PRIOR PRINTER'S NOS. 1044, 1816, 1836, PRINTER'S NO. 2098
1889
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
13 Section 301. Legislative findings.
1 Section 302. Definitions.
2 Section 303. Determination of eligibility.
3 Section 304. Physician and pharmacy participation.
4 Section 305. Drug utilization review system.
5 Section 306. Reduced assistance.
6 Section 307. Rebates for expenses prohibited.
7 Section 308. Request for proposal.
8 Section 309. Drug utilization review and therapeutic
9 interchange.
10 Section 310. Program generally.
11 Section 311. Generic drugs.
12 Section 312. Supply.
13 Section 313. Mail service program.
14 Section 314. Indication of price.
15 Section 315. Reimbursement.
16 Section 316. Nonliability.
17 Section 317. Income verification.
18 Section 318. Contract.
19 Section 319. The Pharmaceutical Assistance Contract for the
20 Elderly Needs Enhancement Tier.
21 Section 320. Board.
22 Section 321. Penalties.
23 Section 322. Prescription Drug Education Program.
24 Section 323. Outreach program.
25 Subchapter B. Prudent Pharmaceutical Purchasing
26 Section 341. Definitions.
27 Section 342. Rebate agreement.
28 Section 343. Disposition of funds.
29 Subchapter C. Pharmaceutical Assistance Clearinghouse
30 Section 361. Definitions.
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1 Section 362. Pharmaceutical Assistance Clearinghouse.
2 Section 363. Toll-free telephone number.
3 Section 364. Assistance available.
4 Section 365. Reporting.
5 Chapter 51. Miscellaneous Provisions
6 Section 5101. Federal programs.
7 Section 5102. Repeals.
8 Section 5103. Effective date.
9 AMENDING THE ACT OF AUGUST 26, 1971 (P.L.351, NO.91), ENTITLED <--
10 "AN ACT PROVIDING FOR A STATE LOTTERY AND ADMINISTRATION
11 THEREOF; AUTHORIZING THE CREATION OF A STATE LOTTERY
12 COMMISSION; PRESCRIBING ITS POWERS AND DUTIES; DISPOSITION OF
13 FUNDS; VIOLATIONS AND PENALTIES THEREFOR; EXEMPTION OF PRIZES
14 FROM STATE AND LOCAL TAXATION AND MAKING AN APPROPRIATION,"
15 FURTHER PROVIDING FOR DEFINITIONS, FOR REQUEST FOR PROPOSAL,
16 FOR PROGRAM GENERALLY, FOR GENERIC DRUGS, FOR RESTRICTED
17 FORMULARY, FOR REIMBURSEMENT, FOR NONLIABILITY, FOR THE
18 PHARMACEUTICAL ASSISTANCE CONTRACT FOR THE ELDERLY NEEDS
19 ENHANCEMENT TIER, FOR THE PHARMACEUTICAL ASSISTANCE REVIEW
20 BOARD, FOR PENALTIES AND FOR THE PRESCRIPTION DRUG EDUCATION
21 PROGRAM; PROVIDING FOR THE PHARMACY BEST PRACTICES AND COST
22 CONTROL PROGRAM; FURTHER PROVIDING FOR DECLARATION OF POLICY,
23 FOR REBATE AGREEMENT, FOR TERMS OF REBATE AGREEMENT AND FOR
24 AMOUNT OF REBATE; PROVIDING FOR A PHARMACEUTICAL ASSISTANCE
25 CLEARINGHOUSE; FURTHER PROVIDING FOR ANNUAL REPORT TO GENERAL
26 ASSEMBLY; AND PROVIDING FOR CONSTRUCTION WITH FEDERAL
27 PROGRAMS.
28 The General Assembly of the Commonwealth of Pennsylvania
29 hereby enacts as follows:
30 CHAPTER 1 <--
31 PRELIMINARY PROVISIONS
32 Section 101. Short title.
33 This act shall be known and may be cited as the
34 Pharmaceutical Reform Act.
35 CHAPTER 3
36 PHARMACEUTICAL MATTERS
37 SUBCHAPTER A
38 PHARMACEUTICAL ASSISTANCE FOR THE ELDERLY
39 Section 301. Legislative findings.
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1 Finding that an increasing number of this Commonwealth's
2 elderly citizens who are living on fixed incomes are
3 experiencing difficulties in meeting the costs of life-
4 sustaining prescription drugs, the General Assembly, in its
5 responsibilities to provide for the health, welfare and safety
6 of the residents of this Commonwealth, hereby continues a
7 limited State pharmaceutical assistance program for the elderly.
8 Section 302. Definitions.
9 The following words and phrases when used in this subchapter
10 shall have the meanings given to them in this section unless the
11 context clearly indicates otherwise:
12 "A-rated generic therapeutically equivalent drug." A drug
13 product that the Commissioner of Food and Drugs of the United
14 States Food and Drug Administration has approved as safe and
15 effective and has determined to be therapeutically equivalent,
16 as listed in "The Approved Drug Products with Therapeutic
17 Equivalence Evaluations" (Food and Drug Administration "Orange
18 Book"), with a specific "A" code designation only.
19 "Average wholesale cost." The cost of a dispensed drug based
20 upon the price published in a national drug pricing system in
21 current use by the Department of Aging as the average wholesale
22 price of a prescription drug in the most common package size.
23 "Average wholesale price." Average wholesale cost.
24 "Board." The Pharmaceutical Assistance Review Board.
25 "CMS." Center for Medicare and Medicaid Services.
26 "Department." The Department of Aging of the Commonwealth.
27 "Eligible claimant." A resident of this Commonwealth for no
28 less than 90 days, who is 65 years of age and older, whose
29 annual income is less than the maximum annual income and who is
30 not otherwise qualified for public assistance under the act of
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1 June 13, 1967 (P.L.31, No.21), known as the Public Welfare Code.
2 "FDA." The United States Food and Drug Administration of the
3 Public Health Service of the Department of Health and Human
4 Services.
5 "Income." All income from whatever source derived,
6 including, but not limited to, salaries, wages, bonuses,
7 commissions, income from self-employment, alimony, support
8 money, cash public assistance and relief, the gross amount of
9 any pensions or annuities, including railroad retirement
10 benefits, all benefits received under the Social Security Act
11 (49 Stat. 620, 42 U.S.C. § 301 et seq.) except Medicare
12 benefits, all benefits received under State unemployment
13 insurance laws and veterans' disability payments, all interest
14 received from the Federal Government or any state government or
15 any instrumentality or political subdivision thereof, realized
16 capital gains, rentals, workmen's compensation and the gross
17 amount of loss of time insurance benefits, life insurance
18 benefits and proceeds, except the first $5,000 of the total of
19 death benefits payments, and gifts of cash or property, other
20 than transfers by gift between members of a household, in excess
21 of a total value of $300, but does not include surplus food or
22 other relief in kind supplied by a government agency or property
23 tax rebate.
24 "Mail service program." A program set forth in section 313
25 to dispense prescription drugs by postal delivery service
26 designated and administered by the department and any entity
27 with which it contracts, upon an enrollee's submission of a
28 prescription and the applicable copayment.
29 "Maintenance drug." A prescription drug prescribed to an
30 individual for a chronic condition the use of which is medically
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1 necessary for a consecutive period of at least 60 days.
2 "Maximum annual income." For PACE eligibility, annual income
3 which shall not exceed $14,500 in the case of single persons nor
4 $17,700 in the case of the combined annual income of persons
5 married to each other. Persons may, in reporting income to the
6 Department of Aging, round the amount of each source of income
7 and the income total to the nearest whole dollar, whereby any
8 amount which is less than 50¢ is eliminated.
9 "PACE." The Pharmaceutical Assistance Contract for the
10 Elderly program provided for in this subchapter.
11 "PACENET." The Pharmaceutical Assistance Contract for the
12 Elderly Needs Enhancement Tier provided for in this subchapter.
13 "Pharmacy." A pharmacy licensed by the Commonwealth.
14 "Prescription drug." All drugs requiring a prescription in
15 this Commonwealth, insulin, insulin syringes and insulin
16 needles. Experimental drugs or drugs prescribed for wrinkle
17 removal or hair growth are prohibited.
18 "Private contractor." A person, partnership or corporate
19 entity that enters into a contract with the Commonwealth to
20 provide services under the provisions of this subchapter.
21 "Program." The Pharmaceutical Assistance Contract for the
22 Elderly (PACE) and the Pharmaceutical Assistance Contract for
23 the Elderly Needs Enhancement Tier (PACENET) as established by
24 this subchapter, unless otherwise specified.
25 "Provider." A pharmacy or dispensing physician enrolled as a
26 provider in the program.
27 Section 303. Determination of eligibility.
28 The department shall adopt regulations relating to the
29 determination of eligibility of prospective claimants and
30 providers, including dispensing physicians, and the
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1 determination and elimination of program abuse. To this end, the
2 department shall establish a compliance unit staffed
3 sufficiently to fulfill this responsibility. The department
4 shall have the power to declare ineligible any claimant or
5 provider who abuses or misuses the established prescription
6 plan. The department shall have the power to investigate cases
7 of suspected provider or recipient fraud.
8 Section 304. Physician and pharmacy participation.
9 Any physician, pharmacist, pharmacy or corporation owned in
10 whole or in part by a physician or pharmacist enrolled as a
11 provider in the program or that has prescribed medication for a
12 claimant in the program who is precluded or excluded for cause
13 from the Department of Public Welfare's medical assistance
14 program shall be precluded or excluded from participation in the
15 program. No physician precluded or excluded from the Department
16 of Public Welfare's medical assistance program shall have claims
17 resulting from prescriptions paid for by the program.
18 Section 305. Drug utilization review system.
19 The department shall ensure that a state-of-the-art
20 therapeutic drug utilization review system is established to
21 monitor and correct misutilization of drug therapies.
22 Section 306. Reduced assistance.
23 Any eligible claimant whose prescription drug costs are
24 covered in part by any other plan of assistance or insurance may
25 be required to receive reduced assistance under the provisions
26 of this subchapter.
27 Section 307. Rebates for expenses prohibited.
28 A system of rebates or reimbursements to the claimant for
29 prescription drugs shall be prohibited.
30 Section 308. Request for proposal.
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1 (a) General.--The department shall prepare a request for
2 proposal for the purpose of providing pharmaceutical assistance
3 for the elderly within this Commonwealth. Upon the adoption of
4 the General Fund budget, the Department of Revenue shall be
5 authorized to transmit the appropriated funds in the State
6 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 shall be available for use in the next
13 fiscal year.
14 (b) Additional requests.--To provide for the continued
15 operation of the program, the department shall prepare, as
16 needed, requests for proposals, in addition to that set forth in
17 subsection (a), for the purpose of providing pharmaceutical
18 assistance for the elderly within this Commonwealth. A request
19 for proposal shall require potential private contractors to
20 submit a proposal for a period of time and with monetary
21 limitations as determined by the department. Upon the enactment
22 of an appropriation from the State Lottery Fund, the Department
23 of Revenue shall be authorized to transmit the appropriated
24 amount to the State Treasurer to be deposited in the
25 Pharmaceutical Assistance Contract for the Elderly Fund. Funds
26 not expended in the fiscal year in which they were appropriated
27 shall not lapse and shall be available for use in the next
28 fiscal year.
29 Section 309. Drug utilization review and therapeutic
30 interchange.
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1 (a) Drug utilization review.--The department shall ensure
2 that a state-of-the-art therapeutic drug utilization review
3 system is established to monitor and correct misutilization of
4 drug therapies.
5 (b) Therapeutic interchange.--The department may develop a
6 therapeutic interchange program based on national medical
7 standards that establish therapeutically equivalent drugs which
8 produce identical levels of clinical effectiveness and outcomes.
9 The program shall authorize pharmacy benefit coverage when a
10 patient's health care provider prescribes a prescription drug
11 not in the program if any of the following apply:
12 (1) The program drug:
13 (i) has not been effective in treating the patient's
14 condition; or
15 (ii) is not expected with reasonable certainty to be
16 effective in treating the patient's condition.
17 (2) The program drug causes or is reasonably expected to
18 cause adverse or harmful reactions in the patient.
19 (3) Other clinical criteria approved by the department
20 are complied with.
21 Section 310. Program generally.
22 (a) Parameters of program.--The program shall include the
23 following:
24 (1) Participating pharmacies shall be paid within 21
25 days of the contracting firm receiving the appropriate
26 substantiation of the transaction. Pharmacies shall be
27 entitled to interest for payment not made within the 21-day
28 period at a rate approved by the board.
29 (2) Collection of the copayment by pharmacies shall be
30 mandatory.
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1 (3) Senior citizens participating in the program are not
2 required to maintain records of each transaction.
3 (4) A system of rebates or reimbursements to eligible
4 claimants for pharmaceutical expenses shall be prohibited.
5 (5) The copayment amount for generic or multi-source
6 drugs shall be less than the copayment amount for single-
7 source drugs.
