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| THE GENERAL ASSEMBLY OF PENNSYLVANIA |
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| SENATE BILL |
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| INTRODUCED BY STACK, KITCHEN, FONTANA, ALLOWAY, BOSCOLA, LEACH, FERLO, RAFFERTY, WOZNIAK, EICHELBERGER, ARGALL AND ERICKSON, MARCH 28, 2011 |
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| REFERRED TO BANKING AND INSURANCE, MARCH 28, 2011 |
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| AN ACT |
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1 | Providing for pharmacy audit procedures. |
2 | The General Assembly of the Commonwealth of Pennsylvania |
3 | hereby enacts as follows: |
4 | Section 1. Short title. |
5 | This act shall be known and may be cited as the Pharmacy |
6 | Audit Integrity Act. |
7 | Section 2. Purpose and intent. |
8 | The purpose of this act is to establish minimum and uniform |
9 | standards and criteria for the audit of pharmacy records. |
10 | Section 3. Definitions. |
11 | The following words and phrases when used in this act shall |
12 | have the meanings given to them in this section unless the |
13 | context clearly indicates otherwise: |
14 | "Pharmacy benefits manager" or "PBM." A person, business or |
15 | other entity that performs pharmacy benefits management. The |
16 | term includes a person or entity acting for a PBM in a |
17 | contractual or employment relationship in the performance of |
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1 | pharmacy benefits management for a managed care company, |
2 | nonprofit hospital or medical service organization, insurance |
3 | company, third-party payor or health program administered by a |
4 | department of the Commonwealth. |
5 | Section 4. Scope of act. |
6 | This act covers an audit of the records of a pharmacy |
7 | conducted by a managed care company, nonprofit hospital or |
8 | medical service organization, insurance company, third-party |
9 | payor, pharmacy benefits manager, a health program administered |
10 | by a department of the Commonwealth or any entity that |
11 | represents a company, group or department. |
12 | Section 5. Procedures for conducting and reporting an audit. |
13 | (a) Procedure.--An entity conducting an audit under this act |
14 | shall conform to the following rules: |
15 | (1) The pharmacy contract shall identify and describe in |
16 | detail the audit procedures. |
17 | (2) The entity conducting an audit shall give the |
18 | pharmacy written notice at least two weeks prior to |
19 | conducting an initial onsite audit for each audit cycle or |
20 | requesting records for an audit conducted offsite. |
21 | (3) The entity conducting the onsite audit shall not |
22 | interfere with the delivery of pharmacist services to a |
23 | patient and shall utilize every effort to minimize |
24 | inconvenience and disruption to pharmacy operations during |
25 | the audit process. |
26 | (4) An audit that involves clinical or professional |
27 | judgment must be conducted by or in consultation with a |
28 | licensed pharmacist applying all applicable Pennsylvania law |
29 | and regulations. |
30 | (5) A clerical or recordkeeping error, such as a |
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1 | typographical error, scrivener's error or computer error |
2 | regarding a required document or record does not constitute |
3 | fraud and claims relating to the error shall be subject to |
4 | neither recoupment nor criminal penalties without proof of |
5 | intent to commit fraud. However, recoupment of any payment or |
6 | overpayment made due to error, strictly limited to the amount |
7 | of the payment or overpayment plus interest, is permissible |
8 | in situations in which the pharmacy knew that services were |
9 | not covered or were provided to an ineligible recipient and |
10 | in which restitution of the amounts paid constitutes a proper |
11 | remedy pursuant to 13 Pa.C.S. Div. 2 (relating to sales). |
12 | (6) A pharmacy may use the records of a hospital, |
13 | physician or other authorized practitioner of the healing |
14 | arts for drugs or medicinal supplies written or transmitted |
15 | by any means of communication for purposes of validating the |
16 | pharmacy record with respect to orders of refills of a legend |
17 | or narcotic drug. |
18 | (7) A finding of an overpayment or underpayment must be |
19 | based on the actual overpayment or underpayment and may not |
20 | be a projection based on the number of patients served having |
21 | a similar diagnosis or on the number of similar orders or |
22 | refills for similar drugs. This paragraph or any other |
23 | section of this act does not prevent any entity from using |
24 | its collected data to target audit resources or to detect |
25 | fraud. |
26 | (8) A finding of an overpayment shall not include the |
27 | dispensing fee amount. However, the dispensing fee does not |
28 | have to be paid in the event that a filled prescription was |
29 | not finally dispensed to or picked up for the intended |
30 | patient. |
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1 | (9) Each pharmacy shall be audited under the same |
2 | standards and parameters as other similarly situated |
3 | pharmacies audited by the entity. |
4 | (10) The period of time covered by an audit may not go |
5 | back in time more than 18 months from the scheduled date of |
6 | the audit. |
7 | (11) An onsite audit may not be initiated or scheduled |
8 | during the first seven calendar days of any month due to the |
9 | high volume of prescriptions filled in the pharmacy during |
10 | that time unless otherwise consented to by the pharmacy. |
11 | (12) The auditing company shall not receive payment |
