BILL ANALYSIS                                                                                                                                                                                                    






                        SENATE HEALTH AND HUMAN SERVICES
                               COMMITTEE ANALYSIS
                        Senator Martha M. Escutia, Chair


          BILL NO:       AB 1098                                      
          A
          AUTHOR:        Romero                                       
          B
          AMENDED:       May 18, 2000
          HEARING DATE:  June 28, 2000                                
          1
          FISCAL:        Rules / Appropriations                       
          0
                                                                      
          9
          CONSULTANT:                                                 
          8
          Miller / cg
                                        

                         AB 1098 - SUPPLEMENTAL ANALYSIS 
                     As proposed to be amended June 28, 2000
          
          The Department of Health Services, subsequent to the June  
          14th  review by the Senate Health and Human Services  
          Committee, has held three open meetings with stake holders  
          interested in AB 1098.  These meetings have resulted in  
          numerous clarifications and changes to the May 18th version  
          of this bill.  These changes are contained in author's  
          amendments pending before the Committee and are described  
          below. 

          In it's prior hearing, the Committee expressed particular  
          concern with provisions of AB 1098 which, in the  
          committee's view, imposed systemic burdens on all Medi-Cal  
          providers; which were unclear in interpretation or  
          application; which created new felonies and penalties and;  
          which failed to assure due process considerations to  
          providers.  The amendments at the time of this analysis  
          address many of the procedural and interpretative concerns  
          of the Committee.  The department and authors are also  
          meeting with staff of the Committee on Public Safety in an  
          effort to resolve concerns over due process and appropriate  
          penalties.  The status of the legal negotiations should be  
          available to the Senate Health and Human Services Committee  
                                                         Continued---



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          prior to the hearing on June 28, 2000.

                          SUMMARY OF PROPOSED AMENDMENTS
           
          SECTION 1241 ADDED- BUSINESS & PROFESSIONS CODE

          Amend     Clarifies that individuals can perform on their  
          own bodies or on their 
                    children home test approved by the FDA.

          SECTION 1 - CLINICAL LABORATORY LAW - BUSINESS &  
          PROFESSIONS CODE 1265 REGARDING NOTICES, CHANGE OF  
          OWNERSHIP OR DIRECTOR AND OPERATION OF LABS.

          Amend     Restore language in 1265(e) that gives laboratory  
          directors and 
                    owners a 30 day period to notify the department  
                    of a major change of laboratory directorship or  
                    ownership.  Delete new language in 1265 (g) that  
                    requires laboratory owners and directors to  
                    notify the department 30 days prior to any change  
                    in laboratory directors and add language that  
                    requires an interim director.  Remaining language  
                    holds lab owners and directors responsible for  
                    operation.

          Amend     Clarify in (j)(1) what is meant by "ceases  
                    operations".

          Amend     (j)(2)-Change record retention requirement from 7  
                    years to 3 years, which is consistent with  
                    Medi-Cal program, and add language to clarify  
                    that the records must be kept for 3 years from  
                    the date of testing, or examination.  Defines  
                    records that must be maintained.
                    
          SECTION 2 - CLINICAL LABORATORY LAW - BUSINESS &  
          PROFESSIONS CODE SECTION 1281.1 RELATING TO SELLING OF A  
          PRODUCT FOR LAB TESTING.

          Amend     Exclude clinical laboratories or other facilities  
          that use specimens for 
                    performing tests or examinations for purposes of  
                    research or teaching.  (Language as drafted does  
                    not affect AB 2714, HemaCare.) 
                                                         Continued---




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          SECTION 3 - CLINICAL LABORATORY LAW - BUSINESS &  
          PROFESSIONS CODE RELATING TO SOLICITATION TO PROCURE BLOOD.

          Amend     Exclude clinical laboratories and other  
                    facilities that use specimens for performing  
                    tests or examinations for purposes of research or  
                    teaching.

          SECTION 7 - CLINICAL LABORATORY LAW - BUSINESS &  
          PROFESSIONS CODE SECTION 1311 REGARDING STATUTE OF  
          LIMITATIONS.

          Amend     Statute of Limitations Section - Change record  
          retention requirement 
                    from 7 years to 3 years.

          SECTION 8 - CLINICAL LABORATORY LAW - BUSINESS &  
          PROFESSIONS CODE SECTION 1320(h) RELATED TO DELIBERATE  
          IMPROPER HANDLING OF SPECIMENS AND PROFESSIONAL CONDUCT.

