HLS 13RS-973 ORIGINAL
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Regular Session, 2013
HOUSE BILL NO. 393
BY REPRESENTATIVES ANDERS AND STUART BISHOP
Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana.
MEDICAID: Provides relative to prescription drug benefits of managed care organizations
participating in the La. Medicaid coordinated care network program
AN ACT1
To enact Part XI of Chapter 3 of Title 46 of the Louisiana Revised Statutes of 1950, to be2
comprised of R.S. 46:460.31 through 460.34, relative to the medical assistance3
program; to provide relative to managed care organizations which provide health4
care services to medical assistance program enrollees; to provide relative to5
prescription drugs; to create and provide for composition and duties of the Medicaid6
Managed Care Pharmaceutical and Therapeutics Committee; to provide for a7
minimum drug formulary; to provide for approval of a drug pharmacopoeia by8
certain legislative committees; to provide for a standard form for the prior9
authorization of prescription drugs; to provide for certain procedures relative to step10
therapy and fail first protocols; to provide for promulgation of rules; and to provide11
for related matters.12
Be it enacted by the Legislature of Louisiana:13
Section 1. Part XI of Chapter 3 of Title 46 of the Louisiana Revised Statutes of 1950,14
comprised of R.S. 46:460.31 through 460.34, is hereby enacted to read as follows:15
PART XI. MEDICAID MANAGED CARE PRESCRIPTION DRUG BENEFITS16
§460.31. Definitions17
As used in this Part, the following terms shall have the meaning ascribed to18
them in this Section unless the context clearly indicates otherwise:19
(1) "Department" means the Department of Health and Hospitals.20 HLS 13RS-973 ORIGINAL
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(2) "Committee" means the Medicaid Managed Care Pharmaceutical and1
Therapeutics Committee created by this Part.2
(3) "Managed care organization" shall have the same meaning as provided3
for that term in 42 CFR 438.2 and shall also mean any entity providing primary care4
case management services to Medicaid recipients pursuant to a contract with the5
department.6
(4) "Medicaid" and "medical assistance program" mean the medical7
assistance program provided for in Title XIX of the Social Security Act.8
(5) "Primary care case management" means a system in which an entity9
contracts with the state to furnish case management services, which include but are10
not limited to the location, coordination, and monitoring of primary health care11
service to Medicaid beneficiaries.12
(6) "Secretary" means the secretary of the Department of Health and13
Hospitals.14
§460.32. Formulary; Medicaid Managed Care Pharmaceutical and Therapeutics15
Committee16
A. Beginning January 1, 2014, all managed care organizations shall provide17
as a pharmacy benefit the minimum drug pharmacopoeia in conjunction with a prior18
approval process which is developed and maintained by the Medicaid Managed Care19
Pharmaceutical and Therapeutics Committee pursuant to the provisions of this20
Section. Nothing in this Part shall prohibit a managed care organization from21
providing drug benefits which are not listed on the minimum drug pharmacopoeia.22
B.(1) The Medicaid Managed Care Pharmaceutical and Therapeutics23
Committee, hereinafter referred to as the "committee", is hereby created within the24
Department of Health and Hospitals. The committee shall be composed of members25
as provided in this Subsection who are appointed by the governor and submitted to26
the Senate for confirmation. The committee shall be representative of the state's27
geographic and demographic composition, including women and minorities.28
(2) The committee shall be comprised of sixteen members as follows:29 HLS 13RS-973 ORIGINAL
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(a) Two physicians nominated by each managed care organization with1
expertise in the area of pharmacology.2
(b) One practicing physician who is participating in the Medicaid program3
as a family practitioner recommended from a list of three names submitted by the4
Louisiana Academy of Family Physicians.5
(c) One practicing physician who is participating in the Medicaid program6
as an internal medicine specialist recommended from a list of three names submitted7
by the Louisiana State Medical Society.8
(d) One practicing physician who is participating in the Medicaid program9
as a pediatrician recommended from a list of three names submitted by the Louisiana10
Chapter of the American Academy of Pediatrics.11
(e) One practicing physician who is participating in the Medicaid program12
as an obstetrician and gynecologist recommended from a list of three names13
submitted by the Louisiana Chapter of the American College of Obstetricians and14
Gynecologists.15
(f) One practicing physician who is participating in the Medicaid program16
as a psychiatrist recommended from a list of three names submitted by the Louisiana17
Psychiatric Medical Association.18
(g) Two practicing physicians who are participating in the Medicaid program19
recommended from a list of six names submitted by the Louisiana Medical20
Association.21
(h) Two practicing pharmacists who are participating in the Medicaid22
pharmacy program recommended from a list of six names submitted by the23
Louisiana Pharmacy Association. One pharmacist shall be an independent24
pharmacist, and one pharmacist shall be a pharmacist representing a chain pharmacy.25
(i) The secretary of the Department of Health and Hospitals or his designee.26
(j) The director of the Medicaid program in the Department of Health and27
Hospitals or his designee.28
(k) The president of the Senate or his designee.29 HLS 13RS-973 ORIGINAL
