BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: SB 128 --------------------------------------------------------------- |AUTHOR: |Wolk and Monning | |---------------+-----------------------------------------------| |VERSION: |March 17, 2015 | --------------------------------------------------------------- --------------------------------------------------------------- |HEARING DATE: |March 25, 2015 | | | --------------------------------------------------------------- --------------------------------------------------------------- |CONSULTANT: |Teri Boughton | --------------------------------------------------------------- SUBJECT : End of life SUMMARY : Permits 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. Protects a person from civil or criminal liability, or professional disciplinary action, for participating in good faith compliance with this bill. Permits a person or entity that elects, for reasons of conscience, morality, or ethics, not to engage in activities authorized pursuant to this bill. Makes it a felony to knowingly alter or forge a request for medication to end an individual's life without his or her authorization or concealing or destroying a rescission of a request for medication if the act is done with the intent or effect of causing the individual's death. Makes it a felony to knowingly coerce or exert undue influence on an individual to request medication for the purpose of ending his or her life. Existing law: 1.Establishes requirements for health care providers when a provider makes a diagnosis that a patient has a terminal illness, including that the patient has a right to comprehensive information and counseling regarding legal end of life options. 2.Requires the comprehensive information to include, but not be limited to: SB 128 (Wolk) Page 2 of ? a. Hospice care at home or in a health care setting; b. A prognosis with and without the continuation of disease-targeted treatment; c. The right to refuse or withdraw from life-sustaining treatment; d. The right to continue to pursue disease-targeted treatment, with or without concurrent palliative care; e. The right to comprehensive pain and symptom management at the end of life, including, but not limited to, adequate pain medication, treatment of nausea, palliative chemotherapy, relief from shortness of breath and fatigue, and other clinical treatments useful when a patient is actively dying; and, f. The right to give individual health care instruction, such as an advance health care directive, and the right to appoint a legally recognized health care decision-maker. 3.Provides, for purposes of a judicial determination, a person has the capacity to give informed consent to a proposed medical treatment if the person is able to do all of the following: a. Respond knowingly and intelligently to queries about that medical treatment. b. Participate in that treatment decision by means of a rational thought process. c. Understand all of the following items of minimum basic medical treatment information with respect to that treatment: i. The nature and seriousness of the illness, disorder, or defect that the person has. ii. The nature of the medical treatment that is being recommended by the person's health care providers. iii. The probable degree and duration of any benefits and risks of any medical SB 128 (Wolk) Page 3 of ? intervention that is being recommended by the person's health care providers, and the consequences of lack of treatment. iv. The nature, risks, and benefits of any reasonable alternatives. 4.Provides that a person who has the capacity to give informed consent to a proposed medical treatment also has the capacity to refuse consent to that treatment. 5.Provides that a resident of a long term care facility lacks capacity to make a decision regarding his or her health care if the resident is unable to understand the nature and consequences of the proposed medical intervention, including its risks and benefits, or is unable to express a preference regarding the intervention. Requires the physician, in making the determination regarding capacity, to interview the patient, review the patient's medical records, and consult with facility staff, family members and friends of the resident, if any have been identified. 6.Makes it a felony to deliberately aid, or advise, or encourage another to commit suicide. 7.Requires licensed health care prescribers eligible to prescribe controlled substances, and pharmacists authorized to dispense controlled substances who dispense Schedule II through IV controlled substances to provide the dispensing information to the Department of Justice (DOJ) on a weekly basis in a format approved and accepted by the DOJ, as specified. 8.Establishes the State Public Health Officer (SPHO), who is a California licensed physician and surgeon with demonstrated medical, public health, and management experience, to serve as the director of the State Department of Public Health (DPH). Establishes the Department of Social Services (DSS) to administer human assistance programs that provide cash aid and services to eligible needy families, and licenses and regulates residential care facilities for the elderly. 9.Licenses and regulates physicians and surgeons under the Medical Practice Act by the Medical Board of California (MBC), SB 128 (Wolk) Page 4 of ? within the Department of Consumer Affairs (DCA) and provides for the licensure and regulation of pharmacies, pharmacists and wholesalers of dangerous drugs or devices by the Board of Pharmacy, also within the DCA. 10.Requires the physician and surgeon last in attendance, or in the case of a patient in a long-term care at the time of death, the physician and surgeon last in attendance or a licensed physician assistant under the supervision of the physician and surgeon last in attendance, on a deceased person, to state on the certificate of death the disease or condition directly leading to death, antecedent causes, other significant conditions contributing to death and any other medical and health section data as may be required on the certificate. Requires the physician and surgeon or physician assistant to specifically indicate the existence of any cancer as defined, of which the physician and surgeon or physician assistant has actual knowledge. This bill: 1.Permits a competent, qualified individual, as defined, who is a terminally ill adult to make a request to receive a prescription for aid in dying medication if all of the following conditions are satisfied: a. The attending physician has determined the individual to be suffering from a terminal illness; b. The individual has voluntarily expressed the wish to receive a prescription for aid in dying medication; c. The individual is a resident of California and is able to establish residency through: i. California driver license or other identification issued by the State of California; ii. Registration to vote; iii. Evidence of property ownership or lease; or, iv. California tax return for the most recent year; and, d. The individual documents his or her request for aid in dying medication, as specified. 2.Prohibits a person from being a "qualified individual" based on age or disability. SB 128 (Wolk) Page 5 of ? 