REGULATORY INTELLIGENCE YEAR-END REPORT - 2022 Health Policy Tracking Service - Issue Briefs Long-Term Care End-of-Life Issues This Issue Brief was written by Louise W. Seiler, B.A., a contributing writer. 12/19/2022 I. BACKGROUND AND INTRODUCTION End-of-life care is the term used to describe the support and medical care given during the time surrounding death, however it takes place. The dying process can come suddenly, or take days, months, or even years. For some, the body systems weaken while the mind stays clear. For others, the body may remain strong which cognitive function declines. The end-of-life experience may vary depending on the person's preferences, needs, or choices. Some people may want to be at home when they die, while others may prefer to seek treatment in a hospital or facility until the very end. The U.S. has seen an increased demand by individuals and families for active participation in medical decision-making that has likely produced corresponding changes in expectations about end-of-life care. Increasingly, people are choosing hospice care at the end of life, which focuses on the care, comfort, and quality of life of a person with a serious illness who is approaching the end of life. Hospice is provided for a person with a terminal illness whose doctor believes he or she has six months or less to live if the illness runs its natural course. Like palliative care, hospice provides comprehensive comfort care as well as support for the family but attempts to cure the person's illness are stopped. End-of-life care can be provided in a variety of settings. The three most common places that people die are at home, in a hospital, or in a care facility. While not everyone has a chance to decide where they will die, people have the ability to plan ahead, by making advance directives that specify preferences about end-of-life care and who can make decisions on one's behalf in the event one becomes incapacitated. Discussion with one's physician can help provide information on available options, and answer questions of not only the patient but one's family. The COVID-19 pandemic has introduced and pushed to the threshold issues in the delivery of end-of-life care that providers in the U.S. must deal with. Among them, visitation by family and friends in end-of-life situations, disparities in care among poor and patients of color, a workforce depleted by burnout and other work opportunities, and unknown occupancy expectations in the future. Because end-of-life issues, including those pertaining to hospice care and advanced care directives, are intrinsically related to the issues surrounding long-term care, developing trends and pending legislation will continue to be monitored by HPTS. For additional information on long-term care, see Health Policy Tracking Service, Long-Term Care, a service of Thomson Reuters. Il. IMPACT OF COVID-19 Nursing homes and other long-term care facilities account for about 1% of the U.S. population, but represented 40% of COVID-19 deaths, according to the COVID Tracking Project. To counter the surging infection and death rates, the administration and agencies implemented mandatory testing and vaccination requirements. To help nursing and hospice facilities deal with financial and staffing issues, certain regulations were relaxed, and funding provided. For additional information on the impact of COVID-19 on long-term care facilities, see Health Policy Tracking Service, Long-Term Care: Funding of Long-Term Care, a service of Thomson Reuters. Waiver of Certain Medicare, Medicaid, CHIP Requirements to Help Hospices Under ? 1135 of the Social Security Act, the HHS Secretary is authorized to waive certain Medicare, Medicaid, and Children's Health Insurance Program program requirements once the President has declared an emergency through the Stafford Act, IFN2] ond the THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. Secretary has declared a Public Health Emergency. President Trump issued such an emergency declaration on March 13, 2020, and the HHS Secretary issued a PHE on January 31, 2020 in response to the spread of COVID-19. As a result of this authority, CMS can grant waivers to ease certain requirements for affected providers. CMS approved hundreds of waiver requests from healthcare providers, state governments, and state hospital associations in 15 states in the early stages of the pandemic. On March 30, 2020, CMS announced an array of blanket waivers and new rules designed to help healthcare providers respond to the COVID-19 outbreak. [FNS] With the announcement of blanket waivers, other states and providers do not need to apply for these waivers and can begin using the flexibilities immediately. For hospice services in particular, CMS provided the following waivers: [FN4] ¢ Use of Volunteers. CMS is waiving the requirement that use volunteers (including at least 5% of patient care hours). * Comprehensive Assessments. CMS is waiving certain requirements related to updating comprehensive assessments of patients. This waiver applies the timeframes for updates to the comprehensive assessment found at 42 CFR ? 418.54(d). Hospices must continue to complete the required assessments and updates, however, the timeframes for updating the assessment may be extended from 15 to 21 days. ¢ Non-Core Services. CMS is waiving the requirement for hospices to provide certain non-core hospice services during the national emergency, including the requirements for physical therapy, occupational therapy, and speech-language pathology. * Onsite Visits for Hospice Aide Supervision. CMS is waiving the requirement that a nurse conduct an onsite supervisory visit every two weeks. This would include waiving the requirements for a nurse or other professional to conduct an onsite visit every two weeks to evaluate if aides are providing care consistent with the care plan, as this may not be physically possible for a period of time. Effect of Vaccines on Mortality Rates in Nursing Homes; Studies Vaccines are having a significant effect on the number of deaths in nursing homes. Since the start of the vaccinations, in late December 2020, deaths have plummeted, falling by more than 60 percent by early February. Experts have found the decline in deaths to have happened 'surprisingly fast" and at an 'amazing' rate. The nursing home data adds to the evidence that vaccines work not only in research venues, but in the real world as well. [FNS] CMS Eases Visitation Restrictions CMS and the Centers for Disease Control and Prevention (CDC) have revised their previous guidance for visitors accessing nursing homes, including service providers such as hospices. The availability of vaccines was a key factor in the update. IFN6] Under the new rules, facilities can allow 'responsible indoor visitation" at all times and for all residents, regardless of vaccination status of the resident or visitor, unless certain scenarios arise that would limit visitation. Scenarios that could limit visitation include the following, according to CMS: « Unvaccinated residents, if the COVID-19 county positivity rate is greater than 10% and less than 70% of residents in the facility are fully vaccinated * Residents with confirmed COVID-19 infection, whether vaccinated or unvaccinated, until they have met the criteria to discontinue transmission-based precautions ¢ Residents in quarantine, whether vaccinated or unvaccinated, until they have met criteria for release from quarantine. The new guidance specifically indicates that facilities should permit 'compassionate care" visits at all times, regardless of a resident's vaccination status, the county's COVID-19 positivity rate, or an outbreak. The agency defines compassionate care to include visits for a resident whose health has sharply declined or is experiencing a significant change in circumstances. The agencies continue to recommend adherence to COVID-19 infection prevention protocols such as social distancing and conducting visits outdoors whenever possible. Use of Telehealth During Pandemic and Beyond During the COVID-19 outbreak, one of the first steps CMS took in response to the COVID-19 public health emergency was to temporarily expand the scope of Medicare telehealth to allow beneficiaries across the country-not just in rural areas-to receive telehealth services from any location, including their homes. CMS also added 135 allowable services, more than doubling the number of services that beneficiaries could receive via telehealth. Additionally, CMS allowed telehealth technology to fulfill many requirements for clinicians to see their patients face-to-face in different health care settings, including hospice. A number of the telehealth flexibilities implemented by CMS impact hospice providers. During the pandemic, hospices may provide interdisciplinary services via telemedicine or audio as long as the patient is receiving routine home care level of care and those telemedicine services which are audio-only services are capable of meeting the patient and caregiver needs. The CARES Act, designed to help the economy and essential industries survive the impact of the COVID-19, also contained provisions related to hospice telehealth, including permitting practitioners to recertify patients via telemedicine appointments rather than face-to-face encounters. A number of stakeholders, as well as members of Congress, have called on CMS to make the actions permanent. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. CMS itself has indicated that it is reviewing the waivers to see which can be implemented on a long-term basis. 'With these transformative changes unleashed over the last several months, it's hard to imagine merely reverting to the way things were before. As the country re-opens, CMS is reviewing the flexibilities the administration has introduced and their early impact on Medicare beneficiaries to inform whether these changes should be made a permanent part of the Medicare program," former CMS Administrator Seema Verma wrote in the journal Health Affairs. [FN7] Pandemic Hits Hospice Revenues A majority of hospice providers (60%) anticipate a decrease in annual revenues in 2020, according to recent research conducted by the National Association for Home Care & Hospice (NAHC). IFN8] The survey, which was conducted over the first three weeks of May 2020, sought information on a broad range of issues, including the extent to which hospices have employed telecommunications technology to help meet patient care needs. Among the contributing factors to revenue drops is a decline in hospice patient admissions and referrals amid the public health emergency. While nearly two-thirds (61 percent) of hospices that responded to the NAHC survey have admitted confirmed COVID-19- positive patients on to service, more than half of respondents saw a decrease in admissions during March 2020 as compared with March 2019. More than a quarter saw a 15% drop or more. Nearly 71% of the hospices reported declining referrals and admissions from nursing facilities, along with 63% experiencing declines in hospital referrals and roughly half seeing a decrease from community referral partners. A majority of the providers also cited increased costs of supplying staff with personal protective equipment (PPE), with hospices calling for more federal funding of PPE supplies among increased costs and high demand. Not surprisingly, according to the report, more than 95% of hospices have had existing patients refuse visits due to fears associated with risk of exposure to COVID-19. And while hospices have been able to provide technology-based visits to continue patient care in some cases, nearly 24 percent of the hospices in the survey were able to substitute virtual visits in only limited or no cases. A large proportion-more than 84 percent-of hospices participating in the survey are using telecommunications technology to provide services to Medicare hospice patients and a similar proportion (approximately 82 percent) use two-way audio-visual communications (among other technologies) for patient care. Use of Antibiotics During COVID-19 Causes Spike in Deaths from Antibiotic-Resistant Superbugs An analysis of deaths from antimicrobial-resistant infections showed a 15% spike during 2020, the first year of the COVID-19 pandemic, due to widespread use of antibiotics, a Special Report from the Centers for Disease Control and Prevention (CDC) has found. [FNS] «Historic gains made on antibiotic stewardship were reversed as antibiotics were often the first option given to treat those who presented with a febrile pulmonary process even though this presentation often represented the viral