          Amend     Delete Section 8 and add section 1287.1 to  
                    address the reckless disregard for patient safety  
                    that exposes the patient to serious bodily  
                    injury.

          SECTION 9 - CLINCIAL LABORATORY LAW - BUSINESS &  
          PROFESSIONS CODE 1320.5 RELATED TO HARM TO MINORS.

          Amend     Delete section 9 and add penalties for serious  
                    bodily injury language to section 1287.1.

          ADD TO BILL BUSINESS & PROFESSIONS CODE SECTION 1324 to  
                    explain that this section does not apply to  
                    automatic revocation under section 1265.

          SECTION 11 - BILLERS - WELFARE & INSTITUTIONS CODE 14040.1  
          RELATED TO BILLERS AND ESTABLISHING REQUIREMENTS.

          Amend     Define billing agents.  Exempt employees and  
                    clinics as defined in Section 1204 (a) and  
                    1206(c).  Definition of billing agents is drafted  
                    in a way that will address some of the concerns  
                    raised by stakeholders to exempt legitimate  
                    billing management groups.
                                                         Continued---




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          Amend     Delete Section 14040.1(e) that prohibits billing  
                    agent compensation based on a percentage of the  
                    billed amount and make general reference to  
                    federal requirements in 14040.5 (2)(c).
           
          SECTION 12 - BILLERS - WELFARE & INSTITUTIONS CODE 14040.5  
          RELATED TO SUSPENSION OF UNDER INVESTIGATION AND IF CASES  
          ARE SETTLED.

          Amend     Specifies that 15 days notice in writing will be  
          given to a billing agent 
                    prior to placing a temporary suspension on the  
               agent.

          Amend     Returns language to original related to  
          settlements in criminal 
                    proceedings.


          
          SECTION 16  -WELFARE & INSTITUTIONS CODE SECTION 14043.36  
          RELATED TO PROHIBITION OF ENROLLMENT IF CONVICTED OF FRAUD  
          OR ABUSE. 

          Amend     In subdivision (a) returns language to original  
          related to settlements 
                    in criminal proceedings.  Clarifies that  
                    investigation if by either the department or law  
                    enforcement agency.

                    In subdivision (b) specifies that temporary  
                    suspension will take effect 15 days after  
                    notification in writing.

          SECTION 21 - WELFARE & INSTITUTIONS CODE 14043.7 RELATED TO  
          SUSPENSION OF PROVIDERS FOR FURNISHING INACCURATE AND  
          INCORRECT INFORMATION.

                    Most stakeholders felt that clarity was needed to  
               distinguish between 
                    error and intent to give incorrect information  
               without plans to correct it.

          Amend     Clarify that (c) relates back to (a) on page 27  
                                                         Continued---




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          and tighten intent of 
                    "Discrepancies" in information".

          Amend     Specifies in (c) that temporary suspension will  
          take effect 15 days 
                    after notification in writing.
          SECTION 22 - WELFARE & INSTITUTIONS CODE SECTION 14043.75  
          RELATED TO EMERGENCY REGULATION AUTHORITY FOR FRUAD AND  
          ABUSE ISSUES.

          Amend     DHS will solicit input from stakeholders prior to  
          finalizing emergency 
                    regulations.  DHS plans to work with stakeholders  
                    informally before emergency regulations are  
                    completed.

          SECTION 25 - WELFARE & INSTITUTIONS CODE SECTION 14107.5

          Amend     Clarify that evidence needed for a withhold of  
          payment for Medi-Cal 
                    reimbursement is that needed in an APA type  
               hearing.

          SECTION 26 - WELFARE & INSTITUTIONS CODE SECTION 14115.5  
          RELATED TO WITHHOLD REIMBURSEMENT OF FUNDS IF THE PROVIDER  
          IS UNDER INVESTIGATION FOR FRAUD AND ABUSE BY ANY SATE,  
          LOCAL OR FEDERAL GOVERNMENT AGENCY.

          Amend     This section on withholds removed from the bill.



          SECTION 29 - WELFARE 7 INSTITUTIONS CODE SECTION 14124.2

                    Advocates thought that requirement to furnish  
               assistance in a visit by 
                    the department was unclear.

          Amend     Clarified to require they furnish information or  
          copies.

