SENATE AMENDED
PRIOR PRINTER'S NOS. 1044, 1816, 1836, PRINTER'S NO. 2871
1889, 2098, 2117, 2794
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, GORDNER AND DALEY,
MARCH 13, 2003
SENATOR THOMPSON, APPROPRIATIONS, IN SENATE, RE-REPORTED AS
AMENDED, OCTOBER 28, 2003
AN ACT
1 Amending the act of August 26, 1971 (P.L.351, No.91), entitled
2 "An act providing for a State Lottery and administration
3 thereof; authorizing the creation of a State Lottery
4 Commission; prescribing its powers and duties; disposition of
5 funds; violations and penalties therefor; exemption of prizes
6 from State and local taxation and making an appropriation,"
7 further providing for definitions, for request for proposal, <--
8 for program generally, for generic drugs, for restricted
9 formulary, for reimbursement, for nonliability, for the
10 Pharmaceutical Assistance Contract for the Elderly Needs
11 Enhancement Tier, for the Pharmaceutical Assistance Review
12 Board; PROVIDING FOR PHARMACY BEST PRACTICES AND COST <--
13 CONTROLS; FURTHER PROVIDING for penalties and, for the <--
14 Prescription Drug Education Program; providing for the <--
15 Pharmacy Best Practices and Cost Control Program; further
16 providing for declaration of policy, PROGRAM, for rebate <--
17 agreement, for terms of rebate agreement and for amount of
1 rebate; providing for a Pharmaceutical Assistance
2 Clearinghouse; further providing for annual report to General
3 Assembly; and providing for construction with Federal
4 programs. PROGRAMS AND FOR A PHARMACY BENEFITS ADMINISTRATOR <--
5 STUDY. CONTINUED USE OF TOBACCO SETTLEMENT FUND. <--
6 The General Assembly of the Commonwealth of Pennsylvania
7 hereby enacts as follows:
8 Section 1. The definitions of "HCFA," and "INCOME," "maximum <--
9 annual income" AND "PROVIDER" in section 502 of the act of <--
10 August 26, 1971 (P.L.351, No.91), known as the State Lottery
11 Law, added November 21, 1996 (P.L.741, No.134), are amended and
12 the section is amended by adding a definition DEFINITIONS to <--
13 read:
14 Section 502. Definitions.
15 The following words and phrases when used in this chapter
16 shall have the meanings given to them in this section unless the
17 context clearly indicates otherwise:
18 * * *
19 "CMS." The Centers for Medicare and Medicaid Services of the
20 United States.
21 "DESI." THE DRUG EFFICACY STUDY IMPLEMENTATION LIST. <--
22 * * *
23 ["HCFA." The Health Care Financing Administration of the
24 United States.]
25 "HEALTH MAINTENANCE ORGANIZATION." AN ORGANIZED SYSTEM WHICH <--
26 COMBINES THE DELIVERY AND FINANCING OF HEALTH CARE AND WHICH
27 PROVIDES BASIC HEALTH SERVICES TO VOLUNTARILY ENROLLED
28 SUBSCRIBERS FOR A FIXED PREPAID FEE.
29 "Income." All income from whatever source derived,
30 including, but not limited to, salaries, wages, bonuses,
31 commissions, income from self-employment, alimony, support
32 money, cash public assistance and relief, the gross amount of
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1 any pensions or annuities, including railroad retirement
2 benefits, all benefits received under the Social Security Act
3 (49 Stat. 620, 42 U.S.C. § 301 et. seq.) (except Medicare
4 benefits), all benefits received under State unemployment
5 insurance laws and veterans' disability payments, all interest
6 received from the Federal Government or any state government or
7 any instrumentality or political subdivision thereof, realized
8 capital gains, rentals, workmen's compensation and the gross
9 amount of loss of time insurance benefits, life insurance
10 benefits and proceeds, except the first [$5,000] $10,000 of the
11 total of death benefits payments, and gifts of cash or property,
12 other than transfers by gift between members of a household, in
13 excess of a total value of $300, but shall not include surplus
14 food or other relief in kind supplied by a government agency or
15 property tax rebate.
16 "Maximum annual income." For PACE eligibility, the term
17 shall mean annual income which shall not exceed [$14,000]
18 $14,500 in the case of single persons nor [$17,200] $17,700 in
19 the case of the combined annual income of persons married to
20 each other. Persons may, in reporting income to the Department
21 of Aging, round the amount of each source of income and the
22 income total to the nearest whole dollar, whereby any amount
23 which is less than 50¢ is eliminated.
24 * * * <--
25 "PREFERRED PROVIDER ORGANIZATION." AN ENTITY ORGANIZED AND
26 OPERATING UNDER 40 PA.C.S. CH. 63 (RELATING TO PROFESSIONAL
27 HEALTH SERVICES PLAN CORPORATIONS).
28 * * *
29 "PROVIDER." A PHARMACY [OR], DISPENSING PHYSICIAN OR <--
30 CERTIFIED REGISTERED NURSE PRACTITIONER ENROLLED AS A PROVIDER
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1 IN THE PROGRAM.
