AB 73,
as amended, Waldron. begin deletePrescriber Prevails Act. end deletebegin insertPatient Access to Prescribed Antiretroviral Drugs for HIV/AIDS Treatment Act.end insert
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.
Thisbegin delete bill would,end deletebegin insert bill,end insert to the extent permitted by federal law,begin insert
wouldend insert provide thatbegin delete 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 circumstancesend deletebegin insert if medically necessary antiretroviral drugs used in the treatment of HIV/AIDS is prescribed by a Medi-Cal beneficiary’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,end insert 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:
This act shall be known, and may be cited as, the
2begin delete Prescriber Prevailsend deletebegin insert Patient Access to Prescribed Antiretroviral
3Drugs for HIV/AIDS Treatmentend insert Act.
Section 14133.06 is added to the Welfare and
5Institutions Code, to read:
(a) It is the intent of the Legislature in enacting this
7section that a Medi-Cal beneficiary shall have prompt access to
8medically necessary drugs for use in the treatment of the conditions
9specified in this section and that have been approved by the federal
10Food and Drug Administration for the treatment of those
11conditions, including drugs that are not
on the formulary of the
12Medi-Cal managed care plan or that are subject to prior
13authorization.
14(b) To the extent permitted by federal law, if a drug in any of
15the following therapeutic drug classes is prescribed by a Medi-Cal
16beneficiary’s treating provider, that drug shall be covered under
17the Medi-Cal program:
18(1) Antiretroviral drugs for HIV/AIDS.
19(2) Antipsychotics.
20(3) Antirejection drugs.
21(4) Drugs used to treat seizures or epilepsy.
P3 1(c) (1) A drug is covered pursuant to this section if the treating
2provider demonstrates, consistent with federal law, that in his or
3her
reasonable, professional judgment, the drug is medically
4necessary and consistent with the federal Food and Drug
5Administration’s labeling and use rules and regulations, as
6supported in at least one of the official compendia, as defined in
7Section 1927(g)(1)(B)(i) of the federal Social Security Act (42
8U.S.C. Sec. 1396r-8(g)(1)(B)(i)), and the drug is not on the
9formulary for the Medi-Cal managed care plan.
10(2) In a case in which a plan denies coverage for a drug
11prescribed under this section, the beneficiary shall be entitled to
12an automatic urgent appeal. For purposes of this paragraph,
13“automatic urgent appeal” means an appeal in which the plan
14immediately notifies the department of the denial of coverage, and
15the beneficiary is not required to take any further action. An
16automatic urgent appeal
shall be resolved within 48 hours after
17denial by the plan. The 48-hour period specified in this paragraph
18shall be in addition to any time prescribed by federal law.
19(3) Medi-Cal managed care plans shall continue to develop
20formularies and may also administer prior authorization programs
21for the drugs specified in subdivision (b). Providers prescribing
22those drugs may be required to provide the plans with requested
23information or clinical documentation to support prior authorization
24requests. The plans may continue to provide a temporary three-day
25supply of medication when medically necessary.
26(4) Consistent with federal law, if a Medi-Cal managed care
27plan is unable to complete a prior authorization due to missing
28information or because
the prescriber’s reasonable, professional
29judgment has not been adequately demonstrated, as required under
30this subdivision, the plan shall issue a notice of action to the
31provider and the beneficiary. The plan shall include in the notice
32of action a description of the information that is required from the
33provider or the beneficiary in order for the plan to complete the
34authorization, and the beneficiary’s rights regarding appeal and
35fair hearing options, and independent review by the Department
36of Managed Health Care.
begin insertSection 14133.06 is added to the end insertbegin insertWelfare and
38Institutions Codeend insertbegin insert, to read:end insert
(a) It is the intent of the Legislature in enacting this
40section that a Medi-Cal beneficiary shall have prompt access to
P4 1medically necessary antiretroviral drugs for use in the treatment
2of HIV/AIDS that have been approved by the federal Food and
3Drug Administration for that purpose, including drugs that are
4not on the formulary of a Medi-Cal managed care plan or that are
5subject to prior authorization.
6(b) To the extent permitted by federal law, if a drug used in the
7treatment of HIV/AIDS as described in subdivision (a) is prescribed
8by a Medi-Cal beneficiary’s treating provider for the treatment of
9HIV/AIDS, and coverage for that prescribed drug is denied by a
10Medi-Cal managed care plan in which the beneficiary is enrolled,
11that denial
shall be reviewed in accordance with this section.
12(c) (1) The denial by a Medi-Cal managed care plan of a drug
13prescribed for the treatment of HIV/AIDS and approved by the
14federal Food and Drug Administration for use in the treatment of
15HIV/AIDS is subject to the urgent appeal process described in
16paragraph (2) if the treating provider demonstrates, consistent
17with federal law, that in his or her reasonable, professional
18judgment, the drug is medically necessary and consistent with the
19federal Food and Drug Administration’s labeling and use rules
20and regulations, as supported in at least one of the official
21compendia identified in Section 1927(g)(1)(B)(i) of the federal
22Social Security Act (42 U.S.C. Sec. 1396r-8(g)(1)(B)(i)), and the
23drug is not on the formulary for the Medi-Cal managed care plan.
24(2) In a case in which a plan denies coverage for a drug
25
prescribed for the treatment of HIV/AIDS and approved by the
26federal Food and Drug Administration for use in the treatment of
27HIV/AIDS, the beneficiary shall be entitled to an urgent appeal in
28accordance with paragraph (1). For purposes of this section,
29“urgent appeal” means an appeal in which the beneficiary, or
30treatment provider with the consent of the beneficiary, requests
31an appeal either orally or in writing. An urgent appeal shall be
32resolved by the plan within 24 hours after the plan receives the
33request. The 24-hour period specified in this paragraph shall be
34in addition to any time prescribed by federal law.
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