BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: SB 19 --------------------------------------------------------------- |AUTHOR: |Wolk | |---------------+-----------------------------------------------| |VERSION: |March 25, 2015 | --------------------------------------------------------------- --------------------------------------------------------------- |HEARING DATE: |April 8, 2015 | | | --------------------------------------------------------------- --------------------------------------------------------------- |CONSULTANT: |Teri Boughton | --------------------------------------------------------------- SUBJECT : Physician Orders for Life Sustaining Treatment form: statewide registry SUMMARY : Establishes a Physician Orders for Life Sustaining Treatment (POLST) Registry operated by the California Health and Human Services Agency (CHHS) for the purpose of collecting a POLST form received from a physician, or his or her designee, and disseminating the information in the form to persons authorized by CHHS. Existing law: 1.Defines advance health care directive or directive to mean either an individual health care instruction or a power of attorney for health care. Requires the Secretary of State to establish a registry system through which a person who has executed a written advance health care directive may register in a central information center, information regarding the advance directive, making that information available upon request to any health care provider, the public guardian, or the legal representative of the registrant. 2.Requires the Secretary of State to establish procedures to verify the identities of health care providers, the public guardian, and other authorized persons requesting information from the registry system. Prohibits a fee from being charged to any health care provider, the public guardian, or other authorized person requesting information from the registry system. 3.Establishes the POLST form and medical intervention and procedures offered by the form, and requires that it be explained by a health care provider, defined as an individual SB 19 (Wolk) Page 2 of ? licensed, certified, or otherwise authorized or permitted by the law of this state to provide health care in the ordinary course of business or practice of a profession. 4.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. 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. 5.Requires a request regarding resuscitative orders to be made by an Emergency Medical Services Authority (EMSA) developed prehospital "Do Not Resuscitate" or other substantially similar form or, an EMSA approved POLST form. 6.Establishes the Confidentiality of Medical Information Act (CMIA) which prohibits any health care provider, health insurer, or medical service contractor from disclosing a patient's medical information without the patient's consent, subject to certain mandatory and voluntary exceptions. 7.Requires under the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) procedures for health care providers, health plans, health care clearinghouses and their business associates for protecting and confidentially handling protected health information. This bill: 1.Establishes the California POLST Registry Act, and requires CHHS to establish and operate a statewide registry system for the purpose of collecting a POLST form received from a physician or physician designee and disseminating the information in the form to an authorized user. 2.Permits the registry to be operated and maintained by a contractor of CHHS. 3.Requires CHHS to adopt all rules necessary for the operation of the registry, and requires but does not limit the rules to include the following: a. The means to submit an initial or subsequent POLST form, or withdraw a form, from the registry, SB 19 (Wolk) Page 3 of ? including a method for electronic delivery and the use of legally sufficient electronic signatures; b. Appropriate and timely methods by which the information may be disseminated to an authorized user; c. Procedures for verifying the identity of an authorized user; d. Procedures to ensure the accuracy of, and to appropriately protect the confidentiality of, POLST forms submitted to the registry; e. That a patient, or when appropriate, his or her legally recognized health care decision maker, receive a confirmation or a receipt that the patient's POLST form has been received by the registry; f. 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, g. The ability of a patient, or when appropriate, his or her legally recognized health care decision maker, to withdraw a POLST form from the registry. 4.Requires 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 CMIA and the regulations promulgated pursuant to HIPAA. 5.Requires 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. 6.Protects 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 SB 19 (Wolk) Page 4 of ? circumstances. 7.Defines 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. FISCAL EFFECT : This bill has not been analyzed by a fiscal committee. COMMENTS : 1.Author's statement. According to the author, the "Physician Orders for Life-Sustaining Treatment" (POLST) is a form that contains a doctor's orders to ensure that a patient's wishes are honored regarding medical treatment towards the end of life. Currently, the POLST form is a paper document, and as such, is oftentimes a key barrier to its effectiveness given that it can be misplaced. Furthermore, there isn't a central database or registry that first responders can access in an emergency situation. 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 funding available to specifically support electronic health records. Several states are developing and a few states have already completed a statewide registry to access POLST forms more effectively. 