PRINTER'S NO. 3163
No. 2263 Session of 2005
INTRODUCED BY McILHATTAN, HESS, THOMAS, GANNON, PYLE, McNAUGHTON, CAPPELLI, ALLEN, ARGALL, ARMSTRONG, BAKER, BALDWIN, BARRAR, BASTIAN, BEBKO-JONES, BELFANTI, BEYER, BIRMELIN, BISHOP, BLAUM, BOYD, CALTAGIRONE, CASORIO, CAUSER, CAWLEY, CIVERA, CLYMER, COHEN, CREIGHTON, CRUZ, CURRY, DALLY, DeLUCA, DENLINGER, DeWEESE, DIVEN, ELLIS, D. EVANS, FABRIZIO, FAIRCHILD, FEESE, FICHTER, FLEAGLE, FRANKEL, GABIG, GEIST, GEORGE, GINGRICH, GOOD, GOODMAN, HABAY, HALUSKA, HARHART, HARRIS, HASAY, HENNESSEY, HERMAN, HERSHEY, HICKERNELL, HUTCHINSON, JAMES, KAUFFMAN, M. KELLER, KENNEY, KILLION, LEH, MACKERETH, MAHER, MAITLAND, MAJOR, MANN, MARKOSEK, MANDERINO, MARSICO, McGILL, McILHINNEY, METCALFE, MILLARD, R. MILLER, S. MILLER, MUNDY, MUSTIO, NAILOR, OLIVER, O'NEILL, PALLONE, PAYNE, PERZEL, PETRARCA, PETRI, PETRONE, PHILLIPS, PICKETT, PISTELLA, QUIGLEY, RAPP, READSHAW, REED, REICHLEY, ROHRER, RUBLEY, SAINATO, SATHER, SAYLOR, SCAVELLO, SCHRODER, SEMMEL, SIPTROTH, S. H. SMITH, SONNEY, STABACK, STAIRS, STEIL, STERN, R. STEVENSON, T. STEVENSON, SURRA, TANGRETTI, E. Z. TAYLOR, J. TAYLOR, TIGUE, TRUE, WALKO, WATSON, WILT, WOJNAROSKI, WRIGHT, YEWCIC, YOUNGBLOOD, McGEEHAN, LEDERER, DiGIROLAMO AND GODSHALL, NOVEMBER 22, 2005
REFERRED TO COMMITTEE ON AGING AND OLDER ADULT SERVICES, NOVEMBER 22, 2005
AN ACT 1 Establishing One Pennsylvania, a program to consolidate and 2 unify procedures and requirements for the administration of 3 all Commonwealth-funded, Commonwealth-administered and 4 Commonwealth-supported drug programs and for reimbursement 5 for pharmacy services. 6 The General Assembly of the Commonwealth of Pennsylvania 7 hereby enacts as follows: 8 Section 1. Short title. 9 This act shall be known and may be cited as the One
1 Pennsylvania Act. 2 Section 2. Definitions. 3 The following words and phrases when used in this act shall 4 have the meanings given to them in this section unless the 5 context clearly indicates otherwise: 6 "Adjudication." 7 (1) Except as provided in paragraph (2), an action taken 8 by the Department of Aging, the Secretary of Aging or a 9 prescription drug plan pursuant to this act that constitutes 10 an adjudication as defined by 2 Pa.C.S. § 101 (relating to 11 definitions), including any of the following: 12 (i) A decision to allow a pharmacy to participate in 13 a prescription drug plan or to suspend, restrict or 14 revoke participation by a pharmacy in a prescription drug 15 plan. 16 (ii) A decision by the department to include or 17 exclude a medication from the formulary. 18 (iii) The establishment of pharmacy reimbursement 19 rates and formulas. 20 (iv) A decision to grant or deny prior authorization 21 for the dispensing of prescription drugs or to approve or 22 disapprove the dispensing of drugs not included on the 23 formulary. 24 (v) An action taken by the program based upon audits 25 of claims submitted for reimbursement by pharmacies. 26 (2) An action taken by the program with respect to 27 determining recipient eligibility shall not be deemed an 28 adjudication subject to this act. 29 "Alerts." Electronic communications between the Department 30 of Aging or the pharmacy benefits consolidation program and 20050H2263B3163 - 2 -
1 pharmacies providing information pertaining to the 2 implementation of this act, including any of the following: 3 (1) Information regarding formularies. 4 (2) Drug utilization review. 5 (3) Prior authorization. 6 (4) Disease management programs. 7 (5) Claims submission and adjudication procedures. 8 (6) Audits. 9 (7) Pharmacy and patient education. 10 "Best price." As defined under section 1927(c) of the Social 11 Security Act (49 Stat. 620, 42 U.S.C. § 1396r-8(c)). 12 "Department." The Department of Aging of the Commonwealth. 13 "Medical assistance program." The program established 14 pursuant to Subarticle (f) of Article IV of the act of June 13, 15 1967 (P.L.31, No.21), known as the Public Welfare Code. 16 "Medicare recipient." An individual residing in this 17 Commonwealth who receives benefits under Part A of Subchapter 18 XVIII of Chapter 7 of the Social Security Act (49 Stat. 620, 42 19 U.S.C. § 301 et seq.) or who is enrolled under Part B, C or D of 20 Subchapter XVIII. 21 "Pharmaceutical manufacturer." A manufacturer as defined by 22 section 1927(k)(5) of the Social Security Act (49 Stat. 620, 42 23 U.S.C. § 1396r-8(k)(5)). 24 "Pharmacy." A pharmacy licensed pursuant to the act of 25 September 27, 1961 (P.L.1700, No.699), known as the Pharmacy 26 Act. 27 "Pharmacy Act." The act of September 27, 1961 (P.L.1700, 28 No.699), known as the Pharmacy Act. 29 "Pharmacy services." The provision of health care services 30 defined as the practice of pharmacy by the act of September 27, 20050H2263B3163 - 3 -
