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To enact sections 3901.41, 3901.411, 3901.412, | 1 |
3901.413, 3901.414, and 3901.415 of the Revised | 2 |
Code to establish standards for the performance of | 3 |
pharmacy audits in Ohio. | 4 |
Section 1. That sections 3901.41, 3901.411, 3901.412, | 5 |
3901.413, 3901.414, and 3901.415 of the Revised Code be enacted to | 6 |
read as follows: | 7 |
Sec. 3901.41. As used in this section and sections 3901.411 | 8 |
to 3901.415 of the Revised Code: | 9 |
(A) "Auditing entity" means any person or government entity | 10 |
that performs a pharmacy audit, including a payer, a pharmacy | 11 |
benefit manager, or a third-party administrator licensed under | 12 |
Chapter 3959. of the Revised Code. | 13 |
(B) "Business day" means any day of the week excluding | 14 |
Saturday, Sunday, and a legal holiday, as defined in section 1.14 | 15 |
of the Revised Code. | 16 |
(C) "Concurrent review" means a claims review within five | 17 |
business days of submission of claims for payment for the | 18 |
provision of dangerous drugs for which the payer or the auditing | 19 |
entity does not impose a penalty or demand to recoup money from | 20 |
the pharmacy in any amount. | 21 |
(D) "Dangerous drug," "pharmacy," "practice of pharmacy," and | 22 |
"prescription" have the same meanings as in section 4729.01 of the | 23 |
Revised Code. | 24 |
(E) "Payer" means any of the following that pays for or | 25 |
processes a claim for payment for the provision of dangerous drugs | 26 |
or pharmacy services: | 27 |
(1) A health insuring corporation, as defined in section | 28 |
1751.01 of the Revised Code; | 29 |
(2) A person authorized to engage in the business of sickness | 30 |
and accident insurance under Title XXXIX of the Revised Code; | 31 |
(3) A person or government entity providing coverage of | 32 |
dangerous drugs or pharmacy services to individuals on a | 33 |
self-insurance basis; | 34 |
(4) A group health plan, as defined in 29 U.S.C. 1167; | 35 |
(5) A service benefit plan, as referenced in 42 U.S.C. | 36 |
1396a(a)(25); | 37 |
(6) A medicaid managed care organization that has entered | 38 |
into a contract with the department of medicaid pursuant to | 39 |
section 5167.10 of the Revised Code; | 40 |
(7) Any other person or government entity that is, by law, | 41 |
contract, or agreement, responsible for paying for or processing a | 42 |
claim for payment for the provision of dangerous drugs or pharmacy | 43 |
services. | 44 |
(F) "Pharmacy audit" means a review of one or more pharmacy | 45 |
records conducted by an auditing entity, one purpose of which is | 46 |
to identify discrepancies in claims for payment for the provision | 47 |
of dangerous drugs or pharmacy services. "Pharmacy audit" does not | 48 |
include concurrent review. | 49 |
(G) "Pharmacy benefit manager" means a person that provides | 50 |
administrative services related to the processing of claims for | 51 |
payment for the provision of dangerous drugs or pharmacy services, | 52 |
including performing pharmacy audit compliance, negotiating | 53 |
pharmaceutical rebate agreements, developing and managing drug | 54 |
formularies and preferred drug lists, and administering programs | 55 |
for payers' prior authorization of claims for payment for the | 56 |
provision of dangerous drugs or pharmacy services. | 57 |
(H) "Pharmacy record" means any record stored electronically | 58 |
or as a hard copy by a pharmacy that relates to the provision of | 59 |
dangerous drugs or pharmacy services or any other component of | 60 |
pharmacist care that is included in the practice of pharmacy. | 61 |
Sec. 3901.411. (A) Except as provided in division (B) of | 62 |
this section, an auditing entity is subject to all of the | 63 |
following conditions when performing a pharmacy audit in this | 64 |
state on or after April 1, 2014: | 65 |
(1) If it is necessary that the pharmacy audit be performed | 66 |
on the premises of a pharmacy, the auditing entity shall give the | 67 |
pharmacy that is the subject of the audit written notice of the | 68 |
date or dates on which the audit will be performed and the range | 69 |
of prescription numbers from which the auditing entity will select | 70 |
pharmacy records to audit. Notice of the date or dates on which | 71 |
the audit will be performed shall be given not less than ten | 72 |
business days before the date the audit is to commence. Notice of | 73 |
the range of prescription numbers from which the auditing entity | 74 |
will select pharmacy records to audit shall be received by the | 75 |
pharmacy not less than seven business days before the date of the | 76 |
audit is to commence. | 77 |
(2) The auditing entity shall not include in the pharmacy | 78 |
audit a review of a claim for payment for the provision of | 79 |
dangerous drugs or pharmacy services if the date of the pharmacy's | 80 |
initial submission of the claim for payment occurred more than | 81 |
twenty-four months before the date the audit commences. | 82 |
(3) Absent an indication that there was an error in the | 83 |
dispensing of a drug, the auditing entity or payer shall not seek | 84 |
to recoup from the pharmacy that is the subject of the audit any | 85 |
amount that the pharmacy audit identifies as being the result of | 86 |
clerical or recordkeeping errors in the absence of financial harm. | 87 |
For purposes of this provision, an error in the dispensing of a | 88 |
