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                                                      PRINTER'S NO. 1875

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

No. 1498 Session of 2007


        INTRODUCED BY DeLUCA, ARGALL, BAKER, BELFANTI, BENNINGHOFF,
           BIANCUCCI, CALTAGIRONE, CAPPELLI, CAUSER, CLYMER, COHEN,
           DENLINGER, EACHUS, EVERETT, FABRIZIO, FREEMAN, GEORGE,
           GIBBONS, GINGRICH, GOODMAN, HARHART, HESS, HUTCHINSON, JAMES,
           KAUFFMAN, MAJOR, MANDERINO, McILHATTAN, R. MILLER, MUNDY,
           MUSTIO, PETRARCA, PETRONE, PHILLIPS, PRESTON, PYLE, REED,
           REICHLEY, SAYLOR, SEIP, SHIMKUS, STERN, SURRA, THOMAS, WALKO,
           WANSACZ, WATSON AND YUDICHAK, JUNE 8, 2007

        REFERRED TO COMMITTEE ON AGING AND OLDER ADULT SERVICES,
           JUNE 8, 2007

                                     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
    10  Pennsylvania Act.
    11  Section 2.  Definitions.
    12     The following words and phrases when used in this act shall
    13  have the meanings given to them in this section unless the
    14  context clearly indicates otherwise:
    15     "Adjudication."
    16         (1)  Except as provided in paragraph (2), an action taken

     1     by the Department of Aging, the Secretary of Aging or a
     2     prescription drug plan pursuant to this act that constitutes
     3     an adjudication as defined by 2 Pa.C.S. § 101 (relating to
     4     definitions), including any of the following:
     5             (i)  A decision to allow a pharmacy to participate in
     6         a prescription drug plan or to suspend, restrict or
     7         revoke participation by a pharmacy in a prescription drug
     8         plan.
     9             (ii)  A decision by the department to include or
    10         exclude a medication from the formulary or preferred drug
    11         list.
    12             (iii)  The establishment of pharmacy reimbursement
    13         rates and formulas.
    14             (iv)  A decision to grant or deny prior authorization
    15         for the dispensing of prescription drugs or to approve or
    16         disapprove the dispensing of drugs not included on the
    17         formulary or preferred drug list.
    18             (v)  An action taken by the program based upon audits
    19         of claims submitted for reimbursement by pharmacies.
    20         (2)  An action taken by the program with respect to
    21     determining recipient eligibility shall not be deemed an
    22     adjudication subject to this act.
    23     "Alerts."  Electronic communications between the Department
    24  of Aging or the pharmacy benefits consolidation program and
    25  pharmacies providing information pertaining to the
    26  implementation of this act, including any of the following:
    27         (1)  Information regarding formularies.
    28         (2)  Preferred drug lists.
    29         (3)  Drug utilization review.
    30         (4)  Prior authorization.
    20070H1498B1875                  - 2 -     

     1         (5)  Disease management programs.
     2         (6)  Claims submission and adjudication procedures.
     3         (7)  Audits.
     4         (8)  Pharmacy and patient education.
     5     "Best price."  As defined under section 1927(c) of the Social
     6  Security Act (49 Stat. 620, 42 U.S.C. § 1396r-8(c)).
     7     "Department."  The Department of Aging of the Commonwealth.
     8     "Medical assistance program."  The program established
     9  pursuant to Subarticle (f) of Article IV of the act of June 13,
    10  1967 (P.L.31, No.21), known as the Public Welfare Code.
    11     "Medicare recipient."  An individual residing in this
    12  Commonwealth who receives benefits under Part A of Subchapter
    13  XVIII of Chapter 7 of the Social Security Act (49 Stat. 620, 42
    14  U.S.C. § 301 et seq.) or who is enrolled under Part B, C or D of
    15  Subchapter XVIII.
    16     "Pharmaceutical manufacturer."  A manufacturer as defined by
    17  section 1927(k)(5) of the Social Security Act (49 Stat. 620, 42
    18  U.S.C. § 1396r-8(k)(5)).
    19     "Pharmacy."  A pharmacy licensed pursuant to the act of
    20  September 27, 1961 (P.L.1700, No.699), known as the Pharmacy
    21  Act.
    22     "Pharmacy Act."  The act of September 27, 1961 (P.L.1700,
    23  No.699), known as the Pharmacy Act.
    24     "Pharmacy services."  The provision of health care services
    25  defined as the practice of pharmacy by the act of September 27,
    26  1961 (P.L.1700, No.699), known as the Pharmacy Act.
    27     "Preferred drug list."  A list of prescription medications
    28  that may be dispensed by a prescription drug plan without prior
    29  authorization or a notation by the prescriber that the
    30  medication is medically necessary and cannot be substituted for
    20070H1498B1875                  - 3 -     

