House committee substitute to the 3rd edition makes the following changes.
Changes the date by which the Department of Health and Human Services must review and revise its current Freestanding Birth Center Fee Schedule from October 1, 2019, to December 1, 2019.
Amends the proposed changes to the definition of the term health benefit plan in Article 56A, Pharmacy Management Benefits, of GS Chapter 58. Previously, the term was defined by statutory cross-reference to GS 58-3-167, which defines health benefit plan in the context of the applicability of acts of the General Assembly to health benefit plans. Instead, defines health benefit plan under Article 56A to mean an accident and health insurance policy or certificate; a nonprofit hospital or medical service corporation contract; a health maintenance organization subscriber contract; a plan provided by a multiple employer welfare arrangement; a plan provided by another benefit arrangement, to the extent permitted by the Employee Retirement Income Security Act of 1974, as amended, or by any waiver of or other exception to that act provided under federal law or regulation; or any plan implemented or administered by the State Health Plan for Teachers and State Employees (SHP). Excludes from the term any plan implemented or administered by the NC or US Department of Health and Human Services, or any successor agency, or its representatives, or any plan consisting of one or more of any combination of benefits described in GS 58-68-25(b) (similar to the term's definition set forth in GS 58-3-167, except the term is defined in GS 58-3-167 to exclude any plan implemented or administered by the SHP, which is included in the term's proposed definition in Article 56A, as amended).
Amends GS 58-56A-3 to require that when calculating an insured's contribution to an out-of-pocket maximum, deductible, copayment, coinsurance, or any other cost-sharing requirement, the insurer or PBM must include any cost-sharing amount paid by the insured or on the insured's behalf for a prescription drug that is (1) without an AB-rated generic equivalent or (2) with an AB-rated generic equivalent if the insured has obtained authorization for the drug through prior authorization from the insurer or PBM, a step therapy protocol, or the exception or appeal process of the insurer or PBM (was, when calculating an insured's overall contribution to any out-of-pocket maximum or any cost-sharing requirement under a health benefit plan, an insurer must include any amounts paid by the insured or paid on behalf of the insured by another person). Defines the term generic equivalent as a drug that has an identical amount of the same active ingredients in the same dosage form; meets applicable standards of strength, quality, and purity according to the specified compendium; and which, if administered in the same amount, would provide comparable therapeutic effects. Excludes from the definition a drug that is listed by the US Food and Drug Administration as having unresolved bioequivalence concerns according to the Administration's most recent publication of approved drug products with therapeutic equivalent evaluations.
Enacts new GS 58-3-222 prohibiting an insurer who offers coverage for prescription drugs from requiring any insured to take any drug with a boxed warning. Requires an insurer who offers coverage for prescription drugs and requires preauthorization as a condition to providing coverage for a drug to immediately provide coverage for the drug during the period of time it takes the insurer to conduct the preauthorization review. Specifies that this does not require an insurer to approve a drug undergoing a preauthorization review. Applies to insurance contracts issued, renewed, or amended on or after October 1, 2020.
Amends the act's long title.
Summary date: Oct 22 2019 - View summary
Summary date: Sep 11 2019 - View summary
House committee substitute to the 2nd edition makes the following changes.
Makes the following modifications to the proposed changes to Article 56A, Pharmacy Management Benefits, of GS Chapter 58.
Repeals GS 58-56A-10, concerning civil penalties for violations regarding pharmacy benefit manager regulations (previously, recodified and modified).
Makes changes to refer to a pharmacy benefits manager as a "PBM" throughout the Article.
