NCAP Legislative Summary -- 2013 A Look at the Bumpy Ride that Was the NC Legislative Session of 13 The 2013 Session of the North Carolina General Assembly was historic. It was the first time since 1868 that a Republican Governor worked with a Legislature also run by Republicans. Back in 1868, the Republicans presided over the volatile time of Post-Civil War Reconstruction. This time, the Republican Majority with veto-proof margins in both chambers -- also presided over a time of volatility, but one that was attributable to a slow recovery from economic recession and the usual disagreements between opposing political parties. But other reasons behind the Session s volatility included the political differences between factions within their own party and the politicians own ambitions. During the Session, House Speaker Thom Tillis (R-Mecklenburg) announced that he would be a candidate for the U.S. Senate seat occupied by Kay Hagan (D-Guilford). Rumors circulated for months that Senate Leader Phil Berger (R-Rockingham) would also be a candidate. The consequences of all of this were major changes in Medicaid, tax and other policies that were driven through both bodies as a political juggernaut quashed debate and ignored opposing ideas. In all, 1751 bills and resolutions were introduced by lawmakers during the 2013 Session 1,024 in the House and 727 bills in the Senate. Of those, 418 are now recorded as Session laws. Lawmakers overrode both of Gov. McCrory s vetoes September 3 and 4. Pharmacy Achievements Significant in Volatile Environment Health care was central to budget debate at the General Assembly and in statements made by Governor Pat McCrory. Time and again, Gov. McCrory blamed Medicaid costs as the reason for the lack of state employees and teachers pay raises. At the same time, the General Assembly left federal money on the table when it turned away from federal resources to comply with and to build infrastructure triggered by the Affordable Care Act (ACA see S4). All the while, the Department of Health and Human Resources continually addressed a myriad of Medicaid crises, cost overruns and staffing snares. Despite all of these complications, pharmacy merited a landmark achievement. After four years of hard work, major public health legislation enabling properly qualified pharmacists to administer CDC recommended vaccines to adults was signed into law (See H832). This huge win for pharmacy will only help to build its bright future among health care providers and with consumers, who will benefit from improved access to this critical public health service. Positioning Pharmacy for Inevitable Change The best advocacy happens one-on-one with elected officials. The interim between the long session and the short session that begins in May, 2014 is a key time for lawmakers to meet with constituents and with health care providers in communities across North Carolina. NCAP members can take part in the most effective advocacy efforts during the interim between legislative sessions right now! Support NCAP s efforts on your behalf by hosting visits for your elected officials at your pharmacies. Reach out to your elected officials/candidates for office by offering fall flu shots. NCAP can help to arrange such visits. Not only will the elected officials appreciate the visits your customers will, too! For more information about participating in advocacy efforts, please contact Evelyn Hawthorne, NCAP s Government Relations Consultant. Thank you for all that you do to support NCAP.
Budget Bills SB402, APPROPRIATIONS ACT OF 2013 Links: Bill Text Money Report An Act to Make Base Budget Appropriations for Current Operations of State Departments, Institutions, and Agencies, and for Other Purposes. 07/26/2013 G Presented to the Governor 07/26/2013. 07/26/2013 G Signed by the Governor 7/26/2013. 07/26/2013 R Chaptered Session Law 2013-360. HB112, MODIFICATIONS/2013 APPROPRIATIONS ACT http://ncleg.net/sessions/2013/bills/house/pdf/h112v4.pdf An Act to Make Technical, Clarifying, and Other Modifications to the Current Operations and Capital Improvements Appropriations Act of 2013 and to Related Legislation. 07/29/2013 G Signed by the Governor 7/29/2013. 07/29/2013 R Chaptered Session Law 2013-363. The drug reimbursement provisions were spelled out in S402, but were rewritten in H 112, as is indicated below. These rates take effect January 1, 2014. H112 also clarifies that state services, co-pays, reimbursement rates, and fees for the Medicaid and NC Health Choice will remain as authorized as of June 30, 2013, unless otherwise indicated. In addition, S402 sets out a shared savings plan to begin January, 2014. The shared savings plan is currently under development and will require a State Plan Amendment to be filed with and approved by the Centers for 2
