BILL ANALYSIS                                                                                                                                                                                                    Ó




           ----------------------------------------------------------------- 
          |SENATE RULES COMMITTEE            |                        SB 464|
          |Office of Senate Floor Analyses   |                              |
          |(916) 651-1520    Fax: (916)      |                              |
          |327-4478                          |                              |
           ----------------------------------------------------------------- 


                                UNFINISHED BUSINESS 


          Bill No:  SB 464
          Author:   Hernandez (D)
          Amended:  5/22/15  
          Vote:     21  

           PRIOR SENATE VOTES NOT RELEVANT

           SENATE BUS, PROF. & ECON. DEV. COMMITTEE:  8-0, 8/27/15
            (pursuant to Senate Rule 29.10)
           AYES:  Hill, Berryhill, Block, Galgiani, Hernandez, Jackson,  
            Mendoza, Wieckowski
           NO VOTE RECORDED:  Bates

           ASSEMBLY FLOOR:  73-1, 8/20/15 - See last page for vote

           SUBJECT:   Healing arts: self-reporting tools


          SOURCE:    Planned Parenthood Affiliates of California

          DIGEST:  This bill permits a physician, registered nurse (RN),  
          certified nurse-midwife (CNM), nurse practitioner (NP),  
          physician assistant (PA), and pharmacist to use a self-screening  
          tool to aid the prescription of self-administered hormonal  
          contraceptives.  

          Assembly Amendments delete the contents of the bill and replace  
          it with the current version.  
          
          ANALYSIS: 

          Existing law:

          1)Prohibits a person or entity from prescribing, dispensing, or  
            furnishing, or causing to be prescribed, dispensed, or  








                                                                     SB 464  
                                                                    Page  2



            furnished, dangerous drugs or dangerous devices on the  
            Internet for delivery to any person in this state, without an  
            appropriate prior examination and medical indication, except  
            as specified.  (BPC § 2242.1) 

          2)Authorizes a RN to dispense a self-administered hormonal  
            contraceptive (SAHC) in accordance with standardized  
            procedures, which shall include demonstration of competency in  
            providing the appropriate prior examination comprised of  
            checking blood pressure, weight, and patient and family health  
            history, including medications taken by the patient.  The  
            appropriate prior examination shall be consistent with the  
            evidence-based practice guidelines adopted by the federal  
            Centers for Disease Control and Prevention (CDC) in  
            conjunction with the United States Medical Eligibility  
            Criteria for Contraceptive Use (USMEC).  (BPC § 2725.2)

          3)Authorizes a pharmacist to furnish SAHC in accordance with  
            standardized procedures developed and approved by both the  
            Board of Pharmacy (BOP) and the Medical Board of California  
            (MBC) in consultation with other entities, as specified, and  
            requires that the protocol mandate the use of a patient  
            self-screening tool to identify risk factors for the use of  
            SAHC, based on current USMEC developed by the federal CDC.    
            (BPC § 4052.3)

          This bill:

          1)Authorizes a physician, RN, CNM, NP, PA, and pharmacist to use  
            a self-screening tool that will identify patient risk factors  
            for the use of SAHC by a patient, and, after an appropriate  
            prior examination, prescribe, furnish, or dispense, as  
            applicable, SAHC to the patient. 

          2)Permits blood pressure, weight, height, and patient health  
            history to be self-reported using the self-screening tool.

          Background


          Telehealth and Self-Screening Tools.  Current law defines  
          telehealth as "the mode of delivering health care services and  








                                                                     SB 464  
                                                                    Page  3



          public health via information and communication technologies to  
          facilitate the diagnosis, consultation, treatment, education,  
          care management, and self-management of a patient's health care  
          while the patient is at the originating site and the health care  
          provider is at a distant site."  Telehealth is neither a  
          distinct technology nor a type of care; it is the remote  
          provision of healthcare services according to the same  
          professional standards governing in-person care.
            
