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        PRIOR PRINTER'S NOS. 1044, 1816               PRINTER'S NO. 1836

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

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, ROBERTS, 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 AND FABRIZIO, MARCH 13, 2003

        AS AMENDED, COMMITTEE ON HEALTH AND HUMAN SERVICES, HOUSE OF
           REPRESENTATIVES, MAY 12, 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     pharmaceutical practices and cost control program AND FOR THE  <--
     5     PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE; imposing additional
     6     powers and duties on the Department of Aging, the Department
     7     of Health, the Department of Public Welfare and the Secretary
     8     of Administration; and making repeals.

     9                         TABLE OF CONTENTS
    10  Chapter 1.  Preliminary Provisions
    11  Section 101.  Short title.
    12  Chapter 3.  Pharmaceutical Matters
    13     Subchapter A.  Pharmaceutical Assistance for the Elderly
    14  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.  Program generally.
     9  Section 310.  Generic drugs.
    10  Section 311.  Supply.
    11  Section 312.  Mail order system.
    12  Section 313.  Indication of price.
    13  Section 314.  Reimbursement.
    14  Section 315.  Nonliability.
    15  Section 316.  Income verification.
    16  Section 317.  Contract.
    17  Section 318.  The Pharmaceutical Assistance Contract for the
    18                 Elderly Needs Enhancement Tier.
    19  Section 319.  Board.
    20  Section 320.  Penalties.
    21  Section 321.  Prescription Drug Education Program.
    22  Section 322.  Outreach program.
    23  Section 323.  Accountability.
    24     Subchapter B.  Prudent Pharmaceutical Purchasing
    25  Section 341.  Definitions.
    26  Section 342.  Rebate agreement.
    27  Section 343.  Disposition of funds.
    28     Subchapter C.  Pharmacy Best Practices and Cost Control
    29                 Program
    30  Section 361.  Definitions.
    20030H0888B1836                  - 2 -     

     1  Section 362.  Committee.
     2  Section 363.  Program.
     3     SUBCHAPTER D.  PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE         <--
     4  SECTION 371.  DEFINITIONS.
     5  SECTION 372.  PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE.
     6  SECTION 373.  TOLL-FREE TELEPHONE NUMBER.
     7  SECTION 374.  ASSISTANCE AVAILABLE.
     8  SECTION 375.  REPORTING.
     9  Chapter 51.  Miscellaneous Provisions
    10  Section 5101.  Federal programs.
    11  Section 5102.  Repeals.
    12  Section 5103.  Effective date.
    13     The General Assembly of the Commonwealth of Pennsylvania
    14  hereby enacts as follows:
    15                             CHAPTER 1
    16                       PRELIMINARY PROVISIONS
    17  Section 101.  Short title.
    18     This act shall be known and may be cited as the
    19  Pharmaceutical Reform Act.
    20                             CHAPTER 3
    21                       PHARMACEUTICAL MATTERS
    22                            SUBCHAPTER A
    23             PHARMACEUTICAL ASSISTANCE FOR THE ELDERLY
    24  Section 301.  Legislative findings.
    25     Finding that an increasing number of this Commonwealth's
    26  elderly citizens who are living on fixed incomes are
    27  experiencing difficulties in meeting the costs of life-
    28  sustaining prescription drugs, the General Assembly, in its
    29  responsibilities to provide for the health, welfare and safety
    30  of the residents of this Commonwealth, hereby continues a
    20030H0888B1836                  - 3 -     

     1  limited State pharmaceutical assistance program for the elderly.
     2  Section 302.  Definitions.
     3     The following words and phrases when used in this subchapter
     4  shall have the meanings given to them in this section unless the
     5  context clearly indicates otherwise:
     6     "A-rated generic therapeutically equivalent drug."  A drug
     7  product that the Commissioner of Food and Drugs of the United
     8  States Food and Drug Administration has approved as safe and
     9  effective and has determined to be therapeutically equivalent,
    10  as listed in "The Approved Drug Products with Therapeutic
    11  Equivalence Evaluations" (Food and Drug Administration "Orange
    12  Book"), with a specific "A" code designation only.
    13     "Average wholesale cost."  The cost of a dispensed drug based
    14  upon the price published in a national drug pricing system in
    15  current use by the Department of Aging as the average wholesale
    16  price of a prescription drug in the most common package size.
    17     "Average wholesale price."  Average wholesale cost.
    18     "Board."  The Pharmaceutical Assistance Review Board.
    19     "CMS."  Center for Medicare and Medicaid Services.
    20     "Department."  The Department of Aging of the Commonwealth.
    21     "Eligible claimant."  A resident of this Commonwealth for no
    22  less than 90 days, who is 65 years of age and older, whose
    23  annual income is less than the maximum annual income and who is
    24  not otherwise qualified for public assistance under the act of
    25  June 13, 1967 (P.L.31, No.21), known as the Public Welfare Code.
    26     "FDA."  The United States Food and Drug Administration of the
    27  Public Health Service of the Department of Health and Human
    28  Services.
    29     "Income."  All income from whatever source derived,
    30  including, but not limited to, salaries, wages, bonuses,
    20030H0888B1836                  - 4 -     

     1  commissions, income from self-employment, alimony, support
     2  money, cash public assistance and relief, the gross amount of
     3  any pensions or annuities, including railroad retirement
     4  benefits, all benefits received under the Social Security Act
     5  (49 Stat. 620, 42 U.S.C. § 301 et seq.) except Medicare
     6  benefits, all benefits received under State unemployment
     7  insurance laws and veterans' disability payments, all interest
     8  received from the Federal Government or any state government or
     9  any instrumentality or political subdivision thereof, realized
    10  capital gains, rentals, workmen's compensation and the gross
    11  amount of loss of time insurance benefits, life insurance
    12  benefits and proceeds, except the first $5,000 of the total of
    13  death benefits payments, and gifts of cash or property, other
    14  than transfers by gift between members of a household, in excess
    15  of a total value of $300, but does not include surplus food or
    16  other relief in kind supplied by a government agency or property
    17  tax rebate.
    18     "Mail service program."  A program set forth in section 312
    19  to dispense prescription drugs by postal delivery service
    20  designated and administered by the department and any entity
    21  with which it contracts, upon an enrollee's submission of a
    22  prescription and the applicable copayment.
    23     "Maintenance drug."  A prescription drug prescribed to an
    24  individual for a chronic condition the use of which is medically
    25  necessary for a consecutive period of at least 60 days.
    26     "Maximum annual income."  For PACE eligibility, annual income
    27  which shall not exceed $14,000 in the case of single persons nor
    28  $17,200 in the case of the combined annual income of persons
    29  married to each other. Persons may, in reporting income to the
    30  Department of Aging, round the amount of each source of income
    20030H0888B1836                  - 5 -     

