BILL ANALYSIS Ó
AB 1739
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Date of Hearing: April 12, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 1739
(Waldron) - As Amended March 16, 2016
SUBJECT: Medi-Cal: allergy testing.
SUMMARY: Requires the Department of Health Care Services
(DHCS), in the evaluation of patients for allergy under
fee-for-service Medi-Cal, to treat serologic-specific IgE tests
and skin tests as equivalent confirmatory tests. Specifically,
this bill:
1)Requires DHCS to treat serologic-specific IgE tests and
percutaneous skin tests equivalent tests in terms of their
sensitivity and accuracy, and to treat them as medically
necessary for those individuals with a medical history
consistent with any of the following:
a) An inhalant allergy;
b) A food allergy;
c) Hymenoptera venom allergy or an allergy to stinging
insects;
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d) Allergic bronchopulmonary aspergillosis;
e) Certain parasitic diseases; and,
f) Allergies to specific drugs.
2)Requires DHCS to update its provider bulletins, as necessary,
to reference the most current professional literature and
guidance related to allergy testing.
EXISTING LAW:
1)Establishes the Medi-Cal program, administered by DHCS, under
which qualified low-income patients receive health care
benefits. Medi-Cal is California's version of the federal
Medical program in which funding is provided by both the state
and federal government.
2)Provides for a schedule of benefits under the Medi-Cal
program, and authorizes the use of utilization control,
including prior authorization, that may be applied to those
covered benefits and that are reviewed for, among, other
things, medical necessity.
FISCAL EFFECT: This bill has not yet been analyzed by a fiscal
committee.
COMMENTS:
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1)PURPOSE OF THIS BILL. According to the author, this bill
ensures that Medi-Cal patients with allergies receive the same
level of care as private health insurance patients based on
nationally recognized professional guidelines. Under existing
coverage and payment policies for fee-for-service Med- Cal
patients, allergy testing using an IgE blood test is not
treated equally with percutaneous skin testing for allergies.
If a primary care physician wishes to diagnose allergies, a
referral to a specialist for skin testing is allowed.
However, if the primary care physician wishes to order a blood
test to diagnose allergies without a referral, the physician
must document a contraindication to skin testing for the blood
test to be ordered. This bill will ensure that primary care
doctors are able to diagnose allergies without referral to a
specialist and will therefore save Medi-Cal patients the time
and effort it takes to find, make an appointment and see one
of the limited number of specialists who accept Medi-Cal
patients. The author believes this will further save the
Medi-Cal system money by reducing the costs associated with
referrals to specialists.
2)BACKGROUND. Asthma is a chronic inflammatory disease of the
airways. Asthma is widespread; in California an estimated 2.5
million adults have asthma along with about 700,000 children.
It is one of the most common chronic diseases of childhood.
The exact cause of asthma is unknown and it cannot be cured.
Asthma can be controlled with self-management education,
appropriate medical care, and avoiding exposure to
environmental triggers. Allergen exposure is a significant
trigger that can worsen symptoms for many patients with
asthma.
Food allergies are an immune-based disease that has become a
serious health concern in the United States. A recent study
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estimates that food allergy affects 5% of children under the
age of five years and 4% of teens and adults, and its
prevalence appears to be on the increase. The symptoms of this
disease can range from mild to severe and, in rare cases, can
lead to anaphylaxis, a severe and potentially life-threatening
allergic reaction. There are no therapies available to prevent
or cure food allergies. The only prevention option for the
patient is to avoid the food allergen.
How best to determine what those allergens are, and how
Medi-Cal coverage policy should approach this issue, was the
subject of an August 12, 2014 Assembly Health Committee
informational hearing, Medi-Cal: When Reimbursement Policies
Interfere with the Standard of Care. Subsequent to the
hearing, on May 15, 2015, Medi-Cal removed the requirement
that laboratories submit documentation of medical necessity
with claims for IgE testing reimbursement. However,
limitations on Medi-Cal coverage for IgE which did not apply
to skin testing remain.
