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                                                      PRINTER'S NO. 3163

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

No. 2263 Session of 2005


        INTRODUCED BY McILHATTAN, HESS, THOMAS, GANNON, PYLE,
           McNAUGHTON, CAPPELLI, ALLEN, ARGALL, ARMSTRONG, BAKER,
           BALDWIN, BARRAR, BASTIAN, BEBKO-JONES, BELFANTI, BEYER,
           BIRMELIN, BISHOP, BLAUM, BOYD, CALTAGIRONE, CASORIO, CAUSER,
           CAWLEY, CIVERA, CLYMER, COHEN, CREIGHTON, CRUZ, CURRY, DALLY,
           DeLUCA, DENLINGER, DeWEESE, DIVEN, ELLIS, D. EVANS, FABRIZIO,
           FAIRCHILD, FEESE, FICHTER, FLEAGLE, FRANKEL, GABIG, GEIST,
           GEORGE, GINGRICH, GOOD, GOODMAN, HABAY, HALUSKA, HARHART,
           HARRIS, HASAY, HENNESSEY, HERMAN, HERSHEY, HICKERNELL,
           HUTCHINSON, JAMES, KAUFFMAN, M. KELLER, KENNEY, KILLION, LEH,
           MACKERETH, MAHER, MAITLAND, MAJOR, MANN, MARKOSEK, MANDERINO,
           MARSICO, McGILL, McILHINNEY, METCALFE, MILLARD, R. MILLER,
           S. MILLER, MUNDY, MUSTIO, NAILOR, OLIVER, O'NEILL, PALLONE,
           PAYNE, PERZEL, PETRARCA, PETRI, PETRONE, PHILLIPS, PICKETT,
           PISTELLA, QUIGLEY, RAPP, READSHAW, REED, REICHLEY, ROHRER,
           RUBLEY, SAINATO, SATHER, SAYLOR, SCAVELLO, SCHRODER, SEMMEL,
           SIPTROTH, S. H. SMITH, SONNEY, STABACK, STAIRS, STEIL, STERN,
           R. STEVENSON, T. STEVENSON, SURRA, TANGRETTI, E. Z. TAYLOR,
           J. TAYLOR, TIGUE, TRUE, WALKO, WATSON, WILT, WOJNAROSKI,
           WRIGHT, YEWCIC, YOUNGBLOOD, McGEEHAN, LEDERER, DiGIROLAMO AND
           GODSHALL, NOVEMBER 22, 2005

        REFERRED TO COMMITTEE ON AGING AND OLDER ADULT SERVICES,
           NOVEMBER 22, 2005

                                     AN ACT

     1  Establishing One Pennsylvania, a program to consolidate and
     2     unify procedures and requirements for the administration of
     3     all Commonwealth-funded, Commonwealth-administered and
     4     Commonwealth-supported drug programs and for reimbursement
     5     for pharmacy services.

     6     The General Assembly of the Commonwealth of Pennsylvania
     7  hereby enacts as follows:
     8  Section 1.  Short title.
     9     This act shall be known and may be cited as the One


     1  Pennsylvania Act.
     2  Section 2.  Definitions.
     3     The following words and phrases when used in this act shall
     4  have the meanings given to them in this section unless the
     5  context clearly indicates otherwise:
     6     "Adjudication."
     7         (1)  Except as provided in paragraph (2), an action taken
     8     by the Department of Aging, the Secretary of Aging or a
     9     prescription drug plan pursuant to this act that constitutes
    10     an adjudication as defined by 2 Pa.C.S. § 101 (relating to
    11     definitions), including any of the following:
    12             (i)  A decision to allow a pharmacy to participate in
    13         a prescription drug plan or to suspend, restrict or
    14         revoke participation by a pharmacy in a prescription drug
    15         plan.
    16             (ii)  A decision by the department to include or
    17         exclude a medication from the formulary.
    18             (iii)  The establishment of pharmacy reimbursement
    19         rates and formulas.
    20             (iv)  A decision to grant or deny prior authorization
    21         for the dispensing of prescription drugs or to approve or
    22         disapprove the dispensing of drugs not included on the
    23         formulary.
    24             (v)  An action taken by the program based upon audits
    25         of claims submitted for reimbursement by pharmacies.
    26         (2)  An action taken by the program with respect to
    27     determining recipient eligibility shall not be deemed an
    28     adjudication subject to this act.
    29     "Alerts."  Electronic communications between the Department
    30  of Aging or the pharmacy benefits consolidation program and
    20050H2263B3163                  - 2 -     

