BILL ANALYSIS Ó
AB 2034
Page 1
Date of Hearing: April 10, 2012
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 2034 (Fuentes) - As Amended: March 29, 2012
SUBJECT : Medical care: genetically handicapping conditions.
SUMMARY : Requires the Department of Health Care Services (DHCS)
to develop a plan for the continued operation of the Genetically
Handicapped Person's Program (GHPP) after implementation of the
federal Patient Protection and Affordable Care Act (ACA).
Specifically, this bill :
1)Requires DHCS to develop the plan in consultation with the
California Health Benefits Exchange and the GHPP Advisory
Committee or an alternative group of stakeholders.
2)Requires the plan to address the following:
a) Preserving the availability of services that are
currently available under the GHPP program, but may not
continue to be otherwise available;
b) Continued coverage to populations that are not covered
by the ACA; and,
c) Adding genetic amyotrophic lateral sclerosis (ALS) to
the GHPP list of conditions. Requires the care and
treatment of ALS to be consistent with existing legislative
intent and findings including the designation of an ALS
Association Certified Center as a "Specialty Care Center"
for specified purposes.
EXISTING LAW :
1)Establishes the GHPP program, administered by the Director of
DHCS, for the medical care of persons with genetically
handicapping conditions, as specified. Also requires access
to social support services to help ameliorate physical,
psychological, and economic problems in order for the
genetically handicapped person to function at an optimal
level.
2)Requires the Director to appoint an 11-member advisory
committee and authorizes the Director, with the guidance of
the advisory committee to expand, by regulation the list of
genetically handicapping conditions beyond those covered by
statute and defines genetically handicapping conditions as a
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disease accepted as being genetic by the American Society of
Human Genetics.
3)Establishes by January 1, 2014, under the ACA, health benefits
insurance exchanges in each state for individuals and small
businesses to purchase health insurance products. Grants
authority to states to operate an exchange and prohibits
insurers participating in the exchange from discriminating
based on pre-existing conditions, health status, and gender.
4)Establishes the Medi-Cal Program, administered by DHCS, which
provides comprehensive health benefits to low-income children,
their parents or caretaker relatives, pregnant women, elderly,
blind or disabled persons, nursing home residents, and
refugees who meet specified eligibility criteria.
5)Establishes Medicare as a federally-sponsored health insurance
program for people age 65 and older; people younger than 65
who have been disabled for 24 months; people diagnosed with
ALS, also known as Lou Gehrig's disease; and those with
end-stage renal disease.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, the purpose of
this bill is to provide access to aggressive multidisciplinary
care for ALS patients through a multi-disciplinary medical
facility such as the ALS Centers of Excellence. The author
argues that this care would help extend the patient's life,
reduce hospital admissions and improve the quality of life for
the patient and family. According to the author, the
progression of the disease involves a patient gradually losing
the ability to use their voluntary muscles. They cannot move
or communicate; although their mental facilities are
completely intact and they are aware of everything, but unable
to communicate in any way. For many patients, the one drug
approved by the federal Food and Drug Administration for the
treatment of ALS shows little if any efficacy in slowing the
progression of the disease. As a result, the focus of
intervention for ALS patients is managing the effects of the
disease progression. According to the author, services like
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nursing home health visits are especially necessary for ALS
patients in a later stage of the disease, who are ultimately
unable to go to the Specialty Care Centers. This bill would
assist those patients who forego treatment because they lack
financial resources to seek medical help.
2)BACKGROUND . ALS is a progressive neurodegenerative disease
that affects motor neurons in the brain and the spinal cord
and is fatal to all who are diagnosed with the disease. The
author states that on average, patients die within two to five
years from the time of diagnosis and unfortunately, there is
no known cause, no known prevention, no diagnostic test, no
long term treatment, and no known cure. According to the
Muscular Dystrophy Association (MDA), without assistive
technologies such as mechanical ventilation and feeding tubes,
the average life expectancy is three to five years after an
ALS diagnosis and about 4-10% live more than 10 years.
According to the ALS Association, the majority of patients
with adult-onset ALS (90%) have no family history of ALS and
present as an isolated case. ALS is directly hereditary in
only a small percentage of families. Objective identification
by genetic mutation is not well enough developed to be
determinative of the distinction between the two types of ALS
and currently family history is the best tool for diagnosis.