     1  a listed prescription medication.
     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 of the United States as a State
    17     pharmaceutical assistance program.
    18         (3)  Programs paying for prescription drugs dispensed to
    19     employees, including programs established by the Public
    20     School Employees' Retirement System, the State Employees'
    21     Retirement System and the State Employees' Benefit Trust
    22     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.
    20070H1498B1875                  - 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     "Retail pharmacy."  A pharmacy licensed to operate pursuant
     9  to the act of September 27, 1961 (P.L.1700, No.699), known as
    10  the Pharmacy Act, which provides services to the general public,
    11  excluding any institutional pharmacy, specialty pharmacy or
    12  mail-order pharmacy.
    13     "Secretary."  The Secretary of Aging of the Commonwealth.
    14     "Social Security Act."  The Social Security Act (49 Stat.
    15  620, 42 U.S.C. § 301 et seq.). A reference to the Social
    16  Security Act shall include regulations implementing the Social
    17  Security Act adopted by the United States Department of Health
    18  and Human Services or the Centers for Medicare and Medicaid
    19  Services.
    20     "State agency."  Any of the following entities that purchases
    21  or provides coverage for prescription medications:
    22         (1)  An agency under the jurisdiction of the Governor.
    23         (2)  An independent agency.
    24         (3)  The General Assembly.
    25         (4)  The unified judicial system.
    26     "State Employees' Benefit Trust Fund."  The trust fund
    27  established to purchase health insurance coverage, including
    28  coverage for prescription medications, for State employees.
    29     "State Employees' Retirement System."  The retirement system
    30  established under 71 Pa.C.S. Part XXV (relating to retirement
    20070H1498B1875                  - 5 -     

     1  for State employees and officers).
     2  Section 3.  One Pennsylvania.
     3     (a)  Establishment.--The department shall establish a
     4  pharmacy benefits consolidation program to be known as One
     5  Pennsylvania. The program shall administer all Commonwealth
     6  prescription drug plans through an integrated system of plan
     7  administration using uniform standards and requirements for the
     8  reimbursement of pharmacies as provided by this act. To the
     9  extent consolidation or the implementation of this act is
    10  prohibited by Federal law or regulations, the department may
    11  modify the requirements of this act or exclude or limit its
    12  application to particular prescription drug plans to the extent
    13  necessary to comply with Federal law or regulations.
    14     (b)  Requirements.--The department shall do all of the
    15  following:
    16         (1)  Manage and implement a uniform formulary and
    17     preferred drug list for the program under this act. A
    18     formulary shall include all prescription drugs for which a
    19     manufacturer has entered into a rebate agreement pursuant to
    20     section 5 and the requirements and restrictions, except for
    21     prior authorization, provided by section 1927(d) the Social
    22     Security Act. A preferred drug list shall comply with the
    23     standards established by Part D, section 1860D-4(b)(3) of the
    24     Social Security Act and any additional regulations as may be
    25     adopted by the department pursuant to this act. The list of
    26     drugs included in the formulary and preferred drug list shall
    27     be publicly available, posted electronically on the Internet
    28     website of the department and communicated to pharmacies
    29     through alerts.
    30         (2)  Ensure that any pharmacy licensed in this
    20070H1498B1875                  - 6 -     