2.What is POLST? According to the POLST Legislative Guide, approved February 28, 2014 by the National POLST Paradigm Task Force, the POLST Paradigm is a clinical process designed to facilitate communication between health care professionals and patients with serious illness or frailty (or their authorized surrogate) where the health care professional would not be surprised if the patient died within the next year. The process encourages shared, informed medical decision-making leading to a set of portable medical orders that respects the patient's goals for care in regard to the use of cardiopulmonary resuscitation and other medical interventions, is applicable across health care settings, and can be reviewed and revised as needed. The POLST paradigm promotes the use of a highly visible, portable medical form that transfers from one setting to another with the patient. It functions as a Do Not Resuscitate order and provides treatment direction for SB 19 (Wolk) Page 5 of ? multiple situations. The form itself is outcome neutral. Its options range from full treatment to comfort care only. As of December 2013, the POLST Paradigm Task Force had endorsed the POLST programs of 16 states, and another 12 states were developing POLST implementation plans. The 16 endorsed states are: California, Colorado, Georgia, Hawaii, Idaho, Louisiana, Montana, New York, North Carolina, Oregon, Pennsylvania, Tennessee, Utah, Washington, West Virginia, and Wisconsin (Wisconsin has been endorsed only regionally). POLST is neither an advance directive nor a replacement for advance directives. However, both documents are helpful for communicating patient wishes when appropriately used. An advance directive is a form in which an individual appoints a person or persons to make health care decisions for the individual if and when the individual loses capacity to make health care decisions (health care power of attorney); and/or provides guidance or instructions for making health care decisions (living will). An advance directive is from the patient, not a medical order. POLST consists of a set of medical orders that applies to a limited population of patients and addresses a limited number of critical medical decisions. POLST is a complement to advance directives in that it serves as a translation tool and a continuity of care assurance. 3.POLST in California. As published in an August 10, 2012 article in the Journal of General Internal Medicine, Implementation of Physician Orders for Life Sustaining Treatment in Nursing Homes in California: Evaluation of a Novel Statewide Dissemination Mechanism, 546 California nursing homes were surveyed and in 82 percent of responding nursing homes, staff received POLST education and 59 percent reported having a formal policy on POLST. Two-thirds had admitted a resident with a POLST and 15 percent of newly admitted residents over the past month had a POLST. Few nursing homes reported difficulty following POLST orders, but 38 percent noted difficulty involving physicians in POLST completion. A 2013 article in the Journal of American Geriatrics Society, Implementing Physician Orders for Life-Sustaining Treatment in California Hospitals: Factors Associated with Adoption, indicates of 349 hospitals surveyed, 81.9 percent responded. Sixty-five percent of hospitals had a policy on POLST, 87 percent had available POLST forms, 84 SB 19 (Wolk) Page 6 of ? percent had educated staff, and 94 percent reported handling POLST properly in the emergency department on admission. Although POLST is widely used in California, a significant minority of hospitals remain unprepared three years after implementation. According to Dr. Neil Wenger of UCLA Health Ethics Center at a December 3, 2014 briefing on POLST in California, based on an evaluation by UCLA, POLST is widely used in California but there are challenges with completing the form and making sure it travels with the patient. Additional problems include incomplete or inaccurate information and for emergency medical responders the documents are not always available. Dr. Wenger suggests a registry is one solution to these challenges. 4.Other California Registries. a. Advance Health Care Directive Registry . The Secretary of State maintains the advance health care directive registry, as required by law, which allows a person who has executed an advance health care directive to register information regarding the directive with the Secretary of State. An advance health care directive can be made a part of the Secretary of State's registry by attaching a copy of the advance health care directive to the Registration of Written Advance Health Care Directive filed with the Secretary of State. As an alternative to providing a copy of the written directive to the Secretary of State, its location can be indicated on the registration form. As of April 3, 2015, there are 4,907 advance health care directives on file. In the past five fiscal years, a total of 2,152 written advance health care directives have been filed for an average of 430 filings per year. For this fiscal year, 279 written advance health care directives have been filed through the month of February. This information is made available upon request to the registrant's health care provider, public guardian, or legal representative. A request for information must state the need for the information. Over the last two years, there has been a spike in the number of inquiries due to the fact that Ventura and Los Angeles counties have been permitted to send email inquiries with supporting documentation. In SB 19 (Wolk) Page 7 of ? the past two years, there has been an average of 526 inquiries each year with a vast majority of the inquiries being email inquiries. Prior to fiscal year 2013-14, an average of two inquiries were received a year. The annual cost to maintain the