3.Prohibits a request for aid in dying medication made on behalf of a patient through a power of attorney, an advance health care directive, or a conservator. 4.Requires a qualified individual wishing to receive a prescription for aid in dying medication to submit two oral requests, a minimum of 15 days apart, and a witnessed written request, as specified, to his or her attending physician. 5.Requires at least two adult witnesses who attest that to the best of their knowledge and belief the individual is competent, acting voluntarily, and not being coerced to sign the request. 6.Permits one of the two witnesses to be related by blood, marriage, or adoption; or be a person entitled to a portion of the person's estate upon death. Permits one of the two witnesses to own, operate, or be employed at a health care facility where the qualified individual is receiving medical treatment or resides. Prohibits the attending physician from being one of the witnesses. 7.Permits a qualified individual to rescind his or her request at any time without regard to their mental state. 8.Requires the attending physician to: a. Make the initial determination whether the requesting adult is competent, has a terminal illness, has voluntarily made the request, and is a qualified individual. b. Ensure the individual is making an informed decision by discussing with him or her the medical diagnosis and prognosis, potential risks with taking the medication, the probable result of taking the medication, the possibility that he or she may choose to obtain the medication but not take it, and the feasible alternatives or additional treatment opportunities including, but not limited to, comfort care, hospice care, palliative care, and pain control. c. Refer the individual to a consulting physician, (defined as a physician who is qualified by specialty or experience to make a professional diagnosis and prognosis regarding the individual's SB 128 (Wolk) Page 6 of ? illness), for medical confirmation of the diagnosis, prognosis, and for a determination that the individual is competent and has complied with this bill. d. Refer the individual for counseling, if appropriate. Defines counseling as one or more consultations, as necessary, between an individual and a California licensed psychiatrist or psychologist for the purpose of determining that the individual is competent and is not suffering from a psychiatric or psychological disorder or depression causing impaired judgment. e. Ensure that the individual's request does not arise from coercion or undue influence by another person. f. Counsel the individual about the importance of having another person present when he or she takes the medication and not taking the medication in a public place. g. Inform the individual that he or she may rescind the request at any time and in any manner. h. Offer the individual an opportunity to rescind the request before prescribing the medication. i. Verify, immediately prior to writing the prescription for medication, that the individual is making an informed decision. j. Ensure that all appropriate steps are carried out in accordance with this bill prior to writing a prescription. aa. Fulfill the record documentation that may be required through regulation by DPH, in consultation with DSS, as specified. 9.Permits the attending physician to deliver the medication in any of the following ways: a. Dispense directly, including ancillary medication intended to minimize discomfort, if the physician is authorized to dispense medicine under California law, has a current United States Drug Enforcement Administration certificate, and complies with any applicable administrative rule or regulation. b. With the individual's written consent, contact a pharmacist, inform the pharmacist of the prescription, and deliver the written prescriptions SB 128 (Wolk) Page 7 of ? personally, by mail, or electronically to the pharmacist, who is required to dispense the medications to the qualified individual, the attending physician, or a person expressly designated by the individual and with the designation delivered to the pharmacist in writing or verbally. 10.Permits delivery of the dispensed medication to the qualified individual, the attending physician, or a person expressly designated by the qualified individual to be made by: personal delivery, United Parcel Service, United States Postal Service, Federal Express, or by messenger service. 11.Requires, prior to a qualified individual obtaining aid in dying medication from the attending physician, the consulting physician to perform all of the following: a. Examine the individual and his or her relevant medical records; b. Confirm in writing the diagnosis and prognosis; c. Verify, in the opinion of the consulting physician, that the qualified individual is competent, acting voluntarily, and has made an informed decision; and, d. Fulfill the record documentation that may be required through regulation by DPH, in consultation with DSS. 12.Permits the attending physician to sign the qualified individual's death certificate unless otherwise prohibited by law. Requires the cause of death to be the underlying terminal illness. 13.Prohibits an individual from receiving a prescription for aid in dying medication unless he or she has made an informed decision. Requires the attending physician, immediately before writing a prescription for aid in dying medication, to verify that the individual is making an informed decision. 14.Establishes a format for the aid in dying medication request and requires that a request be in substantially the same form. Requires the request to be written in the same translated language as any conversations, or consultations between a patient and his or her attending or consulting physicians. Authorizes a written request in English if accompanied by an SB 128 (Wolk) Page 8 of ? interpreters declaration signed under penalty of perjury. Specifies the words of the declaration. Requires the interpreter to be qualified, as specified in Department of Managed Health Care regulations applicable to health care service plans and not related to the qualified individual by blood, marriage, or adoption or be entitled to a portion of the person's estate upon death. 15.Makes a provision in a contract, will, or other agreement, whether written or oral, affecting whether a person may make or rescind a request for aid in dying medication, invalid. Prohibits an obligation owing under any contract in effect on January 1, 2016, from being conditioned upon or affected by a person making or rescinding a request for aid in dying medication. 16.Prohibits the sale, procurement, or issuance of a life, health, accident insurance or annuity policy, health care service plan contract, or health benefit plan, or the rate charged for a policy or plan contract from being conditioned upon, or affected by, a person making or rescinding a request for aid in dying medication. 17.Provides, notwithstanding any other law, that a qualified individual's act of self-administering aid in dying medication may not have an effect upon a life, health, or accident insurance or annuity policy other than that of a natural death from the underlying illness. 