CORRECTIVE REPRINT PRIOR PRINTER'S NOS. 1044, 1816, 1836, PRINTER'S NO. 2117 1889, 2098
No. 888 Session of 2003
INTRODUCED BY VANCE, EACHUS, KENNEY, WALKO, E. Z. TAYLOR, GRUCELA, ADOLPH, BARD, BALDWIN, BARRAR, BASTIAN, BROWNE, BUTKOVITZ, BUXTON, CAPPELLI, CASORIO, CORNELL, CORRIGAN, COSTA, DAILEY, DALLY, J. EVANS, FEESE, FLICK, FREEMAN, GABIG, GERGELY, GILLESPIE, GINGRICH, HARHAI, HARPER, HASAY, HENNESSEY, HERMAN, HERSHEY, HORSEY, JAMES, KELLER, KIRKLAND, LAUGHLIN, LEH, LEWIS, MACKERETH, MAHER, MARSICO, McCALL, McGILL, McNAUGHTON, MELIO, MICOZZIE, R. MILLER, S. MILLER, MUNDY, NAILOR, NICKOL, O'NEILL, PALLONE, PETRARCA, PETRI, PICKETT, PISTELLA, RAYMOND, READSHAW, ROSS, RUBLEY, SAINATO, SAYLOR, SCAVELLO, SCHRODER, SEMMEL, SHANER, SOLOBAY, STEIL, R. STEVENSON, T. STEVENSON, J. TAYLOR, THOMAS, TIGUE, TRAVAGLIO, TURZAI, WANSACZ, WATSON, WEBER, WILT, WRIGHT, YOUNGBLOOD, YUDICHAK, ZUG, FABRIZIO, REED, SAMUELSON, OLIVER, COY, TANGRETTI, HABAY, GEORGE AND GORDNER, MARCH 13, 2003
AS AMENDED ON THIRD CONSIDERATION, HOUSE OF REPRESENTATIVES, JUNE 17, 2003
AN ACT 1 Providing for pharmaceutical assistance for the elderly, for <-- 2 pharmaceutical purchasing, for limited prescription drug 3 redistribution within certain health care facilities and for 4 the Pharmaceutical Assistance Clearinghouse; imposing 5 additional powers and duties on the Department of Aging, the 6 Department of Health, the Department of Public Welfare and 7 the Secretary of Administration; and making repeals. 8 TABLE OF CONTENTS 9 Chapter 1. Preliminary Provisions 10 Section 101. Short title. 11 Chapter 3. Pharmaceutical Matters 12 Subchapter A. Pharmaceutical Assistance for the Elderly
1 Section 301. Legislative findings. 2 Section 302. Definitions. 3 Section 303. Determination of eligibility. 4 Section 304. Physician and pharmacy participation. 5 Section 305. Drug utilization review system. 6 Section 306. Reduced assistance. 7 Section 307. Rebates for expenses prohibited. 8 Section 308. Request for proposal. 9 Section 309. Drug utilization review and therapeutic 10 interchange. 11 Section 310. Program generally. 12 Section 311. Generic drugs. 13 Section 312. Supply. 14 Section 313. Mail service program. 15 Section 314. Indication of price. 16 Section 315. Reimbursement. 17 Section 316. Nonliability. 18 Section 317. Income verification. 19 Section 318. Contract. 20 Section 319. The Pharmaceutical Assistance Contract for the 21 Elderly Needs Enhancement Tier. 22 Section 320. Board. 23 Section 321. Penalties. 24 Section 322. Prescription Drug Education Program. 25 Section 323. Outreach program. 26 Subchapter B. Prudent Pharmaceutical Purchasing 27 Section 341. Definitions. 28 Section 342. Rebate agreement. 29 Section 343. Disposition of funds. 30 Subchapter C. Pharmaceutical Assistance Clearinghouse 20030H0888B2117 - 2 -
1 Section 361. Definitions. 2 Section 362. Pharmaceutical Assistance Clearinghouse. 3 Section 363. Toll-free telephone number. 4 Section 364. Assistance available. 5 Section 365. Reporting. 6 Chapter 51. Miscellaneous Provisions 7 Section 5101. Federal programs. 8 Section 5102. Repeals. 9 Section 5103. Effective date. 10 AMENDING THE ACT OF AUGUST 26, 1971 (P.L.351, NO.91), ENTITLED <-- 11 "AN ACT PROVIDING FOR A STATE LOTTERY AND ADMINISTRATION 12 THEREOF; AUTHORIZING THE CREATION OF A STATE LOTTERY 13 COMMISSION; PRESCRIBING ITS POWERS AND DUTIES; DISPOSITION OF 14 FUNDS; VIOLATIONS AND PENALTIES THEREFOR; EXEMPTION OF PRIZES 15 FROM STATE AND LOCAL TAXATION AND MAKING AN APPROPRIATION," 16 FURTHER PROVIDING FOR DEFINITIONS, FOR REQUEST FOR PROPOSAL, 17 FOR PROGRAM GENERALLY, FOR GENERIC DRUGS, FOR RESTRICTED 18 FORMULARY, FOR REIMBURSEMENT, FOR NONLIABILITY, FOR THE 19 PHARMACEUTICAL ASSISTANCE CONTRACT FOR THE ELDERLY NEEDS 20 ENHANCEMENT TIER, FOR THE PHARMACEUTICAL ASSISTANCE REVIEW 21 BOARD, FOR PENALTIES AND FOR THE PRESCRIPTION DRUG EDUCATION 22 PROGRAM; PROVIDING FOR THE PHARMACY BEST PRACTICES AND COST 23 CONTROL PROGRAM; FURTHER PROVIDING FOR DECLARATION OF POLICY, 24 FOR REBATE AGREEMENT, FOR TERMS OF REBATE AGREEMENT AND FOR 25 AMOUNT OF REBATE; PROVIDING FOR A PHARMACEUTICAL ASSISTANCE 26 CLEARINGHOUSE; FURTHER PROVIDING FOR ANNUAL REPORT TO GENERAL 27 ASSEMBLY; AND PROVIDING FOR CONSTRUCTION WITH FEDERAL 28 PROGRAMS. 29 The General Assembly of the Commonwealth of Pennsylvania 30 hereby enacts as follows: 31 CHAPTER 1 <-- 32 PRELIMINARY PROVISIONS 33 Section 101. Short title. 34 This act shall be known and may be cited as the 35 Pharmaceutical Reform Act. 36 CHAPTER 3 37 PHARMACEUTICAL MATTERS 38 SUBCHAPTER A 39 PHARMACEUTICAL ASSISTANCE FOR THE ELDERLY 20030H0888B2117 - 3 -
1 Section 301. Legislative findings. 2 Finding that an increasing number of this Commonwealth's 3 elderly citizens who are living on fixed incomes are 4 experiencing difficulties in meeting the costs of life- 5 sustaining prescription drugs, the General Assembly, in its 6 responsibilities to provide for the health, welfare and safety 7 of the residents of this Commonwealth, hereby continues a 8 limited State pharmaceutical assistance program for the elderly. 9 Section 302. Definitions. 10 The following words and phrases when used in this subchapter 11 shall have the meanings given to them in this section unless the 12 context clearly indicates otherwise: 13 "A-rated generic therapeutically equivalent drug." A drug 14 product that the Commissioner of Food and Drugs of the United 15 States Food and Drug Administration has approved as safe and 16 effective and has determined to be therapeutically equivalent, 17 as listed in "The Approved Drug Products with Therapeutic 18 Equivalence Evaluations" (Food and Drug Administration "Orange 19 Book"), with a specific "A" code designation only. 20 "Average wholesale cost." The cost of a dispensed drug based 21 upon the price published in a national drug pricing system in 22 current use by the Department of Aging as the average wholesale 23 price of a prescription drug in the most common package size. 24 "Average wholesale price." Average wholesale cost. 25 "Board." The Pharmaceutical Assistance Review Board. 26 "CMS." Center for Medicare and Medicaid Services. 27 "Department." The Department of Aging of the Commonwealth. 28 "Eligible claimant." A resident of this Commonwealth for no 29 less than 90 days, who is 65 years of age and older, whose 30 annual income is less than the maximum annual income and who is 20030H0888B2117 - 4 -
1 not otherwise qualified for public assistance under the act of 2 June 13, 1967 (P.L.31, No.21), known as the Public Welfare Code. 3 "FDA." The United States Food and Drug Administration of the 4 Public Health Service of the Department of Health and Human 5 Services. 6 "Income." All income from whatever source derived, 7 including, but not limited to, salaries, wages, bonuses, 8 commissions, income from self-employment, alimony, support 9 money, cash public assistance and relief, the gross amount of 10 any pensions or annuities, including railroad retirement 11 benefits, all benefits received under the Social Security Act 12 (49 Stat. 620, 42 U.S.C. § 301 et seq.) except Medicare 13 benefits, all benefits received under State unemployment 14 insurance laws and veterans' disability payments, all interest 15 received from the Federal Government or any state government or 16 any instrumentality or political subdivision thereof, realized 17 capital gains, rentals, workmen's compensation and the gross 18 amount of loss of time insurance benefits, life insurance 19 benefits and proceeds, except the first $5,000 of the total of 20 death benefits payments, and gifts of cash or property, other 21 than transfers by gift between members of a household, in excess 22 of a total value of $300, but does not include surplus food or 23 other relief in kind supplied by a government agency or property 24 tax rebate. 25 "Mail service program." A program set forth in section 313 26 to dispense prescription drugs by postal delivery service 27 designated and administered by the department and any entity 28 with which it contracts, upon an enrollee's submission of a 29 prescription and the applicable copayment. 30 "Maintenance drug." A prescription drug prescribed to an 20030H0888B2117 - 5 -
1 individual for a chronic condition the use of which is medically 2 necessary for a consecutive period of at least 60 days. 3 "Maximum annual income." For PACE eligibility, annual income 4 which shall not exceed $14,500 in the case of single persons nor 5 $17,700 in the case of the combined annual income of persons 6 married to each other. Persons may, in reporting income to the 7 Department of Aging, round the amount of each source of income 8 and the income total to the nearest whole dollar, whereby any 9 amount which is less than 50¢ is eliminated. 10 "PACE." The Pharmaceutical Assistance Contract for the 11 Elderly program provided for in this subchapter. 12 "PACENET." The Pharmaceutical Assistance Contract for the 13 Elderly Needs Enhancement Tier provided for in this subchapter. 14 "Pharmacy." A pharmacy licensed by the Commonwealth. 15 "Prescription drug." All drugs requiring a prescription in 16 this Commonwealth, insulin, insulin syringes and insulin 17 needles. Experimental drugs or drugs prescribed for wrinkle 18 removal or hair growth are prohibited. 19 "Private contractor." A person, partnership or corporate 20 entity that enters into a contract with the Commonwealth to 21 provide services under the provisions of this subchapter. 22 "Program." The Pharmaceutical Assistance Contract for the 23 Elderly (PACE) and the Pharmaceutical Assistance Contract for 24 the Elderly Needs Enhancement Tier (PACENET) as established by 25 this subchapter, unless otherwise specified. 26 "Provider." A pharmacy or dispensing physician enrolled as a 27 provider in the program. 28 Section 303. Determination of eligibility. 29 The department shall adopt regulations relating to the 30 determination of eligibility of prospective claimants and 20030H0888B2117 - 6 -