2 Section 2. Sections 503, 504, 508(a), 509, 510(a) and (b), <--
3 512, 515, 516, 519 and 520(b), 520(B), 521(D) AND 522 of the <--
4 SECTION 2. SECTIONS 503, 504 AND 509 OF THE act, added <--
5 November 21, 1996 (P.L.741, No.134), are amended to read:
6 SECTION 503. DETERMINATION OF ELIGIBILITY. <--
7 THE DEPARTMENT SHALL ADOPT REGULATIONS RELATING TO THE
8 DETERMINATION OF ELIGIBILITY OF PROSPECTIVE CLAIMANTS AND
9 PROVIDERS, INCLUDING DISPENSING PHYSICIANS AND CERTIFIED
10 REGISTERED NURSE PRACTITIONERS WHEN ACTING IN ACCORDANCE WITH
11 RULES AND REGULATIONS PROMULGATED BY THE STATE BOARD OF NURSING
12 AS REQUIRED BY THE ACT OF MAY 22, 1951 (P.L.317, NO.69), KNOWN
13 AS THE PROFESSIONAL NURSING LAW, AND THE STATE BOARD OF PHARMACY
14 MINIMUM STANDARDS OF PRACTICE, AND THE DETERMINATION AND
15 ELIMINATION OF PROGRAM ABUSE. TO THIS END, THE DEPARTMENT SHALL
16 ESTABLISH A COMPLIANCE UNIT STAFFED SUFFICIENTLY TO FULFILL THIS
17 RESPONSIBILITY. THE DEPARTMENT SHALL HAVE THE POWER TO DECLARE
18 INELIGIBLE ANY CLAIMANT OR PROVIDER WHO ABUSES OR MISUSES THE
19 ESTABLISHED PRESCRIPTION PLAN. THE DEPARTMENT SHALL HAVE THE
20 POWER TO INVESTIGATE CASES OF SUSPECTED PROVIDER OR RECIPIENT
21 FRAUD.
22 SECTION 504. PHYSICIAN, CERTIFIED REGISTERED NURSE PRACTITIONER
23 AND PHARMACY PARTICIPATION.
24 ANY PHYSICIAN, CERTIFIED REGISTERED NURSE PRACTITIONER,
25 PHARMACIST, PHARMACY OR CORPORATION OWNED IN WHOLE OR IN PART BY
26 A PHYSICIAN, CERTIFIED REGISTERED NURSE PRACTITIONER OR
27 PHARMACIST ENROLLED AS A PROVIDER IN THE PROGRAM OR WHO HAS
28 PRESCRIBED MEDICATION FOR A CLAIMANT IN THE PROGRAM WHO IS
29 PRECLUDED OR EXCLUDED FOR CAUSE FROM THE DEPARTMENT OF PUBLIC
30 WELFARE'S MEDICAL ASSISTANCE PROGRAM SHALL BE PRECLUDED OR
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1 EXCLUDED FROM PARTICIPATION IN THE PROGRAM. NO PHYSICIAN OR
2 CERTIFIED REGISTERED NURSE PRACTITIONER PRECLUDED OR EXCLUDED
3 FROM THE DEPARTMENT OF PUBLIC WELFARE'S MEDICAL ASSISTANCE
4 PROGRAM SHALL HAVE CLAIMS RESULTING FROM PRESCRIPTIONS PAID FOR
5 BY THE PROGRAM.
6 Section 508. Request for proposal. <--
7 (a) General rule.--The department shall prepare a request
8 for proposal for the purpose of providing pharmaceutical
9 assistance for the elderly within this Commonwealth beginning at
10 the expiration, including any option years the department
11 chooses to exercise, of the current vendor contract. Upon the
12 adoption of the General Fund budget, the Department of Revenue
13 shall be authorized to transmit the appropriated funds in the
14 State Lottery Fund to the State Treasurer to be deposited in the
15 Pharmaceutical Assistance Contract for the Elderly Fund. This
16 fund shall consist of appropriations and interest and shall be
17 created by the State Treasurer to fund the operations of the
18 program by the department and the private contractor. Funds not
19 expended in the fiscal year in which they were appropriated
20 shall not lapse and be available for use in the next fiscal
21 year.
22 * * *
23 Section 509. Program generally.
24 The program shall include the following:
25 (1) Participating pharmacies shall be paid within 21
26 days of the contracting firm receiving the appropriate
27 substantiation of the transaction. Pharmacies shall be
28 entitled to interest for payment not made within the 21-day
29 period at a rate approved by the board.
30 (2) Collection of the copayment by pharmacies shall be
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1 mandatory.
2 (3) Senior citizens participating in the program are not
3 required to maintain records of each transaction.
4 (4) A system of rebates or reimbursements to eligible
5 claimants for pharmaceutical expenses shall be prohibited.
6 (5) PACE shall include [a] participant copayment
7 [schedule] schedules for each prescription, including a
8 copayment for generic or multiple-source drugs that is less
9 than the copayment for single-source drugs. [The copayment <--
10 [may increase or decrease] shall be increased or decreased on <--
11 an annual basis by the average percent change of ingredient
12 costs for all prescription drugs, plus a differential to
13 raise the copayment to the next highest 25¢ increment. In
14 addition, the department may approve a request for increase
15 or decrease in the level of copayment based upon the
16 financial experience and projections of PACE and after
17 consultation with the board. The department is prohibited
18 from approving adjustments to the copayment on more than an
19 annual basis.] THE DEPARTMENT SHALL ANNUALLY CALCULATE THE <--
20 COPAYMENT SCHEDULES BASED ON THE PRESCRIPTION DRUGS AND
21 MEDICAL SUPPLIES CONSUMER PRICE INDEX. WHEN THE AGGREGATE
22 IMPACT OF THE PRESCRIPTION DRUGS AND MEDICAL SUPPLIES
23 CONSUMER PRICE INDEX EQUALS OR EXCEEDS $1, THE DEPARTMENT
24 SHALL ADJUST THE COPAYMENT SCHEDULES. EACH COPAYMENT SCHEDULE
25 SHALL NOT BE INCREASED BY MORE THAN $1 IN A CALENDAR YEAR.
26 (6) [The program shall consist of payments to pharmacies <--
27 on behalf of eligible claimants for 90% of the average
28 wholesale costs of prescription drugs which exceed the
29 copayment, plus a dispensing fee of at least [$3.50] $4 or <--
30 the dispensing fee established by the department by
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1 regulation, whichever is greater.] THE PROGRAM PAYMENT SHALL <--
2 BE THE LOWER OF THE FOLLOWING AMOUNTS DETERMINED AS FOLLOWS:
3 (I) 90% OF THE AVERAGE WHOLESALE COST OF THE
4 PRESCRIPTION DRUG DISPENSED:
5 (A) WITH THE ADDITION OF A DISPENSING FEE OF THE
6 GREATER OF:
7 (I) $4; OR
8 (II) THE AMOUNT SET BY THE DEPARTMENT BY
9 REGULATION;
10 (B) THE SUBTRACTION OF THE COPAYMENT; AND
11 (C) IF REQUIRED THE SUBTRACTION OF THE GENERIC
12 DIFFERENTIAL; OR
13 (II) THE PHARMACY'S USUAL CHARGE FOR THE DRUG
14 DISPENSED WITH THE SUBTRACTION OF THE COPAYMENT AND IF
15 REQUIRED THE SUBTRACTION OF THE GENERIC DIFFERENTIAL; OR
16 (III) IF A GENERIC DRUG, THE MOST CURRENT FEDERAL
17 UPPER PAYMENTS LIMITS ESTABLISHED IN THE MEDICAID PROGRAM
18 UNDER 42 CFR § 447.332 (RELATING TO UPPER LIMITS FOR
19 MULTIPLE SOURCE DRUGS), PLUS A DISPENSING FEE OF $4 OR
20 THE AMOUNT SET BY THE DEPARTMENT BY REGULATION, WHICHEVER
21 IS GREATER MINUS THE COPAYMENT. THE DEPARTMENT SHALL <--
22 UPDATE THE AVERAGE WHOLESALE COSTS AND THE FEDERAL UPPER
23 PAYMENT LIMITS AT LEAST EVERY 30 DAYS.
24 (7) In no case shall the Commonwealth or any person
25 enrolled in the program be charged more than the price of the
26 drug at the particular pharmacy on the date of the sale.
27 (8) The Governor may, based upon certified State Lottery
28 Fund revenue that is provided to both the chairman and
29 minority chairman of the Appropriations Committee of the
30 Senate and the chairman and minority chairman of the
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1 Appropriations Committee of the House of Representatives, and
2 after consultation with the board, increase DECREASE the <--
3 eligibility limits above those established in this chapter. <--
4 SECTION 3. SECTION 510(A) OF THE ACT, ADDED NOVEMBER 21, <--
5 1996 (P.L.741, NO.134), IS AMENDED TO READ:
6 Section 510. Generic drugs.
7 (a) In general.--Notwithstanding any other statute or
8 regulation, if an A-rated generic therapeutically equivalent
9 drug is available for dispensing to a claimant, the provider
10 shall dispense the A-rated generic therapeutically equivalent
11 drug to the claimant. THE DEPARTMENT SHALL, UNDER SECTION <--
12 1927(C)(1)(C) OF THE SOCIAL SECURITY ACT (49 STAT. 620 42 U.S.C.