8 (6) Payments as follows:
9 (i) Except as provided in subparagraph (ii), to
10 pharmacies on behalf of eligible claimants for costs of
11 the prescription drug in excess of the copayment as
12 provided in subsections (b) and (c), plus a dispensing
13 fee of $3.50 or the dispensing fee established by the
14 department by regulation, whichever is greater.
15 (ii) For A-rated generic therapeutically equivalent
16 drugs, to pharmacies on behalf of eligible claimants for
17 the upper limits established under 42 CFR § 447.332
18 (relating to upper limits for multiple source drugs),
19 plus a dispensing fee of $4 or the dispensing fee
20 established by the department by regulations, whichever
21 is greater.
22 (7) In no case shall the Commonwealth or any person
23 enrolled in the program be charged more than the price of the
24 drug at the particular pharmacy on the date of the sale.
25 (b) Multiple-source drugs.--Except for brand name drugs that
26 are certified in accordance with subsection (d), the department
27 payment for multiple-source drugs must not exceed the amount
28 that would result from the application of the specific limits
29 established in accordance with subsection (e). If a specific
30 limit has not been established under subsection (e), then the
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1 rule for "other drugs" set forth in subsection (c) applies.
2 (c) Other drugs.--The department payments for brand name
3 drugs certified in accordance with subsection (d) and drugs
4 other than multiple-source drugs for which a specific limit has
5 been established under subsection (e) must not exceed in the
6 aggregate payment levels that the department has determined by
7 applying the lower of the:
8 (1) Estimated acquisition costs plus reasonable
9 dispensing fees established by the department.
10 (2) Providers' usual and customary charges to the
11 general public.
12 (d) Certification of brand-name drugs.--
13 (1) The upper limit for payments for multiple-source
14 drugs for which a specific limit has been established under
15 subsection (e) does not apply if a physician certifies in his
16 or her own handwriting that a specific brand is medically
17 necessary for a particular recipient.
18 (2) The department must decide what certification form
19 and procedure are used.
20 (3) A checkoff box on a form is not acceptable but a
21 notation like "brand necessary" is allowable.
22 (4) The department may allow providers to keep the
23 certification forms if the forms will be available for
24 inspection by the department.
25 (e) Establishment and issuance of a listing of multiple-
26 source drugs.--
27 (1) The department will use the CMS listings that
28 identify and set upper limits for multiple-source drugs that
29 meet the following requirements:
30 (i) All of the formulations of the drug approved by
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1 the Food and Drug Administration (FDA) have been
2 evaluated as therapeutically equivalent in the most
3 current edition of their publication, Approved Drug
4 Products with Therapeutic Equivalence Evaluations,
5 including supplements or in successor publications.
6 (ii) At least three suppliers list the drug, which
7 has been classified by the FDA as category "A" in its
8 publication, Approved Drug Products with Therapeutic
9 Equivalence Evaluations, including supplements or in
10 successor publications, based on all listings contained
11 in current editions, or updates, of published compendia
12 of cost information for drugs available for sale in this
13 Commonwealth.
14 (2) The department publishes the list of multiple-source
15 drugs for which upper limits have been established and any
16 revisions to the list in Medicaid program instructions.
17 (3) The department will identify the sources used in
18 compiling these lists.
19 Section 311. Generic drugs.
20 (a) General.--Notwithstanding any other statute or
21 regulation, if an A-rated generic therapeutically equivalent
22 drug is available for dispensing to a claimant, the provider
23 shall dispense the A-rated generic therapeutically equivalent
24 drug to the claimant. The department shall not reimburse
25 providers for brand name products except in the following
26 circumstances:
27 (1) There is no A-rated generic therapeutically
28 equivalent drug available on the market. This paragraph does
29 not apply to the lack of availability of an A-rated generic
30 therapeutically equivalent drug in the providing pharmacy
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1 unless it can be shown to the department that the provider
2 made reasonable attempts to obtain the A-rated generic
3 therapeutically equivalent drug or that there was an
4 unforeseeable demand and depletion of the supply of the A-
5 rated generic therapeutically equivalent drug. In either
6 case, the department shall reimburse the provider for 90% of
7 the average wholesale cost plus a dispensing fee based on the
8 least expensive A-rated generic therapeutically equivalent
9 drug for the brand drug dispensed.
10 (2) The Department of Health has determined that a drug
11 shall not be recognized as an A-rated generic therapeutically
12 equivalent drug for purpose of substitution under section
13 5(b) of the act of November 24, 1976 (P.L.1163, No.259),
14 referred to as the Generic Equivalent Drug Law.
15 (3) At the time of dispensing, the provider has a
16 prescription on which the brand name drug dispensed is billed
17 to the program by the provider at a usual and customary
18 charge which is equal to or less than the least expensive
19 usual and customary charge of any A-rated generic
20 therapeutically equivalent drug reasonably available on the
21 market to the provider.
22 (b) Copayment.--If a claimant chooses not to accept the A-
23 rated generic therapeutically equivalent drug required by
24 subsection (a), the claimant shall be liable for the copayment
25 and 70% of the average wholesale cost of the brand name drug.
26 (c) Substitution or construction.--The dispensing of an A-
27 rated generic therapeutically equivalent drug in accordance with
28 this subchapter shall not be deemed incorrect substitution under
29 section 6(a) of the Generic Equivalent Drug Law.
30 (d) Medical exception.--A medical exception process shall be
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1 established by the department, which shall be published as a
2 notice in the Pennsylvania Bulletin and distributed to providers
3 and recipients in the program.
4 Section 312. Supply.
5 (a) Requirement.--Except as set forth in subsection (b),
6 prescription benefits for any single prescription shall be
7 limited to a 30-day supply of the prescription drug or 100
8 units, whichever is less for acute conditions.
9 (b) Exceptions.--
10 (1) In the case of diagnosis for acute conditions,
11 prescription benefits for any single prescription shall be
12 limited to a 15-day supply.
13 (2) Subsection (a) shall not apply to topical ointments
14 or gels which are not available in containers which meet the
15 size and supply restrictions set forth in subsection (a).
16 (c) Subsection (a) does not apply to contracts under section
17 313(c).
18 Section 313. Mail service program.
19 (a) General rule.--The department shall encourage the use of
20 a mail service program for maintenance drugs for eligible
21 claimants. Only mail order pharmacy services provided by
22 pharmacies which are licensed by the Commonwealth and which have
23 their principal place of business within this Commonwealth may
24 participate as providers under the program.
25 (b) Minimum standards of practice.--The department shall
26 develop and promulgate specific regulations governing the
27 practice of mail order pharmacy and other enrolled providers to
28 include the following minimum standards of practice to ensure
29 the health, safety and welfare of program participants:
30 (1) The appropriate method by which pharmacies verify
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1 the identity of the eligible claimant and the authenticity of
2 prescriptions received.
3 (2) The appropriate method by which pharmacies mail or
4 deliver prescription drugs ensuring, to the maximum extent
5 possible, that the intended eligible claimant is the actual
6 ultimate recipient of any prescription dispensed.
7 (3) The appropriate method by which pharmacies
8 communicate with eligible claimants in emergency situations.
9 (c) Ninety-day supply.--The department shall negotiate mail
10 order contracts to provide a 90-day supply of drugs to eligible
11 claimants at a single copayment rate equal to a 30-day supply
12 for each order.
13 (d) Option.--An eligible claimant may use the mail service
14 program if the eligible claimant:
15 (1) utilizes a drug deemed by the department to be
16 appropriate for mail order service;
17 (2) has filled a prescription; and
18 (3) has refilled the prescription under paragraph (2) at
19 least once.
20 (e) Rebates.--A mail order contract must include a rebate
21 from the prescription drug manufacturer. The rebate must be at
22 least as much as follows:
23 (1) For a brand-name drug, the sum of subparagraphs (i)
24 and (ii):
25 (i) A dispensing fee of at least $6.
26 (ii) The difference between:
27 (A) the average wholesale price; and
28 (B) 20% of that price.
29 (2) For a generic drug, the sum of subparagraphs (i) and
30 (ii):
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1 (i) A dispensing fee of at least $6.
2 (ii) The difference between:
3 (A) the average wholesale price; and
4 (B) 50% of that price.
5 (f) Negotiated payments.--The department shall not
6 discriminate against a pharmacy that agrees to accept negotiated
7 payment levels with the same terms and conditions and to adhere
8 to quality standards established by the PACE and PACENET
9 programs.
10 Section 314. Indication of price.
11 The retail price of the prescription shall be indicated on
12 the label of the prescription container or furnished by separate
13 receipt.
14 Section 315. Reimbursement.
15 (a) Indication.--The department shall indicate third-party
16 coverage for each eligible claimant.
17 (b) Result.--For-profit third-party insurers and not-for-
18 profit prescription plans shall be responsible for any payments
19 made to a providing pharmacy on behalf of a claimant covered by
20 such a third party.
21 Section 316. Nonliability.
22 (a) General.--Any person rendering service as a member of a
23 utilization review committee for this program shall not be
24 liable for any civil damages as a result of any acts or
25 omissions in rendering the service as a member of any such
26 committee except any acts or omissions intentionally designed to
27 harm or any grossly negligent acts or omissions which result in
28 harm to the person receiving such service.
29 (b) Department personnel.--Any officer or employee of the
30 department rendering service as a member of a utilization review
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1 committee for this program shall not be liable for any civil
2 damages as a result of any acts or omissions in rendering the
3 service as a member of any such committee or as a result of any
4 decision or action in connection with the program except any
5 acts or omissions intentionally designed to harm or any grossly
6 negligent acts or omissions which result in harm to the person
7 receiving such service.
8 Section 317. Income verification.
9 (a) General.--The department shall annually verify the
10 income of eligible claimants by requiring income documentation
11 from the claimants. An application for benefits under this
12 subchapter shall constitute a waiver to the department of all
13 relevant confidentiality requirements relating to the claimant's
14 Pennsylvania State income tax information in the possession of
15 the Department of Revenue. The Department of Revenue shall
16 provide the department with the necessary income information
17 shown on the claimant's Pennsylvania State income tax return
18 solely for income verification purposes.
19 (b) Unlawful act.--It shall be unlawful for any officer,
20 agent or employee of the department to divulge or make known in
21 any manner whatsoever any information gained through access to
22 the Department of Revenue information except for official income
23 verification purposes under this subchapter.
24 (c) Penalty.--A person who violates this chapter commits a
25 misdemeanor and shall, upon conviction, be sentenced to pay a
26 fine of not more than $1,000 or to imprisonment for not more
27 than one year, or both, together with the cost of prosecution,
28 and, if the offender is an officer or employee of the
29 Commonwealth, he shall be dismissed from office or discharged
30 from employment.
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1 (d) Coordination of effort.--To the extent possible, the
2 department and the Department of Public Welfare shall coordinate
3 efforts to facilitate the application and enrollment of eligible
4 older people in the Medicaid Healthy Horizons Program by
5 processing these applications at senior citizens centers and
6 other appropriate facilities providing services to the elderly.
7 Section 318. Contract.
8 The department is authorized to enter into a contract
9 providing for prescription drugs to eligible persons pursuant to
10 this subchapter. The department shall select a proposal that
11 includes, but is not limited to, the criteria set forth in this
12 subchapter.
13 Section 319. The Pharmaceutical Assistance Contract for the
14 Elderly Needs Enhancement Tier.
15 (a) Establishment.--There is hereby established within the
16 department a program to be known as the Pharmaceutical
17 Assistance Contract for the Elderly Needs Enhancement Tier
18 (PACENET).
19 (b) Eligibility.--A claimant with an annual income of not
20 less than $14,500 and not more than $22,450 in the case of a
21 single person and of not less than $17,770 and not more than
22 $30,300 in the case of the combined income of persons married to
23 each other shall be eligible for enhanced pharmaceutical
24 assistance under this section. A person may, in reporting income
25 to the department, round the amount of each source of income and
26 the income total to the nearest whole dollar, whereby any amount
27 which is less than 50¢ is eliminated.
28 (c) Requirements.--Upon enrollment in PACENET, eligible
29 claimants in the income ranges set forth in subsection (b) shall
30 be required to meet a monthly deductible in unreimbursed
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1 prescription drug expenses of $40 per person per month. To
2 qualify for the deductible set forth in this subsection the
3 prescription drug must be purchased for the use of the eligible
4 claimant from a provider as defined in this subchapter. The
5 department, after consultation with the board, shall approve an
6 adjustment in the deductible on an annual basis.
7 (d) Copayment.--The copayment amount for generic or multi-
8 source drugs shall be less than the copayment amount for single-
9 source drugs.
10 Section 320. Board.
11 (a) General.--The Pharmaceutical Assistance Review Board is
12 continued to ensure that the program is providing and continues
13 to provide the assistance intended in a fiscally responsible
14 manner without excessively hampering the pharmacy industry.
15 (b) Membership.--The board shall be comprised of the
16 following eight persons:
17 (1) The Secretary of Aging, who shall serve as its
18 chairman.
19 (2) The Secretary of Revenue.
20 (3) The Secretary of Health.
