BILL ANALYSIS Ó ----------------------------------------------------------------------- |Hearing Date:June 11, 2012 |Bill No:AB | | |761 | ----------------------------------------------------------------------- SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Curren D. Price, Jr., Chair Bill No: AB 761 Author: Roger Hernandez As Amended: June 4, 2012 Fiscal: Yes SUBJECT: Optometrists. SUMMARY: Provides that a laboratory director may include a licensed optometrist and authorizes an optometrist to perform certain clinical laboratory tests or examinations classified as waived under the Clinical Laboratory Improvement Act (CLIA). Existing law: 1) Provides for the licensure and regulation of optometrists by the Board of Optometry (Board). (BPC § 3010) 2) Requires certification by the Board for a licensed optometrist to use therapeutic pharmaceutical agents. (BPC § 3041.3) 3) Authorizes a licensed optometrist certified to use therapeutic pharmaceutical agents to diagnose and treat specific conditions. (BPC § 3041(a)(5); § 3041(b)(2)(c) et seq) 4) Provides for the licensure and regulation of clinical laboratories and personnel by the California Department of Public Health (DPH). (Division 2, Chapter 3, Articles 4-7, Section 1260 et seq. of the Business and Professions Code (BPC); California Code of Regulations (CCR) Title 17, Division 1, Chapter 2. Often referred to as the "CLIA Law.") 5) Prohibits the performance of a clinical laboratory test or examination classified as waived under the federal CLIA of 1988 unless the test or examination is performed under the overall operation and administration of a laboratory director, as defined, AB 761 Page 2 and is performed by specified persons, including certain health care personnel. This bill: 1. Expands the category of persons who may perform CLIA waived tests to include licensed optometrists if the results of the tests can be lawfully utilized within their practice. 2. Provides that a laboratory director may include a licensed optometrist serving as the director of a laboratory which only performs specified CLIA waived tests including the Rapid Pathogen Screening (RPS) Adeno Detector and Tear Osmolarity Test (TOT). 3. Authorizes a licensed optometrist certified to use therapeutic pharmaceutical agents to additionally perform specified CLIA waived tests and examinations that are necessary for the diagnosis of conditions and diseases of the eye or ocular adnexa defined as the adjacent structures of the eye including the extraocular muscles and the eyelids, eyelashes, eyebrows and the conjunctiva. FISCAL EFFECT: According to the Assembly Appropriation Committee analysis dated January 19, 2012, this bill results in additional fee-supported workload at the Department of Public Health in the range of $150,000 annually. COMMENTS: 1. Purpose. The California Optometric Association is the sponsor of the bill. According to the Author, optometrist may order diagnostic tests from a lab. The problem is that the patient and doctor must wait for the test results, which can unnecessarily delay appropriate diagnosis and treatment. Additionally, the patient is often inconvenienced by having to go to a separate location to get a test done that can be sold over the counter. 2. Background. Federal Clinical Laboratory Improvement Amendments of 1988 (CLIA). CLIA law specified that laboratory requirements be based on the complexity of the test performed. It also established provisions for categorizing a test as waived. Tests may be waived from regulatory oversight if they meet certain requirements established by the statute. On February 28, 1992, regulations were published to implement CLIA. Federal Definition of CLIA Waived Tests. According to Federal Regulation 493.15, CLIA-waived tests are test systems that are AB 761 Page 3 simple laboratory examinations and procedures which are cleared by FDA for home use, employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly. California Clinical Laboratory Personnel Requirements. All persons performing, supervising, consulting on, or directing clinical laboratory tests or examinations in California must meet the requirements outlined in the Business and Professions Code irrespective of whether the clinical laboratory is operated under a CLIA certificate or under a state license or registration. (CCR Title 17 § 1039.2 (a)) Currently, optometrists are certified to perform a number of procedures, such as blood draws for patients suspected of having diabetes, suture removal with prior approval of the treating physician and use of an epinephrine auto-injector to counteract anaphylactic reaction. Center for Medicaid Services (CMS). The CMS issued a memo in September of 2006 to provide clarification regarding optometrists serving as laboratory directors of moderate complexity testing under CLIA. The memo states, "The Doctor of Optometry (OD) degree is suitable to meet the personnel qualifications for laboratory director of moderate complexity testing provided the testing is limited to tests related to the medical specialty of optometry." This bill would allow optometrists to administer tests of simple complexity including the RPS Adeno Detector and TOT. RPS Adeno Detector. The RPS Adeno Detector quickly detects the presence of adenovirus in the tear fluid. Adenoviral conjunctivitis, such as "pink eye," represents the most common external ocular infection. This in-office test allows for the rapid detection of Adenoviral antigens directly from human eye fluid on the lower conjunctiva. RPS Adeno Detector kits do not require additional equipment to administer or interpret. Results are achieved in 10 minutes allowing the optometrist to provide a diagnosis and implement a treatment plan before patients leave the office. TOT. Dry eye disease is a common condition in which the eye does not produce enough tears to keep the surface of the eye sufficiently lubricated. The TOT, produced by TearLab Corporation, requires less than 50 nanoliters of tear fluid in order to measure tear osmolarity or fluid of the eye. The TOT can produce a sample AB 761 Page 4 and test result in less than 30 seconds. 