     1  pharmacies providing information pertaining to the
     2  implementation of this act, including any of the following:
     3         (1)  Information regarding formularies.
     4         (2)  Drug utilization review.
     5         (3)  Prior authorization.
     6         (4)  Disease management programs.
     7         (5)  Claims submission and adjudication procedures.
     8         (6)  Audits.
     9         (7)  Pharmacy and patient education.
    10     "Best price."  As defined under section 1927(c) of the Social
    11  Security Act (49 Stat. 620, 42 U.S.C. § 1396r-8(c)).
    12     "Department."  The Department of Aging of the Commonwealth.
    13     "Medical assistance program."  The program established
    14  pursuant to Subarticle (f) of Article IV of the act of June 13,
    15  1967 (P.L.31, No.21), known as the Public Welfare Code.
    16     "Medicare recipient."  An individual residing in this
    17  Commonwealth who receives benefits under Part A of Subchapter
    18  XVIII of Chapter 7 of the Social Security Act (49 Stat. 620, 42
    19  U.S.C. § 301 et seq.) or who is enrolled under Part B, C or D of
    20  Subchapter XVIII.
    21     "Pharmaceutical manufacturer."  A manufacturer as defined by
    22  section 1927(k)(5) of the Social Security Act (49 Stat. 620, 42
    23  U.S.C. § 1396r-8(k)(5)).
    24     "Pharmacy."  A pharmacy licensed pursuant to the act of
    25  September 27, 1961 (P.L.1700, No.699), known as the Pharmacy
    26  Act.
    27     "Pharmacy Act."  The act of September 27, 1961 (P.L.1700,
    28  No.699), known as the Pharmacy Act.
    29     "Pharmacy services."  The provision of health care services
    30  defined as the practice of pharmacy by the act of September 27,
    20050H2263B3163                  - 3 -     

     1  1961 (P.L.1700, No.699), known as the Pharmacy Act.
     2     "Prescription drug."  A covered outpatient drug as defined by
     3  section 1927(k)(2) of the Social Security Act (49 Stat. 620, 42
     4  U.S.C. § 1396r-8(k)(2)).
     5     "Prescription drug plan."  A program that pays for
     6  prescription drugs dispensed to individuals enrolled in the
     7  program that is supported directly or indirectly, in whole or in
     8  part, by public funds, including all of the following:
     9         (1)  The medical assistance program, the Special
    10     Pharmaceutical Benefit Program in the Department of Public
    11     Welfare and the End Stage Renal Program in the Department of
    12     Health.
    13         (2)  The Pharmaceutical Assistance Contract for the
    14     Elderly (PACE) and any other pharmacy program administered by
    15     the Commonwealth that is recognized by the Centers for
    16     Medicare and Medicaid as a State pharmaceutical assistance
    17     program.
    18         (3)  Programs paying for prescription drugs dispensed to
    19     public employees, including programs established by the
    20     Public School Employees' Retirement System, the State
    21     Employees' Retirement System and the State Employees' Benefit
    22     Trust Fund.
    23         (4)  A program that utilizes funds of this Commonwealth,
    24     including the State Lottery Fund, to provide assistance in
    25     obtaining prescription drugs to Medicare recipients.
    26         (5)  Programs where the Commonwealth purchases or
    27     reimburses affiliates or designees for a pharmacy benefit.
    28     The programs shall include the Children's Health Insurance
    29     Program, Workers' Compensation Program and any program
    30     administered by the Department of Corrections.
    20050H2263B3163                  - 4 -     