     1  and the income total to the nearest whole dollar, whereby any
     2  amount which is less than 50¢ is eliminated.
     3     "PACE."  The Pharmaceutical Assistance Contract for the
     4  Elderly program provided for in this subchapter.
     5     "PACENET."  The Pharmaceutical Assistance Contract for the
     6  Elderly Needs Enhancement Tier provided for in this subchapter.
     7     "Pharmacy."  A pharmacy licensed by the Commonwealth.
     8     "Prescription drug."  All drugs requiring a prescription in
     9  this Commonwealth, insulin, insulin syringes and insulin
    10  needles. Experimental drugs or drugs prescribed for wrinkle
    11  removal or hair growth are prohibited.
    12     "Private contractor."  A person, partnership or corporate
    13  entity that enters into a contract with the Commonwealth to
    14  provide services under the provisions of this subchapter.
    15     "Program."  The Pharmaceutical Assistance Contract for the
    16  Elderly (PACE) and the Pharmaceutical Assistance Contract for
    17  the Elderly Needs Enhancement Tier (PACENET) as established by
    18  this subchapter, unless otherwise specified.
    19     "Provider."  A pharmacy or dispensing physician enrolled as a
    20  provider in the program.
    21  Section 303.  Determination of eligibility.
    22     The department shall adopt regulations relating to the
    23  determination of eligibility of prospective claimants and
    24  providers, including dispensing physicians, and the
    25  determination and elimination of program abuse. To this end, the
    26  department shall establish a compliance unit staffed
    27  sufficiently to fulfill this responsibility. The department
    28  shall have the power to declare ineligible any claimant or
    29  provider who abuses or misuses the established prescription
    30  plan. The department shall have the power to investigate cases
    20030H0888B1836                  - 6 -     

     1  of suspected provider or recipient fraud.
     2  Section 304.  Physician and pharmacy participation.
     3     Any physician, pharmacist, pharmacy or corporation owned in
     4  whole or in part by a physician or pharmacist enrolled as a
     5  provider in the program or that has prescribed medication for a
     6  claimant in the program who is precluded or excluded for cause
     7  from the Department of Public Welfare's medical assistance
     8  program shall be precluded or excluded from participation in the
     9  program. No physician precluded or excluded from the Department
    10  of Public Welfare's medical assistance program shall have claims
    11  resulting from prescriptions paid for by the program.
    12  Section 305.  Drug utilization review system.
    13     The department shall ensure that a state-of-the-art
    14  therapeutic drug utilization review system is established to
    15  monitor and correct misutilization of drug therapies.
    16  Section 306.  Reduced assistance.
    17     Any eligible claimant whose prescription drug costs are
    18  covered in part by any other plan of assistance or insurance may
    19  be required to receive reduced assistance under the provisions
    20  of this subchapter.
    21  Section 307.  Rebates for expenses prohibited.
    22     A system of rebates or reimbursements to the claimant for
    23  prescription drugs shall be prohibited.
    24  Section 308.  Request for proposal.
    25     (a)  General.--The department shall prepare a request for
    26  proposal for the purpose of providing pharmaceutical assistance
    27  for the elderly within this Commonwealth. Upon the adoption of
    28  the General Fund budget, the Department of Revenue shall be
    29  authorized to transmit the appropriated funds in the State
    30  Lottery Fund to the State Treasurer to be deposited in the
    20030H0888B1836                  - 7 -     

     1  Pharmaceutical Assistance Contract for the Elderly Fund. This
     2  fund shall consist of appropriations and interest and shall be
     3  created by the State Treasurer to fund the operations of the
     4  program by the department and the private contractor. Funds not
     5  expended in the fiscal year in which they were appropriated
     6  shall not lapse and shall be available for use in the next
     7  fiscal year.
     8     (b)  Additional requests.--To provide for the continued
     9  operation of the program, the department shall prepare, as
    10  needed, requests for proposals, in addition to that set forth in
    11  subsection (a), for the purpose of providing pharmaceutical
    12  assistance for the elderly within this Commonwealth. A request
    13  for proposal shall require potential private contractors to
    14  submit a proposal for a period of time and with monetary
    15  limitations as determined by the department. Upon the enactment
    16  of an appropriation from the State Lottery Fund, the Department
    17  of Revenue shall be authorized to transmit the appropriated
    18  amount to the State Treasurer to be deposited in the
    19  Pharmaceutical Assistance Contract for the Elderly Fund. Funds
    20  not expended in the fiscal year in which they were appropriated
    21  shall not lapse and shall be available for use in the next
    22  fiscal year.
    23  Section 309.  Program generally.
    24     (a)  Parameters of program.--The program shall include the
    25  following:
    26         (1)  Participating pharmacies shall be paid within 21
    27     days of the contracting firm receiving the appropriate
    28     substantiation of the transaction. Pharmacies shall be
    29     entitled to interest for payment not made within the 21-day
    30     period at a rate approved by the board.
    20030H0888B1836                  - 8 -     

     1         (2)  Collection of the copayment by pharmacies shall be
     2     mandatory.
     3         (3)  Senior citizens participating in the program are not
     4     required to maintain records of each transaction.
     5         (4)  A system of rebates or reimbursements to eligible
     6     claimants for pharmaceutical expenses shall be prohibited.
     7         (5)  There shall be the following copayments:
     8             (i)  For generic drugs - $5.
     9             (ii)  For preferred drug list drugs - $10.
    10             (iii)  For drugs which are not on the preferred drug
    11         list - $15.
    12         (6)  Payments as follows:
    13             (i)  Except as provided in subparagraph (ii), to
    14         pharmacies on behalf of eligible claimants for costs of
    15         the prescription drug in excess of the copayment as
    16         provided in subsections (b) and (c), plus a dispensing
    17         fee of $3.50 or the dispensing fee established by the
    18         department by regulation, whichever is greater.
    19             (ii)  For A-rated generic therapeutically equivalent
    20         drugs, to pharmacies on behalf of eligible claimants for
    21         the upper limits established under 42 CFR § 447.332
    22         (relating to upper limits for multiple source drugs),
    23         plus a dispensing fee of $4 or the dispensing fee
    24         established by the department by regulations, whichever
    25         is greater.
    26         (7)  In no case shall the Commonwealth or any person
    27     enrolled in the program be charged more than the price of the
    28     drug at the particular pharmacy on the date of the sale.
    29     (b)  Multiple-source drugs.--Except for brand name drugs that
    30  are certified in accordance with subsection (d), the department
    20030H0888B1836                  - 9 -     

