State Codes and Statutes

Statutes > California > Hsc > 125125-125191

HEALTH AND SAFETY CODE
SECTION 125125-125191



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.



125155.1.  (a) Any person found eligible for services under this
article whose employer-sponsored health coverage is later terminated
or any person who applied for services provided under this article
whose employer-sponsored health coverage was terminated during the
six-month period prior to the date he or she applied for services
pursuant to this article shall be determined ineligible for the
services, unless the reason his or her employer-sponsored health
coverage was terminated was because of one of the following:
   (1) The individual for whom the employer-sponsored coverage had
been available lost coverage because of one or more of the following
reasons:
   (A) A loss of employment or a change in employment status.
   (B) A change of address to a ZIP Code that is not covered by the
employer-sponsored health coverage.
   (C) The individual's employer discontinued health benefits to all
employees or dependents, or ceased to provide coverage or
contributions for the category of employees or dependents applicable
to the person or applicant.
   (D) The death of, or a legal separation or divorce from, the
individual through whom the applicant was covered.
   (2) The applicant's employer-sponsored health coverage became
unavailable because the services paid for under that coverage
attained the lifetime coverage limit.
   (3) Coverage was under a COBRA policy and the COBRA coverage
period has ended.
   (b) A person who applies for services provided pursuant to this
article shall certify, at the time of application, under penalty of
perjury, that he or she was not covered by employer-sponsored health
coverage during the six-month period prior to the date of his or her
application or, if he or she was covered by employer-sponsored health
coverage, attest to why one of the reasons listed in subdivision (a)
is applicable to him or her and provide documentation from the
employer-sponsored health coverage that supports his or her
attestation.
   (c) A person who has been found eligible for services provided
pursuant to this article who is covered by employer-sponsored health
coverage that is terminated shall notify the Genetically Handicapped
Persons Program within 45 days of the effective date of the
termination and, when applicable, provide the program with the
certification described in subdivision (b).
   (d) An applicant or eligible person who fails to comply with
subdivisions (b) and (c) shall be ineligible for services pursuant to
this article for six months. The department shall provide written
notice to all persons found to be ineligible pursuant to this
section. The notice shall provide information on the ability of the
person to appeal or seek a waiver of determinations of ineligibility.
   (e) The department shall provide a process to appeal decisions of
ineligibility based on this section in accordance with the procedures
for resolution of complaints and appeals established for applicants
and persons eligible for services pursuant to Article 5 (commencing
with Section 123800) of Chapter 3 of Part 2.
   (f) The director, on a case-by-case basis, may waive
determinations of ineligibility pursuant to this section, or reduce
the time periods set forth in subdivision (a) or subdivision (d), if
the director determines that the determination or the time periods
will result in undue hardship.
   (g) Notwithstanding Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code, the
department may implement this section by means of Genetically
Handicapped Persons Program policy letters. Following consultation
with a stakeholder workgroup consisting of, but not limited to,
provider associations, provider representatives, and consumer groups
to ensure stakeholder participation in the implementation of this
section, including, but not limited to, any changes deemed necessary
by the department and the stakeholder workgroup to update the
application for enrollment form and the development of regulations,
the department shall, within 18 months from the effective date of
this section, adopt any necessary regulations in accordance with the
requirements of Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of Title 2 of the Government Code.



125157.  (a) The department may require a client under this article
to apply to enroll or otherwise participate in any other state or
federal program or other contractual or legal entitlement that would
provide services to the client that would otherwise be reimbursed
pursuant to this article.
   (b) The department may, when it determines that it is cost
effective, pay the premium for, or otherwise subsidize the subscriber
cost-sharing obligation for, third-party health coverage for a
person eligible for services under this article.
   (c) The department may, for a person eligible for services under
this article, when the person's third-party health coverage would
lapse due to loss of employment, change in health status, lack of
sufficient income or financial resources, or any other reason,
continue the health coverage by paying the costs of continuation of
group coverage pursuant to federal law or converting from a group to
individual plan, when the department determines that it is cost
effective.
   (d) Notwithstanding Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code, the
department may implement this section by means of Genetically
Handicapped Persons Program policy letters. Following consultation
with a stakeholder workgroup consisting of, but not limited to,
provider associations, provider representatives, and consumer groups
to ensure stakeholder participation in the implementation of this
section, including, but not limited to, any changes deemed necessary
by the department and the stakeholder workgroup to update the
application for enrollment form and the development of regulations,
the department shall, within 18 months from the effective date of
this section, adopt any necessary regulations in accordance with the
requirements of Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of Title 2 of the Government Code.




