Full Text of SB0757 103rd General Assembly
SB0757eng 103RD GENERAL ASSEMBLY |
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| 1 | | AN ACT concerning regulation.
| 2 | | Be it enacted by the People of the State of Illinois,
| 3 | | represented in the General Assembly:
| 4 | | Section 5. The Illinois Insurance Code is amended by | 5 | | adding Section 513b7 as follows: | 6 | | (215 ILCS 5/513b7 new) | 7 | | Sec. 513b7. Pharmacy audits. | 8 | | (a) As used in this Section: | 9 | | "Audit" means any physical on-site, remote electronic, or | 10 | | concurrent review of a pharmacist service submitted to the | 11 | | pharmacy benefit manager or pharmacy benefit manager affiliate | 12 | | by a pharmacist or pharmacy for payment. | 13 | | "Auditing entity" means a person or company that performs | 14 | | a pharmacy audit. | 15 | | "Extrapolation" means the practice of inferring a | 16 | | frequency of dollar amount of overpayments, underpayments, | 17 | | nonvalid claims, or other errors on any portion of claims | 18 | | submitted, based on the frequency of dollar amount of | 19 | | overpayments, underpayments, nonvalid claims, or other errors | 20 | | actually measured in a sample of claims. | 21 | | "Misfill" means a prescription that was not dispensed; a | 22 | | prescription that was dispensed but was an incorrect dose, | 23 | | amount, or type of medication; a prescription that was |
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| 1 | | dispensed to the wrong person; a prescription in which the | 2 | | prescriber denied the authorization request; or a prescription | 3 | | in which an additional dispensing fee was charged. | 4 | | "Pharmacy audit" means an audit conducted of any records | 5 | | of a pharmacy for prescriptions dispensed or nonproprietary | 6 | | drugs or pharmacist services provided by a pharmacy or | 7 | | pharmacist to a covered person. | 8 | | "Pharmacy record" means any record stored electronically | 9 | | or as a hard copy by a pharmacy that relates to the provision | 10 | | of a prescription or pharmacy services or other component of | 11 | | pharmacist care that is included in the practice of pharmacy. | 12 | | (b) Notwithstanding any other law, when conducting a | 13 | | pharmacy audit, an auditing entity shall: | 14 | | (1) not conduct an on-site audit of a pharmacy at any | 15 | | time during the first 3 business days of a month or the | 16 | | first 2 weeks and final 2 weeks of the calendar year or | 17 | | during a declared State or federal public health | 18 | | emergency; | 19 | | (2) notify the pharmacy or its contracting agent no | 20 | | later than 14 business days before the date of initial | 21 | | on-site audit; the notification to the pharmacy or its | 22 | | contracting agent shall be in writing and delivered | 23 | | either: | 24 | | (A) by mail or common carrier, return receipt | 25 | | requested; or | 26 | | (B) electronically, not including facsimilie, with |
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| 1 | | electronic receipt confirmation and delivered during | 2 | | normal business hours of operation, addressed to the | 3 | | supervising pharmacist and pharmacy corporate office, | 4 | | if applicable, at least 14 business days before the | 5 | | date of an initial on-site audit; | 6 | | (3) limit the audit period to 24 months after the date | 7 | | a claim is submitted to or adjudicated by the pharmacy | 8 | | benefit manager; | 9 | | (4) provide in writing the list of specific | 10 | | prescription numbers to be included in the audit 14 | 11 | | business days before the on-site audit that may or may not | 12 | | include the final 2 digits of the prescription numbers; | 13 | | (5) use the written and verifiable records of a | 14 | | hospital, physician, or other authorized practitioner that | 15 | | are transmitted by any means of communication to validate | 16 | | the pharmacy records in accordance with State and federal | 17 | | law; | 18 | | (6) limit the number of prescriptions audited to no | 19 | | more than 100 prescriptions per audit and an entity shall | 20 | | not audit more than 200 prescriptions in any 12-month | 21 | | period, except in cases of fraud, waste, or abuse; a | 22 | | refill shall not constitute a separate prescription and a | 23 | | pharmacy shall not be audited more than once every 6 | 24 | | months; | 25 | | (7) provide the pharmacy or its contracting agent with | 26 | | a copy of the preliminary audit report within 45 days |
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| 1 | | after the conclusion of the audit; | 2 | | (8) be allowed to conduct a follow-up audit on site if | 3 | | a remote or desk audit reveals the necessity for a review | 4 | | of additional claims; | 5 | | (9) accept invoice audits as validation invoices from | 6 | | any wholesaler registered with the Department of Financial | 7 | | and Professional Regulation from which the pharmacy has | 8 | | purchased prescription drugs or, in the case of durable | 9 | | medical equipment or sickroom supplies, invoices from an | 10 | | authorized distributor other than a wholesaler; | 11 | | (10) provide the pharmacy or its contracting agent | 12 | | with the ability to provide documentation to address a | 13 | | discrepancy or audit finding if the documentation is | 14 | | received by the pharmacy benefit manager no later than the | 15 | | 45th day after the preliminary audit report was provided | 16 | | to the pharmacy or its contracting agent; the pharmacy | 17 | | benefit manager shall consider a reasonable request from | 18 | | the pharmacy for an extension of time to submit | 19 | | documentation to address or correct any findings in the | 20 | | report; | 21 | | (11) be required to provide the pharmacy or its | 22 | | contracting agent with the final audit report no later | 23 | | than 90 days after the initial audit report was provided | 24 | | to the pharmacy or its contracting agent; | 25 | | (12) conduct the audit in consultation with a | 26 | | pharmacist in specific cases if the audit involves |