     1     "Program."  The pharmacy benefits consolidation program
     2  established pursuant to section 3.
     3     "Public School Employees' Retirement System."  The retirement
     4  system established by 24 Pa.C.S. Part IV (relating to retirement
     5  for school employees).
     6     "Public Welfare Code."  The act of June 13, 1967 (P.L.31,
     7  No.21), known as the Public Welfare Code.
     8     "Secretary."  The Secretary of Aging of the Commonwealth.
     9     "Social Security Act."  The Social Security Act (49 Stat.
    10  620, 42 U.S.C. § 301 et seq.). A reference to the Social
    11  Security Act shall include regulations implementing the Social
    12  Security Act adopted by the United States Department of Health
    13  and Human Services or the Centers for Medicare and Medicaid
    14  Services.
    15     "State agency."  Any of the following entities that purchases
    16  or provides coverage for prescription medications:
    17         (1)  An agency under the jurisdiction of the Governor.
    18         (2)  An independent agency.
    19         (3)  The General Assembly.
    20         (4)  The unified judicial system.
    21     "State Employees' Benefit Trust Fund."  The trust fund
    22  established to purchase health insurance coverage, including
    23  coverage for prescription medications, for State employees.
    24     "State Employees' Retirement System."  The retirement system
    25  established under 71 Pa.C.S. Part XXV (relating to retirement
    26  for State employees and officers).
    27  Section 3.  One Pennsylvania.
    28     (a)  Establishment.--The department shall establish a
    29  pharmacy benefits consolidation program to be known as One
    30  Pennsylvania. The program shall administer all Commonwealth
    20050H2263B3163                  - 5 -     

     1  prescription drug plans through an integrated system of plan
     2  administration using uniform standards and requirements for the
     3  reimbursement of pharmacies as provided by this act. To the
     4  extent consolidation is prohibited by Federal law or
     5  regulations, the department may exclude particular prescription
     6  drug plans from consolidated administration if the prescription
     7  drug plan will be subject to the uniform standards and
     8  requirements of this act, including requirements for the
     9  reimbursement of pharmacies.
    10     (b)  Requirements.--The department shall do all of the
    11  following:
    12         (1)  Manage and implement a uniform formulary for the
    13     program under this act. A formulary shall include all
    14     prescription drugs for which a manufacturer has entered into
    15     a rebate agreement pursuant to section 5 and the requirements
    16     and restrictions, except for prior authorization, provided by
    17     section 1927(d) of the Social Security Act. The list of drugs
    18     included in the formulary shall be publicly available, posted
    19     electronically on the Internet website of the department and
    20     communicated to pharmacies through alerts.
    21         (2)  Ensure that any program of prior authorization
    22     provides for all of the following exceptions:
    23             (i)  No prior authorization shall be required where
    24         the pharmacist confirms that a prescription for the drug
    25         has been filled for the recipient within the 30 to 90
    26         days immediately preceding presentation of the
    27         prescription for dispensing.
    28             (ii)  No prior authorization shall be required where
    29         the prescriber has indicated "MEDICALLY NECESSARY" on the
    30         prescription.
    20050H2263B3163                  - 6 -     

     1         (3)  Ensure that any pharmacy licensed in this
     2     Commonwealth is eligible to provide pharmacy services
     3     according to any regulations adopted by the department
     4     pursuant to this act.
     5         (4)  (i)  Except as provided in subparagraph (ii), make
     6         provisions for generic substitutions in accordance with
     7         the act of November 24, 1976 (P.L.1163, No.259), referred
     8         to as the Generic Equivalent Drug Law.
     9             (ii)  Notwithstanding the provisions of the Generic
    10         Equivalent Drug Law and the act of August 26, 1971
    11         (P.L.351, No.91), known as the State Lottery Law, generic
    12         substitutions shall only be dispensed when it is less
    13         expensive for the program.
    14         (5)  Provide for a program of prospective drug
    15     utilization review consistent with section 1927(g)(2) of the
    16     Social Security Act.
    17         (6)  Provide for prior authorization consistent with the
    18     requirements of section 1927(d)(5) of the Social Security Act
    19     and in accordance with regulations of the department.
    20         (7)  Provide for a program of retrospective drug
    21     utilization review and education consistent with section
    22     1927(g)(2) of the Social Security Act and in accordance with
    23     regulations of the department to ensure that prescriptions
    24     are appropriate, medically necessary and not likely to result
    25     in adverse medical results and to educate providers and
    26     recipients of pharmacy services through the pharmacy
    27     consolidated benefits program and to correct and report
    28     misutilization and abuse by licensed prescribers and
    29     recipients and provide for fraud and abuse audits,
    30     coordinating its activities with the secretary to support
    20050H2263B3163                  - 7 -     