21 (4) Five public members, one appointed by the President
22 pro tempore of the Senate, one appointed by the Minority
23 Leader of the Senate, one appointed by the Speaker of the
24 House of Representatives, one appointed by the Minority
25 Leader of the House of Representatives and one appointed by
26 the Governor. Those appointed by the legislative officers
27 shall include two senior citizens who have not been a part of
28 the pharmacy industry to serve as consumer advocates, one
29 representative of the pharmacy industry and one practicing
30 Pennsylvania pharmacist. The individual appointed by the
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1 Governor must be a physician. A public member who misses two
2 consecutive meetings without good cause acceptable to the
3 chairman shall be replaced by the appointing authority.
4 (c) Annual review.--Using the annual report submitted by the
5 department pursuant to section 2102 of the act of August 26,
6 1971 (P.L.351, No.91), known as the State Lottery Law, and other
7 appropriate data sources, the board shall conduct an annual
8 review. The board shall develop recommendations concerning any
9 changes in the level of copayment, deductible or in the level of
10 fees paid to participating pharmacists. The board shall review
11 the department's therapeutic drug utilization review program on
12 an ongoing basis. The board may also recommend other changes in
13 the structure of the program and direct the department to enter
14 into discussions with the private contractor concerning
15 amendments to the contract, or the department may enter into
16 such discussion if it deems necessary. The copayment or
17 deductible schedule shall only be adjusted on an annual basis.
18 (d) Meetings.--The board shall meet at least two times per
19 year.
20 Section 321. Penalties.
21 (a) General.--It shall be unlawful for any person to:
22 (1) Submit a false or fraudulent claim or application
23 under this subchapter, including, but not limited to:
24 (i) aiding or abetting another in the submission of
25 a false or fraudulent claim or application;
26 (ii) receiving benefits or reimbursement under a
27 Federal, state or a private program for prescription
28 assistance and claiming or receiving duplicative benefits
29 hereunder;
30 (iii) soliciting, receiving, offering or paying any
20030H0888B2098 - 20 -
1 kickback, bribe or rebate, in cash or in kind, from or to
2 any person in connection with the furnishing of services
3 under this subchapter;
4 (iv) engaging in a pattern of submitting claims that
5 repeatedly uses incorrect National Drug Code numbers for
6 the purpose of obtaining wrongful enhanced reimbursement;
7 or
8 (v) otherwise violating any provision of this
9 subchapter.
10 (2) Charge a copay if the amount of the copay exceeds
11 the actual cost of the drug purchased.
12 (b) Civil penalty.--In addition to any appropriate criminal
13 penalty for prohibited acts under this subchapter whether or not
14 that act constitutes a crime under 18 Pa.C.S. (relating to
15 crimes and offenses), a provider who violates this section may
16 be liable for a civil penalty, which shall be collected by the
17 department, in an amount not less than $500 and not more than
18 $10,000 for each violation of this chapter. Each violation
19 constitutes a separate offense. If the department collects three
20 or more civil penalties against the same provider, the provider
21 shall be ineligible to participate in either PACE or PACENET for
22 a period of one year. If more than three civil penalties are
23 collected from any provider, the department may determine that
24 the provider is permanently ineligible to participate in PACE or
25 PACENET.
26 (c) Suspension.--The license of any provider who has been
27 found guilty under this subchapter shall be suspended for a
28 period of one year. The license of any provider who has
29 committed three or more violations of this subchapter may be
30 suspended for a period of one year.
20030H0888B2098 - 21 -
1 (d) Reparation.--Any provider, recipient or other person who
2 is found guilty of a crime for violating this subchapter shall
3 repay three times the value of the material gain received. In
4 addition to the civil penalty authorized pursuant to subsection
5 (b), the department may require the provider, recipient or other
6 person to repay up to three times the value of any material gain
7 to PACE or PACENET.
8 Section 322. Prescription Drug Education Program.
9 The department, in cooperation with the Department of Health,
10 shall develop and implement a Statewide prescription drug
11 education program designed to inform older adults of the dangers
12 of prescription drug abuse and misuse. The prescription dug
13 education program shall include, but not be limited to,
14 information concerning the following:
15 (1) The hazards of prescription drug overdose.
16 (2) The potential dangers of mixing prescription drugs.
17 (3) The danger of retaining unused prescription drugs
18 after the need to take them no longer exists.
19 (4) The necessity to carefully question physicians and
20 pharmacists concerning the effects of taking prescription
21 drugs.
22 (5) The advisability of maintaining a prescription drug
23 profile or other record of prescription drug dosage and
24 frequency of dosage.
25 (6) The desirability of advising family members of the
26 types and proper dosage of prescription drugs which are being
27 taken.
28 (7) The dangers of taking prescription drugs in excess
29 of prescribed dosages.
30 (8) The need to obtain complete, detailed directions
20030H0888B2098 - 22 -
1 from the physician or pharmacist concerning the time period a
2 prescription drug should be taken.
3 Section 323. Outreach program.
4 The department, in consultation with appropriate Commonwealth
5 agencies, shall coordinate the development of an outreach plan
6 to inform potential contractors, providers and enrollees
7 regarding eligibility and available benefits of the PACE and
8 PACENET programs. The plan shall include provisions for reaching
9 special populations, including nonwhite and non-English-speaking
10 people; for reaching different geographic areas, including rural
11 and inner-city areas; and for assuring that special efforts are
12 coordinated within the overall outreach activities throughout
13 this Commonwealth.
14 SUBCHAPTER B
15 PRUDENT PHARMACEUTICAL PURCHASING
16 Section 341. Definitions.
17 The following words and phrases when used in this subchapter
18 shall have the meanings given to them in this section unless the
19 context clearly indicates otherwise:
20 "Covered prescription drug." A legend drug, insulin, an
21 insulin syringe or an insulin needle eligible for payment by the
22 Commonwealth under PACE, PACENET or designated pharmaceutical
23 programs.
24 "Designated pharmaceutical programs." The general assistance
25 program and the Special Pharmaceutical Benefit Program in the
26 Department of Public Welfare and the End Stage Renal Dialysis
27 Program in the Department of Health.
28 "PACE." The program under Subchapter A.
29 "PACENET." The program established under section 319.
30 Section 342. Rebate agreement.
20030H0888B2098 - 23 -
1 PACE, PACENET and designated pharmaceutical programs shall
2 reimburse for any covered prescription drug with a rebate
3 agreement drafted on the same basis as provided in section 1927
4 of Title XIX of the Social Security Act (49 Stat. 620, 42 U.S.C.
5 § 1396 r-8).
6 Section 343. Disposition of funds.
7 (a) PACE and PACENET.--Money received under this subchapter
8 in connection with PACE and PACENET shall be deposited in the
9 Pharmaceutical Assistance Contract for the Elderly Fund.
10 (b) Pharmaceutical programs.--Money received under this
11 subchapter in connection with designated pharmaceutical programs
12 shall be treated as a refund of expenditures to the
13 appropriation which originally provided the funding for the
14 pharmaceutical purchase.
15 SUBCHAPTER C
16 PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE
17 Section 361. 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 "Clearinghouse." The Pharmaceutical Assistance Clearinghouse
22 established in section 362.
23 "Department." The Department of Aging of the Commonwealth.
24 "Patient assistance program." A program offered by a
25 pharmaceutical manufacturer under which the manufacturer
26 provides prescription medications at no charge or at a
27 substantially reduced cost. The term does not include the
28 provision of a drug as part of a clinical trial.
29 Section 362. Pharmaceutical Assistance Clearinghouse.
30 (a) Establishment.--Within 120 days of the effective date of
20030H0888B2098 - 24 -
1 this subchapter, the department shall establish the
2 Pharmaceutical Assistance Clearinghouse. Each pharmaceutical
3 manufacturer that does business in this Commonwealth and offers
4 a patient assistance program shall inform the department of all
5 of the following:
6 (1) The existence of the patient assistance program.
7 (2) The eligibility requirements for the patient
8 assistance program.
9 (3) The drugs covered by the patient assistance program.
10 (4) Information, such as a telephone number, which may
11 be used to apply for the patient assistance program.
12 (b) Information.--The clearinghouse shall maintain the
13 information submitted by pharmaceutical manufacturers and make
14 it available to the public.
15 (c) Staff.--The department shall ensure that the
16 clearinghouse is staffed at least during normal business hours.
17 The department shall contract for the services of a school of
18 pharmacy to staff the clearinghouse.
19 Section 363. Toll-free telephone number.
20 The department shall establish a toll-free telephone number
21 through which the members of the public may obtain information
22 from the clearinghouse about available patient assistance
23 programs.
24 Section 364. Assistance available.
25 (a) Direct.--
26 (1) The clearinghouse shall assist any individual in
27 determining whether a patient assistance program is offered
28 for a particular drug and whether the individual may be
29 eligible to obtain the drug through a patient assistance
30 program.
20030H0888B2098 - 25 -
1 (2) The clearinghouse may assist an individual who
2 wishes to apply for a patient assistance program by assisting
3 with the preparation of an application and coordinating
4 communications between the individual's physician and a
5 pharmaceutical manufacturer on behalf of the individual for
6 the purpose of obtaining approval to participate in the
7 patient assistance program.
8 (b) Referrals.--The clearinghouse shall make referrals to
9 any publicly funded program for which it deems a patient
10 eligible.
11 Section 365. Reporting.
12 The department shall report annually to the Governor and the
13 General Assembly on the activities of the clearinghouse. The
14 report shall include:
15 (1) The number of individuals who have been assisted by
16 the clearinghouse.
17 (2) The number and benefits of patient assistance
18 programs listed with the clearinghouse.
19 (3) The number of patients referred to publicly funded
20 programs under section 364(b). Programs under this paragraph
21 include the Pharmaceutical Assistance Contract for the
22 Elderly Program, medical assistance and programs of the
23 Department of Veterans Affairs.
24 (4) Other information deemed relevant by the department.
25 CHAPTER 51
26 MISCELLANEOUS PROVISIONS
27 Section 5101. Federal programs.
28 If the Federal Government enacts programs similar to PACE or
29 PACENET, the State programs shall be construed to only
30 supplement the Federal programs and all persons qualified for
20030H0888B2098 - 26 -
1 coverage under the Federal program shall utilize that Federal
2 program before utilizing any State program.
3 Section 5102. Repeals.
4 (a) Specific.--Chapters 5 and 7 of the act of August 26,
5 1971 (P.L.351, No.91), known as the State Lottery Law, are
6 repealed.
7 (b) General.--All other acts and parts of acts are repealed
8 insofar as they are inconsistent with this act.