13 § 1396R-8(C)(1)(C)), REIMBURSE PROVIDERS BASED UPON THE MOST
14 CURRENT LISTING OF FEDERAL UPPER PAYMENTS LIMITS ESTABLISHED IN
15 THE MEDICAID PROGRAM UNDER 42 CFR § 447.332 (RELATING TO UPPER
16 LIMITS FOR MULTIPLE SOURCE DRUGS), PLUS A DISPENSING FEE AS SET <--
17 FORTH IN SECTION 509(6). THE DEPARTMENT SHALL UPDATE THE AVERAGE
18 WHOLESALE COSTS AND THE FEDERAL UPPER PAYMENTS LIMITS ON A
19 REGULAR BASIS, AT LEAST EVERY 30 DAYS. The department shall not
20 reimburse providers for brand name products except in the
21 following circumstances:
22 (1) There is no A-rated generic therapeutically
23 equivalent drug available on the market. This paragraph does
24 not apply to the lack of availability of an A-rated generic
25 therapeutically equivalent drug in the providing pharmacy
26 unless it can be shown to the department that the provider
27 made reasonable attempts to obtain the A-rated generic
28 therapeutically equivalent drug or that there was an
29 unforeseeable demand and depletion of the supply of the A-
30 rated generic therapeutically equivalent drug. In either
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1 case, the department shall reimburse the provider [for 90% of <--
2 the average wholesale cost plus a dispensing fee based on the
3 least expensive A-rated generic therapeutically equivalent
4 drug for the brand drug dispensed.] based upon the most <--
5 current listing of Federal upper payment limits established
6 under the Medicaid program as provided under Federal
7 regulations at 42 CFR 447.332 (relating to upper limits for
8 multiple source drugs), in accordance with section
9 1902(a)(30)(A) of the Social Security Act (49 Stat. 620, 42
10 U.S.C. § 1396a(a)(30)(A)), plus a dispensing fee. The
11 department shall review the Federal upper payment limits
12 every 12 months.
13 (2) An A-rated generic therapeutically equivalent drug
14 is deemed by the department, in consultation with a
15 utilization review committee, to have too narrow a
16 therapeutic index for safe and effective dispensing in the
17 community setting. The department shall notify providing
18 pharmacies of A-rated generic therapeutically equivalent
19 drugs that are identified pursuant to this paragraph on a
20 regular basis.
21 (3) The Department of Health has determined that a drug
22 shall not be recognized as an A-rated generic therapeutically
23 equivalent drug for purpose of substitution under section
24 5(b) of the act of November 24, 1976 (P.L.1163, No.259),
25 referred to as the Generic Equivalent Drug Law.
26 (4) At the time of dispensing, the provider has a
27 prescription on which the brand name drug dispensed is billed
28 to the program by the provider at a usual and customary
29 charge which is equal to or less than the least expensive
30 usual and customary charge of any A-rated generic
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1 therapeutically equivalent drug reasonably available on the
2 market to the provider.
3 (b) Generic not accepted.--[If] Except as provided in <--
4 Chapter 6 if a claimant chooses not to accept the A-rated
5 generic therapeutically equivalent drug required by subsection
6 (a), the claimant shall be liable for the copayment and 70% of
7 the average wholesale cost of the brand name drug.
8 * * *
9 SECTION 4. SECTIONS 512, 515, 516, 519 AND 520(B) OF THE <--
10 ACT, ADDED NOVEMBER 21, 1996 (P.L.741, NO.134), ARE AMENDED TO
11 READ:
12 Section 512. Restricted formulary.
13 The department may establish a restricted formulary of the
14 drugs which will not be reimbursed by the program. This
15 formulary shall include only experimental drugs and drugs on the
16 Drug Efficacy Study Implementation List prepared by [the Health
17 Care Finance Administration] CMS. A medical exception may be
18 permitted by the department for reimbursement of a drug on the
19 Drug Efficacy Study Implementation List upon declaration of its
20 necessity on the prescription by the treating physician OR <--
21 CERTIFIED REGISTERED NURSE PRACTITIONER, except that, for DESI
22 drugs for which the FDA has issued a Notice for Opportunity
23 Hearing (NOOH) for the purpose of withdrawing the New Drug
24 Application approved for that drug, reimbursement coverage shall
25 be discontinued under the provisions of this chapter.
26 Section 515. Reimbursement.
27 For-profit third-party insurers, health maintenance
28 organizations, PREFERRED PROVIDER ORGANIZATIONS and not-for- <--
29 profit prescription plans shall be responsible for any payments
30 made to a providing pharmacy on behalf of a claimant covered by
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1 such a third party. FINAL DETERMINATION AS TO THE EXISTENCE OF <--
2 THIRD-PARTY COVERAGE SHALL BE THE RESPONSIBILITY OF THE
3 DEPARTMENT.
4 Section 516. Nonliability.
5 (a) [Persons rendering service] General rule.--Any person
6 rendering service as a member of a utilization review committee
7 for this program shall not be liable for any civil damages as a
8 result of any acts or omissions in rendering the service as a
9 member of any such committee except any acts or omissions
10 intentionally designed to harm or any grossly negligent acts or
11 omissions which result in harm to the person receiving such
12 service.
13 (b) [Officer and employees of department] Department
14 personnel.--Any officer or employee of the department rendering
15 service as a member of a utilization review committee for this
16 program shall not be liable for any civil damages as a result of
17 any acts or omissions in rendering the service as a member of
18 any such committee or as a result of any decision or action in
19 connection with the program except any acts or omissions
20 intentionally designed to harm or any grossly negligent acts or
21 omissions which result in harm to the person receiving such
22 service.
23 Section 519. The Pharmaceutical Assistance Contract for the
24 Elderly Needs Enhancement Tier.
25 (a) Establishment.--There is hereby established within the
26 department a program to be known as the Pharmaceutical
27 Assistance Contract for the Elderly Needs Enhancement Tier
28 (PACENET).
29 (b) PACENET eligibility.--A claimant with an annual income
30 of not less than [$14,000] $14,500 and not more than [$16,000]
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1 $22,500 $23,500 in the case of a single person and of not less <--
2 than [$17,200] $17,700 and not more than [$19,200] $30,500 <--
3 $31,500 in the case of the combined income of persons married to
4 each other shall be eligible for enhanced pharmaceutical
5 assistance under this section. A person may, in reporting income
6 to the department, round the amount of each source of income and
7 the income total to the nearest whole dollar, whereby any amount
8 which is less than 50¢ is eliminated.
9 (c) Deductible.--Upon enrollment in PACENET, eligible
10 claimants in the income ranges set forth in subsection (b) shall
11 be required to meet [an annual] a deductible in unreimbursed
12 prescription drug expenses of [$500] $40 per person[.] per
13 month. The $40 monthly deductible shall be cumulative and shall
14 be applied to subsequent months to determine eligibility. The
15 cumulative deductible shall be determined on a calendar AN <--
16 ENROLLMENT year basis for an annual total deductible not to
17 exceed $480 in a year. To qualify for the deductible set forth
18 in this subsection the prescription drug must be purchased for
19 the use of the eligible claimant from a provider as defined in
20 this chapter. The department, after consultation with the board,
21 [may] shall approve an adjustment in the deductible on an annual <--
22 basis.