     1     compliance with applicable laws and regulations. Pharmacies
     2     shall not be denied payments for medications dispensed based
     3     upon the results of retrospective drug utilization review or
     4     audits, where the medication was dispensed in good faith by
     5     the pharmacy without prior knowledge that the prescription of
     6     a medication was not appropriate or necessary, was likely to
     7     cause adverse medical results or constituted a fraudulent or
     8     abusive practice by the prescriber.
     9         (8)  Establish a program of medication therapy management
    10     consistent with section 1860D-4(c)(2) of the Social Security
    11     Act.
    12         (9)  Provide educational materials for program recipients
    13     of pharmacy services on disease and care management.
    14         (10)  In accordance with section 1927(a) through (d) of
    15     the Social Security Act, bill, recoup and relay to the
    16     medical assistance program manufacturers' drug rebates and
    17     excessive consumer price inflation discounts and resolve
    18     disputes. Upon the establishment of the program, all medical
    19     assistance recipients shall be enrolled in prescription drug
    20     programs for which rebates and discounts are collected
    21     pursuant to section 1927(a) through (d) of the Social
    22     Security Act.
    23         (11)  Adjudicate claims through an electronic claims
    24     management system consistent with section 1927(h) of the
    25     Social Security Act and which allows for an emergency supply
    26     of prescribed medication in the event of equipment failures.
    27         (12)  Create a uniform audit and recoupment system for
    28     all of the following:
    29             (i)  Providers and recipients.
    30             (ii)  Third-party medical resources.
    20050H2263B3163                  - 8 -     

     1         (13)  Provide for the reimbursement of all pharmacies
     2     participating in prescription drug programs on a fee-for-
     3     service basis.
     4         (14)  Allow pharmacists certified in medication therapy
     5     management  by a national accrediting body or by any other
     6     certification process approved by the State Board of Pharmacy
     7     to provide medication therapy management.
     8     (c)  Considerations.--In preparing and managing the uniform
     9  formulary, the department shall enter into agreements with drug
    10  manufacturers to collect and remit to the program discounts,
    11  rebates or other concessions offered by manufacturers.
    12     (d)  Biennial study.--Within 12 months of the effective date
    13  of this section and biennially thereafter, the department shall
    14  conduct a study considering the comprehensive cost of providing
    15  pharmacy services, including any unique costs associated with
    16  participating in each prescription drug plan, including the
    17  providing of medication therapy management, prospective and
    18  retrospective utilization review, managing prior authorization
    19  requirements and implementing drug therapy protocols pursuant to
    20  section 9.1 of the Pharmacy Act, to determine whether pharmacy
    21  reimbursement under this chapter should be adjusted. The study
    22  shall establish, for an efficiently and economically operated
    23  independent pharmacy, a reasonable profit to provide a return on
    24  investment based upon a nationwide review of pharmacy economics,
    25  and based upon the results of the study the department shall
    26  establish payment rates for prescription drug plans pursuant to
    27  section 4 adequate to maintain the rate of return. The full
    28  results of the study and the data collected and evaluated,
    29  excluding any information that discloses the identity of any
    30  particular pharmacy, shall be made publicly available and shall
    20050H2263B3163                  - 9 -     

     1  be reported to the General Assembly.
     2     (e)  Advisory committee.--
     3         (1)  An advisory committee to the department shall be
     4     established consisting of the following members:
     5             (i)  Three members appointed by the Governor.
     6             (ii)  Two members appointed by each of the following:
     7                 (A)  The President pro tempore of the Senate.
     8                 (B)  The Minority Leader of the Senate.
     9                 (C)  The Speaker of the House of Representatives.
    10                 (D)  The Minority Leader of the House of
    11             Representatives.
    12         (2) Each legislative appointing authority shall appoint
    13     one member pursuant to paragraph (1)(ii) involved in the
    14     ownership or operation of independent pharmacies and one
    15     member involved in the ownership or operation of chain
    16     pharmacies.
    17         (3)  Members of the committee shall serve without
    18     compensation but shall be reimbursed for their reasonable and
    19     necessary expenses by the department.
    20         (4)  Members of the committee shall serve for indefinite
    21     terms at the will of their respective appointing authorities.
    22         (5)  Action by the committee shall require a vote by at
    23     least seven members.
    24         (6)  Members of the committee shall annually elect a
    25     chairperson.
    26     (f)  Fees.--The program shall deduct from payments made to
    27  retail pharmacies and remit to the department a fee for each
    28  prescription reimbursed in an amount sufficient to conduct the
    29  studies required by subsection (d) and to monitor the
    30  implementation of the fee schedule established by the department
    20050H2263B3163                 - 10 -     