1 providers, including dispensing physicians, and the 2 determination and elimination of program abuse. To this end, the 3 department shall establish a compliance unit staffed 4 sufficiently to fulfill this responsibility. The department 5 shall have the power to declare ineligible any claimant or 6 provider who abuses or misuses the established prescription 7 plan. The department shall have the power to investigate cases 8 of suspected provider or recipient fraud. 9 Section 304. Physician and pharmacy participation. 10 Any physician, pharmacist, pharmacy or corporation owned in 11 whole or in part by a physician or pharmacist enrolled as a 12 provider in the program or that has prescribed medication for a 13 claimant in the program who is precluded or excluded for cause 14 from the Department of Public Welfare's medical assistance 15 program shall be precluded or excluded from participation in the 16 program. No physician precluded or excluded from the Department 17 of Public Welfare's medical assistance program shall have claims 18 resulting from prescriptions paid for by the program. 19 Section 305. Drug utilization review system. 20 The department shall ensure that a state-of-the-art 21 therapeutic drug utilization review system is established to 22 monitor and correct misutilization of drug therapies. 23 Section 306. Reduced assistance. 24 Any eligible claimant whose prescription drug costs are 25 covered in part by any other plan of assistance or insurance may 26 be required to receive reduced assistance under the provisions 27 of this subchapter. 28 Section 307. Rebates for expenses prohibited. 29 A system of rebates or reimbursements to the claimant for 30 prescription drugs shall be prohibited. 20030H0888B2117 - 7 -
1 Section 308. Request for proposal. 2 (a) General.--The department shall prepare a request for 3 proposal for the purpose of providing pharmaceutical assistance 4 for the elderly within this Commonwealth. Upon the adoption of 5 the General Fund budget, the Department of Revenue shall be 6 authorized to transmit the appropriated funds in the State 7 Lottery Fund to the State Treasurer to be deposited in the 8 Pharmaceutical Assistance Contract for the Elderly Fund. This 9 fund shall consist of appropriations and interest and shall be 10 created by the State Treasurer to fund the operations of the 11 program by the department and the private contractor. Funds not 12 expended in the fiscal year in which they were appropriated 13 shall not lapse and shall be available for use in the next 14 fiscal year. 15 (b) Additional requests.--To provide for the continued 16 operation of the program, the department shall prepare, as 17 needed, requests for proposals, in addition to that set forth in 18 subsection (a), for the purpose of providing pharmaceutical 19 assistance for the elderly within this Commonwealth. A request 20 for proposal shall require potential private contractors to 21 submit a proposal for a period of time and with monetary 22 limitations as determined by the department. Upon the enactment 23 of an appropriation from the State Lottery Fund, the Department 24 of Revenue shall be authorized to transmit the appropriated 25 amount to the State Treasurer to be deposited in the 26 Pharmaceutical Assistance Contract for the Elderly Fund. Funds 27 not expended in the fiscal year in which they were appropriated 28 shall not lapse and shall be available for use in the next 29 fiscal year. 30 Section 309. Drug utilization review and therapeutic 20030H0888B2117 - 8 -
1 interchange. 2 (a) Drug utilization review.--The department shall ensure 3 that a state-of-the-art therapeutic drug utilization review 4 system is established to monitor and correct misutilization of 5 drug therapies. 6 (b) Therapeutic interchange.--The department may develop a 7 therapeutic interchange program based on national medical 8 standards that establish therapeutically equivalent drugs which 9 produce identical levels of clinical effectiveness and outcomes. 10 The program shall authorize pharmacy benefit coverage when a 11 patient's health care provider prescribes a prescription drug 12 not in the program if any of the following apply: 13 (1) The program drug: 14 (i) has not been effective in treating the patient's 15 condition; or 16 (ii) is not expected with reasonable certainty to be 17 effective in treating the patient's condition. 18 (2) The program drug causes or is reasonably expected to 19 cause adverse or harmful reactions in the patient. 20 (3) Other clinical criteria approved by the department 21 are complied with. 22 Section 310. Program generally. 23 (a) Parameters of program.--The program shall include the 24 following: 25 (1) Participating pharmacies shall be paid within 21 26 days of the contracting firm receiving the appropriate 27 substantiation of the transaction. Pharmacies shall be 28 entitled to interest for payment not made within the 21-day 29 period at a rate approved by the board. 30 (2) Collection of the copayment by pharmacies shall be 20030H0888B2117 - 9 -
1 mandatory. 2 (3) Senior citizens participating in the program are not 3 required to maintain records of each transaction. 4 (4) A system of rebates or reimbursements to eligible 5 claimants for pharmaceutical expenses shall be prohibited. 6 (5) The copayment amount for generic or multi-source 7 drugs shall be less than the copayment amount for single- 8 source drugs. 9 (6) Payments as follows: 10 (i) Except as provided in subparagraph (ii), to 11 pharmacies on behalf of eligible claimants for costs of 12 the prescription drug in excess of the copayment as 13 provided in subsections (b) and (c), plus a dispensing 14 fee of $3.50 or the dispensing fee established by the 15 department by regulation, whichever is greater. 16 (ii) For A-rated generic therapeutically equivalent 17 drugs, to pharmacies on behalf of eligible claimants for 18 the upper limits established under 42 CFR § 447.332 19 (relating to upper limits for multiple source drugs), 20 plus a dispensing fee of $4 or the dispensing fee 21 established by the department by regulations, whichever 22 is greater. 23 (7) In no case shall the Commonwealth or any person 24 enrolled in the program be charged more than the price of the 25 drug at the particular pharmacy on the date of the sale. 26 (b) Multiple-source drugs.--Except for brand name drugs that 27 are certified in accordance with subsection (d), the department 28 payment for multiple-source drugs must not exceed the amount 29 that would result from the application of the specific limits 30 established in accordance with subsection (e). If a specific 20030H0888B2117 - 10 -
1 limit has not been established under subsection (e), then the 2 rule for "other drugs" set forth in subsection (c) applies. 3 (c) Other drugs.--The department payments for brand name 4 drugs certified in accordance with subsection (d) and drugs 5 other than multiple-source drugs for which a specific limit has 6 been established under subsection (e) must not exceed in the 7 aggregate payment levels that the department has determined by 8 applying the lower of the: 9 (1) Estimated acquisition costs plus reasonable 10 dispensing fees established by the department. 11 (2) Providers' usual and customary charges to the 12 general public. 13 (d) Certification of brand-name drugs.-- 14 (1) The upper limit for payments for multiple-source 15 drugs for which a specific limit has been established under 16 subsection (e) does not apply if a physician certifies in his 17 or her own handwriting that a specific brand is medically 18 necessary for a particular recipient. 19 (2) The department must decide what certification form 20 and procedure are used. 21 (3) A checkoff box on a form is not acceptable but a 22 notation like "brand necessary" is allowable. 23 (4) The department may allow providers to keep the 24 certification forms if the forms will be available for 25 inspection by the department. 26 (e) Establishment and issuance of a listing of multiple- 27 source drugs.-- 28 (1) The department will use the CMS listings that 29 identify and set upper limits for multiple-source drugs that 30 meet the following requirements: 20030H0888B2117 - 11 -
1 (i) All of the formulations of the drug approved by 2 the Food and Drug Administration (FDA) have been 3 evaluated as therapeutically equivalent in the most 4 current edition of their publication, Approved Drug 5 Products with Therapeutic Equivalence Evaluations, 6 including supplements or in successor publications. 7 (ii) At least three suppliers list the drug, which 8 has been classified by the FDA as category "A" in its 9 publication, Approved Drug Products with Therapeutic 10 Equivalence Evaluations, including supplements or in 11 successor publications, based on all listings contained 12 in current editions, or updates, of published compendia 13 of cost information for drugs available for sale in this 14 Commonwealth. 15 (2) The department publishes the list of multiple-source 16 drugs for which upper limits have been established and any 17 revisions to the list in Medicaid program instructions. 18 (3) The department will identify the sources used in 19 compiling these lists. 20 Section 311. Generic drugs. 21 (a) General.--Notwithstanding any other statute or 22 regulation, if an A-rated generic therapeutically equivalent 23 drug is available for dispensing to a claimant, the provider 24 shall dispense the A-rated generic therapeutically equivalent 25 drug to the claimant. The department shall not reimburse 26 providers for brand name products except in the following 27 circumstances: 28 (1) There is no A-rated generic therapeutically 29 equivalent drug available on the market. This paragraph does 30 not apply to the lack of availability of an A-rated generic 20030H0888B2117 - 12 -
1 therapeutically equivalent drug in the providing pharmacy 2 unless it can be shown to the department that the provider 3 made reasonable attempts to obtain the A-rated generic 4 therapeutically equivalent drug or that there was an 5 unforeseeable demand and depletion of the supply of the A- 6 rated generic therapeutically equivalent drug. In either 7 case, the department shall reimburse the provider for 90% of 8 the average wholesale cost plus a dispensing fee based on the 9 least expensive A-rated generic therapeutically equivalent 10 drug for the brand drug dispensed. 11 (2) The Department of Health has determined that a drug 12 shall not be recognized as an A-rated generic therapeutically 13 equivalent drug for purpose of substitution under section 14 5(b) of the act of November 24, 1976 (P.L.1163, No.259), 15 referred to as the Generic Equivalent Drug Law. 16 (3) At the time of dispensing, the provider has a 17 prescription on which the brand name drug dispensed is billed 18 to the program by the provider at a usual and customary 19 charge which is equal to or less than the least expensive 20 usual and customary charge of any A-rated generic 21 therapeutically equivalent drug reasonably available on the 22 market to the provider. 23 (b) Copayment.--If a claimant chooses not to accept the A- 24 rated generic therapeutically equivalent drug required by 25 subsection (a), the claimant shall be liable for the copayment 26 and 70% of the average wholesale cost of the brand name drug. 27 (c) Substitution or construction.--The dispensing of an A- 28 rated generic therapeutically equivalent drug in accordance with 29 this subchapter shall not be deemed incorrect substitution under 30 section 6(a) of the Generic Equivalent Drug Law. 20030H0888B2117 - 13 -