Makes the following changes to GS 58-56A-2, concerning PBM licensure. Now prohibits any person from acting as, offering to act as, or holding him- or herself out as a PBM without a valid PBM license issued by the Commissioner of Insurance (Commissioner). Adds that licenses are renewable annually, and provides that failure to submit a complete renewal application will result in expiration. Allows the Commissioner to grant an extension for good cause. Requires each application for issuance or renewal to be made upon a form prescribed by the Commissioner and accompanied by a nonrefundable $2,000 application fee or $1,500 annual renewal fee, as appropriate (previously, directed the Commissioner to prescribe the application and authorized the Commissioner to charge the described fees). Modifies the application requirements, now requiring the application for issuance to include specified organizational documents; internal regulations; the names, addresses, official positions, and qualifications of identified individuals responsible for the conduct of affairs of the PBM; annual financial statements or reports; a general description of the business operations; a signed statement regarding PBM officers' past convictions or violations; and any other pertinent information required of the Commissioner (previously, only required the names and addresses of specified officers and agents, and the described signed statement regarding past convictions or violations, of all applicants). Adds a new provision requiring the application information be kept confidential. Authorizes the Commissioner to use the information in any judicial or administrative proceeding instituted against the PBM. Requires an application for renewal to include or be accompanied by any changes in the required application information. Adds new provisions to require applicants to make copies of all contracts with insurers or other persons using the services of the PBM available for inspection by the Commissioner, authorize the Commissioner to refuse license issuance if specified findings are made, and establishes a procedure for notification of refusal to issue a license and a procedure for review of the Commissioner's action. Now requires a PBM to notify the Commissioner of any material change in its ownership, control, or other fact or circumstance affecting its qualification for licensure in the State within 10 business days after the change takes effect (previously, required filing notice of any material change with no time period given). Authorizes the Commissioner to to adopt rules establishing additional licensing and reporting requirements consistent with the Article (was, consistent with the statute).
Further amends GS 58-56A-3, concerning consumer protections, to require disclosure of all incentives, discounts, and rebates received by the PBM and the entities who benefit from the incentives, discounts, and rebates, including amounts received by the PBM, whether in the form of money, reduction in costs, or any other benefit to the PBM.
Further amends GS 58-56A-4, concerning pharmacy and pharmacist protections, to explicitly forbid a PBM from prohibiting or in any way restricting a pharmacy or pharmacist from dispensing any prescription drug allowed to be dispensed under a license to practice pharmacy (previously, did not specifically prohibit a PBH from restricting the dispensing). No longer includes a clarification regarding pharmacists' right to refuse to fill or refill a prescription. Adds a new prohibition to forbid a PBM from coercing, steering, or enticing an insurance provider or an insured to other entities that operate under the umbrella of the PBM.
Makes technical and conforming changes to GS 58-56A-5 to refer to the maximum allowable cost list.
Amends proposed GS 58-56A-20, concerning PBM networks, to additionally prohibit a PBM from denying a pharmacy wholesaler or pharmacy services administration organization the right to participate in a network on the same terms and conditions as other participants in the network (previously, only specifically prohibited denial of properly licensed pharmacists or pharmacies). Regarding a PBM's obligation for payment of services rendered after termination of a pharmacy or pharmacist from a PBM network, excludes cases of fraud, waste, or abuse from the obligation (was, cases of fraud, waste, and abuse).
Makes technical changes to proposed GS 58-56A-25 to refer to the Health Insurance Portability and Accountability Act of 1996 (rather than just HIPAA).
Amends proposed GS 58-56A-35, regarding enforcement, to authorize the Commissioner to contract with consultants and other professionals with relevant experience as necessary and appropriate to conduct an examination or audit of a PBM (previously, authorized to retain certain professionals and specialists as examiners). Adds that the Commissioner must institute a civil action to recover the expenses of an examination against a PBM that refuses or fails to pay the expense of retaining those consultants and professionals. Modifies the confidentiality provisions to now establish that all working papers, information, documents, and copies thereof produced by, obtained by, or disclosed to the Commissioner or any other person in connection with an examination or audit under the statute are confidential, not subject to a subpoena, are not public record, and cannot be made public by the Commissioner or any other person (previously, deemed the information proprietary, confidential and not public record, and prohibited the Commissioner from making the information or data public). Adds that the Commissioner can use the information in any regulatory or legal action brought as part of the Commissioner's official duties. No longer includes related rulemaking authority. Deletes the provisions regarding penalties and disciplinary actions for violations of the Article.