Medicare and Medicaid Services (CMS). The state budget estimates savings through the shared savings of $27 million in FY13-14 and almost $45 million in FY 14-15. The intent of the shared savings plan is to redistribute those funds based upon efficiencies and positive outcomes, but how that aim is achieved is left to DMA/DHHS and remains to be seen. Furthermore, H112 provides an exemption to the prior authorization requirements on medications prescribed to Medicaid and Health Choice recipients for the treatment of mental illness. It also directs DHHS not to require prior authorization for medications on the Preferred Drug List (PDL) that are prescribed for the treatment of mental illness. Other provisions in S402 include the following: A directive to use funds withheld from Community Care of North Carolina (CCNC) to develop a program for Medicaid and Health Choice recipients based upon ChecKmeds NC. The aim is to have 50 participating community pharmacies by June 30, 2015 and 500 community pharmacies by June 30, 2016. The program shall include a PMPM for care coordination and a pay for performance payment. A directive to DHHS to work with CCNC to ensure better pharmacy management and compliance. They are also to identify Medicaid recipients who are frequent pharmacy services users to better manage those cases. $100,000 to study CCNC to see if that model saves money and improves health outcomes. An $8 million recurring cut in the AIDS Drug Assistance Program. The explanation is that this amount better reflects spending. An increase of $1.7 million in recurring funds for the Medication Assistance Program for low-income persons. A grant award of $400,000 to NC MedAssist to expand capacity of the statewide pharmacy program that serves uninsured and low-income persons. Medicaid Policy SB4, NO N.C. EXCHANGE/NO MEDICAID EXPANSION http://ncleg.net/sessions/2013/bills/senate/pdf/s4v5.pdf An Act (1) to Clarify the State's Intent not to Operate a State-Run or "Partnership" Health Benefit Exchange, (2) to Provide that Future Medicaid Eligibility Determinations will be Made by the State Rather Than the Federally Facilitated Exchange, and (3) to Reject the Affordable Care Act's Optional Medicaid Expansion. 03/06/2013 G Signed by the Governor 3/6/2013. 03/06/2013 R Chaptered Session Law 2013-5. Adapted from UNC School of Government Public Health Summary, by Jill Moore The provisions limit North Carolina s participation in implementing the federal Affordable Care Act (ACA) in two ways: by declining to expand Medicaid eligibility to adults who are ineligible under categorical Medicaid programs, and by directing state agencies and institutions not to participate in the implementation of a health benefits exchange in North Carolina. The law became effective March 6, 2013. Medicaid. The ACA included an expansion of Medicaid, the health insurance program for low-income individuals. Medicaid is a voluntary program, but states receive large amounts of federal funding to support it and no state 3
declines to participate in it. At present Medicaid coverage extends only to people who fit into particular categories, such as pregnant women, families with children, or individuals with disabilities. The expansion authorized by the ACA would make individuals with incomes up to 138% of the federal poverty level eligible for Medicaid regardless of whether they fit within a category. This legislation states that North Carolina will not expand Medicaid under the ACA, consistent with National Federation of Independent Business v. Sebelius, 132 S.Ct. 2566(2012), which made Medicaid expansion optional for states. Further, no state agency, department, or institution may attempt to expand the Medicaid eligibility standards provided in the 2011 Appropriations Act (S.L. 2011-145) and other state laws unless directed to do so by the General Assembly. Health Benefits Exchange. The ACA calls for states to set up health benefits exchanges for individuals who are not insured through other means, such as employer-provided insurance. If a state does not set up a health benefits exchange, the federal government will provide an exchange for the state s residents. S.L. 2013-5 prohibits state agencies and institutions from taking actions toward forming a state-run health benefits exchange and from entering any contracts or committing any resources for the provision of services related to the federal exchange under a federal-state partnership model, without the express authorization of the General Assembly. It reserves to the General Assembly the authority to define the level of state interaction, if any, with the