1 (d) Medical exception.--A medical exception process shall be 2 established by the department, which shall be published as a 3 notice in the Pennsylvania Bulletin and distributed to providers 4 and recipients in the program. 5 Section 312. Supply. 6 (a) Requirement.--Except as set forth in subsection (b), 7 prescription benefits for any single prescription shall be 8 limited to a 30-day supply of the prescription drug or 100 9 units, whichever is less for acute conditions. 10 (b) Exceptions.-- 11 (1) In the case of diagnosis for acute conditions, 12 prescription benefits for any single prescription shall be 13 limited to a 15-day supply. 14 (2) Subsection (a) shall not apply to topical ointments 15 or gels which are not available in containers which meet the 16 size and supply restrictions set forth in subsection (a). 17 (c) Subsection (a) does not apply to contracts under section 18 313(c). 19 Section 313. Mail service program. 20 (a) General rule.--The department shall encourage the use of 21 a mail service program for maintenance drugs for eligible 22 claimants. Only mail order pharmacy services provided by 23 pharmacies which are licensed by the Commonwealth and which have 24 their principal place of business within this Commonwealth may 25 participate as providers under the program. 26 (b) Minimum standards of practice.--The department shall 27 develop and promulgate specific regulations governing the 28 practice of mail order pharmacy and other enrolled providers to 29 include the following minimum standards of practice to ensure 30 the health, safety and welfare of program participants: 20030H0888B2117 - 14 -
1 (1) The appropriate method by which pharmacies verify 2 the identity of the eligible claimant and the authenticity of 3 prescriptions received. 4 (2) The appropriate method by which pharmacies mail or 5 deliver prescription drugs ensuring, to the maximum extent 6 possible, that the intended eligible claimant is the actual 7 ultimate recipient of any prescription dispensed. 8 (3) The appropriate method by which pharmacies 9 communicate with eligible claimants in emergency situations. 10 (c) Ninety-day supply.--The department shall negotiate mail 11 order contracts to provide a 90-day supply of drugs to eligible 12 claimants at a single copayment rate equal to a 30-day supply 13 for each order. 14 (d) Option.--An eligible claimant may use the mail service 15 program if the eligible claimant: 16 (1) utilizes a drug deemed by the department to be 17 appropriate for mail order service; 18 (2) has filled a prescription; and 19 (3) has refilled the prescription under paragraph (2) at 20 least once. 21 (e) Rebates.--A mail order contract must include a rebate 22 from the prescription drug manufacturer. The rebate must be at 23 least as much as follows: 24 (1) For a brand-name drug, the sum of subparagraphs (i) 25 and (ii): 26 (i) A dispensing fee of at least $6. 27 (ii) The difference between: 28 (A) the average wholesale price; and 29 (B) 20% of that price. 30 (2) For a generic drug, the sum of subparagraphs (i) and 20030H0888B2117 - 15 -
1 (ii): 2 (i) A dispensing fee of at least $6. 3 (ii) The difference between: 4 (A) the average wholesale price; and 5 (B) 50% of that price. 6 (f) Negotiated payments.--The department shall not 7 discriminate against a pharmacy that agrees to accept negotiated 8 payment levels with the same terms and conditions and to adhere 9 to quality standards established by the PACE and PACENET 10 programs. 11 Section 314. Indication of price. 12 The retail price of the prescription shall be indicated on 13 the label of the prescription container or furnished by separate 14 receipt. 15 Section 315. Reimbursement. 16 (a) Indication.--The department shall indicate third-party 17 coverage for each eligible claimant. 18 (b) Result.--For-profit third-party insurers and not-for- 19 profit prescription plans shall be responsible for any payments 20 made to a providing pharmacy on behalf of a claimant covered by 21 such a third party. 22 Section 316. Nonliability. 23 (a) General.--Any person rendering service as a member of a 24 utilization review committee for this program shall not be 25 liable for any civil damages as a result of any acts or 26 omissions in rendering the service as a member of any such 27 committee except any acts or omissions intentionally designed to 28 harm or any grossly negligent acts or omissions which result in 29 harm to the person receiving such service. 30 (b) Department personnel.--Any officer or employee of the 20030H0888B2117 - 16 -
1 department rendering service as a member of a utilization review 2 committee for this program shall not be liable for any civil 3 damages as a result of any acts or omissions in rendering the 4 service as a member of any such committee or as a result of any 5 decision or action in connection with the program except any 6 acts or omissions intentionally designed to harm or any grossly 7 negligent acts or omissions which result in harm to the person 8 receiving such service. 9 Section 317. Income verification. 10 (a) General.--The department shall annually verify the 11 income of eligible claimants by requiring income documentation 12 from the claimants. An application for benefits under this 13 subchapter shall constitute a waiver to the department of all 14 relevant confidentiality requirements relating to the claimant's 15 Pennsylvania State income tax information in the possession of 16 the Department of Revenue. The Department of Revenue shall 17 provide the department with the necessary income information 18 shown on the claimant's Pennsylvania State income tax return 19 solely for income verification purposes. 20 (b) Unlawful act.--It shall be unlawful for any officer, 21 agent or employee of the department to divulge or make known in 22 any manner whatsoever any information gained through access to 23 the Department of Revenue information except for official income 24 verification purposes under this subchapter. 25 (c) Penalty.--A person who violates this chapter commits a 26 misdemeanor and shall, upon conviction, be sentenced to pay a 27 fine of not more than $1,000 or to imprisonment for not more 28 than one year, or both, together with the cost of prosecution, 29 and, if the offender is an officer or employee of the 30 Commonwealth, he shall be dismissed from office or discharged 20030H0888B2117 - 17 -
1 from employment. 2 (d) Coordination of effort.--To the extent possible, the 3 department and the Department of Public Welfare shall coordinate 4 efforts to facilitate the application and enrollment of eligible 5 older people in the Medicaid Healthy Horizons Program by 6 processing these applications at senior citizens centers and 7 other appropriate facilities providing services to the elderly. 8 Section 318. Contract. 9 The department is authorized to enter into a contract 10 providing for prescription drugs to eligible persons pursuant to 11 this subchapter. The department shall select a proposal that 12 includes, but is not limited to, the criteria set forth in this 13 subchapter. 14 Section 319. The Pharmaceutical Assistance Contract for the 15 Elderly Needs Enhancement Tier. 16 (a) Establishment.--There is hereby established within the 17 department a program to be known as the Pharmaceutical 18 Assistance Contract for the Elderly Needs Enhancement Tier 19 (PACENET). 20 (b) Eligibility.--A claimant with an annual income of not 21 less than $14,500 and not more than $22,450 in the case of a 22 single person and of not less than $17,770 and not more than 23 $30,300 in the case of the combined income of persons married to 24 each other shall be eligible for enhanced pharmaceutical 25 assistance under this section. A person may, in reporting income 26 to the department, round the amount of each source of income and 27 the income total to the nearest whole dollar, whereby any amount 28 which is less than 50¢ is eliminated. 29 (c) Requirements.--Upon enrollment in PACENET, eligible 30 claimants in the income ranges set forth in subsection (b) shall 20030H0888B2117 - 18 -
1 be required to meet a monthly deductible in unreimbursed 2 prescription drug expenses of $40 per person per month. To 3 qualify for the deductible set forth in this subsection the 4 prescription drug must be purchased for the use of the eligible 5 claimant from a provider as defined in this subchapter. The 6 department, after consultation with the board, shall approve an 7 adjustment in the deductible on an annual basis. 8 (d) Copayment.--The copayment amount for generic or multi- 9 source drugs shall be less than the copayment amount for single- 10 source drugs. 11 Section 320. Board. 12 (a) General.--The Pharmaceutical Assistance Review Board is 13 continued to ensure that the program is providing and continues 14 to provide the assistance intended in a fiscally responsible 15 manner without excessively hampering the pharmacy industry. 16 (b) Membership.--The board shall be comprised of the 17 following eight persons: 18 (1) The Secretary of Aging, who shall serve as its 19 chairman. 20 (2) The Secretary of Revenue. 21 (3) The Secretary of Health. 22 (4) Five public members, one appointed by the President 23 pro tempore of the Senate, one appointed by the Minority 24 Leader of the Senate, one appointed by the Speaker of the 25 House of Representatives, one appointed by the Minority 26 Leader of the House of Representatives and one appointed by 27 the Governor. Those appointed by the legislative officers 28 shall include two senior citizens who have not been a part of 29 the pharmacy industry to serve as consumer advocates, one 30 representative of the pharmacy industry and one practicing 20030H0888B2117 - 19 -
