Pharmacy benefits manager shall not have to be licensed as an administrator

A pharmacy benefits manager licensed pursuant to this chapter shall not be required to obtain a license as an administrator pursuant to Article 2 of Chapter 23 of this title to perform any function as a pharmacy benefits manager pursuant to this chapter. History. — Code 1981, § 33-64-6, enacted by Ga. L. 2010, p. 757, § 1/SB 310; Ga. L. 2011, p. 752, § 33/HB 142. 33-64-7. (For effective date, see note.) Commissioner’s authority over rules and regulations. (a) The Commissioner shall enforce the provisions of this chapter and may promulgate rules and regulations to implement the provisions of this chapter to ensure the safe and proper operations of pharmacy benefits managers in this state. (b) In addition to all other authority granted by this title, the Commissioner may: (1) Conduct financial examinations and compliance audits of pharmacy benefits managers to ensure compliance with the provisions of this chapter and rules and regulations implemented pursuant to this chapter; provided, however, that such authority shall not extend to financial examination and compliance audits of pharmacy benefits managers’ conduct in performing services on behalf of the state health benefit plan pursuant to Article 1 of Chapter 18 of Title 45 or the medical assistance program pursuant to Article 7 of Chapter 4 of Title 49. The pharmacy benefits manager subject to a financial examination or compliance audit shall pay all the actual expenses incurred in conducting the examination or audit. When the examination or audit is made by an examiner or auditor who is not a regular employee of the department, the pharmacy benefits manager examined or audited shall pay the proper expenses for the services of the examiner or auditor and his or her assistants and the actual travel and lodging expenses incurred by such examiners, auditors, and assistants in an amount approved by the Commissioner. The examiner or auditor shall file a consolidated accounting of expenses 1081 33-64-7 for the examination or audit with the Commissioner. No pharmacy benefits manager shall pay, and no examiner or auditor shall accept, any additional emolument on account of any examination or audit. When the examination or audit is conducted in whole or in part by regular salaried employees of the department, payment for such services and proper expenses shall be made by the pharmacy benefits manager examined or audited to the Commissioner. The Commissioner shall be authorized to keep a portion of examination or audit fees paid by the pharmacy benefits manager examined or audited to pay for any costs incurred as a result of the examination or audit, and any fees remaining shall be deposited in the state treasury; provided, however, that when a pharmacy benefits manager is examined or audited because of a complaint filed against such pharmacy benefits manager and it is determined by the Commissioner that the complaint was not justified, the expenses incurred as a result of the examination or audit shall not be assessed against the pharmacy benefits manager but shall be borne by the department; (2) Investigate complaints of alleged violations of this chapter; (3) Issue cease and desist orders when a pharmacy benefits manager is taking or threatening to take action in violation of this chapter or rules and regulations implemented pursuant to this chapter; and (4) Order reimbursement to an insured, pharmacy, or dispenser who has incurred a monetary loss as a result of a violation of this chapter or rules and regulations implemented pursuant to this chapter as well as order payment of a fine not to exceed $1,000.00 per violation to an insured, pharmacy, or dispenser who has been aggrieved as a result of a violation of this chapter or rules and regulations implemented pursuant to this chapter. Such fine shall be in addition to and shall not preclude any other fines imposed pursuant to this title. For purposes of this paragraph, a violation shall be considered to have occurred each time a prohibited act is committed. (c) A pharmacy benefits manager shall make its records available to the Commissioner, deidentified of any protected health information, upon written demand and provide cooperation in connection with financial examinations, compliance audits, and investigations. (d) In the event a violation of this chapter or rules and regulations implemented pursuant to this chapter is found following a complaint, the Commissioner may, at his or her discretion, conduct a compliance audit to identify whether any other similar violations have occurred within the state. History. — Code 1981, § 33-64-7, enacted by Ga. L. 2010, p. 757, § 1/SB 310; Ga. L. 2015, p. 337, § 3/HB 470; Ga. L. 2017, p. 494, § 1/HB 276; Ga. L. 2017, p. 1082 497, § 1/SB 103; Ga. L. 2020, p. 768, § 4/HB 946; Ga. L. 2020, p. 780, § 4/SB 313. Delayed effective date. — This Code section, as set out above, becomes effective July 1, 2021. For version of this Code section in effect until July 1, 2021, see the 2020 amendment note. The 2020 amendments. — The first 2020 amendment, effective July 1, 2021, designated the existing provisions as subsection (a); substituted the present provisions of subsection (a) for the former provisions, which read: ‘‘The Commissioner may not enlarge upon or extend the specific provisions of this chapter through any act, rule, or regulation; provided, however, that