2005 California Health and Safety Code Sections 125125-125191 Article 1. Genetically Handicapped Persons Program

125125.  This article shall be known and may be cited as the
Holden-Moscone-Garamendi Genetically Handicapped Person's Program.
125130.  The Director of Health Services shall establish and
administer a program for the medical care of persons with genetically
handicapping conditions, including cystic fibrosis, hemophilia,
sickle cell disease, Huntington's disease, Friedreich's Ataxia,
Joseph's disease, Von Hippel-Landau syndrome, and the following
hereditary metabolic disorders:  phenylketonuria, homocystinuria,
branched chain amino acidurias, disorders of propionate and
methylmalonate metabolism, urea cycle disorders, hereditary orotic
aciduria, Wilson's Disease, galactosemia, disorders of lactate and
pyruvate metabolism, tyrosinemia, hyperornithinemia, and other
genetic organic acidemias that require specialized treatment or
service available from only a limited number of program-approved
sources.
   The program shall also provide access to social support services,
that may help ameliorate the physical, psychological, and economic
problems attendant to genetically handicapping conditions, in order
that the genetically handicapped person may function at an optimal
level commensurate with the degree of impairment.
   The medical and social support services may be obtained through
physicians and surgeons, genetically handicapped person's program
specialized centers, and other providers that qualify pursuant to the
regulations of the department to provide the services.  "Medical
care," as used in this section, is limited to noncustodial medical
and support services.
   The director, with the guidance of the Advisory Committee on
Genetically Handicapped Person's Program, may, by regulation, expand
the list of genetically handicapping conditions covered under this
article.  The director shall adopt regulations that are necessary for
the implementation of this article.  The director, with the approval
of the advisory committee, shall establish priorities for the use of
funds and provision of services under this article.
125135.  As used in this article, "genetically handicapping
condition" shall mean a disease that is accepted as being genetic in
origin by the American Society of Human Genetics.
125140.  The program established under this article shall include
any or all of the following medical and social support services:
   (a) Initial intake and diagnostic evaluation.
   (b) The cost of blood transfusion and use of blood derivatives, or
both.
   (c) Rehabilitation services, including reconstructive surgery.
   (d) Expert diagnosis.
   (e) Medical treatment.
   (f) Surgical treatment.
   (g) Hospital care.
   (h) Physical and speech therapy.
   (i) Occupational therapy.
   (j) Special treatment.
   (k) Materials.
   (l) Appliances and their upkeep, maintenance, and care.
   (m) Maintenance, transportation, or care incidental to any other
form of services.
   (n) Respite care or other existing resources (e.g., sheltered
workshops).
   (o) Genetic and long-term psychological counseling.
   (p) Appropriate administrative staff resources to carry out this
article.  The staff shall include, but not be limited to, at least
one case manager per each 350 clients.
125145.  The director shall appoint an 11-member Advisory Committee
on Genetically Handicapped Person's Program composed of professional
and consumer representatives who shall serve without compensation and
at the discretion of the director.  The director shall seek the
advice of the advisory committee with respect to regulations to be
adopted pursuant to this article.
125150.  The director shall establish the rate structure for
reimbursement of physicians and supportive services.  The rates shall
not be less than the amounts paid for provider services under the
Medi-Cal Act (Chapter 7 (commencing with Section 14000) of Part 3 of
Division 9 of the Welfare and Institutions Code).
125155.  Reimbursement under this article shall not be made for any
services that are available to the recipient under any other private,
state, or federal programs or under other contractual or legal
entitlements, except for those instances where the department
determines that prolonged use of employer health insurance would
jeopardize the recipient's employment.  However, no provision in this
article shall be construed as limiting in any way state
participation in any federal governmental program for medical care of
persons with genetically handicapping conditions.
125160.  The department shall receive and expend all funds made
available to it by the federal government, the state, its political
subdivisions or from other sources for the purposes of this article.
Payment for genetically handicapped person's program shall be made
by the department.