registry is approximately $45,000, excluding overhead costs. Staff support for the filings and inquiries equates to a .5 personnel year. Although there is a $10 registration fee, maintaining the registry is absorbed as part of other programs and services provided by the Business Programs Division through the Business Fees Fund, which consists of a cumulative pool of money paid by all businesses and individuals that are required or are permitted to file documents with the Secretary of State's office. b. California Cancer Registry . According to the California Department of Public Health, California Cancer Registry (CCR) is California's statewide population-based cancer surveillance system. The CCR collects information about all cancers diagnosed in California (except basal and squamous cell carcinoma of the skin and carcinoma in situ of the cervix). In 1985, statewide, population-based cancer reporting was required by law. The CCR is now recognized as one of the leading cancer registries in the world. Due to the size and diversity of the California population, more is now known about the occurrence of cancer in diverse populations than ever before. The CCR has proven to be the cornerstone of a substantial amount of cancer research in the California population. c. California Immunization Information Registry (CAIR) . CAIR is a collaborative effort involving local health departments, the California Department of Public Health (DPH), Immunization Branch, and a spectrum of key stakeholders across the state. There are seven regional registries managed by department staff. CAIR is working to develop an integrated, statewide computerized registry to network each child's full immunization history. SB 19 (Wolk) Page 8 of ? Health care providers and other authorized users log in to the registry using a user ID and password. In addition to accessing patient immunization information, users can utilize the integrated vaccine algorithm to determine vaccinations due, enter new patients or vaccine doses administered, manage vaccine inventory, run patient or inventory reports, or run reminder/recalls on their patients. New patients or vaccine doses can either be entered directly into CAIR using the web interface or can be submitted electronically as aggregated data files (e.g. exported from their EHR systems) for upload to CAIR. Many prominent private and public health care entities already share data electronically with CAIR. Statewide there are 14.9 million patients with 160 million vaccines registered. In 2010, state General Fund support for the registries (approximately $3.5 million) was withdrawn and efforts to integrate the registries were put on hold. Support to users and system enhancements were diminished. 5.Lessons Learned. Pathways to POLST Registry Development: Lessons Learned by Zive and Schmidt, October 2012, examined POLST Paradigm registry systems in seven different states (California, which has no current registry, Idaho, New York, Oregon, Utah, Washington State, and West Virginia). Five of the states studied had either an active registry or an Electronic Form Completion System. Several key findings emerged from the study: 1) Defining the registry's purpose is essential. 2) A mature, widespread POLST program supports more rapid population of the registry. 3) Strong leadership is essential. 4) Integrating into existing health care systems and Electronic Medical Records increases use and economizes resources. 5) Volume of submissions is impacted by the process for submission and who can submit. 6) Launching a registry prematurely can divert resources from other aspects of establishing a successful POLST program. 7) Sustaining funding for registry operations is vital to long-term success. According to the 2012 study, California's POLST is relatively new. Since California is such a large and diverse state, statewide coordination including interaction and communication with local health care leaders has been extremely important. Much of the focus is on quality implementation. Because SB 19 (Wolk) Page 9 of ? emergency responders are overseen by 32 local emergency medical authorities rather than a single statewide entity there is no logical centralized home for a registry. Additionally, the desire to share information electronically expands to health care information beyond POLST, and the state of health information technology is in flux. The registry needs to interface with future health information technology. 6.West Virginia. West Virginia has established the West Virginia e-Directive Registry. With the permission of patients or their legal agents, the electronic registry houses and makes available to treating health care providers advance directive forms, do not resuscitate (DNR) cards, and Physician Orders for Scope of Treatment (POST) forms. The registry is password-protected and HIPAA compliant. As of January 31, 2015, the registry had received 36,526 total forms, which includes POST forms, medical power of attorney and living wills as individual documents and many combined DNR cards and other documents which are helpful in a time of medical crisis. 7.Oregon. Oregon's POLST registry is housed in the Oregon Health Authority and operated on contract with the Oregon Health and Science University Department of Emergency Medicine, which already had a 24-hour Emergency Communication Center. Legislation adopted in Oregon mandated that all completed POLST forms be submitted to the registry by the signer unless the patient opts out. At a December 3, 2014 briefing in Sacramento, Dr. Susan Tolle, an official with the Oregon POLST Registry, indicated that by September 2014, Oregon had received over 225,000 POLST forms. Based on a study using 2010-2011 death records matched with POLST orders of 58,000 decedents, Dr. Tolle indicates that 6.4 percent of patients who specified comfort measures only on their POLST forms died in a hospital and 34.2 percent of people with no POLST form died in a hospital. The study concludes that end-of-life preferences of people who wish to avoid hospitalization as documented in POLST orders are honored. Dr. Tolle identifies as key elements of Oregon's success that the POLST registry contains POLST forms only; that completion of POLST by a patient or caregiver is voluntary; providers must submit POLST forms to the registry but patients can opt out; the registry operates statewide and within the emergency medical response/health system. 