23 (d) Copayment.--For eligible claimants under this section, <--
24 the copayment schedule, which [may] shall be adjusted by the <--
25 department on an annual basis after consultation with the board,
26 (D) COPAYMENT.-- <--
27 (1) FOR ELIGIBLE CLAIMANTS UNDER THIS SECTION, THE
28 COPAYMENT SCHEDULE[, WHICH MAY BE ADJUSTED BY THE DEPARTMENT
29 ON AN ANNUAL BASIS AFTER CONSULTATION WITH THE BOARD,] shall
30 be:
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1 (i) eight dollars for noninnovator multiple source
2 drugs as defined in section 702; or
3 (ii) fifteen dollars for single-source drugs and
4 innovator multiple-source drugs as defined in section
5 702.
6 (2) THE DEPARTMENT SHALL ANNUALLY CALCULATE THE <--
7 COPAYMENT SCHEDULES BASED ON THE PRESCRIPTION DRUGS AND
8 MEDICAL SUPPLIES CONSUMER PRICE INDEX. WHEN THE AGGREGATE
9 IMPACT OF THE PRESCRIPTION DRUGS AND MEDICAL SUPPLIES
10 CONSUMER PRICE INDEX EQUALS OR EXCEEDS $1, THE DEPARTMENT
11 SHALL ADJUST THE COPAYMENT SCHEDULES. EACH COPAYMENT SCHEDULE
12 SHALL NOT BE INCREASED BY MORE THAN $1 IN A CALENDAR YEAR.
13 Section 520. Board.
14 * * *
15 (b) Composition.--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 pharmaceutical industry to serve as consumer advocates
29 [and two representatives], one representative of the
30 pharmaceutical industry[, at least one of whom is a] and one
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1 practicing Pennsylvania pharmacist. The individual appointed
2 by the Governor must be a physician. A public member who
3 misses two consecutive meetings without good cause acceptable
4 to the chairman shall be replaced by the appointing
5 authority.
6 * * *
7 Section 3. The act is amended by adding a section to read: <--
8 Section 520.1. PACE and PACENET Eligibility Advisory Committee.
9 (a) Establishment.--There is established in the department
10 the PACE and PACENET Eligibility Advisory Committee.
11 (b) Composition.--The eligibility advisory committee shall
12 consist of four members who shall be members of the General
13 Assembly and a chairman who shall be appointed by the Governor.
14 The members of the General Assembly shall be appointed as
15 follows:
16 (1) One member appointed by the President pro tempore of
17 the Senate.
18 (2) One member appointed by the Minority Leader of the
19 Senate.
20 (3) One member appointed by the Speaker of the House of
21 Representatives.
22 (4) One member appointed by the Minority Leader of the
23 House of Representatives.
24 (c) Chairman.--Nothing in this section shall be construed as
25 prohibiting the Governor from appointing a member of the General
26 Assembly as chairman .
27 (d) Term.--Members shall serve at the pleasure of the
28 appointing authority.
29 (e) Expenses.--Members of the advisory committee shall serve
30 without compensation but shall be reimbursed for actual and
20030H0888B2871 - 14 -
1 reasonable expenses incurred in the performance of their
2 official duties.
3 (f) Designee.--A designee designated by a member under
4 subsection (b)(1), (2), (3) and (4) may vote and otherwise act
5 on behalf of the member. The designation must be in writing and
6 be delivered to the advisory committee. The designation shall
7 continue in effect until revoked or amended in writing.
8 (g) Quorum.--A majority of the members of the advisory
9 committee then serving shall constitute a quorum of the advisory
10 committee. Only a member or a designee who is physically present
11 at a meeting or able to participate fully in the deliberations
12 by appropriate telecommunications means shall count toward a
13 quorum of the advisory committee.
14 (h) Responsibilities.--The advisory committee shall study
15 the feasibility of expansions and other changes to eligibility
16 under the PACE program and make recommendations to the Governor
17 and the department on an annual basis. In addition, the advisory
18 committee may study and participate, with the approval of the
19 Governor and the department, in advocating at other levels of
20 government proposed changes in the provision of pharmaceutical
21 benefits to senior citizens. The committee may also make
22 recommendations with respect to the terms and conditions under
23 which pharmaceutical companies participate in Commonwealth
24 health care programs for the elderly.