125165.  (a) The department shall determine and establish an
enrollment fee for the services provided pursuant to this article.
   (b) Beginning July 1, 1993, each client eligible for services
shall pay an annual enrollment fee to the department, except as
provided in subdivision (f).
   (c) (1) The annual enrollment fee schedule shall be a sliding
scale based upon family size and income and shall be identical to the
fee schedule established under Section 123900.  The department shall
adjust the scale to reflect changes in the federal poverty level.
Family size shall be based upon the number of persons living with the
applicant who are dependent upon the family income.  Family income
shall include the total gross income of the applicant and other
individuals living with the applicant.
   (2) Until July 1, 1995, the annual enrollment fee for eligible
participants who use the Genetically Handicapped Persons Program but
receive only case management services provided by the program shall
be determined by using 50 percent of the amount specified in the
sliding scale.  On or before July 1, 1995, the department shall
evaluate the revenue enhancement resulting from the use of this
reduced enrollment fee schedule for persons who receive only case
management services.  After July 1, 1995, all eligible participants
shall pay the enrollment fee established pursuant to paragraph (1).
   (d) Notwithstanding any other subdivision, those persons whose
family income exceeds forty thousand dollars ($40,000) per year and
whose cost of care is 20 percent or less of the family's adjusted
gross income shall pay either the enrollment fee or the cost of care,
whichever is greater.  Those persons whose family income exceeds
forty thousand dollars ($40,000) per year and whose cost of care
exceeds 20 percent of the family's adjusted gross income shall pay
the enrollment fee.
   (e) Payment of the enrollment fee is a condition of program
participation and is independent of any other outstanding obligations
to the program.  The department may arrange for periodic payment
during the year if it determines a lump-sum payment will be a
hardship for the family.  The director, on a case-by-case basis, may
waive or reduce the amount of an enrollment fee if the director
determines payment of the fee will result in undue hardship.
Otherwise, failure to pay or arrange for payment of the enrollment
fee within 60 days of the due date shall result in disenrollment and
ineligibility for coverage of treatment services effective 60 days
after the due date of the fee.
   (f) The enrollment fee shall not be charged in the following
cases:
   (1) The client is eligible for the full scope of Medi-Cal
benefits, without being required to pay a share of cost, at the time
of enrollment fee determination.
   (2) The family of the client otherwise eligible to receive
services has a gross annual income of less than 200 percent of the
federal poverty level.
   (g) Upon determination of program eligibility, the department
shall enter into an agreement with the applicant or client legally
responsible for that applicant for payment of the enrollment fee.
   (h) All enrollment fees shall be used in support of the program
for services established under this article.
125170.  The department shall maintain sufficient, appropriate staff
to carry out this article.
125175.  The health care benefits and services specified in this
article, to the extent that the benefits and services are neither
provided under any other federal or state law nor provided nor
available under other contractual or legal entitlements of the
person, shall be provided to any patient who is a resident of this
state and is made eligible by this article.  After the patient has
utilized the contractual or legal entitlements, the payment liability
under Section 125165 shall then be applied to the remaining cost of
genetically handicapped person's services.
125180.  The department shall require all applicants to the program
who may be eligible for cash grant public assistance or for Medi-Cal
to apply for Medi-Cal eligibility prior to becoming eligible for
funded services.
125190.  Notwithstanding any other provision of law, the department
is considered to be the purchaser, but not the dispenser or
distributor, of blood factor products under the Genetically
Handicapped Person's Program.  The department may receive
manufacturers' discounts, rebates, or refunds based on the quantities
purchased under the Genetically Handicapped Person's Program.  The
discounts, rebates, or refunds received pursuant to this section
shall be separate from any agreements for discounts, rebates, or
refunds negotiated pursuant to Section 14105.3 of the Welfare and
Institutions Code or any other program.
