BILL ANALYSIS SB 1369 Page 1 Date of Hearing: June 27, 2006 ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS Gloria Negrete McLeod, Chair SB 1369 (Maldonado) - As Amended: June 19, 2006 SENATE VOTE : 35-1 SUBJECT : Clinical laboratories: anatomic pathology services. SUMMARY : Requires "direct billing" for anatomic pathology services (unless the person performing the services is exempted) and defines anatomic pathology services for this purpose. Specifically, this bill : 1)Expands existing law requiring direct billing for cytologic services relating to the examination of gynecologic slides to apply to the professional assessment and interpretation of anatomic pathology services, as defined. 2)Provides that if a hospital, public health clinic, or nonprofit health clinic orders professional assessment and interpretation of anatomic pathology services, a clinical laboratory shall bill these entities directly for the services provided. 3)Prohibits a clinical laboratory from directly billing a physician who requests the professional assessment and interpretation of anatomic pathology services. 4)Provides that a clinical laboratory may directly bill a physician and surgeon for the preparation of technical slides. 5)Provides that when a clinical laboratory knows, or should know, that a patient is covered by a health care service plan or insurance, it must first attempt to bill the patient's health care service plan or insurance for any amounts in excess of any co-payment, deductible, or coinsurance. If the patient's health care service plan or insurance denies the claim, then the clinical laboratory may bill the patient or a responsible third-party payer. 6)Requires a licensed professional that orders tests from a clinical laboratory to include complete and accurate billing information with the request if the law requires the clinical SB 1369 Page 2 laboratory to directly bill the patient or a third-party payer. 7)Defines anatomic pathology as any of the following: a) Histopathology or surgical pathology, meaning the gross and microscopic examination of organ tissue, as specified; b) Cytopathology, meaning the examination of cells obtained from fluids, aspirates, washings, brushings, or smear, including Pap test examinations, as specified; c) Hematology, meaning the microscopic evaluation of bone marrow aspirates and biopsies and blood smears, as specified; and, d) Sub-cellular pathology and molecular pathology. EXISTING LAW provides for the licensure, regulation and discipline of healing arts professionals by various boards within the Department of Consumer Affairs, and prohibits a licensed healing art professional, unless exempted or employed by an entity that is exempted, from charging, billing, or otherwise soliciting payment from a patient, client, customer or third party payer for cytologic services relating to the examination of gynecologic slides if those services were not actually rendered by the health care professional, or under his or her direct supervision. A licensed medical care professional may not "mark-up" the cost of any clinical laboratory service that is not performed by the licensed medical care professional and itemized in the bill or solicitation for payment. Clinical laboratories that perform cytologic examinations of gynecologic slides are expressly prohibited from billing a physician and surgeon who requests the tests and must directly bill either the patient or responsible third-party payer for these services. FISCAL EFFECT : Unknown COMMENTS : Background . In September 2005, the Wall Street Journal reported that some physicians significantly increase their profits by referring work to an outside clinical laboratory for a given cost and then billing the patient or insurance company at a marked up price, sometimes two or more times greater than the SB 1369 Page 3 actual cost of performing the test. The Wall Street Journal noted that this practice entices doctors to order many tests, thereby driving up the nation's health care bill, and that the practice is "harmful because doctors have an incentive to send work to the cheapest lab, not necessarily the best one, to maximize their profit margins." Purpose of this bill . According to the author, this bill addresses the growing problem of physicians marking up the cost of laboratory tests in order to increase their profits. The author contends that "by requiring the lab to bill the responsible party (insurance company, Medi-Cal, or patient), the incentive for a physician to mark up the cost of the lab service or to split the fee with a lab is eliminated." The author notes that the Center for Health Policy Studies (CHPS) released a study in 1993 that concluded that laboratory charges and utilization rates are higher in states that do not require direct billing, and that the enactment of a national direct billing law would substantially reduce health care costs, by between $2.4 and $3.2 billion a year. The CHPS study found that laboratory charges per