25 Section 4. Sections 521(d) and 522 of the act, added
26 November 21, 1996 (P.L.741, No.134), are amended to read:
27 SECTION 5. THE ACT IS AMENDED BY ADDING A SECTION TO READ: <--
28 SECTION 520.1. PHARMACY BEST PRACTICES AND COST CONTROLS
29 REVIEW.
30 (A) REVIEW PROCESS.--THE SECRETARY SHALL REVIEW AND
20030H0888B2871 - 15 -
1 RECOMMEND PHARMACY BEST PRACTICES AND COST CONTROL MECHANISMS
2 THAT MAINTAIN HIGH QUALITY IN PRESCRIPTION DRUG THERAPIES BUT
3 ARE DESIGNED TO REDUCE THE COST OF PROVIDING PRESCRIPTION DRUGS
4 FOR PACE AND PACENET ENROLLEES INCLUDING:
5 (1) A LIST OF COVERED PRESCRIPTION DRUGS WITH
6 RECOMMENDED COPAYMENT SCHEDULES. IN DEVELOPING THE SCHEDULES,
7 THE DEPARTMENT SHALL TAKE INTO ACCOUNT THE STANDARDS
8 PUBLISHED IN THE UNITED STATES PHARMACOPEIA-DRUG INFORMATION.
9 (2) A DRUG UTILIZATION REVIEW PROCEDURE, INCORPORATING A
10 PRESCRIPTION REVIEW PROCESS FOR COPAYMENT SCHEDULES.
11 (3) A STEP THERAPY PROGRAM THAT SAFELY AND EFFECTIVELY
12 UTILIZES IN A SEQUENTIAL MANNER THE LEAST COSTLY
13 PHARMACOLOGICAL THERAPY TO TREAT THE SYMPTOMS OF OR EFFECT A
14 CURE FOR THE MEDICAL CONDITION OR ILLNESS FOR WHICH THE
15 THERAPY IS PRESCRIBED.
16 (4) EDUCATION PROGRAMS DESIGNED TO PROVIDE INFORMATION
17 AND EDUCATION ON THE THERAPEUTIC AND COST-EFFECTIVE
18 UTILIZATION OF PRESCRIPTION DRUGS TO PHYSICIANS, PHARMACISTS,
19 CERTIFIED REGISTERED NURSE PRACTITIONERS AND OTHER HEALTH
20 CARE PROFESSIONALS AUTHORIZED TO PRESCRIBE AND DISPENSE
21 PRESCRIPTION DRUGS.
22 (B) REPORT AND RECOMMENDATIONS.--NO LATER THAN TWO YEARS
23 FROM THE EFFECTIVE DATE OF THIS SECTION, THE DEPARTMENT SHALL
24 SUBMIT A REPORT WITH RECOMMENDATIONS TO THE AGING AND YOUTH
25 COMMITTEE, THE APPROPRIATIONS COMMITTEE AND THE PUBLIC HEALTH
26 AND WELFARE COMMITTEE OF THE SENATE AND THE AGING AND OLDER
27 ADULT SERVICES COMMITTEE, THE APPROPRIATIONS COMMITTEE AND THE
28 HEALTH AND HUMAN SERVICES COMMITTEE OF THE HOUSE OF
29 REPRESENTATIVES. THE REPORT SHALL INCLUDE INFORMATION REGARDING
30 THE EFFICACY OF THE PHARMACY BEST PRACTICES AND CONTROL
20030H0888B2871 - 16 -
1 MECHANISMS SET FORTH IN SUBSECTION (A) INCLUDING RECOMMENDED
2 COPAYMENT SCHEDULES WITH IMPACTED CLASSES OF DRUGS, EXCEPTIONS,
3 COST EFFECTIVENESS, IMPROVED DRUG UTILIZATION AND THERAPIES,
4 MOVEMENT OF MARKET SHARE AND INCREASED UTILIZATION OF GENERIC
5 DRUGS.
6 SECTION 6. SECTIONS 521(D) AND 522 OF THE ACT, ADDED
7 NOVEMBER 21, 1996 (P.L.741, NO.134), ARE AMENDED TO READ:
8 Section 521. Penalties.
9 * * *
10 (d) [Repayment of gain] Reparation.--Any provider, recipient
11 or other person who is found guilty of a crime for violating
12 this chapter shall repay three times the value of the material
13 gain received. In addition to the civil penalty authorized
14 pursuant to subsection (b), the department may require the
15 provider, recipient or other person to repay up to three times
16 the value of any material gain to PACE or PACENET.
17 Section 522. Prescription drug education program.
18 The department, in cooperation with the Department of Health,
19 shall develop and implement a Statewide prescription drug
20 education program designed to inform older adults of the dangers
21 of prescription drug abuse and misuse. The prescription drug
22 education program shall include, but not be limited to,
23 information concerning the following:
24 (1) The hazards of prescription drug overdose.
25 (2) The potential dangers of mixing prescription drugs.
26 (3) The danger of retaining unused prescription drugs
27 after the need to take them no longer exists.
28 (4) The necessity to carefully question physicians, <--
29 CERTIFIED REGISTERED NURSE PRACTITIONERS and pharmacists
30 concerning the effects of taking prescription drugs[, <--
20030H0888B2871 - 17 -
1 including the differences between brand-name drugs and
2 generically equivalent drugs]. <--
3 (5) The advisability of maintaining a prescription drug
4 profile or other record of prescription drug dosage and
5 frequency of dosage.
6 (6) The desirability of advising family members of the
7 types and proper dosage of prescription drugs which are being
8 taken.
9 (7) The dangers of taking prescription drugs in excess
10 of prescribed dosages.
11 (8) The need to obtain complete, detailed directions
12 from the physician, CERTIFIED REGISTERED NURSE PRACTITIONER <--
13 or pharmacist concerning the time period a prescription drug
14 should be taken.
15 Section 5 3. The act is amended by adding a chapter to read: <--
16 CHAPTER 6
17 PHARMACY BEST PRACTICES AND COST CONTROL PROGRAM
18 Section 601. Definitions.
19 The following words and phrases when used in this chapter
20 shall have the meanings given to them in this section unless the
21 context clearly indicates otherwise:
22 "Committee." The Pharmacy Best Practices and Cost Control
23 Advisory Committee established in section 602.
24 "Department." The Department of Aging of the Commonwealth.
25 "Program." The Pharmacy Best Practices and Cost Control
26 Program established in section 603.
27 "Secretary." The Secretary of Aging of the Commonwealth.
28 Section 602. Advisory committee.
29 (a) Establishment.--The Pharmacy Best Practices and Cost
30 Control Advisory Committee is established in the department.
20030H0888B2871 - 18 -
1 (b) Members.--The committee is comprised of the following
2 Pennsylvania residents:
3 (1) The secretary or a designee, who shall serve as
4 chairperson.
5 (2) Four members appointed by the Governor. One member
6 under this paragraph must possess expertise in medicine, one
7 member must possess expertise in health care, one member must
8 possess expertise in pharmacy and one member must possess
9 expertise in the pharmaceutical industry.
10 (3) One member appointed by the President pro tempore of
11 the Senate and one member appointed by the Minority Leader of
12 the Senate.
13 (4) One member appointed by the Speaker of the House of
14 Representatives and one member appointed by the Minority
15 Leader of the House of Representatives.
16 (c) Terms.--Terms are as follows:
17 (1) The secretary shall serve ex officio.
18 (2) A member under subsection (b)(2) shall serve a term
19 of six years.
20 (3) A member under subsection (b)(3) shall serve a term
21 of four years but may be removed at the pleasure of the
22 appointing authority.
23 (4) A member under subsection (b)(4) shall serve a term
24 of two years but may be removed at the pleasure of the
25 appointing authority.
26 (5) An appointment to fill a vacancy shall be for the
27 period of the unexpired term or until a successor is
28 appointed and qualified.
29 (d) Quorum.--A majority of the members of the committee
30 constitutes a quorum.
20030H0888B2871 - 19 -
1 (e) Compensation.--Members shall receive no payment for
2 their services. Members who are not employees of State
3 government shall be reimbursed for necessary and reasonable
4 expenses incurred in the course of their official duties.
5 (f) Meetings.--Meetings of this committee shall be held in
6 public pursuant to 65 Pa.S.C. Ch. 7 (relating to public
7 meetings).
8 Section 603. Program.
9 (a) Establishment.--The secretary shall establish a Pharmacy
10 Best Practices and Cost Control Program for PACE and PACENET
11 enrollees designed to reduce the cost of providing prescription
12 drugs, while maintaining high quality in prescription drug
13 therapies. The program shall include all of the following:
14 (1) A list of covered prescription drugs under section
15 509 in the program selected by the department upon
16 recommendations by the committee.
17 (2) A drug utilization review procedure, including a
18 prescription review process for copayment schedules.
19 (3) Education programs designed to provide information
20 and education on the therapeutic and cost-effective
21 utilization of prescription drugs to physicians, pharmacists
22 and other health care professionals authorized to prescribe
23 and dispense prescription drugs.
24 (b) Pooling.--The secretary shall evaluate the benefits of
25 participating, but is not required to participate, in joint
26 prescription drug purchasing agreements or pooling arrangements
27 with other states. Such actions shall include:
28 (1) The execution of any lawful joint purchasing or
29 pooling agreements with other participating states which the
30 secretary determines will lower the Medicaid cost of
20030H0888B2871 - 20 -
1 prescription drugs while maintaining high quality in
2 prescription drug therapies.
3 (2) Renegotiation and amendment of existing contracts to
4 which the department is a party if renegotiation and
5 amendment will be of economic benefit to the department.
6 (3) A quarterly report to the committee on the
7 department's progress in securing participation in joint
8 purchasing or pooling agreements.
