BILL ANALYSIS                                                                                                                                                                                                    �






                             SENATE JUDICIARY COMMITTEE
                         Senator Hannah-Beth Jackson, Chair
                              2013-2014 Regular Session


          SB 1357 (Wolk)
          As Amended April 21, 2014
          Hearing Date: April 29, 2014
          Fiscal: Yes
          Urgency: No
          NR


                                        SUBJECT
                                           
           Physician Orders for Life Sustaining Treatment Form: Statewide  
                                      Registry

                                      DESCRIPTION  

          This bill, the California Physician Orders for Life Sustaining  
          Treatment (POLST) Act, would require the California Health and  
          Human Services Agency (CHHS) to operate a statewide registry  
          system for the purpose of collecting POLST forms from health  
          care providers and disseminating that information to authorized  
          users.  This bill would require CHHS to adopt rules for the  
          operation of the registry, and would require that any disclosure  
          of POLST form information be made in accordance with applicable  
          federal privacy laws.  

          This bill would provide immunity for authorized users who obtain  
          information from the registry and act in good faith, as  
          specified.  

                                      BACKGROUND  

          End-of-life is one of the most difficult stages of life and in  
          great need of attention to improve the care and experience of  
          dying individuals.  Data reveals that the majority of  
          Californians prefer to spend their last months in a non-hospital  
          setting, free of pain, and making sure their family is not  
          burdened by their care. Although 70 percent of Californians  
          indicate they would prefer to die a natural death at home, only  
          32 percent of deaths occurred at home.  In addition, care  
          provided at the end of life consumes a disproportionate share of  
          costs.  (Let's Get Healthy California, Task Force Final Report,  
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          December 19, 2012.)

          A number of options exist for those who wish to control their  
          end-of-life care.  Patients may create a "request regarding  
          resuscitative measures," which is a written document signed by  
          the patient and the patient's physician, that directs a  
          healthcare provider regarding resuscitative measures.  These  
          typically come in the form of a "do not resuscitate" order/form  
          (DNR), or a Physician Orders for Life Sustaining Treatment form  
          (POLST).  Patients may also create an advance care directive,  
          which is a form in which an individual appoints a person to make  
          health care decisions if and when the individual loses the  
          capacity to make those decisions for himself and/or provides  
          guidance or instructions for making health care decisions.

          Advance health care directives, which allow another to make  
          health care decisions in the patient's incapacity, are much  
          broader in scope than the DNRs and POLSTs which  are used only  
          in when a patient faces death if not resuscitated or if there is  
          not a specific medical intervention.  DNRs are used when an  
          individual wishes, in a situation where his heart stops beating  
          or he stops breathing, for medical providers to not administer  
          any medical procedure to restart breathing or heart function.   
          Valid DNRs require a properly executed form, and patients are  
          encouraged to also wear a medallion so that first responders  
          will immediately know that the patient does not wish to receive  
          resuscitation.  A copy of the DNR also goes in the patient's  
          permanent medical record.  

          POLSTs cover the DNR situation described above, but also allow  
          an individual to indicate what type of medical interventions she  
          wants when she has a pulse and/or is breathing.  The options,  
          presented as a box one can check, are "comfort measures only,"  
          "limited additional interventions," or "full treatment." The  
          form is easy for first responders and other medical personnel to  
          understand, and is supposed to physically follow a patient in  
          the event that he or she is discharged or transferred to another  
          facility. 

          Medical professionals have found POLSTs useful in determining  
          how to best care for patients while respecting their end-of-life  
          wishes.  However, POLSTs, which are paper forms, are not always  
          accessible and are often lost.  To address the accessibility  
          issue, a handful of states have created POLST registries which  
          allow medical professionals to locate the POLST, or a copy of  
          it, when the paper form is not readily available.  This bill  
                                                                      



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          seeks to ensure that a patient's end-of-life treatment  
          preferences are respected by creating a statewide registry  
          system to provide medical providers with electronic access to  
          POLST forms. 