1 Pennsylvania pharmacist. The individual appointed by the 2 Governor must be a physician. A public member who misses two 3 consecutive meetings without good cause acceptable to the 4 chairman shall be replaced by the appointing authority. 5 (c) Annual review.--Using the annual report submitted by the 6 department pursuant to section 2102 of the act of August 26, 7 1971 (P.L.351, No.91), known as the State Lottery Law, and other 8 appropriate data sources, the board shall conduct an annual 9 review. The board shall develop recommendations concerning any 10 changes in the level of copayment, deductible or in the level of 11 fees paid to participating pharmacists. The board shall review 12 the department's therapeutic drug utilization review program on 13 an ongoing basis. The board may also recommend other changes in 14 the structure of the program and direct the department to enter 15 into discussions with the private contractor concerning 16 amendments to the contract, or the department may enter into 17 such discussion if it deems necessary. The copayment or 18 deductible schedule shall only be adjusted on an annual basis. 19 (d) Meetings.--The board shall meet at least two times per 20 year. 21 Section 321. Penalties. 22 (a) General.--It shall be unlawful for any person to: 23 (1) Submit a false or fraudulent claim or application 24 under this subchapter, including, but not limited to: 25 (i) aiding or abetting another in the submission of 26 a false or fraudulent claim or application; 27 (ii) receiving benefits or reimbursement under a 28 Federal, state or a private program for prescription 29 assistance and claiming or receiving duplicative benefits 30 hereunder; 20030H0888B2117 - 20 -
1 (iii) soliciting, receiving, offering or paying any 2 kickback, bribe or rebate, in cash or in kind, from or to 3 any person in connection with the furnishing of services 4 under this subchapter; 5 (iv) engaging in a pattern of submitting claims that 6 repeatedly uses incorrect National Drug Code numbers for 7 the purpose of obtaining wrongful enhanced reimbursement; 8 or 9 (v) otherwise violating any provision of this 10 subchapter. 11 (2) Charge a copay if the amount of the copay exceeds 12 the actual cost of the drug purchased. 13 (b) Civil penalty.--In addition to any appropriate criminal 14 penalty for prohibited acts under this subchapter whether or not 15 that act constitutes a crime under 18 Pa.C.S. (relating to 16 crimes and offenses), a provider who violates this section may 17 be liable for a civil penalty, which shall be collected by the 18 department, in an amount not less than $500 and not more than 19 $10,000 for each violation of this chapter. Each violation 20 constitutes a separate offense. If the department collects three 21 or more civil penalties against the same provider, the provider 22 shall be ineligible to participate in either PACE or PACENET for 23 a period of one year. If more than three civil penalties are 24 collected from any provider, the department may determine that 25 the provider is permanently ineligible to participate in PACE or 26 PACENET. 27 (c) Suspension.--The license of any provider who has been 28 found guilty under this subchapter shall be suspended for a 29 period of one year. The license of any provider who has 30 committed three or more violations of this subchapter may be 20030H0888B2117 - 21 -
1 suspended for a period of one year. 2 (d) Reparation.--Any provider, recipient or other person who 3 is found guilty of a crime for violating this subchapter shall 4 repay three times the value of the material gain received. In 5 addition to the civil penalty authorized pursuant to subsection 6 (b), the department may require the provider, recipient or other 7 person to repay up to three times the value of any material gain 8 to PACE or PACENET. 9 Section 322. Prescription Drug Education Program. 10 The department, in cooperation with the Department of Health, 11 shall develop and implement a Statewide prescription drug 12 education program designed to inform older adults of the dangers 13 of prescription drug abuse and misuse. The prescription dug 14 education program shall include, but not be limited to, 15 information concerning the following: 16 (1) The hazards of prescription drug overdose. 17 (2) The potential dangers of mixing prescription drugs. 18 (3) The danger of retaining unused prescription drugs 19 after the need to take them no longer exists. 20 (4) The necessity to carefully question physicians and 21 pharmacists concerning the effects of taking prescription 22 drugs. 23 (5) The advisability of maintaining a prescription drug 24 profile or other record of prescription drug dosage and 25 frequency of dosage. 26 (6) The desirability of advising family members of the 27 types and proper dosage of prescription drugs which are being 28 taken. 29 (7) The dangers of taking prescription drugs in excess 30 of prescribed dosages. 20030H0888B2117 - 22 -
1 (8) The need to obtain complete, detailed directions 2 from the physician or pharmacist concerning the time period a 3 prescription drug should be taken. 4 Section 323. Outreach program. 5 The department, in consultation with appropriate Commonwealth 6 agencies, shall coordinate the development of an outreach plan 7 to inform potential contractors, providers and enrollees 8 regarding eligibility and available benefits of the PACE and 9 PACENET programs. The plan shall include provisions for reaching 10 special populations, including nonwhite and non-English-speaking 11 people; for reaching different geographic areas, including rural 12 and inner-city areas; and for assuring that special efforts are 13 coordinated within the overall outreach activities throughout 14 this Commonwealth. 15 SUBCHAPTER B 16 PRUDENT PHARMACEUTICAL PURCHASING 17 Section 341. Definitions. 18 The following words and phrases when used in this subchapter 19 shall have the meanings given to them in this section unless the 20 context clearly indicates otherwise: 21 "Covered prescription drug." A legend drug, insulin, an 22 insulin syringe or an insulin needle eligible for payment by the 23 Commonwealth under PACE, PACENET or designated pharmaceutical 24 programs. 25 "Designated pharmaceutical programs." The general assistance 26 program and the Special Pharmaceutical Benefit Program in the 27 Department of Public Welfare and the End Stage Renal Dialysis 28 Program in the Department of Health. 29 "PACE." The program under Subchapter A. 30 "PACENET." The program established under section 319. 20030H0888B2117 - 23 -
1 Section 342. Rebate agreement. 2 PACE, PACENET and designated pharmaceutical programs shall 3 reimburse for any covered prescription drug with a rebate 4 agreement drafted on the same basis as provided in section 1927 5 of Title XIX of the Social Security Act (49 Stat. 620, 42 U.S.C. 6 § 1396 r-8). 7 Section 343. Disposition of funds. 8 (a) PACE and PACENET.--Money received under this subchapter 9 in connection with PACE and PACENET shall be deposited in the 10 Pharmaceutical Assistance Contract for the Elderly Fund. 11 (b) Pharmaceutical programs.--Money received under this 12 subchapter in connection with designated pharmaceutical programs 13 shall be treated as a refund of expenditures to the 14 appropriation which originally provided the funding for the 15 pharmaceutical purchase. 16 SUBCHAPTER C 17 PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE 18 Section 361. Definitions. 19 The following words and phrases when used in this subchapter 20 shall have the meanings given to them in this section unless the 21 context clearly indicates otherwise: 22 "Clearinghouse." The Pharmaceutical Assistance Clearinghouse 23 established in section 362. 24 "Department." The Department of Aging of the Commonwealth. 25 "Patient assistance program." A program offered by a 26 pharmaceutical manufacturer under which the manufacturer 27 provides prescription medications at no charge or at a 28 substantially reduced cost. The term does not include the 29 provision of a drug as part of a clinical trial. 30 Section 362. Pharmaceutical Assistance Clearinghouse. 20030H0888B2117 - 24 -
1 (a) Establishment.--Within 120 days of the effective date of 2 this subchapter, the department shall establish the 3 Pharmaceutical Assistance Clearinghouse. Each pharmaceutical 4 manufacturer that does business in this Commonwealth and offers 5 a patient assistance program shall inform the department of all 6 of the following: 7 (1) The existence of the patient assistance program. 8 (2) The eligibility requirements for the patient 9 assistance program. 10 (3) The drugs covered by the patient assistance program. 11 (4) Information, such as a telephone number, which may 12 be used to apply for the patient assistance program. 13 (b) Information.--The clearinghouse shall maintain the 14 information submitted by pharmaceutical manufacturers and make 15 it available to the public. 16 (c) Staff.--The department shall ensure that the 17 clearinghouse is staffed at least during normal business hours. 18 The department shall contract for the services of a school of 19 pharmacy to staff the clearinghouse. 20 Section 363. Toll-free telephone number. 21 The department shall establish a toll-free telephone number 22 through which the members of the public may obtain information 23 from the clearinghouse about available patient assistance 24 programs. 25 Section 364. Assistance available. 26 (a) Direct.-- 27 (1) The clearinghouse shall assist any individual in 28 determining whether a patient assistance program is offered 29 for a particular drug and whether the individual may be 30 eligible to obtain the drug through a patient assistance 20030H0888B2117 - 25 -