9 (c) Authorized coverage.--The program shall authorize
10 copayments schedules for each prescription drug. IN ESTABLISHING <--
11 THE SCHEDULES, THE DEPARTMENT SHALL TAKE INTO ACCOUNT THE
12 STANDARDS PUBLISHED IN THE UNITED STATES PHARMACOPEIA-DRUG
13 INFORMATION. THE DEPARTMENT SHALL NOTIFY CLAIMANTS UNDER THE
14 PLAN BY MAIL OF THE BASES FOR THE EXCLUSION OF COVERAGE OF ANY
15 DRUG. When a patient's health care provider prescribes a
16 prescription drug at the higher copayment schedule, the lower
17 copayment shall apply for one year when any of the following
18 conditions are met:
19 (1) The preferred choice has not been effective or, with
20 reasonable certainty, is not expected to be effective in
21 treating the patient's condition.
22 (2) The preferred choice causes or is reasonably
23 expected to cause adverse or harmful reactions in the
24 patient.
25 (3) Other clinical criteria recommended by the committee
26 and approved by the department.
27 (d) Brand necessary.--If the prescriber does not wish
28 substitution to take place, the prescriber shall write "brand
29 necessary" or "no substitution" in the prescriber's own
30 handwriting on the prescription blank, together with a written
20030H0888B2871 - 21 -
1 statement that the generic or the equivalent has not been
2 effective, or with reasonable certainty is not expected to be
3 effective, in treating the patient's medical condition or causes
4 or is reasonably expected to cause adverse or harmful reactions
5 in the patient. In the case of an unwritten prescription, there
6 shall be no substitution if the prescriber expressly indicates
7 to the pharmacist that the brand name drug is necessary and
8 substitution is not allowed because the generic or the
9 equivalent has not been effective, or with reasonable certainty
10 is not expected to be effective, in treating the patient's
11 medical condition or causes or is reasonably expected to cause
12 adverse or harmful reactions in the patient. Approval under this
13 section shall be valid for one year.
14 (e) Exclusions.--The department, with recommendations from
15 the committee, shall determine diseases and therapeutic classes
16 relating to treatment for diseases excluded from the program at
17 the time the program under this section is implemented.
18 (f) Response.--The program's prescriber-indicated prior
19 authorization process shall ensure that there will be a response
20 to a request for prior authorization by telephone or other
21 telecommunication device within 12 hours after receipt of the
22 request for prior authorization and that a minimum of a 72-hour
23 supply of the drug prescribed will be provided in an emergency
24 or when the program does not provide a response within 12 hours.
25 The prior authorization process shall be designed to minimize
26 administrative burdens on prescribers, pharmacists and
27 consumers.
28 (g) Procedure.--The program shall establish procedures for
29 the timely review of prescription drugs newly approved by the
30 Food and Drug Administration, including procedures for the
20030H0888B2871 - 22 -
1 review of newly approved prescription drugs in emergency
2 circumstances.
3 (h) Reports.--The department shall submit annual reports on
4 the program under subsection (a) to the Aging and Youth
5 Committee, the Appropriations Committee and the Public Health
6 and Welfare Committee of the Senate and the Aging and Older
7 Adult Services Committee, the Appropriations Committee and the
8 Health and Human Services Committee of the House of
9 Representatives. The reports shall include classes of drugs,
10 exceptions, cost effectiveness, movement of market share and
11 increased utilization of generic drugs.
12 Section 604. Restriction or substitution process.
13 (a) General rule.--The EXCEPT AS PROVIDED IN SECTION 510, <--
14 THE provisions of this chapter shall not permit the program to
15 develop any drug formulary, prior or retroactive approval
16 system, including higher copayments, or any other similar
17 restriction or substitution process for:
18 (1) Psychotropic drugs.
19 (2) Drugs used in the treatment of human
20 immunodeficiency virus, acquired immune deficiency syndrome
21 or opportunistic infections.
22 (3) ANTIEPILEPTIC DRUGS FOR THE TREATMENT OF EPILEPSY. <--
23 (b) Definition.--As used in this section, the term
24 "psychotropic drug" means a drug used to treat a mental
25 disorder.
26 Section 6 4. Section 701 of the act, added November 21, 1996 <--
27 (P.L.741, No.134), is amended to read:
28 [Section 701. Declaration of policy.
29 The General Assembly finds and declares as follows:
30 (1) The Commonwealth, through assistance programs
20030H0888B2871 - 23 -
1 enacted for the benefit of its citizens, is the largest
2 single payor of prescription medications in Pennsylvania.
3 (2) In order to ensure that the Commonwealth, in
4 expending money on behalf of its citizens, is not unduly
5 harmed by being required to pay a price for pharmaceutical
6 products purchased from manufacturers in excess of that
7 established for other purchasers and reimbursers of these
8 products and to ensure that the Commonwealth can efficiently
9 and prudently expend its money and maximize its ability to
10 provide for the health and welfare of as many of its needy
11 citizens as possible, it is reasonable, necessary and in the
12 public interest to require that pharmaceutical manufacturers
13 offer a discount to the Commonwealth for pharmaceutical
14 products purchased or reimbursed through State agencies.
15 (3) It is in the public interest for pharmaceutical
16 manufacturers to provide the Commonwealth with data relating
17 to the price of pharmaceutical products sold by the
18 manufacturer to public bodies, hospitals, for-profit or
19 nonprofit organizations, other manufacturers or wholesalers
20 doing business in this Commonwealth in order to ensure that
21 the Commonwealth can determine that it is being provided with
22 the best prices offered by the manufacturer.
23 (4) On a national level, there has been a recognition
24 that the need for discounts to State Medicaid agencies, which
25 reimburse for a high volume of pharmaceutical products,
26 exists.
27 (5) On a State level, the General Assembly recognizes
28 that it is in the best interest of its citizens to provide
29 pharmaceutical assistance in a reasonable and cost-efficient
30 manner.
20030H0888B2871 - 24 -
1 (6) Drug price inflation has caused an increase in the
2 amount of public funds expended by PACE and General
3 Assistance.]
4 Section 7. Section 702 of the act is amended by adding a <--
5 definition to read:
6 SECTION 5 7. THE DEFINITION OF "PROVIDER" IN SECTION 702 OF <--
7 THE ACT, ADDED NOVEMBER 21, 1996 (P.L.741, NO.134), IS AMENDED
8 AND THE SECTION IS AMENDED BY ADDING A DEFINITION TO READ:
9 Section 702. Definitions.
10 The following words and phrases when used in this chapter
11 shall have the meanings given to them in this section unless the
12 context clearly indicates otherwise:
13 * * *
14 "Best price." The lowest price available from the
15 manufacturer during the rebate period to any wholesaler,
16 retailer, provider, health maintenance organization, nonprofit
17 entity or any governmental entity subject to the exclusions and
18 special rules set forth in sections 1902 and 1927(c)(1)(C) of
19 the Social Security Act (49 Stat. 620, 42 U.S.C. §§1396c, 1396r-
20 8(c)(1)(C)).