illness of COVID-19, where antibiotics are not effective," the report states. More than 29,400 people died from deaths tied to antibiotic-resistant superbugs, and nearly 40% were infected during a hospital stay. Among people hospitalized with COVID-19, fully 80% received an antibiotic between March and April of 2020, when little was known about the deadly SARS-CoV-2 virus and how to treat infected patients, CDC investigators noted. The report recommends enhancing data systems and sharing to prevent infections and stay ahead of antimicrobial resistance. Such reporting and data was delayed or unavailable for 9 of the 18 antimicrobial resistance threats because of pandemic impacts. Deciding Who Gets Ventilators and Critical Care Resources As the COVID-19 pandemic intensified, providers encountered shortages of critical care resources, such as ventilators and ICU beds, and the real possibility that they might have to decide which patients receive the life-saving care, and which do not. In JAMA Viewpoint, Douglas B. White, MD, MAS, and Bernard Lo, MD, consider the critical question: When demand for ventilators and other intensive treatments far outstrips the supply, what criteria should guide these rationing decisions? [FN 10] Categorically Excluding Large Groups of Patients from Receiving Mechanical Ventilation: Although certain professional society guidelines and some state recommendations exclude from access to ICUs large groups of patients with certain comorbid conditions (such as heart failure, severe chronic lung disease, end-stage renal disease, and severe cognitive impairment), the authors find such exclusions not explicitly justified, and ethically flawed. The criteria for exclusion (long-term prognosis and functional status) are selectively applied to only some types of patients, rather than to all patients being considered for critical care. Moreover, categorical exclusions are too rigid to be used in a dynamic crisis, when ventilator shortages will likely surge and decline episodically during the pandemic, and such exclusions violate a fundamental ethical principle: use the means that are least restrictive to individual liberty to accomplish the public health goal. Focus on Survival to Hospital Discharge: The commonly recommended approach to allocate ventilators to those patients most likely to survive to hospital discharge with treatment is inadequate because it ignores other relevant considerations, such as the number of years of life saved, or giving individuals equal opportunity to pass through the stages of life-childhood, young adulthood, middle age, and old age. Persons who have essential responsibilities in saving lives during the pandemic, such as health care workers and first responders, also deserve heightened priority. Also, it should be made explicit that ventilators will not be allocated on the basis of THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. morally irrelevant considerations, such as sex, race, religion, intellectual disability, insurance status, wealth, citizenship, social status, or social connections. Recommendations for a Multiprinciple Allocation Framework: All patients who meet usual medical indications for ICU beds and ventilators are eligible and are assigned a priority score using a 1 to 8 scale based on (1) patients' likelinood of surviving to hospital discharge, assessed with an objective measure of acute illness severity; and (2) patients' likelihood of achieving longer-term survival based on the presence or absence of comorbid conditions. Also, individuals who perform tasks vital to the public health response are given heightened priority. In the event that there are ties in priority scores, life-cycle considerations are used as a tiebreaker, with priority going to younger patients, who have had less opportunity to live through life's stages. Withdrawing Life Support from One Patient to Provide It to Another. While the need to 'reallocate" ventilators when capacity is overwhelmed is acknowledged, it will be distressing to health care workers, patients, and families, because in ordinary clinical care ventilators are withdrawn only if the family agrees. The following steps could improve such agonizing decisions: ¢ ventilator use should be presented to patients and families as a time-limited therapeutic trial, not an unlimited promise. « the duration of the trial of ventilation must not be too brief, to avoid a 'rapid cycling" of withdrawing ventilators from patients who, if treated for several more days, would have survived. ¢ a triage officer or team, not the treating physician, should make decisions about allocating and discontinuing ventilators. ¢ when mechanical ventilation is discontinued, comprehensive palliative care is imperative. Family members of patients near death should be granted compassionate use of personal protective equipment if possible so that they can be with the dying patient. Health care workers will also need emotional support. In conclusion, the authors urge hospitals and states to establish and implement policies that more fairly allocate scarce critical care resources and that better support dying patients and their families. COVID-19 Mortality Linked to Racial Disparities in Nursing Homes Residents in nursing homes with the highest proportions of non-white residents experience death rates that were over three times higher than those in facilities with high proportions of white residents, a recent study found. IFN11] The researchers, from the University of Chicago, examined differences in the number of COVID-19 deaths in 13,312 nursing homes in the United States of varying racial composition. The study based their findings on data from the Nursing Home COVID-19 Public File from the Centers for Medicare & Medicaid Services, which contains COVID-19 cases and deaths among nursing home residents as self-reported by nursing homes, from July 28 to December 18, 2020. A total of 51,606 COVID-19-associated deaths were reported. Residents of nursing homes with higher proportions of non-white residents were 3.3 times more likely to die than those with the highest proportions of white residents. Researchers attribute the differences to factors such as larger nursing home size and higher infection burden in counties in which nursing homes with high proportions of non-white residents were located. The recommend focusing limited available resources on facilities with high proportions of non-White residents to support nursing homes during potential future outbreaks. Dementia Mortality Increased with Lockdowns Beyond the staggering U.S. deaths caused directly by COVID-19, the Washington Post reports that more than 134,200 people have died from Alzheimer's and other forms of dementia since March. [FN12] That is 13,200 more U.S. deaths caused by dementia than expected, compared with previous years, according to an analysis of federal data by the Post. Legislation Federal ¢ 2021 CONG US HR 7876, introduced May 24, 2022, providing for the use of telehealth to conduct a face-to-face encounter prior to the recertification of eligibility for hospice care during an emergency period. ¢ 2021 CONG US §S 312, reported in Senate June 8, 2021, to expand eligibility for and provide judicial review for the Elderly Home Detention Pilot Program for eligible elderly or terminally ill offenders, provide for compassionate release based on COVID-19 vulnerability, shorten the waiting period for judicial review during the COVID-19 pandemic. * 2021 CONG US S 3985, introduced March 31, 2022, to prohibit the consideration of COVID-19 vaccination status in determining eligibility for organ donation or transplantation, and in providing services by skilled nursing facilities to Medicare or Medicaid beneficiaries. Arizona 2022 AZ H.B. 2633 (NS), adopted June 13, 2022, providing for physical contact of patient's visitors, especially during end-of-life visitation. California THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. 2021 CA A.B. 2546 (NS), amended/substituted May 19, 2022, would require the State Department of Public Health, the State Department of Social Services, and the State Long-Term Care Ombudsman, or their designee, to convene a working group to develop recommendations regarding best practices for public health officials and long-term care facilities, as defined, when developing policies, including certain visitation policies involving designated support persons in end-of-life or other compassionate care visits, related to long-term care facilities during public health emergencies. Colorado * 2022 CO H.B. 1199 (NS), introduced February 7, 2022, providing for 'compassionate care" visitation requirements in end-of-life situations and in other circumstances. ¢ 2022 CO S.B. 53 (NS), engrossed March 29, 2022, concerning visitation rights at healthcare facilities during a pandemic in end-of-life and other situations. Florida 2022 FL S.B. 988 (NS), adopted April 6, 2022, the 'No Patient Left Alone Act'; requiring providers to allow clients to receive in-person visitors in end-of-life situations. Idaho 2022 ID H.B. 668 (NS), introduced February 18, 2022, establishing the Patient Visitation Rights Act affording patients of a hospice house, hospital, or nursing facility certain visitation rights. Illinois ¢ 2021 IL S.B. 109 (NS), adopted July 23, 2021, provides that execution of a practitioner orders for life-sustaining treatment (POLST) form shall not be a requirement for admission to any facility or a precondition to the provision of services by any provider of health care services; provides that an individual may revoke a document directing that resuscitating efforts shall not be implemented; provides that a health care provider facility shall comply with a POLST form, National POLST form, another state's POLST Paradigm portable medical orders form, or an out-of-hospital Do Not Resuscitate (DNR) order sanctioned by a State in the United States that has been executed by an adult and is apparent and immediately available; provides that before voiding or revoking a POLST form consented to by the individual, that individual's legally authorized surrogate decision maker shall first: engage in consultation with the attending health care practitioner, consult the patient's advance directive, if available, and make a good faith effort to act consistently, at all times, with the patient's known wishes, or, if the patient's wishes are not known, using substituted judgment as the standard; provides that when an individual's legally authorized surrogate is making a good faith effort to act consistently with the patient's known wishes to void or revoke a POLST form, if the patient's wishes are unknown and remain unknown after reasonable efforts to discern them, the decision shall be made on the basis of the patient's best interests as determined by the surrogate decision maker. ¢ 2021 IL S.B. 2160 (NS), introduced February 26, 2021, creates the Emergency Situation Essential Caregiver Act; provides that during any emergency situation essential caregivers shall be allowed to visit residents in accordance with the Act; provides that residents of a facility (including hospice) shall be allowed to designate up to 3 essential caregivers who will be allowed to visit and provide care in accordance with this Act in the event of an emergency. lowa 2021 IA H.F. 2203 (NS), introduced March 2, 2022, relating to health care including protections for health care providers against disciplinary actions for acts or omissions related to COVID-19 and to experimental treatments for terminally ill persons. Kansas * 2021 KS H.B. 2126 (NS), introduced January 25, 2021, providing immunity from civil liability for COVID-19 claims for adult care facilities, including hospice providers. * 2021 KS H.B. 2748 (NS), introduced April 1, 2022, enacting the no patient left alone act to require certain healthcare facilities to allow in-person visitation of patients or residents in end-of-life and other situations. Maine 2021 ME H.P. 822 (NS), adopted July 13, 2021, regarding advance health care directives. Michigan 2021 MI H.B. 5637 (NS), engrossed February 23, 2022, to modify the right to try act to include certain drugs and treatments during a COVID-19 pandemic emergency. Minnesota 2021 MN H.F. 4055 (NS), introduced March 7, 2022, and 2021 MN S.F. 3666 (NS), introduced March 2, 2022, providing the right of a patient or resident to a support person present while receiving care or service, including in end-of-life situations. Missouri THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. ¢ 2022 MO H.B. 1861 (NS), engrossed March 2, 2022, relating to COVID-19 vaccination status with