     1     Commonwealth is eligible to provide pharmacy services
     2     according to any regulations adopted by the department
     3     pursuant to this act.
     4         (3)  (i)  Except as provided in subparagraph (ii), make
     5         provisions for generic substitutions in accordance with
     6         the act of November 24, 1976 (P.L.1163, No.259), referred
     7         to as the Generic Equivalent Drug Law.
     8             (ii)  Notwithstanding the provisions of the Generic
     9         Equivalent Drug Law and the act of August 26, 1971
    10         (P.L.351, No.91), known as the State Lottery Law, generic
    11         substitutions shall only be dispensed when it is less
    12         expensive for the program.
    13         (4)  Provide for a program of prospective drug
    14     utilization review consistent with section 1927(g)(2) of the
    15     Social Security Act.
    16         (5)  Provide for prior authorization consistent with the
    17     requirements of section 1927(g)(5)of the Social Security Act
    18     and in accordance with regulations of the department.
    19         (6)  Take all reasonable measures to ascertain the legal
    20     liability of any third parties, including health insurers,
    21     self-insured plans, group health plans as defined by section
    22     607(1) of the Employee Retirement Income Security Act of 1974
    23     (Public Law 93-406, 88 Stat. 829), service benefit plans,
    24     managed care organizations, pharmacy benefit managers, the
    25     Medicare program, other prescription drug plans or other
    26     parties that are, by statute, contract or agreement, legally
    27     responsible for payment for prescription drugs before claims
    28     become the liability of any prescription drug plan subject to
    29     this act and pursue claims against such parties for payment.
    30     Information regarding such third party benefits shall be
    20070H1498B1875                  - 7 -     

     1     included on identification cards issued to persons eligible
     2     to claim benefits from prescription drug plans and shall be
     3     included in all mechanized claims processing and information
     4     retrieval systems, including systems required under section
     5     1903(r) of the Social Security Act. Unless a pharmacy has
     6     actual knowledge regarding the availability of such third-
     7     party benefits to a claimant, a pharmacy is entitled to relay
     8     information regarding the availability of such benefits
     9     provided by the department, and shall not be liable to repay,
    10     in whole or in part, amounts paid by a prescription drug plan
    11     for prescription drugs for which any such third party is
    12     liable.
    13         (7)  Provide for a program of retrospective drug
    14     utilization review and education consistent with section
    15     1927(g)(2) of the Social Security Act and in accordance with
    16     regulations of the department to ensure that prescriptions
    17     are appropriate, medically necessary and not likely to result
    18     in adverse medical results and to educate providers and
    19     recipients of pharmacy services through the pharmacy
    20     consolidated benefits program and to correct and report
    21     misutilization and abuse by licensed prescribers and
    22     recipients and provide for fraud and abuse audits,
    23     coordinating its activities with the secretary to support
    24     compliance with applicable laws and regulations. Pharmacies
    25     shall not be denied payments for medications dispensed based
    26     upon the results of retrospective drug utilization review or
    27     audits, where the medication was dispensed in good faith by
    28     the pharmacy without prior knowledge that the prescription of
    29     a medication was not appropriate or necessary, was likely to
    30     cause adverse medical results or constituted a fraudulent or
    20070H1498B1875                  - 8 -     