          SECTION 31 - WELFARE & INSTITUTIONS CODE SECTION 14170.8  
          RELATED TO AUDITORS OR EXAMINATION TO INCLUDE VERIFICATION  
          OF THE COSTS CLAIMED BY THE PROVIDERS.

                                                         Continued---




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                    Clarified what is meant by "verification of 
                    the costs".

          Amend     Change the language to "verification of what was  
          claimed by the 
                    provider".

          SECTION 33 - FPACT - BUSINESS & PROFESSIONS CODE 1200 et.  
          Seq., WHICH CONFORMS CHANGES TO FPACT TO MEDI-CAL  
          PROVISIONS.

          Amends    DHS has additional changes to make FPACT  
                    consistent with the proposed changes to the  
                    Medi-Cal program.































                                                         Continued---




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                STAFF ANALYSIS PREPARED FOR JUNE 14, 2000 HEARING
                                         
                                     SUBJECT
                                         
                                 Health:  Fraud

                                     SUMMARY  

          This bill implements many measures to combat provider fraud  
          in the Medi-Cal, Family Planning Access Care and Treatment  
          Waiver Program, and other health programs.

                                     ABSTRACT  
          
          1.Requires a laboratory owner or director licensed or  
            registered with DHS to notify DHS in writing within 30  
            days of any change in ownership, name, location and 30  
            days prior to any change in laboratory directors.   
            Failure to do the later would result in the automatic  
            revocation of the clinical laboratory's license or  
            registration.

          2.States that the laboratory owners and directors to whom  
            the current license or registration is issued are jointly  
            and severally responsible to DHS for the operation,  
            maintenance, and conduct of the clinical laboratory and  
            for any violations under the controlling chapter or  
            regulations adopted thereunder.

          3.States that the withdrawal of an application for a  
            license or registration or a renewal does not deprive DHS  
            of its authority to institute or continue a proceeding  
            against the applicant for denial of the license,  
            registration, or renewal or enter an order denying such  
            unless DHS consents in writing to the withdrawal.

          4.States that the suspension, expiration, or forfeiture of  
            a license or registration or its surrender without the  
            written consent of DHS, does not deprive DHS of its  
            authority to institute or continue an action against the  
            license or registration or laboratory owner or director.

          5.Requires the DHS be notified within 10 days whenever a  
            clinical laboratory ceases operations or suspends  
            clinical laboratory practice for any reason.  In such  
                                                         Continued---




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            cases, requires the clinical laboratory preserve its  
            records for a minimum of seven years and maintain an  
            ability to provide the tests or examination results.   
            Creates a civil penalty of $1,000 for each record not  
            retained and the recovery of any of DHS' costs.

          6.Provides for DHS of any person injured as a result of the  
            laboratory's abandonment or failure to retain records, to  
            bring an action in a court for the amount of any damages  
            suffered.

          7.Makes it unlawful for any person to solicit or provide  
            any form of payment or gratuity for human blood or any  
            other human specimen provided for the purpose of clinical  
            laboratory testing or clinical laboratory practice,  
            unless under specified circumstances.  Makes the first  
            conviction punishable by imprisonment in the county jail  
            for up to one year, or by imprisonment in the state  
            prison, or a fine up to $10,000, or by both; a second or  
            subsequent conviction punishable by imprisonment in the  
            state prison.

          8.Makes it unlawful for any person to perform venipuncture,  
            skin puncture, or arterial puncture unless they are  
            authorized under law or regulation. Makes the first  
            conviction punishable by imprisonment in the county jail  
            for up to one year, or by imprisonment in the state  
            prison, or a fine up to $10,000, or by both; a second or  
            subsequent conviction punishable by imprisonment in the  
            state prison.

          9.Provides for DHS to have seven years from the date of  
            discovery by the department of violation of the chapter  
            or regulations adopted thereunder to file an action in  
            court.

          10.Allows the department to deny, suspend, or revoke any  
            license or registration for conduct that may cause harm  
            to a patient by affecting the integrity of a biological  
            specimen or a lab or exam result or for performance by  
            unlicensed laboratory personnel of any unauthorized  
            activity.  Makes violation of the former that results in  
            bodily harm to a human being or involves the taking of  
            blood from a minor child or dependent adult punishable by  
            imprisonment in the county jail for up to one year, or in  
                                                         Continued---




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            state prison for not more than ten years, or by a fine up  
            to $50,000, or by both imprisonment and fine.