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.



125166.  (a) Commencing July 1, 2009, except as provided in
subdivision (d), each client determined or redetermined by the
department to be eligible for services provided pursuant to this
article shall pay an annual enrollment fee to the department as set
forth in this section.
   (b) (1) There shall be an annual enrollment fee based on the
client's adjusted gross income or, if the client is a minor, the
client's parents' or legal guardians' combined adjusted gross income,
as reported on the relevant state or federal income tax forms for
the previous tax year. In calculating the enrollment fee where both a
state and a federal income tax form has been filed, the higher of
the two adjusted gross income amounts shall be used.
   (2) For adjusted gross income between 200 and 299 percent of the
federal poverty level, the annual enrollment fee shall be 1.5 percent
of adjusted gross income.
   (3) For adjusted gross income equal to or greater than 300 percent
of the federal poverty level, the annual enrollment fee shall be 3
percent of adjusted gross income.
   (4) In the event the annual enrollment fee determined pursuant to
paragraph (2) or (3) exceeds the cost of care incurred during the
applicable year, the department shall reduce the enrollment fee by
refund or credit to an amount equal to the cost of care.
   (c) (1) Payment of the enrollment fee is a condition of program
participation.
   (2) The department may arrange for periodic payment of the fee
during the year.
   (3) 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 for the family. 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.
   (d) 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 client who is otherwise eligible to receive services has,
or if the client is a minor, the client's parents or guardians have,
an adjusted gross income of less than 200 percent of the federal
poverty level.
   (e) All enrollment fees shall be used in support of the program
for services provided pursuant to this article.
   (f) Notwithstanding Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code, the
department may implement this section by means of Genetically
Handicapped Persons Program policy letters. Following consultation
with a stakeholder workgroup consisting of, but not limited to,
provider associations, provider representatives, and consumers groups
to ensure stakeholder participation in the implementation of this
section, including, but not limited to, any changes to update the
application for enrollment form and the development of regulations,
the department shall, within 18 months from the effective date of
this section, adopt regulations in accordance with the requirements
of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division
3 of Title 2 of the Government Code.



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 or Section 125166, whichever shall be
applicable at the time, 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.
   (c) 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.
   (d) 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.
   (e) 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.


State Codes and Statutes

Statutes > California > Hsc > 125125-125191

HEALTH AND SAFETY CODE
SECTION 125125-125191



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.