3. Current Related Legislation. SB 1481 (Negrete McLeod, 2012). Exempts a community pharmacy, which solely provides CLIA-waived tests, from the clinical laboratory regulations requiring that the pharmacy hire a laboratory director who is a licensed physician. Requires that the CLIA-waived test be administered by a pharmacist in the course of performing routine patient assessment procedures. Requires the pharmacy to obtain a Certificate of Waiver from the DPH and comply with all CLIA requirements. Exempts a pharmacist from state laboratory licensing requirements if the pharmacist only performs CLIA-waived tests. This measure is currently awaiting a hearing in Assembly Business, Professions and Consumer Protection Committee. 4. Prior Related Legislation. SB 1246 (Negrete McLeod, Chapter 523, Statutes of 2010) expanded the category of persons who may perform clinical laboratory tests or examinations that are classified as waived to include licensed naturopathic doctors if the results of the tests can be lawfully utilized within their practice, and expanded the definition of laboratory director to include naturopathic doctors, as specified, for purposes of waived examinations. SB 1174 (Polanco, Chapter 640, Statutes of 2001) exempted those certified emergency medical technicians and licensed paramedics, providing basic life support services or advanced life support services, who perform only blood glucose tests that are classified as waived clinical laboratory tests under the federal CLIA of 1988, from the laws regulating clinical laboratories. Required the provider of those services to obtain a valid Certificate of Waiver and comply with all other requirements for the performance of waived clinical laboratory tests under applicable federal regulations. SB 585 (Chesbro, Chapter 70, Statutes of 1999) permitted a certified nurse midwife, a licensed nurse practitioner, a licensed physician assistant acting under the supervision of a licensed physician, or a licensed dentist to perform clinical laboratory examinations classified as provider-performed microscopy under the federal CLIA of 1988. SB 366 (Maddy, Chapter 1141, Statutes of 1994) extended the exemption from state clinical laboratory laws to facilities owned and operated by a partnership or professional corporation of five or fewer physicians and surgeons or podiatrists. The exemption AB 761 Page 5 applies only if the clinical laboratory tests or examinations are performed for the patients of the physician, podiatrist, partnership or professional corporation. This law repealed the exemption upon U.S. Department of Health and Human Services recognition of California's conformity with the requirements of federal CLIA of 1988. 5. Arguments in Support. The Sponsor asserts that the bill will allow optometrists to provide better care to their patients. Currently, patient safety is compromised because optometrists cannot legally perform these tests during an office visit. For example, the RPS Adeno Detector can diagnose viral conjunctivitis while the patient is still in the office, which allows the doctor to make an accurate diagnosis and limit spread of disease while simultaneously reducing ocular antibiotic resistance. The American Federation of State, County and Municipal Employees and the United Nurses Associations of California/Union of Health Care Professionals also support the bill stating that the current practice of sending tests to a laboratory unnecessarily delays appropriate diagnosis and treatment. The California Board of Optometry notes that optometrists can already perform waived tests in a lab under the supervision of a laboratory director. This bill will improve patient care and public health by allowing optometrists to perform tests independently. TearLab Corporation indicates that the bill will have a direct impact on the optometrists and their patients who depend on their product to diagnose and manage dry eye disease. Specifically, the measurement of tear fluid osmolarity for the diagnosis of dry eye disease has been well vetted in peer reviewed clinical studies for over 30 years. They also indicate that the TOT can only be performed at the doctor's office, as tear fluid is a fragile sample with insufficient volume to allow for collection and transfer to a reference laboratory for analysis. SUPPORT AND OPPOSITION: Support: California Optometric Association (Sponsor) American Federation of State, County and Municipal Employees California Board of Optometry TearLab Corporation AB 761 Page 6 United Nurses Associations of California/Union of Health Care Professionals Opposition: None received as of June 4, 2012. Consultant:Le Ondra Clark