          11.Authorizes a billing agent to submit claims under the  
            Medi-Cal program and requires DHS to establish standards  
            for the registration of each billing agent.  Gives DHS  
            the authority to complete a background check on  
            applicants for registration.

          12.Requires billing agent applicants to provide DHS a  
            surety bond of at least $50,000.  Requires the billing  
            agent's compensation be related to the cost of processing  
            the billing and not dependent upon the collection of  
            payment. 

          13.Expands the definition of provider to include owners,  
            managing employees, agents of any partnership, group  
            association, corporation, institution, or entity that  
            provides services, goods, supplies, or merchandise,  
            directly or indirectly, to a Medi-Cal beneficiary.

          14.Requires applicants, providers, and persons with an  
            ownership or control interest to submit their social  
            security numbers to DHS to the full extent allowed under  
            federal law.

          15.Requires as a condition of a pharmacy's participation in  
            the Medi-Cal program, that the pharmacy shall have in  
            stock and regularly dispense prescription drugs.

          16.Prohibits the department from enrolling any applicant  
            that has been related to neglect or abuse of a patient in  
            connection with the delivery of health care or in  
            connection with the interference with or obstruction of  
            any investigation into health care related fraud or  
            abuse, that has been found liable for fraud or abuse in  
            any civil proceeding, or has entered into a settlement in  
            a civil or criminal proceeding alleging fraud or abuse in  
            the previous 10 years.

          17.Makes a hiring provider subject to suspension if claims  
            for payment are submitted under their provider numbers by  
            someone who has been previously suspended.

          18.Requires DHS to deactivate immediately provider numbers  
                                                         Continued---




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            of providers whose mail has been returned as not  
            deliverable or when the provider has not submitted a  
            claim for one year.

          19.Prohibits someone who has applied to be a provider and  
            was denied, to reapply for a period of three years.

          20.Gives the director of DHS authority to readopt, repeal,  
            or amend additional regulatory measures to prevent or  
            curtail fraud and abuse and deems them emergency  
            regulations.

          21.Increases the penalty for specified offenses from  
            imprisonment for one year or a fine up to $5,000 to  
            imprisonment up to 10 years or a fine up to three times  
            the amount of the fraud or improper reimbursement, or by  
            both.  If the activity results in serious bodily injury,  
            bodily injury to a minor, or is a threat to public  
            health, the length of imprisonment is not more than 20  
            years.  If the activity results in death, the  
            imprisonment is increased to any term of years or for  
            life, or both.  Bases the length of imprisonment on the  
            sentencing guidelines used by the federal government for  
            false or fraudulent claims. 

          22.Specifies a broad range of property of a person who has  
            engaged in any of the activities subject to fine or  
            imprisonment to be subject to forfeiture to the state.   
            The bill specifies the process by which the forfeiture  
            would take place and the disposition of the property. 

          23.Broadens the ability of the department to collect or  
            withhold payment from a provider on the basis of  
            information or evidence received, including evidence that  
            would be inadmissible under the Evidence Code.

          24.Gives authority to DHS to withhold the reimbursement of  
            funds due a provider as assets pending the outcome of an  
            investigation of fraud or abuse.  The withholding of the  
            payments would not be subject to any other provision of  
            law and would not be subject to appeal or hearing.

          25.Codifies many federal statutes and regulations in state  
            law to clarify that California has the authority given to  
            states under federal law and regulation.
                                                         Continued---




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          26.Conforms many of the above changes in the Medi-Cal  
            program to the Family Planning Access Care and Treatment  
            Waiver Program.

                                  FISCAL IMPACT  

          The bill would result in unknown General Fund savings to  
          the extent the bill results in additional prosecutions of  
          fraud in the Medi-Cal and other health programs. 

                            BACKGROUND AND DISCUSSION  

          In 1998 the FBI launched an investigation into fraudulent  
          Medi-Cal claims which produced 63 convictions.  Over the  
          past several months the combined efforts of the FBI,  
          Attorney General and Department of Health Services have  
          produced an additional 150 arrests.  The majority of these  
          early fraudulent claims involved medical equipment supply  
          companies.  The state has imposed a moratorium on  
          authorizing new medical supply billings, but has recently  
          found indications that similar phony billings to the $18.5  
          billion Medi-Cal program have moved into other services,  
          particularly pharmacy and laboratory services.  A recent  
          departmental check of laboratory service billings found 13  
          of 15 surveyed physicians had not made any of the hundreds  
          of billed referrals.  The Medi-Cal Fraud Unit has reviewed  
          13,000 of the approximately 120,000 Medi-Cal providers and  
          has suspended or is withholding payments to at least 500  
          providers.  The Medi-Cal Fraud Hotline for reporting  
          suspicious activities has received 1,000 calls to date.  