respect to organ transplant procedures. ¢ 2022 MO H.B. 2116 (NS), adopted June 30, 2022, relating to 'compassionate care" visitation rights of patients in end-of-life and other situations in health care facilities including hospitals, long-term care facilities and hospice facilities. New Hampshire ¢ 2021 NH S.B. 74 (NS), adopted July 30, 2021, relative to advance directives for health care decisions, defines 'attending practitioner and 'POLST'; redefines 'near death' as 'actively dying'; further defines the role of a surrogate; and repeals the applicability of certain advanced directives. ¢ 2021 NH S.B. 149 (NS), adopted July 30, 2021, regarding Medicaid spend-down requirements, automated pharmacy systems for long-term care, hospice, and other residential facilities, and blanket CMS waivers for health care during a declared emergency. New Jersey ¢ 2022 NJ S.B. 2520 (NS), introduced May 12, 2022, establishing the 'New Jersey No Patient Left Alone Act," requiring certain facilities to establish policies guaranteeing visitation rights for residents in hospice, long-term care, and veterans' home facilities. * 2022 NJ S.B. 2936 (NS), introduced June 27, 2022, provides Medicaid coverage for certain home visitation program services, including hospice, under certain circumstances. New York ¢ 2021 NY A.B. 3162 (NS), introduced January 22, 2021, establishes a temporary state commission to study and investigate the effects of the COVID-19 pandemic response on deaths in nursing homes; and providing for the repeal of such provisions upon expiration thereof. ¢ 2021 NY A.B. 9928 (NS) and 2021 NY S.B. 6782 (NS), introduced April 19, 2022, establishing a frontline healthcare workers tax credit for clinical and non-clinical frontline healthcare workers and certain long-term care facility workers, including for hospice care, during the novel coronavirus, COVID-19 pandemic. * 2021 NY S.B. 8612 (NS), amended/substituted May 4, 2022, providing for the emergency release of incarcerated individuals who are terminally ill in case of a declared state disaster emergency. North Carolina ¢ 2021 NC H.B. 351 (NS), amended/substituted July 22, 2021, providing patient visitation rights will not be impacted during declared disasters and emergencies, protecting the religious rights of patients by preserving their right to receive visits by clergy members during stays that occur during a declared disaster or emergency in a hospital, nursing home, combination home, hospice care, adult care home, or special care unit, and directing the Department of Health and Human Services to impose a civil penalty for any violation of those rights. ¢ 2021 NC S.B. 191 (NS), adopted October 15, 2021, the No Patient Left Alone Act, providing patient visitation rights will not be impacted during declared disasters and emergencies and directing the department of health and human services to impose a civil penalty for any violation of those rights. Ohio 2021 OH H.B. 120 (NS), engrossed April 21, 2022, to permit compassionate care visits in long-term care facilities during the COVID-19 state of emergency. Oklahoma ¢ 2021 OK S.B. 354 (NS), introduced February 1, 2021, relating to out-of-state transport of dead bodies; providing for deaths in certain counties with shared state jurisdictional boundaries. ¢ 2021 OK H.B. 3313 (NS), engrossed March 21, 2022, modifying the No Patient Left Alone Act, providing for policies related to end-of- life, among other revisions. Pennsylvania ¢ 2021 PA H.B. 208 (NS), introduced January 22, 2021, providing for the disclosure of communicable diseases in certain facilities during disaster emergencies. ¢ 2021 PAS.B. 190 (NS), introduced March 23, 2021, providing for essential family caregivers in facilities, including hospice, during disaster emergencies. South Carolina 2021 SC H.B. 5018 (NS), introduced February 23, 2022, the 'No Patient Left Alone Act," to safeguard patient and resident visitation rights in certain health care facilities during declared disasters and emergencies in compassionate care situations including end-of-life situations. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. Tennessee ¢ 2021 TN H.B. 2535 (NS) and 2021 TN S.B. 2574 (NS), introduced February 2, 2022, requiring nursing homes and assisted-care living facilities to permit at least one family member or patient representative who meets certain conditions to visit a resident of the facility during end-of-life situations if a disaster, emergency, or public health emergency for COVID-19 has been declared. ¢ 2021 TN H.B. 2778 (NS) and 2021 TN S.B. 2169 (NS), introduced February 2, 2022, requiring hospitals to permit at least one family member or patient representative who meets certain conditions to visit a patient of the hospital during end-of-life situations if a disaster, emergency, or public health emergency for COVID-19 has been declared. Washington 2021 WA H.B. 2117 (NS), introduced February 9, 2022, ensuring a terminally ill patient's right to visitors. Ill. HOSPICE AND THE EVOLVING NATURE OF END-OF-LIFE CARE Note: For the impact on hospice and end-of-life care wrought by the COVID-19 pandemic, see II. IMPACT OF COVID-19, above. A report published in January 2019 by LeadingAge IFN13] discusses the development of hospice services over the past half century, current issues of quality assurance and financing, and recommendations for policy changes to make these services more accessible to people at the end of life. The publication describes the genesis of hospice services in the nonprofit sector and the growth of the sector following Medicare's expansion to cover hospice in the 1980s. The analysis notes that hospice's prevalence has skyrocketed in recent years, with the number of providers nearly doubling since 2000, at about 4,200 in 2016. While the use of hospice services has grown, overall utilization remains low. About 28% of Medicare beneficiaries who used the benefit enrolled for fewer than seven days before death. And, there is wide variation from state to state: about 18% of Medicare beneficiaries used hospice in Alaska at the low end, compared to 59% in Arizona. Between 2000 and 2016, the hospice patient population changed drastically. By 2016, hospice was serving more individuals residing in nursing homes and assisted living, in addition to its traditional home-based population, according to the report. In 2016, about half of all Medicare hospice beneficiaries died at home, while one-third died in a nursing home. Terminal conditions treated by the benefits have changed too. While the service was almost exclusively limited to cancer in the past, patients with dementia and heart disease are increasingly using it, too. Produced in conjunction with LeadingAge Ohio and the National Partnership for Hospice Innovation, the report offers several suggestions to bolster use of hospice services: ¢ Ensuring that value-based insurance design under Medicare Advantage gives Medicare beneficiaries access to nonprofit, community- integrated hospice providers; ¢ Full information for Medicare beneficiaries and their families on care options when they are faced with advanced illness; « Increased flexibility for care team composition in rural areas where healthcare workforce shortages are acute; and ¢ Expansion of telehealth options in hospice. While Americans generally agree that discussing end-of-life care with their loved ones is important, a recent study conducted by Bestow [FN14] Iggked into the amount of interest shown by the various states. Wisconsin, New York, New Hampshire, South Dakota, and Ohio were found to be the five states that are most concerned about end-of-life issues. In contrast, Nevada, California, Wyoming, Utah, and Alaska are the five states that are least concerned. End-of-life Discussions Improve Care Outcomes in Last Month of Life While only a fraction of nursing home patients undertake end-of-life discussions, those patients were less likely to die in the hospital and more likely to appoint a surrogate to coordinate their care, according to a study published in Age and Ageing. IFN15] th a study of 674 residents in 78 nursing home facilities in France, researchers found that only about one fifth of the residents discussed end- of-life issues with their physicians. No end-of-life discussions whatsoever were held with a third of patients or their families. Patients who discussed three or more of six end-of-life topics with their physicians and caregivers in their last months of life stood less chance of dying in a hospital and had increased likelihood of appointing a surrogate or representative and a higher likelihood of withdrawing potentially futile life-prolonging treatments, the study found. The six end-of-life topics included talks about the course and prognosis of a resident's disease, the approaching end of life, the possibility of stopping treatments, options for palliative care, psychological issues, and spiritual or existential problems. Minorities and Medicare and Medicaid Recipients' Cancer Care at End of Life A new study has found that people from racial and ethnic minority groups and Medicare and Medicaid recipients are more likely to receive low-value, aggressive cancer interventions at the end of life. Published in JAMA Network Open, IFN'6] the study found that people of Black and Asian or Pacific Islander race, Hispanic ethnicity, with public insurance status, and who were admitted to an urban teaching hospital were more likely to receive this suboptimal care. Investigators examined health records of more than 21,000 patients THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. with metastatic cancer. Together with the results of past studies, the current findings suggest that several clinical care factors are associated with disparities in end-of-life inpatient care management, wrote C. Jillian Tsai, M.D., Ph.D., of the Memorial Sloan Kettering Cancer Center, New York. These include patient-practitioner communication, cultural preferences, access to care and other systemic factors, including biases, she reported. Previous studies have noted that Medicare beneficiaries in the general population are subject to high rates of intensive care, low rates of routine goals-of-care discussions, and low rates of hospice, the report noted. Hospital inpatient care accounts for a large portion of Medicare spending, and similar patterns have been found among Medicaid beneficiaries-with even lower rates of hospice use, the authors noted. 'These results highlight an unmet need for improved quality and equity of end-of-life care among patients with metastatic cancer who receive care management in the inpatient setting." Among patients with metastatic cancer who died in the hospital, increased rates of aggressive high-cost care were associated with Black and Asian or Pacific Islander race, Hispanic ethnicity, public insurance status, and admission to an urban teaching hospital. This study identified groups at risk of receiving high-cost, low- value interventions that may oppose the patient's goals and exacerbate the physical, emotional, and financial burdens of terminal cancer, the researchers concluded. Ethnicity Complicates Discussions of End-of-Life Care The Washington Post reports on a new study finding that 'difficulty discussing end-of-life medical treatments is complicated further when there are ethnic differences that can create subtle barriers between the doctor and patient. " [FNT7] survey of more than 1,000 medical professionals by researchers at Stanford University's Medical School found that virtually all of them encountered difficulties holding end-of-life discussions with their patients. The difficulty was magnified by cultural and ethnic differences that hindered discussion about end-of-life treatment, with 86 percent rating them as 'challenging." Asian physicians reported the most struggles (91.3%), followed by African American (85.3%), Caucasian (83.5%), and Latino doctors (79.3%), according to the study. Miscommunication or a lack of communication arises for a variety of reasons. Sometimes it's because the physician isn't familiar with the religious or spiritual beliefs embraced by some families and hasn't been trained to understand them. In some cultures, for example, people believe that talking about death is an ill omen that speeds its likelihood, the study says. Other times, the barriers exist simply because of language differences, even when medical translators were brought in. That's because medical jargon is not always easily translated. Neither are common phrases such as 'heroic measures." The medical translators can also contribute to the distance between a provider and patient, making