2023 -- S 0563 SUBSTITUTE A ======== LC001940/SUB A ======== S TATE OF RHODE IS LAND IN GENERAL ASSEMBLY JANUARY SESSION, A.D. 2023 ____________ A N A C T RELATING TO INSURANCE -- INSURANCE COVERAGE F OR PREVENTION OF HIV INFECTION Introduced By: Senators Murray, Valverde, Lauria, Pearson, Euer, Lawson, Mack, Acosta, Miller, and Cano Date Introduced: March 07, 2023 Referred To: Senate Health & Human Services It is enacted by the General Assembly as follows: SECTION 1. Title 27 of the General Laws entitled "INSURANCE" is hereby amended by 1 adding thereto the following chapter: 2 CHAPTER 38.3 3 INSURANCE COVERAGE FOR PREVENTION OF HIV INFECTION 4 27-38.3-1. Coverage for prevention of HIV infection. 5 (a) A group health plan and an individual or group health insurance plan shall provide 6 coverage for the prevention treatment of HIV infection under the same terms and conditions as that 7 coverage is provided for other illnesses and diseases. 8 (b) Coverage for the prevention treatment of HIV infection shall not impose any annual or 9 lifetime dollar limitation. 10 (c) Financial requirements and quantitative treatment limitations on coverage for the 11 prevention treatment of HIV infection shall be no more restrictive than the predominant financial 12 requirements applied to substantially all coverage for medical conditions in each treatment 13 classification. 14 (d) Coverage shall not impose non-quantitative treatment limitations for the prevention 15 treatment of HIV infection unless the processes, strategies, evidentiary standards, or other factors 16 used in applying the non-quantitative treatment limitation, as written and in operation, are 17 comparable to, and are applied no more stringently than, the processes, strategies, evidentiary 18 LC001940/SUB A - Page 2 of 6 standards, or other factors used in applying the limitation with respect to medical/surgical benefits 1 in the classification. 2 (e) The following classifications shall be used to apply the coverage requirements of this 3 chapter: 4 (1) Inpatient, in-network; 5 (2) Inpatient, out-of-network; 6 (3) Outpatient, in-network; 7 (4) Outpatient, out-of-network; 8 (5) Emergency care; and 9 (6) Prescription drugs. 10 (f) Payors shall rely upon the criteria of the Society of Infectious Diseases Pharmacists 11 when developing coverage for levels of care for HIV prevention treatment. 12 27-38.3-2. Definitions. 13 As used in this section, unless the context otherwise indicates, the following terms have 14 the following meanings: 15 (1) "CDC guidelines" means guidelines related to the nonoccupational exposure to 16 potential HIV infection, or any subsequent guidelines, published by the federal Department of 17 Health and Human Services, Centers for Disease Control and Prevention. 18 (2) "Financial requirements" means deductibles, copayments, coinsurance, or out-of-19 pocket maximums. 20 (3) "Group health plan" means an employee welfare benefit plan as defined in 29 U.S.C. § 21 1002(1) to the extent that the plan provides health benefits to employees or their dependents directly 22 or through insurance, reimbursement, or otherwise. For purposes of this chapter, a group health 23 plan shall not include a plan that provides health benefits directly to employees or their dependents, 24 except in the case of a plan provided by the state or an instrumentality of the state. 25 (4) "Health insurance plan" means health insurance coverage offered, delivered, issued for 26 delivery, or renewed by a health insurer. 27 (5) "Health insurers" means all persons, firms, corporations, or other organizations offering 28 and assuring health services on a prepaid or primarily expense-incurred basis, including, but not 29 limited to, policies of accident or sickness insurance, as defined by chapter 18 of this title; nonprofit 30 hospital or medical service plans, whether organized under chapter 19 or 20 of this title or under 31 any public law or by special act of the general assembly; health maintenance organizations, or any 32 other entity that insures or reimburses for diagnostic, therapeutic, or preventive services to a 33 determined population on the basis of a periodic premium. Provided, this chapter does not apply to 34 LC001940/SUB A - Page 3 of 6 insurance coverage providing benefits for: 1 (i) Hospital confinement indemnity; 2 (ii) Disability income; 3 (iii) Accident only; 4 (iv) Long-term care; 5 (v) Medicare supplement; 6 (vi) Limited benefit health; 7 (vii) Specific disease indemnity; 8 (viii) Sickness or bodily injury or death by accident or both; and 9 (ix) Other limited benefit policies. 10 (6) "HIV prevention drug" means a preexposure prophylaxis drug, post-exposure 11 prophylaxis drug or other drug approved for the prevention of HIV infection by the federal Food 12 and Drug Administration. 13 (7) "Non-quantitative treatment limitations" means: 14 (i) Medical management standards; 15 (ii) Formulary design and protocols; 16 (iii) Network tier design; 17 (iv) Standards for provider admission to participate in a network; 18 (v) Reimbursement rates and methods for determining usual, customary, and reasonable 19 charges; and 20 (vi) Other criteria that limit scope or duration of coverage for services in the prevention 21 treatment of HIV infection, including restrictions based on geographic location, facility type, and 22 provider specialty. 23 (8) "Post-exposure prophylaxis drug" means a drug or drug combination that meets the 24 clinical eligibility recommendations provided in CDC guidelines following potential exposure to 25 HIV infection. 26 (9) "Preexposure prophylaxis drug" means a drug or drug combination that meets the 27 clinical eligibility recommendations provided in CDC guidelines to prevent HIV infection. 