BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: AB 1739 --------------------------------------------------------------- |AUTHOR: |Waldron | |---------------+-----------------------------------------------| |VERSION: |June 2, 2016 | --------------------------------------------------------------- --------------------------------------------------------------- |HEARING DATE: |June 29, 2016 | | | --------------------------------------------------------------- --------------------------------------------------------------- |CONSULTANT: |Scott Bain | --------------------------------------------------------------- SUBJECT : Medi-Cal: allergy testing SUMMARY : Requires the Department of Health Care Services, for individuals with a medical history of specified allergies, to treat serologic-specific IgE tests (a type of blood test) and skin tests as equivalent confirmatory tests in their clinical efficacy, and to provide the same standard of coverage for either test. Existing law: 1)Establishes the Medi-Cal program, which is administered by the Department of Health Care Services (DHCS), under which qualified low-income individuals receive health care services. 2)Establishes a schedule of benefits under the Medi-Cal program, and authorizes the use of utilization controls, including prior authorization, that may be applied to those covered benefits and that are reviewed for, among other things, medical necessity. Physician services are a covered benefit, subject to utilization controls. 3)Requires, pursuant to Medi-Cal regulation, outpatient physician services to be covered if they are medically necessary to protect life, to prevent significant illness or significant disability, or to alleviate severe pain, subject to limitations. This bill: 1)Requires DHCS to treat serologic-specific IgE tests and percutaneous skin tests as equivalent confirmatory tests in their clinical efficacy, and to provide the same standard of coverage for either test for those individuals with a medical history consistent with any of the following: AB 1739 (Waldron) Page 2 of ? a) An inhalant allergy; b) A food allergy; c) Hymenoptera venom allergy or an allergy to stinging insects; d) Allergic bronchopulmonary aspergillosis (ABPA); e) Certain parasitic diseases; or, f) Allergies to specific drugs. 1)Requires DHCS to update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing. FISCAL EFFECT : According to the Assembly Appropriations Committee, uncertain, likely minor overall fiscal effect in the FFS Medi-Cal program (GF/federal). Blood testing utilization could go up, while utilization of skin tests could go down. The net effect is unknown. PRIOR VOTES : ----------------------------------------------------------------- |Assembly Floor: |79 - 0 | |------------------------------------+----------------------------| |Assembly Appropriations Committee: |19 - 0 | |------------------------------------+----------------------------| |Assembly Health Committee: |18 - 0 | | | | ----------------------------------------------------------------- COMMENTS : 1)Author's statement. According to the author, historically, allergies were diagnosed by an allergy specialist who used a "skin-prick" test to infect the skin of a patient and waited to see what the patient reacted to. This requires a patient to be referred to an allergist by their primary care doctor and requires the patient to undergo a series of pricks to their skin. But now blood tests are equally effective in diagnosing allergies and can be ordered directly by a primary care physician without referring the patient to a specialist. Medi-Cal's provider manual explicitly favors skin testing over blood testing by requiring a primary doctor to identify a "Contraindication" to skin testing before ordering a blood test. This is contrary to National Guidelines. Combined with too few allergy specialists, this creates an access to care problem for Medical patients who need an efficient diagnosis AB 1739 (Waldron) Page 3 of ? and treatment of allergies. This bill would correct this inequity by requiring DHCS to treat blood allergy tests and skin allergy tests as equivalent in their sensitivity and accuracy for confirming allergies. This bill would also require DHCS to update its provider bulletins to reference the most current professional literature and guidance related to allergy testing. 2)Medi-Cal Manual of Criteria. Under existing law, DHCS is authorized to use utilization controls for covered Medi-Cal benefits. The DHCS Manual of Criteria sets for the procedures and codes for providers to use to bill allergy testing and desensitization. It contains the procedure codes and instructions for billing, and the medical reference for the coverage criteria. The Manual of Criteria for allergy testing and desensitization was changed by DHCS in March 2009, June 2012, April 2013, December 2014, and June 2015. Medi-Cal coverage policy of allergy testing was the subject of an August 12, 2014 Assembly Health Committee informational hearing entitled "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 did not apply to skin testing remain. For example, current coverage for the allergen specific IgE test must include documentation in the patient's medical record, with one of the following numbered criteria: a) 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; b) At least one of the following conditions is documented in the patient's medical record: i. Widespread skin disease ii. Patients receiving medications that may confound the results of skin testing or interfere with the detection or management of anaphylaxis; iii. Uncooperative patients; iv. When the history suggests significant risk of anaphylaxis from skin testing; or, v. Patients undergoing work-up for major allergic reaction, including possible anaphylaxis or severe urticarial. AB 1739 (Waldron) Page 4 of ? 