                                CHANGES TO EXISTING LAW

          Existing law  provides that an advanced health care directive is  
          either a document containing (1) individual health care  
          instruction or (2) a power of attorney for health care.   
          Existing law further establishes a process and form for an  
          individual to give instructions about health care decision  
          making and designating an agent to make decisions on his or her  
          behalf. (Prob. Code Sec. 4670 et seq.)

           Existing law  requires the Secretary of State to establish a  
          registry system where advance health care directives may be  
          registered in a central information center, and that information  
          may be made available upon request to any health care provider,  
          the public guardian, or the legal representative of the  
          registrant. (Prob. Code Sec. 4800.)

           Existing law  prohibits failure to register with the Secretary of  
          State from affecting the validity of any advance health care  
          directive. (Prob. Code Sec. 4803.)

           Existing law  requires the Secretary of State to work with the  
          State Department of Health Care Services (DHCS) and the office  
          of the Attorney General (AG) to develop information about end of  
          life care, advance health care directives, and registration of  
          the advance health care directives with the registry. (Prob.  
          Code Sec. 4806.)

           Existing law  requires a request regarding resuscitative orders  
          to be a pre-hospital "Do Not Resuscitate" form, as specified, or  
          an Emergency Medical Services Authority (EMSA) approved POLST  
          form. (Prob. Code Sec. 4780.)

           Existing law  establishes the Physician Orders for Life  
          Sustaining Treatment (POLST) form and requires the form to be  
          completed by a health care provider based on patient preferences  
          and medical indications, and signed by a physician and the  
          patient or his or her legally recognized health care  
          decision-maker. Existing law requires the health care provider,  
          during the process of completing form, to inform the patient  
          about the difference between an advance health care directive  
                                                                      



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          and the POLST form. (Prob. Code Sec. 4870 et seq.)

           Existing law  protects a health care provider from liability  
          regarding a resuscitative measure if the health care provider  
          (1) believes in good faith that his or her action is consistent  
          with the applicable law, and (2) has no knowledge that the  
          action or decision would be inconsistent with a health care  
          decision that the individual would have made on his or her own  
          behalf under like circumstances.  (Prob. Code Sec. 4782.)

           This bill would require the California Health and Human Services  
          Agency (CHHS) to establish and operate a statewide registry  
          system, to be known as the California POLST Registry, for the  
          purpose of collecting POLST forms from a health care providers  
          and disseminating the information in the form to authorized  
          users.  

           This bill  would authorize the registry to be operated and  
          maintained by a contractor of CHHS, and would require CHHS to  
          adopt all rules necessary for the operation of the registry,  
          including:
           the means by which a POLST form may be submitted to the  
            registry, revised, and revoked and include a method for  
            electronic delivery of this information and the use of legally  
            sufficient electronic signature;
           appropriate and timely methods by which the information in the  
            registry may be disseminated to an authorized user;
           procedures for verifying the identity of an authorized user;  
            and 
           procedures to ensure the accuracy of and to appropriately  
            protect the confidentiality of POLST forms submitted to the  
            registry.

           This bill  would make the registry and the information it  
          contains the property of the state and any disclosure of  
          information in POLST forms received by the registry to be made  
          in a manner consistent with the federal Health Insurance  
          Portability and Accountability Act of 1996.

           This bill  would require a health care provider who completes a  
          POLST with a patient or his or her legally recognized health  
          care decision-maker to submit a copy of the POLST to the  
          registry unless the patient or the decision-maker chooses not to  
          participate in the registry.

           This bill  would provide that an authorized user acting upon  
                                                                      



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          information obtained from the registry is not subject to  
          criminal prosecution, civil liability, discipline for  
          unprofessional conduct, administrative sanction, or any other  
          sanction if that person acted in good faith and had no knowledge  
          that the action or decision would be inconsistent with a health  
          care decision that the individual signing the request would have  
          made on his or her own behalf under like circumstances.

