BILL ANALYSIS                                                                                                                                                                                                    



                                                                  AB 1487
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          CONCURRENCE IN SENATE AMENDMENTS
          AB 1487 (Hill)
          As Amended  August 10, 2010
          2/3 vote.  Urgency
           
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          |ASSEMBLY:  |     |(May 18, 2009)  |SENATE: |31-0 |(August 12,    |
          |           |     |                |        |     |2010)          |
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                    (vote not relevant)

          Original Committee Reference:    PUB. S.  

           SUMMARY  :  Extends, to January 1, 2014, the date by which the  
          Department of Public Health (DPH) is required to adopt  
          regulations prescribing sperm processing facilities' handling  
          and storage of sperm from donors who are carriers of human  
          immunodeficiency virus (HIV) and human T lymphotrophic virus  
          (HTLV), and requires a physician providing insemination and  
          advanced reproductive technologies (ART) to make specified  
          disclosures to a recipient of sperm from a HIV or HTLV reactive  
          spouse, partner, or designated donor.

           The Senate amendments  delete the Assembly version of this bill,  
          and instead:

          1)Require the testing of transplant donor tissue for infection  
            with HTLV only in tissues that are rich in viable leukocytes. 

          2)Require a physician providing ART to notify the recipient of  
            sperm from a HIV or HTLV reactive spouse, partner, or  
            designated donor of all of the following:

             a)   Sperm processing may not eliminate all of the risks of  
               HIV or HTLV transmission;

             b)   The sperm may be tested to determine whether or not it  
               is reactive for HIV or HTLV;

             c)   The recipient must document prior to treatment that she  
               has a physician to provide ongoing care during and after  
               her fertility services; and,

             d)   Information about recommendations published by the  
               American Society of Reproductive Medicine (ASRM) regarding  








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               follow-up testing for HIV and HTLV, and a requirement that  
               the recommendations regarding follow-up testing will be  
               documented in the recipient's medical record. 

          3)Clarify that a physician providing ART is not responsible for  
            prophylactic testing, monitoring, and follow-up of the  
            recipient.  Require the physician to recommend follow-up  
            testing for HIV or HTLV, according to ASRM's published  
            guidelines, to the physician who will be providing the  
            recipient's ongoing care, as specified.

          4)Require, in the event the recipient becomes HIV or HTLV  
            positive, the physician assuming ongoing care of the recipient  
            to treat or provide information regarding referral to a  
            physician who can provide ongoing treatment for HIV or HTLV.

          5)Extend the date by which DPH is required to adopt regulations  
            prescribing sperm processing facilities' handling and storage  
            of sperm from donors who are carriers of HIV, HTLV, or any  
            other virus DPH deems appropriate from January 1, 2010, to  
            January 1, 2014.


          6)Permit DPH to propose to adopt, as initial regulations,  
            specified recommendations published by the ASRM using a  
            specified process.

          7)Exempt adoption of regulations for sperm processing facilities  
            from requirements for written responses to public comments and  
            the Administrative Procedure Act. 

          8)Make other minor technical clarifying changes and add an  
            urgency clause to make the provisions of this bill take effect  
            immediately upon enactment.

           EXISTING LAW  :

          1)Requires DPH to adopt, by January 1, 2010, regulations to  
            prescribe sperm processing facilities' handling and storage of  
            sperm from donors who are carriers of HIV, HTLV-1, or any  
            other virus DPH deems appropriate.  Requires sperm processing  
            facilities to follow facility and sperm processing guidelines  
            published by the ASRM until DPH adopts regulations. 

          2)Prohibits the transplantation of tissue into the body of  








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            another, unless the donor of the tissue has been screened and  
            found to be free from infection with HIV, hepatitis B virus  
            (HBV), hepatitis C virus (HCV), HTLV-1, and syphilis, except  
            under specified conditions. 

          3)Allows a recipient of sperm to consent to therapeutic  
            insemination of sperm or use of sperm in other ART even if the  
            sperm donor is found reactive for hepatitis B virus, hepatitis  
            C virus, HIV, HTLV-I, or syphilis if the sperm donor is the  
            spouse of, partner of, or designated donor for the recipient.   


