As Passed by House and Senateh.31

AS PASSED BY HOUSE AND SENATEH.31

2002Page 1

H.31

AN ACT RELATING TO PRESCRIPTION DRUG COST CONTAINMENT AND AFFORDABLE ACCESS

It is hereby enacted by the General Assembly of the State of Vermont:

Sec. 1. 33 V.S.A. chapter 19, subchapter 5 is added to read:

Subchapter 5. Prescription Drug Cost Containment

§ 1997. DEFINITIONS

As used in this subchapter:

(1) “Board” or “drug utilization review board” means the drug utilization review board established by the commissioner in connection with the Medicaid program.

(2) “Commissioner” means the commissioner of prevention, assistance, transition, and health access.

(3) “Department” means the department of prevention, assistance, transition, and health access.

(4) “Health benefit plan” means a health benefit plan with prescription drug coverage offered or administered by a health insurer, as defined by subdivision 9402(7) of Title 18, and the out-of-state counterparts to such plans. The term includes, but is not limited to:

(A) any state public assistance program with a health benefit plan that provides coverage of prescription drugs;

(B) any health benefit plan offered by or on behalf of the state of Vermont or any instrumentality of the state providing coverage for government employees and their dependents that agrees to participate in the program; and

(C) any insured or self-insured health benefit plan that agrees to participate in the program.

(5) “Participating health benefit plan” means a health benefit plan that has agreed to participate in one or more components of the pharmacy best practices and cost control program.

(6) “Program” or “the pharmacy best practices and cost control program” means the pharmacy best practices and cost control program established by this subchapter.

(7) “State public assistance program”, includes, but is not limited to, the Medicaid program, the Vermont health access plan, the Vermont health access plan-pharmacy, VScript and VScript-Expanded, the state children’s health insurance program, the state of Vermont AIDS medication assistance program, the General Assistance program, the pharmacy discount plan program, and the out-of-state counterparts to such programs.

§ 1998. PHARMACY BEST PRACTICES AND COST CONTROL

PROGRAM ESTABLISHED

(a) The commissioner of prevention, assistance, transition, and health access shall establish a pharmacy best practices and cost control program designed to reduce the cost of providing prescription drugs, while maintaining high quality in prescription drug therapies. The program shall include:

(1) A preferred list of covered prescription drugs that identifies preferred choices within therapeutic classes for particular diseases and conditions, including generic alternatives.

(A) The commissioner, and the commissioner of banking, insurance, securities, and health care administration shall implement the preferred drug list as a uniform, statewide preferred drug list by encouraging all health benefit plans in this state to participate in the program.

(B) The commissioner of personnel shall use the preferred drug list in the state employees health benefit plan only if participation in the program will provide economic and health benefits to the state employees health benefit plan and to beneficiaries of the plan, and only if agreed to through the bargaining process between the state of Vermont and the authorized representatives of the employees of the state of Vermont. The provisions of this subdivision do not authorize the actuarial pooling of the state employees health benefit plan with any other health benefit plan, unless otherwise agreed to through the bargaining process between the state of Vermont and the authorized representatives of the employees of the state of Vermont.

(C) The commissioner shall encourage all health benefit plans to implement the preferred drug list as a uniform, statewide preferred drug list by inviting the representatives of each health benefit plan providing prescription drug coverage to residents of this state to participate as observers or nonvoting members in the commissioner’s drug utilization review board, and by inviting such plans to use the preferred drug list in connection with the plans’ prescription drug coverage;

(2) Utilization review procedures, including a prior authorization review process;

(3) Any strategy designed to negotiate with pharmaceutical manufacturers to lower the cost of prescription drugs for program participants, including a supplemental rebate program;

(4) Education programs, including a counterdetailing program, designed to provide information and education on the therapeutic and costeffective utilization of prescription drugs to physicians, pharmacists and other health care professionals authorized to prescribe and dispense prescription drugs;

(5) Alternative pricing mechanisms, including consideration of using maximum allowable cost pricing for generic and other prescription drugs;

(6) Alternative coverage terms, including consideration of providing coverage of over-the-counter drugs where cost-effective in comparison to prescription drugs, and authorizing coverage of dosages capable of permitting the consumer to split each pill if cost-effective and medically appropriate for the consumer;

(7) A simple, uniform prescription form, designed to implement the preferred drug list, and to enable prescribers and consumers to request an exception to the preferred drug list choice with a minimum of cost and time to prescribers, pharmacists and consumers; and

(8) Any other cost containment activity adopted, by rule, by the commissioner that is designed to reduce the cost of providing prescription drugs while maintaining high quality in prescription drug therapies.

(b) The commissioner shall implement the pharmacy best practices and cost control program for Medicaid and all other state public assistance program health benefit plans to the extent permitted by federal law.

(c)(1) The commissioner may implement the pharmacy best practices and cost control program for any other health benefit plan within or outside this state that agrees to participate in the program.

