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Introduced Version Senate Bill 414 History

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Key: Green = existing Code. Red = new code to be enacted


Senate Bill No. 414

(By Senator Hunter, Unger, Redd, Burnette, Love, Kessler, Minard, Caldwell, Edgell, Rowe, Deem, Ross, Fanning and Bailey)

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[Introduced January 25, 2002; referred to the Committee

on Health and Human Resources; and then to the Committee on Finance.]

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A BILL to amend chapter sixteen of the code of West Virginia, one thousand nine hundred thirty-one, as amended, by adding thereto a new article, designated article twenty-nine-c, relating to the "prescription drug assistance project"; setting forth definitions; providing that the department of health and human resources request a waiver of federal law; providing for eligibility criteria; providing for fees and a copayment schedule; creating the "prescription drug price reduction fund"; setting forth purposes of the fund; setting forth sources for the fund to be funded; providing the secretary of health and human resources may transfer moneys from the fund to elderly low-cost drug programs established or maintained in this state; providing for a rebate agreement with drug manufacturers; providing for a rebate amount; providing for discounted prices for qualified residents; providing for the operation of the program; providing that the department administer the program and other medical and pharmaceutical assistance programs; authorizing the department to coordinate with other programs; requiring the department to propose legislative rules to implement the program; and providing for the drug rebate program.