1 1961 (P.L.1700, No.699), known as the Pharmacy Act. 2 "Prescription drug." A covered outpatient drug as defined by 3 section 1927(k)(2) of the Social Security Act (49 Stat. 620, 42 4 U.S.C. § 1396r-8(k)(2)). 5 "Prescription drug plan." A program that pays for 6 prescription drugs dispensed to individuals enrolled in the 7 program that is supported directly or indirectly, in whole or in 8 part, by public funds, including all of the following: 9 (1) The medical assistance program, the Special 10 Pharmaceutical Benefit Program in the Department of Public 11 Welfare and the End Stage Renal Program in the Department of 12 Health. 13 (2) The Pharmaceutical Assistance Contract for the 14 Elderly (PACE) and any other pharmacy program administered by 15 the Commonwealth that is recognized by the Centers for 16 Medicare and Medicaid as a State pharmaceutical assistance 17 program. 18 (3) Programs paying for prescription drugs dispensed to 19 public employees, including programs established by the 20 Public School Employees' Retirement System, the State 21 Employees' Retirement System and the State Employees' Benefit 22 Trust Fund. 23 (4) A program that utilizes funds of this Commonwealth, 24 including the State Lottery Fund, to provide assistance in 25 obtaining prescription drugs to Medicare recipients. 26 (5) Programs where the Commonwealth purchases or 27 reimburses affiliates or designees for a pharmacy benefit. 28 The programs shall include the Children's Health Insurance 29 Program, Workers' Compensation Program and any program 30 administered by the Department of Corrections. 20050H2263B3163 - 4 -
1 "Program." The pharmacy benefits consolidation program 2 established pursuant to section 3. 3 "Public School Employees' Retirement System." The retirement 4 system established by 24 Pa.C.S. Part IV (relating to retirement 5 for school employees). 6 "Public Welfare Code." The act of June 13, 1967 (P.L.31, 7 No.21), known as the Public Welfare Code. 8 "Secretary." The Secretary of Aging of the Commonwealth. 9 "Social Security Act." The Social Security Act (49 Stat. 10 620, 42 U.S.C. § 301 et seq.). A reference to the Social 11 Security Act shall include regulations implementing the Social 12 Security Act adopted by the United States Department of Health 13 and Human Services or the Centers for Medicare and Medicaid 14 Services. 15 "State agency." Any of the following entities that purchases 16 or provides coverage for prescription medications: 17 (1) An agency under the jurisdiction of the Governor. 18 (2) An independent agency. 19 (3) The General Assembly. 20 (4) The unified judicial system. 21 "State Employees' Benefit Trust Fund." The trust fund 22 established to purchase health insurance coverage, including 23 coverage for prescription medications, for State employees. 24 "State Employees' Retirement System." The retirement system 25 established under 71 Pa.C.S. Part XXV (relating to retirement 26 for State employees and officers). 27 Section 3. One Pennsylvania. 28 (a) Establishment.--The department shall establish a 29 pharmacy benefits consolidation program to be known as One 30 Pennsylvania. The program shall administer all Commonwealth 20050H2263B3163 - 5 -