9 Section 5103. Effective date.
10 This act shall take effect immediately.
11 SECTION 1. THE DEFINITIONS OF "HCFA" AND "MAXIMUM ANNUAL <--
12 INCOME" IN SECTION 502 OF THE ACT OF AUGUST 26, 1971 (P.L.351,
13 NO.91), KNOWN AS THE STATE LOTTERY LAW, ADDED NOVEMBER 21, 1996
14 (P.L.741, NO.134), ARE AMENDED AND THE SECTION IS AMENDED BY
15 ADDING A DEFINITION TO READ:
16 SECTION 502. DEFINITIONS.
17 THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS CHAPTER
18 SHALL HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE
19 CONTEXT CLEARLY INDICATES OTHERWISE:
20 * * *
21 "CMS." THE CENTERS FOR MEDICARE AND MEDICAID SERVICES OF THE
22 UNITED STATES.
23 * * *
24 ["HCFA." THE HEALTH CARE FINANCING ADMINISTRATION OF THE
25 UNITED STATES.]
26 "INCOME." ALL INCOME FROM WHATEVER SOURCE DERIVED,
27 INCLUDING, BUT NOT LIMITED TO, SALARIES, WAGES, BONUSES,
28 COMMISSIONS, INCOME FROM SELF-EMPLOYMENT, ALIMONY, SUPPORT
29 MONEY, CASH PUBLIC ASSISTANCE AND RELIEF, THE GROSS AMOUNT OF
30 ANY PENSIONS OR ANNUITIES, INCLUDING RAILROAD RETIREMENT
20030H0888B2098 - 27 -
1 BENEFITS, ALL BENEFITS RECEIVED UNDER THE SOCIAL SECURITY ACT
2 (49 STAT. 620, 42 U.S.C. § 301 ET. SEQ.) (EXCEPT MEDICARE
3 BENEFITS), ALL BENEFITS RECEIVED UNDER STATE UNEMPLOYMENT
4 INSURANCE LAWS AND VETERANS' DISABILITY PAYMENTS, ALL INTEREST
5 RECEIVED FROM THE FEDERAL GOVERNMENT OR ANY STATE GOVERNMENT OR
6 ANY INSTRUMENTALITY OR POLITICAL SUBDIVISION THEREOF, REALIZED
7 CAPITAL GAINS, RENTALS, WORKMEN'S COMPENSATION AND THE GROSS
8 AMOUNT OF LOSS OF TIME INSURANCE BENEFITS, LIFE INSURANCE
9 BENEFITS AND PROCEEDS, EXCEPT THE FIRST [$5,000] $10,000 OF THE
10 TOTAL OF DEATH BENEFITS PAYMENTS, AND GIFTS OF CASH OR PROPERTY,
11 OTHER THAN TRANSFERS BY GIFT BETWEEN MEMBERS OF A HOUSEHOLD, IN
12 EXCESS OF A TOTAL VALUE OF $300, BUT SHALL NOT INCLUDE SURPLUS
13 FOOD OR OTHER RELIEF IN KIND SUPPLIED BY A GOVERNMENT AGENCY OR
14 PROPERTY TAX REBATE.
15 "MAXIMUM ANNUAL INCOME." FOR PACE ELIGIBILITY, THE TERM
16 SHALL MEAN ANNUAL INCOME WHICH SHALL NOT EXCEED [$14,000]
17 $14,500 IN THE CASE OF SINGLE PERSONS NOR [$17,200] $17,700 IN
18 THE CASE OF THE COMBINED ANNUAL INCOME OF PERSONS MARRIED TO
19 EACH OTHER. PERSONS MAY, IN REPORTING INCOME TO THE DEPARTMENT
20 OF AGING, ROUND THE AMOUNT OF EACH SOURCE OF INCOME AND THE
21 INCOME TOTAL TO THE NEAREST WHOLE DOLLAR, WHEREBY ANY AMOUNT
22 WHICH IS LESS THAN 50¢ IS ELIMINATED.
23 * * *
24 SECTION 2. SECTIONS 508(A), 509, 510(A) AND (B), 512, 515,
25 516, 519 AND 520(B) OF THE ACT, ADDED NOVEMBER 21, 1996
26 (P.L.741, NO.134), ARE AMENDED TO READ:
