Bill Text: CA AB374 | 2015-2016 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Health care coverage: prescription drugs.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Passed) 2015-10-08 - Chaptered by Secretary of State - Chapter 621, Statutes of 2015. [AB374 Detail]

Download: California-2015-AB374-Amended.html
BILL NUMBER: AB 374	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  MARCH 2, 2015

INTRODUCED BY   Assembly Member Nazarian

                        FEBRUARY 17, 2015

   An act to add Section 1367.244 to the Health and Safety Code, and
to add Section 10123.197 to the Insurance Code, relating to health
care coverage.



	LEGISLATIVE COUNSEL'S DIGEST


   AB 374, as amended, Nazarian. Health care coverage: prescription
drugs.
   Existing law, the Knox-Keene Health Care Service Plan Act of 1975,
provides for the licensure and regulation of health care service
plans by the Department of Managed Health Care and makes a willful
violation of that act a crime. Existing law also provides for the
regulation of health insurers by the Department of Insurance.
Existing law imposes various requirements and restrictions on health
care service plans and health insurers, including, among other
things, requiring a health care service plan that provides
prescription drug benefits to maintain an expeditious process by
which prescribing providers, as described, may obtain authorization
for a medically necessary nonformulary prescription drug, according
to certain procedures.
   This bill would prohibit a health care service plan or health
insurer that provides medication pursuant to a step therapy or
 first-fail   fail-first  requirement from
applying that requirement to a patient  who has made a step
therapy override determination request  if, in the professional
judgment of the prescribing physician, the step therapy or 
first-fail   fail-first  requirement would be
medically inappropriate for that patient for specified reasons
 .
   Because a willful violation of these requirements with respect to
health care service plans would be a crime, the bill would impose a
state-mandated local program.
   The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
   This bill would provide that no reimbursement is required by this
act for a specified reason.
   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

   SECTION 1.    The Legislature finds and declares all
of the following:  
   (a) Health care service plans and health insurers are increasingly
making use of step therapy or fail-first protocols, hereafter
referred to as step therapy protocol, under which patients are
required to try one or more prescription drugs before coverage is
provided for a drug selected by the patient's health care provider.
 
   (b) Step therapy protocols, when they are based on well-developed
scientific standards and administered in a flexible manner that takes
into account the individual needs of patients, can play an important
role in controlling health care costs.  
   (c) In some cases, requiring a patient to follow a step therapy
protocol may have adverse and even dangerous consequences for the
patient who may either not realize a benefit from taking a
prescription drug or may suffer harm from taking an inappropriate
drug.  
   (d) It is imperative that step therapy protocols preserve the
health care provider's right to make treatment decisions in the best
interest of the patient.  
   (e) Therefore, the Legislature declares it a matter of public
interest that it require health care service plans and health
insurers to base step therapy protocols on appropriate clinical
practice guidelines developed by professional medical societies with
expertise in the condition or conditions under consideration, that
patients be exempt from step therapy protocols when inappropriate or
otherwise not in the best interest of the patients, and that patients
have access to a fair, transparent, and independent process for
requesting an exception to a step therapy protocol when appropriate.

   SECTION 1.   SEC. 2.   Section 1367.244
is added to the Health and Safety Code, to read:
   1367.244.   (a)    A health care service plan
that provides coverage for medications pursuant to a step therapy or
 first-fail   fail-first  protocol shall
not apply that requirement to a patient  who has made a step
therapy override determination request  if, in the professional
judgment of the prescribing physician, the step therapy or 
first-fail   fail-first  requirement would be
medically inappropriate for that patient  for any of the reasons
specified in subdivision (b)  . 
   (b) A step therapy override determination request by a patient
with adequate supporting rationale and documentation from the
prescribing physician shall be expeditiously granted by the plan if
any of the following apply:  
   (1) The prescription drug required by the plan is contraindicated
or will likely cause an adverse reaction by, or physical or mental
harm to, the patient.  
   (2) The prescription drug required by the plan is expected to be
ineffective based on the known relevant physical or mental
characteristics of the patient and the known characteristics of the
prescription drug regimen.  
   (3) The prescription drug required by the plan is not in the best
interest of the patient, based on medical appropriateness.  