     1     abusive practice by the prescriber.
     2         (8)  Establish a program of medication therapy management
     3     consistent with section 1860D-4(c)(2) of the Social Security
     4     Act.
     5         (9)  Provide educational materials for program recipients
     6     of pharmacy services on disease and care management.
     7         (10)  In accordance with section 1927(a) through (d) of
     8     the Social Security Act or Chapter 7 of the act of August 26,
     9     1971 (P.L.351, No.91), known as the State Lottery Law, bill,
    10     recoup and relay to the medical assistance program
    11     manufacturers' drug rebates and excessive consumer price
    12     inflation discounts and resolve disputes. Upon the
    13     establishment of the program, all medical assistance
    14     recipients shall be enrolled in prescription drug programs
    15     for which rebates and discounts are collected pursuant to
    16     section 1927(a) through (d) of the Social Security Act.
    17         (11)  Adjudicate claims through an electronic claims
    18     management system consistent with section 1927(h) of the
    19     Social Security Act and which allows for an emergency supply
    20     of prescribed medication in the event of equipment failures.
    21         (12)  Create a uniform audit and recoupment system
    22     subject to the requirements of section 7(c) for all of the
    23     following:
    24             (i)  Pharmacies, pharmacists, dispensing physicians
    25         and any other providers of pharmacy services.
    26             (ii)  Individuals enrolled in prescription drug plans
    27         and applicants for enrollment in prescription drug plans.
    28             (iii)  Prescription drug plans, pharmacy benefit
    29         managers and other persons providing services related to
    30         the provision of pharmacy services or the administration
    20070H1498B1875                  - 9 -     

     1         of prescription drug plans.
     2             (iv)  Other providers of prescription drug benefits
     3         subject to coordination of benefit requirements with
     4         prescription drug plans, including health insurance
     5         companies, employee benefit plans and trust funds, health
     6         maintenance organizations, Medicare benefit providers,
     7         workers compensation insurers and automobile insurance
     8         companies.
     9             (v)  Pharmaceutical manufacturers, wholesalers and
    10         other suppliers of prescription drugs.
    11         (13)  Provide for the reimbursement of all pharmacies
    12     participating in prescription drug programs on a fee-for-
    13     service basis.
    14         (14)  Allow pharmacists certified in medication therapy
    15     management by a national accrediting body or by any other
    16     certification process approved by the State Board of Pharmacy
    17     to provide medication therapy management.
    18     (c)  Considerations.--In preparing and managing the uniform
    19  formulary and preferred drug list, the department shall enter
    20  into agreements with drug manufacturers to collect and remit to
    21  the program discounts, rebates or other concessions offered by
    22  manufacturers.
    23     (d)  Advisory committee.--
    24         (1)  An advisory committee to the department shall be
    25     established consisting of the following members:
    26             (i)  Three members appointed by the Governor.
    27             (ii)  Two members appointed by each of the following:
    28                 (A)  The President pro tempore of the Senate.
    29                 (B)  The Minority Leader of the Senate.
    30                 (C)  The Speaker of the House of Representatives.
    20070H1498B1875                 - 10 -     

     1                 (D)  The Minority Leader of the House of
     2             Representatives.
     3         (2)  Each legislative appointing authority shall appoint
     4     one member pursuant to paragraph (1)(ii) involved in the
     5     ownership or operation of independent pharmacies and one
     6     member involved in the ownership or operation of chain
     7     pharmacies.
     8         (3)  Members of the committee shall serve without
     9     compensation but shall be reimbursed for their reasonable and
    10     necessary expenses by the department.
    11         (4)  Members of the committee shall serve for indefinite
    12     terms at the will of their respective appointing authorities.
    13         (5)  Action by the committee shall require a vote by at
    14     least seven members.
    15         (6)  Members of the committee shall annually elect a
    16     chairperson.
    17  Section 4.  Reimbursement.
    18     (a)  General rule.--Reimbursement to pharmacies shall include
    19  all of the following:
    20         (1)  Payment sufficient to reimburse retail pharmacies
    21     for the reasonable and necessary costs incurred to purchase
    22     drugs.
    23         (2)  Except to the extent otherwise required by Federal
    24     law or regulations, payments to retail pharmacies pursuant to
    25     paragraph (1) shall be based upon the average retail pharmacy
    26     acquisition cost for a medication without regard to customary
    27     prompt pay discounts in the package size most commonly
    28     purchased by retail pharmacies as determined by the
    29     department pursuant to subsection (d), or a pharmacy's actual
    30     acquisition cost for a medication, whichever amount is
    20070H1498B1875                 - 11 -     