Be it enacted by the Legislature of West Virginia:
That chapter sixteen of the code of West Virginia, one thousand nine hundred thirty-one, as amended, be amended by adding thereto a new article, designated article twenty-nine-c, to read as follows:
ARTICLE 29C. PRESCRIPTION DRUG PRICE ASSISTANCE PROJECT.
§16-29C-1. Definitions.
(a) "Medicare" means coverage under part A or part B of Title XVIII of the federal Social Security Act (42 U.S.C. 1395 to 1395y);
(b) "Pharmacy discount rate" means the maximum retail price minus the rate of medical assistance available to an eligible participant for a particular drug;
(c) "Poverty line" means the nonfarm federal poverty line for the continental United States, as defined by the federal department of labor under 42 U.S.C. 9902 (2);
(d) "Prescription drug" means a prescription drug manufactured by a manufacturer that enters into a rebate agreement pursuant to the provisions of this article;
(e) "Prescription order" means an order for a prescription drug issued by the department which authorizes the purchase of prescription drugs in excess of the financial limitations otherwise provided for under the provisions of this article;
(f) "Department" means the department of health and human resources.
§16-29C-2. Department to request waiver.
(a) The department shall request a waiver, under 42 U.S.C.1315 (a), of federal medicaid laws necessary to permit the department to conduct a project to expand eligibility for medical assistance to include individuals who meet the requirements specified under subsection (b) of this section.
(b) Notwithstanding any provision of this code to the contrary, a person who is a resident of this state, sixty-five years of age or older, who is otherwise ineligible for medical assistance, whose annual household income, as determined by the department, does not exceed one hundred eighty-five percent of the poverty line for a family the size of the individual's eligible family, who has not had available outpatient prescription drug coverage from any source other than under medical assistance for twelve months, and who pays the project enrollment fee as provided in subsection (c) of this section is eligible for medical assistance for the purposes of purchasing a prescription drug by paying the amounts specified in subsection (c). The person may apply to the department, on a form provided by the department together with a program enrollment fee payment, for a determination of eligibility and issuance of a prescription drug card for purchase of prescription drugs under the provisions of this article.
(c) Project participants shall pay all of the following:
(1) For each twelve-month benefit period, a project enrollment fee of twenty-five dollars;
(2) For each twelve-month benefit period, a deductible paid at the pharmacy discount rate that equals one of the following, except that an individual with an annual household income, as specified in subsection (b) of this section, that exceeds one hundred ten percent but does not exceed one hundred thirty percent of the federal poverty line, three hundred dollars;
(A) For an individual with an annual household income, as specified in subsection (b) of this section, that exceeds one hundred thirty percent but does not exceed one hundred fifty- five percent of the federal poverty line, six hundred dollars;
(B) For an individual with an annual household income, as specified in subsection (b) of this section that exceeds one hundred fifty-five percent but does not exceed one hundred eighty-five percent of the federal poverty line, nine hundred dollars.
(C) For an individual with an annual household income, as specified in subsection (c) of this section, that is less than one hundred ten percent of the federal poverty line and, after payment of the deductible as provided for under subdivision (2), subsection (c) of this section, all of the following:
(i) A copayment of ten dollars for each prescription drug that bears only a generic name; and,
(ii) A copayment of twenty dollars for each prescription drug that does not bear only a generic name.
(d) Under the project under subsection (c) of this section, as a condition of participation by a pharmacy or pharmacist, the pharmacy or pharmacist may not charge an individual who is eligible for medical assistance under subsection (b) of this section and who presents a valid prescription order an amount for a prescription drug under the order that exceeds the amounts specified in subdivisions (2) and (3), subsection (c) of this section.
(e) From the senior prescription drug fund, as provided in section three of this article, the department shall pay the pharmacy or pharmacist for a prescription drug purchased as specified under subdivision (3), subsection (c) of this section, the pharmacy discount rate amount for the drug, less copayments.
(f) The department may not implement the project under this section unless all of the following apply:
(1) A waiver that is consistent with all the provisions of this section is granted and in effect. If the department receives the waiver, at the end of the period during which the waiver remains in effect the department shall request any available extension of the waiver;
(2) Sufficient state and federal funds for the project are available.
(g) If a waiver, as specified under subdivision (1), subsection (f), is granted, the department may not implement the project under this section if a national prescription drug benefit program for seniors is created that would provide similar benefits to a similar population and unless the department first submits a plan for project implementation that is approved by a majority of the members of the Legislature.
§16-29C-3. Creation of prescription drug price reduction fund.
(a) There is hereby created in the state treasury a special revolving fund known as the prescription drug price reduction fund. All moneys deposited or accrued in this fund shall be used exclusively:
(1) To reduce or eliminate the costs associated with the procurement of prescription drugs by and for citizens of this state;
(2) To cover administrative costs incurred by the department of health and human resources associated with the administration and furtherance of its obligations;
(3) To receive revenue from manufacturers who pay rebates as provided in section four of this article and any appropriations or allocations specifically designated for the fund;
(4) To reimburse retail pharmacies for discounted prices provided to qualified residents pursuant to section six of this article;