(2) The commissioner of prevention, assistance, transition, and health access, and the secretary of administration shall take all steps necessary to enable Vermont’s participation in joint prescription drug purchasing agreements with any other health benefit plan or organization within or outside this state that agrees to participate with Vermont in such joint purchasing agreements.

(3) The commissioner of personnel shall take all steps necessary to enable the state of Vermont to participate in joint prescription drug purchasing agreements with any other health benefit plan or organization within or outside this state that agrees to participate in such joint purchasing agreements, as may be agreed to through the bargaining process between the state of Vermont and the authorized representatives of the employees of the state of Vermont.

(4) The actions of the commissioners and the secretary shall include:

(A) active collaboration with the Northeast Legislative Association on Prescription Drugs in the Association’s efforts to establish a Prescription Drug Fair Price Coalition;

(B) active collaboration with the Pharmacy RFP Issuing States initiative organized by the West Virginia Public Employees Insurance Agency;

(C) the execution of any joint purchasing agreements or other contracts with any participating health benefit plan or organization within or outside the state which the commissioner determines will lower the cost of prescription drugs for Vermonters while maintaining high quality in prescription drug therapies; and

(D) with regard to participation by the state employees health benefit plan, the execution of any joint purchasing agreements or other contracts with any health benefit plan or organization within or outside the state which the commissioner determines will lower the cost of prescription drugs and provide overall quality of integrated health care services to the state employees health benefit plan and the beneficiaries of the plan, and which is negotiated through the bargaining process between the state of Vermont and the authorized representatives of the employees of the state of Vermont.

(5) The commissioner and the commissioner of personnel may renegotiate and amend existing contracts to which their departments are parties if such renegotiation and amendment will be of economic benefit to the health benefit plans subject to such contracts, and to the beneficiaries of such plans. Any renegotiated or substituted contract shall be designed to improve the overall quality of integrated health care services provided to beneficiaries of such plans.

(6) The commissioners and the secretary shall report quarterly to the health access oversight committee and the joint fiscal committee on their progress in securing Vermont’s participation in such joint purchasing agreements.

(7) The commissioner, the commissioner of personnel, the commissioner of banking, insurance, securities and health care administration, and the secretary of human services shall establish a collaborative process with the Vermont Medical Society, pharmacists, health insurers, consumers, employer organizations and other health benefit plan sponsors, the Northeast Legislative Association on Prescription Drug Pricing, pharmaceutical manufacturer organizations, and other interested parties designed to consider and make recommendations to reduce the cost of prescription drugs for all Vermonters.

(d) A participating health benefit plan other than a state public assistance program may agree with the commissioner to limit the plan’s participation to one or more program components. The commissioner shall supervise the implementation and operation of the pharmacy best practices and cost control program, including developing and maintaining the preferred drug list, to carry out the provisions of the subchapter. The commissioner may include such insured or self-insured health benefit plans as agree to use the preferred drug list or otherwise participate in the provisions of this subchapter. The purpose of this subchapter is to reduce the cost of providing prescription drugs while maintaining high quality in prescription drug therapies.

(e) The commissioner of prevention, assistance, transition, and health access shall develop procedures for the coordination of state public assistance program health benefit plan benefits with pharmaceutical manufacturer patient assistance programs offering free or low cost prescription drugs, including the development of a proposed single application form for such programs. The commissioner may contract with a nongovernmental organization to develop the single application form.

(f)(1) The drug utilization review board shall make recommendations to the commissioner for the adoption of the preferred drug list. The board’s recommendations shall be based upon considerations of clinical efficacy, safety, and cost-effectiveness.

(2) The board shall meet at least quarterly. The board shall comply with the requirements of subchapter 2 of chapter 5 of Title 1 (open meetings) and subchapter 3 of chapter 5 of Title 1 (open records).

(3) To the extent feasible, the board shall review all drug classes included in the preferred drug list at least every 12 months, and may recommend that the commissioner make additions to or deletions from the preferred drug list.

(4) The program shall establish board procedures for the timely review of prescription drugs newly approved by the federal Food and Drug Administration, including procedures for the review of newlyapproved prescription drugs in emergency circumstances.

(5) Members of the board shall receive per diem compensation and reimbursement of expenses in accordance with section 1010 of Title 32.

§ 1999. CONSUMER PROTECTION RULES; PRIOR AUTHORIZATION

(a)(1) The pharmacy best practices and cost control program shall authorize pharmacy benefit coverage when a patient’s health care provider prescribes a prescription drug not on the preferred drug list, or a prescription drug which is not the list’s preferred choice, if either of the circumstances set forth in subdivision (2) or (3) of this subsection applies.

(2)(A) The program shall authorize coverage under the same terms as coverage for preferred choice drugs if the prescriber determines, after consultation with the pharmacist, or with the participating health benefit plan if required by the terms of the plan, that:

(i) the preferred choice has not been effective, or with reasonable certainty is not expected to be effective, in treating the patient’s condition; or

(ii) the preferred choice causes or is reasonably expected to cause adverse or harmful reactions in the patient.