     1     greater.
     2         (3)  Payment for dispensing costs adequate to cover costs
     3     associated with all of the following:
     4             (i)  Wages and salaries.
     5             (ii)  Costs to store and secure inventory.
     6             (iii)  Patient counseling.
     7             (iv)  Drug utilization review.
     8             (v)  Licensing fees.
     9             (vi)  Taxes.
    10             (vii)  Insurance.
    11             (viii)  Other direct and indirect costs of operating
    12         a pharmacy.
    13             (ix)  A reasonable profit to generate a return on the
    14         investment associated with the costs.
    15         (4)  During the first year this section is in effect,
    16     payments pursuant to paragraph (3) shall be not less than $10
    17     for the dispensing of a single source drug as defined by
    18     section 1927(k)(7)(A)(iv) of the Social Security Act or $15
    19     for the dispensing of a multiple-source drug as defined by
    20     section 1927(k)(7)(A)(iv) of the Social Security Act.
    21     Beginning on January 1 of each subsequent year, payment
    22     pursuant to paragraph (3) shall be not less than the prior
    23     year's minimum payments as adjusted based upon the annual
    24     percentage change in Consumer Price Index for medical care
    25     professional services as published by the Bureau of Labor
    26     Statistics of the United States Department of Labor for the
    27     month of December of the immediately prior year.
    28         (5)  Additional payment for:
    29             (i)  Medication therapy management.
    30             (ii)  Concurrent and retrospective utilization
    20070H1498B1875                 - 12 -     

     1         review.
     2             (iii)  Managing prior authorization requirements.
     3             (iv)  To the extent authorized by section 9.1 of the
     4         Pharmacy Act, implementing drug therapy protocols.
     5             (v)  Compounding prescriptions.
     6             (vi)  Preparing specialized packaging for the
     7         administration of medications in long-term care
     8         facilities.
     9             (vii)  Preparing medications for intravenous
    10         administration.
    11             (viii)  Other reasonable and necessary pharmacy
    12         services.
    13     (b)  Prompt payment.--Pharmacies shall be paid within 21 days
    14  of the department's receipt of appropriate substantiation of the
    15  transaction. Pharmacies shall be entitled to interest at the
    16  rate provided by section 806 of the act of April 9, 1929
    17  (P.L.343, No.176), known as The Fiscal Code, for any payment not
    18  made within the 21-day period.
    19     (c)  Average retail pharmacy acquisition costs.--The
    20  department shall determine and publicly make available through
    21  its Internet website the average retail pharmacy acquisition
    22  cost for covered medications pursuant to regulations approved by
    23  the advisory committee in a manner consistent with the
    24  methodology used by the Congressional Budget Office in its
    25  December 26, 2006, report to the Committee on Energy and
    26  Commerce of the United States House of Representatives based
    27  upon a survey of retail pharmacy wholesale invoices or through
    28  the use of commercially available sources of information.
    29  Average pharmacy acquisition costs shall be updated weekly.
    30     (d)  Copayments.--Except for services which are excluded
    20070H1498B1875                 - 13 -     