Enacts GS 58-56A-40, setting forth the Commissioner's authority to suspend, revoke, or refuse to renew the license of a PBM for cause after proper notice and hearing. Enumerates nine triggering offenses, including (1) that the PBM has violated any administrative rule, subpoena, or order of the Commissioner or violation of the Chapter; (2) that the PBM or any officer with management control has been convicted of a felony; or (3) that the financial condition or business practices of the PBM pose an imminent threat to the public health, safety, or welfare of residents. Authorizes the Commissioner to summarily suspend a license upon a written finding that the public health, safety, or welfare requires emergency action. Details the effectiveness and procedure required for orders summarily suspending a license.
Amends the definitions set forth in GS 58-56-2, applicable to Article 56 (Third Party Administrators), to exclude licensed PBMs from the definition of third party administrator.
Makes further technical changes.
Summary date: Aug 13 2019 - View summary
House committee substitute deletes the provisions of the 1st edition and now provides the following.
Enacts new Part 4A to Article 6 of GS Chapter 131E, titled the Birth Center Licensure Act (Act).
Sets out the purpose of the Act and defines terms. Defines birth center as a facility licensed for the primary purpose of performing normal, uncomplicated deliveries that is not a hospital or ambulatory surgical facility, and where births are planned to occur away from the mother's usual residence following a low-risk pregnancy, as that term is defined.
Requires DHHS to review and, as necessary, revise the Freestanding Birth Center Fee Schedule every three years to ensure that the fees are sufficient to cover the costs of services and that the cost for any State-mandated newborn screening is reimbursed at least at cost.
Directs DHHS to inspect birth centers as it deems necessary to investigate unexpected occurrences involving death or serious physical injury and reportable adverse outcomes identified in the rules adopted by the Commission. Requires all licensed birth centers be subject to DHHS inspections at all times. Provides for access to licensed premises by authorized DHHS representatives. Effective December 1, 2019, makes it unlawful for any person to resist proper entry by authorized DHHS representatives upon premises other than a private dwelling. Prohibits those representatives from endangering the health or well-being of any patient being treated in the birth center by his or her entry onto the premises. Grants DHHS the authority to investigate birth centers in the same manner as it investigates hospitals under GS 131E-80(d). Permits public disclosure of information received by the Commission or DHHS through filed reports, license applications, or inspections required or authorized by new Part 4A except where disclosure would violate applicable laws concerning patient records and confidentiality. Prohibits disclosure from identifying the patient involved without permission of the patient or court order.
Creates the seven-member NC Birth Center Commission of DHHS. Specifies the powers and duties of the Commission, including adopting rules establishing standards for licensure, operation, and regulation of birth centers in the state. Details the Commission membership and provides for four-year terms, with members serving for no more than two consecutive terms. Provides parameters for vacancies, removal, and member expenses, as well as Commission quorum and the provision of clerical services. Requires initial appointments be made no later than 60 days after the effective date of the act. Provides for staggered terms. Specifies that partial terms of initial members for staggering member terms do not count as full terms for purposes of the term limitations.
Requires the Commission to adopt rules establishing seven licensure requirements, including: (1) a requirement that the birth center obtain and maintain accreditation with the Commission for the Accreditation of Birth Centers (CABC), and including several documentation and reporting requirements; (2) a requirement that the birth center establish procedures specifying the criteria by which each person's risk status will be evaluated at admission and during labor, pursuant to CABC standards; and (3) a requirement that the birth center develop and submit a plan for complying with the standards of CABC with respect to transfer of care procedures. Requires DHHS to enforce the provisions of new Part 4A and any rules adopted by the Commission.