(B) The prescriber’s determination concerning whether the standards established in this subdivision (2) have been demonstrated shall be final.

(3) The program shall authorize coverage if the patient agrees to pay any additional cost in excess of the benefits provided by the patient’s health benefit plan which is participating in the program. The provisions of this subdivision (3) shall not apply to the extent that they may be inconsistent with any federal Medicaid laws and regulations. The provisions of this subdivision (3) shall not affect implementation by a participating health benefit plan of tiered copayments or other similar cost sharing systems.

(b) The program or any participating health benefit plan shall provide information on how prescribers, pharmacists, beneficiaries, and other interested parties can obtain a copy of the preferred drug list, whether any change has been made to the preferred drug list since it was last issued, and the process by which exceptions to the preferred list may be made.

(c) For HIV and AIDS-related medications used by individuals with HIV or AIDS, the preferred drug list and any utilization review procedures shall not be more restrictive than the drug list and the application of the list used for the state of Vermont AIDS medication assistance program.

(d) The program’s prior authorization process shall not apply to prescription drugs prescribed for the treatment of severe and persistent mental illness including schizophrenia, severe depression, or bipolar disorder.

(e)(1) The prior authorization process shall be designed to minimize administrative burdens on prescribers, pharmacists, and consumers. The provisions of this section shall apply to the program’s prior authorization process, except to the extent that different prior authorization rules are established in section 2004 of this title.

(2) The prior authorization process shall ensure real-time receipt of requests, by telephone, voice mail, facsimile, electronic transmission, or mail on a 24-hour basis, seven days a week.

(3) The prior authorization process shall provide an in-person response to emergency requests by a prescriber with telephone answering queues that do not exceed 10 minutes.

(4) Any request for authorization or approval of a drug that the prescriber indicates, including the clinical reasons for the request, is for an emergency or urgent condition shall be responded to in no more than four hours from the time the program or participating health benefit plan receives the request.

(5) In emergency circumstances, or if the response to a request for prior authorization is not provided within the time period established in subdivision (4) of this subsection, a 72-hour supply of the drug prescribed shall be deemed to be authorized by the program or the participating health benefit plan, provided it is a prescription drug approved by the Food and Drug Administration, and provided, for drugs dispensed to a Medicaid beneficiary, it is subject to a rebate agreement with the Centers for Medicare and Medicaid Services.

(6) The program or participating plan shall provide to participating providers a prior authorization request form for each enrolled beneficiary, known to be a patient of the provider, designed to permit the prescriber to make prior authorization requests in advance of the need to fill the prescription, and designed to be completed without unnecessary delay. The form shall be capable of being stamped with information relating to the participating provider, and if feasible at least one form capable of being copied shall contain known patient information.

(f) The program’s prior authorization process shall require that the prescriber, not the pharmacy, request a prior authorization exception to the requirements of this section. The program may exempt a prescriber from the need to secure prior authorization for a specific drug category if the program determines that the prescriber has written a minimum number of scripts in that category, and the prescriber prescribes prescription drugs on the preferred drug list at or above the minimum threshold for that category.

§ 2000. PHARMACY BENEFIT MANAGEMENT

The commissioner may implement all or a portion of the pharmacy best practices and cost control program through a contract with a third party with expertise in the management of pharmacy benefits.

§ 2001. LEGISLATIVE OVERSIGHT

(a) In connection with the pharmacy best practices and cost control program, the commissioner of prevention, assistance, transition, and health access shall report for review by the health access oversight committee, prior to initial implementation, and prior to any subsequent modifications:

(1) the compilation that constitutes the preferred drug list or list of drugs subject to prior authorization or any other utilization review procedures;

(2) any utilization review procedures, including any prior authorization procedures; and

(3) the procedures by which drugs will be identified as preferred on the preferred drug list, and the procedures by which drugs will be selected for prior authorization or any other utilization review procedure.

(b) The health access oversight committee shall closely monitor implementation of the preferred drug list and utilization review procedures to ensure that the consumer protection standards enacted pursuant to section 1999 of this title are not diminished as a result of implementing the preferred drug list and the utilization review procedures, including any unnecessary delay in access to appropriate medications. The committee shall ensure that all affected interests, including consumers, health care providers, pharmacists and others with pharmaceutical expertise have an opportunity to comment on the preferred drug list and procedures reviewed under this subsection.

(c) The commissioner of prevention, assistance, transition, and health access shall report quarterly to the health access oversight committee concerning the following aspects of the pharmacy best practices and cost control program:

(1) the efforts undertaken to educate health care providers about the preferred drug list and the program’s utilization review procedures;

(2) the number of prior authorization requests made; and

(3) the number of utilization review events (other than prior authorization requests).