it harder to talk frankly about death. Other hindrances to communication came about because of greater distrust of medical professionals among some ethnic groups because of the legacy of the Tuskegee experiments and less 'health literacy," or familiarity with health care procedures. In a later study of end-of-life care for nursing home residents with advanced dementia, investigators found a persistent assumption among clinicians, administrators, and other staff that Black residents' families prefer intensive interventions. The assumption is not necessarily accurate. The researchers observed operations and conducted interviews with 169 staff members in 14 nursing homes across four states. The facilities that practiced low-intensity care for residents with advanced dementia had more pleasant physical environments and more standardized advance care planning processes, reported senior author Susan L. Mitchell, M.D., of Hebrew Senior Life in Boston and Harvard Medical School. These facilities also had greater staff engagement in shared decision-making, and staff members who did not value tube feeding. Yet in all of the nursing homes, staff members expressed assumptions that 'proxies for Black residents were reluctant to engage in advance care planning and favored more aggressive care," the study found. It's a bias that must be addressed, the authors concluded. The study, titled ADVANCE (Assessment of Disparities and Variation for Alzheimer Disease Nursing Home Care at End of Life), was conducted between June, 2018 and July, 2021. [FN18] Black Patients Less Likely to Seek Hospice Care While hospice use is increasing and patients in the U.S. are increasingly dying at home, researchers have found racial disparities in intensity of healthcare treatment at the end of life, including hospice use. IFN19] The objective of the study was to examine differences between Black and White patients in end-of-life care in a population sample with well-characterized causes of death. Researchers used data from the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study, an ongoing population-based cohort study with enrollment between January 25, 2003, and October 3, 2007, with linkage to Medicare claims data. Racial and regional differences in end-of-life outcomes and in stroke mortality among 1212 participants who died in the years 2013 to 2015 were also studied. The study looked at hospice use of three or more days in the last six months of life, as shown in Medicare claims files. Other outcomes included multiple hospitalizations, emergency department visits, and use of intensive procedures in the last six months of life. Cause of death was determined by clinicians using death certificates, proxy interviews, autopsy reports, and medical records. The study found that Black decedents were less likely than White decedents to use hospice for three or more days (34.9% vs. 46.2%). Substantial racial differences in treatment intensity and service use were found among persons who died of cardiovascular disease but not among patients who died of cancer. In analyses adjusted for cause of death (dementia, cancer, cardiovascular disease, and other) and clinical and demographic variables, Black decedents were significantly less likely to use three or more days of hospice and were more likely to have multiple emergency department visits and hospitalizations, and undergo intensive treatment in the last six months of life compared with White decedents. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. Use of Hospice Drugs Varies Widely State by State According to a new study, [FN20] there is wide variation by state in the prescribing of antipsychotics and benzodiazepines to hospice enrollees. The findings highlight the lack of evidence-based guidance for end-of-life prescribing, researchers say. Antipsychotics and benzodiazepines are often utilized to treat distressing symptoms at end of life, however, these medication classes are not without risk when prescribed to older adults including side effects such as sedation, falls, and increased mortality, the report noted. Investigators identified more than 1.3 million Medicare beneficiaries aged 65 years and older who were prescribed any antipsychotic or benzodiazepine during a day of hospice enrollment in 2017. The most common hospice diagnoses in qualified study participants were cancer, heart disease, and dementia. The analysis, representing 4,219 hospices, resulted in state-level averages of adjusted prescribing rates for each drug class. For antipsychotics, prescribing rates ranged from 62% for hospice beneficiaries in Oregon to 15% in Oklahoma. Benzodiazepine prescribing rates varied from 77% in Oregon to 42% in New York. Benzodiazepine prescription fills were higher than antipsychotics in all states. And for each class of drug, five states topped the prescriptions list: Oregon, New Mexico, Washington, New Hampshire and Florida. Despite the routine use of antipsychotics and benzodiazepines to treat distressing end-of-life symptoms, guidance and consensus on best prescribing practices is limited, according to lead author Donovan Maust, MD. Since the drugs are tied to adverse side effects such as sedation and falls in older adults, 'for those patients who are not imminently dying, patients and their care partners may prefer avoiding such medications in order to maintain function and minimize sedation," the authors wrote. Without clear evidence and guidance for hospice, use of these drugs may remain varied and inconsistent. The researchers recommended that future work is needed to understand the sources of state variation and the associated patient outcomes. 'A better understanding of the factors that influence hospice prescribing culture can help inform guidelines and best practices for medication use to balance relief of distressing symptoms while avoiding medication-related harms," they concluded. Hospice Services at Home On November 2, 2021, CMS finalized the home health prospective payment for 2022. The rule aims to accelerate the shift from paying for Medicare home health services based on volume to a system that pays for value, according to the agency's fact sheet. [FN21] it finalizes a nationwide expansion of the successful Home Health Value-Based Purchasing Model and makes updates to the Medicare Home Health Prospective Payment System and the home infusion therapy services payment rates for calendar year 2022, in accordance with existing statutory and regulatory requirements. The final rule makes permanent the changes to the home health Conditions of Participation that were implemented during the COVID-19 public health emergency and finalizes changes to the CoPs to implement a provision of the Consolidated Appropriations Act, 2021. It also finalizes survey and enforcement requirements for hospice programs to implement provisions of the Consolidated Appropriations Act, 2021 (CAA 2021). According to the fact sheet, CMS continues to review and revise its health and safety requirements and survey processes to ensure that they are effective in driving quality of care for hospice programs. In the rule, CMS implements provisions of the CAA 2021 with respect to transparency, oversight, and enforcement of health and safety requirements for hospice programs. These provisions enhance the hospice program survey process by requiring the use of multidisciplinary survey teams, prohibiting surveyor conflicts of interest, expanding CMS-based surveyor training to accrediting organizations (AOs), and requiring AOs with CMS-approved hospice programs to begin use of the Form CMS-2567. Additionally, the provisions require that state survey agencies establish a hospice program complaint hotline. Finally, the rule implements the CAA 2021 provision requiring the establishment of enforcement remedies that may be imposed instead of, or in addition to, termination of participation in the Medicare program for noncompliant hospice programs. The agency notes that it is finalizing the proposed surveyor prohibition of conflicts of interest and enforcement remedy provisions as proposed with two exceptions. First, it is not finalizing the Special Focus Program for poor-performing hospice programs that have repeated cycles of serious health and safety deficiencies. Numerous comments indicated the the proposed provision should not be finalized until a Technical Expert Panel (TEP) is convened to further define the parameters and provide a targeted approach based on national measures. Therefore, CMS is establishing a TEP with stakeholder engagement that integrates the public comments and will finalize this program through future rulemaking. Second, the suspension of payment enforcement remedy will be finalized with modifications to limit the suspension of payment to all new patient admissions, rather than suspension of all or part of the payments to which a hospice program would otherwise be entitled. Terminally ill cancer patients had a better quality of life when they could die at home and avoid intense life-prolonging measures, a 2012 study found. Nearly 400 cancer patients were asked about their treatment preferences and support structures, along with socio- demographic factors. After their loved ones' deaths, caregivers were interviewed and asked about the location of the death, physical and psychological distress, and treatment of the patient. Those who had positive experiences tended to have died at home, had pastoral care, and had a 'therapeutic alliance with the physician." Chemotherapy, feeding tube positioning, and high degrees of anxiety and depression contributed to negative feelings, researchers said. The feelings are something that sometimes can be modified by health care workers, researchers noted. Caregivers and physicians who remain engaged and 'present' with dying patients 'by inviting THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. and answering questions and by treating patients in a way that makes them feel that they matter as fellow human beings - have the capacity to improve a dying patient's [quality of life]," researcher Holly G. Prigerson, Ph.D., said. [FN2] For those who are nearing the end of life dealing with constant flare-ups of various chronic illnesses, 'pre-hospice" care can provide an alternative to hospitals and allow patients to remain at home. End-of-life care is a massive problem that costs the health care system billions and, according to Kaiser Health News, 'has galvanized health providers, hospital administrators and policymakers to search for solutions." N23] In San Diego, for example, a new program called 'Transitions" is designed to give elderly patients the care they want, at home, and keep them out of the hospital. Social workers and nurses regularly visit patients in their homes to explain what they can expect in their final years, help them make end-of-life plans and teach them how to better manage their diseases. Physicians track their health and scrap unnecessary medications. Unlike hospice care, patients don't need to have a prognosis of six months or less, and they can continue getting curative treatment for their illnesses, not just for symptoms. Veterans The Department of Veterans Affairs (VA), in 2009, began a major, four-year investment in improving the quality of end-of-life care for veterans. The Comprehensive End of Life Care Initiative increased the numbers of VA medical center inpatient hospice units and palliative care staff members as well as the amount of palliative care training, quality monitoring, and community outreach. In a study reported in Health Affairs [FN24] esearchers compared hospice use among more than 1.1 million male veterans, aged 65 and older, between 2007 and 2014, with more than 140,000 demographically similar Medicare beneficiaries not enrolled in VA healthcare. By 2011, they found that 44 percent of veterans who died in hospitals took their last breaths in hospice beds, compared to 30 percent in 2008. By 2012, 71 percent of veterans dying of cancer were enrolled in hospice. Additionally, after adjusting for age, race and ethnicity, diagnoses, nursing home use in the last year of life, census region, and urbanicity of a person's last residence, the researchers found a 6.9 to 7.9 percentage-point increase in hospice use over time for the veteran categories, compared to a 5.6 percentage-point increase for nonveterans (the relative increases were 20742 percent and 16 percent, respectively). Researchers concluded that the VA's substantial investment in palliative care appears to have resulted in greater hospice use by older male veterans enrolled in the VA, a critical step forward in caring for veterans