     1  under the Commonwealth's medical assistance program, the
     2  department may require pharmacies to collect a copayment in an
     3  amount set by the department. To the extent a pharmacy is
     4  required by Federal or State law to dispense prescriptions to
     5  persons unable to satisfy copayment obligations, the pharmacy
     6  shall be reimbursed for uncollected copayment amounts. The
     7  department shall neither require copayments from beneficiaries
     8  nor deduct copayment amounts from pharmacy reimbursements for
     9  any particular classes of drugs or prescription drug plan
    10  recipients to the extent there is good cause to conclude that
    11  copayment requirements will result in noncompliance with
    12  prescription drug treatment protocols and will increase overall
    13  health care costs or result in imminent and substantial risk of
    14  harm or injury to recipients or other persons. Except to the
    15  extent prohibited by Federal law, the department may accept
    16  compensation for the purpose of reducing or eliminating
    17  copayments from drug manufacturers, distributors, health care
    18  plans or other persons or organizations for the purpose of
    19  encouraging therapeutically desirable compliance with
    20  prescription drug treatment protocols.
    21  Section 5.  Rebate agreement.
    22     (a)  Required agreements.--Except as provided in subsection
    23  (b), the department shall not include on the formulary of
    24  preferred drug list established pursuant to section 3(b)(1) any
    25  prescription drug unless the department and the pharmaceutical
    26  manufacturer have entered into a rebate agreement covering that
    27  prescription drug on terms comparable to agreements executed
    28  pursuant to section 1927(a), (b), (c) and (d) of the Social
    29  Security Act. The rebate agreement shall provide that, unless
    30  prohibited by Federal law, the rebate shall be based on the best
    20070H1498B1875                 - 14 -     

     1  price and that additional rebates shall be paid if the
     2  pharmaceutical manufacturer increases the price of the drug by
     3  an amount greater than the increase in the Consumer Price Index
     4  for All Urban Consumers. Nothing in this act shall prevent the
     5  department from negotiating agreements for the payment of
     6  additional rebates and discounts for the benefit of the medical
     7  assistance program or from entering into rebate and discount
     8  agreements for other plans which have been consolidated into the
     9  program for greater rebates and discounts than are required
    10  pursuant to section 1927(c) of the Social Security Act.
    11     (b)  Exceptions.--Subsection (a) shall not apply if the
    12  availability of the drug is essential to the health of members
    13  of the pharmacy consolidated benefits program as determined by
    14  the department.
    15     (c)  Contracts.--Pharmaceutical manufacturers must enter into
    16  a rebate agreement with the department to obtain reimbursement
    17  for prescription drugs included under this act. The rebate shall
    18  be paid by the manufacturer not later than 30 days after the
    19  date of receipt of information necessary to calculate the amount
    20  of the rebate. The department shall have the authority to levy a
    21  15% surcharge penalty on any rebate not in dispute that remains
    22  unpaid for 90 or more days.
    23  Section 6.  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
    20070H1498B1875                 - 15 -     

     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 and the department in audits of pharmacies participating
    12  in the pharmacy consolidation benefits program. The audit manual
    13  shall provide that:
    14         (1)  Any actions taken to recover or recoup payments to
    15     pharmacies, seek restitution or impose interest, penalties or
    16     other sanctions upon pharmacies will be taken in compliance
    17     with the procedures provided by the audit manual.
    18         (2)  Except when otherwise justified by emergency
    19     circumstances, allegations of criminal conduct or threats to
    20     public health, pharmacies shall be given at least 30 days'
    21     advance notice of any onsite audits.
    22         (3)  Except when otherwise justified by emergency
    23     circumstances, allegations of criminal conduct or threats to
    24     public health, audits will not interfere with the delivery of
    25     services to patients, disrupt pharmacy operations or impose
    26     any unreasonable burdens upon pharmacies or pharmacists.
    27         (4)  Any audit involving clinical or professional
    28     judgment will be conducted by or in consultation with a
    29     properly qualified consulting pharmacist.
    30         (5)  Pharmacies will not be subject to claims for the
    20070H1498B1875                 - 16 -     