1 prescription drug plans through an integrated system of plan 2 administration using uniform standards and requirements for the 3 reimbursement of pharmacies as provided by this act. To the 4 extent consolidation is prohibited by Federal law or 5 regulations, the department may exclude particular prescription 6 drug plans from consolidated administration if the prescription 7 drug plan will be subject to the uniform standards and 8 requirements of this act, including requirements for the 9 reimbursement of pharmacies. 10 (b) Requirements.--The department shall do all of the 11 following: 12 (1) Manage and implement a uniform formulary for the 13 program under this act. A formulary shall include all 14 prescription drugs for which a manufacturer has entered into 15 a rebate agreement pursuant to section 5 and the requirements 16 and restrictions, except for prior authorization, provided by 17 section 1927(d) of the Social Security Act. The list of drugs 18 included in the formulary shall be publicly available, posted 19 electronically on the Internet website of the department and 20 communicated to pharmacies through alerts. 21 (2) Ensure that any program of prior authorization 22 provides for all of the following exceptions: 23 (i) No prior authorization shall be required where 24 the pharmacist confirms that a prescription for the drug 25 has been filled for the recipient within the 30 to 90 26 days immediately preceding presentation of the 27 prescription for dispensing. 28 (ii) No prior authorization shall be required where 29 the prescriber has indicated "MEDICALLY NECESSARY" on the 30 prescription. 20050H2263B3163 - 6 -
1 (3) Ensure that any pharmacy licensed in this 2 Commonwealth is eligible to provide pharmacy services 3 according to any regulations adopted by the department 4 pursuant to this act. 5 (4) (i) Except as provided in subparagraph (ii), make 6 provisions for generic substitutions in accordance with 7 the act of November 24, 1976 (P.L.1163, No.259), referred 8 to as the Generic Equivalent Drug Law. 9 (ii) Notwithstanding the provisions of the Generic 10 Equivalent Drug Law and the act of August 26, 1971 11 (P.L.351, No.91), known as the State Lottery Law, generic 12 substitutions shall only be dispensed when it is less 13 expensive for the program. 14 (5) Provide for a program of prospective drug 15 utilization review consistent with section 1927(g)(2) of the 16 Social Security Act. 17 (6) Provide for prior authorization consistent with the 18 requirements of section 1927(d)(5) of the Social Security Act 19 and in accordance with regulations of the department. 20 (7) Provide for a program of retrospective drug 21 utilization review and education consistent with section 22 1927(g)(2) of the Social Security Act and in accordance with 23 regulations of the department to ensure that prescriptions 24 are appropriate, medically necessary and not likely to result 25 in adverse medical results and to educate providers and 26 recipients of pharmacy services through the pharmacy 27 consolidated benefits program and to correct and report 28 misutilization and abuse by licensed prescribers and 29 recipients and provide for fraud and abuse audits, 30 coordinating its activities with the secretary to support 20050H2263B3163 - 7 -
1 compliance with applicable laws and regulations. Pharmacies 2 shall not be denied payments for medications dispensed based 3 upon the results of retrospective drug utilization review or 4 audits, where the medication was dispensed in good faith by 5 the pharmacy without prior knowledge that the prescription of 6 a medication was not appropriate or necessary, was likely to 7 cause adverse medical results or constituted a fraudulent or 8 abusive practice by the prescriber. 9 (8) Establish a program of medication therapy management 10 consistent with section 1860D-4(c)(2) of the Social Security 11 Act. 12 (9) Provide educational materials for program recipients 13 of pharmacy services on disease and care management. 14 (10) In accordance with section 1927(a) through (d) of 15 the Social Security Act, bill, recoup and relay to the 16 medical assistance program manufacturers' drug rebates and 17 excessive consumer price inflation discounts and resolve 18 disputes. Upon the establishment of the program, all medical 19 assistance recipients shall be enrolled in prescription drug 20 programs for which rebates and discounts are collected 21 pursuant to section 1927(a) through (d) of the Social 22 Security Act. 23 (11) Adjudicate claims through an electronic claims 24 management system consistent with section 1927(h) of the 25 Social Security Act and which allows for an emergency supply 26 of prescribed medication in the event of equipment failures. 27 (12) Create a uniform audit and recoupment system for 28 all of the following: 29 (i) Providers and recipients. 30 (ii) Third-party medical resources. 20050H2263B3163 - 8 -