1)Medical literature on blood and skin tests for 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 2)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 allergic sensitizations. A physician from 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. The physician writes that, 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. The CaliforniaHealth+ Advocates (CH+A) writes in support that this bill will improve patient care, eliminate unnecessary restrictions on primary care physicians' ability to utilize blood tests as a diagnostic tool for determining sensitivity to allergens in Medi-Cal patients, save money by ensuring timely diagnosis of allergies in Medi-Cal patients, and eliminate unnecessary referrals to an allergist for skin testing. In doing so, CH+A writes this bill eliminate unnecessary barriers to care and create greater equity across our health system. 3)Opposition. DHCS writes in opposition that this bill will change current Medi-Cal policy and contradicts the recommendation of the American Academy of Allergy, Asthma, and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI). DHCS states Medi-Cal's allergy testing AB 1739 (Waldron) Page 5 of ? policy is based upon the AAAAI and ACAAI clinical practice guidelines that recommend the skin prick test as the preferred procedure to test for allergies, and Medi-Cal allows for IgE test when the patient's medical condition requires another mode of testing other than skin prick. DHCS writes this bill do not reflect current practice guidelines from the leading medical associations for allergy testing, and DHCS writes that AAAAI is working on a new primer/guideline for allergy testing that it expects to publish later this year. DHCS concludes by noting that current Medi-Cal policy for ordering IgE tests does not pose a barrier to access for fee-for-service beneficiaries as DHCS data shows that more beneficiaries are receiving IgE tests than skin prick tests, and when DHCS removed manual review for IgE tests as skin prick tests, nearly six times as many beneficiaries received the IgE test as skin prick tests. 4)Policy issues. a) Statutory declaration of equivalent confirmatory tests. This bill, as written, would statutorily require DHCS to declare serologic-specific IgE tests and percutaneous skin tests as equivalent confirmatory tests in their clinical efficacy, and would require DHCS to provide the same standard of coverage. The impetus for this bill is current Medi-Cal coverage for the serologic-specific IgE tests is subject to additional criteria that existing skin allergy tests are not. Proponents cite medical literature as to why current Medi-Cal coverage is out-of-date and not consistent with other payors and current medical literature. However, statutorily declaring two types tests as equivalent in clinical efficacy has the disadvantage of codifying a coverage standard that, even if accurate now, may not be accurate in the future if allergy testing improves. Codifying such a standard in existing law would require subsequent statutory changes if medical evidence and practice guidelines change. In addition, statutorily requiring the same standard of coverage may limit DHCS and Medi-Cal managed care plans' ability to negotiate lower prices if the tests are of equal efficacy but the cost of a particular test is significantly higher than the other. Finally, the Legislature is generally not well equipped to evaluate the clinical efficacy of competing medical tests and procedures, as compared to peer-reviewed literature published in scientific or medical journals, national expert panels, or consensus AB 1739 (Waldron) Page 6 of ? practice guidelines. b) Coverage based on medical history. The coverage in this bill is for individuals with a medical history consistent with various allergies, including a food allergy, an allergy to venom or stinging insects, drug allergies or an inhalant allergy. However, allergy testing is typically used to strengthen a diagnosis of patients who present with allergy symptoms following a clinical history and physical examination. These individuals may or may not have a medical history consistent with allergies. In lieu of coverage based on medical history, the coverage in this bill could be based on "symptoms compatible with an allergic disorder" or words to that effect. To address the issues in a) and b), alternative language to the language in this bill is as follows: 14133.75(a)The department shall treat serologic-specific IgE tests and percutaneous skin tests as equivalent confirmatory tests in their clinical efficacy, and shall provide the same standard of coverage for either test for those individuals with a medical history consistent with any of the following:The department shall provide the same standard of coverage for serologic-specific IgE tests and percutaneous skin tests if peer-reviewed medical literature supports a determination that those tests are equivalent confirmatory tests in terms of their clinical efficacy. If that determination is made the department shall provide coverage for either test for a beneficiary who has symptoms consistent with any of the following: (1) An inhalant allergy. (2) A food allergy. (3) Hymenoptera venom allergy or an allergy to stinging insects. (4) Allergic bronchopulmonary aspergillosis (ABPA). (5) Certain parasitic diseases. (6) Allergies to specific drugs. (7) The department shall update its provider bulletins, as necessary, to reference the most current professional literature and guidance related to allergy testing SUPPORT AND OPPOSITION : Support: Thermo-Fisher Scientific (sponsor) American Federation of State, County and Municipal Employees, AFL-CIO AB 1739 (Waldron) Page 7 of ? California Life Sciences Association One individual Oppose: Department of Health Care Services -- END --