           This bill  would define an "authorized user" as a person  
          authorized by CHHS to submit information to, or to receive  
          information from, the POLST registry, including health care  
          providers.

                                        COMMENT
           
           1.Stated need for the bill
           
          According to the author:

            Currently, the POLST form is a paper document and a key  
            barrier to the effectiveness of the POLST is inaccessibility  
            of the document which is intended to guide care. A statewide  
            electronic POLST registry in California would help ensure  
            immediate access to vital medical orders by emergency medical  
            personnel.  In an era of ever-increasing technology and  
            federal support specifically designed to expedite meaningful  
            use of electronic health records, many states are developing  
            electronic registries and/or other systems facilitating the  
            completion of, and access to POLST forms.

           2.Responsibilities of emergency medical providers under this  
            bill 
           
          This bill would require a medical provider who completes a POLST  
          to submit a copy to the POLST registry unless the patient  
          chooses not to participate in the registry, and would create  
          immunity for any authorized user of the registry who has acted  
          in good faith and without knowledge that his or her action would  
          be inconsistent with that of the patient if the patient could  
          have acted on his own behalf. 

          The immunity under this bill is nearly identical to the  
          protections extended to health care providers under existing law  
          dealing with resuscitative measures (i.e., DNRs and POLSTs).   
          Thus, including it in this bill will not change the liability  
          for health care providers acting in good faith but as applied to  
                                                                      



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          this context the immunity could insulate health care providers  
          from a wrongful death law suit when they relied on data that was  
          inaccurately entered or transmitted from the POLST Registry.  As  
          discussed in Comment 3, this bill raises the question of whether  
          state or contractor operating the registry should be liable in a  
          wrongful death suit resulting from inaccurate information  
          received from the POLST registry. 

          In addition, creating a POLST registry arguably creates new  
          responsibilities for health care providers. In theory, POLST  
          forms are posted for medical providers to see.  Emergency  
          medical technicians (EMTs) often look on a patient's  
          refrigerator when called to someone's home, and in health care  
          facilities, the POLST form is posted outside the patient's door.  
           The author argues that "the problem is that paper POLST forms  
          are often lost, misplaced, or not efficiently communicated  
          between electronic medical records?healthcare providers must by  
          default provide aggressive care like cardiopulmonary  
          resuscitation and intensive care."  In support of this bill the  
          WISE & Healthy Aging Long-Term Care Ombudsman Program writes:

            The POLST tool is rendered useless if it does not physically  
            move with the person to each treatment setting.  SB 1357 would  
            remedy that by providing a registry that a medical  
            professional could access to obtain these important documents.

          However, after the creation of a registry, it is not clear  
          whether health care professionals and first responders, such as  
          EMTs, will be required to access an online database prior to  
          administering medical treatment. If not required by statute,  
          health care providers could be required by an employer's policy  
          to check for POLST instructions. Arguably, this could create an  
          extra, and potentially time consuming, step before an individual  
          is provided life-saving treatment, and could have the unintended  
          consequence of compromising the quality of care for individuals  
          who have not created a POLST.  In response, the author writes  
          "our bill encourages but doesn't mandate EMT's look for POLST  
          forms. They can utilize the dispatch center which serves as a  
          hub of communication and retrieving information about a  
          patient."

          Staff notes that the bill does not create or require a dispatch  
          center, nor does it encourage or prohibit health care  
          professionals to look for POLST forms.  The bill, as written,  
          merely requires California Health and Human Services Agency  
          (CHHS) to create the registry and the laws CHHS and the registry  
                                                                      



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          must comply with.  

           3.Liability associated with a state-run POLST registry
           
          This bill would require CHHS to establish and operate a  
          statewide POLST Registry, and would require CHHS to adopt all  
          rules necessary for the operation of the registry.  The bill  
          would also allow the registry to be operated and maintained by a  
          contractor.  