     1  payment for multiple-source drugs must not exceed the amount
     2  that would result from the application of the specific limits
     3  established in accordance with subsection (e). If a specific
     4  limit has not been established under subsection (e), then the
     5  rule for "other drugs" set forth in subsection (c) applies.
     6     (c)  Other drugs.--The department payments for brand name
     7  drugs certified in accordance with subsection (d) and drugs
     8  other than multiple-source drugs for which a specific limit has
     9  been established under subsection (e) must not exceed in the
    10  aggregate payment levels that the department has determined by
    11  applying the lower of the:
    12         (1)  Estimated acquisition costs plus reasonable
    13     dispensing fees established by the department.
    14         (2)  Providers' usual and customary charges to the
    15     general public.
    16     (d)  Certification of brand-name drugs.--
    17         (1)  The upper limit for payments for multiple-source
    18     drugs for which a specific limit has been established under
    19     subsection (e) does not apply if a physician certifies in his
    20     or her own handwriting that a specific brand is medically
    21     necessary for a particular recipient.
    22         (2)  The department must decide what certification form
    23     and procedure are used.
    24         (3)  A checkoff box on a form is not acceptable but a
    25     notation like "brand necessary" is allowable.
    26         (4)  The department may allow providers to keep the
    27     certification forms if the forms will be available for
    28     inspection by the department.
    29     (e)  Establishment and issuance of a listing of multiple-
    30  source drugs.--
    20030H0888B1836                 - 10 -     

     1         (1)  The department will use the CMS listings that
     2     identify and set upper limits for multiple-source drugs that
     3     meet the following requirements:
     4             (i)  All of the formulations of the drug approved by
     5         the Food and Drug Administration (FDA) have been
     6         evaluated as therapeutically equivalent in the most
     7         current edition of their publication, Approved Drug
     8         Products with Therapeutic Equivalence Evaluations,
     9         including supplements or in successor publications.
    10             (ii)  At least three suppliers list the drug, which
    11         has been classified by the FDA as category "A" in its
    12         publication, Approved Drug Products with Therapeutic
    13         Equivalence Evaluations, including supplements or in
    14         successor publications, based on all listings contained
    15         in current editions, or updates, of published compendia
    16         of cost information for drugs available for sale
    17         nationally IN THIS COMMONWEALTH.                           <--
    18         (2)  The department publishes the list of multiple-source
    19     drugs for which upper limits have been established and any
    20     revisions to the list in Medicaid program instructions.
    21         (3)  The department will identify the sources used in
    22     compiling these lists.
    23  Section 310.  Generic drugs.
    24     (a)  General.--Notwithstanding any other statute or
    25  regulation, if an A-rated generic therapeutically equivalent
    26  drug is available for dispensing to a claimant, the provider
    27  shall dispense the A-rated generic therapeutically equivalent
    28  drug to the claimant. The department shall not reimburse
    29  providers for brand name products except in the following
    30  circumstances:
    20030H0888B1836                 - 11 -     

     1         (1)  There is no A-rated generic therapeutically
     2     equivalent drug available on the market. This paragraph does
     3     not apply to the lack of availability of an A-rated generic
     4     therapeutically equivalent drug in the providing pharmacy
     5     unless it can be shown to the department that the provider
     6     made reasonable attempts to obtain the A-rated generic
     7     therapeutically equivalent drug or that there was an
     8     unforeseeable demand and depletion of the supply of the A-
     9     rated generic therapeutically equivalent drug. In either
    10     case, the department shall reimburse the provider for 90% of
    11     the average wholesale cost plus a dispensing fee based on the
    12     least expensive A-rated generic therapeutically equivalent
    13     drug for the brand drug dispensed.
    14         (2)  An A-rated generic therapeutically equivalent drug    <--
    15     is deemed by the department, in consultation with a
    16     utilization review committee, to have too narrow a
    17     therapeutic index for safe and effective dispensing in the
    18     community setting. The department shall notify providing
    19     pharmacies of A-rated generic therapeutically equivalent
    20     drugs that are identified pursuant to this paragraph on a
    21     regular basis.
    22         (3) (2)  The Department of Health has determined that a
    23     drug shall not be recognized as an A-rated generic
    24     therapeutically equivalent drug for purpose of substitution
    25     under section 5(b) of the act of November 24, 1976 (P.L.1163,
    26     No.259), referred to as the Generic Equivalent Drug Law.
    27         (4) (3)  At the time of dispensing, the provider has a     <--
    28     prescription on which the brand name drug dispensed is billed
    29     to the program by the provider at a usual and customary
    30     charge which is equal to or less than the least expensive
    20030H0888B1836                 - 12 -     

     1     usual and customary charge of any A-rated generic
     2     therapeutically equivalent drug reasonably available on the
     3     market to the provider.
     4     (b)  Copayment.--If a claimant chooses not to accept the A-
     5  rated generic therapeutically equivalent drug required by
     6  subsection (a), the claimant shall be liable for the copayment
     7  and 70% of the average wholesale cost of the brand name drug.
     8     (c)  Substitution or construction.--The dispensing of an A-
     9  rated generic therapeutically equivalent drug in accordance with
    10  this subchapter shall not be deemed incorrect substitution under
    11  section 6(a) of the Generic Equivalent Drug Law.
    12     (d)  Medical exception.--A medical exception process shall be
    13  established by the department, which shall be published as a
    14  notice in the Pennsylvania Bulletin and distributed to providers
    15  and recipients in the program.
    16  Section 311.  Supply.
    17     (a)  Requirement.--Except as set forth in subsection (b),
    18  prescription benefits for any single prescription shall be
    19  limited to a 30-day supply of the prescription drug or 100
    20  units, whichever is less for acute conditions.
    21     (b)  Exceptions.--
    22         (1)  In the case of diagnosis for acute conditions,
    23     prescription benefits for any single prescription shall be
    24     limited to a 15-day supply.
    25         (2)  Subsection (a) shall not apply to topical ointments
    26     or gels which are not available in containers which meet the
    27     size and supply restrictions set forth in subsection (a).
    28     (c)  Subsection (a) does not apply to contracts under section
    29  312(c).
    30  Section 312.  Mail service program.
    20030H0888B1836                 - 13 -     