18.Protects a person, notwithstanding any other law, from civil or criminal liability or professional disciplinary action for participating in good faith compliance with this bill, including an individual who is present when a qualified individual self-administers the prescribed aid in dying medication. 19.Prohibits a health care provider or professional organization or association from censoring, disciplining, suspending, or revoking licensure, privileges, membership, or administering other penalty to an individual for participating or refusing to participate in good faith compliance with this bill. 20.Provides that a request by an individual to an attending physician or to a pharmacist to dispense aid in dying medication or to provide aid in dying medication in good faith SB 128 (Wolk) Page 9 of ? compliance with the provisions of this bill does not constitute neglect or elder abuse for any purpose of law or provide the sole basis for the appointment of a guardian or conservator. 21.Requires participation in activities authorized pursuant to this bill to be voluntary. Permits a person or entity that elects, for reasons of conscience, morality, or ethics, not to engage in activities authorized pursuant to this bill, and provides that a person or entity is not required to take any action in support of a patient's decision under this bill, except as otherwise required by law. 22.Requires, if a health care provider is unable or unwilling to carry out an individual's request under this bill and the individual transfers care to a new health care provider, the prior health care provider to transfer, upon request, a copy of the individual's relevant medical records to the new health care provider. 23.Provides that nothing in this bill prevents a health care provider from providing an individual with health care services that do not constitute participation in this bill. 24.Prohibits a health care provider from being sanctioned for: making an initial determination that an individual has a terminal illness and informing him or her of the medical prognosis; providing information about the End of Life Option Act to a patient upon the request of the individual; providing an individual, upon request, with a referral to another physician; or, contracting with an individual to act outside the course and scope of the provider's capacity as an employee or independent contractor of a health care provider that prohibits activities under this bill. 25.Provides, notwithstanding any contrary provision in this bill, the immunities and prohibitions on sanctions of a health care provider are solely reserved for actions taken pursuant to this bill and those providers may not be sanctioned for conduct and actions not included and provided for in this bill if the conduct and actions do not comply with the standards and practices set forth by the MBC. 26.Makes it a felony to knowingly alter or forge a request for medication to end an individual's life without his or her SB 128 (Wolk) Page 10 of ? authorization or concealing or destroying a rescission of a request for medication if the act is done with the intent or effect of causing the individual's death. 27.Makes it a felony to knowingly coerce or exert undue influence on an individual to request medication for the purpose of ending his or her life or to destroy a rescission of a request. 28.Provides that nothing in a particular section of this bill limits further liability for civil damages resulting from other negligent conduct or intentional misconduct by any person. Provides that the penalties in a particular section do not preclude criminal penalties applicable under any law for conduct inconsistent with the provisions of this bill. 29.Provides that nothing in this bill may be construed to authorize a physician or any other person to end an individual's life by lethal injection, mercy killing, or active euthanasia. Provides that actions taken in accordance with this bill shall not, for any purpose, constitute suicide, assisted suicide, mercy killing, homicide, or elder abuse under the law. 30.Requires DPH, in consultation with DSS, to adopt regulations establishing reporting requirements for physicians and pharmacists to determine utilization and compliance with this bill. 31.Requires the information collected under 30) to be confidential and collected in a manner that protects the privacy of the patient, the patient's family, and any medical provider or pharmacist involved with the patient. 32.Requires DPH to provide an annual compliance and utilization statistical report aggregated by age, gender, race, ethnicity, and primary language spoken at home and other data determined relevant, and requires the report to be made public 30 days upon completion. 33.Requires a person who has custody or control of any unused aid in dying medication to personally deliver the unused medication to the nearest qualified facility that properly disposes of controlled substances, or if none is available, dispose of it by lawful means. SB 128 (Wolk) Page 11 of ? 34.Requires any governmental entity that incurs costs resulting from a qualified individual terminating his or her life in a public place to have a claim against the estate of the qualified individual to recover those costs and reasonable attorney fees. 35.Establishes legislative findings and declarations that any limitation in this bill to public access to personally identifiable patient data is necessary to protect the privacy rights of the patient and his or her family, the interests of protecting the privacy rights of the patient and his or her family in this situation strongly outweigh the public interest in having access to personally identifiable data relating to services, and the public statistical report is sufficient to satisfy the public's right to access. 36.Makes provisions of this bill severable if any provision is held invalid. FISCAL EFFECT : This bill has not been analyzed by a fiscal committee. COMMENTS : 1.Author's statement. According to the authors, SB 128, the End of Life Option Act would give qualified, terminally ill patients in California, who have been given a prognosis of less than six months to live, the autonomy to exercise ultimate decision-making authority in end of life decisions. By giving these patients the legal right to ask for and receive a lethal prescription from his/her physician, SB 128 would provide one more option to the number of options one has when faced with the end of life. Furthermore, there are provisions to safeguard patients and to allow voluntary participation by physicians, pharmacists and healthcare facilities. This medical practice is already recognized in five other states. Terminally ill Californians should not have to leave the state in order to have a peaceful death. In the end, how each of us spends the end of our lives is a deeply personal decision. That decision should remain with the individual, as a matter of personal freedom and liberty, without criminalizing those who help to honor our wishes and ease our suffering. SB 128 (Wolk) Page 12 of ? 