the Commissioner is authorized to enforce any specific provision of this chapter and may promulgate rules 33-64-8 and regulations to effectuate the specific provisions of this chapter.’’; and added subsections (b) — (d). The second 2020 amendment, effective July 1, 2021, made identical changes. See the Editor’s notes for applicability. Editor’s notes. — Ga. L. 2017, p. 494, § 3/HB 276 and Ga. L. 2017, p. 497, § 3/SB 103, not codified by the General Assembly, provide that the amendments by these Acts shall apply to all contracts issued, delivered, or issued for delivery in this state on and after July 1, 2017. Ga. L. 2020, p. 768, § 9(a)/HB 946 and Ga. L. 2020, p. 780, § 9(a)/SB 313, not codified by the General Assembly, provide, in part, that the amendment by that Act shall apply to all contracts issued, delivered, or issued for delivery in this state on and after July 1, 2021. 33-64-8. Electronic prior authorization drug requests with health care providers. (a) As used in this Code section, ‘‘electronic prior authorization’’ or ‘‘e-prior authorization’’ means a requirement that a prescriber obtain approval via electronic media from a health plan to prescribe a specific medication prior to dispensing. Facsimiles shall not be considered an electronic submission under this Code section except in the event that such electronic media is temporarily unavailable due to system failure or outage. (b) No later than 24 months after the adoption of standards by the National Council of Prescription Drug Programs, the department shall under the direction of the Commissioner adopt standards by which the pharmacy benefits manager shall exchange standard e-prior authorization requests with health care providers for drugs and devices using electronic data interchange standards consistent with those adopted by the National Council of Prescription Drug Programs. Such standards shall support clinical workflow decision support of the physician provider. (c) No later than 24 months after the adoption of standards by the National Council of Prescription Drug Programs, e-prior authorization requests shall be accessible and submitted by providers to pharmacy benefits managers and health plans through secure electronic transmissions utilizing the current National Council of Prescription Drug Programs electronic prior authorization standard. (d) Nothing in this Code section shall require any health care provider to participate in e-prior authorization or electronic prior 1083 33-64-9 authorization in order to obtain the necessary authorization for patient care. History. — Code 1981, § 33-64-8, enacted by Ga. L. 2012, p. 1134, § 1/SB 416. 33-64-9. Requirements for use of maximum allowable cost pricing by pharmacy benefits managers; appeals; enforcement authority. (a) Upon each contract execution or renewal between a pharmacy benefits manager and a pharmacy or between a pharmacy benefits manager and a pharmacy’s contracting representative or agent, such as a pharmacy services administrative organization, a pharmacy benefits manager shall, with respect to such contract or renewal: (1) Include in such contract or renewal the sources utilized to determine multi-source generic drug pricing, such as maximum allowable cost or any successive benchmark pricing formula, and update such pricing information at least every five business days, provided that such pricing information update shall be at least every 14 business days for those contracts pursuant to Article 7 of Chapter 4 of Title 49; and (2) Maintain a procedure to eliminate products from the multi-source generic list of drugs subject to such pricing or modify multi-source generic drug pricing within five business days when such drugs do not meet the standards and requirements of this Code section in order to remain consistent with pricing changes in the marketplace. (b) A pharmacy benefits manager shall reimburse pharmacies for drugs subject to multi-source generic drug pricing based upon pricing information which has been updated within five business days as set forth in paragraph (1) of subsection (a) of this Code section. (c) A pharmacy benefits manager may not place a drug on a multi-source generic list unless there are at least two therapeutically equivalent, multi-source generic drugs, or at least one generic drug available from only one manufacturer, generally available for purchase by network pharmacies from national or regional wholesalers. (d) All contracts between a pharmacy benefits manager and a contracted pharmacy or between a pharmacy benefits manager and a pharmacy’s contracting representative or agent, such as a pharmacy services administrative organization, shall include a process to internally appeal, investigate, and resolve disputes regarding multi-source generic drug pricing. The process shall include the following: (1) The right to appeal shall be limited to 14 calendar days following reimbursement of the initial claim; and 1084 33-64-9.1 (2) A requirement that the health benefit plan issuer or pharmacy benefits manager shall respond to an appeal described in subsection (a) of this Code section no later than 14 calendar days after the date the appeal was received by such health benefit plan issuer or pharmacy benefits manager. (e) For appeals that are denied, the pharmacy benefits manager shall provide the reason for the denial and identify the national drug code of a drug product that may be