     1     (a)  General rule.--The department shall require ENCOURAGE     <--
     2  the use of a mail service program for maintenance drugs for
     3  eligible claimants. Only mail order pharmacy services provided
     4  by pharmacies which are licensed by the Commonwealth and which
     5  have their principal place of business within this Commonwealth
     6  may participate as providers under the program.
     7     (b)  Minimum standards of practice.--The department shall
     8  develop and promulgate specific regulations governing the
     9  practice of mail order pharmacy and other enrolled providers to
    10  include the following minimum standards of practice to ensure
    11  the health, safety and welfare of program participants:
    12         (1)  The appropriate method by which pharmacies verify
    13     the identity of the eligible claimant and the authenticity of
    14     prescriptions received.
    15         (2)  The appropriate method by which pharmacies mail or
    16     deliver prescription drugs ensuring, to the maximum extent
    17     possible, that the intended eligible claimant is the actual
    18     ultimate recipient of any prescription dispensed.
    19         (3)  The appropriate method by which pharmacies
    20     communicate with eligible claimants in emergency situations.
    21     (c)  Ninety-day supply.--The department shall negotiate mail
    22  order contracts to provide a 90-day supply of drugs to eligible
    23  claimants at a single copayment rate equal to a 30-day supply
    24  for each order.
    25     (d)  Requirement.--An EXCEPT AS SET FORTH IN SUBSECTION (E),   <--
    26  AN eligible claimant shall use the mail service program if the
    27  eligible claimant:
    28         (1)  utilizes a maintenance drug;
    29         (2)  has filled a prescription; and
    30         (3)  has refilled the prescription under paragraph (2) at
    20030H0888B1836                 - 14 -     

     1     least once.
     2     (E)  EXCEPTION.--SUBSECTION (D) SHALL NOT APPLY TO AN          <--
     3  ELIGIBLE CLAIMANT WHO SUBMITS TO THE DEPARTMENT, IN A FORM
     4  ACCEPTABLE TO THE DEPARTMENT, A WRITTEN STATEMENT ASSERTING THE
     5  ELIGIBLE CLAIMANT'S RIGHT TO FILL PRESCRIPTIONS AT THE PHARMACY
     6  CHOSEN BY THE ELIGIBLE CLAIMANT.
     7     (e) (F)  Rebates.--A mail order contract must include a        <--
     8  rebate from the prescription drug manufacturer. The rebate must
     9  be at least as much as follows:
    10         (1)  For a brand-name drug, the sum of subparagraphs (i)
    11     and (ii):
    12             (i)  A dispensing fee of at least $6.
    13             (ii)  The difference between:
    14                 (A)  the average wholesale price; and
    15                 (B)  20% of that price.
    16         (2)  For a generic drug, the sum of subparagraphs (i) and
    17     (ii):
    18             (i)  A dispensing fee of at least $6.
    19             (ii)  The difference between:
    20                 (A)  the average wholesale price; and
    21                 (B)  50% of that price.
    22     (f) (G)  Negotiated payments.--The department shall not        <--
    23  discriminate against a pharmacy that agrees to accept negotiated
    24  payment levels with the same terms and conditions and to adhere
    25  to quality standards established by the PACE and PACENET
    26  programs.
    27  Section 313.  Indication of price.
    28     The retail price of the prescription shall be indicated on
    29  the label of the prescription container or furnished by separate
    30  receipt.
    20030H0888B1836                 - 15 -     

     1  Section 314.  Reimbursement.
     2     (A)  INDICATION.--THE DEPARTMENT SHALL INDICATE THIRD-PARTY    <--
     3  COVERAGE FOR EACH ELIGIBLE CLAIMANT.
     4     (B)  RESULT.--For-profit third-party insurers and not-for-     <--
     5  profit prescription plans shall be responsible for any payments
     6  made to a providing pharmacy on behalf of a claimant covered by
     7  such a third party.
     8  Section 315.  Nonliability.
     9     (a)  General.--Any person rendering service as a member of a
    10  utilization review committee for this program shall not be
    11  liable for any civil damages as a result of any acts or
    12  omissions in rendering the service as a member of any such
    13  committee except any acts or omissions intentionally designed to
    14  harm or any grossly negligent acts or omissions which result in
    15  harm to the person receiving such service.
    16     (b)  Department personnel.--Any officer or employee of the
    17  department rendering service as a member of a utilization review
    18  committee for this program shall not be liable for any civil
    19  damages as a result of any acts or omissions in rendering the
    20  service as a member of any such committee or as a result of any
    21  decision or action in connection with the program except any
    22  acts or omissions intentionally designed to harm or any grossly
    23  negligent acts or omissions which result in harm to the person
    24  receiving such service.
    25  Section 316.  Income verification.
    26     (a)  General.--The department shall annually verify the
    27  income of eligible claimants by requiring income documentation
    28  from the claimants. An application for benefits under this
    29  subchapter shall constitute a waiver to the department of all
    30  relevant confidentiality requirements relating to the claimant's
    20030H0888B1836                 - 16 -     

     1  Pennsylvania State income tax information in the possession of
     2  the Department of Revenue. The Department of Revenue shall
     3  provide the department with the necessary income information
     4  shown on the claimant's Pennsylvania State income tax return
     5  solely for income verification purposes.
     6     (b)  Unlawful act.--It shall be unlawful for any officer,
     7  agent or employee of the department to divulge or make known in
     8  any manner whatsoever any information gained through access to
     9  the Department of Revenue information except for official income
    10  verification purposes under this subchapter.
    11     (c)  Penalty.--A person who violates this chapter commits a
    12  misdemeanor and shall, upon conviction, be sentenced to pay a
    13  fine of not more than $1,000 or to imprisonment for not more
    14  than one year, or both, together with the cost of prosecution,
    15  and, if the offender is an officer or employee of the
    16  Commonwealth, he shall be dismissed from office or discharged
    17  from employment.
    18     (d)  Coordination of effort.--To the extent possible, the
    19  department and the Department of Public Welfare shall coordinate
    20  efforts to facilitate the application and enrollment of eligible
    21  older people in the Medicaid Healthy Horizons Program by
    22  processing these applications at senior citizens centers and
    23  other appropriate facilities providing services to the elderly.
    24  Section 317.  Contract.
    25     The department is authorized to enter into a contract
    26  providing for prescription drugs to eligible persons pursuant to
    27  this subchapter. The department shall select a proposal that
    28  includes, but is not limited to, the criteria set forth in this
    29  subchapter.
    30  Section 318.  The Pharmaceutical Assistance Contract for the
    20030H0888B1836                 - 17 -     