2.Other States. According to the National Conference of State Legislatures, four states currently allow a person to request medication to end one's life, including: Montana, Oregon, Vermont, and Washington. Montana's authorization was determined in the 2008 case of Baxter v. State of Montana. In January 2014, New Mexico's authorization was determined in Morris v. New Mexico, however the New Mexico Attorney General has appealed the district court's ruling. According to the Albuquerque Journal News, a decision is not expected for several months. Oregon, Vermont and Washington have authorized the practice in statute, by voter initiative in Oregon (passed in 1994 and enacted in 1997) and Washington (in 2008). In 2013, Vermont passed legislation to authorize physician aid in dying. Arkansas and Idaho have enacted laws which specifically prohibit physician aid in dying. 3.Other Countries. Belgium, the Netherlands, Luxembourg, Switzerland and, beginning next year, Canada, allow physician aid in dying. The Netherlands and Belgium also allow euthanasia (medication administered by a physician). Belgium extended its law in 2014 to include children of any age living with terminal illness. In the Netherlands, the law is not available to children under 12 years old and for teenagers, the law requires parental consent. 4.Oregon Data. According to the Oregon Public Health Division 2013 report, from 1998 to 2013, 1,173 were prescribed aid with dying medication and 752 deaths occurred as a result of ingesting prescribed medications. From 1998 to 2013 the gender break down of those who died from ingesting a lethal dose of medication was 52 percent male and 48 percent female. Less than 32 percent of the individuals who ingested the medication were between ages 18-64. Almost 70 percent were over aged 65. The race breakdown was white (97 percent), African American (.1 percent), American Indian (.3 percent), Asian (1.1 percent), Pacific Islander (.1 percent), other (.1 percent), two or more races (.3 percent), and Hispanic (.7 percent). Over 46 percent of those who ingested the medication were married and the remaining 64 percent were widowed, never married, divorced, or status was unknown (three individuals). Less than 28 percent of those who ingested the medication had a high school education or less and 72 percent had some college or higher education levels (five individuals had unknown status). Ninety percent of those who ingested the SB 128 (Wolk) Page 13 of ? medication were enrolled in hospice. Sixty-three percent had private insurance, 35 percent had Medicare, Medicaid or other governmental insurance, and less than two percent were uninsured (35 individuals had unknown status). Almost 80 percent of those who ingested the medication had malignant neoplasms, seven percent had Amyotrophic lateral sclerosis, five percent had chronic lower respiratory disease, two percent had heart disease, one percent had HIV/AIDS and six percent had other illnesses. Six percent of those who ingested the medication were referred for psychiatric evaluation. Ninety-four informed their family of their decision. Ninety-five percent died at home, four percent died in long-term care, and .1 percent died in the hospital. Ninety-one percent of those who ingested the medication were concerned about loss of autonomy, 89 percent were concerned about being less able to engage in activities that make life enjoyable, 81 percent were concerned about loss of dignity, 50 percent were concerned about losing bodily function, 40 percent were concerned about being a burden on family, friends or caregivers, 23 percent were concerned about inadequate pain control, and three percent were concerned about financial implications of treatment. There were 22 complications of regurgitation reported and six individuals regained consciousness after ingesting the medications. A range of between 15 and 1,009 days elapsed from the first request for medication and death. 5.Brittany Maynard. According to Compassion and Choices, a nonprofit that works to expand end of life choices, Brittany Maynard was a California native with a terminal brain cancer diagnosis who moved to Oregon to access its death with dignity law. Brittany Maynard died in Oregon after taking aid in dying medication on November 1, 2014. In the final weeks of her life, Ms. Maynard partnered with Compassion and Choices to launch a campaign to make aid in dying an open and accessible medical practice in California and throughout the country. According to Brittany Maynard, as published on CNN Opinion Tuesday, October 7, 2014, "Because the rest of my body is young and healthy, I am likely to physically hang on for a long time even though cancer is eating my mind. I probably would have suffered in hospice care for weeks or even months. And my family would have had to watch that." After moving to Oregon with her family, establishing the residency requirements, and finding new physicians, Ms. Maynard obtained aid in dying medication. "Now that I've had the prescription SB 128 (Wolk) Page 14 of ? filled and it's in my possession, I have experienced a tremendous sense of relief. And if I decide to change my mind about taking the medication, I will not take it?..When my suffering becomes too great, I can say to all those I love, I love you; come be by my side, and come say goodbye as I pass into whatever's next." 6.Seattle Program. According to an April 11, 2013, New England Journal of Medicine article, Seattle Cancer Care Alliance established a physician aid in dying program at a comprehensive cancer center in Seattle that serves the Pacific Northwest. A total of 114 patients inquired about the program between March 5, 2009, and December 31, 2011. Of these, 44 (38.6 percent) did not pursue the program, and 30 (26.3 percent) initiated the process but either elected not to continue or died before completion. Of the 40 participants who, after counseling and upon request, received a prescription for a lethal dose of secobarbital (35.1 percent of the 114 patients who inquired about the program), all died, 24 after medication ingestion (60 percent of those obtaining prescriptions). The participants at the center accounted for 15.7 percent of all participants in the program in Washington (255 persons) and were typically white, male, and well educated. The most common reasons for participation were loss of autonomy (97.2 percent), inability to engage in enjoyable activities (88.9 percent), and loss of dignity (75.0 percent). Eleven participants lived for more than 6 months after prescription receipt. The article concludes, qualitatively, patients and families were grateful to receive the lethal prescription, whether it was used or not, and overall, the program has been well accepted by patients and clinicians. 