125155.1.  (a) Any person found eligible for services under this
article whose employer-sponsored health coverage is later terminated
or any person who applied for services provided under this article
whose employer-sponsored health coverage was terminated during the
six-month period prior to the date he or she applied for services
pursuant to this article shall be determined ineligible for the
services, unless the reason his or her employer-sponsored health
coverage was terminated was because of one of the following:
   (1) The individual for whom the employer-sponsored coverage had
been available lost coverage because of one or more of the following
reasons:
   (A) A loss of employment or a change in employment status.
   (B) A change of address to a ZIP Code that is not covered by the
employer-sponsored health coverage.
   (C) The individual's employer discontinued health benefits to all
employees or dependents, or ceased to provide coverage or
contributions for the category of employees or dependents applicable
to the person or applicant.
   (D) The death of, or a legal separation or divorce from, the
individual through whom the applicant was covered.
   (2) The applicant's employer-sponsored health coverage became
unavailable because the services paid for under that coverage
attained the lifetime coverage limit.
   (3) Coverage was under a COBRA policy and the COBRA coverage
period has ended.
   (b) A person who applies for services provided pursuant to this
article shall certify, at the time of application, under penalty of
perjury, that he or she was not covered by employer-sponsored health
coverage during the six-month period prior to the date of his or her
application or, if he or she was covered by employer-sponsored health
coverage, attest to why one of the reasons listed in subdivision (a)
is applicable to him or her and provide documentation from the
employer-sponsored health coverage that supports his or her
attestation.
   (c) A person who has been found eligible for services provided
pursuant to this article who is covered by employer-sponsored health
coverage that is terminated shall notify the Genetically Handicapped
Persons Program within 45 days of the effective date of the
termination and, when applicable, provide the program with the
certification described in subdivision (b).
   (d) An applicant or eligible person who fails to comply with
subdivisions (b) and (c) shall be ineligible for services pursuant to
this article for six months. The department shall provide written
notice to all persons found to be ineligible pursuant to this
section. The notice shall provide information on the ability of the
person to appeal or seek a waiver of determinations of ineligibility.
   (e) The department shall provide a process to appeal decisions of
ineligibility based on this section in accordance with the procedures
for resolution of complaints and appeals established for applicants
and persons eligible for services pursuant to Article 5 (commencing
with Section 123800) of Chapter 3 of Part 2.
   (f) The director, on a case-by-case basis, may waive
determinations of ineligibility pursuant to this section, or reduce
the time periods set forth in subdivision (a) or subdivision (d), if
the director determines that the determination or the time periods
will result in undue hardship.
   (g) Notwithstanding Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code, the
department may implement this section by means of Genetically
Handicapped Persons Program policy letters. Following consultation
with a stakeholder workgroup consisting of, but not limited to,
provider associations, provider representatives, and consumer groups
to ensure stakeholder participation in the implementation of this
section, including, but not limited to, any changes deemed necessary
by the department and the stakeholder workgroup to update the
application for enrollment form and the development of regulations,
the department shall, within 18 months from the effective date of
this section, adopt any necessary regulations in accordance with the
requirements of Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of Title 2 of the Government Code.



125157.  (a) The department may require a client under this article
to apply to enroll or otherwise participate in any other state or
federal program or other contractual or legal entitlement that would
provide services to the client that would otherwise be reimbursed
pursuant to this article.
   (b) The department may, when it determines that it is cost
effective, pay the premium for, or otherwise subsidize the subscriber
cost-sharing obligation for, third-party health coverage for a
person eligible for services under this article.
   (c) The department may, for a person eligible for services under
this article, when the person's third-party health coverage would
lapse due to loss of employment, change in health status, lack of
sufficient income or financial resources, or any other reason,
continue the health coverage by paying the costs of continuation of
group coverage pursuant to federal law or converting from a group to
individual plan, when the department determines that it is cost
effective.
   (d) Notwithstanding Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code, the
department may implement this section by means of Genetically
Handicapped Persons Program policy letters. Following consultation
with a stakeholder workgroup consisting of, but not limited to,
provider associations, provider representatives, and consumer groups
to ensure stakeholder participation in the implementation of this
section, including, but not limited to, any changes deemed necessary
by the department and the stakeholder workgroup to update the
application for enrollment form and the development of regulations,
the department shall, within 18 months from the effective date of
this section, adopt any necessary regulations in accordance with the
requirements of Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of Title 2 of the Government Code.




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.