(5) To reimburse the department of health and human resources for contracted services,administrative and associated computer costs, professional fees paid to participating retail pharmacies and other reasonable program costs; and
(6) To benefit the prescription drug price reduction program.
(b) Moneys from the following sources may be placed into the fund:
(1) All public funds transferred by any public agency to the department of health and human resources prescription drug price reduction program for deposit in the fund as contemplated or permitted by applicable laws;
(2) All private funds contributed, donated or bequeathed by corporations, individuals or other entities to the fund as contemplated and permitted by applicable laws;
(3) Interest which accrued on amounts in the fund from sources identified in subdivisions (1) and (2) of this subsection; and
(4) Any federal financial participation matching the amounts referred to in subdivisions (1), (2) and (3) of this subsection, in accordance with applicable federal law.
(c) Any balance remaining in the senior prescription drug fund at the end of any state fiscal year shall not revert to the state treasury but shall remain in this fund and shall be used only in a manner consistent with this article.
(d) Moneys received into the fund shall not be counted or credited as part of the legislative general appropriation to the state prescription price reduction program.
(e) The fund shall be administered by the department of health and human resources. Moneys shall be disbursed from the fund on a quarterly basis. The secretary of the department shall implement the provisions of this article prior to the receipt of any transfer, contribution, donation or bequest from any public or private source.
(f) Except for the payment of administrative costs as provided in this section, appropriation from this fund for any other purposes is void and prohibited.
(g) Notwithstanding any provision of law to the contrary, surplus funds may also be transferred to any elderly low-cost drug program established or maintained in this state with the approval of the secretary of health and human resources.
§16-29C-4. Rebate agreement.
A drug manufacturer that sells prescription drugs in this state pursuant to any state authorized program requiring discounted prices or any other publicly supported pharmaceutical assistance program shall enter into a rebate agreement with the department for this program. The rebate agreement must require the manufacturer or labeler to make rebate payments to the state each calendar quarter or according to a schedule established by the secretary of health and human resources.
§16-29C-5. Rebate amount.
(a) The secretary of health and human resources shall negotiate the amount of the rebate required from a manufacturer in accordance with this section.
(b)The secretary of health and human resources shall take into consideration the rebate calculated under the Medicaid rebate program pursuant to 42 United States Code, Section 1396r- 8, the average wholesale price of prescription drugs and any other information on prescription drug prices and price discounts.
(c) The secretary of health and human resources shall use his or her best efforts to obtain an initial rebate amount equal to or greater than the rebate calculated under the Medicaid program pursuant to 42 United States Code, Section 1396r-8.
(d) With respect to any rebate, the secretary of the department of health and human resources shall use his or her best efforts to obtain an amount equal to or greater than the amount of any discount, rebate or price reduction for prescription drugs provided to the federal government.
§16-29C-6. Discounted prices for qualified residents.
(a) Any participating retail pharmacy that sells prescription drugs covered by a rebate agreement pursuant to section twelve of this article shall discount the retail price of those drugs sold to qualified residents.
(b) The secretary of the department of health and human resources shall establish discounted prices for drugs covered by a rebate agreement and shall promote the use of efficacious and reduced-cost drugs, taking into consideration reduced prices for state and federally capped drug programs, differential dispensing fees, administrative overhead and incentive payments.
(c) Beginning the first day of January, two thousand four, a participating retail pharmacy shall offer the initial discounted price.
(d) No later than the first day of October, two thousand four, a participating retail pharmacy shall offer the secondary discounted price.
(e) In determining the amount of discounted prices, the secretary of the department of health and human resources shall consider an average of all rebates provided pursuant to section twelve of this article, weighted by sales of drugs subject to these rebates over the most recent twelve-month period for which the information is available.
§16-29C-7. Operation of program.
(a) The requirements of this section apply to participating retail pharmacies.
(b) The West Virginia board of pharmacy shall propose rules for legislative approval in accordance with article three, chapter twenty-nine-a of this code, requiring disclosure by participating retail pharmacies to qualified residents of the amount of savings provided as a result of the program. The rules must consider and protect information that is proprietary in nature.
(c) The secretary of the department of health and human resources may not impose transaction charges under this program on retail pharmacies that submit claims or receive payments under the program.
(d) A participating retail pharmacy shall submit claims to the department to verify the amount charged to qualified residents under sections twelve and thirteen of this article.
(e) On a weekly or biweekly basis, the department of health and human resources must reimburse a participating retail pharmacy for discounted prices provided to qualified residents under section twelve of this article and for professional fees, which must be prescribed by rule proposed for legislative approval in accordance with article three, chapter twenty-nine-a of this code, by the secretary of health and human resources. The amount of the initial professional fee must be set at three dollars per prescription.
(f) The department of health and human resources shall collect utilization data from the participating retail pharmacies submitting claims necessary to calculate the amount of the rebate from the manufacturer. The department shall protect the confidentiality of all information subject to confidentiality protection under state or federal law, rule or regulation.
§16-29C-8. Action with regard to nonparticipating manufacturers.