12 | based on a percentage of the amount recovered. |
13 | (b) Written report.--An entity conducting an audit under |
14 | this act shall provide the pharmacy with a written report of the |
15 | audit and comply with the following requirements: |
16 | (1) The preliminary audit report must be delivered to |
17 | the pharmacy or its corporate parent within 90 days after the |
18 | conclusion of the audit. |
19 | (2) A pharmacy shall be allowed at least 60 days |
20 | following receipt of the preliminary audit report in which to |
21 | produce documentation to address any discrepancy found during |
22 | the audit. |
23 | (3) A final audit report shall be delivered to the |
24 | pharmacy or its corporate parent within 120 days after |
25 | receipt of the preliminary audit report or final appeal, as |
26 | provided for in section 6, whichever is later. |
27 | (4) The audit report must be signed and include the |
28 | signature of any pharmacist participating in the audit. |
29 | (5) Any recoupments of disputed funds shall only occur |
30 | after final internal disposition of the audit, including the |
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1 | appeal process as set forth in section 6. |
2 | (6) Interest shall not accrue during the audit period. |
3 | (7) An entity conducting an audit shall provide a copy |
4 | of the final audit report, after completion of any review |
5 | process, to the plan sponsor. |
6 | Section 6. Appeal process. |
7 | The following shall apply: |
8 | (1) The National Council for Prescription Drug Programs |
9 | (NCPDP) or any other recognized national industry standard |
10 | shall be used to evaluate claims submission and product size |
11 | disputes. |
12 | (2) An entity conducting an audit shall establish a |
13 | written appeal process under which a pharmacy may appeal an |
14 | unfavorable preliminary audit report to the entity. |
15 | (3) If, following the appeal, the entity finds that an |
16 | unfavorable audit report or any portion of the report is |
17 | unsubstantiated, the entity shall dismiss the audit report or |
18 | the portion without the necessity of any further action. |
19 | Section 7. Extrapolation audits. |
20 | Notwithstanding any other provision in this act, an entity |
21 | conducting an audit under this act shall not use the accounting |
22 | practice of extrapolation in calculating recoupments or |
23 | penalties for audits. An extrapolation audit means an audit of a |
24 | sample of prescription drug benefit claims submitted by a |
25 | pharmacy to the entity conducting the audit that is then used to |
26 | estimate audit results for a larger batch or group of claims not |
27 | reviewed by the auditor. |
28 | Section 8. Third-party resources. |
29 | (a) Third-party resources.--An entity covered by this act |
30 | shall take all reasonable measures to ascertain the legal |
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1 | liability of any third parties, including health insurers, self- |
2 | insured plans, group health plans as defined by section 607(1) |
3 | of the Employee Retirement Income Security Act of 1974 (Public |
4 | Law 93-406, 88 Stat. 829), service benefit plans, managed care |
5 | organizations, pharmacy benefit managers, the Medicare program, |
6 | other prescription drug plans or other parties that are by |
7 | statute, contract or agreement legally responsible for payment |
8 | for prescription drugs before claims become the liability of any |
9 | prescription drug plan administered by the pharmacy benefit |
10 | manager. |
11 | (b) Identification cards and claims processing systems.-- |
12 | Information regarding third-party resources identified pursuant |
13 | to subsection (a) shall be included on identification cards |
14 | issued by a PBM or prescription drug plan to persons eligible |
15 | for prescription drug benefits and shall be included in all |
16 | mechanized claims processing systems established by a PBM or |
17 | prescription drug plan, including systems required under section |
18 | 1903(r) of the Social Security Act (49 Stat. 620, 42 U.S.C. § |
19 | 301 et seq.). Where information regarding third-party resources |
20 | is made available to pharmacies on identification cards or |
21 | through mechanized claims processing systems, a PBM may direct a |
22 | pharmacy to submit claims for payment to the third parties prior |
23 | to submission to the PBM or prescription drug plan, provided |
24 | that this requirement shall not apply when a pharmacy has a |
25 | reasonable basis to believe that a claim is not covered by |
26 | available third-party resources based upon a diagnosis code or |
27 | other information available to the pharmacy. |
28 | (c) Claims against pharmacies.--Provided that a pharmacy |
29 | makes reasonable inquiries of recipients regarding the |
30 | availability of third-party resources, unless a pharmacy has |
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1 | actual knowledge regarding the availability of third-party |
2 | resources available to a claimant for pharmacy benefits, a |
3 | pharmacy is entitled to rely on information regarding the |
4 | availability of third-party resources provided by a PBM, and |
5 | shall not be liable to repay in whole or in part for any amounts |
6 | for which any third party is liable. PBMs and prescription drug |
7 | plans are hereby authorized to and shall pursue claims from the |
8 | third-party resources. Upon the effective date of this act, this |
9 | subsection shall apply to all pending and future claims against |
10 | pharmacies asserted by PBMs or prescription drug plans, |
11 | including claims relating to benefits provided to recipients |
12 | prior to the effective date of this act. |
13 | (d) Applicability.--This section shall apply to agencies of |