          The administration has proposed tripling the number of  
          auditors and investigators assigned to the Department of  
          Health Services to 436 at a cost of $34.7 million in  
          2000-01 budget.  The Attorney General is also proposed to  
          receive an additional $4 million for increased  
          investigation and prosecution.  A second major part of the  
          effort to reduce Medi-Cal fraud is contained in this bill  
          which imposes numerous administrative restrictions, extends  
          legal liability, creates new offenses, expands departmental  
          authority to revoke licensure, denies participation of  
          convicted providers, increases penalties for fraudulent  
          activity and broadens the authority of the state to  
          prosecute fraud. 
                                                         Continued---




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          The proposed statutory and regulatory actions in the fraud  
          prevention program are unusually expansive and affect a  
          particularly varied group of providers.  Numerous  
          stake-holders, while supportive of the intent of AB 1098,  
          have communicated concerns with certain provisions of this  
          bill.  The California Retailers Association believes  
          several changes in pharmaceutical reporting and billing  
          present an undue burden for new companies and recommends  
          that California enact enrollment procedures similar to the  
          federal Medicare program as an alternative.  The California  
          Primary Care Association notes that community clinics,  
          which typically perform minimal laboratory services like  
          waived testing and provider-performed microscopy services  
          for clinic patients are subject to C.L.I.A. and all of the  
          provisions of this measure without any history of abuse.   
          The California Society of Pathologists, the Radiological  
          Society and Medical Product Suppliers support the bills  
          purpose but note several particular provisions such as  
          prior notice for a change in lab directors; maintenance of  
          records for all purchases, bills, and test reports for  
          seven years; and revocation of licensure for mislabeling  
          lab specimens are extremely burdensome to providers with  
          little corresponding benefit.  The California Medical  
          Billing Association shares many of these same concerns.   
          Planned Parenthood is concerned that the extensive new  
          regulation may lend itself to discriminatory and 


















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          arbitrary enforcement.  Los Angeles County has recommended  
          formal linkage of state fraud control efforts with those  
          already in existence in local governments.

          The American College of Emergency Physicians opposes AB  
          1098 because the measure prohibits billing arrangements in  
          which the billing contractor is paid on a percentage basis.  
           The emergency room doctors note that such as arrangement  
          provides a proper incentive to pursue collection and that  
          alternative arrangements do not.  The California Medical  
          Association, also in opposition, objects to several  
          provisions but is principally concerned that payment may be  
          withheld based on unsupported hearsay or gossip without any  
          supporting evidence.  California Medical Association  
          comments that such practices threaten the viability of  
          small providers and will have a chilling effect on all  
          Medi-Cal providers. 

          Almost all of the stakeholders are in communication with  
          the Administration on these issues.  However, this issue is  
          before the Legislature late in the session and will, in all  
          likelihood, only have one policy hearing. 

                                     COMMENTS
                                         
          The scope and effect of this measure is unusually broad,  
          and the bill would benefit from additional review and  
          negotiation between the sponsor and the provider community.  
           Senate Health and Human Services could advance the bill to  
          meet necessary deadlines and to allow continued discussion,  
          but also recommend that the appropriate Assembly Committee  
          review the progress of negotiation when the measure is  
          before that House on concurrence

                                  PRIOR ACTIONS
              (Prior votes are not applicable to this version of the  
                                     bill)
                                        
          Assembly Floor:               74-0Pass
          Assembly Appropriations:      21-0Do Pass to Consent
          Assembly Health:              14-0Do Pass to Consent

                                    POSITIONS  

          Support:       Office of the Governor (sponsor)
                         California School Employees Association




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                         Department of Health Services
                         Los Angeles County

          Oppose:   American College of Emergency Physicians
                         California Medical Association

          Organizations Expressing Concern:
                         California Association of Medical Products  
          Suppliers
                         California Clinical Laboratory Association
                         California Medical Billing Association
                         California Primary Care Association
                         California Radiological Society
                         California Retailers Association
                         California Society of Pathologists
                         Los Angeles County
                         Planned Parenthood

                                   -- END --