28 (10) "Quantitative treatment limitations" means numerical limits on coverage for the 29 preventive treatment of HIV infection based on the frequency of treatment, number of visits, days 30 of coverage, days in a waiting period, or other similar limits on the scope or duration of treatment. 31 27-38.3-3. Coverage required. 32 A health insurer offering a health plan in this state shall provide coverage for an HIV 33 prevention drug that has been prescribed by a provider. Each long-acting injectable drug with a 34 LC001940/SUB A - Page 4 of 6 different duration shall constitute a separate method of administration. Coverage under this section 1 is subject to the following; 2 (1) If the federal Food and Drug Administration has approved one or more HIV prevention 3 drugs that use the same method of administration, a health insurer is not required to cover all 4 approved drugs as long as the insurer covers at least one approved drug for each method of 5 administration with no out-of-pocket cost. 6 (2) A health insurer is not required to cover any preexposure prophylaxis drug or post-7 exposure prophylaxis drug dispensed or administered by an out-of-network pharmacy provider 8 unless the enrollee's health plan provides an out-of-network pharmacy benefit. 9 (3) A health insurer shall not prohibit or permit a pharmacy benefits manager to prohibit a 10 pharmacy provider from dispensing or administering any HIV prevention drugs. 11 27-38.3-4. Limits on prior authorization and step therapy requirements. 12 Notwithstanding any requirements to the contrary, a health insurer shall not subject any 13 HIV prevention drug to any prior authorization or step therapy requirement except as provided in 14 this section. If the federal Food and Drug Administration has approved one or more methods of 15 administering HIV prevention drugs, an insurer is not required to cover all of the approved drugs 16 without prior authorization or step therapy requirements as long as the insurer covers at least one 17 approved drug for each method of administration without prior authorization or step therapy 18 requirements. If prior authorization or step therapy requirements are met for a particular enrollee 19 with regard to a particular HIV prevention drug, the insurer is required to cover that drug with no 20 out-of-pocket cost to the enrollee. 21 27-38.3-5. Coverage for laboratory testing related to HIV prevention drugs. 22 A health insurer offering a health plan in this state shall provide coverage with no out-of-23 pocket cost for any ancillary or support service determined by the department of health that is 24 necessary to: 25 (1) Ensure that such a drug is prescribed and administered to a person who is not infected 26 with HIV and has no medical contraindications to the use of such drug; and 27 (2) Monitor such a person to ensure the safe and effective ongoing use of such a drug 28 through: 29 (i) An office visit; 30 (ii) Laboratory testing; 31 (iii) Testing for a sexually transmitted infection; 32 (iv) Medication self-management and adherence counseling; or 33 (v) Any health service specified as part of comprehensive HIV prevention drug services by 34 LC001940/SUB A - Page 5 of 6 the United States Department of Health and Human Services, the United States Centers for Disease 1 Control and Prevention or the United States Preventive Services Task Force. 2 27-38.3-6. Medical necessity and appropriateness of treatment. 3 (a) Upon request of the reimbursing health insurers, all providers of prevention treatment 4 of HIV infection shall furnish medical records or other necessary data which substantiates that 5 initial or continued treatment is at all times medically necessary and/or appropriate. When the 6 provider cannot establish the medical necessity and/or appropriateness of the treatment modality 7 being provided, neither the health insurer nor the patient shall be obligated to reimburse for that 8 period or type of care that was not established. Exception to the preceding requirement can only be 9 made if the patient has been informed of the provisions of this subsection and has agreed in writing 10 to continue to receive treatment at their own expense. 11 (b) The health insurers, when making the determination of medically necessary and 12 appropriate treatment, shall do so in a manner consistent with that used to make the determination 13 for the treatment of other diseases or injuries covered under the health insurance policy or 14 agreement. 15 (c) Any subscriber who is aggrieved by a denial of benefits provided under this chapter 16 may appeal a denial in accordance with the rules and regulations promulgated by the department 17 of health pursuant to chapter 17.12 of title 23. 18 27-38.3-7. Network coverage. 19 The healthcare benefits outlined in this chapter apply only to services delivered within the 20 health insurer’s provider network; provided that, all health insurers shall be required to provide 21 coverage for those benefits mandated by this chapter outside of the health insurer’s provider 22 network where it can be established that the required services are not available from a provider in 23 the health insurer’s network. 24 SECTION 2. This act shall take effect on January 1, 2024. 25 ======== LC001940/SUB A ======== LC001940/SUB A - Page 6 of 6 EXPLANATION BY THE LEGISLATIVE COUNCIL OF A N A C T RELATING TO INSURANCE -- INSURANCE COVERAGE F OR PREVENTION OF HIV INFECTION *** This act would require coverage for the treatment of pre-exposure prophylaxis (PrEP) for 1 the prevention of HIV and post-exposure prophylaxis (PEP) for treatment of HIV infection, 2 commencing January 1, 2024. 3 This act would take effect on January 1, 2024. 4 ======== LC001940/SUB A ========