federal exchange that will operate within North Carolina. It directs the Departments of Insurance and Health and Human Services to cease all expenditures under federal grants designed to support the exchange, but to draw down funds to reimburse expenses already incurred to the extent possible. NC FAST. NC FAST (North Carolina Families Accessing Services through Technology) is an information technology system that is used to determine eligibility for a number of public assistance programs, including Medicaid. Section 2 of S.L. 2013-5 directs the Department of Health and Human Services to ensure that NC FAST can and will be used to provide Medicaid eligibility determinations for the federally operated health benefits exchange in North Carolina. It further directs the Department to seek federal funding at the 90/10 match rate to fund the eligibility determinations, if funds for the state s share are available from existing appropriations for NC FAST and the total amount of the state match does not exceed $5 million. SB137, PROHIBIT CO-PAY WAIVER/MEDICAID PROVIDERS http://ncleg.net/sessions/2013/bills/senate/pdf/s137v5.pdf An Act to Prohibit the Regular Business Practice of Waiving Required Medicaid and Health Choice Recipient Co-Payments by Certain Providers. 06/19/2013 G Signed by the Governor 6/19/2013. 06/19/2013 R Chaptered Session Law 2013-145. The provisions direct that health care providers cannot waive the collection of co-payments owed by Medicaid or Health Choice recipients with the intent to induce recipients to purchase, lease, or order items or services from the provider. A violation of this provision will result in a suspension or termination of the provider's participation in Medicaid and Health Choice. Providers waiving co-payments will have violated this provision unless they do so for the following reasons. The waiver is authorized. 4
The provider decides on an individual basis that the collection of the co-payment amount would place a substantial financial hardship on the recipient. The provider has made a good faith effort to collect the co-payment but the reasonable efforts fail. The provider is a health care facility regulated pursuant to GS Chapter 131E or GS Chapter 122C or is owned or operated by the State. The provisions are effective October 1, 2013, applying to acts committed on or after that date. Pharmacy Practice HB675, AMEND PHARMACY LAWS http://ncleg.net/sessions/2013/bills/house/pdf/h675v6.pdf An Act Amending Laws Pertaining to the Regulation of Pharmacy Technicians, Pharmacy Audits, and Prescriptions for Schedule Ii Substances. 07/29/2013 G Signed by the Governor 7/29/2013. 07/29/2013 R Chaptered Session Law 2013-379. The bill addresses a number of issues in the practice of pharmacy. Pharmacy Technician Changes The bill adds a definition for certified pharmacy technician as a pharmacy technician who (1) has passed a nationally recognized pharmacy technician certification board examination, or its equivalent, that has been approved by the North Carolina Board of Pharmacy (NCBOP) and (2) maintains certification from a nationally recognized pharmacy technician certification board that has been approved by the NCBOP. It also provides that the registration program for pharmacy technicians identifies people who are employed or eligible for employment as pharmacy technicians. The bill amends the requirements for the registration of noncertified pharmacy technicians to require the NCBOP to register noncertified pharmacy technicians who (1) pay the required fee, (2) are employed by a pharmacy holding a valid permit under Article 4A of GS Chapter 90, and (3) complete a required training program provided by the supervising pharmacist-manager. The provisions direct the NCBOP to register (or renew registration for) a certified pharmacy technician who (1) pays the required fee and (2) provides proof of current certification. The pharmacist-manager s responsibilities to noncertified pharmacy technicians are also addressed. The provisions require the pharmacist-manager to notify the NCBOP within 21 days of the date that the pharmacy technician began employment. The bill also identifies the responsibilities of a pharmacist manager to certified pharmacy technicians. The bill provides that a pharmacist-manager may hire a certified pharmacy technician who has registered with the NCBOP and requires the certified pharmacy technician to notify the NC Board within 10 days of beginning employment as a pharmacy technician. The provisions require the NCBOP to allow a pharmacist to supervise more than two pharmacy technicians only if the additional pharmacy technicians are certified pharmacy technicians. The bill adds these items to the list of violations which may result in disciplinary action by the NCBOP against a pharmacy technician: (1) negligence in assisting a pharmacist in preparing and dispensing prescription medications, and (2) failing (was, willfully violated) to comply with the laws and rules governing pharmacy technicians. 5