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(l) The speaker of the House of Representatives or his designee.1
(m) A Medicaid recipient who is enrolled with a prepaid entity.2
(3) Other physicians who participate in the Medicaid program in various3
subspecialties may act as consultants to the committee as needed.4
(4) Members of the committee shall be governed by either the Code of5
Governmental Ethics, R.S. 42:1101 et seq., or the code of ethics of their respective6
profession.7
(5) The committee shall meet only in public and shall permit public8
comment prior to voting on any changes in the preferred drug list. Minutes of each9
meeting shall be made available to the public within five days after the minutes are10
approved by the committee. All documents that are distributed to the committee and11
not subject to state or federal confidentiality laws shall be made available to the12
public within five days after the committee meets.13
(6) The pharmacopoeia developed by the committee shall comply with all14
applicable state and federal laws, rules, and regulations. The committee may15
recommend additions and deletions to the pharmacopoeia, and the pharmacopoeia16
may change in accordance with those recommendations. The committee shall also17
advise the secretary on policy recommendations related to the prudent administration18
of the Medicaid managed care drug program. The secretary shall ensure that all19
actions of the committee comply with applicable state and federal laws, rules, and20
regulations prior to implementation or modification of the pharmacopoeia. The21
clinical decisions regarding the preferred drug list shall be made transparent through22
a written report that is publicly available. If a decision of the committee is contrary23
to clinical evidence found in labeling, drug compendia, or peer reviewed literature,24
such decisions shall be justified in writing.25
(7) The committee may establish a drug list to be utilized by all managed26
care organizations that utilize a prior approval process or any other process or27
combination of processes that prove to be cost-effective in the medical assistance28 HLS 13RS-973 ORIGINAL
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program. At minimum, any prior approval process shall meet all of the following1
criteria:2
(a) Provide for a response by telephone or other form of telecommunication3
device within a maximum of twenty-four hours of a request for prior authorization.4
(b) Provide for the dispensing of a minimum of a seventy-two hour supply5
of a covered outpatient prescription drug in an emergency situation as provided by6
federal rule or regulation.7
(c) Comply with all applicable federal laws, rules, and regulations.8
(d) Involve medical personnel, including but not limited to pharmacists,9
pharmacy technicians, nurses, and physicians.10
(e) Assure that a qualified, licensed physician is available for consultation11
during the prior approval process.12
(8) Any drug approved by the United States Food and Drug Administration13
shall be added to the formulary as soon as it becomes commercially available. The14
committee shall conduct an evidence-based analysis of the drug to determine if the15
drug shall be maintained on the formulary. The analysis shall include but not be16
limited to the medical evidence of the clinical effectiveness of the drug as well as17
evidence of the cost-effectiveness of the drug in treating illness and disease. The18
determination by the committee on any new drug approval by the United States Food19
and Drug Administration shall be made no later than ninety days after the drug20
becomes commercially available. Prior to a drug being prior authorized, it must have21
been reviewed by the committee.22
(9) The department shall not implement the pharmacopoeia authorized by23
this Section until the initial pharmacopoeia is submitted to and approved by the24
House and Senate committees on health and welfare. The committees may only25
approve or reject the pharmacopoeia and may not add specific drugs to or delete26
specific drugs from the pharmacopoeia.27 HLS 13RS-973 ORIGINAL
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C. The department is hereby authorized to promulgate all such rules and1
regulations, in accordance with the Administrative Procedure Act, as are necessary2
to implement the provisions of this Section.3
§460.33. Prior authorization form; requirements4
A. Beginning January 1, 2014, all managed care organizations shall utilize5
a single-page prior authorization form duly promulgated by the department in6
accordance with the Administrative Procedure Act.7
B. The department shall promulgate rules and regulations prior to January8
1, 2014, that establish the form which shall be utilized by all managed care9
organizations. The department may consult with the managed care organizations as10
necessary in development of the prior authorization form.11
§460.34. Step therapy; fail first protocols; requirements12
A. Each managed care organization which utilizes step therapy or fail first13
protocols shall comply with the provisions of this Section.14
B. When medications for the treatment of any medical condition are15
restricted for use by a managed care organization by a step therapy or fail first16
protocol, the prescribing physician shall be provided with and have access to a clear17
and convenient process to expeditiously request an override of such restriction from18
the managed care organization. The managed care organization shall expeditiously19
grant an override of such restriction under any of the following circumstances:20
(1) The prescribing physician can demonstrate to the managed care21