21 * * *
22 "PROVIDER." A LICENSED PHARMACY [OR], LICENSED DISPENSING <--
23 PHYSICIAN OR CERTIFIED REGISTERED NURSE PRACTITIONER ENROLLED AS
24 A PROVIDER IN PACE, PACENET OR DESIGNATED PHARMACEUTICAL
25 PROGRAMS.
26 * * *
27 Section 8 6. Sections 703(e), 704(c)(1) and 705(a) and (b) <--
28 SECTION 8. SECTIONS 703(E) AND 704(C)(1) of the act, added <--
29 November 21, 1996 (P.L.741, No.134), are amended to read:
30 Section 703. Rebate agreement.
20030H0888B2871 - 25 -
1 * * *
2 (e) Drug formulary.--Except as provided in section 512 and <--
3 Chapter 6, there shall be no drug formulary[, prior or <--
4 retroactive approval system or any similar restriction] imposed <--
5 on the coverage of outpatient drugs made by manufacturers who
6 have agreements in effect with the Commonwealth to pay rebates
7 for drugs utilized in PACE and PACENET, provided that such
8 outpatient drugs were approved for marketing by the Food and
9 Drug Administration. This subsection shall not apply to any act
10 taken by the department pursuant to its therapeutic drug
11 utilization review program under section 505.
12 Section 704. Terms of rebate agreement.
13 * * *
14 (c) Manufacturer provision of price information.--
15 (1) Each manufacturer with an agreement in effect under
16 this chapter shall report the average manufacturer price and
17 the best price for all covered prescription drugs produced by
18 that manufacturer to the department not later than 30 days
19 after the last day of each quarter.
20 * * *
21 SECTION 9. SECTION 705(A) AND (C) OF THE ACT, ADDED NOVEMBER <--
22 21, 1996, (P.L.741, NO.134), ARE AMENDED AND THE SECTION IS
23 AMENDED BY ADDING A SUBSECTION TO READ:
24 Section 705. Amount of rebate.
25 (a) Single-source drugs and innovator multiple-source
26 drugs.--With respect to single-source drugs and innovator
27 multiple-source drugs, each manufacturer shall remit a rebate to
28 the Commonwealth pursuant to the determination established by <--
29 section 1927(c)(1)(C) of the Social Security Act (49 Stat. 620,
30 42 U.S.C. § 1396r-8(c)(1)(C)). [Except as otherwise provided in <--
20030H0888B2871 - 26 -
1 this section, the amount of the rebate to the Commonwealth per
2 calendar quarter with respect to each dosage form and strength
3 of single-source drugs and innovator multiple-source drugs shall
4 be as follows:
5 (1) For quarters beginning after September 30, 1992, and
6 ending before January 1, 1997, the product of the total
7 number of units of each dosage form and strength reimbursed
8 by PACE and General Assistance in the quarter and the
9 difference between the average manufacturer price and 85% of
10 that price, after deducting customary prompt payment
11 discounts, for the quarter.
12 (2) For quarters beginning after December 31, 1996, AND <--
13 ENDING BEFORE JANUARY 1, 2003, the product of the total
14 number of units of each dosage form and strength reimbursed
15 by PACE, PACENET and designated pharmaceutical programs in
16 the quarter and the difference between the average
17 manufacturer price and 83% of that price, after deducting
18 customary prompt payment discounts.] <--
19 (3) FOR QUARTERS BEGINNING AFTER DECEMBER 31, 2002, EACH <--
20 MANUFACTURER SHALL REMIT A REBATE TO THE COMMONWEALTH FOR THE
21 TOTAL NUMBER OF UNITS OF EACH DOSAGE FORM AND STRENGTH
22 REIMBURSED BY PACE, PACENET AND DESIGNATED PHARMACEUTICAL
23 PROGRAMS IN THE QUARTER PURSUANT TO THE DETERMINATION
24 ESTABLISHED BY SECTION 1927(C)(1) OF THE SOCIAL SECURITY ACT
25 (49 STAT. 620, 42 U.S.C. § 1396R-8(C)(1)).
26 (b) Rebate for other drugs.-- <--
27 [(1) The amount of the rebate to the Commonwealth for a
28 calendar quarter with respect to covered prescription drugs
29 which are noninnovator multiple-source drugs shall be equal
30 to the product of:
20030H0888B2871 - 27 -
1 (i) the applicable percentage of the average
2 manufacturer price, after deducting customary prompt
3 payment discounts, for each dosage form and strength of
4 such drugs for the quarter; and
5 (ii) the number of units of such form and dosage
6 reimbursed by PACE and General Assistance in the quarter.
7 (2) For the purposes of paragraph (1), the applicable
8 percentage for calendar quarters beginning after September
9 30, 1992, and ending before January 1, 1997, is 11%.] With
10 respect to covered prescription drugs which are noninnovator
11 multiple-source drugs, each manufacturer shall remit a rebate
12 to the Commonwealth pursuant to the determination established
13 by section 1927(c)(1)(C) of the Social Security Act. BY <--
14 SECTION 1927(C)(3) OF THE SOCIAL SECURITY ACT (49 STAT. 620,
15 42 U.S.C. § 1396R-8(C)(3)).
16 * * *
17 (C) REVISED REBATE FOR OTHER DRUGS.--BEGINNING AFTER <--
18 DECEMBER 31, 1996, AND ENDING BEFORE JANUARY 1, 2004, ALL OF THE
19 FOLLOWING SHALL APPLY:
20 (1) THE AMOUNT OF THE REBATE TO THE COMMONWEALTH FOR A
21 CALENDAR QUARTER WITH RESPECT TO COVERED PRESCRIPTION DRUGS
22 WHICH ARE NONINNOVATOR MULTIPLE-SOURCE DRUGS SHALL BE THE
23 GREATER OF THE PRODUCT OF:
24 (I) THE APPLICABLE PERCENTAGE OF THE AVERAGE
25 MANUFACTURER PRICE, AFTER DEDUCTING CUSTOMARY PROMPT
26 PAYMENT DISCOUNTS, FOR EACH DOSAGE FORM AND STRENGTH OF
27 SUCH DRUGS FOR THE QUARTER; AND
28 (II) THE NUMBER OF UNITS OF SUCH FORM AND DOSAGE
29 REIMBURSED BY PACE, PACENET AND DESIGNATED PHARMACEUTICAL
30 PROGRAMS IN THE QUARTER.
20030H0888B2871 - 28 -
1 (2) FOR PURPOSES OF PARAGRAPH (1), THE APPLICABLE
2 PERCENTAGE IS 17%.
3 (C.1) REBATES FOR OTHER DRUGS FOR QUARTERS BEGINNING AFTER
4 DECEMBER 31, 2003.--FOR QUARTERS BEGINNING AFTER DECEMBER 31,
5 2003, ALL OF THE FOLLOWING SHALL APPLY:
6 (1) THE AMOUNT OF THE REBATE TO THE COMMONWEALTH FOR A
7 CALENDAR QUARTER WITH RESPECT TO COVERED PRESCRIPTION DRUGS
8 WHICH ARE NONINNOVATOR MULTIPLE-SOURCE DRUGS SHALL BE EQUAL
9 TO THE PRODUCT OF:
10 (I) THE APPLICABLE PERCENTAGE OF THE AVERAGE
11 MANUFACTURER PRICE, AFTER DEDUCTING CUSTOMARY PROMPT
12 PAYMENT DISCOUNTS, FOR EACH DOSAGE FORM AND STRENGTH OF
13 SUCH DRUGS FOR THE QUARTER; AND
14 (II) THE NUMBER OF UNITS OF SUCH FORM AND DOSAGE
15 REIMBURSED BY PACE, PACENET AND DESIGNATED PHARMACEUTICAL
16 PROGRAMS IN THE QUARTER.
17 (2) FOR PURPOSES OF PARAGRAPH (1), THE APPLICABLE
18 PERCENTAGE IS 14%.
19 Section 9 7 10. The act is amended by adding a chapter to <--
20 read:
21 CHAPTER 8
22 PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE
23 Section 801. Definitions.
24 The following words and phrases when used in this chapter
25 shall have the meanings given to them in this section unless the
26 context clearly indicates otherwise:
27 "Clearinghouse." The Pharmaceutical Assistance Clearinghouse
28 established in section 802.
