HLS 19RS-797 ENGROSSED
2019 Regular Session
HOUSE BILL NO. 538
BY REPRESENTATIVE LEBAS
Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana.
PHARMACISTS: Provides relative to pharmacy record audits
1 AN ACT
2To amend and reenact R.S. 22:1856.1(B)(introductory paragraph), (2), (3), (7)(b), and (8),
3 (D)(1)(introductory paragraph) and (2)(introductory paragraph), and (F), to enact
4 R.S. 22:1856.1(D)(3), and to repeal R.S. 22:1856.1(G)(3) and (4), relative to
5 pharmacy record audits; to provide for applicability of laws relative to such audits;
6 to provide relative to procedures for such audits; to repeal provisions relative to
7 onsite audits; to provide relative to audits conducted by or in consultation with
8 licensed pharmacists; to provide limitations on recoupment of reimbursements paid
9 to pharmacists; and to provide for related matters.
10Be it enacted by the Legislature of Louisiana:
11 Section 1. R.S. 22:1856.1(B)(introductory paragraph), (2), (3), (7)(b), and (8),
12(D)(1)(introductory paragraph) and (2)(introductory paragraph), and (F) are hereby amended
13and reenacted and R.S. 22:1856.1(D)(3) is hereby enacted to read as follows:
14 ยง1856.1. Pharmacy record audits; recoupment; appeals
15 * * *
16 B. Notwithstanding any other provision of law to the contrary, when an
17 onsite audit of the records of a pharmacy is conducted by an entity, the audit shall
18 be conducted in accordance with the following criteria:
19 * * *
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HB NO. 538
1 (2) No entity shall conduct an on-site audit at a particular pharmacy more
2 than one time annually. However, the provisions of this Paragraph shall not apply
3 when an entity must return to a pharmacy to complete an audit already in progress,
4 or there is an identified history of errors, an identified activity which a reasonable
5 man would believe to be inappropriate, or illegal activity that the entity has brought
6 to the attention of the pharmacy owner or corporate headquarters of the pharmacy.
7 (3)(a) The entity or any vendor or subcontractor of the entity which conducts
8 the initial onsite audit shall give the pharmacy notice at least two weeks before
9 conducting the initial onsite audit for each audit cycle.
10 (b) If the audit, review, or investigation is initiated based on or involves
11 alleged fraud or willful misrepresentation, notice before the initial on-site audit is not
12 mandatory where it could impede the audit, review, or investigation.
13 * * *
14 (7)
15 * * *
16 (b) A pharmacy shall be allowed at least thirty days following receipt of the
17 preliminary audit report in which to initiate an appeal to address any discrepancy
18 found during an on-site audit, as provided in Subsection E of this Section.
19 * * *
20 (8) Any audit which involves clinical judgment shall be conducted by or in
21 consultation with a licensed pharmacist licensed in Louisiana.
22 * * *
23 D.(1) No pharmacy shall be subject to recoupment of any portion of the
24 reimbursement for the dispensed product of a prescription unless one or more of the
25 following has occurred at the point of adjudication:
26 * * *
27 (2) Recoupment of claims shall be based on the actual financial harm to the
28 entity, or on the actual overpayment or underpayment, at the point of adjudication.
29 A finding of an overpayment that is the result of dispensing in excess of the benefit
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HB NO. 538
1 design, as established by the plan sponsor, shall be calculated as the difference
2 between what was dispensed in accordance with the prescriber's orders and the
3 dispensing requirements as set forth by the benefit design. Calculations of
4 overpayments shall not include dispensing fees unless one or more of the following
5 conditions has been satisfied:
6 * * *
7 (3) If any entity determines that the processed or adjudicated claim of a
8 pharmacy qualifies for recoupment based upon the use of manufacturer coupon or
9 copay card, such recoupment shall come from the beneficiary of the reduction if the
10 product is approved by the United States Food and Drug Administration through the
11 new drug application process or abbreviated new drug application, or is an
12 investigational drug which is a biological product as defined in R.S. 40:1169.3.
13 * * *
14 F. Unless otherwise provided for in the network agreement, pharmacies or
15 payors may seek mediation to resolve contractual disputes related to pricing or
16 on-site audits.
17 * * *
18 Section 2. R.S. 22:1856.1(G)(3) and (4) are hereby repealed in their entirety.
DIGEST
The digest printed below was prepared by House Legislative Services. It constitutes no part
of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute
part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)]
HB 538 Engrossed 2019 Regular Session LeBas
Abstract: Provides relative to conditions and procedures for pharmacy record audits.
Present law provides criteria for auditing of pharmacy records, including a protocol for
onsite audits, by the following entities:
(1)Managed care companies.
(2)Insurance companies.
(3)Third-party payors.
(4)Representatives of managed care companies including pharmacy benefit managers,
insurance companies, and third-party payors.
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HB NO. 538
Proposed law repeals all provisions relative to onsite audits of pharmacy records by these
entities.
Present law requires that any audit involving clinical judgment be conducted by or in
consultation with a licensed pharmacist. Proposed law revises present law to require that
such audits be conducted by or in consultation with a pharmacist who is licensed in this
state.
Present law provides that no pharmacy shall be subject to recoupment of any portion of the
reimbursement for the dispensed product of a prescription unless certain conditions are met.
Proposed law revises present law to require that these conditions occur at the point of
adjudication in order for the pharmacy to be subject to recoupment.
Proposed law stipulates that if any entity determines that the processed or adjudicated
pharmacy claim qualifies for recoupment based upon the use of a manufacturer coupon or
copay card, then the recoupment shall come from the beneficiary of the reduction if the
product is approved by the U.S. Food and Drug Administration through the new drug
application process or abbreviated new drug application, or is an investigational drug which
is a biological product as defined in present law.
Proposed law repeals present law relative to pharmacy record audits providing that present
law shall not apply to any federally funded activity specifically preempted by law or rule,
or to any audit conducted pursuant to the participation of a pharmacy in the La. Medicaid
program.
(Amends R.S. 22:1856.1(B)(intro. para.), (2), (3), (7)(b), and (8), (D)(1)(intro. para.) and
(2)(intro. para.), and (F); Adds R.S. 22:1856.1(D)(3); Repeals 22:1856.1(G)(3) and (4))
Summary of Amendments Adopted by House
The Committee Amendments Proposed by House Committee on Health and Welfare to
the original bill:
1. Delete proposed law providing that any audit of a pharmacy with its principal
place of business in this state shall be conducted by a pharmacist licensed in
Louisiana. Provide instead that any audit which involves clinical judgment shall
be conducted by or in consultation with a pharmacist licensed in Louisiana.
2. Provide that proposed law relative to recoupment based upon the use of a
manufacturer coupon or copay card shall apply only if the product is approved
by the U.S. Food and Drug Administration through the new drug application
process or abbreviated new drug application, or is an investigational drug which
is a biological product as defined in present law.
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CODING: Words in struck through type are deletions from existing law; words underscored
are additions.