Audits The provisions prohibit entities auditing pharmacies from recouping any dispute funds, charges, or other penalties form a pharmacy until the deadline for initiating the appeals process has passed, or after the final internal disposition of an audit, whichever is later, unless fraud or misrepresentation is reasonably suspected. It further provides that the amount of the recoupment does not include any portion of the prescription product cost, except in cases of fraud or misrepresentation. Also, a pharmacy subject to an audit by any responsible party may have that recoupment of claim based on the actual financial harm to the entity or actual overpayment or underpayment. The provisions allow recoupment of reimbursement when dispensing in excess of the benefit design, prescriptions are not filled according to the prescriber's order, and when the pharmacy makes an overpayment. The calculations of overpayment can include dispensing fees when fraud or intentional and willful misrepresentation by the pharmacy is present. Procedures for calculating overpayments are set out. The auditing entity may have access to a previous audit report only if the auditing entity prepared it. Audit vendors or subcontractors are required to identify the responsible party on whose behalf the audit is being conducted. The provisions stipulate that a pharmacy has a right to use any prescription that complies with federal or state laws and regulations at the time of dispensing to validate a claim in connection with a prescription, prescription refill, or a change in a prescription Other The provisions also prohibit dispensing a Schedule II substance more than six months after the date it was prescribed. Effective October 1, 2013. HB832, EXPAND PHARMACISTS' IMMUNIZING AUTHORITY http://ncleg.net/sessions/2013/bills/house/pdf/h832v6.pdf An Act to Protect the Public's Health by Increasing Access to Immunizations and Vaccines Through the Expanded Role of Immunizing Pharmacists. 07/03/2013 G Signed by the Governor 7/3/2013. 07/03/2013 R Chaptered Session Law 2013-246. The bill provides that pharmacists who meet the qualifications and requirements to administer any CDC required vaccine by prescription. It also allows them to administer five key vaccines in addition to influenza -- by protocol to individuals age 18 and older. Those vaccines are pneumococcal and zoster, which are currently allowed by prescription only, Hepatitis B, meningococcal and Tdap. Flu would continue under protocol for persons 14 years of age and older. The bill also includes a provision for pharmacists to have access to the state immunization registry. The NC Immunization Branch is phasing-in participating pharmacies this fall, beginning in the western part of North Carolina. NCAP participated in a work group to address screening and safety procedures required by the bill. Others participating in the group, in addition to NCAP and NCRMA are the Association of Community Pharmacists, the NC Medical Society, the NC Academy of Family Physicians and the NC Pediatric Society. The provisions become effective October 1, 2013. NCAP supported this bill and advanced legislation at the General Assembly on which this bill was based in 2010, 2011 and 2012. This year s effort was spearheaded by the NC Retail Merchants Association and NCAP is grateful 6
for their partnership. Additionally, NC Board of Pharmacy Chairman Gene Minton, RPh, was instrumental in garnering the legislative support and in coaxing others in the healthcare community to work with pharmacy for passage of this public health initiative. SB20, GOOD SAMARITAN LAW/NALOXONE ACCESS http://ncleg.net/sessions/2013/bills/senate/pdf/s20v7.pdf An Act to Provide Limited Immunity from Prosecution for (1) Certain Drug-Related Offenses Committed by an Individual Who Seeks Medical Assistance for a Person Experiencing a Drug-Related Overdose and (2) Certain Drug-Related Offenses Committed by an Individual Experiencing a Drug-Related Overdose and in Need of Medical Assistance; to Provide Immunity from Civil or Criminal Liability for (1) Practitioners Who Prescribe an Opioid Antagonist to Certain Third Parties and (2) Certain Individuals Who Administer an Opioid Antagonist to a Person Experiencing a Drug-Related Overdose; and to Provide Limited Immunity from Prosecution for Certain Alcohol-Related Offenses Committed by Persons Under the Age of 21 Who Seek Medical Assistance for Another Person. 