1 program. 2 (2) The clearinghouse may assist an individual who 3 wishes to apply for a patient assistance program by assisting 4 with the preparation of an application and coordinating 5 communications between the individual's physician and a 6 pharmaceutical manufacturer on behalf of the individual for 7 the purpose of obtaining approval to participate in the 8 patient assistance program. 9 (b) Referrals.--The clearinghouse shall make referrals to 10 any publicly funded program for which it deems a patient 11 eligible. 12 Section 365. Reporting. 13 The department shall report annually to the Governor and the 14 General Assembly on the activities of the clearinghouse. The 15 report shall include: 16 (1) The number of individuals who have been assisted by 17 the clearinghouse. 18 (2) The number and benefits of patient assistance 19 programs listed with the clearinghouse. 20 (3) The number of patients referred to publicly funded 21 programs under section 364(b). Programs under this paragraph 22 include the Pharmaceutical Assistance Contract for the 23 Elderly Program, medical assistance and programs of the 24 Department of Veterans Affairs. 25 (4) Other information deemed relevant by the department. 26 CHAPTER 51 27 MISCELLANEOUS PROVISIONS 28 Section 5101. Federal programs. 29 If the Federal Government enacts programs similar to PACE or 30 PACENET, the State programs shall be construed to only 20030H0888B2117 - 26 -
1 supplement the Federal programs and all persons qualified for 2 coverage under the Federal program shall utilize that Federal 3 program before utilizing any State program. 4 Section 5102. Repeals. 5 (a) Specific.--Chapters 5 and 7 of the act of August 26, 6 1971 (P.L.351, No.91), known as the State Lottery Law, are 7 repealed. 8 (b) General.--All other acts and parts of acts are repealed 9 insofar as they are inconsistent with this act. 10 Section 5103. Effective date. 11 This act shall take effect immediately. 12 SECTION 1. THE DEFINITIONS OF "HCFA" AND "MAXIMUM ANNUAL <-- 13 INCOME" IN SECTION 502 OF THE ACT OF AUGUST 26, 1971 (P.L.351, 14 NO.91), KNOWN AS THE STATE LOTTERY LAW, ADDED NOVEMBER 21, 1996 15 (P.L.741, NO.134), ARE AMENDED AND THE SECTION IS AMENDED BY 16 ADDING A DEFINITION TO READ: 17 SECTION 502. DEFINITIONS. 18 THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS CHAPTER 19 SHALL HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE 20 CONTEXT CLEARLY INDICATES OTHERWISE: 21 * * * 22 "CMS." THE CENTERS FOR MEDICARE AND MEDICAID SERVICES OF THE 23 UNITED STATES. 24 * * * 25 ["HCFA." THE HEALTH CARE FINANCING ADMINISTRATION OF THE 26 UNITED STATES.] 27 "INCOME." ALL INCOME FROM WHATEVER SOURCE DERIVED, 28 INCLUDING, BUT NOT LIMITED TO, SALARIES, WAGES, BONUSES, 29 COMMISSIONS, INCOME FROM SELF-EMPLOYMENT, ALIMONY, SUPPORT 30 MONEY, CASH PUBLIC ASSISTANCE AND RELIEF, THE GROSS AMOUNT OF 20030H0888B2117 - 27 -
1 ANY PENSIONS OR ANNUITIES, INCLUDING RAILROAD RETIREMENT 2 BENEFITS, ALL BENEFITS RECEIVED UNDER THE SOCIAL SECURITY ACT 3 (49 STAT. 620, 42 U.S.C. § 301 ET. SEQ.) (EXCEPT MEDICARE 4 BENEFITS), ALL BENEFITS RECEIVED UNDER STATE UNEMPLOYMENT 5 INSURANCE LAWS AND VETERANS' DISABILITY PAYMENTS, ALL INTEREST 6 RECEIVED FROM THE FEDERAL GOVERNMENT OR ANY STATE GOVERNMENT OR 7 ANY INSTRUMENTALITY OR POLITICAL SUBDIVISION THEREOF, REALIZED 8 CAPITAL GAINS, RENTALS, WORKMEN'S COMPENSATION AND THE GROSS 9 AMOUNT OF LOSS OF TIME INSURANCE BENEFITS, LIFE INSURANCE 10 BENEFITS AND PROCEEDS, EXCEPT THE FIRST [$5,000] $10,000 OF THE 11 TOTAL OF DEATH BENEFITS PAYMENTS, AND GIFTS OF CASH OR PROPERTY, 12 OTHER THAN TRANSFERS BY GIFT BETWEEN MEMBERS OF A HOUSEHOLD, IN 13 EXCESS OF A TOTAL VALUE OF $300, BUT SHALL NOT INCLUDE SURPLUS 14 FOOD OR OTHER RELIEF IN KIND SUPPLIED BY A GOVERNMENT AGENCY OR 15 PROPERTY TAX REBATE. 16 "MAXIMUM ANNUAL INCOME." FOR PACE ELIGIBILITY, THE TERM 17 SHALL MEAN ANNUAL INCOME WHICH SHALL NOT EXCEED [$14,000] 18 $14,500 IN THE CASE OF SINGLE PERSONS NOR [$17,200] $17,700 IN 19 THE CASE OF THE COMBINED ANNUAL INCOME OF PERSONS MARRIED TO 20 EACH OTHER. PERSONS MAY, IN REPORTING INCOME TO THE DEPARTMENT 21 OF AGING, ROUND THE AMOUNT OF EACH SOURCE OF INCOME AND THE 22 INCOME TOTAL TO THE NEAREST WHOLE DOLLAR, WHEREBY ANY AMOUNT 23 WHICH IS LESS THAN 50¢ IS ELIMINATED. 24 * * * 25 SECTION 2. SECTIONS 508(A), 509, 510(A) AND (B), 512, 515, 26 516, 519 AND 520(B) OF THE ACT, ADDED NOVEMBER 21, 1996 27 (P.L.741, NO.134), ARE AMENDED TO READ: 28 SECTION 508. REQUEST FOR PROPOSAL. 29 (A) GENERAL RULE.--THE DEPARTMENT SHALL PREPARE A REQUEST 30 FOR PROPOSAL FOR THE PURPOSE OF PROVIDING PHARMACEUTICAL 20030H0888B2117 - 28 -
1 ASSISTANCE FOR THE ELDERLY WITHIN THIS COMMONWEALTH BEGINNING AT 2 THE EXPIRATION, INCLUDING ANY OPTION YEARS THE DEPARTMENT 3 CHOOSES TO EXERCISE, OF THE CURRENT VENDOR CONTRACT. UPON THE 4 ADOPTION OF THE GENERAL FUND BUDGET, THE DEPARTMENT OF REVENUE 5 SHALL BE AUTHORIZED TO TRANSMIT THE APPROPRIATED FUNDS IN THE 6 STATE LOTTERY FUND TO THE STATE TREASURER TO BE DEPOSITED IN THE 7 PHARMACEUTICAL ASSISTANCE CONTRACT FOR THE ELDERLY FUND. THIS 8 FUND SHALL CONSIST OF APPROPRIATIONS AND INTEREST AND SHALL BE 9 CREATED BY THE STATE TREASURER TO FUND THE OPERATIONS OF THE 10 PROGRAM BY THE DEPARTMENT AND THE PRIVATE CONTRACTOR. FUNDS NOT 11 EXPENDED IN THE FISCAL YEAR IN WHICH THEY WERE APPROPRIATED 12 SHALL NOT LAPSE AND BE AVAILABLE FOR USE IN THE NEXT FISCAL 13 YEAR. 14 * * * 15 SECTION 509. PROGRAM GENERALLY. 16 THE PROGRAM SHALL INCLUDE THE FOLLOWING: 17 (1) PARTICIPATING PHARMACIES SHALL BE PAID WITHIN 21 18 DAYS OF THE CONTRACTING FIRM RECEIVING THE APPROPRIATE 19 SUBSTANTIATION OF THE TRANSACTION. PHARMACIES SHALL BE 20 ENTITLED TO INTEREST FOR PAYMENT NOT MADE WITHIN THE 21-DAY 21 PERIOD AT A RATE APPROVED BY THE BOARD. 22 (2) COLLECTION OF THE COPAYMENT BY PHARMACIES SHALL BE 23 MANDATORY. 24 (3) SENIOR CITIZENS PARTICIPATING IN THE PROGRAM ARE NOT 25 REQUIRED TO MAINTAIN RECORDS OF EACH TRANSACTION. 26 (4) A SYSTEM OF REBATES OR REIMBURSEMENTS TO ELIGIBLE 27 CLAIMANTS FOR PHARMACEUTICAL EXPENSES SHALL BE PROHIBITED. 28 (5) PACE SHALL INCLUDE [A] PARTICIPANT COPAYMENT 29 [SCHEDULE] SCHEDULES FOR EACH PRESCRIPTION, INCLUDING A 30 COPAYMENT FOR GENERIC OR MULTIPLE-SOURCE DRUGS THAT IS LESS 20030H0888B2117 - 29 -
1 THAN THE COPAYMENT FOR SINGLE-SOURCE DRUGS. THE COPAYMENT 2 [MAY INCREASE OR DECREASE] SHALL BE INCREASED OR DECREASED ON 3 AN ANNUAL BASIS BY THE AVERAGE PERCENT CHANGE OF INGREDIENT 4 COSTS FOR ALL PRESCRIPTION DRUGS, PLUS A DIFFERENTIAL TO 5 RAISE THE COPAYMENT TO THE NEXT HIGHEST 25¢ INCREMENT. IN 6 ADDITION, THE DEPARTMENT MAY APPROVE A REQUEST FOR INCREASE 7 OR DECREASE IN THE LEVEL OF COPAYMENT BASED UPON THE 8 FINANCIAL EXPERIENCE AND PROJECTIONS OF PACE AND AFTER 9 CONSULTATION WITH THE BOARD. THE DEPARTMENT IS PROHIBITED 10 FROM APPROVING ADJUSTMENTS TO THE COPAYMENT ON MORE THAN AN 11 ANNUAL BASIS. 12 (6) THE PROGRAM SHALL CONSIST OF PAYMENTS TO PHARMACIES 13 ON BEHALF OF ELIGIBLE CLAIMANTS FOR 90% OF THE AVERAGE 14 WHOLESALE COSTS OF PRESCRIPTION DRUGS WHICH EXCEED THE 15 COPAYMENT, PLUS A DISPENSING FEE OF AT LEAST [$3.50] $4 OR 16 THE DISPENSING FEE ESTABLISHED BY THE DEPARTMENT BY 17 REGULATION, WHICHEVER IS GREATER. 18 (7) IN NO CASE SHALL THE COMMONWEALTH OR ANY PERSON 19 ENROLLED IN THE PROGRAM BE CHARGED MORE THAN THE PRICE OF THE 20 DRUG AT THE PARTICULAR PHARMACY ON THE DATE OF THE SALE. 21 (8) THE GOVERNOR MAY, BASED UPON CERTIFIED STATE LOTTERY 22 FUND REVENUE THAT IS PROVIDED TO BOTH THE CHAIRMAN AND 23 MINORITY CHAIRMAN OF THE APPROPRIATIONS COMMITTEE OF THE 24 SENATE AND THE CHAIRMAN AND MINORITY CHAIRMAN OF THE 25 APPROPRIATIONS COMMITTEE OF THE HOUSE OF REPRESENTATIVES, AND 26 AFTER CONSULTATION WITH THE BOARD, INCREASE THE ELIGIBILITY 27 LIMITS ABOVE THOSE ESTABLISHED IN THIS CHAPTER. 28 SECTION 510. GENERIC DRUGS. 29 (A) IN GENERAL.--NOTWITHSTANDING ANY OTHER STATUTE OR 30 REGULATION, IF AN A-RATED GENERIC THERAPEUTICALLY EQUIVALENT 20030H0888B2117 - 30 -
1 DRUG IS AVAILABLE FOR DISPENSING TO A CLAIMANT, THE PROVIDER 2 SHALL DISPENSE THE A-RATED GENERIC THERAPEUTICALLY EQUIVALENT 3 DRUG TO THE CLAIMANT. THE DEPARTMENT SHALL NOT REIMBURSE 4 PROVIDERS FOR BRAND NAME PRODUCTS EXCEPT IN THE FOLLOWING 5 CIRCUMSTANCES: 6 (1) THERE IS NO A-RATED GENERIC THERAPEUTICALLY 7 EQUIVALENT DRUG AVAILABLE ON THE MARKET. THIS PARAGRAPH DOES 8 NOT APPLY TO THE LACK OF AVAILABILITY OF AN A-RATED GENERIC 9 THERAPEUTICALLY EQUIVALENT DRUG IN THE PROVIDING PHARMACY 10 UNLESS IT CAN BE SHOWN TO THE DEPARTMENT THAT THE PROVIDER 11 MADE REASONABLE ATTEMPTS TO OBTAIN THE A-RATED GENERIC 12 THERAPEUTICALLY EQUIVALENT DRUG OR THAT THERE WAS AN 13 UNFORESEEABLE DEMAND AND DEPLETION OF THE SUPPLY OF THE A- 14 RATED GENERIC THERAPEUTICALLY EQUIVALENT DRUG. IN EITHER 15 CASE, THE DEPARTMENT SHALL REIMBURSE THE PROVIDER [FOR 90% OF 16 THE AVERAGE WHOLESALE COST PLUS A DISPENSING FEE BASED ON THE 17 LEAST EXPENSIVE A-RATED GENERIC THERAPEUTICALLY EQUIVALENT 18 DRUG FOR THE BRAND DRUG DISPENSED.] BASED UPON THE MOST 19 CURRENT LISTING OF FEDERAL UPPER PAYMENT LIMITS ESTABLISHED 20 UNDER THE MEDICAID PROGRAM AS PROVIDED UNDER FEDERAL 21 REGULATIONS AT 42 CFR 447.332 (RELATING TO UPPER LIMITS FOR 22 MULTIPLE SOURCE DRUGS), IN ACCORDANCE WITH SECTION 23 1902(A)(30)(A) OF THE SOCIAL SECURITY ACT (49 STAT. 620, 42 24 U.S.C. § 1396A(A)(30)(A)), PLUS A DISPENSING FEE. THE 25 DEPARTMENT SHALL REVIEW THE FEDERAL UPPER PAYMENT LIMITS 26 EVERY 12 MONTHS. 27 (2) AN A-RATED GENERIC THERAPEUTICALLY EQUIVALENT DRUG 28 IS DEEMED BY THE DEPARTMENT, IN CONSULTATION WITH A 29 UTILIZATION REVIEW COMMITTEE, TO HAVE TOO NARROW A 30 THERAPEUTIC INDEX FOR SAFE AND EFFECTIVE DISPENSING IN THE 20030H0888B2117 - 31 -
1 COMMUNITY SETTING. THE DEPARTMENT SHALL NOTIFY PROVIDING 2 PHARMACIES OF A-RATED GENERIC THERAPEUTICALLY EQUIVALENT 3 DRUGS THAT ARE IDENTIFIED PURSUANT TO THIS PARAGRAPH ON A 4 REGULAR BASIS. 5 (3) THE DEPARTMENT OF HEALTH HAS DETERMINED THAT A DRUG 6 SHALL NOT BE RECOGNIZED AS AN A-RATED GENERIC THERAPEUTICALLY 7 EQUIVALENT DRUG FOR PURPOSE OF SUBSTITUTION UNDER SECTION 8 5(B) OF THE ACT OF NOVEMBER 24, 1976 (P.L.1163, NO.259), 9 REFERRED TO AS THE GENERIC EQUIVALENT DRUG LAW. 10 (4) AT THE TIME OF DISPENSING, THE PROVIDER HAS A 11 PRESCRIPTION ON WHICH THE BRAND NAME DRUG DISPENSED IS BILLED 12 TO THE PROGRAM BY THE PROVIDER AT A USUAL AND CUSTOMARY 13 CHARGE WHICH IS EQUAL TO OR LESS THAN THE LEAST EXPENSIVE 14 USUAL AND CUSTOMARY CHARGE OF ANY A-RATED GENERIC 15 THERAPEUTICALLY EQUIVALENT DRUG REASONABLY AVAILABLE ON THE 16 MARKET TO THE PROVIDER. 17 (B) GENERIC NOT ACCEPTED.--[IF] EXCEPT AS PROVIDED IN 18 CHAPTER 6 IF A CLAIMANT CHOOSES NOT TO ACCEPT THE A-RATED 19 GENERIC THERAPEUTICALLY EQUIVALENT DRUG REQUIRED BY SUBSECTION 20 (A), THE CLAIMANT SHALL BE LIABLE FOR THE COPAYMENT AND 70% OF 21 THE AVERAGE WHOLESALE COST OF THE BRAND NAME DRUG. 22 * * * 23 SECTION 512. RESTRICTED FORMULARY. 24 THE DEPARTMENT MAY ESTABLISH A RESTRICTED FORMULARY OF THE 25 DRUGS WHICH WILL NOT BE REIMBURSED BY THE PROGRAM. THIS 26 FORMULARY SHALL INCLUDE ONLY EXPERIMENTAL DRUGS AND DRUGS ON THE 27 DRUG EFFICACY STUDY IMPLEMENTATION LIST PREPARED BY [THE HEALTH 28 CARE FINANCE ADMINISTRATION] CMS. A MEDICAL EXCEPTION MAY BE 29 PERMITTED BY THE DEPARTMENT FOR REIMBURSEMENT OF A DRUG ON THE 30 DRUG EFFICACY STUDY IMPLEMENTATION LIST UPON DECLARATION OF ITS 20030H0888B2117 - 32 -