125166.  (a) Commencing July 1, 2009, except as provided in
subdivision (d), each client determined or redetermined by the
department to be eligible for services provided pursuant to this
article shall pay an annual enrollment fee to the department as set
forth in this section.
   (b) (1) There shall be an annual enrollment fee based on the
client's adjusted gross income or, if the client is a minor, the
client's parents' or legal guardians' combined adjusted gross income,
as reported on the relevant state or federal income tax forms for
the previous tax year. In calculating the enrollment fee where both a
state and a federal income tax form has been filed, the higher of
the two adjusted gross income amounts shall be used.
   (2) For adjusted gross income between 200 and 299 percent of the
federal poverty level, the annual enrollment fee shall be 1.5 percent
of adjusted gross income.
   (3) For adjusted gross income equal to or greater than 300 percent
of the federal poverty level, the annual enrollment fee shall be 3
percent of adjusted gross income.
   (4) In the event the annual enrollment fee determined pursuant to
paragraph (2) or (3) exceeds the cost of care incurred during the
applicable year, the department shall reduce the enrollment fee by
refund or credit to an amount equal to the cost of care.
   (c) (1) Payment of the enrollment fee is a condition of program
participation.
   (2) The department may arrange for periodic payment of the fee
during the year.
   (3) 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 for the family. 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.
   (d) 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 client who is otherwise eligible to receive services has,
or if the client is a minor, the client's parents or guardians have,
an adjusted gross income of less than 200 percent of the federal
poverty level.
   (e) All enrollment fees shall be used in support of the program
for services provided pursuant to this article.
   (f) Notwithstanding Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code, the
department may implement this section by means of Genetically
Handicapped Persons Program policy letters. Following consultation
with a stakeholder workgroup consisting of, but not limited to,
provider associations, provider representatives, and consumers groups
to ensure stakeholder participation in the implementation of this
section, including, but not limited to, any changes to update the
application for enrollment form and the development of regulations,
the department shall, within 18 months from the effective date of
this section, adopt regulations in accordance with the requirements
of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division
3 of Title 2 of the Government Code.



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 or Section 125166, whichever shall be
applicable at the time, 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.
   (c) 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.
   (d) 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.
   (e) 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.



State Codes and Statutes

State Codes and Statutes

Statutes > California > Hsc > 125125-125191

HEALTH AND SAFETY CODE
SECTION 125125-125191



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.



125155.1.  (a) Any person found eligible for services under this
article whose employer-sponsored health coverage is later terminated
or any person who applied for services provided under this article
whose employer-sponsored health coverage was terminated during the
six-month period prior to the date he or she applied for services
pursuant to this article shall be determined ineligible for the
services, unless the reason his or her employer-sponsored health
coverage was terminated was because of one of the following:
   (1) The individual for whom the employer-sponsored coverage had
been available lost coverage because of one or more of the following
reasons:
   (A) A loss of employment or a change in employment status.
   (B) A change of address to a ZIP Code that is not covered by the
employer-sponsored health coverage.
   (C) The individual's employer discontinued health benefits to all
employees or dependents, or ceased to provide coverage or
contributions for the category of employees or dependents applicable
to the person or applicant.
   (D) The death of, or a legal separation or divorce from, the
individual through whom the applicant was covered.
   (2) The applicant's employer-sponsored health coverage became
unavailable because the services paid for under that coverage
attained the lifetime coverage limit.
   (3) Coverage was under a COBRA policy and the COBRA coverage
period has ended.
   (b) A person who applies for services provided pursuant to this
article shall certify, at the time of application, under penalty of
perjury, that he or she was not covered by employer-sponsored health
coverage during the six-month period prior to the date of his or her
application or, if he or she was covered by employer-sponsored health
coverage, attest to why one of the reasons listed in subdivision (a)
is applicable to him or her and provide documentation from the
employer-sponsored health coverage that supports his or her
attestation.
   (c) A person who has been found eligible for services provided
pursuant to this article who is covered by employer-sponsored health
coverage that is terminated shall notify the Genetically Handicapped
Persons Program within 45 days of the effective date of the
termination and, when applicable, provide the program with the
certification described in subdivision (b).
   (d) An applicant or eligible person who fails to comply with
subdivisions (b) and (c) shall be ineligible for services pursuant to
this article for six months. The department shall provide written
notice to all persons found to be ineligible pursuant to this
section. The notice shall provide information on the ability of the
person to appeal or seek a waiver of determinations of ineligibility.
   (e) The department shall provide a process to appeal decisions of
ineligibility based on this section in accordance with the procedures
for resolution of complaints and appeals established for applicants
and persons eligible for services pursuant to Article 5 (commencing
with Section 123800) of Chapter 3 of Part 2.
   (f) The director, on a case-by-case basis, may waive
determinations of ineligibility pursuant to this section, or reduce
the time periods set forth in subdivision (a) or subdivision (d), if
the director determines that the determination or the time periods
will result in undue hardship.
   (g) Notwithstanding Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code, the
department may implement this section by means of Genetically
Handicapped Persons Program policy letters. Following consultation
with a stakeholder workgroup consisting of, but not limited to,
provider associations, provider representatives, and consumer groups
to ensure stakeholder participation in the implementation of this
section, including, but not limited to, any changes deemed necessary
by the department and the stakeholder workgroup to update the
application for enrollment form and the development of regulations,
the department shall, within 18 months from the effective date of
this section, adopt any necessary regulations in accordance with the
requirements of Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of Title 2 of the Government Code.



