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2003 Session

Budget Amendments - HB1400 (Conference Report)

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Preferred Drug List Design (language only)

Item 325 #4c

Item 325 #4c

Health And Human Resources
Medical Assistance Services, Department of

Language
Page 322, strike lines 56 through 58 and insert:
"ZZ.1. Notwithstanding § 32.1-331.12 et seq., Code of Virginia, the Department of Medical Assistance Services, in consultation with the Department of Mental Health, Mental Retardation and Substance Abuse Services, shall amend the State Plan for Medical Assistance Services to modify the delivery system of pharmaceutical products to include a Preferred Drug List program no later than January 1, 2004.  In developing the modifications, the Department shall consider input from physicians, pharmacists, pharmaceutical manufacturers, patient advocates, and others, as appropriate.
2.  The Department shall utilize a Pharmacy and Therapeutics Committee to assist in the development and ongoing administration of the Preferred Drug List program.  The Pharmacy and Therapeutics Committee shall be composed of 8 to 12 members, including the Commissioner of the Department of Mental Health, Mental Retardation and Substance Abuse Services, or his designee.  Other members shall be selected or approved by the Department.  The membership shall include a ratio of physicians to pharmacists of 2:1.  Physicians on the Committee shall be licensed in Virginia, one of whom shall be a psychiatrist, and one of whom specializes in care for the aging.    Pharmacists on the Committee shall be licensed in Virginia, one of whom shall have clinical expertise in mental health drugs, and one of whom has clinical expertise in community-based mental health treatment.  The Pharmacy and Therapeutics Committee shall recommend to the Department (i) which therapeutic classes of drugs should be subject to the Preferred Drug List program and prior authorization requirements; (ii) specific drugs within each therapeutic class to be included on the preferred drug list; (iii) appropriate exclusions for medications, including atypical anti-psychotics,
used for the treatment of serious mental illnesses such as bi-polar disorders, schizophrenia, and depression; (iv) appropriate exclusions for medications used for the treatment of brain disorders, cancer and HIV-related conditions; (v) appropriate exclusions for therapeutic classes in which there is only one drug in the therapeutic class or there is very low utilization, or for which it is not cost-effective to include in the Preferred Drug List program; and (vi) appropriate grandfather clauses when prior authorization would interfere with established complex drug regimens that have proven to be clinically effective.  In developing and maintaining the preferred drug list, the cost effectiveness of any given drug shall be considered only after it is determined to be safe and clinically effective.
3.  The Department shall establish a process for acting on the recommendations made by the Pharmacy and Therapeutics Committee, including documentation of any decisions which deviate from the recommendations of the Committee.
4.  The Preferred Drug List program shall include provisions for (i) the dispensing of a 72-hour emergency supply of the prescribed drug when requested by a physician and a dispensing fee to be paid to the pharmacy for such supply; (ii) prior authorization decisions to be made within 24 hours and timely notification of the recipient and/or the prescribing physician of any delays or negative decisions; (iii) an expedited review process of denials by the department; and (iv) consumer and provider education, training and information regarding the Preferred Drug List prior to implementation, and ongoing communications to include computer access to information and multilingual material.
5.  The Preferred Drug List program shall generate savings as determined by the Department that are net of any administrative expenses to implement and administer the program of not less than $9,000,000 in general funds in fiscal year 2004 and not less than $18,000,000 in general funds in each fiscal year thereafter.  The final design of the program, including all operational components, shall be completed no later than April 2, 2003.  The Department shall submit a report on the final main design components of the program to the Chairmen of the House Appropriations and Senate Finance Committees no later than April 1, 2003.
6.  Notwithstanding § 32.1-331.12 et seq., Code of Virginia, to implement these changes, the Department of Medical Assistance Services shall promulgate emergency regulations to become effective within 280 days or less from the enactment of this act. With respect to such state plan amendments and regulations, the provisions of § 32.1-331.12 et seq., Code of Virginia, shall not apply.  In addition, the Department shall work with the Department of Mental Health, Mental Retardation, and Substance Abuse Services to consider utilizing a Preferred Drug List program for its non-Medicaid clients."
Page 323, strike lines 1 through 23.


Explanation
(This amendment adds language setting forth criteria for the design of the Medicaid Preferred Drug List program. The preferred drug list will be implemented no later than January 1, 2004. It directs the Department of Medical Assistance Services to use a Pharmacy and Therapeutics Committee composed of physicians and pharmacists to recommend (a) the therapeutic categories to be included on the Preferred Drug List, (b) appropriate exclusions for certain medications used to treat serious mental illnesses, brain disorders, cancer, and HIV-related conditions, and (c) appropriate grandfather clauses when prior authorization would interfere with established complex drug regimens that have proven to be clinically effective. In developing and maintaining the preferred drug list, the cost effectiveness of any given drug shall be considered only after it is determined to be safe and clinically effective. It requires the department to document any decisions regarding the development of the Preferred Drug List that deviate from the recommendations of the Pharmacy and Therapeutics Committee. It also adds language allowing for a limited supply of an individual's prescription to be covered in an emergency and requires immediate prior authorization decisions and notification of negative decisions to patients and their physicians. It requires patient and physician education and training, and ongoing communications on the program. The design of the program requires savings to the Medicaid pharmacy program of approximately $18 million in general funds annually, net of administrative expenses; however, only $9 million in general fund savings are assumed in fiscal year 2004, since the program would not be implemented until January 1, 2004. Nothing in this language prohibits the Department of Medical Assistance Services from using reference pricing or negotiating supplemental rebates. Language is added to allow for the issuance of emergency regulations to implement the program. Finally, language is added directing the Department of Medical Assistance Services to work with the Department of Mental Health, Mental Retardation, and Substance Abuse Services to consider utilizing a preferred drug list for its non-Medicaid clients.)