BILL ANALYSIS Ó SENATE JUDICIARY COMMITTEE Senator Hannah-Beth Jackson, Chair 2015 - 2016 Regular Session SB 19 (Wolk) Version: March 25, 2015 Hearing Date: April 28, 2015 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, including the means by which POLST forms would be submitted, revised, revoked, and would require that the ability to review the forms for accuracy be made available. This bill would require that the POLST form be made part of the patient's official medical record, and 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 SB 19 (Wolk) Page 2 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, 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 health care directive (AHCD), which is a document 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 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 or her heart stops beating or he or she stops breathing, for medical providers to not administer any medical procedure to restart breathing or heart function. POLSTs cover the DNR situation described above, but also allow an individual to indicate what type of medical intervention he or she wants when he or she has a pulse and/or is breathing. The options, presented as a box to be checked, 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 reportedly often lost. To address the SB 19 (Wolk) Page 3 of ? 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 similarly 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 the 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 SB 19 (Wolk) Page 4 of ? 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 and the POLST form. (Prob. Code Sec. 4780 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 (Registry) for the purpose of collecting POLST forms from health care providers or their designees, and disseminating the information in the form to authorized users. This bill would allow 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 an initial or subsequent POLST form may be submitted to or withdrawn from the Registry, and include a method for electronic delivery of this information and the use of legally sufficient electronic signatures; appropriate and timely methods by which the information may be disseminated to an authorized user; procedures for verifying the identity of an authorized user; procedures to ensure the accuracy of, and to appropriately protect the confidentiality of, POLST forms submitted to the Registry; that a patient or his or her legally recognized health care decision maker, when appropriate, receive confirmation or a receipt that the patient's POLST form has been received by the Registry; the ability of the physician who signed the POLST form, his or her designee, the patient, or when appropriate, his or her legally recognized health care decision maker, to review the information in the patient's POLST form after it has been entered into the Registry, and to confirm it is accurate, prior to it being available to an authorized user; and the ability of a patient, or when appropriate, his or her legally recognized health care decision maker, to withdraw a SB 19 (Wolk) Page 5 of ? POLST form from the Registry. This bill would require the operation of the registry to comply with state and federal privacy and security laws and regulations, including, but not limited to, compliance with the Confidentiality of Medical Information Act (CMIA) and the regulations promulgated pursuant to HIPAA. This bill would require a physician, or physician designee, who completes a POLST form with a patient or his or her legally recognized health care decision maker, to include the POLST form in the patient's official medical record and submit a copy to the Registry, unless the patient or the legally recognized health care decision maker chooses not to participate in the Registry. This bill would define authorized user as a person authorized by CHHS to submit information to, or receive information from, the POLST registry, including health care providers and their designees. This bill would protect an authorized user acting upon information obtained from the registry from criminal prosecution, civil liability, discipline for unprofessional conduct, administrative sanction, or any other sanction, if the 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 POLST form would have made on his or her own behalf, or on behalf of the patient, under the circumstances. COMMENT 1.Stated need for the bill According to the author: Healthcare professionals have found the POLST form very useful, when they have access to it; however often times the POLST form doesn't always travel along with the patient. POLST orders in particular can be critical to making important determinations such as whether or not to: transfer a patient to a hospital; initiate intubation and mechanical ventilation; or attempt resuscitation after cardiac arrest. There may be only minutes in which to make these vital decisions. SB 19 (Wolk) Page 6 of ? It is important to develop an electronic registry of these documents and the wishes or medical orders they contain. Therefore, individuals' wishes regarding life-sustaining treatments are known and honored across all health care settings. 