Allows the Commission, its members, and staff to release confidential or nonpublic information to any health care licensure board or authorized DHHS personnel with enforcement or investigative responsibilities concerning licensure action.
Adds the following provisions to new Part 4A. Except as otherwise provided, the following provisions are effective one year after the rules promulgated by the Commission are adopted, and applicable to licenses granted on or after that date.
Prohibits the establishment or operation of a birth center in the state without first obtaining a license from the Department of Health and Human Services (DHHS) pursuant to new Part 4A. Requires DHHS to provide applications for licensure and details the information required to be included in applications. Directs DHHS to issue a license upon the recommendation of the NC Birth Center Commission (Commission) if it finds the applicant is in compliance with the provisions of Part 4A and any rules adopted by the Commission. Provides that the license is valid for one year and is required to designate the number of beds and the number of rooms on the licensed premises. Establishes a $400 nonrefundable annual license fee to be credited to DHHS as a departmental receipt and applied to offset costs for licensing and inspecting birth centers, as well as a nonrefundable $17.50 annual per-birthing room fee. Provides for license renewal by DHHS pursuant to rules adopted by the Commission. Establishes that a license is not transferable or assignable except with written approval of DHHS. Requires operators to post the license on the licensed premises in an area accessible to the public. Allows currently operating and accredited birthing centers to continue operations as the Commission is constituted and promulgates permanent rules. Requires those operating birth centers to submit completed applications and requisite fees to the Division of Health Service Regulation within 90 days of the effective date of the Commission's permanent rules regarding licensure applications. Requires the application and fee to be received or postmarked no later than 90 days after the rules are adopted.
Authorizes the denial, suspension, or revocation of a license for substantial failure to comply with the provisions of Part 4A or rules adopted by the Commission. Authorizes the DHHS Secretary or a designee to suspend the admission of any new patients to a birth center if the birth center conditions are detrimental to the health or safety of any patient. Establishes that the suspension is effective until the Secretary or a designee is satisfied that the conditions or circumstances merit its removal. Further, clarifies that this authority is in addition to the authority to suspend or revoke the license of the birth center. Provides for a birth center to contest any adverse action on its license pursuant to GS Chapter 150B (APA).
Prohibits a licensed birth center from representing or providing services outside of the scope of the license. Sets the following limitations on services at a licensed birth center: (1) surgical procedures must be limited to those normally accomplished during an uncomplicated birth, (2) no abortions can be performed, (3) no general or conduction anesthesia can be performed, and (4) no vaginal birth after cesarean or trial of labor after cesarean can be performed.
Adds a new statute to the Part to make it a Class 3 misdemeanor to operate a birth center without a license, punishable by a fine of up to $50 for the first offense and up to $500 for each subsequent offense. Specifies that each day of continuing violation after conviction is considered a separate offense. Effective one year after the rules promulgated by the Commission are adopted.
Directs DHHS to, by October 1, 2019, review, and as necessary, revise, its current Freestanding Birth Center Fee Schedule to ensure that the fees are sufficient to cover the costs of services and that the cost for any State-mandated newborn screening is reimbursed at least at cost. Additionally directs DHHS to develop a birth center licensure application consistent with the Part's requirements and make it available upon the adoption of the rules by the Commission.
Makes the following changes to Article 56A, Pharmacy Management Benefits, of GS Chapter 58.
Adds claim, claims processing service, maximum allowable cost list, out-of-pocket-costs, pharmacy administration organization, pharmacist services, and pharmacy benefits manager affiliate to the defined terms set out in GS 58-56A-1. Amends the definition of health benefit plan to now refer to the definition set out for the term in GS 58-3-167, and makes conforming changes to the definition. Amends the definition of maximum allowable cost price to mean the maximum amount that a pharmacy benefits manager will reimburse a pharmacy for the cost of generic or multiple source prescription drugs, medical products, or devices (was, the maximum per unit reimbursement amount for multiple source prescription drugs, medical products, or devices). Amends the definition of pharmacy benefits manager to include any entity who contracts with a pharmacy on behalf of an insurer or third-party administrator to administer or manage prescription drug benefits to perform three specified functions: (1) processing claims for prescription drugs or medical supplies or providing retail network management for pharmacies or pharmacists, (2) paying pharmacies or pharmacists for prescription drugs or medical supplies, or (3) negotiating rebates with manufacturers for drugs paid for or procured as described in the Article (previously, the definition did not specify functions performed by the manager). Makes conforming organizational changes.