125157.  (a) The department may require a client under this article
to apply to enroll or otherwise participate in any other state or
federal program or other contractual or legal entitlement that would
provide services to the client that would otherwise be reimbursed
pursuant to this article.
   (b) The department may, when it determines that it is cost
effective, pay the premium for, or otherwise subsidize the subscriber
cost-sharing obligation for, third-party health coverage for a
person eligible for services under this article.
   (c) The department may, for a person eligible for services under
this article, when the person's third-party health coverage would
lapse due to loss of employment, change in health status, lack of
sufficient income or financial resources, or any other reason,
continue the health coverage by paying the costs of continuation of
group coverage pursuant to federal law or converting from a group to
individual plan, when the department determines that it is cost
effective.
   (d) Notwithstanding Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code, the
department may implement this section by means of Genetically
Handicapped Persons Program policy letters. Following consultation
with a stakeholder workgroup consisting of, but not limited to,
provider associations, provider representatives, and consumer groups
to ensure stakeholder participation in the implementation of this
section, including, but not limited to, any changes deemed necessary
by the department and the stakeholder workgroup to update the
application for enrollment form and the development of regulations,
the department shall, within 18 months from the effective date of
this section, adopt any necessary regulations in accordance with the
requirements of Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of Title 2 of the Government Code.




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.



125166.  (a) Commencing July 1, 2009, except as provided in
subdivision (d), each client determined or redetermined by the
department to be eligible for services provided pursuant to this
article shall pay an annual enrollment fee to the department as set
forth in this section.
   (b) (1) There shall be an annual enrollment fee based on the
client's adjusted gross income or, if the client is a minor, the
client's parents' or legal guardians' combined adjusted gross income,
as reported on the relevant state or federal income tax forms for
the previous tax year. In calculating the enrollment fee where both a
state and a federal income tax form has been filed, the higher of
the two adjusted gross income amounts shall be used.
   (2) For adjusted gross income between 200 and 299 percent of the
federal poverty level, the annual enrollment fee shall be 1.5 percent
of adjusted gross income.
   (3) For adjusted gross income equal to or greater than 300 percent
of the federal poverty level, the annual enrollment fee shall be 3
percent of adjusted gross income.
   (4) In the event the annual enrollment fee determined pursuant to
paragraph (2) or (3) exceeds the cost of care incurred during the
applicable year, the department shall reduce the enrollment fee by
refund or credit to an amount equal to the cost of care.
   (c) (1) Payment of the enrollment fee is a condition of program
participation.
   (2) The department may arrange for periodic payment of the fee
during the year.
   (3) 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 for the family. 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.
   (d) 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 client who is otherwise eligible to receive services has,
or if the client is a minor, the client's parents or guardians have,
an adjusted gross income of less than 200 percent of the federal
poverty level.
   (e) All enrollment fees shall be used in support of the program
for services provided pursuant to this article.
   (f) Notwithstanding Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code, the
department may implement this section by means of Genetically
Handicapped Persons Program policy letters. Following consultation
with a stakeholder workgroup consisting of, but not limited to,
provider associations, provider representatives, and consumers groups
to ensure stakeholder participation in the implementation of this
section, including, but not limited to, any changes to update the
application for enrollment form and the development of regulations,
the department shall, within 18 months from the effective date of
this section, adopt regulations in accordance with the requirements
of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division
3 of Title 2 of the Government Code.



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 or Section 125166, whichever shall be
applicable at the time, 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.
   (c) 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.
   (d) 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.
   (e) 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.