     1  pursuant to the studies. The department shall establish and
     2  administer the fee based upon the recommendations and approval
     3  of the advisory committee in the same manner as provided for
     4  nursing facility assessments pursuant to section 805-A of the
     5  Public Welfare Code.
     6  Section 4.  Reimbursement.
     7     (a)  General rule.--
     8         (1)  Pharmacies reimbursed under this act on and after
     9     the effective date of this section shall be paid at fee-for-
    10     service rates no less than the rate for reimbursement under
    11     the PACE program in effect on December 31, 2004, until
    12     reimbursement rates are established based on the results of
    13     the study conducted pursuant to section 3(d).
    14         (2)  Upon the establishment of reimbursement rates,
    15     pharmacies shall earn a rate of return at least equivalent to
    16     the rate of return earned by participation in the PACE
    17     program as of December 31, 2004, taking into consideration
    18     the changes in the composition of drugs dispensed pursuant to
    19     the formulary and any incremental costs associated with
    20     obtaining prior authorizations.
    21     (b)  Components.--Reimbursement to pharmacies shall include
    22  all of the following:
    23         (1)  Payment for prescription product costs adequate to
    24     cover the reasonable and necessary costs associated with all
    25     of the following:
    26             (i)  Acquisition and delivery to the pharmacy.
    27             (ii)  Inventory management.
    28             (iii)  Storage and security.
    29             (iv)  Quality assurance.
    30             (v)  Compliance with regulatory requirements.
    20050H2263B3163                 - 11 -     

     1             (vi)  Reasonable profit to generate a return on the
     2         investment associated with reasonable and necessary
     3         costs.
     4         (2)  Payment for dispensing costs adequate to cover costs
     5     associated with all of the following:
     6             (i)  Professional services provided.
     7             (ii)  Wages and salaries.
     8             (iii)  Patient counseling.
     9             (iv)  Drug utilization review.
    10             (v)  Licensing fees.
    11             (vi)  Taxes.
    12             (vii)  Insurance.
    13             (viii)  Other direct and indirect costs of operating
    14         a pharmacy.
    15             (ix)  A reasonable profit to generate a return on the
    16         investment associated with the costs.
    17         (3)  An additional dispensing cost payment associated
    18     with dispensing drugs other than single source drugs as
    19     defined by section 1927(k)(7)(A)(iv) of the Social Security
    20     Act.
    21         (4)  Additional payment for:
    22             (i)  Medication therapy management.
    23             (ii)  Concurrent and retrospective utilization
    24         review.
    25             (iii)  Managing prior authorization requirements.
    26             (iv)  To the extent authorized by section 9.1 of the
    27         Pharmacy Act, implementing drug therapy protocols.
    28     (c)  Prompt payment.--Pharmacies shall be paid within 21 days
    29  of the department's receipt of appropriate substantiation of the
    30  transaction. Pharmacies shall be entitled to interest at the
    20050H2263B3163                 - 12 -     

     1  rate provided by section 806 of the act of April 9, 1929
     2  (P.L.343, No.176), known as The Fiscal Code, for any payment not
     3  made within the 21-day period.
     4     (d)  Source of pricing information.--Pricing information
     5  utilized in reimbursement formulas shall be based upon a
     6  published compendium of prices, selected by the advisory
     7  committee and approved and designated by the department by
     8  regulation. The information shall be updated weekly.
     9     (e)  Copayments.--Except for services which are excluded
    10  under the Commonwealth's medical assistance program, the
    11  department may require pharmacies to collect a copayment in an
    12  amount set by the department. To the extent a pharmacy is
    13  required by Federal or State law to dispense prescriptions to
    14  persons unable to satisfy copayment obligations, the pharmacy
    15  shall be reimbursed for uncollectible copayment amounts. The
    16  department shall neither require copayments from beneficiaries
    17  nor deduct copayment amounts from pharmacy reimbursements for
    18  any particular classes of drugs or prescription drug plan
    19  recipients to the extent there is good cause to conclude that
    20  copayment requirements will result in noncompliance with
    21  prescription drug treatment protocols and will increase overall
    22  health care costs or result in imminent and substantial risk of
    23  harm or injury to recipients or other persons. Except to the
    24  extent prohibited by Federal law, the department may accept
    25  compensation for the purpose of reducing or eliminating
    26  copayments from drug manufacturers, distributors, health care
    27  plans, or other persons or organizations for the purpose of
    28  encouraging therapeutically desirable compliance with
    29  prescription drug treatment protocols.
    30     (f)  Maximum allowable cost limits.--Except as otherwise
    20050H2263B3163                 - 13 -     