     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)  Eligibility.--A claimant with an annual income of not
     7  less than $17,000 and not more than $20,000 in the case of a
     8  single person and of not less than $20,001 and not more than
     9  $23,200 in the case of the combined income of persons married to
    10  each other shall be eligible for enhanced pharmaceutical
    11  assistance under this section. A person may, in reporting income
    12  to the department, round the amount of each source of income and
    13  the income total to the nearest whole dollar, whereby any amount
    14  which is less than 50¢ is eliminated.
    15     (c)  Requirements.--Upon enrollment in PACENET, eligible
    16  claimants in the income ranges set forth in subsection (b) shall
    17  be required to meet a monthly deductible in unreimbursed
    18  prescription drug expenses of $50 $40 per person per month. To    <--
    19  qualify for the deductible set forth in this subsection the
    20  prescription drug must be purchased for the use of the eligible
    21  claimant from a provider as defined in this subchapter. The
    22  department, after consultation with the board, may approve an
    23  adjustment in the deductible on an annual basis.
    24     (d)  Copayments.--The following are the copayments:
    25         (1)  For generic drugs - $6.
    26         (2)  For preferred drug list drugs - $12.
    27         (3)  For drugs which are not on the preferred drug list -
    28     $18.
    29  Section 319.  Board.
    30     (a)  General.--The Pharmaceutical Assistance Review Board is
    20030H0888B1836                 - 18 -     

     1  continued to ensure that the program is providing and continues
     2  to provide the assistance intended in a fiscally responsible
     3  manner without excessively hampering the pharmaceutical PHARMACY  <--
     4  industry.
     5     (b)  Membership.--The board shall be comprised of the
     6  following eight persons:
     7         (1)  The Secretary of Aging, who shall serve as its
     8     chairman.
     9         (2)  The Secretary of Revenue.
    10         (3)  The Secretary of Health.
    11         (4)  Five public members, one appointed by the President
    12     pro tempore of the Senate, one appointed by the Minority
    13     Leader of the Senate, one appointed by the Speaker of the
    14     House of Representatives, one appointed by the Minority
    15     Leader of the House of Representatives and one appointed by
    16     the Governor. Those appointed by the legislative officers
    17     shall include two senior citizens who have not been a part of
    18     the pharmaceutical PHARMACY industry to serve as consumer      <--
    19     advocates, and two representatives of the pharmaceutical       <--
    20     industry, at least one of whom is a ONE REPRESENTATIVE OF THE  <--
    21     PHARMACY INDUSTRY AND ONE practicing Pennsylvania pharmacist.
    22     The individual appointed by the Governor must be a physician.
    23     A public member who misses two consecutive meetings without
    24     good cause acceptable to the chairman shall be replaced by
    25     the appointing authority.
    26     (c)  Annual review.--Using the annual report submitted by the
    27  department pursuant to section 2102 of the act of August 26,
    28  1971 (P.L.351, No.91), known as the State Lottery Law, and other
    29  appropriate data sources, the board shall conduct an annual
    30  review. The board shall develop recommendations concerning any
    20030H0888B1836                 - 19 -     

     1  changes in the level of copayment, deductible or in the level of
     2  fees paid to participating pharmacists. The board shall review
     3  the department's therapeutic drug utilization review program on
     4  an ongoing basis. The board may also recommend other changes in
     5  the structure of the program and direct the department to enter
     6  into discussions with the private contractor concerning
     7  amendments to the contract, or the department may enter into
     8  such discussion if it deems necessary. The copayment or
     9  deductible schedule shall only be adjusted on an annual basis.
    10     (d)  Meetings.--The board shall meet at least two times per
    11  year.
    12  Section 320.  Penalties.
    13     (a)  General.--It shall be unlawful for any person to:
    14         (1)  Submit a false or fraudulent claim or application
    15     under this subchapter, including, but not limited to:
    16             (i)  aiding or abetting another in the submission of
    17         a false or fraudulent claim or application;
    18             (ii)  receiving benefits or reimbursement under a
    19         Federal, state or a private program for prescription
    20         assistance and claiming or receiving duplicative benefits
    21         hereunder;
    22             (iii)  soliciting, receiving, offering or paying any
    23         kickback, bribe or rebate, in cash or in kind, from or to
    24         any person in connection with the furnishing of services
    25         under this subchapter;
    26             (iv)  engaging in a pattern of submitting claims that
    27         repeatedly uses incorrect National Drug Code numbers for
    28         the purpose of obtaining wrongful enhanced reimbursement;
    29         or
    30             (v)  otherwise violating any provision of this
    20030H0888B1836                 - 20 -     

     1         subchapter.
     2         (2)  Charge a copay if the amount of the copay exceeds
     3     the actual cost of the drug purchased.
     4     (b)  Civil penalty.--In addition to any appropriate criminal
     5  penalty for prohibited acts under this subchapter whether or not
     6  that act constitutes a crime under 18 Pa.C.S. (relating to
     7  crimes and offenses), a provider who violates this section may
     8  be liable for a civil penalty, which shall be collected by the
     9  department, in an amount not less than $500 and not more than
    10  $10,000 for each violation of this chapter. Each violation
    11  constitutes a separate offense. If the department collects three
    12  or more civil penalties against the same provider, the provider
    13  shall be ineligible to participate in either PACE or PACENET for
    14  a period of one year. If more than three civil penalties are
    15  collected from any provider, the department may determine that
    16  the provider is permanently ineligible to participate in PACE or
    17  PACENET.
    18     (c)  Suspension.--The license of any provider who has been
    19  found guilty under this subchapter shall be suspended for a
    20  period of one year. The license of any provider who has
    21  committed three or more violations of this subchapter may be
    22  suspended for a period of one year.
    23     (d)  Reparation.--Any provider, recipient or other person who
    24  is found guilty of a crime for violating this subchapter shall
    25  repay three times the value of the material gain received. In
    26  addition to the civil penalty authorized pursuant to subsection
    27  (b), the department may require the provider, recipient or other
    28  person to repay up to three times the value of any material gain
    29  to PACE or PACENET.
    30  Section 321.  Prescription Drug Education Program.
    20030H0888B1836                 - 21 -     

     1     The department, in cooperation with the Department of Health,
     2  shall develop and implement a Statewide prescription drug
     3  education program designed to inform older adults of the dangers
     4  of prescription drug abuse and misuse. The prescription dug
     5  education program shall include, but not be limited to,
     6  information concerning the following:
     7         (1)  The hazards of prescription drug overdose.
     8         (2)  The potential dangers of mixing prescription drugs.
     9         (3)  The danger of retaining unused prescription drugs
    10     after the need to take them no longer exists.
    11         (4)  The necessity to carefully question physicians and
    12     pharmacists concerning the effects of taking prescription
    13     drugs, including the differences between brand-name drugs and  <--
    14     generically equivalent drugs.
    15         (5)  The advisability of maintaining a prescription drug
    16     profile or other record of prescription drug dosage and
    17     frequency of dosage.
    18         (6)  The desirability of advising family members of the
    19     types and proper dosage of prescription drugs which are being
    20     taken.
    21         (7)  The dangers of taking prescription drugs in excess
    22     of prescribed dosages.
    23         (8)  The need to obtain complete, detailed directions
    24     from the physician or pharmacist concerning the time period a
    25     prescription drug should be taken.
    26  Section 322.  Outreach program.
    27     The department, in consultation with appropriate Commonwealth
    28  agencies, shall coordinate the development of an outreach plan
    29  to inform potential contractors, providers and enrollees
    30  regarding eligibility and available benefits of the PACE and
    20030H0888B1836                 - 22 -     