8.California Pilot Project. In October of 2014, the California SB 19 (Wolk) Page 10 of ? HealthCare Foundation (CHCF) issued a request for information to learn about the technical, infrastructure, and cost requirements for developing a POLST Registry in a single California community. CHCF was looking for information from vendors around the technology, operational, and support services necessary to establish a POLST registry and estimates of corresponding costs. The ideal technical solution(s) should receive the POLST information for patients from varied sources, communicate POLST records to emergency responders and other medical professionals, and maintain data accuracy by interfacing with medical and public health information systems (such as the California death registry). CHCF also requested letters of interest from California communities with the ability to convene acute care hospitals, medical groups, nursing homes, hospices, and emergency medical services to test a registry platform that would make POLST records available to authorized providers telephonically, electronically, or both. The ideal provider community would be able to modify clinical workflows to use the pilot POLST registry, integrate the POLST form into electronic health record systems, and explore a sustainable financing model. A decision by CHCF to move forward with a pilot is not expected until September. 9.Double referral. This bill is double referred. Should it pass out of this committee it will be referred to the Senate Judiciary Committee. 10.Related legislation. a. SB 128 (Wolk and Monning), would permit a competent, qualified individual who is a terminally ill adult to receive a prescription for aid in dying medication if certain conditions are met, such as two oral requests, a minimum of 15 days apart, and a written request signed by two witnesses, is provided to his or her attending physician, the attending physician refers the patient to a consulting physician to confirm diagnosis and competency of the patient, and the attending physician refers the patient for counseling, if appropriate. This bill is scheduled for hearing in the Senate Judiciary Committee on April 7, 2015. b. AB 972 (Jones), requires DPH to inform a patient diagnosed with cancer by, or receiving cancer therapy SB 19 (Wolk) Page 11 of ? treatment from, a specified health care practitioner, or a hospital or other facility within an area designated as a cancer reporting area of the reporting requirement, and requires DPH to also notify a patient of specified information, including, among other things, that DPH is authorized to release confidential patient information to health researchers. This bill is pending in the Assembly Health Committee. c. AB 637 (Campos) allows 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. AB 637 is scheduled for a hearing in the Assembly Judiciary Committee on April 7, 2015. d. AB 791 (Cooley) requires 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. AB 791 is scheduled for a hearing in the Assembly Health Committee on April 21, 2015. 11.Prior legislation. SB 1357 (Wolk), of 2014, would have established a POLST registry at CHHS. The bill was held on the Senate Appropriations suspense file. AB 2452 (Pan), of 2014, would have required the Secretary of State to transfer the contents of its advance health care directive's registry to the DPH on January 1, 2016, and would have required DPH to maintain a health care decision registry, to be referred to as the California Health Care Decisions Online Registry. The bill was never scheduled for a hearing in the Senate Judiciary Committee. AB 1683 (Jones), of 2014, would have required DPH to inform all patients diagnosed with, or being treated for cancer that their case has been reported to the Ken Maddy CCR within six months of their case being reported. This bill was held on the Assembly Appropriations suspense file. AB 3000 (Wolk), Chapter 266, Statutes of 2008, created POLST in California, which is a standardized form to reflect a SB 19 (Wolk) Page 12 of ? 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 and Nation), Chapter 434, Statutes of 2005, created the Advance Directives and Terminal Illness Decisions Program, which requires the Secretary of State to work with the Department of Health Services (now DHCS) and the Attorney General (AG) to develop 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. This act also requires links to be provided for this information on the websites of the Secretary of State, DHCS, the AG, Department of Managed Health Care, Department of Insurance, Board of Registered Nursing, and the Medical Board of California. AB 2442 (Canciamilla), Chapter 882, Statutes of 2004, requires the Secretary of State, as part of the duties associated with the advance health care directive registry, to receive and release a person's advance health care directive and transmit the information to the registry of another jurisdiction upon request. It requires the Secretary of State to respond by the close of business on the next business day to a request for information received from the emergency department of a general acute care hospital. 