1 (13) Provide for the reimbursement of all pharmacies 2 participating in prescription drug programs on a fee-for- 3 service basis. 4 (14) Allow pharmacists certified in medication therapy 5 management by a national accrediting body or by any other 6 certification process approved by the State Board of Pharmacy 7 to provide medication therapy management. 8 (c) Considerations.--In preparing and managing the uniform 9 formulary, the department shall enter into agreements with drug 10 manufacturers to collect and remit to the program discounts, 11 rebates or other concessions offered by manufacturers. 12 (d) Biennial study.--Within 12 months of the effective date 13 of this section and biennially thereafter, the department shall 14 conduct a study considering the comprehensive cost of providing 15 pharmacy services, including any unique costs associated with 16 participating in each prescription drug plan, including the 17 providing of medication therapy management, prospective and 18 retrospective utilization review, managing prior authorization 19 requirements and implementing drug therapy protocols pursuant to 20 section 9.1 of the Pharmacy Act, to determine whether pharmacy 21 reimbursement under this chapter should be adjusted. The study 22 shall establish, for an efficiently and economically operated 23 independent pharmacy, a reasonable profit to provide a return on 24 investment based upon a nationwide review of pharmacy economics, 25 and based upon the results of the study the department shall 26 establish payment rates for prescription drug plans pursuant to 27 section 4 adequate to maintain the rate of return. The full 28 results of the study and the data collected and evaluated, 29 excluding any information that discloses the identity of any 30 particular pharmacy, shall be made publicly available and shall 20050H2263B3163 - 9 -
1 be reported to the General Assembly. 2 (e) Advisory committee.-- 3 (1) An advisory committee to the department shall be 4 established consisting of the following members: 5 (i) Three members appointed by the Governor. 6 (ii) Two members appointed by each of the following: 7 (A) The President pro tempore of the Senate. 8 (B) The Minority Leader of the Senate. 9 (C) The Speaker of the House of Representatives. 10 (D) The Minority Leader of the House of 11 Representatives. 12 (2) Each legislative appointing authority shall appoint 13 one member pursuant to paragraph (1)(ii) involved in the 14 ownership or operation of independent pharmacies and one 15 member involved in the ownership or operation of chain 16 pharmacies. 17 (3) Members of the committee shall serve without 18 compensation but shall be reimbursed for their reasonable and 19 necessary expenses by the department. 20 (4) Members of the committee shall serve for indefinite 21 terms at the will of their respective appointing authorities. 22 (5) Action by the committee shall require a vote by at 23 least seven members. 24 (6) Members of the committee shall annually elect a 25 chairperson. 26 (f) Fees.--The program shall deduct from payments made to 27 retail pharmacies and remit to the department a fee for each 28 prescription reimbursed in an amount sufficient to conduct the 29 studies required by subsection (d) and to monitor the 30 implementation of the fee schedule established by the department 20050H2263B3163 - 10 -