7.Excluded/different provisions comparison with other States. a. Oregon's Statute (OR) requires a physician to refer a patient to counseling if he or she believes the patient is suffering from a psychiatric or psychological disorder or depression causing impaired judgment. SB 128 requires a physician to refer to counseling, if appropriate. OR prohibits the medication from being prescribed until the psychologist or psychiatrist determines that the patient is not suffering from a psychiatric or psychological disorder or depression causing impaired judgment. Similar provisions are in Washington's Statute (WA). SB 128 (Wolk) Page 15 of ? There is no similar explicit prohibition on the prescription until the patient is cleared by the psychiatrist or psychologist in SB 128. b. OR requires the attending physician to recommend that the patient notify the next of kin but also states that the patient's refusal to notify next of kin is not a reason to deny the request. Similar provisions are in WA. There is no similar provision in SB 128. c. OR requires the physician to wait 48 hours from receiving the written request before writing the prescription. Similar provisions are in WA and Vermont's Statute (VT). There is no similar provision in SB 128. d. OR requires documentation in a patient's medical record by the attending physician, and consulting physician, and determinations of the counseling session, if performed. Similar provisions are in WA and VT. There is no similar provision in SB 128. This same requirement existed in AB 374 of 2007. e. OR requires annual review of a sample of records. WA requires an annual review of all records. SB 128 says a physician is required to report if DPH requires it through regulations. f. OR allows a health care provider to prohibit another provider from participating on the premises of the prohibiting provider if the policy has been disclosed to the provider. It also allows for sanctions if the prohibited provider violates the policy. Similar provisions are in WA. There is no similar provision in SB 128. 8.U.S. End of Life Care. A 2014 publication of the Institute of Medicine (IOM), Dying in America: Improving quality and Honoring individual preferences near the end of life. the IOM Committee on Approaching Death: Addressing Key End-of-Life Issues (committee) identified persistent major gaps in care near the end of life that require urgent attention. Understanding and perceptions of death and dying vary considerably across the population and are influenced by culture, socioeconomic status, and education, as well as by misinformation and fear. Engaging people in defining their own values, goals, and preferences concerning care at the end of life and ensuring that their care team understands their wishes has proven remarkably elusive and challenging. While the clinical fields of hospice and palliative care have become more established, the number of specialists in these fields is SB 128 (Wolk) Page 16 of ? too small, and too few clinicians in primary and specialty fields that entail caring for individuals with advanced serious illnesses are proficient in basic palliative care. Often, clinicians are reluctant to have honest and direct conversations with patients and families about end of life issues. Patients and families face additional difficulties presented by the health care system itself, which does not provide adequate financial or organizational support for the kinds of health care and social services that might truly make a difference to them. The committee believes a patient-centered, family-oriented approach to care near the end of life should be a high national priority and that compassionate, affordable, and effective care for these patients is an achievable goal. 9.Death Certificate. According to the MBC newsletter (Summer 2014), physicians are advised not to put mechanisms of death on the death certificate (such as cardiopulmonary arrest) because mechanisms are not the cause of death. Instead, the newsletter suggests the physician use the condition that immediately led to the death, for example, Arteriosclerotic Cardiovascular Disease or Hypertensive Health Disease. If the decedent has significant medical history, which did not cause the death, but likely contributed to the poor health and subsequent death, the death certificate allows those conditions to be listed. A physician must attest death certificates within 15 hours. Any person required to fill out a certificate of death who fails, neglects, or refuses to perform such duty is guilty of a misdemeanor. 10.Evidence of Problems? An article published in the Michigan Law Review in June of 2008, referenced by opponents of the bill, examines the Oregon Death with Dignity Act, drawing from case studies and information provided by doctors, families and other care givers. The article concludes that seemingly reasonable safeguards for the care and protection of terminally ill patients written into the Oregon law are being circumvented. The article indicates that the Oregon Public Health Division does not collect the information it would need to effectively monitor the law. The article draws on six cases (four with independent information from more than one source, and one with information provided by an opponent of aid in dying and another with information provided by a proponent). The case studies present examples of situations where a prescribing physician regretted not discussing the SB 128 (Wolk) Page 17 of ? case with the patient's regular physician, a psychologist cleared a patient based on the results of a test administered by her family and without seeing the patient, a physician declined a request, did not refer the patient to counseling and the patient committed suicide the next day, a psychological evaluation suggested possible coercion by the family but aid in dying medication was prescribed, aid in dying was prescribed after a patient made a request to two different physicians instead of two requests to the same physician, and a patient with a history of depressive disorder may have delayed aid in dying by a year and reconnected with family because of support provided by a volunteer. Another document provided by the Disability Rights Education and Defense Fund describes a situation where a patient's caretaker was prosecuted by federal investigators for real estate fraud and mistreatment of the patient after his death by physician aid in dying. This document also describes a situation where a family member helped a patient take the medication rather than through self-administration. 11.Role of Pharmacist. According to a 2011 article in the American Journal of Health System Pharmacists, based on experience in Washington and Oregon, physicians issuing prescriptions to be dispensed at a pharmacy must notify the pharmacist in advance. The physician must either deliver the written prescription personally or mail it to the pharmacist. Once the prescription is filled, it may be obtained by the physician, the patient, or an agent of the patient (e.g., family member). Oral medication counseling must be offered to the patient or patient's agent and provided in person, whenever practical, and in a private area; the pharmacist can offer to provide counseling over the telephone. Secobarbital is the medication most commonly prescribed for physician assisted suicide, followed by pentobarbital. The lethal dose prescribed is typically 9 grams of secobarbital in capsules or 10 grams of pentobarbital liquid, to be consumed at one time. The contents of the secobarbital capsules or the pentobarbital liquid should be mixed with a sweet substance such as juice to mask the bitter taste. Until the time of use, the medication must be stored out of reach of children and kept away from others to prevent unintentional overdose or abuse. The pharmacist or physician should instruct patients to take the lethal dose on an empty stomach to increase the rate of absorption. The typical dose of pentobarbital as an oral hypnotic for adults is 100-200 milligrams at bedtime, and that SB 128 (Wolk) Page 18 of ? of secobarbital is 100 milligrams orally at bedtime. Patients receiving the lethal dose of secobarbital or pentobarbital should be instructed to take an antiemetic (e.g., metoclopramide) about one hour before ingesting the barbiturate to prevent nausea and vomiting. Cases of vomiting after taking an antiemetic have been reported~ in the event of vomiting after medication ingestion, patients should be instructed to have a family member contact the attending physician to determine the course of action. Patients should be instructed that if12. they decide not to end their life after ingesting the medication, they must contact emergency medical services to begin lifesaving measures. 