     1  PACENET programs. The plan shall include provisions for reaching
     2  special populations, including nonwhite and non-English-speaking
     3  people; for reaching different geographic areas, including rural
     4  and inner-city areas; and for assuring that special efforts are
     5  coordinated within the overall outreach activities throughout
     6  this Commonwealth.
     7  Section 323.  Accountability.
     8     (a)  Audits.--The PACE and PACENET programs shall be subject
     9  to an audit by an independent entity at least once each fiscal
    10  year. This subsection shall include fiscal audits, provider
    11  claims audits, benefits manager administration audits and
    12  manufacturer's rebate audits.
    13     (b)  Conduct of audit.--The audit shall be conducted in
    14  accordance with generally accepted auditing standards as
    15  prescribed by the American Institute of Certified Public
    16  Accountants, the Governmental Accounting Standards Board, the
    17  United States General Accounting Office or other professionally
    18  recognized entities that prescribe auditing standards.
    19     (c)  Access.--The auditor shall be entitled to have access to
    20  all of the books, accounts, confidential or nonconfidential
    21  reports, vouchers or other records of information in the
    22  department and its contractors including access to all
    23  electronic data. The auditor shall have access to copyrighted or
    24  restricted information obtained by the department and its
    25  contractors under subscription agreements and utilized in the
    26  preparation of economic estimates only for audit purposes.
    27     (d)  Purpose and report.--The audit shall determine the
    28  following:
    29         (1)  Whether the records, books and accounts of the
    30     department and its contractors accurately reflect the
    20030H0888B1836                 - 23 -     

     1     financial and fiscal operations.
     2         (2)  Whether effective accounting control over revenues,
     3     obligations, expenditures, assets and liabilities is
     4     maintained.
     5         (3)  Whether the department and its contractors have
     6     obligated, expended, received and used State funds in
     7     accordance with the purpose for which those funds have been
     8     appropriated.
     9         (4)  Whether the records, books and accounts of the
    10     department and its contractors fairly and accurately reflect
    11     the financial and fiscal operations relating to the
    12     obligation receipt, expenditure and use of State funds.
    13         (5)  Whether the department and its contractors are
    14     managing and utilizing resources, personnel, property,
    15     equipment and space in an economical and efficient manner
    16     including causes of inefficiencies or uneconomical practices,
    17     inadequacies in management information systems, internal and
    18     administrative procedures, organizational structure, use of
    19     resources, allocation of personnel, purchasing policies and
    20     equipment.
    21         (6)  Whether financial, program and statistical reports
    22     of the department and its contractors contain useful data and
    23     are fairly presented.
    24         (7)  Whether the objectives and intended benefits are
    25     being achieved efficiently and effectively.
    26         (8)  Whether the programs are being performed and
    27     administered as authorized and required by law.
    28         (9)  Whether the benefits manager and pharmacy providers
    29     are accurately transmitting and billing PACE and PACENET
    30     prescription claims.
    20030H0888B1836                 - 24 -     

     1     (e)  Report.--The auditor shall submit an annual report of
     2  its findings, conclusions and recommendations to the department
     3  and its contractors and to the Aging and Youth Committee, the
     4  Appropriations Committee and the Public Health and Welfare
     5  Committee of the Senate and the Aging and Older Adult Services
     6  Committee, the Appropriations Committee and the Health and Human
     7  Services Committee of the House of Representatives.
     8     (f)  Response.--The Department of Aging shall respond to the
     9  audit report within 30 days of its release.
    10     (G)  CONTRACT.--THE DEPARTMENT SHALL CONTRACT FOR THE AUDIT    <--
    11  AS FOLLOWS:
    12         (1)  THE AUDITOR SHALL EARN A BASIC FEE NOT TO EXCEED
    13     $200,000. THIS FEE SHALL BE CREDITED TO THE DEPARTMENT IF THE
    14     AUDITOR IS COMPENSATED UNDER PARAGRAPH (2) IN THE AMOUNT OF
    15     AT LEAST $600,000.
    16         (2)  THE AUDITOR SHALL EARN 30% OF THE FUNDS COLLECTED BY
    17     THE DEPARTMENT AS A RESULT OF THE AUDIT.
    18                            SUBCHAPTER B
    19                 PRUDENT PHARMACEUTICAL PURCHASING
    20  Section 341.  Definitions.
    21     The following words and phrases when used in this subchapter
    22  shall have the meanings given to them in this section unless the
    23  context clearly indicates otherwise:
    24     "Covered prescription drug."  A legend drug, insulin, an
    25  insulin syringe or an insulin needle eligible for payment by the
    26  Commonwealth under PACE, PACENET or designated pharmaceutical
    27  programs.
    28     "Designated pharmaceutical programs."  The general assistance
    29  program and the Special Pharmaceutical Benefit Program in the
    30  Department of Public Welfare and the End Stage Renal Dialysis
    20030H0888B1836                 - 25 -     

     1  Program in the Department of Health.
     2     "PACE."  The program under Subchapter A.
     3     "PACENET."  The program established under section 318.
     4  Section 342.  Rebate agreement.
     5     PACE, PACENET and designated pharmaceutical programs shall
     6  reimburse for any covered prescription drug with a rebate
     7  agreement drafted on the same basis as provided in section 1927
     8  of Title XIX of the Social Security Act (49 Stat. 620, 42 U.S.C.
     9  § 1396 r-8).
    10  Section 343.  Disposition of funds.
    11     (a)  PACE and PACENET.--Money received under this subchapter
    12  in connection with PACE and PACENET shall be deposited in the
    13  Pharmaceutical Assistance Contract for the Elderly Fund.
    14     (b)  Pharmaceutical programs.--Money received under this
    15  subchapter in connection with designated pharmaceutical programs
    16  shall be treated as a refund of expenditures to the
    17  appropriation which originally provided the funding for the
    18  pharmaceutical purchase.
    19                            SUBCHAPTER C
    20          PHARMACY BEST PRACTICES AND COST CONTROL PROGRAM
    21  Section 361.  Definitions.
    22     The following words and phrases when used in this subchapter
    23  shall have the meanings given to them in this section unless the
    24  context clearly indicates otherwise:
    25     "Committee."  The Pharmacy Best Practices and Cost Control
    26  Advisory Committee established in section 362.
    27     "Department."  The Department of Aging of the Commonwealth.
    28     "Program."  The Pharmacy Best Practices and Cost Control
    29  Program established in section 363.
    30     "Secretary."  The Secretary of Aging of the Commonwealth.
    20030H0888B1836                 - 26 -     