According to the MDA, several genes associated with ALS have
been identified. Some, when flawed or mutated, cause the
disease directly. Others influence susceptibility to the
disease. Approximately 15% of those identified as genetic ALS
are associated with a mutation of a SOD1 gene. Recent
research had identified correlations in at least three other
genetic mutations. However, there is no genetic test that
distinguishes genetic ALS from sporadic ALS. More recent
research has identified a genetic defect common to ALS and
frontotemporal dementia (FTD), however, why some patients
develop FTD and others ALS, despite carrying the same genetic
defect is unknown.
3)GHPP . GHPP, established in 1975, provides comprehensive
health care coverage for persons with specified genetic
diseases including cystic fibrosis; hemophilia; sickle cell
disease and thelassemia; chronic degenerative neurologic
diseases including Huntington's Disease, Friedrieich's Ataxia,
and Joseph's Disease; and metabolic diseases including
phenylketonuria. GHPP also provides access to social support
services that may help ameliorate the physical and
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psychological problems attendant to genetically handicapping
conditions.
a) Eligibility and cost-sharing . There is no income limit
for GHPP. Person's eligible for GHPP must reside in
California, have a qualifying genetic disease and if under
age 21, be financially ineligible for California Children's
Services (CCS). GHPP clients with an adjusted gross income
between 200% and 299% of the federal poverty level (FPL)
pay an enrollment fee that is 1.5% of their adjusted gross
income; clients of families at an income level of 300% or
greater pay an enrollment fee equal to 3% of the adjusted
gross income.
b) Qualifying genetic disease . According to DHCS,
hemophilia was the first medical condition covered by GHPP.
Legislation has added other conditions such as cystic
fibrosis, sickle cell disease, inherited neurological
diseases such as Huntington's disease, Friedreich's Ataxia,
Von Hippel-Landau syndrome and other hereditary metabolic
disorders such as phenylketonuria that require specialized
treatment or services available from only a limited number
of program-approved sources.
c) Program-approved providers and services . In order for a
provider, including a Special Care Center, to be eligible
to participate in GHPP, the provider must comply with
program standards established by DHCS and must have a
Medi-Cal ID number. Approval is done jointly with the CCS
program because there is substantial overlap with CCS of
genetic eligible conditions and GHPP uses the CCS program
standards. However, there are no CCS standards for ALS
providers, including Special Care Centers as most people do
not show symptoms under age 21. According to DHCS there is
currently a substantial backlog of potential CCS/GHPP
providers awaiting approval and the process takes at least
a year.
GHPP Special Care Centers are located throughout California
and are usually connected with tertiary level medical
centers. According to DHCS, the Special Care Centers are a
system that provides coordinated care to clients through
multi-disciplinary and multi-specialty teams consisting of
doctors, nurses, social workers, and other health team
members. Except for the services of a primary care
provider, all other covered out-patient services must have
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a referral from the Special Care Center and must be
coordinated with the Center. GHPP also covers medications
prescribed by a treating physician if they are included in
the Medi-Cal formulary.
d) Caseload and Funding . The estimated case load for 2011
is 1,623 individuals. Of that 503 have hemophilia, 487
have cystic fibrosis, 366 have sickle cell anemia, 157 have
Huntington's, and 133 qualify as having genetic metabolic
disorders. The total expenditures for 2011-12 are
estimated to be $93.5 million, of which $80.1 million is
for the cost of care of those with hemophilia. The funding
is a mix of General Fund, Federal Funds from the Safety Net
Care Pool Funds from the California Bridge to Reform 2010
Medicaid Section 1115(a) Waiver, enrollment fees and blood
factor drug rebates.
e) Payer of last resort . GHPP clients with other health
coverage, such as private insurance may apply for GHPP
benefits; however GHPP will only cover limited services.
These include an annual outpatient Special Care Center
assessment, evaluation and case conference and services not
covered by the health plan. Clients with Medicare may also
apply, however the Medicare Part A (hospital care) or Part
B (medical services) must be billed first and prior
authorization must be obtained from the GHPP. Clients with
Medi-Cal may apply for GHPP benefits. Medi-Cal clients,
including those enrolled in a Medi-Cal Managed Care plan,
will receive the same services they are receiving from
Medi-Cal in addition to the services available through the
GHPP. An example of an additional service is Special Care
Center services. Once the Medi-Cal clients are enrolled
into this program, GHPP will case manage their case.
Clients who are eligible for Medi-Cal and Medicare (dual
eligibles) must enroll in Medicare Part D for drug
coverage. For clients who are Medicare only, Part D
enrollment is optional, however once enrolled clients are
only eligible for medications specifically excluded from
coverage by Medicare Part D.