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| 1 | | clinical or professional judgment; | 2 | | (13) not chargeback, recoup, or collect penalties from | 3 | | a pharmacy until the time period to file an appeal of the | 4 | | final pharmacy audit report has passed or the appeals | 5 | | process has been exhausted, whichever is later, unless the | 6 | | identified discrepancy is expected to exceed $25,000, in | 7 | | which case the auditing entity may withhold future | 8 | | payments in excess of that amount until the final | 9 | | resolution of the audit; | 10 | | (14) not compensate the employee or contractor | 11 | | conducting the audit based on a percentage of the amount | 12 | | claimed or recouped pursuant to the audit; | 13 | | (15) not use extrapolation to calculate penalties or | 14 | | amounts to be charged back or recouped unless otherwise | 15 | | required by federal law or regulation; any amount to be | 16 | | charged back or recouped due to overpayment may not exceed | 17 | | the amount the pharmacy was overpaid; | 18 | | (16) not include dispensing fees in the calculation of | 19 | | overpayments unless a prescription is considered a | 20 | | misfill, the medication is not delivered to the patient, | 21 | | the prescription is not valid, or the prescriber denies | 22 | | authorizing the prescription; and | 23 | | (17) conduct a pharmacy audit under the same standards | 24 | | and parameters as conducted for other similarly situated | 25 | | pharmacies audited by the auditing entity. | 26 | | (c) Except as otherwise provided by State or federal law, |
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| 1 | | an auditing entity conducting a pharmacy audit may have access | 2 | | to a pharmacy's previous audit report only if the report was | 3 | | prepared by that auditing entity. | 4 | | (d) Information collected during a pharmacy audit shall be | 5 | | confidential by law, except that the auditing entity | 6 | | conducting the pharmacy audit may share the information with | 7 | | the health benefit plan for which a pharmacy audit is being | 8 | | conducted and with any regulatory agencies and law enforcement | 9 | | agencies as required by law. | 10 | | (e) A pharmacy may not be subject to a chargeback or | 11 | | recoupment for a clerical or recordkeeping error in a required | 12 | | document or record, including a typographical error or | 13 | | computer error, unless the pharmacy benefit manager can | 14 | | provide proof of intent to commit fraud or such error results | 15 | | in actual financial harm to the pharmacy benefit manager, a | 16 | | health plan managed by the pharmacy benefit manager, or a | 17 | | consumer. | 18 | | (f) A pharmacy shall have the right to file a written | 19 | | appeal of a preliminary and final pharmacy audit report in | 20 | | accordance with the procedures established by the entity | 21 | | conducting the pharmacy audit. | 22 | | (g) No interest shall accrue for any party during the | 23 | | audit period, beginning with the notice of the pharmacy audit | 24 | | and ending with the conclusion of the appeals process. | 25 | | (h) An auditing entity must provide a copy to the plan | 26 | | sponsor of its claims that were included in the audit, and any |
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| 1 | | recouped money shall be returned to the plan sponsor, unless | 2 | | otherwise contractually agreed upon by the plan sponsor and | 3 | | the pharmacy benefit manager. | 4 | | (i) The parameters of an audit must comply with | 5 | | manufacturer listings or recommendations, unless otherwise | 6 | | prescribed by the treating provider, and must be covered under | 7 | | the individual's health plan, for the following: | 8 | | (1) the day supply for eyedrops must be calculated so | 9 | | that the consumer pays only one 30-day copayment if the | 10 | | bottle of eyedrops is intended by the manufacturer to be a | 11 | | 30-day supply; | 12 | | (2) the day supply for insulin must be calculated so | 13 | | that the highest dose prescribed is used to determine the | 14 | | day supply and consumer copayment; and | 15 | | (3) the day supply for topical product must be | 16 | | determined by the judgment of the pharmacist or treating | 17 | | provider upon the treated area. | 18 | | (j) This Section shall not apply to: | 19 | | (1) audits in which suspected fraud, waste, or abuse | 20 | | or other intentional or willful misrepresentation is | 21 | | evidenced by a physical review, review of claims data or | 22 | | statements, or other investigative methods; | 23 | | (2) audits of claims paid for by federally funded | 24 | | programs; or | 25 | | (3) concurrent reviews or desk audits that occur | 26 | | within 3 business days after transmission of a claim and |
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| 1 | | in which no chargeback or recoupment is demanded.
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