Enacts GS 58-56A-2 to now require licensure by the Commissioner of Insurance (Commissioner) for a person or organization to establish or operate as a pharmacy benefits manager in the state for health benefit plans. Directs the Commissioner to prescribe the application for a license. Authorizes the Commissioner to charge an initial application fee of $2,000 and an annual renewal fee of $1,500. Sets forth five exclusive components the application must contain, including contact information of the pharmacy benefits manager, the manager's agent for service of process, each person with management control over the pharmacy benefits manager, and each person with a beneficial ownership interest in the pharmacy benefits manager. Further requires the application to include a signed statement indicating that no officer with management or control of the pharmacy benefits manager has been convicted of a felony or has violated any requirements of applicable state or federal law, or a signed statement describing any relevant conviction or violation. Mandates that any applicant or licensed pharmacy benefits manager must file a notice describing any material modification to the information required of applications. Authorizes the Commissioner to adopt rules establishing the licensing requirements of pharmacy benefits managers consistent with the statute.
Adds to GS 58-56A-3 concerning consumer protections. Restricts a pharmacy benefit manager from prohibiting a pharmacist or pharmacy from charging a minimal shipping and handling fee to the insured for a mailed or delivered prescription if the pharmacist or pharmacy discloses to the insured prior to delivery: the fee amount, that the fee cannot be reimbursed, and that the charge is agreed to by the health benefit plan or pharmacy benefits manager. Adds that when calculating the insured's overall contribution to any out-of-pocket maximum or any cost-sharing requirement under the health benefit plan, the insurer must include any amounts paid by the insured or paid on the insured's behalf to the extent allowed by state and federal law. Eliminates the requirement for the Department to report any violations of the statute or GS 58-56A-4 to the Attorney General.
Amends GS 58-56A-4, regarding pharmacy and pharmacist protections, to now provide the following. Requires there to be a justification for each adjustment or fee for processing a claim or otherwise related to adjudication of a claim, specifically justification on the remittance advice or as set out in contract and agreed upon by the pharmacy or pharmacist for each adjustment or fee. Maintains the provision that excludes from the statute's provisions claims under an employee benefit plan under the Employee Retirement Income Security Act or Medicare Part D. Provides that Article 56A does not abridge the right of a pharmacist to refuse service if the pharmacist believes it would be harmful to the patient, not in the patient's best interest, or if there is a question to the prescription's validity. Specifies that the provisions do not limit overpayment recovery efforts by a pharmacy benefits manager. Provides that a pharmacy or pharmacist cannot be prohibited or restricted by a pharmacy benefits manager from dispensing any prescription drug consistent with pharmacy licensure laws, including specialty drugs dispensed by a credentialed and accredited pharmacy. Prohibits a pharmacy benefits manager from penalizing or retaliating against a pharmacist or pharmacy for exercising rights provided by Article 56A, unless conduct amounts to a breach of contract. Establishes that a claim for pharmacist services cannot be retroactively denied or reduced after adjudication of the claim unless one of five circumstances apply, including that the original claim was submitted fraudulently.
Adds to GS 58-56A-5, concerning the maximum allowable cost price of prescription drugs. Requires pharmacy benefits managers to ensure that dispensing fees are not included in the calculation of maximum allowable cost price. Requires pharmacy benefits managers to establish an administrative appeals procedure for reimbursement if less than the net amount that the network paid to the suppliers of the drug. Sets forth parameters for the appeal procedure.