1 pursuant to the studies. The department shall establish and 2 administer the fee based upon the recommendations and approval 3 of the advisory committee in the same manner as provided for 4 nursing facility assessments pursuant to section 805-A of the 5 Public Welfare Code. 6 Section 4. Reimbursement. 7 (a) General rule.-- 8 (1) Pharmacies reimbursed under this act on and after 9 the effective date of this section shall be paid at fee-for- 10 service rates no less than the rate for reimbursement under 11 the PACE program in effect on December 31, 2004, until 12 reimbursement rates are established based on the results of 13 the study conducted pursuant to section 3(d). 14 (2) Upon the establishment of reimbursement rates, 15 pharmacies shall earn a rate of return at least equivalent to 16 the rate of return earned by participation in the PACE 17 program as of December 31, 2004, taking into consideration 18 the changes in the composition of drugs dispensed pursuant to 19 the formulary and any incremental costs associated with 20 obtaining prior authorizations. 21 (b) Components.--Reimbursement to pharmacies shall include 22 all of the following: 23 (1) Payment for prescription product costs adequate to 24 cover the reasonable and necessary costs associated with all 25 of the following: 26 (i) Acquisition and delivery to the pharmacy. 27 (ii) Inventory management. 28 (iii) Storage and security. 29 (iv) Quality assurance. 30 (v) Compliance with regulatory requirements. 20050H2263B3163 - 11 -
1 (vi) Reasonable profit to generate a return on the 2 investment associated with reasonable and necessary 3 costs. 4 (2) Payment for dispensing costs adequate to cover costs 5 associated with all of the following: 6 (i) Professional services provided. 7 (ii) Wages and salaries. 8 (iii) Patient counseling. 9 (iv) Drug utilization review. 10 (v) Licensing fees. 11 (vi) Taxes. 12 (vii) Insurance. 13 (viii) Other direct and indirect costs of operating 14 a pharmacy. 15 (ix) A reasonable profit to generate a return on the 16 investment associated with the costs. 17 (3) An additional dispensing cost payment associated 18 with dispensing drugs other than single source drugs as 19 defined by section 1927(k)(7)(A)(iv) of the Social Security 20 Act. 21 (4) Additional payment for: 22 (i) Medication therapy management. 23 (ii) Concurrent and retrospective utilization 24 review. 25 (iii) Managing prior authorization requirements. 26 (iv) To the extent authorized by section 9.1 of the 27 Pharmacy Act, implementing drug therapy protocols. 28 (c) Prompt payment.--Pharmacies shall be paid within 21 days 29 of the department's receipt of appropriate substantiation of the 30 transaction. Pharmacies shall be entitled to interest at the 20050H2263B3163 - 12 -
1 rate provided by section 806 of the act of April 9, 1929 2 (P.L.343, No.176), known as The Fiscal Code, for any payment not 3 made within the 21-day period. 4 (d) Source of pricing information.--Pricing information 5 utilized in reimbursement formulas shall be based upon a 6 published compendium of prices, selected by the advisory 7 committee and approved and designated by the department by 8 regulation. The information shall be updated weekly. 9 (e) Copayments.--Except for services which are excluded 10 under the Commonwealth's medical assistance program, the 11 department may require pharmacies to collect a copayment in an 12 amount set by the department. To the extent a pharmacy is 13 required by Federal or State law to dispense prescriptions to 14 persons unable to satisfy copayment obligations, the pharmacy 15 shall be reimbursed for uncollectible copayment amounts. The 16 department shall neither require copayments from beneficiaries 17 nor deduct copayment amounts from pharmacy reimbursements for 18 any particular classes of drugs or prescription drug plan 19 recipients to the extent there is good cause to conclude that 20 copayment requirements will result in noncompliance with 21 prescription drug treatment protocols and will increase overall 22 health care costs or result in imminent and substantial risk of 23 harm or injury to recipients or other persons. Except to the 24 extent prohibited by Federal law, the department may accept 25 compensation for the purpose of reducing or eliminating 26 copayments from drug manufacturers, distributors, health care 27 plans, or other persons or organizations for the purpose of 28 encouraging therapeutically desirable compliance with 29 prescription drug treatment protocols. 30 (f) Maximum allowable cost limits.--Except as otherwise 20050H2263B3163 - 13 -