drug is any of the following: selecting an incorrect drug, issuing | 89 |
incorrect directions, or dispensing a drug to the incorrect | 90 |
patient. | 91 |
(4) The auditing entity shall not use the accounting practice | 92 |
of extrapolation when calculating a monetary penalty to be imposed | 93 |
or amount to be recouped as the result of the pharmacy audit. | 94 |
(B)(1) The condition in division (A)(1) of this section does | 95 |
not apply if, prior to the audit, the auditing entity has | 96 |
evidence, from its review of claims data, statements, or physical | 97 |
evidence or its use of other investigative methods, indicating | 98 |
that fraud or other intentional or willful misrepresentation | 99 |
exists. | 100 |
(2) The condition in division (A)(3) of this section does not | 101 |
apply if the auditing entity has evidence, from its review of | 102 |
claims data, statements, or physical evidence or its use of other | 103 |
investigative methods, indicating that fraud or other intentional | 104 |
or willful misrepresentation exists. | 105 |
(3) Division (A)(4) of this section does not apply when the | 106 |
accounting practice of extrapolation is required by state or | 107 |
federal law. | 108 |
Sec. 3901.412. A pharmacy may do any of the following when a | 109 |
pharmacy audit is performed: | 110 |
(A) Validate a pharmacy record by using original or | 111 |
photocopied records from hospitals, physicians, or other health | 112 |
care providers; | 113 |
(B) Validate one or more claims for payment for the provision | 114 |
of dangerous drugs or pharmacy services by using either of the | 115 |
following: | 116 |
(1) An original pharmacy record or photocopy of the record; | 117 |
(2) An original prescription or photocopy of the prescription | 118 |
in any form that constitutes a valid prescription in this state, | 119 |
including a written prescription, a prescription made through an | 120 |
electronic prescribing system, a prescription delivered by | 121 |
facsimile, a prescription made by issuing an order for medication | 122 |
administration, and the record a pharmacist maintains under | 123 |
section 4729.37 of the Revised Code documenting a prescription | 124 |
received by telephone. | 125 |
(C) Resubmit a disputed or denied claim for payment using any | 126 |
commercially reasonable method of resubmission, including | 127 |
resubmission by facsimile, mail, or electronic means, as long as | 128 |
the time period for resubmissions established by the relevant | 129 |
payer has not expired. | 130 |
Sec. 3901.413. (A) Except as provided in division (B) of | 131 |
this section, all of the following apply after a pharmacy audit is | 132 |
completed: | 133 |
(1) A pharmacy shall be given not less than thirty days from | 134 |
the date of the on-sight audit to provide the auditing entity any | 135 |
additional information necessary to complete the preliminary audit | 136 |
report. | 137 |
(2) Not later than sixty business days after the audit is | 138 |
completed, the auditing entity shall deliver a preliminary audit | 139 |
report to the pharmacy that was the subject of the audit. | 140 |
(3) A pharmacy that disputes any finding in the preliminary | 141 |
audit report may submit documentation to the auditing entity to | 142 |
appeal the finding. A pharmacy shall be given not less than thirty | 143 |
business days to make the submission and may request an extension | 144 |
of the time period given. The auditing entity shall grant a | 145 |
request for an extension if it is reasonable. | 146 |
A pharmacy's submission of documentation to appeal the | 147 |
finding shall be made in accordance with the procedure the | 148 |
auditing entity has established under section 3901.414 of the | 149 |
Revised Code. | 150 |
(4)(a) An auditing entity shall deliver a final audit report | 151 |
to the pharmacy that was the subject of the audit. Except as | 152 |
provided in division (A)(4)(b) of this section, the report shall | 153 |
be delivered not later than one hundred twenty business days after | 154 |
the later of a pharmacy's receipt of a preliminary audit report. | 155 |
(b) If an auditing entity has granted a pharmacy's request | 156 |
for an extension of the time to submit documentation to appeal a | 157 |
finding in the preliminary audit report under division (A)(3) of | 158 |
this section, the time limit described in division (A)(4)(a) of | 159 |
this section for the delivery of the final audit report is waived. | 160 |
Instead, the auditing entity shall deliver the final audit report | 161 |
not later than one hundred twenty days after the pharmacy's | 162 |
submission of the documentation. | 163 |
(B) The provisions of division (A) of this section do not | 164 |
apply if the auditing entity has evidence, from its review of | 165 |
claims data, statements, or physical evidence or its use of other | 166 |
investigative methods, indicating that fraud or other intentional | 167 |
or willful misrepresentation exists. | 168 |
Sec. 3901.414. Each auditing entity in this state shall | 169 |
establish in writing separate procedures for a pharmacy to appeal | 170 |
one or more findings in a preliminary audit report issued under | 171 |
section 3901.413 of the Revised Code. | 172 |
Sec. 3901.415. Sections 3901.411 to 3901.414 of the Revised | 173 |
Code shall not apply to an auditing entity that is a medicaid | 174 |
managed care organization if application of those sections to the | 175 |
entity would be in violation of federal law. | 176 |