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  








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            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  








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          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.








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           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  








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          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