purchased by contracted pharmacies at a price at or below the maximum allowable cost. (f ) If the appeal is successful, the health benefit plan issuer or pharmacy benefits manager shall: (1) Adjust the maximum allowable cost price that is the subject of the appeal effective on the day after the date the appeal is decided; (2) Apply the adjusted maximum allowable cost price to all similarly situated pharmacists and pharmacies as determined by the health plan issuer or pharmacy benefits manager; and (3) Allow the pharmacist or pharmacy that succeeded in the appeal to reverse and rebill the pharmacy benefits claim giving rise to the appeal. (g) Appeals shall be upheld if: (1) The pharmacy being reimbursed for the drug subject to the multi-source generic drug pricing in question was not reimbursed as required in subsection (b) of this Code section; or (2) The drug subject to the multi-source generic drug pricing in question does not meet the requirements set forth in subsection (c) of this Code section. (h) The Commissioner shall have enforcement authority over this Code section. History. — Code 1981, § 33-64-9, enacted by Ga. L. 2015, p. 337, § 4/HB 470. 33-64-9.1. (Effective January 1, 2021) Reimbursement methodologies utilized by pharmacy benefits managers. (a)(1) Any methodologies utilized by a pharmacy benefits manager in connection with reimbursement pursuant to Code Section 33-64-9 shall be filed with the Commissioner for use in determining maximum allowable cost appeals; provided, however, that methodologies not otherwise subject to disclosure under Article 4 of Chapter 18 of Title 50 shall be treated as confidential and shall not be subject to disclosure. 1085 33-64-9.1 INSURANCE 33-64-9.1 (2) A pharmacy benefits manager shall utilize the national average drug acquisition cost as a point of reference for the ingredient drug product component of a pharmacy’s reimbursement for drugs appearing on the national average drug acquisition cost list and shall produce a report every four months, which shall be provided to the Commissioner and published by the pharmacy benefits manager on a website available to the public for no less than 24 months, of all drugs appearing on the national average drug acquisition cost list reimbursed 10 percent and below the national average drug acquisition cost, as well as all drugs reimbursed 10 percent and above the national average drug acquisition cost. For each drug in the report, a pharmacy benefits manager shall include the month the drug was dispensed, the quantity of the drug dispensed, the amount the pharmacy was reimbursed per unit or dosage, whether the dispensing pharmacy was an affiliate, whether the drug was dispensed pursuant to a state or local government health plan, and the average national average drug acquisition cost for the month the drug was dispensed. Such report shall exclude drugs dispensed pursuant to 42 U.S.C. Section 256b. (3) This subsection shall not apply to Medicaid under Chapter 4 of Title 49 when the department reimburses providers directly for each covered service; provided, however, that it shall apply to Medicaid managed care programs administered through care management organizations. (4) This subsection shall take effect on January 1, 2021; provided, however, that prior to July 1, 2021, upon written request, a pharmacy benefits manager shall be granted an extension by the Commissioner of up to six months for its initial filing required pursuant to paragraph (1) of this subsection if the pharmacy benefits manager certifies it is in need of such extension. (b) On and after July 1, 2021, a pharmacy benefits manager shall not: (1) Discriminate in reimbursement, assess any fees or adjustments, or exclude a pharmacy from the pharmacy benefit manager’s network on the basis that the pharmacy dispenses drugs subject to an agreement under 42 U.S.C. Section 256b; or (2) Engage in any practice that: (A) In any way bases pharmacy reimbursement for a drug on patient outcomes, scores, or metrics; provided, however, that nothing shall prohibit pharmacy reimbursement for pharmacy care, including dispensing fees from being based on patient outcomes, scores, or metrics so long as the patient outcomes, scores, or metrics are disclosed to and agreed to by the pharmacy in advance; 1086 33-64-9.1 REGULATION OF PHARMACY BENEFITS MANAGERS 33-64-10 (B) Includes imposing a point-of-sale fee or retroactive fee; or (C) Derives any revenue from a pharmacy or insured in connection with performing pharmacy benefits management services; provided, however, that this shall not be construed to prohibit pharmacy benefits managers from receiving deductibles or copayments. (c) This Code section shall also apply to pharmacy benefits managers’ reimbursements to dispensers. History. — Code 1981, § 33-64-9.1, enacted by Ga. L. 2020, p. 768, § 5/HB 946; Ga. L. 2020, p. 780, § 5/SB 313. Effective date. — This Code Section becomes effective January 1, 2021. See Editor’s note for applicability. Editor’s notes. — Ga. L. 2020, p. 768, § 5/HB 946 and Ga. L. 2020, p. 780, § 5/SB 313, both enacted a Code section designated 33-64-9.1 and contained identical provisions. Ga. L. 2020, p. 768, § 9(b)/HB 946 and Ga. L. 2020, p. 780, § 9(b)/SB 313, not codified by the General Assembly, provide that the amendment to this Code section is applicable to all contracts issued, delivered, or issued for delivery in this state on and after January 1, 2021.