          4)Requires the physician providing insemination or ART services  
            to advise the donor and recipient of the potential medical  
            risks associated with receiving sperm from a reactive donor.   
            Requires the donor and recipient to sign a document affirming  
            their consent and comprehension of the medical repercussions.   


          5)Allows the use of sperm from a donor who has tested reactive  
            for syphilis for insemination or ART after the donor has been  
            treated for syphilis.  Allows the use of sperm from a donor  
            who has tested reactive for HBV for insemination or ART after  
            the recipient has been vaccinated against HBV. 

          6)Allows the use of sperm from a donor who has tested reactive  
            for HIV or HTLV-1 for insemination or ART after the sperm has  
            been processed to minimize the risk of infection for that  
            specific donation and where informed and mutual consent has  
            occurred.  Requires the physician to inform the recipient that  
            processing may not remove all risks of HIV or HTLV-1  
            transmission, that the sperm may be tested to determine  
            whether it is free of HIV or HTLV-1, and the harmful effects  
            that testing may have on the sperm.  

          7)Requires the physician to verify that a donor who has tested  
            reactive for HIV or HTLV-1 is under the care of a physician  
            managing the HIV or HTLV-1 infection, in order to minimize the  
            risk of transmission.  Requires the physician to provide  
            appropriate prophylactic treatment to the recipient to  
            minimize the risk of infection. 

           AS PASSED BY THE ASSEMBLY  , this bill increased from $3 to $6 the  
          fee charged for each inmate-initiated medical visit by an inmate  
          confined in a county or city jail.








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           FISCAL EFFECT :  According to the Senate Appropriations  
          Committee, pursuant to Senate Rule 28.8, negligible state costs.  


           COMMENTS  :  According to the author, HIV is now considered a  
          chronic disease, and many HIV-infected adults have near normal  
          life expectancy with typical life goals such as starting a  
          family.  The author states that due to advances in reproductive  
          technologies, sperm washing can separate healthy sperm from the  
          other components in semen that may contain HIV, removing 99.9%  
          of HIV particles, so HIV- and HTLV-infected sperm can be used in  
          ART with virtually no risk of transmission to mother and baby.   
          Over 4,500 assisted reproduction procedures are documented in  
          the literature with no reports of HIV transmission when using  
          standardized sperm washing methods with either intrauterine  
          insemination or in-vitro fertilization.  SB 443 (Migden),  
          Chapter 207, Statutes of 2007, was intended to ensure access to  
          reproductive treatment for HIV-discordant couples (HIV-positive  
          male and HIV-negative female).  However, the author states SB  
          443 was unclear about which medical professionals were  
          responsible for the care of the infected sperm donor and for  
          follow-up of the recipient, and included some medical  
          terminology that was inaccurate or insufficiently inclusive.   
          Also, sperm infected with different types of HTLV, not just  
          HTLV-I, can be safely used once processed, so this bill uses the  
          broader language.  The author argues this bill is needed to fix  
          those problems.  

          The processing of sperm from a donor testing reactive for HIV or  
          HTLV is commonly referred to as sperm washing.  Numerous studies  
          have confirmed that HIV is primarily found in white blood cells  
          and plasma in semen, not generally within the sperm itself.  The  
          sperm washing process involves centrifuging the semen in order  
          to separate it from the sperm.  This process can also involve a  
          "swim-up" technique that removes inactive sperm.  The remaining  
          active sperm can then be used for insemination or ART.  Numerous  
          studies report that the sperm-washing process reduces HIV levels  
          in sperm, and the technology and procedures continue to improve.  
           

          This bill was substantially amended in the Senate and the  
          Assembly-approved version of this bill was deleted.  This bill,  
          as amended in the Senate, is inconsistent with Assembly actions.









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           Analysis Prepared by  :    Cassie Rafanan / HEALTH / (916)  
          319-2097  
           

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