   (4) The patient is stable on a prescription drug selected by their
health care provider for the medical condition under consideration.
 
   (5) The prescription drug required by the plan has not been
approved by the federal Food and Drug Administration for the patient'
s condition.  
   (c) Upon the granting of a step therapy override determination,
the health care service plan shall authorize coverage for the
prescription drug prescribed by the patient's treating health care
provider, provided such prescription drug is a covered prescription
drug under that policy or contract.  
   (d) For purposes of this section, "step therapy override
determination" means a determination as to whether a step therapy
protocol should apply in a particular patient's situation, or whether
the step therapy protocol should be overridden in favor of immediate
coverage of the health care provider's selected prescription drug.
 
   (e) This section does not prevent a health care service plan from
requiring a patient to try an AB-rated generic equivalent drug prior
to providing coverage for the equivalent branded prescription drug.
This section does not prevent a health care provider from prescribing
a prescription drug that is determined to be medically appropriate.

   SEC. 2.   SEC. 3.   Section 10123.197 is
added to the  Health and Safety   Insurance
 Code, to read:
   10123.197.   (a)    A health insurer that
provides coverage for medications pursuant to a step therapy or
 first-fail   fail-first protocol shall not
apply that requirement to a patient  who has made a step therapy
override determination request  if, in the professional
judgment of the prescribing physician, the step therapy or 
first-fail   fail-first  requirement would be
medically inappropriate for that patient  for any of the reasons
  specified in subdivision (b)  . 
   (b) A step therapy override determination request by a patient
with adequate supporting rationale and documentation from the
prescribing physician shall be expeditiously granted by the health
insurer if any of the following apply:  
   (1) The prescription drug required by the health insurer is
contraindicated or will likely cause an adverse reaction by, or
physical or mental harm to, the patient.  
   (2) The prescription drug required by the health insurer is
expected to be ineffective based on the known relevant physical or
mental characteristics of the patient and the known characteristics
of the prescription drug regimen.  
   (3) The prescription drug required by the health insurer is not in
the best interest of the patient, based on medical appropriateness.
 
   (4) The patient is stable on a prescription drug selected by his
or her health care provider for the medical condition under
consideration.  
   (5) The prescription drug required by the health insurer has not
been approved by the federal Food and Drug Administration for the
patient's condition.  
   (c) Upon the granting of a step therapy override determination,
the health insurer shall authorize coverage for the prescription drug
prescribed by the patient's treating health care provider, provided
the prescription drug is a covered prescription drug under that
policy.  
   (d) For purposes of this section, "step therapy override
determination" means a determination as to whether a step therapy
protocol should apply in a particular patient's situation, or whether
the step therapy protocol should be overridden in favor of immediate
coverage of the health care provider's selected prescription drug.
 
   (e) This section does not prevent a health insurer from requiring
a patient to try an AB-rated generic equivalent drug prior to
providing coverage for the equivalent branded prescription drug. This
section does not prevent a health care provider from prescribing a
prescription drug that is determined to be medically appropriate.
 
   No reimbursement is required by this act pursuant to Section 6 of
Article XIII B of the California Constitution because the only costs
that may be incurred by a local agency or school district will be
incurred because this act creates a new crime or infraction,
eliminates a crime or infraction, or changes the penalty for a crime
or infraction, within the meaning of Section 17556 of the Government
Code, or changes the definition of a crime within the meaning of
Section 6 of Article XIII B of the California Constitution. 

   SEC. 4.    No reimbursement is required by this act
pursuant to Section 6 of Article XIII B of the California
Constitution because the only costs that may be incurred by a local
agency or school district will be incurred because this act creates a
new crime or infraction, eliminates a crime or infraction, or
changes the penalty for a crime or infraction, within the meaning of
Section 17556 of the Government Code, or changes the definition of a
crime within the meaning of Section 6 of Article XIII B of the
California Constitution.                                    
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