29 "Department." The Department of Aging of the Commonwealth.
30 "Patient assistance program." A program offered by a
20030H0888B2871 - 29 -
1 pharmaceutical manufacturer under which the manufacturer
2 provides prescription medications at no charge or at a
3 substantially reduced cost. The term does not include the
4 provision of a drug as part of a clinical trial.
5 "VOLUNTARY HEALTH ORGANIZATION." AN ORGANIZATION WHOSE MAIN <--
6 PURPOSE IS TO EDUCATE THE PUBLIC ON THE SYMPTOMS, TREATMENTS AND
7 RESEARCH OF A DISEASE AND THAT MAY PROVIDE SUPPORT FOR PERSONS
8 WHO HAVE THE DISEASE.
9 Section 802. Pharmaceutical Assistance Clearinghouse.
10 (a) Establishment.--Within 120 days of the effective date of
11 this chapter, the department shall establish the Pharmaceutical
12 Assistance Clearinghouse. Each pharmaceutical manufacturer that
13 does business in this Commonwealth and offers a patient
14 assistance program shall inform the department of all of the
15 following:
16 (1) The existence of the patient assistance program.
17 (2) The eligibility requirements for the patient
18 assistance program.
19 (3) The drugs covered by the patient assistance program.
20 (4) Information, such as a telephone number, which may
21 be used to apply for a patient assistance program.
22 (b) Information.--The clearinghouse shall maintain the
23 information submitted by pharmaceutical manufacturers AND ANY <--
24 APPROPRIATE VOLUNTARY HEALTH ORGANIZATION THAT WOULD LIKE TO
25 PARTICIPATE and make it available to the public.
26 (c) Staff.--The department shall ensure that the
27 clearinghouse is staffed at least during normal business hours.
28 The department shall contract for the services of a school of <--
29 pharmacy to staff the clearinghouse.
30 Section 803. Toll-free telephone number.
20030H0888B2871 - 30 -
1 The department shall establish a toll-free telephone number
2 through which members of the public may obtain information from
3 the clearinghouse about available patient assistance programs.
4 Section 804. Assistance available.
5 (a) Direct.--
6 (1) The clearinghouse shall assist without charge an
7 individual in determining whether a patient assistance
8 program is offered for a particular drug and whether the
9 individual may be eligible to obtain the drug through a
10 patient assistance program.
11 (2) The clearinghouse may assist without charge an
12 individual who wishes to apply for a patient assistance
13 program by assisting with the preparation of an application
14 and coordinating communications between the individual's
15 physician, OR CERTIFIED REGISTERED NURSE PRACTITIONER and a <--
16 pharmaceutical manufacturer on behalf of the individual for
17 the purpose of obtaining approval to participate in the
18 patient assistance program.
19 (b) Referrals.--The clearinghouse shall make referrals to AN <--
20 APPROPRIATE VOLUNTARY HEALTH ORGANIZATION OR any publicly funded
21 program for which it deems a patient eligible.
22 Section 805. Reporting.
23 The department shall report annually to the Governor and the
24 General Assembly on the activities of the clearinghouse. The
25 report shall include:
26 (1) The number of individuals who have been assisted by
27 the clearinghouse under section 804(a)(1) and the number of
28 such individuals under section 804(a)(2).
29 (2) The number and benefits of patient assistance
30 programs listed with the clearinghouse.
20030H0888B2871 - 31 -
1 (3) The number of patients referred to publicly funded
2 programs under section 804(b). Programs under this paragraph
3 include, but are not limited to, the Pharmaceutical
4 Assistance Contract for the Elderly Program, medical
5 assistance and programs of the Department of Veterans
6 Affairs.
7 (4) Other information deemed relevant by the department.
8 Section 806. Internet availability of information.
9 The department shall maintain and provide to the public the
10 information under this chapter on its World Wide Web site. The
11 department shall also provide to appropriate organizations the
12 information necessary for the organizations to establish a link
13 to the location of clearinghouse information on the department's
14 World Wide Web site.
15 Section 10 8 11. Section 2102(a) of the act, added November <--
16 21, 1996 (P.L.741, No.134), is amended to read:
17 Section 2102. Annual report to General Assembly.
18 (a) Submission of report.--The department shall submit a
19 report no later than April 1 of each year to the chairman and
20 minority chairman of the Aging and Youth Committee of the
21 Senate, the chairman and minority chairman of the Aging and
22 [Youth] Older Adult Services Committee of the House of
23 Representatives and the Pharmaceutical Assistance Review Board.
24 * * *
25 Section 11 9 12. The act is amended by adding sections A <--
26 SECTION 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
20030H0888B2871 - 32 -
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. utilization purposes.
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 13. FUNDING, TO THE EXTENT AUTHORIZED BY SECTION <--
22 306(B)(VII) OF THE ACT OF JUNE 26, 2001 (P.L.755, NO.77), KNOWN
23 AS THE TOBACCO SETTLEMENT ACT, SHALL CONTINUE TO BE APPROPRIATED
24 FROM THE TOBACCO SETTLEMENT FUND TO THE PHARMACEUTICAL
25 ASSISTANCE CONTRACT FOR THE ELDERLY FUND TO SUPPORT THE PROGRAM
26 EXPANSIONS CONTAINED IN THIS ACT.
27 Section 12 10 14. The Department of Aging may use a PACE or <--
28 PACENET program applicant's most recent ANNUAL income <--
29 information to determine program eligibility until April 1,
30 2004.
20030H0888B2871 - 33 -
1 SECTION 11 15. THE AMENDMENT OF SECTIONS 703(E), 704(C)(1) <--
2 AND 705(A) AND (B) SECTION 704(C)(1) OF THE ACT SHALL APPLY <--
3 RETROACTIVELY TO JANUARY 1, 2003.
4 Section 13 12 16. This act shall take effect as follows: <--
5 (1) The following provisions shall take effect January
6 1, 2004:
7 (i) The amendment or addition of the definitions of
8 "CMS," "HFCA" and "maximum annual income" in section 502
9 of the act.
10 (ii) The amendment of section 519 of the act.
11 (2) THE ADDITION OF SECTION 509(8) OF THE ACT SHALL TAKE <--
12 EFFECT JANUARY 1, 2005.
13 (2) (3) The remainder of this act shall take effect <--
14 immediately.
E14L67VDL/20030H0888B2871 - 34 -