          Telehealth may be facilitated by many mediums, including  
          telephone, videoconferencing, store-and-forward technology, and  
          increasingly, by mobile devices connected to the Internet.

          A self-screening tool is not defined in law; it is any  
          instrument by which an individual reports health information.   
          BOP is developing a paper checklist as its self-screening tool,  
          and there exist mobile apps that record consumers' answers in  
          response to online prompts that are also considered  
          self-screening tools.  

          Requirements for Prescribing SAHC.  Current law authorizes a  
          physician, RN, CNM, NP, PA, or a pharmacist to prescribe,  
          furnish, or dispense SAHC.  However, current laws and  
          regulations are not specific as to the exact protocols required  
          for each licensee to provide SAHC to patients.  

          Physician:  An appropriate prior examination is mandated by law  
          prior to a physician prescribing a SAHC.  However, an in-person  
          examination is not required and a physician is expected to use  
          his or her professional judgment in determining the appropriate  
          standard of care for each patient.  

          RN, CNM, NP, PA: These licensees are required to furnish or  
          dispense SAHC pursuant to standardized procedures, which are the  
          legal mechanism for non-physicians to perform functions which  
          would otherwise be considered the practice of medicine,  
          including prescribing drugs.  Standardized procedures are  
          policies and protocols developed by a health facility or  
          organized health care system, with input from administrators and  
          health professionals, which establish parameters for medical  
          care.  These licensees are also required to conduct an  
          appropriate prior examination before dispensing or furnishing  








                                                                     SB 464  
                                                                    Page  4



          SAHC on the Internet for delivery to any person in this state,  
          but what constitutes an appropriate prior examination is  
          undefined. 

          As part of their standardized procedures for dispensing SAHC,  
          RNs are required to demonstrate competency in providing an  
          appropriate prior examination, which is comprised of checking  
          blood pressure, weight, and collecting patient and family health  
          history.  Current law further states that the appropriate prior  
          examination by a RN shall be consistent with the evidence-based  
          practice guidelines adopted by the CDC.  

          The CDC recommended in their June 14, 2013 Morbidity and  
          Mortality Weekly Report that, "among healthy women, few  
          examinations or tests are needed before initiation of combined  
          hormonal contraceptives."  They recommend that blood pressure be  
          measured and that weight and body mass may be useful for  
          monitoring SAHC use over time.  However, nothing in the CDC  
          recommendation states that a RN must measure blood pressure and  
          weight for each patient prior to furnishing SAHC, and it is  
          reasonable to infer that an accurate self-reporting of the same  
          information would yield the necessary information.  

          Pharmacist:  Pharmacists may furnish SAHC in accordance with  
          standardized procedures developed and approved by the BOP and  
          MBC.  These standardized procedures have not yet been adopted,  
          but the law states they must include a patient self-screening  
          tool to identify risk factors based on the same CDC guidelines  
          as required by RN protocols. The initial regulations formalizing  
          the standardized procedures approved by the MBC and BOP required  
          that the pharmacist also measure a patient's seated blood  
          pressure, in addition to the information collected by the  
          self-screening tool.  However, at the July 29, 2015 BOP meeting,  
          the BOP voted to modify the protocol so that a pharmacist may  
          accept self-reported blood pressure at his or her discretion.   
          This modification must now be approved by the MBC.
           
           This bill acknowledges the need for patient health information,  
          including blood pressure and weight, to appropriately recommend  
          a SAHC, but permits practitioners to rely on information  
          provided by the patient, rather than measured by the  
          practitioner.  








                                                                     SB 464  
                                                                    Page  5



          
          Self-Reported Health Metrics and Safety of SAHC.  Accepting  
          self-reported medical information for SAHC is supported by  
          numerous medical reports and journals because of the nature of  
          the drugs themselves, effective self-screening, and the greater  
          risks of unintended pregnancies.  

