2010 California Code
Health and Safety Code
Chapter 6. Human Immunodeficiency Virus (hiv) Treatment ...

120950.  The Legislature hereby finds and declares all of the
following:
   (a) State-of-art knowledge regarding treatment of people infected
with the human immunodeficiency virus (HIV) indicates that active HIV
infection (AIDS) can be a manageable, though chronic, condition with
the use of drugs such as zidovudine (AZT), aerosolized pentamidine,
and ganciclovir. AIDS experts across the nation agree that early
intervention with these drugs can prolong life, minimize the related
occurrences of more serious illnesses, reduce more costly treatments,
and maximize the HIV-infected person's vitality and productivity.
   (b) For reasons of compassion and cost effectiveness, the State of
California has a compelling interest in ensuring that its citizens
infected with the HIV virus have access to these drugs.
   (c) The department subsidizes the cost of these drugs for persons
who do not have private health coverage, are not eligible for
Medi-Cal, or cannot afford to purchase the drug privately. The
subsidy program is funded through state and federal sources.
   (d) Congress is expected to place limitations on the federal
subsidy program that will jeopardize access to these life-prolonging
drugs for people whose income is higher than federal income
eligibility cap but lower than the state's income eligibility cap.
   (e) It is critical that suffering persons with limited income have
access to life-prolonging drugs. It is also critical that persons
currently eligible for the subsidy program remain eligible regardless
of changes that may result from the congressional action and the
enactment of this chapter. However, it is appropriate that people who
can afford to pay a portion of the cost of treatment be obligated to
share the cost of these drugs.



120955.  (a) (1) To the extent that state and federal funds are
appropriated in the annual Budget Act for these purposes, the
director shall establish and may administer a program to provide drug
treatments to persons infected with human immunodeficiency virus
(HIV), the etiologic agent of acquired immunodeficiency syndrome
(AIDS). If the director makes a formal determination that, in any
fiscal year, funds appropriated for the program will be insufficient
to provide all of those drug treatments to existing eligible persons
for the fiscal year and that a suspension of the implementation of
the program is necessary, the director may suspend eligibility
determinations and enrollment in the program for the period of time
necessary to meet the needs of existing eligible persons in the
program.
   (2) The director, in consultation with the AIDS Drug Assistance
Program Medical Advisory Committee, shall develop, maintain, and
update as necessary a list of drugs to be provided under this
program. The list shall be exempt from the requirements of the
Administrative Procedures Act (Chapter 3.5 (commencing with Section
11340), Chapter 4 (commencing with Section 11370), and Chapter 5
(commencing with Section 11500) of Part 1 of Division 3 of Title 2 of
the Government Code), and shall not be subject to the review and
approval of the Office of Administrative Law. In addition, the
director shall notify the fiscal and policy committees of the
Legislature of any additions, deletions, or restrictions to the list
within 15 business days of the action. At a minimum, this
notification shall describe the specific change to the formulary, the
reason for the action taken, the estimated number of people it may
affect, and any estimate of costs or savings where applicable.
   (b) The director may grant funds to a county public health
department through standard agreements to administer this program in
that county. To maximize the recipients' access to drugs covered by
this program, the director shall urge the county health department in
counties granted these funds to decentralize distribution of the
drugs to the recipients.
   (c) The director shall establish a rate structure for
reimbursement for the cost of each drug included in the program.
Rates shall not be less than the actual cost of the drug. However,
the director may purchase a listed drug directly from the
manufacturer and negotiate the most favorable bulk price for that
drug.
   (d) Manufacturers of the drugs on the list shall pay the
department a rebate equal to the rebate that would be applicable to
the drug under Section 1927(c) of the federal Social Security Act (42
U.S.C. Sec. 1396r-8(c)) plus an additional rebate to be negotiated
by each manufacturer with the department, except that no rebates
shall be paid to the department under this section on drugs for which
the department has received a rebate under Section 1927(c) of the
federal Social Security Act (42 U.S.C. Sec. 1396r-8(c)) or that have
been purchased on behalf of county health departments or other
eligible entities at discount prices made available under Section
256b of Title 42 of the United States Code.
   (e) The department shall submit an invoice, not less than two
times per year, to each manufacturer for the amount of the rebate
required by subdivision (d).
   (f) Drugs may be removed from the list for failure to pay the
rebate required by subdivision (d), unless the department determines
that removal of the drug from the list would cause substantial
medical hardship to beneficiaries.
   (g) The department may adopt emergency regulations to implement
amendments to this chapter made during the 1997-98 Regular Session,
in accordance with the Administrative Procedure Act, Chapter 3.5
(commencing with Section 11340) of Part 1 of Division 3 of Title 2 of
the Government Code. The initial adoption of emergency regulations
shall be deemed to be an emergency and considered by the Office of
Administrative Law as necessary for the immediate preservation of the
public peace, health and safety, or general welfare. Emergency
regulations adopted pursuant to this section shall remain in effect
for no more than 180 days.
   (h) Reimbursement under this chapter shall not be made for any
drugs that are available to the recipient under any other private,
state, or federal programs, or under any other contractual or legal
entitlements, except that the director may authorize an exemption
from this subdivision where exemption would represent a cost savings
to the state.
   (i) The department may also subsidize certain cost-sharing
requirements for persons otherwise eligible for the AIDS Drug
Assistance Program (ADAP) with existing non-ADAP drug coverage by
paying for prescription drugs included on the ADAP formulary within
the existing ADAP operational structure up to, but not exceeding, the
amount of that cost-sharing obligation. This cost sharing may only
be applied in circumstances in which the other payer recognizes the
ADAP payment as counting toward the individual's cost-sharing
obligation.