13.Unused Medication Disposal. As referenced in the 2011 American Journal of Health System Pharmacists article, patients need to be informed of appropriate disposal methods in case the medication is not taken~ the Food and Drug Administration provides guidance on that issue. Secobarbital and pentobarbital are not among the medications recommended for disposal by flushing, and they should be placed in the household trash after mixing with14. an unpalatable substance such as coffee grounds. Unused medications also can be brought to a drug "take back" program involving law enforcement personnel. Patients are not permitted to return controlled substance medications to a pharmacy. 15.Double referral. This bill is double referred. Should it pass out of this committee, it will be referred to the Senate Committee on Judiciary. 16.Related legislation. a. SB 19 (Wolk) establishes the Physician Orders for Life Sustaining Treatment (POLST) registry. SB 19 is currently pending in the Senate Health Committee. b. SB 149 (Stone), SB 715 (Anderson) and AB 159 (Calderon) permits a manufacturer of an investigational drug, biological product, or device to make the product available to eligible patients with terminal illnesses, and authorizes a health plan to provide coverage for any investigational drug, biological product, or device made available pursuant to these provisions. The bill also prohibits the MBC and the Osteopathic Medical Board of California from taking any disciplinary action against the license of a physician based solely on the SB 128 (Wolk) Page 19 of ? physician's recommendation to an eligible patient regarding, or prescription for or treatment with, an investigational drug, biological product, or device, provided that the recommendation or prescription is consistent with medical standards of care. SB 149 and SB 715 are scheduled to be heard in the Senate Health Committee on April 15, 2015. SB 159 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 currently pending in the Assembly Judiciary Committee. 17.Prior legislation. a. AB 2139 (Eggman), Chapter 568, Statutes of 2014 requires a health care provider, when making a diagnosis that a patient has a terminal illness, to notify the patient of his or her right to comprehensive information and counseling regarding legal end-of-life options. Extends the right to request information to a person authorized to make health care decisions for the patient and specifies that the information may be provided at the time of diagnosis or at a subsequent visit with the health care provider. b. SB 1357 (Wolk), would have established a Physician Orders for Life Sustaining Treatment registry at the California Health and Human Services Agency. SB 1357 was held on the Senate Appropriations suspense file. c. AB 2747 (Berg), Chapter 683, Statutes of 2008, facilitates end-of-life care communication between doctors and their patients by enacting the California Right to Know End-of-Life Act of 2008 to ensure that health care providers provide critically-needed information in carefully-circumscribed instances. d. AB 3000 (Wolk), Chapter 266, Statutes of 2008, creates 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 SB 128 (Wolk) Page 20 of ? treatment consistent with a patient's wishes. e. AB 374 (Berg), of 2007, would have enacted the California Compassionate Choices Act, which would authorize competent adults who have been determined by two physicians to be suffering from a terminal disease to make a request for medication to hasten the end of their lives in a humane manner. AB 374 was moved to the inactive file on the Assembly Floor without a vote recorded. f. AB 651 (Berg), of 2006, would have established a procedure for a competent adult person who is terminally ill and expected to die within six months to obtain from his or her physician a prescription for medication that he or she may self-administer in order to end his or her life. AB 651 failed passage in the Senate Judiciary Committee. g. AB 654 (Berg), of 2005, would have enacted the California Compassionate Choices Act, which would authorize competent adults who have been determined by two physicians to be suffering from a terminal disease to make a request for medication to hasten the end of their lives in a humane and dignified manner. AB 654 was moved to the inactive file on the Assembly Floor without a vote recorded. h. AB 891 (Alquist), Chapter 658, Statutes of 1999, streamlined and updated the provisions governing health care decisions for adults without decision-making capacity. Specifically, this bill repealed the provisions governing durable powers of attorney for health care and the Natural Death Act, and revised and recast these provisions as part of a new Health Care 1.Support. Compassion and Choices writes that too many suffer needlessly at the end of life, too many endure unrelenting pain and other symptoms, and too many turn to violent means at the end of life when medical aid could help them die peacefully. This bill is modeled after legislation in Oregon and other states where aid in dying has been proven to be good policy and safe medical practice. California voters support the medical option of aid in dying by more than two to one margin (64 percent support compared to 24 percent oppose). SB 128 (Wolk) Page 21 of ? Studies show patients who receive counseling about end of life choices score higher on quality of life and mood measures than patients who do not. Courts have upheld this right. In 1997, the United States Court of Appeals for the Ninth Circuit upheld Oregon's first-in-the-nation Death With Dignity Act (passed by ballot in 1994). On December 31, 2009, Montana Supreme Court ruled in a 5-2 vote that terminally ill Montanans have the right to choose aid in dying under state law. In January 2014, New Mexico Second Judicial District Judge Nan Nash issued a landmark decision that terminally ill, mentally competent adults have a fundamental right to aid in dying under the substantive due process clause of the New Mexico State Constitution. On February 6, 2014, the Canada Supreme Court ruled that prohibition of assisted dying violates the right to life, liberty and security of the person and is not in accordance with principles of fundamental justice. The AIDS Healthcare Foundation writes that when a person with HIV reaches the end of life with treatment options no longer available, it is inhumane that we fail to provide them with the choice that would bring them peace. The Secular Coalition for California supports the development of new public policy based on science and reason and indicates that the benefits of this bill are supported by extensive scientific