27 SECTION 508. REQUEST FOR PROPOSAL.
28 (A) GENERAL RULE.--THE DEPARTMENT SHALL PREPARE A REQUEST
29 FOR PROPOSAL FOR THE PURPOSE OF PROVIDING PHARMACEUTICAL
30 ASSISTANCE FOR THE ELDERLY WITHIN THIS COMMONWEALTH BEGINNING AT
20030H0888B2098 - 28 -
1 THE EXPIRATION, INCLUDING ANY OPTION YEARS THE DEPARTMENT
2 CHOOSES TO EXERCISE, OF THE CURRENT VENDOR CONTRACT. UPON THE
3 ADOPTION OF THE GENERAL FUND BUDGET, THE DEPARTMENT OF REVENUE
4 SHALL BE AUTHORIZED TO TRANSMIT THE APPROPRIATED FUNDS IN THE
5 STATE LOTTERY FUND TO THE STATE TREASURER TO BE DEPOSITED IN THE
6 PHARMACEUTICAL ASSISTANCE CONTRACT FOR THE ELDERLY FUND. THIS
7 FUND SHALL CONSIST OF APPROPRIATIONS AND INTEREST AND SHALL BE
8 CREATED BY THE STATE TREASURER TO FUND THE OPERATIONS OF THE
9 PROGRAM BY THE DEPARTMENT AND THE PRIVATE CONTRACTOR. FUNDS NOT
10 EXPENDED IN THE FISCAL YEAR IN WHICH THEY WERE APPROPRIATED
11 SHALL NOT LAPSE AND BE AVAILABLE FOR USE IN THE NEXT FISCAL
12 YEAR.
13 * * *
14 SECTION 509. PROGRAM GENERALLY.
15 THE PROGRAM SHALL INCLUDE THE FOLLOWING:
16 (1) PARTICIPATING PHARMACIES SHALL BE PAID WITHIN 21
17 DAYS OF THE CONTRACTING FIRM RECEIVING THE APPROPRIATE
18 SUBSTANTIATION OF THE TRANSACTION. PHARMACIES SHALL BE
19 ENTITLED TO INTEREST FOR PAYMENT NOT MADE WITHIN THE 21-DAY
20 PERIOD AT A RATE APPROVED BY THE BOARD.
21 (2) COLLECTION OF THE COPAYMENT BY PHARMACIES SHALL BE
22 MANDATORY.
23 (3) SENIOR CITIZENS PARTICIPATING IN THE PROGRAM ARE NOT
24 REQUIRED TO MAINTAIN RECORDS OF EACH TRANSACTION.
25 (4) A SYSTEM OF REBATES OR REIMBURSEMENTS TO ELIGIBLE
26 CLAIMANTS FOR PHARMACEUTICAL EXPENSES SHALL BE PROHIBITED.
27 (5) PACE SHALL INCLUDE [A] PARTICIPANT COPAYMENT
28 [SCHEDULE] SCHEDULES FOR EACH PRESCRIPTION, INCLUDING A
29 COPAYMENT FOR GENERIC OR MULTIPLE-SOURCE DRUGS THAT IS LESS
30 THAN THE COPAYMENT FOR SINGLE-SOURCE DRUGS. THE COPAYMENT
20030H0888B2098 - 29 -
1 [MAY INCREASE OR DECREASE] SHALL BE INCREASED OR DECREASED ON
2 AN ANNUAL BASIS BY THE AVERAGE PERCENT CHANGE OF INGREDIENT
3 COSTS FOR ALL PRESCRIPTION DRUGS, PLUS A DIFFERENTIAL TO
4 RAISE THE COPAYMENT TO THE NEXT HIGHEST 25¢ INCREMENT. IN
5 ADDITION, THE DEPARTMENT MAY APPROVE A REQUEST FOR INCREASE
6 OR DECREASE IN THE LEVEL OF COPAYMENT BASED UPON THE
7 FINANCIAL EXPERIENCE AND PROJECTIONS OF PACE AND AFTER
8 CONSULTATION WITH THE BOARD. THE DEPARTMENT IS PROHIBITED
9 FROM APPROVING ADJUSTMENTS TO THE COPAYMENT ON MORE THAN AN
10 ANNUAL BASIS.
11 (6) THE PROGRAM SHALL CONSIST OF PAYMENTS TO PHARMACIES
12 ON BEHALF OF ELIGIBLE CLAIMANTS FOR 90% OF THE AVERAGE
13 WHOLESALE COSTS OF PRESCRIPTION DRUGS WHICH EXCEED THE
14 COPAYMENT, PLUS A DISPENSING FEE OF AT LEAST [$3.50] $4 OR
15 THE DISPENSING FEE ESTABLISHED BY THE DEPARTMENT BY
16 REGULATION, WHICHEVER IS GREATER.
17 (7) IN NO CASE SHALL THE COMMONWEALTH OR ANY PERSON
18 ENROLLED IN THE PROGRAM BE CHARGED MORE THAN THE PRICE OF THE
19 DRUG AT THE PARTICULAR PHARMACY ON THE DATE OF THE SALE.
20 (8) THE GOVERNOR MAY, BASED UPON CERTIFIED STATE LOTTERY
21 FUND REVENUE THAT IS PROVIDED TO BOTH THE CHAIRMAN AND
22 MINORITY CHAIRMAN OF THE APPROPRIATIONS COMMITTEE OF THE
23 SENATE AND THE CHAIRMAN AND MINORITY CHAIRMAN OF THE
24 APPROPRIATIONS COMMITTEE OF THE HOUSE OF REPRESENTATIVES, AND
25 AFTER CONSULTATION WITH THE BOARD, INCREASE THE ELIGIBILITY
26 LIMITS ABOVE THOSE ESTABLISHED IN THIS CHAPTER.
27 SECTION 510. GENERIC DRUGS.
28 (A) IN GENERAL.--NOTWITHSTANDING ANY OTHER STATUTE OR
29 REGULATION, IF AN A-RATED GENERIC THERAPEUTICALLY EQUIVALENT
30 DRUG IS AVAILABLE FOR DISPENSING TO A CLAIMANT, THE PROVIDER
20030H0888B2098 - 30 -
1 SHALL DISPENSE THE A-RATED GENERIC THERAPEUTICALLY EQUIVALENT
2 DRUG TO THE CLAIMANT. THE DEPARTMENT SHALL NOT REIMBURSE
3 PROVIDERS FOR BRAND NAME PRODUCTS EXCEPT IN THE FOLLOWING
4 CIRCUMSTANCES:
5 (1) THERE IS NO A-RATED GENERIC THERAPEUTICALLY
6 EQUIVALENT DRUG AVAILABLE ON THE MARKET. THIS PARAGRAPH DOES
7 NOT APPLY TO THE LACK OF AVAILABILITY OF AN A-RATED GENERIC
8 THERAPEUTICALLY EQUIVALENT DRUG IN THE PROVIDING PHARMACY
9 UNLESS IT CAN BE SHOWN TO THE DEPARTMENT THAT THE PROVIDER
10 MADE REASONABLE ATTEMPTS TO OBTAIN THE A-RATED GENERIC
11 THERAPEUTICALLY EQUIVALENT DRUG OR THAT THERE WAS AN
12 UNFORESEEABLE DEMAND AND DEPLETION OF THE SUPPLY OF THE A-
13 RATED GENERIC THERAPEUTICALLY EQUIVALENT DRUG. IN EITHER
14 CASE, THE DEPARTMENT SHALL REIMBURSE THE PROVIDER [FOR 90% OF
15 THE AVERAGE WHOLESALE COST PLUS A DISPENSING FEE BASED ON THE
16 LEAST EXPENSIVE A-RATED GENERIC THERAPEUTICALLY EQUIVALENT
17 DRUG FOR THE BRAND DRUG DISPENSED.] BASED UPON THE MOST
18 CURRENT LISTING OF FEDERAL UPPER PAYMENT LIMITS ESTABLISHED
19 UNDER THE MEDICAID PROGRAM AS PROVIDED UNDER FEDERAL
20 REGULATIONS AT 42 CFR 447.332 (RELATING TO UPPER LIMITS FOR
21 MULTIPLE SOURCE DRUGS), IN ACCORDANCE WITH SECTION
22 1902(A)(30)(A) OF THE SOCIAL SECURITY ACT (49 STAT. 620, 42
23 U.S.C. § 1396A(A)(30)(A)), PLUS A DISPENSING FEE. THE
24 DEPARTMENT SHALL REVIEW THE FEDERAL UPPER PAYMENT LIMITS
25 EVERY 12 MONTHS.
26 (2) AN A-RATED GENERIC THERAPEUTICALLY EQUIVALENT DRUG
27 IS DEEMED BY THE DEPARTMENT, IN CONSULTATION WITH A
28 UTILIZATION REVIEW COMMITTEE, TO HAVE TOO NARROW A
29 THERAPEUTIC INDEX FOR SAFE AND EFFECTIVE DISPENSING IN THE
30 COMMUNITY SETTING. THE DEPARTMENT SHALL NOTIFY PROVIDING
20030H0888B2098 - 31 -
1 PHARMACIES OF A-RATED GENERIC THERAPEUTICALLY EQUIVALENT
2 DRUGS THAT ARE IDENTIFIED PURSUANT TO THIS PARAGRAPH ON A
3 REGULAR BASIS.
4 (3) THE DEPARTMENT OF HEALTH HAS DETERMINED THAT A DRUG
5 SHALL NOT BE RECOGNIZED AS AN A-RATED GENERIC THERAPEUTICALLY
6 EQUIVALENT DRUG FOR PURPOSE OF SUBSTITUTION UNDER SECTION
7 5(B) OF THE ACT OF NOVEMBER 24, 1976 (P.L.1163, NO.259),
8 REFERRED TO AS THE GENERIC EQUIVALENT DRUG LAW.
9 (4) AT THE TIME OF DISPENSING, THE PROVIDER HAS A
10 PRESCRIPTION ON WHICH THE BRAND NAME DRUG DISPENSED IS BILLED
11 TO THE PROGRAM BY THE PROVIDER AT A USUAL AND CUSTOMARY
12 CHARGE WHICH IS EQUAL TO OR LESS THAN THE LEAST EXPENSIVE
13 USUAL AND CUSTOMARY CHARGE OF ANY A-RATED GENERIC
14 THERAPEUTICALLY EQUIVALENT DRUG REASONABLY AVAILABLE ON THE
15 MARKET TO THE PROVIDER.
16 (B) GENERIC NOT ACCEPTED.--[IF] EXCEPT AS PROVIDED IN
17 CHAPTER 6 IF A CLAIMANT CHOOSES NOT TO ACCEPT THE A-RATED
18 GENERIC THERAPEUTICALLY EQUIVALENT DRUG REQUIRED BY SUBSECTION
19 (A), THE CLAIMANT SHALL BE LIABLE FOR THE COPAYMENT AND 70% OF
20 THE AVERAGE WHOLESALE COST OF THE BRAND NAME DRUG.
21 * * *
22 SECTION 512. RESTRICTED FORMULARY.
23 THE DEPARTMENT MAY ESTABLISH A RESTRICTED FORMULARY OF THE
24 DRUGS WHICH WILL NOT BE REIMBURSED BY THE PROGRAM. THIS
25 FORMULARY SHALL INCLUDE ONLY EXPERIMENTAL DRUGS AND DRUGS ON THE
26 DRUG EFFICACY STUDY IMPLEMENTATION LIST PREPARED BY [THE HEALTH
27 CARE FINANCE ADMINISTRATION] CMS. A MEDICAL EXCEPTION MAY BE
28 PERMITTED BY THE DEPARTMENT FOR REIMBURSEMENT OF A DRUG ON THE
29 DRUG EFFICACY STUDY IMPLEMENTATION LIST UPON DECLARATION OF ITS
30 NECESSITY ON THE PRESCRIPTION BY THE TREATING PHYSICIAN, EXCEPT
20030H0888B2098 - 32 -
1 THAT, FOR DESI DRUGS FOR WHICH THE FDA HAS ISSUED A NOTICE FOR
2 OPPORTUNITY HEARING (NOOH) FOR THE PURPOSE OF WITHDRAWING THE
3 NEW DRUG APPLICATION APPROVED FOR THAT DRUG, REIMBURSEMENT
4 COVERAGE SHALL BE DISCONTINUED UNDER THE PROVISIONS OF THIS
5 CHAPTER.
6 SECTION 515. REIMBURSEMENT.
7 FOR-PROFIT THIRD-PARTY INSURERS, HEALTH MAINTENANCE
8 ORGANIZATIONS AND NOT-FOR-PROFIT PRESCRIPTION PLANS SHALL BE
9 RESPONSIBLE FOR ANY PAYMENTS MADE TO A PROVIDING PHARMACY ON
10 BEHALF OF A CLAIMANT COVERED BY SUCH A THIRD PARTY.
11 SECTION 516. NONLIABILITY.
12 (A) [PERSONS RENDERING SERVICE] GENERAL RULE.--ANY PERSON
13 RENDERING SERVICE AS A MEMBER OF A UTILIZATION REVIEW COMMITTEE
14 FOR THIS PROGRAM SHALL NOT BE LIABLE FOR ANY CIVIL DAMAGES AS A
15 RESULT OF ANY ACTS OR OMISSIONS IN RENDERING THE SERVICE AS A
16 MEMBER OF ANY SUCH COMMITTEE EXCEPT ANY ACTS OR OMISSIONS
17 INTENTIONALLY DESIGNED TO HARM OR ANY GROSSLY NEGLIGENT ACTS OR
18 OMISSIONS WHICH RESULT IN HARM TO THE PERSON RECEIVING SUCH
19 SERVICE.
20 (B) [OFFICER AND EMPLOYEES OF DEPARTMENT] DEPARTMENT
21 PERSONNEL.--ANY OFFICER OR EMPLOYEE OF THE DEPARTMENT RENDERING
22 SERVICE AS A MEMBER OF A UTILIZATION REVIEW COMMITTEE FOR THIS
23 PROGRAM SHALL NOT BE LIABLE FOR ANY CIVIL DAMAGES AS A RESULT OF
24 ANY ACTS OR OMISSIONS IN RENDERING THE SERVICE AS A MEMBER OF
25 ANY SUCH COMMITTEE OR AS A RESULT OF ANY DECISION OR ACTION IN
26 CONNECTION WITH THE PROGRAM EXCEPT ANY ACTS OR OMISSIONS
27 INTENTIONALLY DESIGNED TO HARM OR ANY GROSSLY NEGLIGENT ACTS OR
28 OMISSIONS WHICH RESULT IN HARM TO THE PERSON RECEIVING SUCH
29 SERVICE.
30 SECTION 519. THE PHARMACEUTICAL ASSISTANCE CONTRACT FOR THE
20030H0888B2098 - 33 -
1 ELDERLY NEEDS ENHANCEMENT TIER.
2 (A) ESTABLISHMENT.--THERE IS HEREBY ESTABLISHED WITHIN THE
3 DEPARTMENT A PROGRAM TO BE KNOWN AS THE PHARMACEUTICAL
4 ASSISTANCE CONTRACT FOR THE ELDERLY NEEDS ENHANCEMENT TIER
5 (PACENET).
6 (B) PACENET ELIGIBILITY.--A CLAIMANT WITH AN ANNUAL INCOME
7 OF NOT LESS THAN [$14,000] $14,500 AND NOT MORE THAN [$16,000]
8 $22,500 IN THE CASE OF A SINGLE PERSON AND OF NOT LESS THAN
9 [$17,200] $17,700 AND NOT MORE THAN [$19,200] $30,500 IN THE
10 CASE OF THE COMBINED INCOME OF PERSONS MARRIED TO EACH OTHER
11 SHALL BE ELIGIBLE FOR ENHANCED PHARMACEUTICAL ASSISTANCE UNDER
12 THIS SECTION. A PERSON MAY, IN REPORTING INCOME TO THE
13 DEPARTMENT, ROUND THE AMOUNT OF EACH SOURCE OF INCOME AND THE
14 INCOME TOTAL TO THE NEAREST WHOLE DOLLAR, WHEREBY ANY AMOUNT
15 WHICH IS LESS THAN 50¢ IS ELIMINATED.
16 (C) DEDUCTIBLE.--UPON ENROLLMENT IN PACENET, ELIGIBLE
17 CLAIMANTS IN THE INCOME RANGES SET FORTH IN SUBSECTION (B) SHALL
18 BE REQUIRED TO MEET [AN ANNUAL] A DEDUCTIBLE IN UNREIMBURSED
19 PRESCRIPTION DRUG EXPENSES OF [$500] $40 PER PERSON[.] PER
20 MONTH. THE $40 MONTHLY DEDUCTIBLE SHALL BE CUMULATIVE AND SHALL
21 BE APPLIED TO SUBSEQUENT MONTHS TO DETERMINE ELIGIBILITY. THE
22 CUMULATIVE DEDUCTIBLE SHALL BE DETERMINED ON A CALENDAR YEAR
23 BASIS FOR AN ANNUAL TOTAL DEDUCTIBLE NOT TO EXCEED $480 IN A
24 YEAR. TO QUALIFY FOR THE DEDUCTIBLE SET FORTH IN THIS SUBSECTION
25 THE PRESCRIPTION DRUG MUST BE PURCHASED FOR THE USE OF THE
26 ELIGIBLE CLAIMANT FROM A PROVIDER AS DEFINED IN THIS CHAPTER.
27 THE DEPARTMENT, AFTER CONSULTATION WITH THE BOARD, [MAY] SHALL
28 APPROVE AN ADJUSTMENT IN THE DEDUCTIBLE ON AN ANNUAL BASIS.
29 (D) COPAYMENT.--FOR ELIGIBLE CLAIMANTS UNDER THIS SECTION,
30 THE COPAYMENT SCHEDULE, WHICH [MAY] SHALL BE ADJUSTED BY THE
20030H0888B2098 - 34 -
1 DEPARTMENT ON AN ANNUAL BASIS AFTER CONSULTATION WITH THE BOARD,
2 SHALL BE:
3 (I) EIGHT DOLLARS FOR NONINNOVATOR MULTIPLE SOURCE
4 DRUGS AS DEFINED IN SECTION 702; OR
5 (II) FIFTEEN DOLLARS FOR SINGLE-SOURCE DRUGS AND
6 INNOVATOR MULTIPLE-SOURCE DRUGS AS DEFINED IN SECTION
7 702.
8 SECTION 520. BOARD.
9 * * *
10 (B) COMPOSITION.--THE BOARD SHALL BE COMPRISED OF THE
11 FOLLOWING EIGHT PERSONS:
12 (1) THE SECRETARY OF AGING, WHO SHALL SERVE AS ITS
13 CHAIRMAN.
14 (2) THE SECRETARY OF REVENUE.
15 (3) THE SECRETARY OF HEALTH.