organization, based on sound clinical evidence, that the preferred treatment required22
under step therapy or fail first protocol has been ineffective in the treatment of the23
Medicaid enrollee's disease or medical condition.24
(2) The prescribing physician can demonstrate to the managed care25
organization, based on sound clinical evidence, that the preferred treatment required26
under the step therapy or fail first protocol is reasonably expected to be ineffective27
based on the known relevant physical or mental characteristics and medical history28
of the Medicaid enrollee and known characteristics of the drug regimen.29 HLS 13RS-973 ORIGINAL
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(3) The prescribing physician can demonstrate to the managed care1
organization, based on sound clinical evidence, that the preferred treatment required2
under the step therapy or fail first protocol will cause or will likely cause an adverse3
reaction or other physical harm to the Medicaid enrollee.4
C. The duration of any step therapy or fail first protocol shall not be longer5
in duration than the customary period for the medication when such treatment is6
demonstrated by the prescribing physician to be clinically ineffective. When the7
managed care organization can demonstrate, through sound clinical evidence, that8
the originally prescribed medication is likely to require more than the customary9
period for such medication to provide any relief or an amelioration to the Medicaid10
enrollee, the step therapy or fail first protocol may be extended for an additional11
period of time no longer than the original customary period for the medication.12
Section 2. This Act shall become effective upon signature by the governor or, if not13
signed by the governor, upon expiration of the time for bills to become law without signature14
by the governor, as provided by Article III, Section 18 of the Constitution of Louisiana. If15
vetoed by the governor and subsequently approved by the legislature, this Act shall become16
effective on the day following such approval.17
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)]
Anders HB No. 393
Abstract: Provides relative to prescription drug benefits of managed care organizations
participating in the La. Medicaid coordinated care network program.
Provisions relative to Medicaid Managed Care Pharmaceutical and Therapeutics
Committee and drug formulary:
Proposed law requires, beginning Jan. 1, 2014, that all managed care organizations
participating in the La. Medicaid program provide as a pharmacy benefit the minimum drug
pharmacopoeia in conjunction with a prior approval process developed by the Medicaid
Managed Care Pharmaceutical and Therapeutics Committee established by proposed law.
Provides that nothing in proposed law shall prohibit a managed care organization from
providing drug benefits which are not listed on the minimum drug pharmacopoeia.
Proposed law creates the Medicaid Managed Care Pharmaceutical and Therapeutics
Committee ("committee") within the Department of Health and Hospitals (DHH). Provides HLS 13RS-973 ORIGINAL
HB NO. 393
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that the committee shall be composed of 16 members appointed by the governor and
submitted to the Senate for confirmation. Further provides that the committee shall be
representative of the state's geographic and demographic composition, including women and
minorities.
Proposed law provides that the committee shall be comprised of the following persons:
(1)Two physicians nominated by each managed care organization with expertise in the
area of pharmacology.
(2)One practicing physician who is participating in the Medicaid program as a family
practitioner recommended from a list of three names submitted by the Louisiana
Academy of Family Physicians.
(3)One practicing physician who is participating in the Medicaid program as an internal
medicine specialist recommended from a list of three names submitted by the
Louisiana State Medical Society.
(4)One practicing physician who is participating in the Medicaid program as a
pediatrician recommended from a list of three names submitted by the Louisiana
Chapter of the American Academy of Pediatrics.
(5)One practicing physician who is participating in the Medicaid program as an
obstetrician and gynecologist recommended from a list of three names submitted by
the Louisiana Chapter of the American College of Obstetricians and Gynecologists.
(6)One practicing physician who is participating in the Medicaid program as a
psychiatrist recommended from a list of three names submitted by the Louisiana
Psychiatric Medical Association.
(7)Two practicing physicians who are participating in the Medicaid program
recommended from a list of six names submitted by the Louisiana Medical
Association.
(8)Two practicing pharmacists who are participating in the Medicaid pharmacy program
recommended from a list of six names submitted by the Louisiana Pharmacy
Association. One pharmacist shall be an independent pharmacist and one pharmacist
shall be a pharmacist representing a chain pharmacy.
(9)The secretary of DHH or his designee.
(10)The director of the Medicaid program in DHH or his designee.
(11)The president of the Senate or his designee.
(12)The speaker of the House of Representatives or his designee.
(13)A Medicaid recipient who is enrolled with a prepaid entity.
Proposed law provides that other physicians who participate in the Medicaid program in
various subspecialties may act as consultants to the committee as needed.
Proposed law provides that members of the committee shall be governed by either the Code
of Governmental Ethics or the code of ethics of their respective profession.