          In support of the bill, Vynca, a healthcare technology company  
          specializing in electronic POLST documentation and registry  
          integration, writes that they have the "the technical capability  
          and experience to contribute the technical infrastructure of the  
          proposed California POLST registry."  Vynca is currently  
          assisting the state of Oregon with an electronic implementation  
          for their POLST completion, and fully supports a similar  
          construct in California. 

          Staff notes that healthcare providers in Oregon currently access  
          the POLST registry through a telephone hotline, because the  
          electronic format and retrieval system is not yet completed.   
          Thus, it is difficult to say how such a system will function, or  
          whether it will work well for California's substantially larger  
          population and different health care structure. For example,  
          with the 38 million people in California, if EMTs call to check  
          the registry on the way to each emergency, it would appear to  
          require significant staff and resources to field these calls 24  
          hours a day. 

          Furthermore, the presence of an electronic registry raises  
          issues of liability if the system malfunctions, if there is a  
          security breach, or if data is entered inaccurately.  These  
          questions of liability are further complicated by the presence  
          of a contractor.  Those liability issues could take the form of  
          a wrongful death suit against the state or contractor as a  
          result of inaccurate information which resulted in the death of  
          an individual at a time when his or her life could have been  
          saved.   

          For example, imagine the scenario where a health care provider  
          goes to the aid of a person in cardiac arrest and cannot  
          physically locate a POLST form. The doctor then accesses the  
          POLST registry and finds a form associated with the patient by  
          name and birthday.  The electronic POLST information indicates  
          that the patient wishes to die a natural death, and has agreed  
                                                                      



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          to forgo any resuscitation. The doctor therefore allows the  
          patient to die, only to subsequently discover from the family  
          who produces the original POLST form that the information the  
          physician received from the registry was inaccurate and the  
          patient wished to be resuscitated. 

          Given the recent challenges that the State of California has had  
          with respect to information technology, staff notes that the  
          above issues could be addressed if patient wore a medallion that  
          clearly states his or her wishes, or by requiring POLST forms to  
          move with the patient.  Regarding the use of medallions, the  
          Emergency Medical Services Association writes that "although  
          optional, use of a wrist or neck medallion facilitates prompt  
          identification of the patient, avoids the problem of lost or  
          misplaced forms, and is strongly encouraged."

           4.Feasibility of state-wide registry
           
          Arguably, there is broad consensus on the benefits of medical  
          providers being able to access POLST forms easily and in a  
          timely manner.  However, there is no agreement as to how, when,  
          or where a registry should be implemented.  In 2012, a report on  
          behalf of the National POLST Paradigm Task Force was published,  
          and questioned whether California was ready to implement a POLST  
          registry.  The report questioned the age of California's POLST  
          program, and emphasized the need for statewide coordination and  
          leadership. The report noted that the state of health  
          information technology is in flux, and as of 2012 there was no  
          clear choice for appropriate technology to serve such a large  
          and diverse state.  Furthermore, the report noted that, "because  
          emergency responders in California are overseen by 32 local  
          emergency medical authorities, rather than a single statewide  
          agency, there is no logical centralized home for the registry."  
          (Pathways to POLST Development: Lessons Learned, found at <  
          http://www.polst.org  
          /wp-content/uploads/2012/12/POLST-Registry.pdf> as of April 24,  
          2014.)  It is not clear that there have been any developments  
          since this report was released in 2012 significant enough to  
          suggest that California is now ready to create a statewide  
          registry.

          Furthermore, only six states have implemented a POLST registry,  
          and with varying degrees of success.  Thus, there are very few  
          models to look to when creating California's program.  Given the  
          experiences of other states, the author provided the Committee  
          with the following questions which the Legislature may want to  
                                                                      



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          consider:

                 How should the data be accessed? Oregon permits access  
               only through a telephone hotline, while other states allow  
               access online.  Is use of mobile devises recommended? 
                 Where should the registry be housed, and which agency or  
               department or private party should be responsible for its  
               administration? 
                 How will the development and maintenance of the registry  
               be funded, and how sustainable is that funding? 
                 Who should develop the registry? Is it advisable to  
               contract with a private company or university? 
                 Should POLST forms be part of a patient's medical  
               records, like DNRs? 
                 Will there be interoperability with other state health  
               data systems? 