16 (4) FIVE PUBLIC MEMBERS, ONE APPOINTED BY THE PRESIDENT
17 PRO TEMPORE OF THE SENATE, ONE APPOINTED BY THE MINORITY
18 LEADER OF THE SENATE, ONE APPOINTED BY THE SPEAKER OF THE
19 HOUSE OF REPRESENTATIVES, ONE APPOINTED BY THE MINORITY
20 LEADER OF THE HOUSE OF REPRESENTATIVES AND ONE APPOINTED BY
21 THE GOVERNOR. THOSE APPOINTED BY THE LEGISLATIVE OFFICERS
22 SHALL INCLUDE TWO SENIOR CITIZENS WHO HAVE NOT BEEN A PART OF
23 THE PHARMACEUTICAL INDUSTRY TO SERVE AS CONSUMER ADVOCATES
24 [AND TWO REPRESENTATIVES], ONE REPRESENTATIVE OF THE
25 PHARMACEUTICAL INDUSTRY[, AT LEAST ONE OF WHOM IS A] AND ONE
26 PRACTICING PENNSYLVANIA PHARMACIST. THE INDIVIDUAL APPOINTED
27 BY THE GOVERNOR MUST BE A PHYSICIAN. A PUBLIC MEMBER WHO
28 MISSES TWO CONSECUTIVE MEETINGS WITHOUT GOOD CAUSE ACCEPTABLE
29 TO THE CHAIRMAN SHALL BE REPLACED BY THE APPOINTING
30 AUTHORITY.
20030H0888B2098 - 35 -
1 * * *
2 SECTION 3. THE ACT IS AMENDED BY ADDING A SECTION TO READ:
3 SECTION 520.1. PACE AND PACENET ELIGIBILITY ADVISORY COMMITTEE.
4 (A) ESTABLISHMENT.--THERE IS ESTABLISHED IN THE DEPARTMENT
5 THE PACE AND PACENET ELIGIBILITY ADVISORY COMMITTEE.
6 (B) COMPOSITION.--THE ELIGIBILITY ADVISORY COMMITTEE SHALL
7 CONSIST OF FOUR MEMBERS WHO SHALL BE MEMBERS OF THE GENERAL
8 ASSEMBLY AND A CHAIRMAN WHO SHALL BE APPOINTED BY THE GOVERNOR.
9 THE MEMBERS OF THE GENERAL ASSEMBLY SHALL BE APPOINTED AS
10 FOLLOWS:
11 (1) ONE MEMBER APPOINTED BY THE PRESIDENT PRO TEMPORE OF
12 THE SENATE.
13 (2) ONE MEMBER APPOINTED BY THE MINORITY LEADER OF THE
14 SENATE.
15 (3) ONE MEMBER APPOINTED BY THE SPEAKER OF THE HOUSE OF
16 REPRESENTATIVES.
17 (4) ONE MEMBER APPOINTED BY THE MINORITY LEADER OF THE
18 HOUSE OF REPRESENTATIVES.
19 (C) CHAIRMAN.--NOTHING IN THIS SECTION SHALL BE CONSTRUED AS
20 PROHIBITING THE GOVERNOR FROM APPOINTING A MEMBER OF THE GENERAL
21 ASSEMBLY AS CHAIRMAN .
22 (D) TERM.--MEMBERS SHALL SERVE AT THE PLEASURE OF THE
23 APPOINTING AUTHORITY.
24 (E) EXPENSES.--MEMBERS OF THE ADVISORY COMMITTEE SHALL SERVE
25 WITHOUT COMPENSATION BUT SHALL BE REIMBURSED FOR ACTUAL AND
26 REASONABLE EXPENSES INCURRED IN THE PERFORMANCE OF THEIR
27 OFFICIAL DUTIES.
28 (F) DESIGNEE.--A DESIGNEE DESIGNATED BY A MEMBER UNDER
29 SUBSECTION (B)(1), (2), (3) AND (4) MAY VOTE AND OTHERWISE ACT
30 ON BEHALF OF THE MEMBER. THE DESIGNATION MUST BE IN WRITING AND
20030H0888B2098 - 36 -
1 BE DELIVERED TO THE ADVISORY COMMITTEE. THE DESIGNATION SHALL
2 CONTINUE IN EFFECT UNTIL REVOKED OR AMENDED IN WRITING.
3 (G) QUORUM.--A MAJORITY OF THE MEMBERS OF THE ADVISORY
4 COMMITTEE THEN SERVING SHALL CONSTITUTE A QUORUM OF THE ADVISORY
5 COMMITTEE. ONLY A MEMBER OR A DESIGNEE WHO IS PHYSICALLY PRESENT
6 AT A MEETING OR ABLE TO PARTICIPATE FULLY IN THE DELIBERATIONS
7 BY APPROPRIATE TELECOMMUNICATIONS MEANS SHALL COUNT TOWARD A
8 QUORUM OF THE ADVISORY COMMITTEE.
9 (H) RESPONSIBILITIES.--THE ADVISORY COMMITTEE SHALL STUDY
10 THE FEASIBILITY OF EXPANSIONS AND OTHER CHANGES TO ELIGIBILITY
11 UNDER THE PACE PROGRAM AND MAKE RECOMMENDATIONS TO THE GOVERNOR
12 AND THE DEPARTMENT ON AN ANNUAL BASIS. IN ADDITION, THE ADVISORY
13 COMMITTEE MAY STUDY AND PARTICIPATE, WITH THE APPROVAL OF THE
14 GOVERNOR AND THE DEPARTMENT, IN ADVOCATING AT OTHER LEVELS OF
15 GOVERNMENT PROPOSED CHANGES IN THE PROVISION OF PHARMACEUTICAL
16 BENEFITS TO SENIOR CITIZENS. THE COMMITTEE MAY ALSO MAKE
17 RECOMMENDATIONS WITH RESPECT TO THE TERMS AND CONDITIONS UNDER
18 WHICH PHARMACEUTICAL COMPANIES PARTICIPATE IN COMMONWEALTH
19 HEALTH CARE PROGRAMS FOR THE ELDERLY.
20 SECTION 4. SECTIONS 521(D) AND 522 OF THE ACT, ADDED
21 NOVEMBER 21, 1996 (P.L.741, NO.134), ARE AMENDED TO READ:
22 SECTION 521. PENALTIES.
23 * * *
24 (D) [REPAYMENT OF GAIN] REPARATION.--ANY PROVIDER, RECIPIENT
25 OR OTHER PERSON WHO IS FOUND GUILTY OF A CRIME FOR VIOLATING
26 THIS CHAPTER SHALL REPAY THREE TIMES THE VALUE OF THE MATERIAL
27 GAIN RECEIVED. IN ADDITION TO THE CIVIL PENALTY AUTHORIZED
28 PURSUANT TO SUBSECTION (B), THE DEPARTMENT MAY REQUIRE THE
29 PROVIDER, RECIPIENT OR OTHER PERSON TO REPAY UP TO THREE TIMES
30 THE VALUE OF ANY MATERIAL GAIN TO PACE OR PACENET.
20030H0888B2098 - 37 -
1 SECTION 522. PRESCRIPTION DRUG EDUCATION PROGRAM.
2 THE DEPARTMENT, IN COOPERATION WITH THE DEPARTMENT OF HEALTH,
3 SHALL DEVELOP AND IMPLEMENT A STATEWIDE PRESCRIPTION DRUG
4 EDUCATION PROGRAM DESIGNED TO INFORM OLDER ADULTS OF THE DANGERS
5 OF PRESCRIPTION DRUG ABUSE AND MISUSE. THE PRESCRIPTION DRUG
6 EDUCATION PROGRAM SHALL INCLUDE, BUT NOT BE LIMITED TO,
7 INFORMATION CONCERNING THE FOLLOWING:
8 (1) THE HAZARDS OF PRESCRIPTION DRUG OVERDOSE.
9 (2) THE POTENTIAL DANGERS OF MIXING PRESCRIPTION DRUGS.
10 (3) THE DANGER OF RETAINING UNUSED PRESCRIPTION DRUGS
11 AFTER THE NEED TO TAKE THEM NO LONGER EXISTS.
12 (4) THE NECESSITY TO CAREFULLY QUESTION PHYSICIANS AND
13 PHARMACISTS CONCERNING THE EFFECTS OF TAKING PRESCRIPTION
14 DRUGS[, INCLUDING THE DIFFERENCES BETWEEN BRAND-NAME DRUGS
15 AND GENERICALLY EQUIVALENT DRUGS].
16 (5) THE ADVISABILITY OF MAINTAINING A PRESCRIPTION DRUG
17 PROFILE OR OTHER RECORD OF PRESCRIPTION DRUG DOSAGE AND
18 FREQUENCY OF DOSAGE.
19 (6) THE DESIRABILITY OF ADVISING FAMILY MEMBERS OF THE
20 TYPES AND PROPER DOSAGE OF PRESCRIPTION DRUGS WHICH ARE BEING
21 TAKEN.
22 (7) THE DANGERS OF TAKING PRESCRIPTION DRUGS IN EXCESS
23 OF PRESCRIBED DOSAGES.
24 (8) THE NEED TO OBTAIN COMPLETE, DETAILED DIRECTIONS
25 FROM THE PHYSICIAN OR PHARMACIST CONCERNING THE TIME PERIOD A
26 PRESCRIPTION DRUG SHOULD BE TAKEN.
27 SECTION 5. THE ACT IS AMENDED BY ADDING A CHAPTER TO READ:
28 CHAPTER 6
29 PHARMACY BEST PRACTICES AND COST CONTROL PROGRAM
30 SECTION 601. DEFINITIONS.
20030H0888B2098 - 38 -
1 THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS CHAPTER
2 SHALL HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE
3 CONTEXT CLEARLY INDICATES OTHERWISE:
4 "COMMITTEE." THE PHARMACY BEST PRACTICES AND COST CONTROL
5 ADVISORY COMMITTEE ESTABLISHED IN SECTION 602.
6 "DEPARTMENT." THE DEPARTMENT OF AGING OF THE COMMONWEALTH.
7 "PROGRAM." THE PHARMACY BEST PRACTICES AND COST CONTROL
8 PROGRAM ESTABLISHED IN SECTION 603.
9 "SECRETARY." THE SECRETARY OF AGING OF THE COMMONWEALTH.
10 SECTION 602. ADVISORY COMMITTEE.
11 (A) ESTABLISHMENT.--THE PHARMACY BEST PRACTICES AND COST
12 CONTROL ADVISORY COMMITTEE IS ESTABLISHED IN THE DEPARTMENT.
13 (B) MEMBERS.--THE COMMITTEE IS COMPRISED OF THE FOLLOWING
14 PENNSYLVANIA RESIDENTS:
15 (1) THE SECRETARY OR A DESIGNEE, WHO SHALL SERVE AS
16 CHAIRPERSON.
17 (2) FOUR MEMBERS APPOINTED BY THE GOVERNOR. ONE MEMBER
18 UNDER THIS PARAGRAPH MUST POSSESS EXPERTISE IN MEDICINE, ONE
19 MEMBER MUST POSSESS EXPERTISE IN HEALTH CARE, ONE MEMBER MUST
20 POSSESS EXPERTISE IN PHARMACY AND ONE MEMBER MUST POSSESS
21 EXPERTISE IN THE PHARMACEUTICAL INDUSTRY.
22 (3) ONE MEMBER APPOINTED BY THE PRESIDENT PRO TEMPORE OF
23 THE SENATE AND ONE MEMBER APPOINTED BY THE MINORITY LEADER OF
24 THE SENATE.
25 (4) ONE MEMBER APPOINTED BY THE SPEAKER OF THE HOUSE OF
26 REPRESENTATIVES AND ONE MEMBER APPOINTED BY THE MINORITY
27 LEADER OF THE HOUSE OF REPRESENTATIVES.
28 (C) TERMS.--TERMS ARE AS FOLLOWS:
29 (1) THE SECRETARY SHALL SERVE EX OFFICIO.