          For example, the American College of Obstetricians and  
          Gynecologists (ACOG) advocated for over-the-counter availability  
          of SAHCs in 2014, noting that the primary risk associated with  
          SAHC, venous thromboembolism (blood clots) is "extremely low,"  
          and that women can self-screen for contraindications.  Further,  
          the risk of blood clots due to SAHC is lower than the same risk  
          of clotting in pregnancy.  A 2014 article in the American  
          Journal of Obstetrics and Gynecology reported on a study  
          indicating that on average, there is a low prevalence of medical  
          contraindications in women of reproductive age overall, so there  
          is a very small portion of the population for whom information  
          on a self-screening tool is truly vital.    

          This bill aims to clarify that existing and potential telehealth  
          providers operate in accordance with current law by stating that  
          practitioners who are currently authorized to provide SAHC may  
          do so by relying on self-reported health information.

          FISCAL EFFECT:   Appropriation:    No          Fiscal  
          Com.:YesLocal:   No


          According to the Assembly Appropriations analysis, this bill  
          will have negligible costs to affected professional licensing  
          boards within the Department of Consumer Affairs.  




          SUPPORT:   (Verified8/27/15)


          Planned Parenthood Affiliates of California (source)
          California Medical Association
          California Primary Care Association 








                                                                     SB 464  
                                                                    Page  6



          Community Action Fund of Planned Parenthood of Orange and San  
          Bernardino Counties
          Icebreaker Health
          NARAL Pro-Choice California
          Planned Parenthood Action Fund of Santa Barbara, Ventura and San  
          Luis Obispo Counties
          Planned Parenthood Action Fund of the Pacific Southwest
          Planned Parenthood Advocacy Project Los Angeles County
          Planned Parenthood Mar Monte
          Planned Parenthood Northern California Action Fund
          Planned Parenthood Pasadena and San Gabriel Valley
          Numerous individuals. 


          OPPOSITION:   (Verified8/27/15)


          California Catholic Conference
          California Nurses Association
          California Right to Life Committee, Inc.

          ARGUMENTS IN SUPPORT:  "Planned Parenthood supports efforts to  
          better serve our patients through the development and expansion  
          of telehealth services. Telehealth is a safe, effective delivery  
          system that expands access to health care for people who  
          otherwise would have to travel a long distance to see a  
          provider. 

          "SB 464 seeks to help improve preventive health services by  
          increasing access to services in rural communities through the  
          utilization of telemedicine by allowing patients to provide  
          information to a health provider through a self-screening tool,  
          including family history, blood pressure, or weight.  As  
          technology advances, telehealth will include models where  
          patients communicate directly with a distant provider and are  
          not physically present in a provider's office."

          ARGUMENTS IN OPPOSITION:The California Catholic Conference  
          writes in opposition, "Young girls, and other minors under the  
          age of 18, would be able to receive contraceptives ? without an  
          actual medical exam and without the consent of their parent(s)  
          or guardian(s).  Further, without any oversight, these dangerous  








                                                                     SB 464  
                                                                    Page  7



          drugs could easily get into the wrong hands of human traffickers  
          or the hands of young people."

          ASSEMBLY FLOOR:  73-1, 8/20/15
          AYES:  Achadjian, Alejo, Baker, Bigelow, Bloom, Bonilla, Bonta,  
            Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu,  
            Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier,  
            Beth Gaines, Cristina Garcia, Eduardo Garcia, Gatto, Gipson,  
            Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Roger Hernández,  
            Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine,  
            Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty,  
            Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell,  
            Olsen, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas,  
            Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner,  
            Weber, Wilk, Williams, Wood, Atkins
          NOES:  Gallagher
          NO VOTE RECORDED:  Travis Allen, Brough, Chu, Harper, Patterson,  
            Waldron


           Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104,   
          Sarah Huchel / B., P. & E.D. / (916) 651-4104
          8/28/15 15:24:23


                                   ****  END  ****