The names of manufacturers who do not enter into rebate agreements pursuant to this article are public information. The department shall impose prior authorization requirements in the Medicaid program provided under chapter nine of this code, as permitted by law, for the dispensing of prescription drugs provided by those manufacturers.
§16-29C-9. Medical assistance programs.
The department of health and human resources shall administer the program and other medical and pharmaceutical assistance programs, as provided under this article, in a manner that is advantageous to the programs and to the enrollees in those programs. In implementing the requirements of this article the department may coordinate the other programs and this program and may take actions to enhance efficiency, reduce the cost of prescription drugs and maximize the benefits to the programs and enrollees, including providing the benefits of this program to enrollees in other programs.
§16-29C-10. Rule making.
The department shall propose rules for legislative approval
in accordance with article three, chapter twenty-nine-a of this code to implement the provisions of this article.
§16-29C-11. Waivers.
The department may seek any waivers of federal law, rule or regulation necessary to implement the provisions of this article.
§16-29C-12. Drug rebate program.
(a) Effective the first day of May, two thousand five, payment must be denied for drugs from manufacturers that do not enter into a rebate agreement with the department for prescription drugs included in the list of approved drugs under this program. Each agreement must provide that the pharmaceutical manufacturer make rebate payments for both the basic and supplemental components of the program to the department according to the following schedule.
(b) For the quarters beginning the first day of October, two thousand five, the rebate percentage is equal to the percentage recommended by the federal Health Care Financing Administration of the manufacturer?s wholesale price for the total number of dosage units of each form and strength of a prescription drug that the department reports as reimbursed to providers of prescription drugs, provided payments are not due until thirty days following the manufacturer?s receipt of utilization data supplied by the department, including the number of dosage units reimbursed to providers of prescription drugs during the period for which payments are due.
(c) Beginning the first day of October, two thousand seven, the department shall seek to achieve an aggregate rebate amount from all rebate agreements that is six percentage points higher than that required by subsection (b) of this section, provided rebates result in a net increase in the rebate revenue available to the prescription drug price reduction program. In the event the department is not able to achieve the rebate amount required by this subsection without compromising the best interests of recipients of the prescription drug price reduction program, it shall report to the health and human resources committee of each house of the Legislature and the finance committees of each house of the Legislature having jurisdiction over appropriations and financial affairs in the first regular session of the Legislature commencing after it is determined that the requirements of this subsection are not attainable.
(d) Upon receipt of data from the department, the pharmaceutical manufacturer shall calculate the quarterly payment. If a discrepancy is discovered, the department may, at its expense, hire a mutually agreed-upon independent auditor to verify the pharmaceutical manufacturer's calculation. If a discrepancy is discovered, the department shall justify its data or refund any excess payment to the pharmaceutical manufacturer. If the dispute over the rebate amount is not resolved, a request for a hearing with supporting documentation must be submitted to the secretary of health and human resources in accordance with the provisions of article five, chapter twenty-nine-a of this code. Failure to resolve the dispute may be cause for terminating the drug rebate agreement and denying payment to the pharmaceutical manufacturer for any drugs.
(e) Any prescription drug of a manufacturer that does not enter into an agreement is not reimbursable unless the department determines the prescription drug is essential.
(f) All prescription drugs of a pharmaceutical manufacturer that enters into an agreement pursuant to this section that appear on the list of approved drugs under this program must be immediately available and the cost of the drugs must be reimbursed and is not subject to any restrictions or prior authorization requirements, except as provided in this section. If the secretary of the department of health and human resources establishes maximum retail prices for prescription drugs pursuant to the provisions of this article, the department shall propose rules for legislative approval in accordance with the provisions of article three, chapter twenty-nine-a of this code for the prescription drug price reduction program requiring the use of a drug formulary and prior authorization for the dispensing of certain drugs to be listed on a formulary.




NOTE: The purpose of this bill is to provide for the "prescription drug assistance project." In creating the program the bill includes provisions that address the following: Setting forth definitions; providing that the department of health and human resources request a waiver of federal law; providing for eligibility criteria; providing for fees and a copayment schedule; creation of the "prescription drug price reduction fund"; setting forth purposes of the fund; setting forth sources for the fund to be funded; providing the secretary of health and human resources may transfer moneys from the fund to elderly low-cost drug programs established or maintained in this state; providing for a rebate agreement with drug manufacturers; providing for a rebate amount; providing for discounted prices for qualified residents; providing for the operation of the program; providing that the department administer the program and other medical and pharmaceutical assistance programs; authorizing the department to coordinate with other programs; requiring the department to propose legislative rules to implement the program; and, providing for the drug rebate program.

This article is new; therefore, strike-throughs and underscoring have been omitted.




































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