1 required by Federal law or State regulation, to the extent 2 reimbursement formulas adopted by the department limit payments 3 to pharmacies for any class or group of prescription drugs 4 unrelated to published prices for the particular drug dispensed, 5 the maximum allowable cost limits established by the department 6 shall: 7 (1) apply only to multiple source drugs as defined by 8 section 1927(k)(7)(A)(i) of the Social Security Act and for 9 which there are no fewer than three nationally available 10 sources of supply, and which are available for distribution 11 in Pennsylvania; 12 (2) be determined pursuant to regulations adopted by the 13 department that set forth the specific formulas used to 14 calculate the limits and specify the sources of information 15 used in the calculations; 16 (3) be publicly disclosed, posted electronically to the 17 department's Internet website, distributed to pharmacies 18 using alerts and regularly and periodically updated; 19 (4) include a minimum payment for each prescription 20 dispensed to provide reasonable compensation for the costs 21 associated with acquiring and dispensing the medications; and 22 (5) not apply to a prescription for which the dispensing 23 of a particular product is determined by the prescriber to be 24 medically necessary. 25 Section 5. Rebate agreement. 26 (a) Required agreements.--Except as provided in subsection 27 (b), the department shall not include on the formulary 28 established pursuant to section 3(b)(1) any prescription drug 29 unless the department and the pharmaceutical manufacturer have 30 entered into a rebate agreement covering that prescription drug 20050H2263B3163 - 14 -
1 on terms comparable to agreements executed pursuant to section 2 1927(a), (b), (c) and (d) of the Social Security Act. The rebate 3 agreement shall provide that, unless prohibited by Federal law, 4 the rebate shall be based on the best price and that additional 5 rebates shall be paid if the pharmaceutical manufacturer 6 increases the price of the drug by an amount greater than the 7 increase in the Consumer Price Index for All Urban Consumers. 8 Nothing in this act shall prevent the department from 9 negotiating agreements for the payment of additional rebates and 10 discounts for the benefit of the medical assistance program or 11 from entering into rebate and discount agreements for other 12 plans which have been consolidated into the program for greater 13 rebates and discounts than are required pursuant to section 14 1927(c) of the Social Security Act. 15 (b) Exceptions.--Subsection (a) shall not apply if the 16 availability of the drug is essential to the health of members 17 of the pharmacy consolidated benefits program, as determined by 18 the department. 19 (c) Contracts.--Pharmaceutical manufacturers must enter into 20 a rebate agreement with the department to obtain reimbursement 21 for prescription drugs included under this act. The rebate shall 22 be paid by the manufacturer not later than 30 days after the 23 date of receipt of information necessary to calculate the amount 24 of the rebate. The department shall have the authority to levy a 25 15% surcharge penalty on any rebate, not in dispute, that 26 remains unpaid for 90 or more days. 27 (d) Past-due rebates.--The department shall have the 28 authority to levy a 15% surcharge penalty on any rebate, not in 29 dispute, that is more than one year past due, upon notification 30 to the manufacturer. The surcharge penalty shall be in addition 20050H2263B3163 - 15 -
1 to any interest and penalties authorized by law or by provisions 2 of any contracts. The notice shall afford the manufacturer 90 3 days to satisfy the past-due rebate claim. 4 Section 6. Pharmacies and dispensing physicians. 5 (a) General rule.--Pharmacies and dispensing physicians 6 participating in the PACE program shall, as a condition of 7 participation in that program, agree to the conditions set forth 8 in this section. 9 (b) Medicare recipients.--Any pharmacy or dispensing 10 physician participating in the PACE program shall, as a 11 condition of participation in that program, agree to sell 12 prescription drugs to Medicare recipients participating in the 13 prescription drug discount care program pursuant to section 14 1860D-21 of the Social Security Act at the PACE program price. 