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.POLST forms may conflict with advance health care directives Advance health care directives (AHCD) give an individual the power to give instructions about his or her own health care, and/or the ability to name someone else to make health care decisions for him or her in the event of incapacity. The AHCD may assist in guiding inpatient treatment decisions, and is recommended for all adults, regardless of their health status. The POLST form, which has been described as a complement to an AHCD, is different in that it is filled out by a physician, near the end of life, and is generally used to guide actions by Emergency Medical Personnel (EMP). In the event that a patient has executed both a POLST and an AHCD, to the extent that the two documents are in conflict, the last executed document controls. Generally, the two documents are distinct because they were designed to address different topics, but there remains the potential for quite a bit of overlap which can lead to challenges in determining exactly what a patient's wishes are. In 2010, California Advocates for Nursing Home Reform (CANHR) wrote a policy brief and noted a number of issues with the POLST form and POLST law. CANHR described the following situation where a patient's wishes were overridden by the wishes of his son. Unfortunately, the POLST law permits third parties to expressions of a patient's preferences, undermining the primary purpose of POLST and setting California privacy law and advance health care decision making on their heads. For example, E.H. from Fairfield, California, reports that his friend wrote an AHCD directing that he receive all treatment necessary to prolong his life. The friend's son (and, it SB 19 (Wolk) Page 7 of ? should be noted, his heir) nonetheless later signed a POLST directing his father receive comfort care only. His father passed away soon after. This situation highlights the importance of the two documents being read together because, arguably, the physician would not have signed the POLST form if he was aware of the AHCD indicating that the patient's wishes were contrary to those his son was expressing. The POLST form asks a physician to indicate whether he has read a patient's AHCD, but there is no statutory obligation to do so. In addition, because an AHCD, like a will, can be stored anywhere, this requirement does little to ensure the physician signing a POLST knows of the AHCD's existence. Storing the two documents together will help health care providers easily access an AHCD, and will help ensure that health care providers have all relevant information at their disposal when seeking to carry out a patient's wishes. Staff further notes that emergency medical technicians who consult the POLST Registry would not necessarily know if a patient had an AHCD, executed either prior to or after the POLST form. This could lead to emergency medical decisions that are not in line with a patient's expressed wishes and potentially violate the controlling legal document. Two simple safeguards could arguably help ensure that the patient's wishes are respected and that physicians are protected from malpractice suits, and the state is protected from wrongful death law suits. First, physicians should be required to review any advance health care directive that the patient has completed, and second, the Registry should house both advance health care directives and POLST forms so that they can be viewed together. Staff notes that those two safeguards would be consistent with the directions on the POLST form which state: "POLST does not replace the Advance Directive. When available, review the Advance Directive and POLST form to ensure consistency, and update forms appropriately to resolve any conflicts." CANHR, in reluctant opposition to this bill writes, "we have long thought that AHCDs are generally superior to POLSTs for advance care planning, but under [this bill] AHCDs will continue to languish in a registry system that is ancient, unused, and virtually worthless. If the state is going to create a state of the art registry for POLST, it ought to include AHCDs." 3.Registry may be maintained by a contactor SB 19 (Wolk) Page 8 of ? At present, there is broad agreement regarding the benefits of medical providers being able to easily access POLST forms 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].) The author argues that California is indeed ready for a Registry, and has used the Oregon registry as an example of how to implement a POLST registry in this state. Vynca, a healthcare technology company specializing in electronic POLST documentation and registry integration that is currently assisting the state of Oregon with the electronic implementation for their POLST completion, testified in Committee and wrote in support of SB 1357 that they have "the technical capability and experience to contribute the technical infrastructure of the proposed California POLST registry." Staff notes, however, 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. Oregon's population is roughly 10 percent of California's, and largely speaks English as a first language, unlike California where over 40 percent of persons speak a language other than English at home. Thus, it is difficult to say how such a system will function, or whether it will work well for California's substantially larger, more diverse population and different health care structure. Perhaps more relevant to the feasibility of a California POLST Registry would be a review of how a POLST registry actually SB 19 (Wolk) Page 9 of ? works in one or more communities in California. The California Health Care Foundation (CHCF) has studied the feasibility of a California POLST Registry pilot project. That study identified a number of information technology (IT) vendors who have expressed an interest in and ability to develop the IT platform, along with a handful of communities willing and able to serve as pilot communities. By reviewing the successes and challenges of that project, should it be funded by a private foundation, CHHS will arguably better understand what qualities the Registry, and the contractors associated with it, must possess to be successful in California. Thus, to the extent that this bill authorizes CHHS to have the Registry operated and maintained by a contractor, CHHS should look to all relevant programs, including any California pilot project operated with private funds, for guidance in choosing contractors and where to house the Registry. 