study and data. They strongly encourage policymakers to base their decisions regarding this legislation on sound, tested evidence, not superstition and unsubstantiated fear-mongering. Equality California indicates that this issue is particularly important to them because of its impact on the lesbian, gay, bisexual, and transgender community. The roots of the "death with dignity" movement owe much to mothers of men dying painfully during the early days of the AIDS epidemic. Almost one hundred physicians have registered their support for this bill. Many write about witnessing patients suffer horrifically painful deaths because the standard of care medication management and surgery is not effective at controlling terminal pain. Pain medication can cause disabling side effects. One physician writes that providing terminally ill patients with this humane option is preferable to the desperate and covert self-help practices some patients are currently forced to employ. Providing this autonomy and choice to the vulnerable and dying is one of the last SB 128 (Wolk) Page 22 of ? comforting things we can do for our fellow humans. Another physician writes that patients and families have asked for relief from suffering but he has been unable to provide this which he believes is his role as their physician. A physician and cancer patient indicates he has urged the California Medical Association (of which he is a member) to take a neutral position on this bill. He asserts that palliative sedation is a poor substitute to offer as an alternative, and he would not want to rely on a doctor sedating him into unconsciousness in preference to having the key to exit in his own possession. 2.Opposition. The California Disability Alliance indicates it has a broad agenda for promoting health, independence and full community inclusion of persons with disabilities but is convinced that legalizing physician assisted suicide or euthanasia in the present environment of increasingly cost-driven health care budgeting decisions will adversely affect their efforts to achieve these goals and will result in unnecessary deaths among people in poverty, people with disabilities, and elderly people. California Family Alliance states there is no true way to protect against undue influence for those who seek to profit from a patient's early death. The California Family Alliance writes the true compassionate approach is to provide terminal patients with a variety of viable life-affirming options, including physical, mental and emotional support. The California Foundation for Independent Living Centers believes that people with disabilities and their families will still face more subtle, behind-the-scenes forms of persuasion coercion. The disability community is convinced that the perception that death is preferable to living with a disability is still pervasive. The Arc and United Cerebral Palsy California Collaboration opposes this bill based on a long and shameful history and on recent experience, people with developmental disabilities and their families simply do not believe that any regulations and safeguards will actually protect them adequately from being pressured or even forced into ending their lives prematurely. The Association of Northern California Oncologists opposes this bill because it is contrary to a physician's oath and primary responsibility to do no harm, legalizing physician-assisted suicide undermines the valuable and overwhelmingly successful work of hospice and pain and palliative care colleagues, and SB 128 (Wolk) Page 23 of ? the legislation is based on a common misunderstanding that it is easy to determine when a patient is terminal. Hematologists/oncologists are the first to recognize that it is notoriously difficult for physicians to know when their patients are terminal. Data from Oregon finds that many patients have been prescribed life-ending medications and have lived more than a year after the prescription has been filled. The Agudath Israel of California, a Jewish advocacy group, is concerned because of California's diversity and more advanced medical system with many more large and advanced medical centers that they are not sure the same results would be seen here as in Oregon. The Alliance of Catholic Health Care (Alliance) indicates that California law already gives every patient the right to refuse extraordinary end of life treatment. Both the Alliance and the California Hospital Association are opposed to this bill not allowing sanctions on health care providers who participate in aid in dying contrary to a hospital's policy. The Alliance also fears that if aid in dying becomes a legal right or "settled law," it will be extremely difficult to limit it to a small group of terminal patients. Additionally, the Alliance is concerned that once a patient obtains a lethal dose of drugs there is no transparency and cites a quote associated with the Oregon Department of Human Services "?the reporting requirements can only ensure that the process for obtaining lethal medications complies with the law." The Alliance states that we cannot determine whether physician-assisted suicide is being practiced outside the framework of the Death with Dignity Act. The Alliance also refers to a Yale study of the Netherlands that indicated in 18 percent of the cases there were complications and the physician intervened and ended the life of the patient. The Alliance also raises concerns that there is no definition of active euthanasia. Several thousands of individuals registered their opposition including some physicians. One physician writes that the bill wrongly assumes all physicians are ideal moral agents. Physicians are under increasing stress, workloads and cost pressures. It takes no great skill and very little time to write a lethal prescription and it takes consummate skill and lots of effort to provide good end of life care. 3.Concerns. The California Medical Association expresses concerns that physician assisted suicide would undermine trust in the physician-patient relationship, as patients may fear or suspect that a physician will steer them toward physician SB 128 (Wolk) Page 24 of ? assisted suicide rather than pursing a more difficult course of treatment. CMA is also concerned that some patients may feel pressured or coerced to accept physician assisted suicide, particularly if the patient feels obligated to relieve their loved ones of the burden of caring for them. CMA writes that the right to fatal, life-ending medications would become an expectation, and ultimately a duty, fueled by those members of society whose existence is expensive or otherwise could be considered burdensome. 