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, requires 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. AB 48 (Cedillo), Chapter 368, Statutes of 2000, renamed the CCR the Ken Maddy CCR. AB 136 (Connelly), Chapter 841, Statutes of 1985, established CCR. 12.Support. According to the Coalition for Compassionate Care SB 19 (Wolk) Page 13 of ? of California (CCCC), POLST has been widely adopted in California, almost 95 percent of California hospitals have admitted a patient with a POLST and 87 percent have blank forms available; 69 percent of nursing homes had reported admitting a resident with a POLST form and 81 percent report a staff member had completed a POLST with a resident; and after hearing a description of POLST almost two thirds of Californians say they would definitely or probably want to complete a POLST form if they were seriously ill. CCCC states that gaining access to a patient's POLST during a medical crisis is a critical factor in honoring patients' wishes and a statewide registry will eliminate delays in care and confusion. Hospitals have written that POLST is an important care planning tool, but it does little good if the information is not easily available in a time of crisis. POLST forms sometimes get lost when patients transition from care settings and a statewide registry would eliminate this problem. Others write that POLST facilitates free and informed consent required for medical treatments and procedures for persons who are frail and elderly or who have a compromised medical condition. There are common roadblocks to effective use of POLST but the registry can be a solution. The Long Term Care Ombusdsman Services of San Luis Obispo indicates many people who have a POLST do not have the document available when they are in an emergency room or receiving assistance from paramedics/EMTs. The creation of a registry will greatly improve access to these forms when they are needed most. The California Assisted Living Association writes that this bill's effort to make POLST forms available online in a secure format reinforces the important issue of honoring end of life wishes. 13.Support in Concept. The Medical Board of California supports the concept of making the POLST form available electronically and establishing a statewide POLST Registry. The Board can only support the concept at this point, as many of the details of the implementation of the Registry are not included in this bill. Currently, this bill does not address funding, who will have access to the POLST forms as authorized users, or how the electronic registry will operate. 14.Opposition. The California Right to Life Committee, Inc., opposes this bill because the organization believes the goals of this bill are directly tied to SB 128. The California Right to Life Committee, Inc., believes this bill is another interjection of the state into the medical field and will SB 19 (Wolk) Page 14 of ? result in an authorization of the death industry to heavily pressure ill, elderly or disabled, especially low-income citizens to succumb to their sales pitch and seek to end their own lives. 15.Oppose unless amended. The California Advocates for Nursing Home Reform (CANHR) believes using state resources to create a POLST registry without including advance health care directives represents a significant missed opportunity and threatens to further relegate advance health care directives to second class status compared to POLST. CANHR believes the POLST promotion has exacerbated some of the form's problems, namely the form does not need to be signed by patients and can sometimes be used to override their actual wishes. CANHR writes that the advance health care directives are generally superior to POLSTs for advance care planning, but under this bill, advance health care directives will continue to languish in a registry system that is ancient, unused, and virtually useless. 16.Is California ready for a statewide registry? There are many issues with regard to the registry yet to be worked out. Is CHHS the appropriate entity to house the registry? Would CHHS delegate to one of the departments under its jurisdiction? Should the POLST registry be housed together with the advance health care directive registry? The low uptake of the advance health care directive registry suggests that the Secretary of State may not be the appropriate place to house a POLST registry. Will a POLST registry have better uptake? DPH has some experience with other registries. Since advance directives and POLST forms complement one another perhaps the registries should be housed together. According to the October 2012 lessons learned report there were a number of issues raised that suggested California wasn't quite ready for a POLST registry. What has changed since that report was published? Has California's POLST program matured enough? Is there leadership at the state level? Does California have the resources now to support this activity? Should the state support development of a registry through a pilot project prior to the creation of a statewide registry? 17.Technical amendments. a. On page 3 (b)(1) and (b)(7) appear to be duplicative and should be revised. b. On page 2, line 31 a technical amendment is SB 19 (Wolk) Page 15 of ? suggested in (b)(6) ?.. prior to the information being available toanother authorized user s. SUPPORT AND OPPOSITION : Support: The Coalition for Compassionate Care of California (sponsor) 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 Petaluma Valley Hospital Providence Health and Services Southern California Queen of the Valley Medical Center Riverside Family Physicians Santa Rosa Memorial Hospital St. Joseph Hospital, Orange St. Jude Medical Center, Fullerton Numerous individuals Oppose: California Advocates for Nursing Home Reform (unless amended) California Right to Life Committee Numerous individuals -- END --