4.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. The presence of an electronic registry raises issues of liability in the event that the system malfunctions, if there is a security breach, or if data is entered inaccurately. 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 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. California has a long history of challenges with respect to information technology, dating as far back as 1994 when a failed DMV system was abandoned after the state had already spent $50 million. In 2012, the state controller's office reported that "one of the state's biggest technology endeavors, a $371 million SB 19 (Wolk) Page 10 of ? overhaul of the government payroll system, is beset with problems and in danger of collapsing. (Chris Megerian, Overhaul of California government payroll system at risk of collapse, Los Angeles Times, Dec. 21, 2012.) Again in 2013, the DMV canceled a technology overhaul after spending $135 million, and in 2012 the Judicial Council shelved a Court Case Management System after only partial implementation. (California's courts, minus computers; The Los Angeles Times, March 27, 2012.) Given the above track record, this Committee's analysis of SB 1357 noted concerns about the ability of the state to effectively develop a database. Although there was broad consensus regarding the benefits of medical providers being able to access POLST forms easily, the Committee questioned the reliability of presently unknown contractors, software, and methods of operation. Moreover, it is unclear who, if anyone at all, would be held liable in the event that the program malfunctioned or information was entered into the registry inaccurately. Because the POLST registry necessarily deals with life and death, the Committee recognized that any error could result in death and potentially a wrongful death suit. The immunity provision 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, and would also serve to 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. However, as a matter of policy, the question arises as to whether a contractor operating the Registry could be liable in a suit resulting from the inaccurate transmission of information that was reasonably relied upon by a health care provider. The following amendment would clarify that contractors are not protected from liability under the bill, thereby ensuring that a contractor could be liable in the event of negligence on its part. Author's amendment: On page 4, strike lines 17-24, and insert "A health care provider who honors a patient's request regarding SB 19 (Wolk) Page 11 of ? resuscitative obtained from the registry is not subject to criminal prosecution, civil liability, discipline for unprofessional conduct, administrative sanction, or any other sanction as set forth in Probate Code Section 4782." Support : AARP; Alliance of Catholic Health Care; Blue Shield of California; California Assisted Living Association; California Association of Physician Groups; California Chapter American College of Emergency Physicians; California Commission on Aging California Hospital Association; California Long Term-Care Ombudsman Association; Long Term Ombudsman Services of San Luis Obispo County; Medical Board of California; Petaluma Valley Hospital; Providence Health and Services Southern California; Queen of the Valley Medical Center; Redwood Memorial Hospital; Riverside Family Physicians; Santa Rosa Memorial Hospital; St. Joseph Hospital, Eureka; St. Joseph Hospital, Orange; St. Jude Medical Center, Fullerton Opposition : California Advocates for Nursing Home Reform (unless amended) HISTORY Source : The Coalition for Compassionate Care of California Related Pending Legislation : AB 637 (Campos) would allow nurse practitioners and physician assistants, acting under the supervision of the physician and within the scope of practice authorized by law, to sign a POLST form. This bill was heard in the Assembly Judiciary Committee on April 7, 2015, and is currently on the Assembly Floor. AB 791 (Cooley) would require the State Medicaid Health Information Technology Plan to specify the process by which patient advance health care directive information would be managed, including the secure preparation, storage, printing, and display of the patient's advance health direction information, as prescribed. This bill is scheduled for hearing in the Assembly Health Committee on April 21, 2015. Prior Legislation : SB 1357 (Wolk, 2014) would have established a POLST registry at SB 19 (Wolk) Page 12 of ? CHHS. This bill was held on the Senate Appropriations suspense file. AB 2452 (Pan, 2014) required, 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 was never scheduled for hearing in the Senate Judiciary Committee. AB 3000 (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 2445 (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. 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 Health Committee (Ayes 9, Noes 0) ************** SB 19 (Wolk) Page 13 of ?