125191.  (a) The department may enter into contracts with one or
more manufacturers on a negotiated or bid basis as the purchaser, but
not the dispenser or distributor, of factor replacement therapies
under the Genetically Handicapped Person's Program for the purpose of
enabling the department to obtain the full range of available
therapies and services required for clients with hematological
disorders at the most favorable price and to enable the department,
notwithstanding any other provision of state law, to obtain
discounts, rebates, or refunds from the manufacturers based upon the
large quantities purchased under the program.  Nothing in this
subdivision shall interfere with the usual and customary distribution
practices of factor replacement therapies.  In order to achieve
maximum cost savings, the Legislature hereby determines that an
expedited contract process under this section is necessary.
Therefore, a contract under this subdivision may be entered into on a
negotiated basis and shall be exempt from Chapter 2 (commencing with
Section 10290) of Part 2 of Division 2 of the Public Contract Code
and Chapter 6 (commencing with Section 14825) of Part 5.5 of Division
3 of the Government Code.  Contracts entered pursuant to this
subdivision shall be confidential and shall be exempt from disclosure
under the California Public Records Act (Chapter 3.5 (commencing
with Section 6250) of Division 7 of Title 1 of the Government Code).
   (b) (1) Factor replacement therapy manufacturers shall calculate
and pay interest on late or unpaid rebates.  The interest shall not
apply to any prior period adjustments of unit rebate amounts or
department utilization adjustments.  Manufacturers shall calculate
and pay interest on late or unpaid rebates for quarters that begin on
or after the effective date of the act that added this subdivision.
   (2) Following the final resolution of any dispute regarding the
amount of a rebate, any underpayment by a manufacturer shall be paid
with interest calculated pursuant to paragraph (4), and any
overpayment, together with interest at the rate calculated pursuant
to paragraph (4), shall be credited by the department against future
rebates due.
   (3) Interest pursuant to paragraphs (1) and (2) shall begin
accruing 38 calendar days from the date of mailing the invoice,
including supporting utilization data sent to the manufacturer.
Interest shall continue to accrue until the date of mailing of the
manufacturer's payment.
   (4) Interest rates and calculations pursuant to paragraphs (1) and
(2) shall be identical to interest rates and calculations set forth
in the federal Centers for Medicare and Medicaid Services' Medicaid
Drug Rebate Program Releases or regulations.
   (b) If the department has not received a rebate payment, including
interest, within 180 days of the date of mailing of the invoice,
including supporting utilization data, a factor replacement therapy
manufacturer's contract with the department shall be deemed to be in
default and the contract may be terminated in accordance with the
terms of the contract.  This subdivision does not limit the
department's right to otherwise terminate a contract in accordance
with the terms of that contract.
   (c) The department may enter into contracts on a bid or negotiated
basis with manufacturers, distributors, dispensers, or suppliers of
pharmaceuticals, appliances, durable medical equipment, medical
supplies, and other product-type health care services and
laboratories for the purpose of obtaining the most favorable prices
to the state and to assure adequate access and quality of the product
or service.  In order to achieve maximum cost savings, the
Legislature hereby determines that an expedited contract process
under this subdivision is necessary.  Therefore, contracts under this
subdivision may be entered into on a negotiated basis and shall be
exempt from Chapter 2 (commencing with Section 10290) of Part 2 of
Division 2 of the Public Contract Code and Chapter 6 (commencing with
Section 14825) of Part 5.5 of Division 3 of the Government Code.
This subdivision shall not apply to pharmacies or suppliers that
provide blood, blood derivatives, or blood factor products, or any
product or service provided by those pharmacies or suppliers.
   (d) The department may contract with one or more manufacturers of
each multisource prescribed product or supplier of outpatient
clinical laboratory services on a bid or negotiated basis.  Contracts
for outpatient clinical laboratory services shall require that the
contractor be a clinical laboratory licensed or certified by the
State of California or certified under Section 263a of Title 42 of
the United States Code.  Nothing in this subdivision shall be
construed as prohibiting the department from contracting with less
than all manufacturers or clinical laboratories, including just one
manufacturer or clinical laboratory, on a bid or negotiated basis.