30 (2) A MEMBER UNDER SUBSECTION (B)(2) SHALL SERVE A TERM
20030H0888B2098 - 39 -
1 OF SIX YEARS.
2 (3) A MEMBER UNDER SUBSECTION (B)(3) SHALL SERVE A TERM
3 OF FOUR YEARS BUT MAY BE REMOVED AT THE PLEASURE OF THE
4 APPOINTING AUTHORITY.
5 (4) A MEMBER UNDER SUBSECTION (B)(4) SHALL SERVE A TERM
6 OF TWO YEARS BUT MAY BE REMOVED AT THE PLEASURE OF THE
7 APPOINTING AUTHORITY.
8 (5) AN APPOINTMENT TO FILL A VACANCY SHALL BE FOR THE
9 PERIOD OF THE UNEXPIRED TERM OR UNTIL A SUCCESSOR IS
10 APPOINTED AND QUALIFIED.
11 (D) QUORUM.--A MAJORITY OF THE MEMBERS OF THE COMMITTEE
12 CONSTITUTES A QUORUM.
13 (E) COMPENSATION.--MEMBERS SHALL RECEIVE NO PAYMENT FOR
14 THEIR SERVICES. MEMBERS WHO ARE NOT EMPLOYEES OF STATE
15 GOVERNMENT SHALL BE REIMBURSED FOR NECESSARY AND REASONABLE
16 EXPENSES INCURRED IN THE COURSE OF THEIR OFFICIAL DUTIES.
17 (F) MEETINGS.--MEETINGS OF THIS COMMITTEE SHALL BE HELD IN
18 PUBLIC PURSUANT TO 65 PA.S.C. CH. 7 (RELATING TO PUBLIC
19 MEETINGS).
20 SECTION 603. PROGRAM.
21 (A) ESTABLISHMENT.--THE SECRETARY SHALL ESTABLISH A PHARMACY
22 BEST PRACTICES AND COST CONTROL PROGRAM FOR PACE AND PACENET
23 ENROLLEES DESIGNED TO REDUCE THE COST OF PROVIDING PRESCRIPTION
24 DRUGS, WHILE MAINTAINING HIGH QUALITY IN PRESCRIPTION DRUG
25 THERAPIES. THE PROGRAM SHALL INCLUDE ALL OF THE FOLLOWING:
26 (1) A LIST OF COVERED PRESCRIPTION DRUGS UNDER SECTION
27 509 IN THE PROGRAM SELECTED BY THE DEPARTMENT UPON
28 RECOMMENDATIONS BY THE COMMITTEE.
29 (2) A DRUG UTILIZATION REVIEW PROCEDURE, INCLUDING A
30 PRESCRIPTION REVIEW PROCESS FOR COPAYMENT SCHEDULES.
20030H0888B2098 - 40 -
1 (3) EDUCATION PROGRAMS DESIGNED TO PROVIDE INFORMATION
2 AND EDUCATION ON THE THERAPEUTIC AND COST-EFFECTIVE
3 UTILIZATION OF PRESCRIPTION DRUGS TO PHYSICIANS, PHARMACISTS
4 AND OTHER HEALTH CARE PROFESSIONALS AUTHORIZED TO PRESCRIBE
5 AND DISPENSE PRESCRIPTION DRUGS.
6 (B) POOLING.--THE SECRETARY SHALL EVALUATE THE BENEFITS OF
7 PARTICIPATING, BUT IS NOT REQUIRED TO PARTICIPATE, IN JOINT
8 PRESCRIPTION DRUG PURCHASING AGREEMENTS OR POOLING ARRANGEMENTS
9 WITH OTHER STATES. SUCH ACTIONS SHALL INCLUDE:
10 (1) THE EXECUTION OF ANY LAWFUL JOINT PURCHASING OR
11 POOLING AGREEMENTS WITH OTHER PARTICIPATING STATES WHICH THE
12 SECRETARY DETERMINES WILL LOWER THE MEDICAID COST OF
13 PRESCRIPTION DRUGS WHILE MAINTAINING HIGH QUALITY IN
14 PRESCRIPTION DRUG THERAPIES.
15 (2) RENEGOTIATION AND AMENDMENT OF EXISTING CONTRACTS TO
16 WHICH THE DEPARTMENT IS A PARTY IF RENEGOTIATION AND
17 AMENDMENT WILL BE OF ECONOMIC BENEFIT TO THE DEPARTMENT.
18 (3) A QUARTERLY REPORT TO THE COMMITTEE ON THE
19 DEPARTMENT'S PROGRESS IN SECURING PARTICIPATION IN JOINT
20 PURCHASING OR POOLING AGREEMENTS.
21 (C) AUTHORIZED COVERAGE.--THE PROGRAM SHALL AUTHORIZE
22 COPAYMENTS SCHEDULES FOR EACH PRESCRIPTION DRUG. WHEN A
23 PATIENT'S HEALTH CARE PROVIDER PRESCRIBES A PRESCRIPTION DRUG AT
24 THE HIGHER COPAYMENT SCHEDULE, THE LOWER COPAYMENT SHALL APPLY
25 FOR ONE YEAR WHEN ANY OF THE FOLLOWING CONDITIONS ARE MET:
26 (1) THE PREFERRED CHOICE HAS NOT BEEN EFFECTIVE OR, WITH
27 REASONABLE CERTAINTY, IS NOT EXPECTED TO BE EFFECTIVE IN
28 TREATING THE PATIENT'S CONDITION.
29 (2) THE PREFERRED CHOICE CAUSES OR IS REASONABLY
30 EXPECTED TO CAUSE ADVERSE OR HARMFUL REACTIONS IN THE
20030H0888B2098 - 41 -
1 PATIENT.
2 (3) OTHER CLINICAL CRITERIA RECOMMENDED BY THE COMMITTEE
3 AND APPROVED BY THE DEPARTMENT.
4 (D) BRAND NECESSARY.--IF THE PRESCRIBER DOES NOT WISH
5 SUBSTITUTION TO TAKE PLACE, THE PRESCRIBER SHALL WRITE "BRAND
6 NECESSARY" OR "NO SUBSTITUTION" IN THE PRESCRIBER'S OWN
7 HANDWRITING ON THE PRESCRIPTION BLANK, TOGETHER WITH A WRITTEN
8 STATEMENT THAT THE GENERIC OR THE EQUIVALENT HAS NOT BEEN
9 EFFECTIVE, OR WITH REASONABLE CERTAINTY IS NOT EXPECTED TO BE
10 EFFECTIVE, IN TREATING THE PATIENT'S MEDICAL CONDITION OR CAUSES
11 OR IS REASONABLY EXPECTED TO CAUSE ADVERSE OR HARMFUL REACTIONS
12 IN THE PATIENT. IN THE CASE OF AN UNWRITTEN PRESCRIPTION, THERE
13 SHALL BE NO SUBSTITUTION IF THE PRESCRIBER EXPRESSLY INDICATES
14 TO THE PHARMACIST THAT THE BRAND NAME DRUG IS NECESSARY AND
15 SUBSTITUTION IS NOT ALLOWED BECAUSE THE GENERIC OR THE
16 EQUIVALENT HAS NOT BEEN EFFECTIVE, OR WITH REASONABLE CERTAINTY
17 IS NOT EXPECTED TO BE EFFECTIVE, IN TREATING THE PATIENT'S
18 MEDICAL CONDITION OR CAUSES OR IS REASONABLY EXPECTED TO CAUSE
19 ADVERSE OR HARMFUL REACTIONS IN THE PATIENT. APPROVAL UNDER THIS
20 SECTION SHALL BE VALID FOR ONE YEAR.
21 (E) EXCLUSIONS.--THE DEPARTMENT, WITH RECOMMENDATIONS FROM
22 THE COMMITTEE, SHALL DETERMINE DISEASES AND THERAPEUTIC CLASSES
23 RELATING TO TREATMENT FOR DISEASES EXCLUDED FROM THE PROGRAM AT
24 THE TIME THE PROGRAM UNDER THIS SECTION IS IMPLEMENTED.
25 (F) RESPONSE.--THE PROGRAM'S PRESCRIBER-INDICATED PRIOR
26 AUTHORIZATION PROCESS SHALL ENSURE THAT THERE WILL BE A RESPONSE
27 TO A REQUEST FOR PRIOR AUTHORIZATION BY TELEPHONE OR OTHER
28 TELECOMMUNICATION DEVICE WITHIN 12 HOURS AFTER RECEIPT OF THE
29 REQUEST FOR PRIOR AUTHORIZATION AND THAT A MINIMUM OF A 72-HOUR
30 SUPPLY OF THE DRUG PRESCRIBED WILL BE PROVIDED IN AN EMERGENCY
20030H0888B2098 - 42 -
1 OR WHEN THE PROGRAM DOES NOT PROVIDE A RESPONSE WITHIN 12 HOURS.
2 THE PRIOR AUTHORIZATION PROCESS SHALL BE DESIGNED TO MINIMIZE
3 ADMINISTRATIVE BURDENS ON PRESCRIBERS, PHARMACISTS AND
4 CONSUMERS.
5 (G) PROCEDURE.--THE PROGRAM SHALL ESTABLISH PROCEDURES FOR
6 THE TIMELY REVIEW OF PRESCRIPTION DRUGS NEWLY APPROVED BY THE
7 FOOD AND DRUG ADMINISTRATION, INCLUDING PROCEDURES FOR THE
8 REVIEW OF NEWLY APPROVED PRESCRIPTION DRUGS IN EMERGENCY
9 CIRCUMSTANCES.
10 (H) REPORTS.--THE DEPARTMENT SHALL SUBMIT ANNUAL REPORTS ON
11 THE PROGRAM UNDER SUBSECTION (A) TO THE AGING AND YOUTH
12 COMMITTEE, THE APPROPRIATIONS COMMITTEE AND THE PUBLIC HEALTH
13 AND WELFARE COMMITTEE OF THE SENATE AND THE AGING AND OLDER
14 ADULT SERVICES COMMITTEE, THE APPROPRIATIONS COMMITTEE AND THE
15 HEALTH AND HUMAN SERVICES COMMITTEE OF THE HOUSE OF
16 REPRESENTATIVES. THE REPORTS SHALL INCLUDE CLASSES OF DRUGS,
17 EXCEPTIONS, COST EFFECTIVENESS, MOVEMENT OF MARKET SHARE AND
18 INCREASED UTILIZATION OF GENERIC DRUGS.
19 SECTION 604. RESTRICTION OR SUBSTITUTION PROCESS.
20 (A) GENERAL RULE.--THE PROVISIONS OF THIS CHAPTER SHALL NOT
21 PERMIT THE PROGRAM TO DEVELOP ANY DRUG FORMULARY, PRIOR OR
22 RETROACTIVE APPROVAL SYSTEM, INCLUDING HIGHER COPAYMENTS, OR ANY
23 OTHER SIMILAR RESTRICTION OR SUBSTITUTION PROCESS FOR
24 PSYCHOTROPIC DRUGS.
25 (B) DEFINITION.--AS USED IN THIS SECTION, THE TERM
26 "PSYCHOTROPIC DRUG" MEANS A DRUG USED TO TREAT A MENTAL
27 DISORDER.
28 SECTION 6. SECTION 701 OF THE ACT IS AMENDED TO READ:
29 [SECTION 701. DECLARATION OF POLICY.
30 THE GENERAL ASSEMBLY FINDS AND DECLARES AS FOLLOWS:
20030H0888B2098 - 43 -
1 (1) THE COMMONWEALTH, THROUGH ASSISTANCE PROGRAMS
2 ENACTED FOR THE BENEFIT OF ITS CITIZENS, IS THE LARGEST
3 SINGLE PAYOR OF PRESCRIPTION MEDICATIONS IN PENNSYLVANIA.
4 (2) IN ORDER TO ENSURE THAT THE COMMONWEALTH, IN
5 EXPENDING MONEY ON BEHALF OF ITS CITIZENS, IS NOT UNDULY
6 HARMED BY BEING REQUIRED TO PAY A PRICE FOR PHARMACEUTICAL
7 PRODUCTS PURCHASED FROM MANUFACTURERS IN EXCESS OF THAT
8 ESTABLISHED FOR OTHER PURCHASERS AND REIMBURSERS OF THESE
9 PRODUCTS AND TO ENSURE THAT THE COMMONWEALTH CAN EFFICIENTLY
10 AND PRUDENTLY EXPEND ITS MONEY AND MAXIMIZE ITS ABILITY TO
11 PROVIDE FOR THE HEALTH AND WELFARE OF AS MANY OF ITS NEEDY
12 CITIZENS AS POSSIBLE, IT IS REASONABLE, NECESSARY AND IN THE
13 PUBLIC INTEREST TO REQUIRE THAT PHARMACEUTICAL MANUFACTURERS
14 OFFER A DISCOUNT TO THE COMMONWEALTH FOR PHARMACEUTICAL
15 PRODUCTS PURCHASED OR REIMBURSED THROUGH STATE AGENCIES.
16 (3) IT IS IN THE PUBLIC INTEREST FOR PHARMACEUTICAL
17 MANUFACTURERS TO PROVIDE THE COMMONWEALTH WITH DATA RELATING
18 TO THE PRICE OF PHARMACEUTICAL PRODUCTS SOLD BY THE
19 MANUFACTURER TO PUBLIC BODIES, HOSPITALS, FOR-PROFIT OR
20 NONPROFIT ORGANIZATIONS, OTHER MANUFACTURERS OR WHOLESALERS
21 DOING BUSINESS IN THIS COMMONWEALTH IN ORDER TO ENSURE THAT
22 THE COMMONWEALTH CAN DETERMINE THAT IT IS BEING PROVIDED WITH
23 THE BEST PRICES OFFERED BY THE MANUFACTURER.
24 (4) ON A NATIONAL LEVEL, THERE HAS BEEN A RECOGNITION
25 THAT THE NEED FOR DISCOUNTS TO STATE MEDICAID AGENCIES, WHICH
26 REIMBURSE FOR A HIGH VOLUME OF PHARMACEUTICAL PRODUCTS,
27 EXISTS.
28 (5) ON A STATE LEVEL, THE GENERAL ASSEMBLY RECOGNIZES
29 THAT IT IS IN THE BEST INTEREST OF ITS CITIZENS TO PROVIDE
30 PHARMACEUTICAL ASSISTANCE IN A REASONABLE AND COST-EFFICIENT
20030H0888B2098 - 44 -
1 MANNER.
2 (6) DRUG PRICE INFLATION HAS CAUSED AN INCREASE IN THE
3 AMOUNT OF PUBLIC FUNDS EXPENDED BY PACE AND GENERAL
4 ASSISTANCE.]
5 SECTION 7. SECTION 702 OF THE ACT IS AMENDED BY ADDING A
6 DEFINITION TO READ:
7 SECTION 702. DEFINITIONS.
8 THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS CHAPTER
9 SHALL HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE
10 CONTEXT CLEARLY INDICATES OTHERWISE:
11 * * *
12 "BEST PRICE." THE LOWEST PRICE AVAILABLE FROM THE
13 MANUFACTURER DURING THE REBATE PERIOD TO ANY WHOLESALER,
14 RETAILER, PROVIDER, HEALTH MAINTENANCE ORGANIZATION, NONPROFIT
15 ENTITY OR ANY GOVERNMENTAL ENTITY SUBJECT TO THE EXCLUSIONS AND
16 SPECIAL RULES SET FORTH IN SECTIONS 1902 AND 1927(C)(1)(C) OF
17 THE SOCIAL SECURITY ACT (49 STAT. 620, 42 U.S.C. §§1396C, 1396R-
18 8(C)(1)(C)).