15 In no case shall a Medicare recipient be charged more than the 16 price of the drug to a cash-paying customer receiving the same 17 or similar services at the particular pharmacy on the date of 18 the sale. 19 (c) Limitation on participation.--Any pharmacist, pharmacy 20 or dispensing physician that is precluded or excluded for cause 21 from the medical assistance program shall be precluded or 22 excluded from participation in this act. 23 Section 7. Regulations and adjudications. 24 (a) Regulations.--The department shall seek recommendations 25 of the advisory committee prior to promulgating rules and 26 regulations, as necessary, to carry out the provisions of this 27 act. 28 (b) Policies.--The department, acting in consultation with 29 the advisory committee, shall promulgate statements of policy, 30 as necessary, to carry out the provisions of this act. No 20050H2263B3163 - 16 -
1 statement of policy adopted by the department shall have the 2 force and effect of law or regulation or may modify the 3 provisions of any regulations adopted by the department. All 4 statements of policy adopted by the department shall, except in 5 emergency circumstances, be published for notice and comment 6 prior to adoption and shall be published in the Pennsylvania 7 Bulletin and the Pennsylvania Code. 8 (c) Audit manual.--Based upon its regulations and policies, 9 the department shall adopt a manual setting forth procedures, 10 guidelines and standards to be utilized by prescription drug 11 plans in audits of pharmacies participating in the pharmacy 12 consolidation benefits program. Decisions regarding audits shall 13 conform to the requirements of the manual and shall not involve 14 the imposition of sanctions upon pharmacies for minor, isolated 15 or good-faith errors and omissions in the processing of claims 16 and shall not require the recoupment or restitution of 17 overpayments made to pharmacies based upon errors or omissions 18 of prescription drug plans in implementing payment reimbursement 19 formula, unless the payments are clearly and obviously excessive 20 or are the result of incorrect actions taken by pharmacies in 21 submitting claims for processing. 22 (d) Adjudications.--Adjudications conducted by the 23 department shall be subject to 2 Pa.C.S. Ch. 5 Subch. A 24 (relating to practice and procedure of Commonwealth agencies) 25 and Ch. 7 Subch. A (relating to judicial review of Commonwealth 26 agency action). The department shall adopt rules of procedure 27 regarding the conduct of adjudications involving pharmacies 28 consistent with the provisions of 67 Pa.C.S. §§ 1102 (relating 29 to hearings before the bureau) through 1105 (relating to 30 determinations, review, appeal and enforcement). 20050H2263B3163 - 17 -
1 Section 8. Applicability. 2 This act shall apply to the medical assistance program unless 3 the secretary, in consultation with the Department of Public 4 Welfare, determines that the application is a violation of 5 Federal law or an existing contractual agreement. Nothing in 6 this act shall supersede or impede an existing contractual 7 agreement. Contractual agreements in effect on the effective 8 date of this section shall not be renewed or extended to the 9 extent inconsistent with the requirements of this act, and the 10 department shall promptly enter into negotiations to modify any 11 contractual agreements inconsistent with this act to conform to 12 the requirements of this act. 13 Section 9. Prohibited activities. 14 It shall be unlawful for any individual, partnership or 15 corporation to solicit, receive, offer or pay any kickback, 16 bribe or rebate in cash or in kind from or to any person in 17 connection with the furnishing of services under this act to the 18 same extent as prohibited with respect to Federal health 19 programs by paragraphs (1) and (2) of section 1128 (b)(1) and 20 (2) of the Social Security Act, subject to the safe harbors from 21 sanctions provided by sections 1877(a)(1) and 1860D-4(e)(6) of 22 the Social Security Act. Violations of this section shall be 23 subject to the sanctions, penalties and remedies under section 24 1407 of the Public Welfare Code. 25 Section 40. Effective date. 26 This act shall take effect in 60 days. K1L35MSP/20050H2263B3163 - 18 -