120956.  (a) The AIDS Drug Assistance Program Rebate Fund is hereby
created as a special fund in the State Treasury.
   (b) All rebates collected from drug manufacturers on drugs
purchased through the AIDS Drugs Assistance Program (ADAP)
implemented pursuant to this chapter and, notwithstanding Section
16305.7 of the Government Code, interest earned on these moneys shall
be deposited in the fund exclusively to cover costs related to the
purchase of drugs and services provided through ADAP.
   (c) Notwithstanding Section 13340 of the Government Code, moneys
in the fund shall be continuously appropriated without regard to
fiscal year to State Department of Health Services and available for
expenditure for those purposes specified under this section.



120960.  (a) The department shall establish uniform standards of
financial eligibility for the drugs under the program established
under this chapter.
   (b) Nothing in the financial eligibility standards shall prohibit
drugs to an otherwise eligible person whose adjusted gross income
does not exceed fifty thousand dollars ($50,000) per year. However,
the director may authorize drugs for persons with incomes higher than
fifty thousand dollars ($50,000) per year if the estimated cost of
those drugs in one year is expected to exceed 20 percent of the
person's adjusted gross income.
   (c) The department shall establish and may administer a payment
schedule to determine the payment obligation of a person receiving
drugs. No person shall be obligated for payment whose adjusted gross
income is less than four times the federal poverty level. The payment
obligation shall be the lesser of the following:
   (1) Two times the person's annual state income tax liability, less
funds expended by the person for health insurance premiums.
   (2) The cost of drugs.
   (d) Persons who have been determined to have a payment obligation
pursuant to subdivision (c) shall be advised by the department of
their right to request a reconsideration of that determination to the
department. Written notice of the right to request a reconsideration
shall be provided to the person at the time that notification is
given that he or she is subject to a payment obligation. The payment
determination shall be reconsidered if one or more of the following
apply:
   (1) The determination was based on an incorrect calculation made
pursuant to subdivision (b).
   (2) There has been a substantial change in income since the
previous eligibility determination that has resulted in a current
income that is inadequate to meet the calculated payment obligation.
   (3) Unavoidable family or medical expenses that reduce the
disposable income and that result in current income that is
inadequate to meet the payment obligation.
   (4) Any other situation that imposes undue financial hardship on
the person and would restrict his or her ability to meet the payment
obligation.
   (e) The department may exempt a person, who has been determined to
have a payment obligation pursuant to subdivision (c), from the
obligation if both of the following criteria are satisfied:
   (1) One or more of the circumstances specified in subdivision (d)
exist.
   (2) The department has determined that the payment obligation will
impose an undue financial hardship on the person.
   (f) If a person requests reconsideration of the payment obligation
determination, the person shall not be obligated to make any payment
until the department has completed the reconsideration request
pursuant to subdivision (d). If the department denies the exemption,
the person shall be obligated to make payments for drugs received
while the reconsideration request is pending.
   (g) A county public health department administering this program
pursuant to an agreement with the director pursuant to subdivision
(b) of Section 120955 shall use no more than 5 percent of total
payments it collects pursuant to this section to cover any
administrative costs related to eligibility determinations, reporting
requirements, and the collection of payments.
   (h) A county public health department administering this program
pursuant to subdivision (b) of Section 120955 shall provide all drugs
added to the program pursuant to subdivision (a) of Section 120955
within 60 days of the action of the director, subject to the
repayment obligations specified in subdivision (d) of Section 120965.