1 NECESSITY ON THE PRESCRIPTION BY THE TREATING PHYSICIAN, EXCEPT 2 THAT, FOR DESI DRUGS FOR WHICH THE FDA HAS ISSUED A NOTICE FOR 3 OPPORTUNITY HEARING (NOOH) FOR THE PURPOSE OF WITHDRAWING THE 4 NEW DRUG APPLICATION APPROVED FOR THAT DRUG, REIMBURSEMENT 5 COVERAGE SHALL BE DISCONTINUED UNDER THE PROVISIONS OF THIS 6 CHAPTER. 7 SECTION 515. REIMBURSEMENT. 8 FOR-PROFIT THIRD-PARTY INSURERS, HEALTH MAINTENANCE 9 ORGANIZATIONS AND NOT-FOR-PROFIT PRESCRIPTION PLANS SHALL BE 10 RESPONSIBLE FOR ANY PAYMENTS MADE TO A PROVIDING PHARMACY ON 11 BEHALF OF A CLAIMANT COVERED BY SUCH A THIRD PARTY. 12 SECTION 516. NONLIABILITY. 13 (A) [PERSONS RENDERING SERVICE] GENERAL RULE.--ANY PERSON 14 RENDERING SERVICE AS A MEMBER OF A UTILIZATION REVIEW COMMITTEE 15 FOR THIS PROGRAM SHALL NOT BE LIABLE FOR ANY CIVIL DAMAGES AS A 16 RESULT OF ANY ACTS OR OMISSIONS IN RENDERING THE SERVICE AS A 17 MEMBER OF ANY SUCH COMMITTEE EXCEPT ANY ACTS OR OMISSIONS 18 INTENTIONALLY DESIGNED TO HARM OR ANY GROSSLY NEGLIGENT ACTS OR 19 OMISSIONS WHICH RESULT IN HARM TO THE PERSON RECEIVING SUCH 20 SERVICE. 21 (B) [OFFICER AND EMPLOYEES OF DEPARTMENT] DEPARTMENT 22 PERSONNEL.--ANY OFFICER OR EMPLOYEE OF THE DEPARTMENT RENDERING 23 SERVICE AS A MEMBER OF A UTILIZATION REVIEW COMMITTEE FOR THIS 24 PROGRAM SHALL NOT BE LIABLE FOR ANY CIVIL DAMAGES AS A RESULT OF 25 ANY ACTS OR OMISSIONS IN RENDERING THE SERVICE AS A MEMBER OF 26 ANY SUCH COMMITTEE OR AS A RESULT OF ANY DECISION OR ACTION IN 27 CONNECTION WITH THE PROGRAM EXCEPT ANY ACTS OR OMISSIONS 28 INTENTIONALLY DESIGNED TO HARM OR ANY GROSSLY NEGLIGENT ACTS OR 29 OMISSIONS WHICH RESULT IN HARM TO THE PERSON RECEIVING SUCH 30 SERVICE. 20030H0888B2117 - 33 -
1 SECTION 519. THE PHARMACEUTICAL ASSISTANCE CONTRACT FOR THE 2 ELDERLY NEEDS ENHANCEMENT TIER. 3 (A) ESTABLISHMENT.--THERE IS HEREBY ESTABLISHED WITHIN THE 4 DEPARTMENT A PROGRAM TO BE KNOWN AS THE PHARMACEUTICAL 5 ASSISTANCE CONTRACT FOR THE ELDERLY NEEDS ENHANCEMENT TIER 6 (PACENET). 7 (B) PACENET ELIGIBILITY.--A CLAIMANT WITH AN ANNUAL INCOME 8 OF NOT LESS THAN [$14,000] $14,500 AND NOT MORE THAN [$16,000] 9 $22,500 IN THE CASE OF A SINGLE PERSON AND OF NOT LESS THAN 10 [$17,200] $17,700 AND NOT MORE THAN [$19,200] $30,500 IN THE 11 CASE OF THE COMBINED INCOME OF PERSONS MARRIED TO EACH OTHER 12 SHALL BE ELIGIBLE FOR ENHANCED PHARMACEUTICAL ASSISTANCE UNDER 13 THIS SECTION. A PERSON MAY, IN REPORTING INCOME TO THE 14 DEPARTMENT, ROUND THE AMOUNT OF EACH SOURCE OF INCOME AND THE 15 INCOME TOTAL TO THE NEAREST WHOLE DOLLAR, WHEREBY ANY AMOUNT 16 WHICH IS LESS THAN 50¢ IS ELIMINATED. 17 (C) DEDUCTIBLE.--UPON ENROLLMENT IN PACENET, ELIGIBLE 18 CLAIMANTS IN THE INCOME RANGES SET FORTH IN SUBSECTION (B) SHALL 19 BE REQUIRED TO MEET [AN ANNUAL] A DEDUCTIBLE IN UNREIMBURSED 20 PRESCRIPTION DRUG EXPENSES OF [$500] $40 PER PERSON[.] PER 21 MONTH. THE $40 MONTHLY DEDUCTIBLE SHALL BE CUMULATIVE AND SHALL 22 BE APPLIED TO SUBSEQUENT MONTHS TO DETERMINE ELIGIBILITY. THE 23 CUMULATIVE DEDUCTIBLE SHALL BE DETERMINED ON A CALENDAR YEAR 24 BASIS FOR AN ANNUAL TOTAL DEDUCTIBLE NOT TO EXCEED $480 IN A 25 YEAR. TO QUALIFY FOR THE DEDUCTIBLE SET FORTH IN THIS SUBSECTION 26 THE PRESCRIPTION DRUG MUST BE PURCHASED FOR THE USE OF THE 27 ELIGIBLE CLAIMANT FROM A PROVIDER AS DEFINED IN THIS CHAPTER. 28 THE DEPARTMENT, AFTER CONSULTATION WITH THE BOARD, [MAY] SHALL 29 APPROVE AN ADJUSTMENT IN THE DEDUCTIBLE ON AN ANNUAL BASIS. 30 (D) COPAYMENT.--FOR ELIGIBLE CLAIMANTS UNDER THIS SECTION, 20030H0888B2117 - 34 -
1 THE COPAYMENT SCHEDULE, WHICH [MAY] SHALL BE ADJUSTED BY THE 2 DEPARTMENT ON AN ANNUAL BASIS AFTER CONSULTATION WITH THE BOARD, 3 SHALL BE: 4 (I) EIGHT DOLLARS FOR NONINNOVATOR MULTIPLE SOURCE 5 DRUGS AS DEFINED IN SECTION 702; OR 6 (II) FIFTEEN DOLLARS FOR SINGLE-SOURCE DRUGS AND 7 INNOVATOR MULTIPLE-SOURCE DRUGS AS DEFINED IN SECTION 8 702. 9 SECTION 520. BOARD. 10 * * * 11 (B) COMPOSITION.--THE BOARD SHALL BE COMPRISED OF THE 12 FOLLOWING EIGHT PERSONS: 13 (1) THE SECRETARY OF AGING, WHO SHALL SERVE AS ITS 14 CHAIRMAN. 15 (2) THE SECRETARY OF REVENUE. 16 (3) THE SECRETARY OF HEALTH. 17 (4) FIVE PUBLIC MEMBERS, ONE APPOINTED BY THE PRESIDENT 18 PRO TEMPORE OF THE SENATE, ONE APPOINTED BY THE MINORITY 19 LEADER OF THE SENATE, ONE APPOINTED BY THE SPEAKER OF THE 20 HOUSE OF REPRESENTATIVES, ONE APPOINTED BY THE MINORITY 21 LEADER OF THE HOUSE OF REPRESENTATIVES AND ONE APPOINTED BY 22 THE GOVERNOR. THOSE APPOINTED BY THE LEGISLATIVE OFFICERS 23 SHALL INCLUDE TWO SENIOR CITIZENS WHO HAVE NOT BEEN A PART OF 24 THE PHARMACEUTICAL INDUSTRY TO SERVE AS CONSUMER ADVOCATES 25 [AND TWO REPRESENTATIVES], ONE REPRESENTATIVE OF THE 26 PHARMACEUTICAL INDUSTRY[, AT LEAST ONE OF WHOM IS A] AND ONE 27 PRACTICING PENNSYLVANIA PHARMACIST. THE INDIVIDUAL APPOINTED 28 BY THE GOVERNOR MUST BE A PHYSICIAN. A PUBLIC MEMBER WHO 29 MISSES TWO CONSECUTIVE MEETINGS WITHOUT GOOD CAUSE ACCEPTABLE 30 TO THE CHAIRMAN SHALL BE REPLACED BY THE APPOINTING 20030H0888B2117 - 35 -
1 AUTHORITY. 2 * * * 3 SECTION 3. THE ACT IS AMENDED BY ADDING A SECTION TO READ: 4 SECTION 520.1. PACE AND PACENET ELIGIBILITY ADVISORY COMMITTEE. 5 (A) ESTABLISHMENT.--THERE IS ESTABLISHED IN THE DEPARTMENT 6 THE PACE AND PACENET ELIGIBILITY ADVISORY COMMITTEE. 7 (B) COMPOSITION.--THE ELIGIBILITY ADVISORY COMMITTEE SHALL 8 CONSIST OF FOUR MEMBERS WHO SHALL BE MEMBERS OF THE GENERAL 9 ASSEMBLY AND A CHAIRMAN WHO SHALL BE APPOINTED BY THE GOVERNOR. 10 THE MEMBERS OF THE GENERAL ASSEMBLY SHALL BE APPOINTED AS 11 FOLLOWS: 12 (1) ONE MEMBER APPOINTED BY THE PRESIDENT PRO TEMPORE OF 13 THE SENATE. 14 (2) ONE MEMBER APPOINTED BY THE MINORITY LEADER OF THE 15 SENATE. 16 (3) ONE MEMBER APPOINTED BY THE SPEAKER OF THE HOUSE OF 17 REPRESENTATIVES. 18 (4) ONE MEMBER APPOINTED BY THE MINORITY LEADER OF THE 19 HOUSE OF REPRESENTATIVES. 20 (C) CHAIRMAN.--NOTHING IN THIS SECTION SHALL BE CONSTRUED AS 21 PROHIBITING THE GOVERNOR FROM APPOINTING A MEMBER OF THE GENERAL 22 ASSEMBLY AS CHAIRMAN . 23 (D) TERM.--MEMBERS SHALL SERVE AT THE PLEASURE OF THE 24 APPOINTING AUTHORITY. 25 (E) EXPENSES.--MEMBERS OF THE ADVISORY COMMITTEE SHALL SERVE 26 WITHOUT COMPENSATION BUT SHALL BE REIMBURSED FOR ACTUAL AND 27 REASONABLE EXPENSES INCURRED IN THE PERFORMANCE OF THEIR 28 OFFICIAL DUTIES. 29 (F) DESIGNEE.--A DESIGNEE DESIGNATED BY A MEMBER UNDER 30 SUBSECTION (B)(1), (2), (3) AND (4) MAY VOTE AND OTHERWISE ACT 20030H0888B2117 - 36 -
1 ON BEHALF OF THE MEMBER. THE DESIGNATION MUST BE IN WRITING AND 2 BE DELIVERED TO THE ADVISORY COMMITTEE. THE DESIGNATION SHALL 3 CONTINUE IN EFFECT UNTIL REVOKED OR AMENDED IN WRITING. 4 (G) QUORUM.--A MAJORITY OF THE MEMBERS OF THE ADVISORY 5 COMMITTEE THEN SERVING SHALL CONSTITUTE A QUORUM OF THE ADVISORY 6 COMMITTEE. ONLY A MEMBER OR A DESIGNEE WHO IS PHYSICALLY PRESENT 7 AT A MEETING OR ABLE TO PARTICIPATE FULLY IN THE DELIBERATIONS 8 BY APPROPRIATE TELECOMMUNICATIONS MEANS SHALL COUNT TOWARD A 9 QUORUM OF THE ADVISORY COMMITTEE. 10 (H) RESPONSIBILITIES.--THE ADVISORY COMMITTEE SHALL STUDY 11 THE FEASIBILITY OF EXPANSIONS AND OTHER CHANGES TO ELIGIBILITY 12 UNDER THE PACE PROGRAM AND MAKE RECOMMENDATIONS TO THE GOVERNOR 13 AND THE DEPARTMENT ON AN ANNUAL BASIS. IN ADDITION, THE ADVISORY 14 COMMITTEE MAY STUDY AND PARTICIPATE, WITH THE APPROVAL OF THE 15 GOVERNOR AND THE DEPARTMENT, IN ADVOCATING AT OTHER LEVELS OF 16 GOVERNMENT PROPOSED CHANGES IN THE PROVISION OF PHARMACEUTICAL 17 BENEFITS TO SENIOR CITIZENS. THE COMMITTEE MAY ALSO MAKE 18 RECOMMENDATIONS WITH RESPECT TO THE TERMS AND CONDITIONS UNDER 19 WHICH PHARMACEUTICAL COMPANIES PARTICIPATE IN COMMONWEALTH 20 HEALTH CARE PROGRAMS FOR THE ELDERLY. 21 SECTION 4. SECTIONS 521(D) AND 522 OF THE ACT, ADDED 22 NOVEMBER 21, 1996 (P.L.741, NO.134), ARE AMENDED TO READ: 23 SECTION 521. PENALTIES. 24 * * * 25 (D) [REPAYMENT OF GAIN] REPARATION.--ANY PROVIDER, RECIPIENT 26 OR OTHER PERSON WHO IS FOUND GUILTY OF A CRIME FOR VIOLATING 27 THIS CHAPTER SHALL REPAY THREE TIMES THE VALUE OF THE MATERIAL 28 GAIN RECEIVED. IN ADDITION TO THE CIVIL PENALTY AUTHORIZED 29 PURSUANT TO SUBSECTION (B), THE DEPARTMENT MAY REQUIRE THE 30 PROVIDER, RECIPIENT OR OTHER PERSON TO REPAY UP TO THREE TIMES 20030H0888B2117 - 37 -
1 THE VALUE OF ANY MATERIAL GAIN TO PACE OR PACENET. 2 SECTION 522. PRESCRIPTION DRUG EDUCATION PROGRAM. 3 THE DEPARTMENT, IN COOPERATION WITH THE DEPARTMENT OF HEALTH, 4 SHALL DEVELOP AND IMPLEMENT A STATEWIDE PRESCRIPTION DRUG 5 EDUCATION PROGRAM DESIGNED TO INFORM OLDER ADULTS OF THE DANGERS 6 OF PRESCRIPTION DRUG ABUSE AND MISUSE. THE PRESCRIPTION DRUG 7 EDUCATION PROGRAM SHALL INCLUDE, BUT NOT BE LIMITED TO, 8 INFORMATION CONCERNING THE FOLLOWING: 9 (1) THE HAZARDS OF PRESCRIPTION DRUG OVERDOSE. 10 (2) THE POTENTIAL DANGERS OF MIXING PRESCRIPTION DRUGS. 11 (3) THE DANGER OF RETAINING UNUSED PRESCRIPTION DRUGS 12 AFTER THE NEED TO TAKE THEM NO LONGER EXISTS. 13 (4) THE NECESSITY TO CAREFULLY QUESTION PHYSICIANS AND 14 PHARMACISTS CONCERNING THE EFFECTS OF TAKING PRESCRIPTION 15 DRUGS[, INCLUDING THE DIFFERENCES BETWEEN BRAND-NAME DRUGS 16 AND GENERICALLY EQUIVALENT DRUGS]. 17 (5) THE ADVISABILITY OF MAINTAINING A PRESCRIPTION DRUG 18 PROFILE OR OTHER RECORD OF PRESCRIPTION DRUG DOSAGE AND 19 FREQUENCY OF DOSAGE. 20 (6) THE DESIRABILITY OF ADVISING FAMILY MEMBERS OF THE 21 TYPES AND PROPER DOSAGE OF PRESCRIPTION DRUGS WHICH ARE BEING 22 TAKEN. 23 (7) THE DANGERS OF TAKING PRESCRIPTION DRUGS IN EXCESS 24 OF PRESCRIBED DOSAGES. 25 (8) THE NEED TO OBTAIN COMPLETE, DETAILED DIRECTIONS 26 FROM THE PHYSICIAN OR PHARMACIST CONCERNING THE TIME PERIOD A 27 PRESCRIPTION DRUG SHOULD BE TAKEN. 28 SECTION 5. THE ACT IS AMENDED BY ADDING A CHAPTER TO READ: 29 CHAPTER 6 30 PHARMACY BEST PRACTICES AND COST CONTROL PROGRAM 20030H0888B2117 - 38 -