3)MEDI-CAL PROVIDER MANUAL. The current Medi-Cal Provider
Manual states that coverage for allergen specific IgE must
include documentation in the patient's medical record with one
of the following numbered criteria:
"1. The patient has persistent asthma and the
test is needed to determine the potential
sensitivity to perennial indoor allergens to which
the patient is exposed, or
2. At least one of the following conditions
is documented in the patient's medical record:
Widespread skin disease
Patients receiving medications that may
confound the results of skin testing or interfere
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with the detection or management of anaphylaxis
Uncooperative patients
When the history suggests significant risk
of anaphylaxis from skin testing
Patients undergoing work-up for major
allergic reaction, including possible anaphylaxis or
severe urticarial."
The provider manual also states that manual review of the
claims is no longer required. Without evidence of medical
necessity documented in the patient's medical record, claims
billed may be denied.
In correspondence between the former Chair of the Assembly
Health Committee and the Director of DHCS the former Chair
expressed his concern that Medi-Cal policy, even with the
changes of May 15, 2016, unnecessarily inhibits access and
timely care for many Medi-Cal patients and is inconsistent
with the latest science or with many policies in the
commercial markets and other state Medicaid programs.
4)IgE COVERAGE POLICY BY OTHER INSURERS. Anthem Health
Insurance and Kaiser Permanente both cover allergy blood tests
and skin tests equivalently. According to information
requested by the Committee and provided by the sponsor, two of
six Medicare claims processing contractors (representing 20
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states) treat blood tests and skin test equivalently, the
others currently do not. The sponsor states that it has
embarked on an educational campaign with the other 4
contractors.
5)MEDICAL LITERATURE. In a December 2010 report of the National
Institute of Allergy and Infectious Diseases (NIAID) sponsored
expert panel entitled Guidelines for the Diagnosis and
Management of Food Allergy in the U.S., published in the
Journal of Allergy and Clinical Immunology, it is stated that
both IgE blood tests and skin tests are safe and useful for
identifying food allergies. In a February 2010 article in the
Journal of Allergy and Clinical Immunology from Johns Hopkins
School of Medicine entitled Clinical Laboratory Assessment of
Immediate-type Hypersensitivity it is stated that: "For food
and respiratory allergy, IgE antibody as detected in the
serum by using current autoanalyzer technology and in
the skin by using the epicutaneous test are considered
equivalent as confirmatory tests in terms of their sensitivity
and accuracy. " In a supplement to the March 2008 issue of the
Annals of Allergy, Asthma, & Immunology entitled Allergy
Diagnostic Testing: An Updated Practice Parameter, it is
stated that: "There are no clinical scenarios in which
immunoassays for allergen specific IgE can be considered
either absolutely indicated or contraindicated. There are some
situations in which immunoassays may be preferable to skin
testing for the diagnostic evaluation of patients."
6)SUPPORT. Thermo Fisher Scientific, the sponsor of this bill,
argues that Medi-Cal's coverage policy for allergy testing is
inconsistent with national guidelines, best practices, and the
most recent scientific literature. Food allergy guidelines of
the NIAID and the asthma guidelines of the National Heart,
Lung, and Blood Institute's recognize that blood tests and
skin tests are equivalent in their efficacy for diagnosing
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allergic sensitizations. Miller Children's Hospital in Long
Beach states that updating testing guidelines will have a
major positive impact on Medi-Cal patients suffering from
allergies. In a perfect world, every patient suffering from
an allergic disease would receive their care from a
specialist. Unfortunately, allergy specialists are a very
scarce resource especially for the Medi-Cal population, with
unacceptably long wait times. It is not realistic for DHCS,
or any payer, to rely solely on the efforts of specialists to
be able to skin test every Medi-Cal patient that requires an
allergy test.
7)TECHNICAL AMENDMENT. The Committee may suggest the following
amendment: On page 3, line 17-18, delete "treat them as
medically necessary" and replace with "provide the same
standard of coverage for either test."
REGISTERED SUPPORT / OPPOSITION:
Support
Thermo Fisher Scientific (sponsor)
Miller Children's Hospital
Opposition
None on file.
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Analysis Prepared by:John Gilman / HEALTH / (916) 319-2097