with serious illnesses. Use of Home Hospice Increasing Recent research has found that rates of hospice utilization were higher among veterans than other Medicare decedents, with over half of veterans receiving care in the home. IFN25] The findings reflect a growing industry-wide trend toward community-based care. The study, from the U.S. Department of Veterans Affairs (VA) Home Based Primary Care (VA-HBPC), found rates of home hospice utilization among veterans increased from 2008 to 2016. More than 60% of veterans died at home compared to less than 50% of non-veterans in community-based settings, according to authors Suzanne Gillespie, M.D., and Orna Intrator. Veterans were less likely to use end-of-life care in other settings, with approximately 11% dying in inpatient hospice units, 14% in hospitals, and 11% in nursing homes. The VA began the Comprehensive End-of-Life Initiative in 2009 to improve the quality of end-of-life care among veterans and increase dying veterans' enrollment in hospice for care more aligned with their goals. The initiative has led to an increase of roughly 778% increase in hospice use among veterans. [FN26] Dementia Soars at End of Life Among U.S. Adults In a study to determine the degree to which diagnosis of Alzheimer disease and related dementias has changed at the end of life between 2004 and 2017, researchers found that nearly half of older adults in the U.S. receive a diagnosis of dementia shortly before their death. The number has spiked by more than 34% in two decades, according to the study. [FN27] The researchers, from the University of Michigan, analyzed fee-for-service Medicare billings from 3.5 million patients aged 67 and older, between 2004 and 2017. Approximately 35% of billing claims from 2004 included at least one mention of dementia within two years of death. By 2017, more than 47% claims did so. Researchers found that the increases were more evident in inpatient, hospice, and home health settings. The investigators attribute the increase to an increased awareness among clinicians, patients and caregivers, and a spike in recorded diagnoses from 2011 to 2013. Those years saw a substantial increase in the number of diagnoses Medicare allowed on claims. Taken as a whole, the results suggest that underdiagnosis of dementia is declining, according to lead author Matthew A. Davis, Ph.D., MPH. Intensity of end-of-life care has declined on most measures, but not on some key invasive procedures, the investigation also revealed. There has been a notable decrease in the use of feeding tubes in nursing homes, for example. In the general population, there has been an increase in hospice use and lower likelihood of dying in the hospital despite the persistence of frequent transfers, Davis reported. There has been no corresponding decrease in the use of invasive life-prolonging procedures such as mechanical ventilation and dialysis, the authors added. Emergency Departments Rarely Send Seniors with Dementia to Hospice THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -10- Despite the high rate of patients with dementia visiting emergency departments (EDs) needing end-of-life care, most patients typically transition to nonhospice settings and frequently retum to the ED, according to a new study. [FN28] Investigators analyzed claims from 29,626 Medicare recipients with Alzheimer's disease and related dementia, tracking discharge settings when compared to their peers without dementia. In the 12 months following an ED visit, those with dementia were more likely to be transferred to acute care, revisit the ED, or experience an inpatient stay, according to the study. Patients with dementia also were twice as likely to die during those 12 months, at 32%, than their peers without dementia. Yet discharge to hospice was just as low for these patients as for the comparison group, at only 0.2% for each, the investigators found. The findings are notable in part because patients with dementia are generally high users of hospice care, the authors wrote. Approximately 45% of those in hospice settings have either primary or comorbid dementia. As the population of people with dementia grows, there will be a need for better-aligned ED treatment and discharge plans, the investigators contended. These plans should keep in mind the clinical status and preferences of people with dementia and their caregivers, the authors concluded. [FN29] OIG Report Cites Hospice Quality Problems According to a recent audit [FN3O] by the Department of Health and Human Services' Office of Inspector General, a majority of hospices recently had at least one deficiency in the quality of care they provide. The OIG based the study on an analysis of CMS's deficiency and complaint data from 2012 through 2016. It analyzed data from State agencies and accrediting organizations and also reviewed the survey reports from State agencies for a purposive sample of 50 serious deficiencies. The OIG found that over 80 percent of the hospices had at least one deficiency. The most common types of deficiencies involved poor care planning, mismanagement of aide services, and inadequate assessments of beneficiaries. The report also recommended that CMS should implement existing OIG recommendations to strengthen the survey process, establish additional enforcement remedies, and provide more information to beneficiaries and their caregivers. In addition, it recommended that CMS: * expand the deficiency data that accrediting organizations report to CMS and use these data to strengthen its oversight of hospices; ¢ take the steps necessary to seek statutory authority to include information from accrediting organizations on Hospice Compare (CMS's website that contains limited information about individual hospices); ¢ include on Hospice Compare the survey reports from State agencies; * include on Hospice Compare the survey reports from accrediting organizations, once authority is obtained; * educate hospices about common deficiencies and those that pose particular risks to beneficiaries; and ¢ increase oversight of hospices with a history of serious deficiencies. CMS either concurred or partially concurred with all the recommendations except the third. To address the issues described in the OIG reports, the National Association for Home Care & Hospice (NAHC) has made recommendations to CMS and other stakeholders. *3"] NAHC recommends increasing the frequency of surveys for hospices that have a history of serious deficiencies, including unannounced spot checks, making state agency and accreditation organization reports publicly available, and additional action to improve CMS' process for capturing and responding to patient complaints and to strengthen the effectiveness of the survey process. NAHC also called for CMS to evaluate the consistency of state agency surveyor and accreditation organization surveyor actions that pertain to Medicare Conditions of Participation, as well as CMS regional office interpretations and applications. They also advocated annual audits to ensue survey accuracy. Where People Die: Study Analysis of data from the CDC and the National Center for Health Statistics finds that more people are dying at home and in hospice than in nursing facilities and hospitals. Authored by Sara H. Cross, of Duke University Sanford School of Public Policy, and Haider J. Warraich, of Veterans Affairs Boston Healthcare System, the study looked at natural deaths in the United States from 2003 through 2017. N32] Between 2003 and 2017, there were nearly 35.2 million natural deaths, according to the study. Most were attributed to cardiovascular disease (29.3%), followed by cancer (24.5%), respiratory disease (10.5%), dementia (7.9%), and stroke (5.9%). Between 2003 and 2017, deaths occurring in hospitals decreased from 39.7% in 2003 to 29.8% in 2017; deaths at nursing facilities decreased from 23.6% to 20.8%. Whereas the number of deaths at home increased from 23.8% in 2003 to 30.7% in 2017; deaths at hospice facilities increased from 0.2% to 8.3%. These trends were seen across all disease groups. Home has surpassed the hospital as the most common place of death in the U.S. for the first time since the early 20th century, according to co-author Warraich. The study also found that younger patients, female patients, and racial and ethnic minorities had lower odds of death at home than did older patients, male patients, and white patients. Patients with cancer had the greatest odds of death at home and death at a hospice facility and the lowest odds of death at a nursing facility relative to other conditions. Patients with dementia had the greatest odds of death at a nursing facility, and patients with respiratory disease had the greatest odds of death at a hospital. Patients with stroke had the lowest odds of death at home, and patients with cardiovascular disease had the lowest odds of death at a hospice facility relative to other conditions. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -11- Effect of Loneliness Lonely older adults are burdened by more health symptoms and receive more intensive end-of-life care than their peers who don't suffer from loneliness, researchers at the University of Michigan have found. IFN33] The investigators studied records of 2,896 decedents older than 50 years who died between 2004 and 2014, after excluding those who were ineligible for surveys assessing loneliness or had missing or incomplete loneliness or symptom data. They found that one third of the decedents were lonely. Compared with nonlonely individuals, lonely decedents were more likely to use life support in the last two years of life and to die in a nursing home. No significant differences in other measures of intense care (late hospice enrollment, number of hospitalizations, or dialysis use) or likelihood of advance care planning were observed, the study noted. The researchers determined that lonely older people may be burdened by more symptoms and exposed to more intense end-of-life care compared with nonlonely people. Clinicians must do more to screen for and intervene in cases of loneliness among older adults at the end of life, not only during the dying period, they concluded. Recent Legislative Activity Federal «2021 CONG US HR 7176, introduced March 21, 2022, to provide a burial allowance for certain veterans who die at home while in receipt of hospice care furnished by the Department of Veterans Affairs. * 2021 CONG US §S 368, introduced February 23, 2021, would allow the use of telehealth, as clinically appropriate, to conduct a face-to- face encounter for hospice care under Medicare. California ¢ 2021 CA A.B. 323 (NS), adopted October 4, 2021, redefines a class 'AA' violation as a class 'A' violation that the department determines to have been a substantial factor, as described, in the death of a resident of a long-term health care facility; increases the civil penalties for a class 'A,' 'AA,' or 'B' violation by a skilled nursing facility or intermediate care facility. ¢ 2021 CAA.B. 1186 (NS), introduced February 18, 2021, would make technical, nonsubstantive changes to the provisions of the California Hospice Licensure Act of 1990 imposing criminal penalties. * 2021 CAA.B. 1280 (NS), adopted October 4, 2021, prohibits a hospice provider, employed hospice staff, or an agent for the hospice from paying referral sources for the referral of patients to the hospice. The bill would prohibit a hospice salesperson, recruiter, agent, or employee who receives compensation or remuneration for hospice referrals or admissions from providing consultation on hospice services, hospice election, or informed consent to a patient, patient's family, or patient's representative. The bill also requires a specified person, including a registered nurse or medical social worker, to complete the election of hospice, informed consent, completed signatures, and counsel on the election of hospice with a patient, patient's family, or patient's representative; requires a hospice to provide verbal and written notice of the patient's rights and responsibilities to the patient or the patient's representative, ina language and manner the person understands, before providing care. * 2021 CAA.B. 1852 (NS), adopted July 19, 2022, adds licensed hospice facilities to the list of facilities authorized to use an automated drug delivery system, and expressly includes an automated unit dose system within the definition of an automated drug delivery system. By expanding the scope of a crime, the bill imposes a state-mandated local program. ¢ 2021 CA A.B. 1884 (NS), introduced February 8, 2022, requiring that a licensed hospice be inspected by a