test, utilization per enrollee, and charges per enrollee were markedly higher in states that did not have direct-billing laws in place. Finally, the author maintains that "by removing the possibility that economic motivation may dictate the referral of outside anatomic pathology services, patients can be assured that their physicians are choosing the pathologist or laboratory to evaluate biopsy specimens and other anatomic pathology services on the basis of quality and professional expertise." Unintended consequences . Recent amendments to this bill provide that it is unlawful for a medical professional to bill a patient or third-party payer for the "professional assessment and interpretation" of anatomic pathology services unless actually performed by the medical professional. Effectively, these amendments narrow the application of the existing direct-billing requirement so that it would allow a medical professional to bill for some anatomic pathology services (e.g., the technical preparation of samples) even if those services are performed by another individual. As such, these amendments confuse and undo aspects of existing law regarding direct billing. This does not appear to be the author's intent and the Committee may wish to amend this bill so that it applies to all aspects of anatomic pathology services, not just the "professional assessment and interpretation" of anatomic pathology services. SB 1369 Page 4 Support . The California Society of Pathologists (CSP), supports this bill arguing that it "removes the potential conflict of interest by the referring physician who might choose a lab based upon the opportunity to mark-up the actual charge by the rendering lab or pathologist" and notes that Medicare has required direct-billing since 1994. CSP asserts that this bill ensures that a physician refers anatomic pathology services to a given clinical laboratory because of the quality and professional expertise of the clinical laboratory, not because of economic motivation. With the recent amendments to this bill, the California Society of Dermatology & Dermatologic Surgery (CSDDS) has changed its position to support. CSDDS supported the general objectives of this bill, but was concerned that it inadvertently limited "the capacity of physicians and surgeons to render their licensed professional services and bill third party payers for the services rendered." Opposition . Quest Diagnostics opposes this bill, arguing that it "is not modeled after laws in other states (such as Arizona, Iowa, and Montana) and as a result falls short of the author's intent." Quest maintains that this bill would make it more difficult for it to operate efficiently. One of Quest's major concerns with this bill is that it would not permit clinical laboratories to bill one another for work referred by one clinical laboratory to another. One of Quest's laboratories is the Nichols laboratory "which does highly specialized and complex tests that cannot be performed by other labs. These referring labs will do the non-complex tests and then send tissue samples to Nichols Institute for the more specialized anatomic pathology tests." Quest asserts that lab-to-lab billing for anatomic laboratory services in these instances is appropriate and will ensure "that all of the work is presented on a single bill to the payer." The California Clinical Laboratory Association (CCLA) opposes this bill arguing that California's existing anti-mark up law prohibits a third party from marking up the cost of a laboratory test when no additional services were actually performed and already addresses the problem that this bill seeks to solve. CCLA adds that this bill "has provisions which will make existing law more complicated and more difficult to enforce" and notes that it would support this bill if it were amended to SB 1369 Page 5 simply require direct billing for all laboratory services. Related legislation . SB 165 (Machado), Chapter 319, Statutes of 2003, provided that a clinical laboratory could bill for cytologic services relating to the examination of gynecologic slides that were performed by one of its affiliated clinical laboratories. AB 474 (Tanner), Chapter 295, Statutes of 1991, required "direct billing" for cytologic services relating to the examination of gynecological slides. AB 2544 (Tanner), Chapter 1019, Statutes of 1990, permitted clinical laboratories to directly bill persons or clinics that provide cytologic examinations of gynecological services free of charge or on a sliding scale. Technical amendment . On page 3, line 1, insert a comma after "hospital". Double-referral . This bill has also been referred to the Assembly Committee on Health. REGISTERED SUPPORT / OPPOSITION : Support California Society of Dermatology & Dermatologic Surgery California Society of Pathologists Opposition California Academy of Family Physicians California Clinical Laboratory Association Quest Diagnostics Analysis Prepared by : Pablo Garza / B. & P. / (916) 319-3301