04/09/2013 G Signed by the Governor 4/9/2013. 04/09/2013 R Chaptered Session Law 2013-23. The bill provides that a person who seeks medical assistance for someone experiencing a drug-related overdose and who did not physically supply the drugs to the person experiencing the drug-related overdose will not be prosecuted for the listed violations if the evidence for prosecution was obtained due to seeking medical assistance. It also prohibits prosecution of a person experiencing an overdose who needs medical assistance, as specified. The bill enacts a new GS 90-106.2 to provide immunity to practitioners who prescribe or distribute an opioid antagonist, as defined, to certain persons, and to recipients who administer the opioid antagonist to another. The bill provides limited immunity for the prosecution of possession or consumption of alcoholic beverages for people under the age of 21 when the person was seeking medical assistance for another individual and that act was the sole reason law enforcement became aware of the violation. Immunity applies when the person acted in good faith, used his or her own name when contacting authorities, and remained with the individual needing medical assistance. Applies to offenses committed on or after April 9, 2013. SB83, ENCOURAGE VOLUNTEER CARE IN FREE CLINICS http://ncleg.net/sessions/2013/bills/senate/pdf/s83v5.pdf An Act to Encourage Volunteer Health Care in Free Clinics by Limiting the Liability of Medical and Health Care Providers If the Free Clinic Provides Patients with Notice of Limited Liability. 05/13/2013 G Signed by the Governor 5/13/2013. 05/13/2013 R Chaptered Session Law 2013-49. The bill aims to encourage volunteers to work in free clinics by limiting liability of health care providers when the free clinic provides patients with notice of the limited liability. The bill also provides such liability protections to nonprofit community health referral service that refers low-income patients to medical or health care for free services if the referral service maintains liability insurance covering the acts and omissions of the referral service 7
and any liability. The provisions are effective October 1, 2013, and apply to claims that arise on or after that date. HB247, FREEDOM TO NEGOTIATE HEALTH CARE RATES http://ncleg.net/sessions/2013/bills/house/pdf/h247v4.pdf An Act to Allow Health Providers and Health Insurers to Freely Negotiate Reimbursement Rates by Prohibiting Contract Provisions that Restrict Rate Negotiations. 05/08/2013 G Signed by the Governor 5/8/2013. 05/08/2013 R Chaptered Session Law 2013-46. As the title indicates, the bill aims to allow health care providers and insurers to freely negotiate payment rates by disallowing contract provisions that restrict rate negotiations. The bill has a provision to clarify that the act should not affect any pending litigation. The provisions take effect October 1, 2013. Drugs and Crime HB29, METHAMPHETAMINE/OFFENSE/PENALTIES http://ncleg.net/sessions/2013/bills/house/pdf/h29v3.pdf An Act to Create the Offense of Possession of Pseudoephedrine If the Defendant Has a Prior Conviction for the Possession or Manufacture of Methamphetamine, and to Aggravate the Penalty for Manufacturing Methamphetamine When Children, Disabled, or Elderly are Present, as Recommended by the House Select Committee on Methamphetamine Abuse. 06/19/2013 G Signed by the Governor 6/19/2013. 06/19/2013 R Chaptered Session Law 2013-124. The bill creates the offense of possession of a pseudoephedrine product by a person previously convicted of the possession or manufacture of methamphetamine. It also provides for an enhanced sentence (an increase of 24 to 48 months added to the minimum term to which the offender is sentenced, depending on the circumstance) if a person is convicted of manufacturing methamphetamine under and children, the disabled or the elderly are present at the manufacturing location and provides that the penalties are cumulative. The provisions become effective December 1, 2013 and apply to offenses committed on or after that date. SB222, REVISE CONTROLLED SUBSTANCES REPORTING http://ncleg.net/sessions/2013/bills/senate/pdf/s222v4.pdf An Act to Revise the North Carolina Controlled Substances Reporting System Act, as Recommended by the Child Fatality Task Force. 06/19/2013 G Signed by the Governor 6/19/2013. 06/19/2013 R Chaptered Session Law 2013-152. This bill makes a number of changes to the Controlled Substances Reporting System to better track abuse of controlled substances. The parts of the bill that affect pharmacists are the changes in reporting times to the controlled substances database. The provisions direct dispensers to report no later than the close of business three days after the prescription s delivery, beginning the next day; however, dispensers are encouraged to report the information no later than 24 hours after the prescription was delivered. The bill adds method of 8