1 SECTION 601. DEFINITIONS. 2 THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS CHAPTER 3 SHALL HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE 4 CONTEXT CLEARLY INDICATES OTHERWISE: 5 "COMMITTEE." THE PHARMACY BEST PRACTICES AND COST CONTROL 6 ADVISORY COMMITTEE ESTABLISHED IN SECTION 602. 7 "DEPARTMENT." THE DEPARTMENT OF AGING OF THE COMMONWEALTH. 8 "PROGRAM." THE PHARMACY BEST PRACTICES AND COST CONTROL 9 PROGRAM ESTABLISHED IN SECTION 603. 10 "SECRETARY." THE SECRETARY OF AGING OF THE COMMONWEALTH. 11 SECTION 602. ADVISORY COMMITTEE. 12 (A) ESTABLISHMENT.--THE PHARMACY BEST PRACTICES AND COST 13 CONTROL ADVISORY COMMITTEE IS ESTABLISHED IN THE DEPARTMENT. 14 (B) MEMBERS.--THE COMMITTEE IS COMPRISED OF THE FOLLOWING 15 PENNSYLVANIA RESIDENTS: 16 (1) THE SECRETARY OR A DESIGNEE, WHO SHALL SERVE AS 17 CHAIRPERSON. 18 (2) FOUR MEMBERS APPOINTED BY THE GOVERNOR. ONE MEMBER 19 UNDER THIS PARAGRAPH MUST POSSESS EXPERTISE IN MEDICINE, ONE 20 MEMBER MUST POSSESS EXPERTISE IN HEALTH CARE, ONE MEMBER MUST 21 POSSESS EXPERTISE IN PHARMACY AND ONE MEMBER MUST POSSESS 22 EXPERTISE IN THE PHARMACEUTICAL INDUSTRY. 23 (3) ONE MEMBER APPOINTED BY THE PRESIDENT PRO TEMPORE OF 24 THE SENATE AND ONE MEMBER APPOINTED BY THE MINORITY LEADER OF 25 THE SENATE. 26 (4) ONE MEMBER APPOINTED BY THE SPEAKER OF THE HOUSE OF 27 REPRESENTATIVES AND ONE MEMBER APPOINTED BY THE MINORITY 28 LEADER OF THE HOUSE OF REPRESENTATIVES. 29 (C) TERMS.--TERMS ARE AS FOLLOWS: 30 (1) THE SECRETARY SHALL SERVE EX OFFICIO. 20030H0888B2117 - 39 -
1 (2) A MEMBER UNDER SUBSECTION (B)(2) SHALL SERVE A TERM 2 OF SIX YEARS. 3 (3) A MEMBER UNDER SUBSECTION (B)(3) SHALL SERVE A TERM 4 OF FOUR YEARS BUT MAY BE REMOVED AT THE PLEASURE OF THE 5 APPOINTING AUTHORITY. 6 (4) A MEMBER UNDER SUBSECTION (B)(4) SHALL SERVE A TERM 7 OF TWO YEARS BUT MAY BE REMOVED AT THE PLEASURE OF THE 8 APPOINTING AUTHORITY. 9 (5) AN APPOINTMENT TO FILL A VACANCY SHALL BE FOR THE 10 PERIOD OF THE UNEXPIRED TERM OR UNTIL A SUCCESSOR IS 11 APPOINTED AND QUALIFIED. 12 (D) QUORUM.--A MAJORITY OF THE MEMBERS OF THE COMMITTEE 13 CONSTITUTES A QUORUM. 14 (E) COMPENSATION.--MEMBERS SHALL RECEIVE NO PAYMENT FOR 15 THEIR SERVICES. MEMBERS WHO ARE NOT EMPLOYEES OF STATE 16 GOVERNMENT SHALL BE REIMBURSED FOR NECESSARY AND REASONABLE 17 EXPENSES INCURRED IN THE COURSE OF THEIR OFFICIAL DUTIES. 18 (F) MEETINGS.--MEETINGS OF THIS COMMITTEE SHALL BE HELD IN 19 PUBLIC PURSUANT TO 65 PA.S.C. CH. 7 (RELATING TO PUBLIC 20 MEETINGS). 21 SECTION 603. PROGRAM. 22 (A) ESTABLISHMENT.--THE SECRETARY SHALL ESTABLISH A PHARMACY 23 BEST PRACTICES AND COST CONTROL PROGRAM FOR PACE AND PACENET 24 ENROLLEES DESIGNED TO REDUCE THE COST OF PROVIDING PRESCRIPTION 25 DRUGS, WHILE MAINTAINING HIGH QUALITY IN PRESCRIPTION DRUG 26 THERAPIES. THE PROGRAM SHALL INCLUDE ALL OF THE FOLLOWING: 27 (1) A LIST OF COVERED PRESCRIPTION DRUGS UNDER SECTION 28 509 IN THE PROGRAM SELECTED BY THE DEPARTMENT UPON 29 RECOMMENDATIONS BY THE COMMITTEE. 30 (2) A DRUG UTILIZATION REVIEW PROCEDURE, INCLUDING A 20030H0888B2117 - 40 -
1 PRESCRIPTION REVIEW PROCESS FOR COPAYMENT SCHEDULES. 2 (3) EDUCATION PROGRAMS DESIGNED TO PROVIDE INFORMATION 3 AND EDUCATION ON THE THERAPEUTIC AND COST-EFFECTIVE 4 UTILIZATION OF PRESCRIPTION DRUGS TO PHYSICIANS, PHARMACISTS 5 AND OTHER HEALTH CARE PROFESSIONALS AUTHORIZED TO PRESCRIBE 6 AND DISPENSE PRESCRIPTION DRUGS. 7 (B) POOLING.--THE SECRETARY SHALL EVALUATE THE BENEFITS OF 8 PARTICIPATING, BUT IS NOT REQUIRED TO PARTICIPATE, IN JOINT 9 PRESCRIPTION DRUG PURCHASING AGREEMENTS OR POOLING ARRANGEMENTS 10 WITH OTHER STATES. SUCH ACTIONS SHALL INCLUDE: 11 (1) THE EXECUTION OF ANY LAWFUL JOINT PURCHASING OR 12 POOLING AGREEMENTS WITH OTHER PARTICIPATING STATES WHICH THE 13 SECRETARY DETERMINES WILL LOWER THE MEDICAID COST OF 14 PRESCRIPTION DRUGS WHILE MAINTAINING HIGH QUALITY IN 15 PRESCRIPTION DRUG THERAPIES. 16 (2) RENEGOTIATION AND AMENDMENT OF EXISTING CONTRACTS TO 17 WHICH THE DEPARTMENT IS A PARTY IF RENEGOTIATION AND 18 AMENDMENT WILL BE OF ECONOMIC BENEFIT TO THE DEPARTMENT. 19 (3) A QUARTERLY REPORT TO THE COMMITTEE ON THE 20 DEPARTMENT'S PROGRESS IN SECURING PARTICIPATION IN JOINT 21 PURCHASING OR POOLING AGREEMENTS. 22 (C) AUTHORIZED COVERAGE.--THE PROGRAM SHALL AUTHORIZE 23 COPAYMENTS SCHEDULES FOR EACH PRESCRIPTION DRUG. WHEN A 24 PATIENT'S HEALTH CARE PROVIDER PRESCRIBES A PRESCRIPTION DRUG AT 25 THE HIGHER COPAYMENT SCHEDULE, THE LOWER COPAYMENT SHALL APPLY 26 FOR ONE YEAR WHEN ANY OF THE FOLLOWING CONDITIONS ARE MET: 27 (1) THE PREFERRED CHOICE HAS NOT BEEN EFFECTIVE OR, WITH 28 REASONABLE CERTAINTY, IS NOT EXPECTED TO BE EFFECTIVE IN 29 TREATING THE PATIENT'S CONDITION. 30 (2) THE PREFERRED CHOICE CAUSES OR IS REASONABLY 20030H0888B2117 - 41 -
1 EXPECTED TO CAUSE ADVERSE OR HARMFUL REACTIONS IN THE 2 PATIENT. 3 (3) OTHER CLINICAL CRITERIA RECOMMENDED BY THE COMMITTEE 4 AND APPROVED BY THE DEPARTMENT. 5 (D) BRAND NECESSARY.--IF THE PRESCRIBER DOES NOT WISH 6 SUBSTITUTION TO TAKE PLACE, THE PRESCRIBER SHALL WRITE "BRAND 7 NECESSARY" OR "NO SUBSTITUTION" IN THE PRESCRIBER'S OWN 8 HANDWRITING ON THE PRESCRIPTION BLANK, TOGETHER WITH A WRITTEN 9 STATEMENT THAT THE GENERIC OR THE EQUIVALENT HAS NOT BEEN 10 EFFECTIVE, OR WITH REASONABLE CERTAINTY IS NOT EXPECTED TO BE 11 EFFECTIVE, IN TREATING THE PATIENT'S MEDICAL CONDITION OR CAUSES 12 OR IS REASONABLY EXPECTED TO CAUSE ADVERSE OR HARMFUL REACTIONS 13 IN THE PATIENT. IN THE CASE OF AN UNWRITTEN PRESCRIPTION, THERE 14 SHALL BE NO SUBSTITUTION IF THE PRESCRIBER EXPRESSLY INDICATES 15 TO THE PHARMACIST THAT THE BRAND NAME DRUG IS NECESSARY AND 16 SUBSTITUTION IS NOT ALLOWED BECAUSE THE GENERIC OR THE 17 EQUIVALENT HAS NOT BEEN EFFECTIVE, OR WITH REASONABLE CERTAINTY 18 IS NOT EXPECTED TO BE EFFECTIVE, IN TREATING THE PATIENT'S 19 MEDICAL CONDITION OR CAUSES OR IS REASONABLY EXPECTED TO CAUSE 20 ADVERSE OR HARMFUL REACTIONS IN THE PATIENT. APPROVAL UNDER THIS 21 SECTION SHALL BE VALID FOR ONE YEAR. 22 (E) EXCLUSIONS.--THE DEPARTMENT, WITH RECOMMENDATIONS FROM 23 THE COMMITTEE, SHALL DETERMINE DISEASES AND THERAPEUTIC CLASSES 24 RELATING TO TREATMENT FOR DISEASES EXCLUDED FROM THE PROGRAM AT 25 THE TIME THE PROGRAM UNDER THIS SECTION IS IMPLEMENTED. 26 (F) RESPONSE.--THE PROGRAM'S PRESCRIBER-INDICATED PRIOR 27 AUTHORIZATION PROCESS SHALL ENSURE THAT THERE WILL BE A RESPONSE 28 TO A REQUEST FOR PRIOR AUTHORIZATION BY TELEPHONE OR OTHER 29 TELECOMMUNICATION DEVICE WITHIN 12 HOURS AFTER RECEIPT OF THE 30 REQUEST FOR PRIOR AUTHORIZATION AND THAT A MINIMUM OF A 72-HOUR 20030H0888B2117 - 42 -
1 SUPPLY OF THE DRUG PRESCRIBED WILL BE PROVIDED IN AN EMERGENCY 2 OR WHEN THE PROGRAM DOES NOT PROVIDE A RESPONSE WITHIN 12 HOURS. 3 THE PRIOR AUTHORIZATION PROCESS SHALL BE DESIGNED TO MINIMIZE 4 ADMINISTRATIVE BURDENS ON PRESCRIBERS, PHARMACISTS AND 5 CONSUMERS. 6 (G) PROCEDURE.--THE PROGRAM SHALL ESTABLISH PROCEDURES FOR 7 THE TIMELY REVIEW OF PRESCRIPTION DRUGS NEWLY APPROVED BY THE 8 FOOD AND DRUG ADMINISTRATION, INCLUDING PROCEDURES FOR THE 9 REVIEW OF NEWLY APPROVED PRESCRIPTION DRUGS IN EMERGENCY 10 CIRCUMSTANCES. 11 (H) REPORTS.--THE DEPARTMENT SHALL SUBMIT ANNUAL REPORTS ON 12 THE PROGRAM UNDER SUBSECTION (A) TO THE AGING AND YOUTH 13 COMMITTEE, THE APPROPRIATIONS COMMITTEE AND THE PUBLIC HEALTH 14 AND WELFARE COMMITTEE OF THE SENATE AND THE AGING AND OLDER 15 ADULT SERVICES COMMITTEE, THE APPROPRIATIONS COMMITTEE AND THE 16 HEALTH AND HUMAN SERVICES COMMITTEE OF THE HOUSE OF 17 REPRESENTATIVES. THE REPORTS SHALL INCLUDE CLASSES OF DRUGS, 18 EXCEPTIONS, COST EFFECTIVENESS, MOVEMENT OF MARKET SHARE AND 19 INCREASED UTILIZATION OF GENERIC DRUGS. 20 SECTION 604. RESTRICTION OR SUBSTITUTION PROCESS. 21 (A) GENERAL RULE.--THE PROVISIONS OF THIS CHAPTER SHALL NOT 22 PERMIT THE PROGRAM TO DEVELOP ANY DRUG FORMULARY, PRIOR OR 23 RETROACTIVE APPROVAL SYSTEM, INCLUDING HIGHER COPAYMENTS, OR ANY 24 OTHER SIMILAR RESTRICTION OR SUBSTITUTION PROCESS FOR: 25 (1) PSYCHOTROPIC DRUGS. 26 (2) DRUGS USED IN THE TREATMENT OF HUMAN 27 IMMUNODEFICIENCY VIRUS, ACQUIRED IMMUNE DEFICIENCY SYNDROME 28 OR OPPORTUNISTIC INFECTIONS. 29 (B) DEFINITION.--AS USED IN THIS SECTION, THE TERM 30 "PSYCHOTROPIC DRUG" MEANS A DRUG USED TO TREAT A MENTAL 20030H0888B2117 - 43 -
1 DISORDER.
2 SECTION 6. SECTION 701 OF THE ACT IS AMENDED TO READ:
3 [SECTION 701. DECLARATION OF POLICY.
4 THE GENERAL ASSEMBLY FINDS AND DECLARES AS FOLLOWS:
5 (1) THE COMMONWEALTH, THROUGH ASSISTANCE PROGRAMS
6 ENACTED FOR THE BENEFIT OF ITS CITIZENS, IS THE LARGEST
7 SINGLE PAYOR OF PRESCRIPTION MEDICATIONS IN PENNSYLVANIA.
8 (2) IN ORDER TO ENSURE THAT THE COMMONWEALTH, IN
9 EXPENDING MONEY ON BEHALF OF ITS CITIZENS, IS NOT UNDULY
10 HARMED BY BEING REQUIRED TO PAY A PRICE FOR PHARMACEUTICAL
11 PRODUCTS PURCHASED FROM MANUFACTURERS IN EXCESS OF THAT
12 ESTABLISHED FOR OTHER PURCHASERS AND REIMBURSERS OF THESE
13 PRODUCTS AND TO ENSURE THAT THE COMMONWEALTH CAN EFFICIENTLY
14 AND PRUDENTLY EXPEND ITS MONEY AND MAXIMIZE ITS ABILITY TO
15 PROVIDE FOR THE HEALTH AND WELFARE OF AS MANY OF ITS NEEDY
16 CITIZENS AS POSSIBLE, IT IS REASONABLE, NECESSARY AND IN THE
17 PUBLIC INTEREST TO REQUIRE THAT PHARMACEUTICAL MANUFACTURERS
18 OFFER A DISCOUNT TO THE COMMONWEALTH FOR PHARMACEUTICAL
19 PRODUCTS PURCHASED OR REIMBURSED THROUGH STATE AGENCIES.
20 (3) IT IS IN THE PUBLIC INTEREST FOR PHARMACEUTICAL
21 MANUFACTURERS TO PROVIDE THE COMMONWEALTH WITH DATA RELATING
22 TO THE PRICE OF PHARMACEUTICAL PRODUCTS SOLD BY THE
23 MANUFACTURER TO PUBLIC BODIES, HOSPITALS, FOR-PROFIT OR
24 NONPROFIT ORGANIZATIONS, OTHER MANUFACTURERS OR WHOLESALERS
25 DOING BUSINESS IN THIS COMMONWEALTH IN ORDER TO ENSURE THAT
26 THE COMMONWEALTH CAN DETERMINE THAT IT IS BEING PROVIDED WITH
27 THE BEST PRICES OFFERED BY THE MANUFACTURER.
28 (4) ON A NATIONAL LEVEL, THERE HAS BEEN A RECOGNITION
29 THAT THE NEED FOR DISCOUNTS TO STATE MEDICAID AGENCIES, WHICH
30 REIMBURSE FOR A HIGH VOLUME OF PHARMACEUTICAL PRODUCTS,
20030H0888B2117 - 44 -
1 EXISTS. 2 (5) ON A STATE LEVEL, THE GENERAL ASSEMBLY RECOGNIZES 3 THAT IT IS IN THE BEST INTEREST OF ITS CITIZENS TO PROVIDE 4 PHARMACEUTICAL ASSISTANCE IN A REASONABLE AND COST-EFFICIENT 5 MANNER. 6 (6) DRUG PRICE INFLATION HAS CAUSED AN INCREASE IN THE 7 AMOUNT OF PUBLIC FUNDS EXPENDED BY PACE AND GENERAL 8 ASSISTANCE.] 9 SECTION 7. SECTION 702 OF THE ACT IS AMENDED BY ADDING A 10 DEFINITION TO READ: 11 SECTION 702. DEFINITIONS. 12 THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS CHAPTER 13 SHALL HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE 14 CONTEXT CLEARLY INDICATES OTHERWISE: 15 * * * 16 "BEST PRICE." THE LOWEST PRICE AVAILABLE FROM THE 17 MANUFACTURER DURING THE REBATE PERIOD TO ANY WHOLESALER, 18 RETAILER, PROVIDER, HEALTH MAINTENANCE ORGANIZATION, NONPROFIT 19 ENTITY OR ANY GOVERNMENTAL ENTITY SUBJECT TO THE EXCLUSIONS AND 20 SPECIAL RULES SET FORTH IN SECTIONS 1902 AND 1927(C)(1)(C) OF 21 THE SOCIAL SECURITY ACT (49 STAT. 620, 42 U.S.C. §§1396C, 1396R- 22 8(C)(1)(C)). 23 * * * 24 SECTION 8. SECTIONS 703(E), 704(C)(1) AND 705(A) AND (B) OF 25 THE ACT, ADDED NOVEMBER 21, 1996 (P.L.741, NO.134), ARE AMENDED 26 TO READ: 27 SECTION 703. REBATE AGREEMENT. 28 * * * 29 (E) DRUG FORMULARY.--EXCEPT AS PROVIDED IN SECTION 512 AND 30 CHAPTER 6, THERE SHALL BE NO DRUG FORMULARY, PRIOR OR 20030H0888B2117 - 45 -