representative every 3 years and that results of an inspection be made available to the public to the extent consistent with federal and state privacy laws; requiring that the recertification of the terminal illness of a patient be conducted by at least one independent physician in conjunction with the medical director of the hospice or the physician member of the hospice interdisciplinary group, to the extent permitted by federal law. ¢ 2021 CAA.B. 2673 (NS), adopted September 29, 2022, would generally replace the term 'hospice' with 'hospice agency"; provide that hospice agency licenses are not transferable; would specify that only the person or entity initially issued the license may use the license for 5 years; would revise and expand the department's application requirements, and would additionally require an applicant who has not previously qualified for a hospice agency license to demonstrate and provide evidence of an unmet need of hospice services in the geographic region; would require the department, by January 1, 2024, to adopt emergency regulations to implement the recommendations in a specified report of the California State Auditor and require the department to maintain the general moratorium on new hospice agency licenses until the department adopts the regulations; would require the regulations to establish guidelines for assessing the appropriateness of a hospice agency's ratio of patients to nurses, require minimum standards of training and experience, and establish timelines for reporting changes to application information, as specified. The bill would require the moratorium to end on the earlier of 2 years from the date that the California State Auditor publishes a report on hospice agency licensure, or the date the emergency regulations are adopted. ¢ 2021 CA S.B. 664 (NS), adopted October 4, 2021, would impose, beginning on January 1, 2022, a moratorium on issuing a new license to provide hospice services, unless the department makes a written finding that an applicant for a new license, or with a license application pending on January 1, 2022, has shown a demonstrable need for hospice services in the area where the applicant proposes to operate based on the concentration of all existing hospice services in that area. The moratorium would end either 365 days from THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -12- the date that the California State Auditor publishes a report on hospice licensure or when these provisions are repealed on January 1, 2027, whichever is soonest. ¢ 2021 CA S.B. 1346 (NS), adopted September 30, 2022, until January 1, 2030, authorizes a regional pilot program in the Counties of Santa Clara and San Mateo and the City and County of San Francisco for the purpose of implementing and maintaining a repository and distribution program for the donation of surplus medication and redistribution to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. The bill requires participating pharmacies in the regional pilot program to be owned or operated by one of the 3 counties and not on probation with the California State Board of Pharmacy; authorizes donated medication to be transferred more than once, but only within a county, and would allow donated medication from multiple facilities to be commingled by the participating entity; requires participants to maintain a system of recording and logging donated medication to allow the tracking, as specified, and to disclose to the Board of Pharmacy any medication errors, within 30 days of discovery of the error by the participating entity. The bill also, on January 1, 2028, requires the Board of Pharmacy to submit to the Legislature an evaluation of the regional pilot program and the pilot program participants' compliance to program requirements. The bill expands the list of entities that may act as a donor organization and includes hospice agencies and facilities. This bill authorizes any pharmacy, licensed in California and not on probation with the California State Board of Pharmacy, to donate unused, unexpired medication, as specified. Colorado * 2022 CO H.B. 1167 (NS), introduced February 7, 2022, granting a supervising health-care provider or health-care facility the authority to identify and select a temporary proxy decision-maker (temporary proxy) to make emergency medical treatment decisions for an adult patient who has been determined, by the patient's attending physician, to lack decisional capacity to make informed consent to or refusal of medical treatments. The temporary proxy is to be utilized only in emergency circumstances when an otherwise legally authorized proxy decision-maker cannot be located. The bill outlines guidelines for selecting the temporary proxy and when the authority of the temporary proxy terminates. ¢ 2022 CO H.B. 1246 (NS), adopted June 8, 2022, concerning the registration of a pharmacy located within a hospice inpatient unit as a specialized prescription drug outlet, and making an appropriation. Connecticut 2022 CT H.B. 5227 (NS), amended/substituted April 26, 2022, establishing a community ombudsman program to respond to complaints regarding home and community-based long-term care services and supports (including hospice), in programs administered by the Department of Social Services. Hawaii 2021 HI H.B. 224 (NS), introduced January 22, 2021, exempts hospice, psychiatric, and substance abuse facilities and certain dialysis center services from the certificate of need requirements. Indiana 2022 IN H.B. 1217 (NS), introduced January 25, 2022, requiring copies of a perinatal hospice services brochure be provided to a pregnant woman whose unborn child has been diagnosed with a lethal fetal anomaly and is intending to have an abortion. Maine ¢ 2021 ME H.P. 234 (NS), adopted June 14, 2021, to prevent accidental overdoses by establishing a protocol for disposal of hospice medications used in the home. ¢ 2021 ME H.P. 1272 (NS), introduced May 19, 2021, to ensure home care and hospice providers are included in Maine's emergency response plans. Maryland * 2022 MD H.B. 903 (NS), introduced February 7, 2022, requiring a health care provider or health care institution to ensure the provision or continuation of life-sustaining care under certain circumstances; regulating the development and use by agencies of measures that discount the value of a life based on an individual's disability and utilization management measures; authorizing the General Assembly to appoint certain members to intervene in certain cases. ¢ 2022 MD S.B. 440 (NS), introduced January 26, 2022, establishing the Commission to Study the Health Care Workforce Crisis in Maryland to examine certain areas related to health care workforce shortages in the State, including the extent of the workforce shortage, short-term solutions to the workforce shortage, future health care workforce needs, and the relationship between the Maryland Department of Health and the health occupations boards. Massachusetts 2021 MA H.D. 1330 (NS), draft/request February 5, 2021, relative to delegation of the administration of or assistance with the administration of medications in the home to a home health aide and or a hospice aide. Michigan THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -13- ¢ 2021 MI S.B. 404 (NS), introduced April 29, 2021, to prohibit the implementation of policies in medical facilities that ban other individuals from being present during certain medical procedures or during the end of life of certain individuals; to provide for the powers and duties of certain state and local governmental officers and entities; and to prescribe civil sanctions. ¢ 2021 MI S.B. 939 (NS), introduced March 1, 2022, providing criteria for certifying a perinatal hospice program. Minnesota ¢ 2021 MN H.F. 331 (NS), introduced January 25, 2021, requiring disclosure of a person's status as a registered predatory offender to a hospice provider. Mississippi 2022 MS H.B. 330 (NS), introduced January 4, 2022, providing an exception to the moratorium on the issuance of certificates of need for home health agencies to authorize the state department of health to issue up to five certificates of need to the recipients of the five new hospice licenses issued under section 41-85-7(3). Missouri 2022 MO S.B. 1029 (NS), introduced January 6, 2022, relating to health care facility inspections and other oversight by the Department of Health and Senior Services, including hospice certification. New Jersey ¢ 2022 NJ A.B. 2525 (NS), introduced February 14, 2022, and 2022 NJ S.B. 1935 (NS), introduced March 3, 2022, 'Linnette Lebron's Law," modifies procedures for marriage or civil union where a party is terminally ill. ¢ 2022 NJ S.B. 1490 (NS), introduced February 10, 2022, permitting use of automated dispensing devices in long-term care facilities and hospice care programs. New York ¢ 2021 NY A.B. 1075 (NS), introduced January 7, 2021, directs the commissioner of labor to conduct a labor market study of the home care and hospice workforce and establishes a temporary labor task force for home care and hospice services and occupations to examine and make recommendations regarding competitive labor market factors, reimbursement, programs and other state policy actions necessary to support recruitment and retention of the home care and hospice workforce in the broader, competitive health labor market. ¢ 2021 NY A.B. 4594 (NS), amended/substituted April 15, 2021, permitting up to one hundred percent of beds in hospice residences to be dually certified as both hospice and in-patient beds with the approval of the commissioner of health. ¢ 2021 NY A.B. 8472 (NS), introduced November 20, 2021, prohibiting the establishment of new for-profit hospices or increasing the capacity of existing for-profit hospices. ¢ 2021 NY S.B. 3761 (NS), introduced January 30, 2021, directs the commissioner of labor to conduct a labor market study of the home care and hospice workforce; and establishing a temporary labor task force for home care and hospice services and occupations. ¢ 2021 NY S.B. 5506 (NS), amended/substituted April 14, 2021, relates to permitting all beds in hospice residences to be dually certified as both hospice and in-patient beds. ¢ 2021 NY S.B. 7626 (NS), introduced December 22, 2021, authorizing residents of assisted living programs to receive hospice services; directs the commissioner of health to convene a workgroup of stakeholders to make recommendations as to coordination and division of services, responsibilities, and reimbursement of assisted living programs and hospice programs. ¢ 2021 NY S.B. 9387 (NS), introduced May 23, 2022, relating to prohibiting the establishment of new for-profit hospices. Oklahoma ¢ 2021 OK H.B. 1879 (NS), introduced February 1, 2021, relating to hospice and other health services, allowing for multiple designated representatives of residents in certain situations. ¢ 2021 OK S.B. 1155 (NS), introduced February 7, 2022, relating to hospice license; prohibiting distance requirement between facilities or other properties owned or leased by a hospice. Ohio 2021 OH S.B. 160 (NS), adopted June 14, 2022, the Veteran Information Act, requiring certain entities to inform veterans about available health care benefits, including hospice services. Pennsylvania ¢ 2021 PA H.B. 2425 (NS), amended/substituted October 18, 2022, providing for communication duties between the Department of Health and the Department of Human Services with certain agencies and the Department of Aging relating to abuse of adults and older adults in hospice and long-term care facilities. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -14- ¢ 2021 PAH.B. 2712 (NS), introduced June 28, 2022, providing for limitations on capital distributions after certain acquisitions of target firm health systems, including for-profit hospitals, hospice facilities, or nursing homes located in this Commonwealth that is bought by a private fund. ¢ 2021 PA S.B. 1271 (NS), introduced July 18, 2022, would prohibit for-profit entities from owning or managing hospitals and other health systems, including hospice agencies or nursing homes. ¢ 2021 PAS.B. 1274 (NS), introduced July 18, 2022, prohibiting separation of real property from a health system (including hospices and nursing homes) without input from the community, the Attorney General and the Department of Health. * 2021 PA 8.B. 1275 (NS), introduced July 18, 2022, providing for limitations on capital distributions after certain acquisitions of target firm health systems, including hospice agencies and nursing homes. Rhode Island 2021 RI H.B. 7282 (NS), introduced February 2, 2022, creating a four-year pilot program to provide scholarships to certified nursing assistants employed in certain high needs fields, including in long-term care and hospice facilities. Virginia * 2022 VA H.B. 145 (NS), adopted April 7, 2022, for hospice program licensing, adds physician assistants added to the list of hospice personnel who may be part of a medically directed interdisciplinary team. ¢ 2022 VA S.B. 169 (NS), adopted April 7, 2022, extending to licensed practical nurses the authority to pronounce the death of a patient in hospice, provided that certain conditions are met. ¢ 2022 VA S.B. 580 (NS), amended/substituted January 27, 2022, directing the Department of Health to remove the triennial audit requirement for hospices and home care organizations. West Virginia 2021 WV H.B. 2078 (NS), introduced February 10, 2021, relating to creating the Nondiscrimination in Involuntary Denial of Treatment Act; requiring the provision of medical treatment under certain circumstances; requiring the disclosure of policies related to the life- preserving treatment a patient may receive or be denied; requiring the Department of Health and Human Resources to maintain and report on certain information. IV. COSTS AND FUNDING OF END-OF-LIFE CARE Medicare Funding Currently, the Medicare hospice benefit covers the costs of palliative care for an individual who is terminally ill, in the individual's home, or in a nursing facility. Medicare does not have a long-term custodial nursing facility benefit, so that if an individual elects the Medicare hospice benefit in a nursing facility, the individual's room and board are not covered by Medicare and the individual or a third-party payor must pay for the costs of the room and board. For those individuals who are dually eligible for Medicare and Medicaid who elect the Medicare hospice benefit, Medicare is financially responsible for the hospice care and the Medicaid program is the third-party payor responsible for the nursing facility room and board expense. For the nursing facility room and board care, the Medicaid program must provide for payment in an amount equal to at least 95 percent of the Medicaid daily nursing facility rate (the rate the state Medicaid program pays for nursing facility services furnished to an individual who has not elected to receive hospice care). Historically, the Medicaid program has paid the hospice provider for the nursing facility room and board expenses of dually eligible individuals who elect the hospice benefit, and the hospice provider has then passed through this payment to the nursing facility. CMS released its final rule updating the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year 2022. The rule makes changes to the labor shares of the hospice payment rates and finalizes clarifying regulations changes to the election statement addendum that was implemented last year, on October 1, 2020. In addition, the rule makes permanent selected regulatory blanket waivers that were issued to Medicare-participating hospice agencies during the COVID-19 public health emergency (PHE) and updates the hospice conditions of participation. On July 29, 2022, the Centers for Medicare & Medicaid Services (CMS) adopted a final rule updating the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2023. The update will give hospices a 3.8% bump in their per diem payments for 2023, more than the 2.7% the agency initially proposed for next year, which many providers and industry groups contended was too small in light of rising expenses. The rule also increases the hospice aggregate cap for next year by a corresponding 3.8% to $32,486.92. The final rule establishes a permanent mitigation policy to smooth the impact of year-to-year changes in hospice payments related to changes in the hospice wage index. In addition, the rule updates the Hospice Quality Reporting Program (HORP) and discusses further development of the Hospice Outcomes and Patient Evaluation (HOPE) assessment instrument; updates the Quality Measures (QMs) that will be in effect in FY 2023 for the HQRP and future QMs; updates the Consumer Assessment of Healthcare Providers and Systems, Hospice Survey Mode Experiment, discusses a request for information on health equity, and updates the hospice survey and enforcement procedures. The regulations take effect October 1, 2022. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -15- In 2021, hospice and palliative care was offered by 53 Medicare Advantage plans through the value-based insurance design (VBID) model, according to CMS. Payers and hospice providers had the option to participate in a demonstration project in 2021 (referred to as the 'Medicare Advantage hospice carve-in'), to test the inclusion of hospice in VBID. The carve-in will begin at a time when Medicare Advantage premiums have dropped significantly, despite expanding benefits, even as the number of beneficiaries increases nationwide. '*N*41 The U.S. Department of Health & Human Services Office of the Inspector General (OIG) is planning a nationwide audit of hospice eligibility for calendar year 2023, Hospice News reports. IFN35] The audit will focus on patients who did not have a hospitalization or emergency department visit prior to electing hospice. OIG will contact individual hospices to request Medicare claims and associated documentation. The impetus for the 2023 audit comes from the results of previous inquiries. Hospice eligibility is one of the most frequently targeted issues in regulatory enforcement, and hospice organizations are under increasing legal and regulatory scrutiny related to medical necessity complaints under the False Claims Act and the closely related anti-kickback statute. A leading report from Bass, Barry, and Sims in 2021 shows that a primary cause of fraud involves hospices billing Medicare for services for which patients were not eligible. This resulted in several multi-million-dollar settlements during 2020, with amounts ranging from $1 million to $5.25 million. OIG reports can be impactful. Two reports in 2019 indicated condition-level deficiencies that posed serious safety risks in 20% of hospices surveyed by regulators. The reports led the CMS to overhaul its survey process in 2021, including new provisions for surveyor training and greater transparency for consumers. Dementia Care Researchers in Washington, D.C., examined whether hospice use for persons with Alzheimer disease and related dementias (ADRD) changed between 2008 and 2019 in conjunction with Medicare policy changes that aimed to reduce long hospice stays. According to the study, published online on May 6, 2022, in the JAMA Health Forum, IFN36] found immediate declines in the share of patients receiving hospice care with ADRD and a slower growth in use of hospice care among patients with ADRD after implementation of the 2014 Improving Medicare Post-Acute Care Transformation Act (IMPACT) and the two-tier payment system compared with prepolicy trends. Data for the study were included for 11,124,992 unique hospice episodes between 2008 and 2019 among Medicare hospice beneficiaries aged 65 years or older at the time of enrollment. The researchers found that during the months of the IMPACT Act passage and implementation, the percentage of new enrollees with an ADRD code decreased significantly but rose again during the following months. At the time of implementation of the 2016 two-tier payment system, no significant changes were observed, but the average rate of increase was slower during the subsequent period than in earlier periods. In conclusion, this cross-sectional study of Medicare hospice claims data suggested that recent Medicare policies were associated with immediate and lasting reductions in the share of patients receiving hospice care with an ADRD code, compared with expectations from pre-implementation trends. The researchers recommend future research should examine mechanisms through which hospices enacted change and consequences for quality of care. Medicare Advantage Organizations Include Medicare Hospice Benefit Beginning January 1, 2021, participating Medicare Advantage Organizations can include the Medicare hospice benefit in their Part A benefits package. IFNS7] The CY 2021 Hospice Benefit Component is part of the larger Value-Based Insurance Design (VBID) Model, which has 19 Medicare Advantage organizations (MAOs), providing care to 1.6 million Medicare patients in 45 states, the District of Columbia, and Puerto Rico. [FN38] Currently, when an enrollee in a Medicare Advantage plan elects hospice, Fee-for-Service (FFS) Medicare becomes financially responsible for most services, while the MAO retains responsibility for certain services (e.g., supplemental benefits). Under the Hospice Benefit Component of the VBID Model, participating MAOs retain responsibility for all Original Medicare services, including hospice care. The Hospice Benefit Component of the Model implements a set of changes recommended by the Medicare Payment Advisory Commission (MedPAC), the Health and Human Services (HHS) Office of Inspector General (OIG), and other stakeholders. Medicare Advantage Beneficiary Disenrollments Increase in Last Year of Life Medicare Advantage (MA) beneficiaries are disenrolling from MA and transitioning to fee-for-service (FFS) coverage in the last year of life at twice the rate of other beneficiaries, according to a report released by the Government Accountability Office (GAO). IFNSS] Under MA, CMS contracts with private MA plans to provide health care coverage to Medicare beneficiaries. GAO analyzed CMS disenrollment and mortality data for 2015 through 2018-the most current data at the time of the analysis-to examine the extent of MA beneficiary disenrollment in the last year of life. Stakeholders told GAO that, among other reasons, beneficiaries in the last of year life may disenroll because of potential limitations accessing specialized care under MA. Prior GAO and other studies have shown that beneficiaries in poorer health are more likely to disenroll from MA to join FFS, which may indicate that they encountered issues with their care under MA. Beneficiaries in the last year of life are generally in poorer health and often require high-cost care, the report states. While CMS monitors MA disenrollments, the agency does not specifically review THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -16- disenrollments by beneficiaries in the last year of life. Doing so could help CMS better ensure the care provided to these beneficiaries, the GAO advises. The report also noted that beneficiaries in the last year of life who disenrolled from MA to join FFS increased Medicare costs as they moved from MA's fixed payment arrangement to FFS, where payments are based on the amount and cost of services provided. GAO's analysis shows that FFS payments for beneficiaries who disenrolled in 2016 were $422 million higher than their estimated MA payments had they remained in MA, and were $490 million higher for those that disenrolled in 2017. Quality Reporting Hospices are required to report on the quality of care received by Medicare patients, under a final rule published by CMS in 2011. [FN40] The rule implements Affordable Care Act requirements, including a hospice quality reporting program, and clarifies previously adopted policies on hospice face-to-face certifications, said Jonathan Blum, deputy administrator and director of CMS' Center for Medicare. Additionally, the final rule also revises how CMS calculates each hospice's yearly aggregate cap. Federal law requires that CMS impose a limit on the aggregate Medicare payments a hospice provider receives annually. CMS calculates each hospice's aggregate cap by multiplying the number of patients served by the hospice in a cap year by a cap amount. Medicare payments made to a hospice during the cap year that exceed the hospice's aggregate cap must be refunded to Medicare. In this final rule, CMS: ¢ Changes the way it counts hospice patients for the 2012 cap accounting year and beyond. This rule also finalizes that the new counting method be applied to past cap years in certain instances. * Allows hospice providers who do not want a change in their patient counting method to elect to continue using the current method. * Allows any hospice physician to perform the face-to-face encounter regardless of whether that same physician recertifies the patient's terminal illness and composes the recertification narrative. « Implements a hospice quality reporting program, which includes a timeframe for reporting, as required by section 3004 of the Affordable Care Act. The measures that are being adopted in this final rule for the FY 2014 program are one measure endorsed by the National Quality Forum related to pain management and one structural measure that assesses whether a hospice administers a Quality Assessment and Performance Improvement (QAPI) program that contains at least three indicators related to patient care. In 2017, CMS updated the hospice quality reporting requirements. In a final rule, CMS specifies public reporting measures derived from the CAHPS? Hospice Survey, and provides an update on the Hospice Quality Reporting Program, as mandated by ? 