eye Care Act, sought 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.
NCAP Partners with NCHA to “Pnockout Pneumonia”: Elevating the Importance of the Pharmacist in this Public Health Initiative
Ralph H. Raasch, Editor, North Carolina Pharmacist
At the end of this column, the announcement publication of the North Carolina Hospital Association’s (NCHA) 2017 Quality Goal to reduce pneumonia mortality and readmission rates in North Carolina is presented. First, the following narrative is background information that would be of interest to the readership. North Carolina Pharmacist and NCAPintend to provide quarterly updates on the Pnockout Pneumonia Campaign over at least the next two years, and to provide support from the North Carolina Pharmacy Community to this campaign.
The Data 1. During Second Quarter 2016, the latest period for which stateby-state data are available, North Carolina ranked 49th highest (worst!) out of 50 states in 30day mortality rate. The mortality rate was 17.6%. The 30-day readmission rate for the same period ranked North Carolina as 28 out of 50 states.
2. As would be expected because of population differences, mortality by county (number of deaths) varied widely over 2016. The fewest deaths (75) occurred in Washington County, while 2849 people died of pneumonia in Wake County. Mortality rates were also quite variable on a county-by-county basis. 3. Recent pneumococcal vaccination rates for adults aged > 65 years were recently reported by the CDC and published in MMWR on July 14, 2017. Go to: https://www.cdc.gov/mmwr/ volumes/66/wr/mm6627a4. htm?s_cid=mm6627a4_e Current CDC recommendations are to vaccinate adults aged > 65 years with both pneumococcal conjugate (PCV13) and polysaccharide (PPSV23) vaccines in series. Note the table provided in the citation above, and the data from North Carolina. An assessment of claims submitted for Medicare beneficiaries revealed that only 23.3 percent of these eligible adults received both vaccines between mid-September 2015 and mid-September 2016. Clearly, these vaccination rates in North Carolina (and in all states) can be significantly improved. Pharmacists can improve these vaccination rates.
The Goals as Approved by the NCHA Board of Trustees, March 2017. 1. Over 2 years, reduce the annual mortality rate from the 2016 baseline by 7.5%. Such a reduction would equal the national average for pneumonia mortality of 16.3%.
2. Over 2 years, reduce pneumonia readmissions by 5.4%, which would result in the inclusion of North Carolina Hospitals in the top 25% quartile of hospitals nationally.
The Impact of these Goals on an Annual Basis 1. 1000 North Carolina Lives Saved. 2. 950 Readmissions Prevented. 3. $ 8,835,000 Saved.
nockout neumona P
Pneumonia Pnockout Campaign
In March 2017, the NCHA Board of Trustees approved a two-year Quality Goal to reduce pneumonia (PNE) mortality and readmission rates to put North Carolina at and below the national average. Specifically, the goal is to:
• Reduce the PNE mortality rate by 7.5% to the national average over 2 years • Reduce PNE readmissions by 5.4% over 2 years to target top 25% quartile
CAMPAIGN PARTICIPATION
Participating hospitals and health systems will be asked to identify one to two opportunities to improve based on their internal performance on the identified measures. Community partners and post-acute care providers will be invited to participate with hospitals and health systems. Each organization will commit to lead its improvement efforts. NCHA Quality Center staff, with guidance from an Advisory Council, will provide participating teams with technical support, education and best practice learning/sharing. NCHA will provide data to member organizations to support this work and will coordinate a public education campaign, including media and collateral materials.
OPPORTUNITIES
• Participate as an NCHA member organization or partner in the Quality Goal. • Provide education, information as part of the learning collaborative. • Support public education/outreach efforts outside the hospital setting. • Commit to funding/underwriting toward the campaign.
TIMELINE
May/June: NCHA Quality Center staff introduces goal to member hospitals and health systems and prospective partner organizations July: Kickoff at NCHA Summer Membership Meeting (July 19-21) Aug-Sept: Enrollment continues Oct: Learning and Action Network/Public campaign begins Nov: World Pneumonia Day is November 12 CONTACT: For more information, contact Karen Southard, interim executive director of the NCHA Quality Center, at 919-677-4121 or ksouthard@ncha.org or Trish Vandersea, program manager for NC ACT, at 919677-4115 or tvandersea@ncha.org.
PNEUMONIA FACTS
• North Carolina is ranked 49 of 50 states for its pneumonia mortality rate, with 73% of hospitals below the CMS national benchmark. • More than half of all N.C. hospitals are above the national benchmark for 30-day pneumonia readmission rates. • Pneumonia is most often acquired in the community, outside of the hospital setting. • CDC recommends pneumococcal vaccination for all adults 65 years or older. According to 2015 data from the Behavioral Risk Factor
Surveillance System, 73.6% of North