120965.  (a) Effective March 15, 1991, a person determined eligible
for benefits under this chapter shall be subject to the payment
obligation specified in subdivision (c) of Section 120960.
   (b) Persons who are receiving benefits under a HIV drug treatment
subsidy program administered by the department prior to March 15,
1991, shall not be subject to the payment obligation specified in
subdivision (c) of Section 120960.
   (c) Notwithstanding subdivision (b), if any person is disenrolled
from eligibility in a HIV drug treatment subsidy program administered
by the department for any reason after March 15, 1991, the
subsequent enrollment of that person for benefits under this chapter
shall be in accordance with the payment obligation specified in
subdivision (c) of Section 120960.
   (d) Notwithstanding subdivision (b), if a drug is added pursuant
to subdivision (a) of Section 120955, any person determined eligible
for benefits under this chapter, regardless of the date of
enrollment, shall be subject to the payment obligation specified in
subdivision (c) of Section 120960 for the added drug. The payment
obligation for any other drug shall be determined in accordance with
subdivision (b).



120966.  (a) (1) The program established under this chapter shall
make available to any eligible person under this chapter any
antiviral drug that is approved by the federal Food and Drug
Administration for treatment of human immunodeficiency virus (HIV) or
acquired immune deficiency syndrome (AIDS), prescribed by the
beneficiary's medical care provider, and approved by the AIDS Drug
Assistance Program Medical Advisory Committee of the Office of AIDS
if determined by the State Department of Health Services that the new
antiviral drug would be used as an additional treatment option, and
anticipated client utilization represents no significant additional
cost to the program and does not require the removal of another
antiviral drug from the formulary.
   (2) Any federal Food and Drug Administration-approved antiviral
drug that is determined by the State Department of Health Services to
represent a significant additional cost to the program shall be made
available if, after an analysis is conducted by the department, it
determines that the program has an adequate budget to fund the
addition of the new drug.
   (3) The department shall use all reasonable means to ensure that
the determination required in paragraph (1) or the analysis required
by paragraph (2) are performed as promptly as possible.
   (b) Notwithstanding any other provision of law, any antiviral drug
that is approved pursuant to paragraph (1) of subdivision (a) for
addition to the formulary of drugs program established by this
chapter shall be available to patients covered by the program
established by this chapter within 30 days of the Office of AIDS
being notified by the drug's manufacturer of the FDA approval.