payment, specialty of practitioner, and documentation of photographic identification presented by the person seeking the prescription if required, to the list of information required to be reported. Controlled substances that are directly dispensed and those who dispense a 48 hour supply of controlled substances are excluded from the reporting requirements. Health care entities, as defined in the law, who transmit the data, are provided with civil or criminal liability as a result of transmitting the data. The bill expands the list of persons to whom the Department of Health and Human Services (DHHS) may release data from the controlled substances reporting system to include a sheriff or a police chief or their designees who are Assigned to investigate the diversion and illegal use of prescription medication or pharmaceutical products identified in Article 5 of GS Chapter 90 as schedule II through V controlled substances Engaged in a bona fide specific investigation related to the enforcement of laws governing licit drugs under a lawful court order. The Attorney General s Office is directed to review any findings reported by DHHS to determine if those should be reported to the SBI and the appropriate sheriff for investigation of possible violations of state or federal law regarding controlled substances. The bill also specifies that data from the controlled substances reporting system released by DHHS to SBI special agents may be shared with other SBI agents in Diversion & Environmental Crimes Unit, and other agents engaged in a bona fide specific investigation related to the enforcement of laws governing licit drugs. The provisions amend statutes addressing confidentiality by making technical and clarifying changes. It also provides that information can be reported regarding the prescribing practice of a practitioner pursuant to rules adopted in subsection (b2). The bill amends GS 90-113.74(b2) to establish that in order to receive a report pursuant to subdivision (2) of subsection (b1) of this section, an agency responsible for licensing, registering, or certifying a practitioner with prescriptive or dispensing authority must adopt rules establishing the criteria by which the Department may report the information to the agency. Civil fines and penalties are raised and DHHS is given broader authority to review prescribing patterns and data. The changes to reporting by dispensers become effective January 1, 2014 for prescriptions delivered on or after that date. The rest of the provisions became law June 19, 2013. SB252, INCREASE PENALTY/CONTROLLED SUBSTANCE CRIMES http://ncleg.net/sessions/2013/bills/senate/pdf/s252v4.pdf An Act to Increase the Criminal Penalty for Certain Violations of the Controlled Substances Act. 06/12/2013 G Signed by the Governor 6/12/2013. 06/12/2013 R Chaptered Session Law 2013-90. The provisions raise the penalties for certain violations of the Controlled Substances Act under GS 90-108 to a Class G felony. The provision limits, however, the statutory violations that are punishable as a Class G felony to violations of (a)(14), which makes it unlawful for an employee of a registrant or practitioner who is authorized to possess controlled substances or has access to controlled substances by virtue of his employment to embezzle or fraudulently or knowingly and willfully misapply or divert to his own use or other unauthorized or illegal use 9
or to take, make away with, or secrete, with intent to embezzle or fraudulently or knowingly and willfully misapply or divert to his own use or other unauthorized or illegal use, any controlled substance which shall have come into his possession or under his care. The provisions are effective December 1, 2013, and apply to offenses committed on or after that date. SB368, COUNTY/SHERIFF FEE CHANGES/FELONY ESCAPE http://ncleg.net/sessions/2013/bills/senate/pdf/s368v7.pdf An Act to Provide for a Ten-Dollar Co-Pay for Prescription Medication Dispensed in a County Jail, to Provide the Pistol Permit Fee to be an Application Fee, and to Make It a Felony to Escape from a County Facility When Charged with and Being Held for a Felony. 08/23/2013 G Signed by the Governor 8/23/2013. 08/23/2013 R Chaptered Session Law 2013-389. The bill provides that each governmental unit operating a local confinement facility establish a fee of no more than $10 for a 30 day supply or less of a prescription drug. The dispensing fee provision became effective August 1, 2013. 10