1 RETROACTIVE APPROVAL SYSTEM OR ANY SIMILAR RESTRICTION IMPOSED 2 ON THE COVERAGE OF OUTPATIENT DRUGS MADE BY MANUFACTURERS WHO 3 HAVE AGREEMENTS IN EFFECT WITH THE COMMONWEALTH TO PAY REBATES 4 FOR DRUGS UTILIZED IN PACE AND PACENET, PROVIDED THAT SUCH 5 OUTPATIENT DRUGS WERE APPROVED FOR MARKETING BY THE FOOD AND 6 DRUG ADMINISTRATION. THIS SUBSECTION SHALL NOT APPLY TO ANY ACT 7 TAKEN BY THE DEPARTMENT PURSUANT TO ITS THERAPEUTIC DRUG 8 UTILIZATION REVIEW PROGRAM UNDER SECTION 505. 9 SECTION 704. TERMS OF REBATE AGREEMENT. 10 * * * 11 (C) MANUFACTURER PROVISION OF PRICE INFORMATION.-- 12 (1) EACH MANUFACTURER WITH AN AGREEMENT IN EFFECT UNDER 13 THIS CHAPTER SHALL REPORT THE AVERAGE MANUFACTURER PRICE AND 14 THE BEST PRICE FOR ALL COVERED PRESCRIPTION DRUGS PRODUCED BY 15 THAT MANUFACTURER TO THE DEPARTMENT NOT LATER THAN 30 DAYS 16 AFTER THE LAST DAY OF EACH QUARTER. 17 * * * 18 SECTION 705. AMOUNT OF REBATE. 19 (A) SINGLE-SOURCE DRUGS AND INNOVATOR MULTIPLE-SOURCE 20 DRUGS.--WITH RESPECT TO SINGLE-SOURCE DRUGS AND INNOVATOR 21 MULTIPLE-SOURCE DRUGS, EACH MANUFACTURER SHALL REMIT A REBATE TO 22 THE COMMONWEALTH PURSUANT TO THE DETERMINATION ESTABLISHED BY 23 SECTION 1927(C)(1)(C) OF THE SOCIAL SECURITY ACT (49 STAT. 620, 24 42 U.S.C. § 1396R-8(C)(1)(C)). [EXCEPT AS OTHERWISE PROVIDED IN 25 THIS SECTION, THE AMOUNT OF THE REBATE TO THE COMMONWEALTH PER 26 CALENDAR QUARTER WITH RESPECT TO EACH DOSAGE FORM AND STRENGTH 27 OF SINGLE-SOURCE DRUGS AND INNOVATOR MULTIPLE-SOURCE DRUGS SHALL 28 BE AS FOLLOWS: 29 (1) FOR QUARTERS BEGINNING AFTER SEPTEMBER 30, 1992, AND 30 ENDING BEFORE JANUARY 1, 1997, THE PRODUCT OF THE TOTAL 20030H0888B2117 - 46 -
1 NUMBER OF UNITS OF EACH DOSAGE FORM AND STRENGTH REIMBURSED 2 BY PACE AND GENERAL ASSISTANCE IN THE QUARTER AND THE 3 DIFFERENCE BETWEEN THE AVERAGE MANUFACTURER PRICE AND 85% OF 4 THAT PRICE, AFTER DEDUCTING CUSTOMARY PROMPT PAYMENT 5 DISCOUNTS, FOR THE QUARTER. 6 (2) FOR QUARTERS BEGINNING AFTER DECEMBER 31, 1996, THE 7 PRODUCT OF THE TOTAL NUMBER OF UNITS OF EACH DOSAGE FORM AND 8 STRENGTH REIMBURSED BY PACE, PACENET AND DESIGNATED 9 PHARMACEUTICAL PROGRAMS IN THE QUARTER AND THE DIFFERENCE 10 BETWEEN THE AVERAGE MANUFACTURER PRICE AND 83% OF THAT PRICE, 11 AFTER DEDUCTING CUSTOMARY PROMPT PAYMENT DISCOUNTS.] 12 (B) REBATE FOR OTHER DRUGS.-- 13 [(1) THE AMOUNT OF THE REBATE TO THE COMMONWEALTH FOR A 14 CALENDAR QUARTER WITH RESPECT TO COVERED PRESCRIPTION DRUGS 15 WHICH ARE NONINNOVATOR MULTIPLE-SOURCE DRUGS SHALL BE EQUAL 16 TO THE PRODUCT OF: 17 (I) THE APPLICABLE PERCENTAGE OF THE AVERAGE 18 MANUFACTURER PRICE, AFTER DEDUCTING CUSTOMARY PROMPT 19 PAYMENT DISCOUNTS, FOR EACH DOSAGE FORM AND STRENGTH OF 20 SUCH DRUGS FOR THE QUARTER; AND 21 (II) THE NUMBER OF UNITS OF SUCH FORM AND DOSAGE 22 REIMBURSED BY PACE AND GENERAL ASSISTANCE IN THE QUARTER. 23 (2) FOR THE PURPOSES OF PARAGRAPH (1), THE APPLICABLE 24 PERCENTAGE FOR CALENDAR QUARTERS BEGINNING AFTER SEPTEMBER 25 30, 1992, AND ENDING BEFORE JANUARY 1, 1997, IS 11%.] WITH 26 RESPECT TO COVERED PRESCRIPTION DRUGS WHICH ARE NONINNOVATOR 27 MULTIPLE-SOURCE DRUGS, EACH MANUFACTURER SHALL REMIT A REBATE 28 TO THE COMMONWEALTH PURSUANT TO THE DETERMINATION ESTABLISHED 29 BY SECTION 1927(C)(1)(C) OF THE SOCIAL SECURITY ACT. 30 * * * 20030H0888B2117 - 47 -
1 SECTION 9. THE ACT IS AMENDED BY ADDING A CHAPTER TO READ: 2 CHAPTER 8 3 PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE 4 SECTION 801. DEFINITIONS. 5 THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS CHAPTER 6 SHALL HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE 7 CONTEXT CLEARLY INDICATES OTHERWISE: 8 "CLEARINGHOUSE." THE PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE 9 ESTABLISHED IN SECTION 802. 10 "DEPARTMENT." THE DEPARTMENT OF AGING OF THE COMMONWEALTH. 11 "PATIENT ASSISTANCE PROGRAM." A PROGRAM OFFERED BY A 12 PHARMACEUTICAL MANUFACTURER UNDER WHICH THE MANUFACTURER 13 PROVIDES PRESCRIPTION MEDICATIONS AT NO CHARGE OR AT A 14 SUBSTANTIALLY REDUCED COST. THE TERM DOES NOT INCLUDE THE 15 PROVISION OF A DRUG AS PART OF A CLINICAL TRIAL. 16 SECTION 802. PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE. 17 (A) ESTABLISHMENT.--WITHIN 120 DAYS OF THE EFFECTIVE DATE OF 18 THIS CHAPTER, THE DEPARTMENT SHALL ESTABLISH THE PHARMACEUTICAL 19 ASSISTANCE CLEARINGHOUSE. EACH PHARMACEUTICAL MANUFACTURER THAT 20 DOES BUSINESS IN THIS COMMONWEALTH AND OFFERS A PATIENT 21 ASSISTANCE PROGRAM SHALL INFORM THE DEPARTMENT OF ALL OF THE 22 FOLLOWING: 23 (1) THE EXISTENCE OF THE PATIENT ASSISTANCE PROGRAM. 24 (2) THE ELIGIBILITY REQUIREMENTS FOR THE PATIENT 25 ASSISTANCE PROGRAM. 26 (3) THE DRUGS COVERED BY THE PATIENT ASSISTANCE PROGRAM. 27 (4) INFORMATION, SUCH AS A TELEPHONE NUMBER, WHICH MAY 28 BE USED TO APPLY FOR A PATIENT ASSISTANCE PROGRAM. 29 (B) INFORMATION.--THE CLEARINGHOUSE SHALL MAINTAIN THE 30 INFORMATION SUBMITTED BY PHARMACEUTICAL MANUFACTURERS AND MAKE 20030H0888B2117 - 48 -
1 IT AVAILABLE TO THE PUBLIC. 2 (C) STAFF.--THE DEPARTMENT SHALL ENSURE THAT THE 3 CLEARINGHOUSE IS STAFFED AT LEAST DURING NORMAL BUSINESS HOURS. 4 THE DEPARTMENT SHALL CONTRACT FOR THE SERVICES OF A SCHOOL OF 5 PHARMACY TO STAFF THE CLEARINGHOUSE. 6 SECTION 803. TOLL-FREE TELEPHONE NUMBER. 7 THE DEPARTMENT SHALL ESTABLISH A TOLL-FREE TELEPHONE NUMBER 8 THROUGH WHICH MEMBERS OF THE PUBLIC MAY OBTAIN INFORMATION FROM 9 THE CLEARINGHOUSE ABOUT AVAILABLE PATIENT ASSISTANCE PROGRAMS. 10 SECTION 804. ASSISTANCE AVAILABLE. 11 (A) DIRECT.-- 12 (1) THE CLEARINGHOUSE SHALL ASSIST WITHOUT CHARGE AN 13 INDIVIDUAL IN DETERMINING WHETHER A PATIENT ASSISTANCE 14 PROGRAM IS OFFERED FOR A PARTICULAR DRUG AND WHETHER THE 15 INDIVIDUAL MAY BE ELIGIBLE TO OBTAIN THE DRUG THROUGH A 16 PATIENT ASSISTANCE PROGRAM. 17 (2) THE CLEARINGHOUSE MAY ASSIST WITHOUT CHARGE AN 18 INDIVIDUAL WHO WISHES TO APPLY FOR A PATIENT ASSISTANCE 19 PROGRAM BY ASSISTING WITH THE PREPARATION OF AN APPLICATION 20 AND COORDINATING COMMUNICATIONS BETWEEN THE INDIVIDUAL'S 21 PHYSICIAN AND A PHARMACEUTICAL MANUFACTURER ON BEHALF OF THE 22 INDIVIDUAL FOR THE PURPOSE OF OBTAINING APPROVAL TO 23 PARTICIPATE IN THE PATIENT ASSISTANCE PROGRAM. 24 (B) REFERRALS.--THE CLEARINGHOUSE SHALL MAKE REFERRALS TO 25 ANY PUBLICLY FUNDED PROGRAM FOR WHICH IT DEEMS A PATIENT 26 ELIGIBLE. 27 SECTION 805. REPORTING. 28 THE DEPARTMENT SHALL REPORT ANNUALLY TO THE GOVERNOR AND THE 29 GENERAL ASSEMBLY ON THE ACTIVITIES OF THE CLEARINGHOUSE. THE 30 REPORT SHALL INCLUDE: 20030H0888B2117 - 49 -
1 (1) THE NUMBER OF INDIVIDUALS WHO HAVE BEEN ASSISTED BY 2 THE CLEARINGHOUSE UNDER SECTION 804(A)(1) AND THE NUMBER OF 3 SUCH INDIVIDUALS UNDER SECTION 804(A)(2). 4 (2) THE NUMBER AND BENEFITS OF PATIENT ASSISTANCE 5 PROGRAMS LISTED WITH THE CLEARINGHOUSE. 6 (3) THE NUMBER OF PATIENTS REFERRED TO PUBLICLY FUNDED 7 PROGRAMS UNDER SECTION 804(B). PROGRAMS UNDER THIS PARAGRAPH 8 INCLUDE, BUT ARE NOT LIMITED TO, THE PHARMACEUTICAL 9 ASSISTANCE CONTRACT FOR THE ELDERLY PROGRAM, MEDICAL 10 ASSISTANCE AND PROGRAMS OF THE DEPARTMENT OF VETERANS 11 AFFAIRS. 12 (4) OTHER INFORMATION DEEMED RELEVANT BY THE DEPARTMENT. 13 SECTION 806. INTERNET AVAILABILITY OF INFORMATION. 14 THE DEPARTMENT SHALL MAINTAIN AND PROVIDE TO THE PUBLIC THE 15 INFORMATION UNDER THIS CHAPTER ON ITS WORLD WIDE WEB SITE. THE 16 DEPARTMENT SHALL ALSO PROVIDE TO APPROPRIATE ORGANIZATIONS THE 17 INFORMATION NECESSARY FOR THE ORGANIZATIONS TO ESTABLISH A LINK 18 TO THE LOCATION OF CLEARINGHOUSE INFORMATION ON THE DEPARTMENT'S 19 WORLD WIDE WEB SITE. 20 SECTION 10. SECTION 2102(A) OF THE ACT, ADDED NOVEMBER 21, 21 1996 (P.L.741, NO.134), IS AMENDED TO READ: 22 SECTION 2102. ANNUAL REPORT TO GENERAL ASSEMBLY. 23 (A) SUBMISSION OF REPORT.--THE DEPARTMENT SHALL SUBMIT A 24 REPORT NO LATER THAN APRIL 1 OF EACH YEAR TO THE CHAIRMAN AND 25 MINORITY CHAIRMAN OF THE AGING AND YOUTH COMMITTEE OF THE 26 SENATE, THE CHAIRMAN AND MINORITY CHAIRMAN OF THE AGING AND 27 [YOUTH] OLDER ADULT SERVICES COMMITTEE OF THE HOUSE OF 28 REPRESENTATIVES AND THE PHARMACEUTICAL ASSISTANCE REVIEW BOARD. 29 * * * 30 SECTION 11. THE ACT IS AMENDED BY ADDING SECTIONS TO READ: 20030H0888B2117 - 50 -
1 SECTION 2103. FEDERAL PROGRAMS. 2 IF THE FEDERAL GOVERNMENT ENACTS PROGRAMS SIMILAR TO PACE OR 3 PACENET, THE STATE PROGRAMS SHALL BE CONSTRUED TO ONLY 4 SUPPLEMENT THE FEDERAL PROGRAMS AND ALL PERSONS QUALIFIED FOR 5 COVERAGE UNDER THE FEDERAL PROGRAM SHALL UTILIZE THAT FEDERAL 6 PROGRAM BEFORE UTILIZING ANY STATE PROGRAM. 7 SECTION 2104. PHARMACY BENEFITS ADMINISTRATOR STUDY. 8 (A) STUDY.--THE DEPARTMENT OF AGING SHALL CONDUCT A STUDY ON 9 THE EFFECTS WITHIN THE PACE AND PACENET PROGRAMS OF IMPLEMENTING 10 A PHARMACY BENEFITS ADMINISTRATOR COMPONENT. THE STUDY SHALL 11 EXAMINE THE ABILITY OF THE PHARMACY BENEFITS ADMINISTRATOR TO DO 12 THE FOLLOWING: 13 (1) NEGOTIATE REBATES ON BEHALF OF THE PLAN. 14 (2) CREATE A DRUG CRITERIA FOR ENROLLMENT WITHIN THE 15 PROGRAM. 16 (3) CONTRACT WITH PROVIDERS. 17 (4) CONDUCT ENROLLMENT ADJUDICATION ON BEHALF OF 18 APPLICANTS. 19 (B) REPORT.--THE DEPARTMENT SHALL SUBMIT A REPORT NO LATER 20 THAN ONE YEAR FROM THE EFFECTIVE DATE OF THIS SECTION TO THE 21 CHAIRMAN AND MINORITY CHAIRMAN OF THE AGING AND YOUTH COMMITTEE 22 OF THE SENATE, THE CHAIRMAN AND MINORITY CHAIRMAN OF THE AGING 23 AND OLDER ADULT SERVICES COMMITTEE OF THE HOUSE OF 24 REPRESENTATIVES AND THE PHARMACEUTICAL ASSISTANCE REVIEW BOARD. 25 SECTION 12. THE DEPARTMENT OF AGING MAY USE A PACE OR 26 PACENET PROGRAM APPLICANT'S MOST RECENT INCOME INFORMATION TO 27 DETERMINE PROGRAM ELIGIBILITY UNTIL APRIL 1, 2004. 28 SECTION 13. THIS ACT SHALL TAKE EFFECT AS FOLLOWS: 29 (1) THE FOLLOWING PROVISIONS SHALL TAKE EFFECT JANUARY 30 1, 2004: 20030H0888B2117 - 51 -
1 (I) THE AMENDMENT OR ADDITION OF THE DEFINITIONS OF 2 "CMS," "HFCA" AND "MAXIMUM ANNUAL INCOME" IN SECTION 502 3 OF THE ACT. 4 (II) THE AMENDMENT OF SECTION 519 OF THE ACT. 5 (2) THE REMAINDER OF THIS ACT SHALL TAKE EFFECT 6 IMMEDIATELY. E14L67VDL/20030H0888B2117 - 52 -