     1  required by Federal law or State regulation, to the extent
     2  reimbursement formulas adopted by the department limit payments
     3  to pharmacies for any class or group of prescription drugs
     4  unrelated to published prices for the particular drug dispensed,
     5  the maximum allowable cost limits established by the department
     6  shall:
     7         (1)  apply only to multiple source drugs as defined by
     8     section 1927(k)(7)(A)(i) of the Social Security Act and for
     9     which there are no fewer than three nationally available
    10     sources of supply, and which are available for distribution
    11     in Pennsylvania;
    12         (2)  be determined pursuant to regulations adopted by the
    13     department that set forth the specific formulas used to
    14     calculate the limits and specify the sources of information
    15     used in the calculations;
    16         (3)  be publicly disclosed, posted electronically to the
    17     department's Internet website, distributed to pharmacies
    18     using alerts and regularly and periodically updated;
    19         (4)  include a minimum payment for each prescription
    20     dispensed to provide reasonable compensation for the costs
    21     associated with acquiring and dispensing the medications; and
    22         (5)  not apply to a prescription for which the dispensing
    23     of a particular product is determined by the prescriber to be
    24     medically necessary.
    25  Section  5.  Rebate agreement.
    26     (a)  Required agreements.--Except as provided in subsection
    27  (b), the department shall not include on the formulary
    28  established pursuant to section 3(b)(1) any prescription drug
    29  unless the department and the pharmaceutical manufacturer have
    30  entered into a rebate agreement covering that prescription drug
    20050H2263B3163                 - 14 -     

     1  on terms comparable to agreements executed pursuant to section
     2  1927(a), (b), (c) and (d) of the Social Security Act. The rebate
     3  agreement shall provide that, unless prohibited by Federal law,
     4  the rebate shall be based on the best price and that additional
     5  rebates shall be paid if the pharmaceutical manufacturer
     6  increases the price of the drug by an amount greater than the
     7  increase in the Consumer Price Index for All Urban Consumers.
     8  Nothing in this act shall prevent the department from
     9  negotiating agreements for the payment of additional rebates and
    10  discounts for the benefit of the medical assistance program or
    11  from entering into rebate and discount agreements for other
    12  plans which have been consolidated into the program for greater
    13  rebates and discounts than are required pursuant to section
    14  1927(c) of the Social Security Act.
    15     (b)  Exceptions.--Subsection (a) shall not apply if the
    16  availability of the drug is essential to the health of members
    17  of the pharmacy consolidated benefits program, as determined by
    18  the department.
    19     (c)  Contracts.--Pharmaceutical manufacturers must enter into
    20  a rebate agreement with the department to obtain reimbursement
    21  for prescription drugs included under this act. The rebate shall
    22  be paid by the manufacturer not later than 30 days after the
    23  date of receipt of information necessary to calculate the amount
    24  of the rebate. The department shall have the authority to levy a
    25  15% surcharge penalty on any rebate, not in dispute, that
    26  remains unpaid for 90 or more days.
    27     (d)  Past-due rebates.--The department shall have the
    28  authority to levy a 15% surcharge penalty on any rebate, not in
    29  dispute, that is more than one year past due, upon notification
    30  to the manufacturer. The surcharge penalty shall be in addition
    20050H2263B3163                 - 15 -     