19 * * *
20 SECTION 8. SECTIONS 703(E), 704(C)(1) AND 705(A) AND (B) OF
21 THE ACT, ADDED NOVEMBER 21, 1996 (P.L.741, NO.134), ARE AMENDED
22 TO READ:
23 SECTION 703. REBATE AGREEMENT.
24 * * *
25 (E) DRUG FORMULARY.--EXCEPT AS PROVIDED IN SECTION 512 AND
26 CHAPTER 6, THERE SHALL BE NO DRUG FORMULARY, PRIOR OR
27 RETROACTIVE APPROVAL SYSTEM OR ANY SIMILAR RESTRICTION IMPOSED
28 ON THE COVERAGE OF OUTPATIENT DRUGS MADE BY MANUFACTURERS WHO
29 HAVE AGREEMENTS IN EFFECT WITH THE COMMONWEALTH TO PAY REBATES
30 FOR DRUGS UTILIZED IN PACE AND PACENET, PROVIDED THAT SUCH
20030H0888B2098 - 45 -
1 OUTPATIENT DRUGS WERE APPROVED FOR MARKETING BY THE FOOD AND
2 DRUG ADMINISTRATION. THIS SUBSECTION SHALL NOT APPLY TO ANY ACT
3 TAKEN BY THE DEPARTMENT PURSUANT TO ITS THERAPEUTIC DRUG
4 UTILIZATION REVIEW PROGRAM UNDER SECTION 505.
5 SECTION 704. TERMS OF REBATE AGREEMENT.
6 * * *
7 (C) MANUFACTURER PROVISION OF PRICE INFORMATION.--
8 (1) EACH MANUFACTURER WITH AN AGREEMENT IN EFFECT UNDER
9 THIS CHAPTER SHALL REPORT THE AVERAGE MANUFACTURER PRICE AND
10 THE BEST PRICE FOR ALL COVERED PRESCRIPTION DRUGS PRODUCED BY
11 THAT MANUFACTURER TO THE DEPARTMENT NOT LATER THAN 30 DAYS
12 AFTER THE LAST DAY OF EACH QUARTER.
13 * * *
14 SECTION 705. AMOUNT OF REBATE.
15 (A) SINGLE-SOURCE DRUGS AND INNOVATOR MULTIPLE-SOURCE
16 DRUGS.--WITH RESPECT TO SINGLE-SOURCE DRUGS AND INNOVATOR
17 MULTIPLE-SOURCE DRUGS, EACH MANUFACTURER SHALL REMIT A REBATE TO
18 THE COMMONWEALTH PURSUANT TO THE DETERMINATION ESTABLISHED BY
19 SECTION 1927(C)(1)(C) OF THE SOCIAL SECURITY ACT (49 STAT. 620,
20 42 U.S.C. § 1396R-8(C)(1)(C)). [EXCEPT AS OTHERWISE PROVIDED IN
21 THIS SECTION, THE AMOUNT OF THE REBATE TO THE COMMONWEALTH PER
22 CALENDAR QUARTER WITH RESPECT TO EACH DOSAGE FORM AND STRENGTH
23 OF SINGLE-SOURCE DRUGS AND INNOVATOR MULTIPLE-SOURCE DRUGS SHALL
24 BE AS FOLLOWS:
25 (1) FOR QUARTERS BEGINNING AFTER SEPTEMBER 30, 1992, AND
26 ENDING BEFORE JANUARY 1, 1997, THE PRODUCT OF THE TOTAL
27 NUMBER OF UNITS OF EACH DOSAGE FORM AND STRENGTH REIMBURSED
28 BY PACE AND GENERAL ASSISTANCE IN THE QUARTER AND THE
29 DIFFERENCE BETWEEN THE AVERAGE MANUFACTURER PRICE AND 85% OF
30 THAT PRICE, AFTER DEDUCTING CUSTOMARY PROMPT PAYMENT
20030H0888B2098 - 46 -
1 DISCOUNTS, FOR THE QUARTER.
2 (2) FOR QUARTERS BEGINNING AFTER DECEMBER 31, 1996, THE
3 PRODUCT OF THE TOTAL NUMBER OF UNITS OF EACH DOSAGE FORM AND
4 STRENGTH REIMBURSED BY PACE, PACENET AND DESIGNATED
5 PHARMACEUTICAL PROGRAMS IN THE QUARTER AND THE DIFFERENCE
6 BETWEEN THE AVERAGE MANUFACTURER PRICE AND 83% OF THAT PRICE,
7 AFTER DEDUCTING CUSTOMARY PROMPT PAYMENT DISCOUNTS.]
8 (B) REBATE FOR OTHER DRUGS.--
9 [(1) THE AMOUNT OF THE REBATE TO THE COMMONWEALTH FOR A
10 CALENDAR QUARTER WITH RESPECT TO COVERED PRESCRIPTION DRUGS
11 WHICH ARE NONINNOVATOR MULTIPLE-SOURCE DRUGS SHALL BE EQUAL
12 TO THE PRODUCT OF:
13 (I) THE APPLICABLE PERCENTAGE OF THE AVERAGE
14 MANUFACTURER PRICE, AFTER DEDUCTING CUSTOMARY PROMPT
15 PAYMENT DISCOUNTS, FOR EACH DOSAGE FORM AND STRENGTH OF
16 SUCH DRUGS FOR THE QUARTER; AND
17 (II) THE NUMBER OF UNITS OF SUCH FORM AND DOSAGE
18 REIMBURSED BY PACE AND GENERAL ASSISTANCE IN THE QUARTER.
19 (2) FOR THE PURPOSES OF PARAGRAPH (1), THE APPLICABLE
20 PERCENTAGE FOR CALENDAR QUARTERS BEGINNING AFTER SEPTEMBER
21 30, 1992, AND ENDING BEFORE JANUARY 1, 1997, IS 11%.] WITH
22 RESPECT TO COVERED PRESCRIPTION DRUGS WHICH ARE NONINNOVATOR
23 MULTIPLE-SOURCE DRUGS, EACH MANUFACTURER SHALL REMIT A REBATE
24 TO THE COMMONWEALTH PURSUANT TO THE DETERMINATION ESTABLISHED
25 BY SECTION 1927(C)(1)(C) OF THE SOCIAL SECURITY ACT.
26 * * *
27 SECTION 9. THE ACT IS AMENDED BY ADDING A CHAPTER TO READ:
28 CHAPTER 8
29 PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE
30 SECTION 801. DEFINITIONS.
20030H0888B2098 - 47 -
1 THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS CHAPTER
2 SHALL HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE
3 CONTEXT CLEARLY INDICATES OTHERWISE:
4 "CLEARINGHOUSE." THE PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE
5 ESTABLISHED IN SECTION 802.
6 "DEPARTMENT." THE DEPARTMENT OF AGING OF THE COMMONWEALTH.
7 "PATIENT ASSISTANCE PROGRAM." A PROGRAM OFFERED BY A
8 PHARMACEUTICAL MANUFACTURER UNDER WHICH THE MANUFACTURER
9 PROVIDES PRESCRIPTION MEDICATIONS AT NO CHARGE OR AT A
10 SUBSTANTIALLY REDUCED COST. THE TERM DOES NOT INCLUDE THE
11 PROVISION OF A DRUG AS PART OF A CLINICAL TRIAL.
12 SECTION 802. PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE.
13 (A) ESTABLISHMENT.--WITHIN 120 DAYS OF THE EFFECTIVE DATE OF
14 THIS CHAPTER, THE DEPARTMENT SHALL ESTABLISH THE PHARMACEUTICAL
15 ASSISTANCE CLEARINGHOUSE. EACH PHARMACEUTICAL MANUFACTURER THAT
16 DOES BUSINESS IN THIS COMMONWEALTH AND OFFERS A PATIENT
17 ASSISTANCE PROGRAM SHALL INFORM THE DEPARTMENT OF ALL OF THE
18 FOLLOWING:
19 (1) THE EXISTENCE OF THE PATIENT ASSISTANCE PROGRAM.
20 (2) THE ELIGIBILITY REQUIREMENTS FOR THE PATIENT
21 ASSISTANCE PROGRAM.
22 (3) THE DRUGS COVERED BY THE PATIENT ASSISTANCE PROGRAM.
23 (4) INFORMATION, SUCH AS A TELEPHONE NUMBER, WHICH MAY
24 BE USED TO APPLY FOR A PATIENT ASSISTANCE PROGRAM.
25 (B) INFORMATION.--THE CLEARINGHOUSE SHALL MAINTAIN THE
26 INFORMATION SUBMITTED BY PHARMACEUTICAL MANUFACTURERS AND MAKE
27 IT AVAILABLE TO THE PUBLIC.
28 (C) STAFF.--THE DEPARTMENT SHALL ENSURE THAT THE
29 CLEARINGHOUSE IS STAFFED AT LEAST DURING NORMAL BUSINESS HOURS.
30 THE DEPARTMENT SHALL CONTRACT FOR THE SERVICES OF A SCHOOL OF
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1 PHARMACY TO STAFF THE CLEARINGHOUSE.
2 SECTION 803. TOLL-FREE TELEPHONE NUMBER.
3 THE DEPARTMENT SHALL ESTABLISH A TOLL-FREE TELEPHONE NUMBER
4 THROUGH WHICH MEMBERS OF THE PUBLIC MAY OBTAIN INFORMATION FROM
5 THE CLEARINGHOUSE ABOUT AVAILABLE PATIENT ASSISTANCE PROGRAMS.
6 SECTION 804. ASSISTANCE AVAILABLE.
7 (A) DIRECT.--
8 (1) THE CLEARINGHOUSE SHALL ASSIST WITHOUT CHARGE AN
9 INDIVIDUAL IN DETERMINING WHETHER A PATIENT ASSISTANCE
10 PROGRAM IS OFFERED FOR A PARTICULAR DRUG AND WHETHER THE
11 INDIVIDUAL MAY BE ELIGIBLE TO OBTAIN THE DRUG THROUGH A
12 PATIENT ASSISTANCE PROGRAM.
13 (2) THE CLEARINGHOUSE MAY ASSIST WITHOUT CHARGE AN
14 INDIVIDUAL WHO WISHES TO APPLY FOR A PATIENT ASSISTANCE
15 PROGRAM BY ASSISTING WITH THE PREPARATION OF AN APPLICATION
16 AND COORDINATING COMMUNICATIONS BETWEEN THE INDIVIDUAL'S
17 PHYSICIAN AND A PHARMACEUTICAL MANUFACTURER ON BEHALF OF THE
18 INDIVIDUAL FOR THE PURPOSE OF OBTAINING APPROVAL TO
19 PARTICIPATE IN THE PATIENT ASSISTANCE PROGRAM.
20 (B) REFERRALS.--THE CLEARINGHOUSE SHALL MAKE REFERRALS TO
21 ANY PUBLICLY FUNDED PROGRAM FOR WHICH IT DEEMS A PATIENT
22 ELIGIBLE.
23 SECTION 805. REPORTING.
24 THE DEPARTMENT SHALL REPORT ANNUALLY TO THE GOVERNOR AND THE
25 GENERAL ASSEMBLY ON THE ACTIVITIES OF THE CLEARINGHOUSE. THE
26 REPORT SHALL INCLUDE:
27 (1) THE NUMBER OF INDIVIDUALS WHO HAVE BEEN ASSISTED BY
28 THE CLEARINGHOUSE UNDER SECTION 804(A)(1) AND THE NUMBER OF
29 SUCH INDIVIDUALS UNDER SECTION 804(A)(2).
30 (2) THE NUMBER AND BENEFITS OF PATIENT ASSISTANCE
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1 PROGRAMS LISTED WITH THE CLEARINGHOUSE.
2 (3) THE NUMBER OF PATIENTS REFERRED TO PUBLICLY FUNDED
3 PROGRAMS UNDER SECTION 804(B). PROGRAMS UNDER THIS PARAGRAPH
4 INCLUDE, BUT ARE NOT LIMITED TO, THE PHARMACEUTICAL
5 ASSISTANCE CONTRACT FOR THE ELDERLY PROGRAM, MEDICAL
6 ASSISTANCE AND PROGRAMS OF THE DEPARTMENT OF VETERANS
7 AFFAIRS.
8 (4) OTHER INFORMATION DEEMED RELEVANT BY THE DEPARTMENT.
9 SECTION 806. INTERNET AVAILABILITY OF INFORMATION.
10 THE DEPARTMENT SHALL MAINTAIN AND PROVIDE TO THE PUBLIC THE
11 INFORMATION UNDER THIS CHAPTER ON ITS WORLD WIDE WEB SITE. THE
12 DEPARTMENT SHALL ALSO PROVIDE TO APPROPRIATE ORGANIZATIONS THE
13 INFORMATION NECESSARY FOR THE ORGANIZATIONS TO ESTABLISH A LINK
14 TO THE LOCATION OF CLEARINGHOUSE INFORMATION ON THE DEPARTMENT'S
15 WORLD WIDE WEB SITE.
16 SECTION 10. SECTION 2102(A) OF THE ACT, ADDED NOVEMBER 21,
17 1996 (P.L.741, NO.134), IS AMENDED TO READ:
18 SECTION 2102. ANNUAL REPORT TO GENERAL ASSEMBLY.
19 (A) SUBMISSION OF REPORT.--THE DEPARTMENT SHALL SUBMIT A
20 REPORT NO LATER THAN APRIL 1 OF EACH YEAR TO THE CHAIRMAN AND
21 MINORITY CHAIRMAN OF THE AGING AND YOUTH COMMITTEE OF THE
22 SENATE, THE CHAIRMAN AND MINORITY CHAIRMAN OF THE AGING AND
23 [YOUTH] OLDER ADULT SERVICES COMMITTEE OF THE HOUSE OF
24 REPRESENTATIVES AND THE PHARMACEUTICAL ASSISTANCE REVIEW BOARD.
25 * * *
26 SECTION 11. THE ACT IS AMENDED BY ADDING SECTIONS TO READ:
27 SECTION 2103. FEDERAL PROGRAMS.
28 IF THE FEDERAL GOVERNMENT ENACTS PROGRAMS SIMILAR TO PACE OR
29 PACENET, THE STATE PROGRAMS SHALL BE CONSTRUED TO ONLY
30 SUPPLEMENT THE FEDERAL PROGRAMS AND ALL PERSONS QUALIFIED FOR
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1 COVERAGE UNDER THE FEDERAL PROGRAM SHALL UTILIZE THAT FEDERAL
2 PROGRAM BEFORE UTILIZING ANY STATE PROGRAM.
3 SECTION 2104. PHARMACY BENEFITS ADMINISTRATOR STUDY.
4 (A) STUDY.--THE DEPARTMENT OF AGING SHALL CONDUCT A STUDY ON
5 THE EFFECTS WITHIN THE PACE AND PACENET PROGRAMS OF IMPLEMENTING
6 A PHARMACY BENEFITS ADMINISTRATOR COMPONENT. THE STUDY SHALL
7 EXAMINE THE ABILITY OF THE PHARMACY BENEFITS ADMINISTRATOR TO DO
8 THE FOLLOWING:
9 (1) NEGOTIATE REBATES ON BEHALF OF THE PLAN.
10 (2) CREATE A DRUG CRITERIA FOR ENROLLMENT WITHIN THE
11 PROGRAM.
12 (3) CONTRACT WITH PROVIDERS.
13 (4) CONDUCT ENROLLMENT ADJUDICATION ON BEHALF OF
14 APPLICANTS.
15 (B) REPORT.--THE DEPARTMENT SHALL SUBMIT A REPORT NO LATER
16 THAN ONE YEAR FROM THE EFFECTIVE DATE OF THIS SECTION TO THE
17 CHAIRMAN AND MINORITY CHAIRMAN OF THE AGING AND YOUTH COMMITTEE
18 OF THE SENATE, THE CHAIRMAN AND MINORITY CHAIRMAN OF THE AGING
19 AND OLDER ADULT SERVICES COMMITTEE OF THE HOUSE OF
20 REPRESENTATIVES AND THE PHARMACEUTICAL ASSISTANCE REVIEW BOARD.
21 SECTION 12. THE DEPARTMENT OF AGING MAY USE A PACE OR
22 PACENET PROGRAM APPLICANT'S MOST RECENT INCOME INFORMATION TO
23 DETERMINE PROGRAM ELIGIBILITY UNTIL APRIL 1, 2004.
24 SECTION 13. THIS ACT SHALL TAKE EFFECT AS FOLLOWS:
25 (1) THE FOLLOWING PROVISIONS SHALL TAKE EFFECT JANUARY
26 1, 2004:
27 (I) THE AMENDMENT OR ADDITION OF THE DEFINITIONS OF
28 "CMS," "HFCA" AND "MAXIMUM ANNUAL INCOME" IN SECTION 502
29 OF THE ACT.
30 (II) THE AMENDMENT OF SECTION 519 OF THE ACT.
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1 (2) THE REMAINDER OF THIS ACT SHALL TAKE EFFECT
2 IMMEDIATELY.
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