          In response to these questions, the author argues that  
          "California is indeed ready for a POLST registry, largely  
          because from 2007 to 2012 physicians use of electronic health  
          records (EHR) increased from 37 percent to 59 percent and it is  
          likely that from 2012 to now we have seen a similar increase  
          toward full EHR penetration. Further, the author contends that  
          for the past year and half, the Coalition for Compassionate Care  
          of California (CCCC) has been actively exploring options for and  
          issues around establishing a successful electronic registry.   
          CCCC and the Institute for Population Health at UC Davis are  
          anticipating a pilot project for an electronic registry in two  
          regions of California (Northern & Southern).  Likewise, the  
          California HealthCare Foundation is conducting a feasibility  
          study to examine what it would take to implement a successful  
          POLST registry in California and ensure its sustainability."

          However, in consideration of the questions raised above, the  
          author offers the following amendment which would delay  
          implementation of the registry for an additional year. 

          Author's amendment

                Delay implementation of California's POLST registry until  
               January 1, 2016. 
           1.Opposition's concerns
           
          The California Right to Life Committee, Inc. writes in  
          opposition that "the POLST form does not guarantee the  
          individual person's total control over the possible treatments  
                                                                      



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          and therapies available [and]?exonerates the physician and any  
          medical team from liability by encouraging a patient to sign a  
          form which rejects all curative and restorative treatment." 


           Support  :  California Chapter of the American College of  
          Emergency Physicians; California Long-Term Care Ombudsman  
          Association; Coalition for Compassionate Care of California;  
          Congress of California Seniors; Long Term Care Ombudsman  
          Services of San Luis Obispo County; Riverside Family Physicians;  
          Vynca; WISE and Healthy Aging Long-Term Care Ombudsman Program

           Opposition  :  California Right to Life Committee, Inc.

                                        HISTORY
           
           Source  :  Author 

           Related Pending Legislation  :  AB 2452 (Pan) would require,  
          commencing on January 1, 2016, the Secretary of State to  
          establish and maintain access, as specified, to a secure portion  
          of the Secretary of State's Internet Web site that provides an  
          electronic reproduction of an advance health care directive and  
          other specified documents submitted to the registry system. This  
          bill is currently pending in the Assembly Health Committee.

           Prior Legislation  :

          AB 300 (Wolk, Chapter 266, Statutes of 2008) created POLST in  
                                                            California, which is a standardized form to reflect a broader  
          vision of resuscitative or life sustaining requests and to  
          encourage the use of POLST orders to better handle resuscitative  
          or life sustaining treatment consistent with a patient's wishes.

          AB 1676 (Richman, Chapter 434, Statutes of 2005) created the  
          Advance Directives and Terminal Illness Decisions Program, which  
          required the development of information about end of life care,  
          advance health care directives, and registration of the advance  
          health care directives at the Advance Health Care Directive  
          Registry.

          AB 2442 (Canciamilla, Chapter 882, Statutes of 2004) required  
          the Secretary of State to receive and release a person's advance  
          health care directive and transmit the information to the  
          Advance Health Care Directive Registry of another jurisdiction  
          upon request. 
                                                                      



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          AB 891 (Alquist, Chapter 658, Statutes of 2000) established the  
          Health Care Decisions Law which also governs advance health care  
          directives.

          SB 1857 (Watson, Chapter 1280, Statutes of 1994) required the  
          Secretary of State to establish a central registry for power of  
          attorney for health care or a Natural Death Act declaration.   
          This legislation was repealed and replaced by the Health Care  
          Decisions Law.

           Prior Vote  :  Senate Committee on Health (Ayes 8, Noes 0)

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