     1  to any interest and penalties authorized by law or by provisions
     2  of any contracts. The notice shall afford the manufacturer 90
     3  days to satisfy the past-due rebate claim.
     4  Section 6.  Pharmacies and dispensing physicians.
     5     (a)  General rule.--Pharmacies and dispensing physicians
     6  participating in the PACE program shall, as a condition of
     7  participation in that program, agree to the conditions set forth
     8  in this section.
     9     (b)  Medicare recipients.--Any pharmacy or dispensing
    10  physician participating in the PACE program shall, as a
    11  condition of participation in that program, agree to sell
    12  prescription drugs to Medicare recipients participating in the
    13  prescription drug discount care program pursuant to section
    14  1860D-21 of the Social Security Act at the PACE program price.
    15  In no case shall a Medicare recipient be charged more than the
    16  price of the drug to a cash-paying customer receiving the same
    17  or similar services at the particular pharmacy on the date of
    18  the sale.
    19     (c)  Limitation on participation.--Any pharmacist, pharmacy
    20  or dispensing physician that is precluded or excluded for cause
    21  from the medical assistance program shall be precluded or
    22  excluded from participation in this act.
    23  Section 7.  Regulations and adjudications.
    24     (a)  Regulations.--The department shall seek recommendations
    25  of the advisory committee prior to promulgating rules and
    26  regulations, as necessary, to carry out the provisions of this
    27  act.
    28     (b)  Policies.--The department, acting in consultation with
    29  the advisory committee, shall promulgate statements of policy,
    30  as necessary, to carry out the provisions of this act. No
    20050H2263B3163                 - 16 -     

     1  statement of policy adopted by the department shall have the
     2  force and effect of law or regulation or may modify the
     3  provisions of any regulations adopted by the department. All
     4  statements of policy adopted by the department shall, except in
     5  emergency circumstances, be published for notice and comment
     6  prior to adoption and shall be published in the Pennsylvania
     7  Bulletin and the Pennsylvania Code.
     8     (c) Audit manual.--Based upon its regulations and policies,
     9  the department shall adopt a manual setting forth procedures,
    10  guidelines and standards to be utilized by prescription drug
    11  plans in audits of pharmacies participating in the pharmacy
    12  consolidation benefits program. Decisions regarding audits shall
    13  conform to the requirements of the manual and shall not involve
    14  the imposition of sanctions upon pharmacies for minor, isolated
    15  or good-faith errors and omissions in the processing of claims
    16  and shall not require the recoupment or restitution of
    17  overpayments made to pharmacies based upon errors or omissions
    18  of prescription drug plans in implementing payment reimbursement
    19  formula, unless the payments are clearly and obviously excessive
    20  or are the result of incorrect actions taken by pharmacies in
    21  submitting claims for processing.
    22     (d)  Adjudications.--Adjudications conducted by the
    23  department shall be subject to 2 Pa.C.S. Ch. 5 Subch. A
    24  (relating to practice and procedure of Commonwealth agencies)
    25  and Ch. 7 Subch. A (relating to judicial review of Commonwealth
    26  agency action). The department shall adopt rules of procedure
    27  regarding the conduct of adjudications involving pharmacies
    28  consistent with the provisions of 67 Pa.C.S. §§ 1102 (relating
    29  to hearings before the bureau) through 1105 (relating to
    30  determinations, review, appeal and enforcement).
    20050H2263B3163                 - 17 -     

     1  Section 8.  Applicability.
     2     This act shall apply to the medical assistance program unless
     3  the secretary, in consultation with the Department of Public
     4  Welfare, determines that the application is a violation of
     5  Federal law or an existing contractual agreement. Nothing in
     6  this act shall supersede or impede an existing contractual
     7  agreement. Contractual agreements in effect on the effective
     8  date of this section shall not be renewed or extended to the
     9  extent inconsistent with the requirements of this act, and the
    10  department shall promptly enter into negotiations to modify any
    11  contractual agreements inconsistent with this act to conform to
    12  the requirements of this act.
    13  Section 9. Prohibited activities.
    14     It shall be unlawful for any individual, partnership or
    15  corporation to solicit, receive, offer or pay any kickback,
    16  bribe or rebate in cash or in kind from or to any person in
    17  connection with the furnishing of services under this act to the
    18  same extent as prohibited with respect to Federal health
    19  programs by paragraphs (1) and (2) of section 1128 (b)(1) and
    20  (2) of the Social Security Act, subject to the safe harbors from
    21  sanctions provided by sections 1877(a)(1) and 1860D-4(e)(6) of
    22  the Social Security Act. Violations of this section shall be
    23  subject to the sanctions, penalties and remedies under section
    24  1407 of the Public Welfare Code.
    25  Section 40.  Effective date.
    26     This act shall take effect in 60 days.



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