Proposed law requires all of the following of the committee:
(1)That it meet only in public. HLS 13RS-973 ORIGINAL
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(2)That it permit public comment prior to voting on any changes in the preferred drug
list.
(3)That it make available minutes of each meeting to the public within five days after
approval of the minutes.
(4)That it make available to the public within five days of any committee meeting all
documents distributed to it which are not subject to state or federal confidentiality
laws shall be made available.
Proposed law stipulates that the pharmacopoeia developed by the committee shall comply
with all applicable state and federal laws, rules, and regulations. Provides that the committee
may recommend additions and deletions to the pharmacopoeia. Further requires that the
committee advise the secretary of DHH on policy recommendations related to the prudent
administration of the Medicaid managed care drug program.
Proposed law requires the secretary of DHH to ensure that all actions of the committee
comply with applicable state and federal laws, rules, and regulations prior to implementation
or modification of the pharmacopoeia. Provides that clinical decisions regarding the
preferred drug list shall be made transparent through a written report that is publicly
available. Further provides that if a decision of the committee is contrary to clinical
evidence found in labeling, drug compendia, or peer reviewed literature, such decisions shall
be justified in writing.
Proposed law authorizes the committee to establish a drug list to be utilized by all managed
care organizations that utilize a prior approval process or any other process or combination
of processes that prove to be cost-effective in the medical assistance program. Requires that
any prior approval process shall meet, at minimum, the following criteria:
(1)Provide for a response by telephone or other form of telecommunication device
within 24 hours of a request for prior authorization.
(2)Provide for the dispensing of a minimum of a 72-hour supply of a covered outpatient
prescription drug in an emergency situation as provided by federal rule or regulation.
(3)Comply with all applicable federal laws, rules, and regulations.
(4)Involve medical personnel, including but not limited to pharmacists, pharmacy
technicians, nurses, and physicians.
(5)Assure that a qualified, licensed physician is available for consultation during the
prior approval process.
Proposed law provides that any drug approved by the U.S. Food and Drug Administration
shall be added to the formulary as soon as it becomes commercially available. Provides
procedures by which the committee may determine whether the drug will be maintained on
the formulary.
Proposed law prohibits DHH from implementing the pharmacopoeia authorized by proposed
law before the initial pharmacopoeia is submitted to and approved by the legislative
committees on health and welfare. Provides that the legislative committees may only
approve or reject the pharmacopoeia and may not add or delete specific drugs.
Provisions relative to step therapy and fail first protocols:
Proposed law requires, beginning Jan. 1, 2014, that all managed care organizations
participating in the La. Medicaid program utilize a single page prior authorization form to
be issued by DHH. Requires DHH to promulgate rules and regulations that establish the HLS 13RS-973 ORIGINAL
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form, and authorizes DHH to consult with the managed care organizations as necessary in
development of the form.
Proposed law requires that each managed care organization which utilizes step therapy or
fail first protocols comply with the provisions of proposed law.
Proposed law provides that when medications are restricted for use by a managed care
organization by a step therapy or fail first protocol, the prescribing physician shall be
provided with and have access to a clear and convenient process to expeditiously request an
override of such restriction from the managed care organization. Requires the managed care
organization to expeditiously grant an override of such restriction under any of the following
circumstances:
(1)The prescribing physician can demonstrate to the managed care organization, based
on sound clinical evidence, that the preferred treatment required under step therapy
or fail first protocol has been ineffective in the treatment of the Medicaid enrollee's
disease or medical condition.
(2)The prescribing physician can demonstrate to the managed care organization, based
on sound clinical evidence, that the preferred treatment required under the step
therapy or fail first protocol is reasonably expected to be ineffective based on the
known relevant physical or mental characteristics and medical history of the
Medicaid enrollee and known characteristics of the drug regimen.
(3)The prescribing physician can demonstrate to the managed care organization, based
on sound clinical evidence, that the preferred treatment required under the step
therapy or fail first protocol will cause or will likely cause an adverse reaction or
other physical harm to the Medicaid enrollee.
Proposed law provides that the duration of any step therapy or fail first protocol shall not be
longer in duration than the customary period for the medication when such treatment is
demonstrated by the prescribing physician to be clinically ineffective. Provides that when
the managed care organization can demonstrate, through sound clinical evidence, that the
originally prescribed medication is likely to require more than the customary period for such
medication to provide any relief or an amelioration to the Medicaid enrollee, the step therapy
or fail first protocol may be extended for an additional period of time no longer than the
original customary period for the medication.
Effective date:
Effective upon signature of governor or lapse of time for gubernatorial action.
(Adds R.S. 46:460.31-460.34)