     1     recovery or recoupment of payments, restitution, interest,
     2     penalties or other sanctions for minor, isolated or good-
     3     faith errors and omissions in the processing of claims unless
     4     the pharmacies engage in fraud, intentional misconduct,
     5     willful or grossly negligent activities or create threats to
     6     the health and safety of patients.
     7         (6)  Claims for the recovery or recoupment of payments,
     8     restitution, interest, penalties or other sanctions shall not
     9     be based upon statistical sampling and projection or
    10     extrapolation techniques.
    11         (7)  Errors or omissions in records may be corrected and
    12     the validity of records confirmed through the use of any
    13     reliable source of information, including records and reports
    14     provided by prescribing and treating health care
    15     professionals, health care facilities, by reliance upon
    16     electronic copies of original records or through the use of
    17     other confirming documents, records, reports or testimony.
    18         (8)  No audit shall be conducted more than 12 months
    19     after the date a claim was submitted for payment.
    20         (9)  No contingent fee compensation or payment shall be
    21     made to any consultant or advisor conducting or assisting in
    22     the conduct of an audit.
    23         (10)  Upon the conclusion of an audit, an exit interview
    24     will be conducted explaining any claims asserted and offering
    25     a pharmacy an informal opportunity to respond to any claims
    26     before a written audit report is produced.
    27         (11)  Following the production of a written audit report,
    28     a pharmacy shall be given at least 60 days in which to
    29     respond to the report, provide any additional required
    30     documentation or present objections to the audit, before the
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     1     audit shall be deemed a final adjudication subject to review
     2     pursuant to subsection (d).
     3     (d)  Adjudications.--Adjudications conducted by the
     4  department shall be subject to 2 Pa.C.S. Ch. 5 Subch. A
     5  (relating to practice and procedure of Commonwealth agencies)
     6  and Ch. 7 Subch. A (relating to judicial review of Commonwealth
     7  agency action). The department shall adopt rules of procedure
     8  regarding the conduct of adjudications involving pharmacies
     9  consistent with the provisions of 67 Pa.C.S. §§ 1102 (relating
    10  to hearings before the bureau), 1103 (relating to supersedeas),
    11  1104 (relating to subpoenas) and 1105 (relating to
    12  determinations, review, appeal and enforcement).
    13  Section 7.  Applicability.
    14     This act shall apply to the medical assistance program except
    15  to the extent the secretary, in consultation with the Department
    16  of Public Welfare, determines that the application is a
    17  violation of Federal law or an existing contractual agreement.
    18  Nothing in this act shall supersede or impede an existing
    19  contractual agreement. Contractual agreements in effect on the
    20  effective date of this section shall not be renewed or extended
    21  to the extent inconsistent with the requirements of this act,
    22  and the department shall promptly enter into negotiations to
    23  modify any contractual agreements inconsistent with this act to
    24  conform to the requirements of this act.
    25  Section 8.  Prohibited activities.
    26     It shall be unlawful for any individual, partnership or
    27  corporation to solicit, receive, offer or pay any kickback,
    28  bribe or rebate in cash or in kind from or to any person in
    29  connection with the furnishing of services under this act to the
    30  same extent as prohibited with respect to Federal health
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     1  programs by section 1128(b)(1) and (2) of the Social Security
     2  Act, subject to the safe harbors from sanctions provided by
     3  sections 1877(a)(1) and 1860D-4(e)(6) of the Social Security
     4  Act. Violations of this section shall be subject to the
     5  sanctions, penalties and remedies under section 1407 of the
     6  Public Welfare Code.
     7  Section 9.  Repeals.
     8     (a)  Intent.--The General Assembly declares that the repeal
     9  under subsection (b) is necessary to effectuate the purposes of
    10  this act.
    11     (b)  Provision.--Section 509 of the act of August 26, 1971
    12  (P.L.351, No.91), known as the State Lottery Law, is repealed.
    13     (c)  General.--All other acts and parts of acts are repealed
    14  insofar as they are inconsistent with this act.
    15  Section 10.  Effective date.
    16     This act shall take effect as follows:
    17         (1)  Sections 3(d), 4(a)(4) and 6 shall take effect
    18     immediately.
    19         (2)  The remainder of this act shall take effect in one
    20     year.







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