4)SUPPORT . The sponsor, the California ALS Advocacy Committee,
writes in support that as GHPP currently partners with
Specialty Care Centers to provide enhanced services for
patients who are suffering from diseases currently covered by
GHPP, this bill would align patients who have the genetic form
of ALS with the multi-disciplinary care provided at these
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Specialty Care Centers. The sponsor explains that ALS
patients require specialists from up to nine separate fields
of medicine and at these centers they are able to see their
specialists within a matter of hours in one setting. The
sponsor also states, in support, that GHPP coverage would
extend much needed services such as skilled nursing home
health visits; durable medical equipment; mental health
services; and medical foods.
Disability Rights California (DRC), also in support, writes that
one of the organization's explicit priorities is to update the
list of disabilities under GHPP. DRC further states that the
addition of familial ALS means that at least the 10% of people
with this type of ALS would have access to the social support
services that may help with problems associated with their
condition.
5)PREVIOUS LEGISLATION .
a) AB 5 X4 (Evans), Chapter 5, Fourth Extraordinary
Session, Statutes of 2009, the health budget trailer bill,
limited the eligibility of individuals with GHPP-eligible
conditions for a period of up to six months if they were
terminated from employer-sponsored health insurance unless
certain conditions occur, redrafted the enrollment fee to
be 1.5% of total gross income for families with incomes
from 200% to 300% of FPL and up to 3% families with incomes
greater than 300% of FPL and authorized payment of premiums
for other health coverage in lieu of GHPP.
b) SB 1503 (Steinberg), Chapter 409, Statutes of 2008
defined an ALS Center of Excellence as a "specialty care
center" to which a health care service plan must have a
procedure for referring enrollees who have certain serious
conditions requiring specialized medical care over a
prolonged period
6)POLICY COMMENT . In addition to the author's goal of making
GHPP services available to person's suffering from genetic
ALS, the approach taken by this bill proposes a path to
resolution of a number of future technical and policy
dilemmas. Specifically these are as follows:
a) Interaction with ACA implementation . As of January 1,
2014 the ACA requires all individuals to obtain health care
coverage. Individuals or those in families with modified
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adjusted gross income below 133% FPL will be eligible for
Medi-Cal. This includes childless adults under age 65 who
do not qualify for Medicare and could include persons
intended to benefit from this bill but who were not
previously eligible for either program. Persons with
income between 133% and 400% of the FPL will be eligible to
purchase subsidized health care coverage through the
Exchange. The ACA also prohibits insurers from denying
coverage for a pre-existing condition such as ALS.
Eligibility for GHPP might continue where not all benefits
are covered by an ACA health plan. It makes sense to
determine who is eligible and for what types of services
for all GHPP clients coincident with adding any new
conditions, such as ALS in a cohesive and comprehensive
fashion through a planning process with input from all
stakeholders.
b) Modernizing and Streamlining GHPP . The GHPP program is
in need of updating, not only as a result of potential
changes in the availability of new coverage under the ACA,
but because of underlying deficiencies. For instance no
disease has been added since Von Hippel-Lindau, sometime
before 1991. In addition, the Advisory Committee that is
required by existing law is not currently functioning and
no members have been appointed. Finally, the current law
defines a "genetically handicapping condition" as meaning a
disease accepted as being genetic in origin by the American
Society of Human Genetics. However, this entity has
informed the sponsor that it does not perform this function
and the organization does not respond to inquiries. This
bill will allow a comprehensive re-examination of
qualifying conditions in light of current scientific and
medical knowledge. In addition, the program standards for
Special Care Centers for persons with inherited neurologic
diseases haven't been updated since 1981. According to
DHCS there is also a shortage of staff and a substantial
backlog in certifications for new providers. Without
improvements in the process, this would be a barrier to the
addition of ALS specialty centers as only four of the 13
that are currently certified by the National ALS
Association are currently associated with GHPP approved
Specialty Centers.
c) How to Diagnosis Genetic ALS . In the case of the
current medical conditions covered by the GHPP such as
hemophilia or sickle cell the eligibility is a yes or no
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question based on a medical diagnosis of the disease. On
the other hand, genetic ALS is a subset of ALS and the
diagnosis and identification may depend on undocumented or
unreliable family medical history. As mentioned above, the
science of genetic identification is still evolving. The
approach taken by this bill will allow the standards for
eligibility to be set in a scientific fashion in
consultation with medical and genetic experts as the
science evolves.
REGISTERED SUPPORT / OPPOSITION :
Support
California ALS Advocacy Committee (Sponsor)
California Medical Association
Disability Rights California
The ALS Association, Orange County Chapter
Opposition
None on file.
Analysis Prepared by : Marjorie Swartz / HEALTH / (916)
319-2097