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 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.
(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 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)