Enacts GS 58-56A-20 to authorize pharmacy benefits managers to maintain more than one network for different pharmacy services. Allows each individual network to have terms and conditions and require different pharmacy accreditation standards or certification requirements for participating in the network, so long as the standards and requirements are applied without regard to a pharmacy's or pharmacist's status as an independent pharmacy or pharmacy benefits manager affiliate. Prohibits denying the right to any properly licensed pharmacist or pharmacy from participating in the network on the same terms and conditions of other participants in the network. Requires pharmacy performance measure or pay-for-performance networks to use a nationally recognized entity aiding in improving pharmacy performance measures. Details restrictions and limitations concerning pharmacy performance measures. Provides that a pharmacist or pharmacy that is a member of a pharmacy service administration organization that enters into a contract with a health benefit plan issuer or a pharmacy benefits manager on the pharmacy's behalf is entitled to receive a copy of the contract provisions applicable to the pharmacy from that organization. Establishes that termination of a pharmacy or pharmacist from a network does not release the pharmacy benefits manager from the obligation to make any payment due to the pharmacy or pharmacist for pharmacist services properly rendered according to the contract; excludes cases of fraud, waste, and abuse.
Enacts GS 58-65A-25 to prohibit a pharmacy benefits manager from, in any way prohibited by HIPAA, transferring or sharing records related to prescription information containing patient-identifiable and prescriber-identifiable data to a pharmacy benefits manager affiliate.
Enacts GS 58-65A-35 to provide for the enforcement of the Article by the Commissioner by means of examination, as described. Authorizes the Commissioner to retain professionals and specialists as examiners, with the cost of their retention placed upon the pharmacy benefits manager. Deems information or data acquired pending, during, and after the examination of any pharmacy benefits manager nonpublic, proprietary, and confidential. Authorizes the Commissioner to promulgate reasonable and necessary rules after proper notice and hearing. Makes violations of Article 56A subject to penalties under GS 58-56A-40, as codified and amended, as well as subjects a pharmacy benefits manager to revocation of or refusal to renew a license to operate, after proper notice and hearing. Requires the Commissioner to report any violations of the Article to the Attorney General.
Recodifies GS 58-56A-10 as GS 58-56A-40, regarding civil penalties for violations of Article 56A. Makes clarifying, conforming, and technical changes.
Amends 58-2-40(5) to require the Commissioner to report in detail to the Attorney General any violations of laws relative to pharmacy benefits managers.
Applies to any contracts entered into on or after March 1, 2020.
Makes conforming changes to the act's titles.
Summary date: Mar 28 2019 - View summary
Identical to H 179, filed 2/26/19.
Amends the following laws in GS Chapter 20 to regulate mini-trucks.
Adds mini-truck to the defined terms in GS 20-4.01, defining the term, as a type of passenger vehicle, to mean a motor vehicle designed, used, or maintained primarily for the transportation of property and having four wheels, an engine displacement of 660cc or less, and physical measurements not exceeding those specified.
Amends GS 20-87(12) concerning registration fees for low-speed vehicles, setting the registration fee for mini-trucks to be the same as the fee for private passenger vehicles of not more than 15 passengers (identical to the fee for low-speed vehicles). Adds that low-speed vehicle and mini-truck rentals are to have the same registration fee charged for U-drive-it automobiles.
Amends GS 20-121.1, expanding the provisions regarding the operation of low-speed vehicles on certain roadways, including those on registration and insurance, to also apply to the operation of mini-trucks. Limits the operation of mini-trucks to streets and highways with a 55 miles per hour or less speed limit. Requires the road safety equipment of low-speed vehicles and mini-trucks, such as headlamps, turn signal lamps, reflectors, windshield wipers, speedometers, and seatbelts, be maintained in working order . Prohibits mini-trucks from antique vehicle or historic vehicle qualification under GS 20-79.4(b).