14 | the Commonwealth managing health care programs and their agents. |
15 | This section shall also apply to other entities described in |
16 | section 4 only to the extent that they engage in coordination of |
17 | benefits between multiple plans. Subsection (c) shall apply to |
18 | all section 4 entities covered by this act. |
19 | Section 9. Fraud. |
20 | (a) Exceptions.--Fraud shall not include the following: |
21 | (1) Payments for prescriptions where the proper |
22 | pharmaceutical was delivered to the intended patient, who is |
23 | eligible for benefits, in the prescribed amounts. |
24 | (2) Errors outlined in section 5(a)(5). |
25 | (b) Investigations.--Nothing in this act shall prevent |
26 | investigations by the law enforcement agencies of the |
27 | Commonwealth or the United States or use by entities under |
28 | section 4 of collected data or other information to detect |
29 | actual fraud by pharmacies or pharmacy personnel intended to |
30 | defraud prescription drug plans. |
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1 | (c) Restrictions on audits.--The restrictions on audits in |
2 | section 5(a)(10) do not apply once a pattern of systematic fraud |
3 | has been established in order to allow for recovery of |
4 | fraudulently obtained overpayments. |
5 | Section 10. Administration of this act by Commonwealth |
6 | agencies. |
7 | Provisions of this act shall not apply to the extent |
8 | determined by applicable Federal agencies to be contrary to |
9 | Federal law or regulations or to disqualify the Commonwealth in |
10 | whole or in part for Federal financial participation in |
11 | Commonwealth health programs or other Federal benefits, |
12 | subsidies or payments. However, the Commonwealth shall appeal |
13 | any such determinations made by Federal agencies and attempt to |
14 | obtain waivers or other agreements of understanding with Federal |
15 | agencies in order to fully implement this act. To avoid the risk |
16 | that the Commonwealth may be required to repay Federal financial |
17 | participation or other benefits, subsidies or payments, the |
18 | Commonwealth may request determinations from applicable Federal |
19 | agencies regarding whether any provisions of this act violate |
20 | Federal laws or regulations or disqualify the Commonwealth in |
21 | whole or in part for Federal financial participation in |
22 | Commonwealth health programs or other Federal benefits, |
23 | subsidies or payments. |
24 | Section 11. Pharmacy Error Reduction Committee. |
25 | (a) Establishment.--The Pharmacy Error Reduction Committee |
26 | is established to create a real-time, electronic pharmacy error |
27 | reduction system for Commonwealth prescription drug programs and |
28 | shall have as its purpose the reduction of prescription errors |
29 | in order to save the Commonwealth money and reduce |
30 | administrative burdens on businesses. The system shall check |
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1 | multiple databases to ensure that the pharmacy filings contain |
2 | the correct information. The system shall check each pharmacy |
3 | claim for the following information: physician name, physician |
4 | license number, name of prescription, prescription dosage, |
5 | patient name, name of patient's insurance provider, patient's |
6 | insurance identification number, as well as other information |
7 | that will reduce errors and has been approved by a majority vote |
8 | of the committee. If a pharmacy claim does not contain the |
9 | correct information, the pharmacy error reduction system shall |
10 | return the claim to the pharmacist for correction and |
11 | resubmission. |
12 | (b) Membership.--The committee shall consist of: |
13 | (1) Two members of the State Board of Pharmacy elected |
14 | by a majority of the board to serve on the committee. |
15 | (2) Two practicing pharmacists selected by the Governor |
16 | from a list submitted by a State trade association that |
17 | represents practicing pharmacists before the Department of |
18 | Public Welfare, the Department of Aging, the General Assembly |
19 | and other governmental bodies. |
20 | (3) Two practicing physicians selected by the Governor |
21 | from a list submitted by a State trade association that |
22 | represents all practicing physicians before the Department of |
23 | Public Welfare, the Department of Aging, the General Assembly |
24 | and other governmental bodies. |
25 | (4) The Secretary of Public Welfare or a designee, who |
26 | shall serve as the chairperson of the committee. |
27 | (5) The commissioner of the Department of State's Bureau |
28 | of Professional and Occupational Affairs or a designee. |
29 | (6) The Secretary of Aging or a designee. |
30 | (c) Powers and duties.--The committee shall: |
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1 | (1) Hold meetings to discuss and develop an electronic |
2 | pharmacy error reduction system. |
3 | (2) Consider issuing a request for proposals to develop |
4 | software, programs and other items to create and implement |
5 | the electronic pharmacy error reduction system or utilize |
6 | existing departmental staff, equipment and technology to |
7 | produce and implement the pharmacy error reduction system. |
8 | (3) Provide the electronic pharmacy error reduction |
9 | system to pharmacies throughout this Commonwealth. |
10 | (4) Obtain and share information to develop and |
11 | implement the electronic pharmacy error reduction system. |
12 | (d) Time period for completion of duties.--The committee |
13 | shall complete its work within one year of the effective date of |
14 | this section. |
15 | Section 12. Effective date. |
16 | This act shall take effect in 60 days. |
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