     1  § 362.  Advisory committee.
     2     (a)  Establishment.--The Pharmacy Best Practices and Cost
     3  Control Advisory Committee is established in the department.
     4     (b)  Members.--The committee is comprised of the following:
     5         (1)  The secretary or a designee, who shall serve as
     6     chairperson.
     7         (2)  Four members appointed by the Governor. Members
     8     under this paragraph must possess expertise in medicine or
     9     pharmacy.
    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.
    20030H0888B1836                 - 27 -     

     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  Section 363.  Program.
     6     (a)  Establishment.--The secretary shall establish a Pharmacy
     7  Best Practices and Cost Control Program for PACE and PACENET
     8  enrollees designed to reduce the cost of providing prescription
     9  drugs, while maintaining high quality in prescription drug
    10  therapies. The program shall be implemented consistent with
    11  section 1927 of the Social Security Act (49 Stat. 620, 42 U.S.C.
    12  § 1396r-8). The program shall include all of the following:
    13         (1)  A preferred list of covered prescription drugs which
    14     identifies preferred choices within selected therapeutic
    15     classes for particular diseases and conditions, including
    16     generic alternatives. Therapeutic classes and drugs to be
    17     preferred in the classes shall be selected by the department
    18     upon recommendations by the committee.
    19         (2)  Utilization review procedures, including a prior
    20     authorization review process which meets the requirements of
    21     section 1927(d)(5) of the Social Security Act (42 U.S.C. §
    22     1396r-8(d)(5)).
    23         (3)  A supplemental rebate program or any other strategy
    24     designed to negotiate with pharmaceutical manufacturers to
    25     lower the cost of prescription drugs for the department's
    26     Medicaid program.
    27         (4)  Education programs, including a counterdetailing
    28     program, designed to provide information and education on the
    29     therapeutic and cost-effective utilization of prescription
    30     drugs to physicians, pharmacists and other health care
    20030H0888B1836                 - 28 -     

     1     professionals authorized to prescribe and dispense
     2     prescription drugs.
     3         (5)  Any other cost containment activity adopted by the
     4     department which is designed to reduce the cost of providing
     5     prescription drugs while maintaining high quality in
     6     prescription drug therapies.
     7     (b)  Pooling.--The secretary shall evaluate the benefits of
     8  participating, but is not required to participate, in joint
     9  prescription drug purchasing agreements or pooling arrangements
    10  with other states. Such actions shall include:
    11         (1)  The execution of any lawful joint purchasing or
    12     pooling agreements with other participating states which the
    13     secretary determines will lower the Medicaid cost of
    14     prescription drugs while maintaining high quality in
    15     prescription drug therapies.
    16         (2)  Renegotiation and amendment of existing contracts to
    17     which the department is a party if renegotiation and
    18     amendment will be of economic benefit to the department.
    19     (c)  Reports.--The secretary shall report quarterly to the
    20  committee on the department's progress in securing participation
    21  in joint purchasing or pooling agreements.
    22     (d)  Authorized coverage.--The program shall authorize
    23  pharmacy benefit coverage when a patient's health care provider
    24  prescribes a prescription drug not on the preferred drug list or
    25  a prescription drug which is not the list's preferred choice
    26  under the same terms as coverage for preferred choice drugs if
    27  any of the following apply:
    28         (1)  The preferred choice has not been effective or, with
    29     reasonable certainty, is not expected to be effective in
    30     treating the patient's condition.
    20030H0888B1836                 - 29 -     

     1         (2)  The preferred choice causes or is reasonably
     2     expected to cause adverse or harmful reactions in the
     3     patient.
     4         (3)  Other clinical criteria recommended by the committee
     5     and approved by the department is complied with.
     6         (4)  If the prescriber does not wish substitution to take
     7     place, the prescriber shall write "brand necessary" or "no
     8     substitution" in the prescriber's own handwriting on the
     9     prescription blank, together with a written statement that
    10     the generic or therapeutic equivalent has not been effective,
    11     or with reasonable certainty is not expected to be effective,
    12     in treating the patient's medical condition or causes or is
    13     reasonably expected to cause adverse or harmful reactions in
    14     the patient. In the case of an unwritten prescription, there
    15     shall be no substitution if the prescriber expressly
    16     indicates to the pharmacist that the brand name drug is
    17     necessary and substitution is not allowed because the generic
    18     or therapeutic equivalent has not been effective, or with
    19     reasonable certainty is not expected to be effective, in
    20     treating the patient's medical condition or causes or is
    21     reasonably expected to cause adverse or harmful reactions in
    22     the patient.
    23     (e)  Exclusions.--The department, with recommendations from
    24  the committee, shall determine diseases and therapeutic classes
    25  relating to treatment for diseases excluded from the program as
    26  to Medicaid enrollees already taking specified drugs at the time
    27  the program is implemented.
    28     (f)  Response.--The program's PRESCRIBER-INDICATED prior       <--
    29  authorization process shall ensure that there will be a response
    30  to a request for prior authorization by telephone or other
    20030H0888B1836                 - 30 -     

     1  telecommunication device within 24 hours after receipt of the
     2  request for prior authorization and that a 72-hour supply of the
     3  drug prescribed will be provided in an emergency or when the
     4  program does not provide a response within 24 hours. The prior
     5  authorization process shall be designed to minimize
     6  administrative burdens on prescribers, pharmacists and
     7  consumers.
     8     (g)  Procedure.--The program shall establish procedures for
     9  the timely review of prescription drugs newly approved by the
    10  Food and Drug Administration, including procedures for the
    11  review of newly approved prescription drugs in emergency
    12  circumstances.
    13     (h)  Reports.--The department shall submit annual reports on
    14  the programs under subsection (a) and (b) to the Aging and Youth
    15  Committee, the Appropriations Committee and the Public Health
    16  and Welfare Committee of the Senate and the Aging and Older
    17  Adult Services Committee, the Appropriations Committee and the
    18  Health and Human Services Committee of the House of
    19  Representatives. The reports shall include classes of drugs,
    20  exceptions, cost effectiveness, movement of market share and
    21  increased utilization of generic drugs.
    22                            SUBCHAPTER D                            <--
    23              PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE
    24  SECTION 371.  DEFINITIONS.
    25     THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS SUBCHAPTER
    26  SHALL HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE
    27  CONTEXT CLEARLY INDICATES OTHERWISE:
    28     "CLEARINGHOUSE."  THE PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE
    29  ESTABLISHED IN SECTION 372.
    30     "DEPARTMENT."  THE DEPARTMENT OF AGING OF THE COMMONWEALTH.
    20030H0888B1836                 - 31 -     