4.Policy Comments. a. Oregon as a Model. Some of the provisions contained in the laws in Oregon, Washington and Vermont identified in comment 7 could be argued are safeguards that have contributed to the successful implementation in those states. The authors may wish to reconsider their inclusion in SB 128. b. Reporting Agency. SB 128 requires the DPH, in consultation with DSS, to establish reporting requirements for physicians and pharmacists. As noted at a recent Senate Budget Subcommittee on Health and Human Services hearing, on March 3, 2015, the State Auditor notified the Legislature that DPH remains a high-risk agency due to weakness in program administration and because it has been slow to implement recommendations, especially those that have a direct impact on public health and safety. DPH delivers a broad range of public health programs. Some of these programs complement and support the activities of local health agencies in controlling environmental hazards, preventing and controlling disease, and providing health services to populations who have special needs. Others are solely state-operated programs, such as those that license health care facilities. Given the challenges at DPH the authors may wish to reconsider giving DPH this reporting responsibility. Additionally, it is not clear why DSS has been included as a consulting agency. If DPH remains as the reporting agency, the authors may wish to consider adding a deadline on when the regulations should be promulgated and when first report and annual reports are expected. It is also not clear what action DPH can take if the physicians and pharmacists do not comply with the reporting requirements. SB 128 (Wolk) Page 25 of ? c. Hospice. As indicated in the IOM report, hospice is an important approach to addressing the palliative care needs of patients with limited life expectancy and their families. For people with a terminal illness or at high risk of dying in the near future, hospice is a comprehensive, socially supportive, pain-reducing, and comforting alternative to technologically elaborate, medically centered interventions. In fact, the director of the Seattle Cancer Care Alliance, Dr. Anthony Back, indicates in a September 24, 2014, Medscape interview, that hospice is especially for patients who have the option for dying at home. "Hospice mobilizes all those resources and helps organize them and helps connect them to the team and the clinic or the hospital. That's part of showing patients that we can provide this continuous care that flows from the hospital to the clinic to the home. So palliative care and hospice are linchpins. It would be weird to have some kind of protocol for assisted suicide if you didn't have really good palliative care in place." Vermont requires the physician to record in the patient's medical record an attestation that the patient was enrolled in hospice care at the time of the patient's oral and written requests for medication to hasten his or her death or that the physician informed the patient of all feasible end-of-life services. The authors may wish to consider a requirement that the patient is receiving either hospice or palliative care at the time of the request for aid in dying medication. This would ensure that the patient has access to pain management and emotional support at the time of the request. d. Model notice. Opponents have referred to two Oregon patients with terminal cancer who were sent notifications by an Oregon health plan (the equivalent of a Medi-Cal managed care plan) that denied cancer treatment but offered coverage for end-of-life care including physician aid in dying. The authors may wish to consider amendments to ensure that notifications from health plans regarding aid in dying coverage are carefully crafted to not convey a message that a person may interpret as being pressured by the plan to end his or her life earlier than through the natural progression of the terminal illness. This could be accomplished by the development of a focus tested model notice by health insurance regulators in consultation with interested stakeholders. SB 128 (Wolk) Page 26 of ? 5.Technical and clarifying amendments. a. The bill requires an interpreter to be qualified as described in subparagraph (H) of paragraph (2) of subdivision (c) of Section 1300.67.04 of Title 28 of the California Code of Regulations. It is not clear what qualifications are being required. The regulation refers to health plan standards. Since aid in dying is not guaranteed to be a covered benefit, it is not appropriate to reference the plan standards. However, the regulation also references standards promulgated by the California Healthcare Interpreters Association or the National Council on Interpreting in Healthcare. The authors may wish to amend this bill to reference these standards directly. b. Opponents have raised a concern that the law could be interpreted to allow a patient to get around the two requests at least 15 days apart requirement. The concern is that if a physician declines the request, upon requesting consideration by a second physician, the two requests within 15 days would be met even though the two requests were not made to the same provider. The authors may wish to make it clear that the requirements under 443.3 must be made to the same attending physician. SUPPORT AND OPPOSITION : Support: AIDS Healthcare Foundation Alameda County Board of Supervisors American Federation of State, County and Municipal Employees, AFL-CIO American Medical Student Association American Medical Women's Association California Council of Churches IMPACT California Primary Care Association California Senior Legislature Compassion & Choices Conference of California Bar Associations Congress of California Seniors County of Santa Cruz, Board of Supervisors Death with Dignity National Center SB 128 (Wolk) Page 27 of ? Democratic Party of Orange County Democratic Party of Santa Barbara County Equality California Gay and Lesbian Medical Association Gray Panthers of Long Beach Hemlock Society of San Diego I Care for Your Loved One: Compassionate Senior Services Insurance Commissioner Dave Jones Laguna Woods Democratic Club Lompoc Valley Democratic Club National Center for Lesbian Rights National Council of Jewish Women California Older Women's League of San Francisco Progressive Democrats of America, California San Francisco for Democracy San Mateo County Democracy for America Secular Coalition for California Sonoma County Democratic Party Trinity County Progressives U.S. Senator Dianne Feinstein Thousands of individuals Oppose: Agudath Israel of California Alliance of Catholic Health Care Arc and United Cerebral Palsy California Collaboration Association of Northern California Oncologists Autistic Self-Advocacy Network California Catholic Conference California Disability Alliance California Family Alliance California Foundation for Independent Living Centers California Hospital Association California Nurses for Ethical Standards California ProLife Council Calvary Chapel Golden Springs Capitol Resource Institute Concerned Women for America Dignity Health Disability Rights Education and Defense Fund Faith and Public Policy (Ministry of Calvary Chapel Chino Hills) International Life Services Life Legal Defense Foundation SB 128 (Wolk) Page 28 of ? Life Priority Network Medical Oncology Association of Southern California Mission Hospital (St. Joseph Health) Mission Hospital Laguna Beach National Right to Life Council North Orange County ProLife Chapter Pajaro Valley Senior Coalition Petaluma Valley Hospital Providence Health and Services Queen of the Valley Medical Center Redwood Memorial Hospital San Joaquin ProLife Council Santa Rosa Memorial Hospital Scholl Institute of Bioethics Sisters of Social Service of Los Angeles St. Joseph Hospital, Eureka St. Joseph Hospital, Orange St. Mary Medical Center Thousands of individuals -- END --