120968.  The Office of AIDS shall report to the Legislature no later
than October 1, 2000, the status of consumer protections for the
AIDS drug program established pursuant to this chapter, including a
report on the contractor's performance in each of the following
areas:
   (a) Filling of patient prescriptions within 24 hours of
submission, and shipping of mail order prescriptions within 48 hours.
   (b) Subcontracting with any willing provider, including a report
on any denials of contracts with providers and the reason for denial.
   (c) Provision of information regarding program policies,
procedures, enrollment procedures, eligibility guidelines, and lists
of drugs covered in appropriate literacy levels in English, Spanish,
Mandarin/Cantonese, Tagalog, and in other languages as determined by
the department.
   (d) Development of a timely and accessible grievance procedure for
clients, promotion of that procedure among clients, and utilization.




120970.  In the event the department utilizes a contractor or
subcontractor to administer any aspect of the program provided for
under this chapter, the following additional client assistance
provisions shall apply:
   (a) The contractor shall, either directly or through subcontracted
pharmacy outlets, obtain and dispense the necessary drugs, in their
approved forms according to the program formulary, and shall comply
with all applicable provisions of the California Pharmacy Law
(Chapter 9 (commencing with Section 4000) of Division 2 of the
Business and Professions Code) and regulations adopted thereunder.
   (b) Upon receipt of notification by the department, the contractor
shall be able to accommodate additions or changes in the formulary
within 10 business days.
   (c) Clients shall receive drugs from a participating pharmacy
either directly, through the client's designated representative, or
mailed or delivered to the client's place of residence by the
contractor or subcontractor, whichever the client prefers. Proof of
delivery of the prescription to the client's designated address, by
signature acknowledging receipt thereof, shall be required for all
mail order prescriptions.
   (d) Clients shall have their prescriptions filled within 24 hours
of submission of prescription requests, and mail order prescriptions
shall be shipped by the contractor within 48 hours of receipt of
client prescription requests.
   (e) The contractor shall provide 24-hour free telephone and fax
machine access for physicians and surgeons, or medical care providers
as authorized under state law, to call in or transmit prescriptions
for mail order pharmacy.
   (f) Clients shall have toll-free telephone access during business
hours to speak with licensed pharmacists for medication counseling
and for mail order prescription requests. The contractor shall
provide consultation in the prevention of potentially harmful drug
interactions in connection with prescriptions filled for clients.
   (g) The contractor shall have the ability to subcontract with any
willing provider, including independent and sole proprietorship
pharmacies, provided the subcontractor accepts the rates offered by
the contractor, supplies the contractor with timely information, and
complies with necessary contract terms and conditions and other needs
of the program as determined by the contractor or the department.
   (h) It is the intent of the Legislature that the contractor
subcontract with all willing providers accepting the terms and
conditions provided for in subdivisions (a) to (g), inclusive, in
order to facilitate continuity of care for clients under this
chapter.
   (i) All types of information, whether written or oral, concerning
a client, made or kept in connection with the administration of this
program shall be confidential, and shall not be used or disclosed
except for purposes directly connected with the administration of the
program.
   (j) Information regarding program policies and procedures,
including enrollment procedures, eligibility guidelines, and lists of
drugs covered, shall be made available to clients in appropriate
literacy levels in English, Spanish, Mandarin/Cantonese, Tagalog, and
in other languages, as determined by the department.
   (k) The contractor shall develop and maintain a timely and
accessible grievance procedure for clients to resolve problems
regarding all components of the delivery of drugs under this chapter.




120971.  (a) In the event state expenditures for the AIDS Drug
Assistance Program (ADAP) are identified by California to be used as
a certified public expenditure for the purpose of obtaining federal
financial participation under the Medi-Cal program for any purposes,
including federal demonstration waivers, the State Department of
Health Care Services and the State Department of Public Health shall
ensure the integrity of the ADAP in meeting its maintenance-of-effort
requirements to receive federal funds and to obtain all ADAP drug
rebates to support the ADAP.
   (b) The State Department of Health Care Services and the State
Department of Public Health shall keep the appropriate policy and
fiscal committees of the Legislature informed of any potential
concerns that may arise in the event that state expenditures for the
ADAP are used as a certified public expenditure as described in
subdivision (a).