     1     "PATIENT ASSISTANCE PROGRAM."  A PROGRAM OFFERED BY A
     2  PHARMACEUTICAL MANUFACTURER UNDER WHICH THE MANUFACTURER
     3  PROVIDES PRESCRIPTION MEDICATIONS AT NO CHARGE OR AT A
     4  SUBSTANTIALLY REDUCED COST. THE TERM DOES NOT INCLUDE THE
     5  PROVISION OF A DRUG AS PART OF A CLINICAL TRIAL.
     6  SECTION 372.  PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE.
     7     (A)  ESTABLISHMENT.--WITHIN 120 DAYS OF THE EFFECTIVE DATE OF
     8  THIS SUBCHAPTER, THE DEPARTMENT SHALL ESTABLISH THE
     9  PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE. EACH PHARMACEUTICAL
    10  MANUFACTURER THAT DOES BUSINESS IN THIS COMMONWEALTH AND OFFERS
    11  A PATIENT ASSISTANCE PROGRAM SHALL INFORM THE DEPARTMENT OF ALL
    12  OF THE FOLLOWING:
    13         (1)  THE EXISTENCE OF THE PATIENT ASSISTANCE PROGRAM.
    14         (2)  THE ELIGIBILITY REQUIREMENTS FOR THE PATIENT
    15     ASSISTANCE PROGRAM.
    16         (3)  THE DRUGS COVERED BY THE PATIENT ASSISTANCE PROGRAM.
    17         (4)  INFORMATION, SUCH AS A TELEPHONE NUMBER, WHICH MAY
    18     BE USED TO APPLY FOR THE PATIENT ASSISTANCE PROGRAM.
    19     (B)  INFORMATION.--THE CLEARINGHOUSE SHALL MAINTAIN THE
    20  INFORMATION SUBMITTED BY PHARMACEUTICAL MANUFACTURERS AND MAKE
    21  IT AVAILABLE TO THE PUBLIC.
    22     (C)  STAFF.--THE DEPARTMENT SHALL ENSURE THAT THE
    23  CLEARINGHOUSE IS STAFFED AT LEAST DURING NORMAL BUSINESS HOURS.
    24  THE DEPARTMENT SHALL CONTRACT FOR THE SERVICES OF A SCHOOL OF
    25  PHARMACY TO STAFF THE CLEARINGHOUSE.
    26  SECTION 373.  TOLL-FREE TELEPHONE NUMBER.
    27     THE DEPARTMENT SHALL ESTABLISH A TOLL-FREE TELEPHONE NUMBER
    28  THROUGH WHICH THE MEMBERS OF THE PUBLIC MAY OBTAIN INFORMATION
    29  FROM THE CLEARINGHOUSE ABOUT AVAILABLE PATIENT ASSISTANCE
    30  PROGRAMS.
    20030H0888B1836                 - 32 -     

     1  SECTION 374.  ASSISTANCE AVAILABLE.
     2     (A)  DIRECT.--
     3         (1)  THE CLEARINGHOUSE SHALL ASSIST ANY INDIVIDUAL IN
     4     DETERMINING WHETHER A PATIENT ASSISTANCE PROGRAM IS OFFERED
     5     FOR A PARTICULAR DRUG AND WHETHER THE INDIVIDUAL MAY BE
     6     ELIGIBLE TO OBTAIN THE DRUG THROUGH A PATIENT ASSISTANCE
     7     PROGRAM.
     8         (2)  THE CLEARINGHOUSE MAY ASSIST AN INDIVIDUAL WHO
     9     WISHES TO APPLY FOR A PATIENT ASSISTANCE PROGRAM BY ASSISTING
    10     WITH THE PREPARATION OF AN APPLICATION AND COORDINATING
    11     COMMUNICATIONS BETWEEN THE INDIVIDUAL'S PHYSICIAN AND A
    12     PHARMACEUTICAL MANUFACTURER ON BEHALF OF THE INDIVIDUAL FOR
    13     THE PURPOSE OF OBTAINING APPROVAL TO PARTICIPATE IN THE
    14     PATIENT ASSISTANCE PROGRAM.
    15     (B)  REFERRALS.--THE CLEARINGHOUSE SHALL MAKE REFERRALS TO
    16  ANY PUBLICLY FUNDED PROGRAM FOR WHICH IT DEEMS A PATIENT
    17  ELIGIBLE.
    18  SECTION 375.  REPORTING.
    19     THE DEPARTMENT SHALL REPORT ANNUALLY TO THE GOVERNOR AND THE
    20  GENERAL ASSEMBLY ON THE ACTIVITIES OF THE CLEARINGHOUSE. THE
    21  REPORT SHALL INCLUDE:
    22         (1)  THE NUMBER OF INDIVIDUALS WHO HAVE BEEN ASSISTED BY
    23     THE CLEARINGHOUSE.
    24         (2)  THE NUMBER AND BENEFITS OF PATIENT ASSISTANCE
    25     PROGRAMS LISTED WITH THE CLEARINGHOUSE.
    26         (3)  THE NUMBER OF PATIENTS REFERRED TO PUBLICLY FUNDED
    27     PROGRAMS UNDER SECTION 374(B). PROGRAMS UNDER THIS PARAGRAPH
    28     INCLUDE THE PHARMACEUTICAL ASSISTANCE CONTRACT FOR THE
    29     ELDERLY PROGRAM, MEDICAL ASSISTANCE AND PROGRAMS OF THE
    30     DEPARTMENT OF VETERANS AFFAIRS.
    20030H0888B1836                 - 33 -     

     1         (4)  OTHER INFORMATION DEEMED RELEVANT BY THE DEPARTMENT.
     2                             CHAPTER 51
     3                      MISCELLANEOUS PROVISIONS
     4  Section 5101.  Federal programs.
     5     If the Federal Government enacts programs similar to PACE or
     6  PACENET, the State programs shall be construed to only
     7  supplement the Federal programs and all persons qualified for
     8  coverage under the Federal program shall utilize that Federal
     9  program before utilizing any State program.
    10  Section 5102.  Repeals.
    11     (a)  Specific.--Chapters 5 and 7 of the act of August 26,
    12  1971 (P.L.351, No.91), known as the State Lottery Law, are
    13  repealed.
    14     (b)  General.--All other acts and parts of acts are repealed
    15  insofar as they are inconsistent with this act.
    16  Section 5103.  Effective date.
    17     This act shall take effect immediately.









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