BILL NUMBER: AB 73 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JANUARY 5, 2016
AMENDED IN ASSEMBLY MAY 4, 2015
AMENDED IN ASSEMBLY MARCH 16, 2015
INTRODUCED BY Assembly Member Waldron
DECEMBER 18, 2014
An act to add Section 14133.06 to the Welfare and Institutions
Code, relating to Medi-Cal.
LEGISLATIVE COUNSEL'S DIGEST
AB 73, as amended, Waldron. Prescriber Prevails Act.
Patient Access to Prescribed Antiretroviral Drugs for
HIV/AIDS Treatment Act.
Existing law establishes the Medi-Cal program, administered by the
State Department of Health Care Services, under which qualified
low-income individuals receive health care services. The Medi-Cal
program is, in part, governed and funded by federal Medicaid Program
provisions. Existing law specifies the benefits provided pursuant to
the program, including the purchase of prescribed drugs that are
covered subject to utilization controls. Utilization controls include
a requirement that the treatment provider obtain prior authorization
for providing medical treatment, as specified.
This bill would, bill, to the extent
permitted by federal law, would provide that
drugs in specified therapeutic drug classes that are prescribed by a
Medi-Cal beneficiary's treating provider are covered Medi-Cal
benefits. The bill would require, except as specified, that a
Medi-Cal managed care plan cover the drug if the treating provider
demonstrates that the drug is medically necessary, not on the
Medi-Cal managed care plan formulary, and consistent with federal
rules and regulations for labeling and use, under which circumstances
if medically necessary antiretroviral drugs used in
the treatment of HIV/AIDS is prescribed by a Medi-Cal beneficiar
y's treating provider for that purpose, and coverage for
that prescribed drug is denied by a Medi-Cal managed care plan in
which the beneficiary is enrolled, that denial shall be reviewed in
accordance with the bill. This bill would provide that if the
treating provider demonstrates, consistent with federal law, that in
his or her reasonable, professional judgment, the drug is medically
necessary and consistent with the federal Food and Drug
Administration's labeling and use rules and regulations, as
specified, the beneficiary would be entitled to an automatic
urgent appeal, as defined.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. This act shall be known, and may be cited as, the
Prescriber Prevails Patient Access to
Prescribed Antiretroviral Drugs for HIV/AIDS Treatment Act.
SEC. 2. Section 14133.06 is added to the
Welfare and Institutions Code, to read:
14133.06. (a) It is the intent of the Legislature in enacting
this section that a Medi-Cal beneficiary shall have prompt access to
medically necessary drugs for use in the treatment of the conditions
specified in this section and that have been approved by the federal
Food and Drug Administration for the treatment of those conditions,
including drugs that are not on the formulary of the Medi-Cal managed
care plan or that are subject to prior authorization.
(b) To the extent permitted by federal law, if a drug in any of
the following therapeutic drug classes is prescribed by a Medi-Cal
beneficiary's treating provider, that drug shall be covered under the
Medi-Cal program:
(1) Antiretroviral drugs for HIV/AIDS.
(2) Antipsychotics.
(3) Antirejection drugs.
(4) Drugs used to treat seizures or epilepsy.
(c) (1) A drug is covered pursuant to this section if the treating
provider demonstrates, consistent with federal law, that in his or
her reasonable, professional judgment, the drug is medically
necessary and consistent with the federal Food and Drug
Administration's labeling and use rules and regulations, as supported
in at least one of the official compendia, as defined in Section
1927(g)(1)(B)(i) of the federal Social Security Act (42 U.S.C. Sec.
1396r-8(g)(1)(B)(i)), and the drug is not on the formulary for the
Medi-Cal managed care plan.
(2) In a case in which a plan denies coverage for a drug
prescribed under this section, the beneficiary shall be entitled to
an automatic urgent appeal. For purposes of this paragraph,
"automatic urgent appeal" means an appeal in which the plan
immediately notifies the department of the denial of coverage, and
the beneficiary is not required to take any further action. An
automatic urgent appeal shall be resolved within 48 hours after
denial by the plan. The 48-hour period specified in this paragraph
shall be in addition to any time prescribed by federal law.
(3) Medi-Cal managed care plans shall continue to develop
formularies and may also administer prior authorization programs for
the drugs specified in subdivision (b). Providers prescribing those
drugs may be required to provide the plans with requested information
or clinical documentation to support prior authorization requests.
The plans may continue to provide a temporary three-day supply of
medication when medically necessary.
(4) Consistent with federal law, if a Medi-Cal managed care plan
is unable to complete a prior authorization due to missing
information or because the prescriber's reasonable, professional
judgment has not been adequately demonstrated, as required under this
subdivision, the plan shall issue a notice of action to the provider
and the beneficiary. The plan shall include in the notice of action
a description of the information that is required from the provider
or the beneficiary in order for the plan to complete the
authorization, and the beneficiary's rights regarding appeal and fair
hearing options, and independent review by the Department of Managed
Health Care.
SEC. 2. Section 14133.06 is added to the
Welfare and Institutions Code , to read:
14133.06. (a) It is the intent of the Legislature in enacting
this section that a Medi-Cal beneficiary shall have prompt access to
medically necessary antiretroviral drugs for use in the treatment of
HIV/AIDS that have been approved by the federal Food and Drug
Administration for that purpose, including drugs that are not on the
formulary of a Medi-Cal managed care plan or that are subject to
prior authorization.
(b) To the extent permitted by federal law, if a drug used in the
treatment of HIV/AIDS as described in subdivision (a) is prescribed
by a Medi-Cal beneficiary's treating provider for the treatment of
HIV/AIDS, and coverage for that prescribed drug is denied by a
Medi-Cal managed care plan in which the beneficiary is enrolled, that
denial shall be reviewed in accordance with this section.
(c) (1) The denial by a Medi-Cal managed care plan of a drug
prescribed for the treatment of HIV/AIDS and approved by the federal
Food and Drug Administration for use in the treatment of HIV/AIDS is
subject to the urgent appeal process described in paragraph (2) if
the treating provider demonstrates, consistent with federal law, that
in his or her reasonable, professional judgment, the drug is
medically necessary and consistent with the federal Food and Drug
Administration's labeling and use rules and regulations, as supported
in at least one of the official compendia identified in Section 1927
(g)(1)(B)(i) of the federal Social Security Act (42 U.S.C. Sec.
1396r-8(g)(1)(B)(i)), and the drug is not on the formulary for the
Medi-Cal managed care plan.
(2) In a case in which a plan denies coverage for a drug
prescribed for the treatment of HIV/AIDS and approved by the federal
Food and Drug Administration for use in the treatment of HIV/AIDS,
the beneficiary shall be entitled to an urgent appeal in accordance
with paragraph (1). For purposes of this section, "urgent appeal"
means an appeal in which the beneficiary, or treatment provider with
the consent of the beneficiary, requests an appeal either orally or
in writing. An urgent appeal shall be resolved by the plan within 24
hours after the plan receives the request. The 24-hour period
specified in this paragraph shall be in addition to any time
prescribed by federal law.