3004(c) of the Affordable Care Act. In accordance with section 1814(i)(5)(A) of the Act, hospices that fail to meet quality reporting requirements receive a 2.0 annual percentage point reduction to their payments. The rule finalizes eight measures from CAHPS Hospice Survey data already submitted by hospices. The rule also finalizes the extension or exception for quality reporting purposes from 30 calendar days to 90 calendar days after the date that an extraordinary circumstance occurred, and describes plans to publicly display quality measure data via Hospice Compare in August 2017. Additionally, this rule outlines policies and procedures associated with the public reporting of the quality measures used in the hospice program. The rule was published in the Federal Register on August 4, 2017. [FNAt] Effective October 1, 2021, CMS released updates to the Hospice Quality Reporting Program and finalizing changes for the Home Health Quality Reporting Program to address exceptions related to the COVID-19 PHE (beginning with the January 2022 public reporting). The rule also implements a new measure in the Hospice Quality Reporting Program called the Hospice Care Index. The measure includes 10 quality indicators calculated using claims data, which represent different aspects of hospice care. According to the final rule, hospice star ratings will be integrated into Care Compare. CMS unveiled its online Care Compare tool last September. It rolled the agency's eight quality reporting sites into a single resource. Patients, families, referral sources, and payers are increasingly paying attention to these data when selecting a hospice provider to work with. Hospices who fail to comply with quality reporting requirements will incur a 2% point reduction to their annual payment update percentage increase for that year. [FN42] Two new quality measures for hospice providers-Hospice Visits in the Last Days of Life and the Hospice Care Index-are now detailed by CMS in its Hospice Quality Reporting Program Quality Measure Specifications User's Manual, which became effective on October 1, 2021. [FN43] CMS will evaluate hospices' performance on these measures via analysis of claims data, which the agency already collects. Providers will not be required to do any additional data collection or reporting. The visits-during-last-days-of-life measure is designed to assess the percentage of patients who received in-person visits from a registered nurse, physician, nurse practitioner, or physician assistant during at least two days of a patient's final three days before dying. CMS will use claims data from the previous eight quarters to calculate a hospice's performance on this measure. This measure replaces a previous one, Hospice Visits When Death is Imminent, which was part of the Hospice Item Set, nine publicly reported quality metrics. The principal difference is the data source, the use of claims as opposed to provider reports. Hospice Compare Website CMS unveiled the Hospice Compare [FN44] hospice providers on their performance and assist consumers in making decisions that are right for them. According to CMS, providers can start a conversation with their patients and family members about how the new Hospice Compare website impacts them by: website on August 16, 2017. The goal of Hospice Compare is to help consumers compare [FN45] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -17- ¢ Explaining that the compare website provides a snapshot of the quality of care a hospice offers; ¢ Encouraging patients and their family members to review quality ratings; and * Helping to strengthen patients and family members' ability to make the best decisions for their care. The seven National Quality Forum-endorsed hospice and palliative care quality measures initially displayed on Hospice Compare are: ¢ Treatment preferences * Beliefs/values addressed ¢ Pain screening ¢ Pain assessment ¢ Dyspnea screening ¢ Dyspnea treatment ¢ Patients treated with opioids who are given a bowel regimen Prior to the release of data on Hospice Compare, hospices will be given the opportunity to review their quality measure results during a 30-day preview period using a Hospice Provider Preview Report, which will be issued quarterly by CMS. Rehabilitation Services at End of Life A recent study has revealed that potentially unnecessary and harmful high intensity rehabilitation services for residents of nursing homes are increasing. The trend is on the rise for patients in the last 30 days of life, indicating that the services may be interfering with appropriate end-of-life care, according to University of Rochester Medical Center researchers. [FN46] A desire by skilled nursing facilities to maximize reimbursement rates may be driving the trend, and has drawn the attention of federal regulators. Nursing home Medicare reimbursement rates are based on categories that place patients into resource utilization groups (RUGs) based on the complexity, intensity, and amount of staff time dedicated to their care. Patients who receive high levels of rehabilitation services fall into a category that makes these facilities eligible to collect the highest level of reimbursement for their care. The authors of the study analyzed data from 647 nursing home facilities in New York State, focusing on residents who had received very high to ultrahigh rehabilitation services (physical, occupational, and speech therapy) during the last 30 days of life. Very high intensity rehabilitation is defined as 520 minutes or greater per week and ultrahigh as 720 minutes or greater, or the equivalent of two hours of rehab per day. They found that residents receiving ultrahigh rehabilitation had increased by 65 percent between 2012 and 2015 and that most of the rehabilitation therapy residents received was concentrated in the last seven days of life. They also found that there was a significantly higher use of these services in for-profit nursing home compared to not-for-profit homes. Costs of Younger vs. Older Seniors Contrary to widely held beliefs about the costs of end-of-life care, younger seniors, with potentially longer life expectancies, are amassing the largest medical bills, and not Americans in their 80s and 90s, according to a new analysis that examines the relative costs of end-of-life care. The study, conducted by the Kaiser Family Foundation, analyzed Medicare claims data for 2014 for all beneficiaries who died the same year. It found that that average Medicare spending per person peaked at age 73-at $43,353. That compared with $33,381 per person for 85-year-olds, and $27,779 per person among 90-year-olds. Kaiser researchers said their findings suggest that providers, patients, and their families may favor more costly, lifesaving care for younger seniors, and turn to hospice care when patients are older. Medicare covered eight of 10 people in the U.S. who died in 2014, establishing it as the largest insurer of medical care provided at the end of life, according to the Kaiser report. Medicare spent an average of $34,529 on each of them, and most of that money (51%) went to inpatient hospital expense. The rest was spent mostly on skilled nursing facilities, home health care and hospice (23%) or physicians (13%) or medication, 6%. Overall, the largest portion, 31%, of per capita spending for all beneficiaries goes to inpatient hospital expenses. Overall, the aging baby boomer population is leading to a decrease in the growth of spending on patients' last years of life. More beneficiaries are younger and healthier, and they are living longer, so their last years of life are cheaper. Kaiser's analysis covered only traditional Medicare beneficiaries during the calendar year in which they died and did not include spending in the full 12 months before their deaths. The report also did not include spending on beneficiaries in Medicare Advantage because data was unavailable. '""47] End-of-Life Costs on the Rise Kaiser Health News reports that nearly one in three Medicare patients undergo an operation in the final year of life, even though evidence shows that many are more likely to be harmed than to benefit from it. [FN48] 4 2011 study, reported in The Lancet, researched THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -18- the deaths in 2008 of fee-for-service Medicare beneficiaries in their last year of life. It found that 31.9% of the beneficiaries had surgical procedures during the year before death and 18% underwent a procedure in their last month of life. The researchers examined the relation between receipt of an inpatient procedure and both age and geographical region. Dr. Rita Redberg, cardiologist at the University of California-San Francisco, believes that the practice is driven by financial incentives that reward doctors for doing procedures, as well as a medical culture in which patients and doctors are reluctant to talk about how surgical interventions should be prescribed more judiciously. Although about 25 percent of Medicare spending in the U.S. occurs in the last year of people's lives, a new study finds that there is very little spending on patients whose death within the year is highly likely. For example, the researchers discovered that less than 5 percent of Medicare spending is applied to the single highest-risk percentile of all individuals-and their predicted one-year mortality rate is just 46 percent. 'What we discovered is, very little money is spent on people who we know with high probability are going to die in a short amount of time," Co-author Amy Finkelstein says. In fact, fewer than 10 percent of people who die in a given year have a predicted one- year mortality rate over 50 percent. The researchers found that even when people are admitted to a hospital in what turns out to be their last year of life, fewer than 4 per cent of those patients have a predicted one-year mortality rate of 80 percent or higher at the time of admission. Medicare Sequestration Delayed President Biden signed legislation on April 14, 2021, extending the moratorium on Medicare sequestration, after the U.S. House of Representatives passed the Medicare Sequester Relief Act, which extended mandated 2% Medicare cuts to healthcare providers until the end of 2021. Sequestration was established in 2014 by the Budget Control Act. The practice reduced payments to hospice and other health care providers by 2% across the board. Under current law, hospice providers must return payments to CMS if the total paid exceeds the Medicare payment cap allowance. CMS includes the sequestered 2% as part of the total, even though hospices do not receive those funds. Last year, Congress temporarily suspended sequestration via the CARES Act, providing hospices with much-needed financial relief. Providers have contended with declines in hospice patient admissions and referrals amid the public health emergency, as well as increased paid leave and paid time off for staff and skyrocketing costs for personal protective equipment and supplies. [FN49] Concurrent Hospice and Curative Care Offers Cost Savings, Patient and Family Satisfaction A somewhat obscure payment model demonstration, the Medicare Care Choices Model (MCCM), has been been found to reduce costs, improve quality and family satisfaction, and keep patients in their homes, CMS has found. [FNS0] | aunched in 2016 to explore the idea of allowing hospice patients to receive concurrent curative care, it was initially slated to complete in 2020 but was extended until December 2021. CMS recently published its annual report for the program, which indicated that the model was achieving virtually every one of its goals. The report focuses on 4,574 Medicare beneficiaries who enrolled in the program between January 2016 and September 2020 and who died by March of 2021. The enrollees were Medicare fee-for-service beneficiaries with a six-month terminal prognosis, and diagnosed with cancer, congestive heart failure, chronic obstructive pulmonary disease, or HIV/AIDS, and made the choice to enroll in MCCM. CMS found that the total net cost of care for MCCM patients was 14% less than those for a control group, generating about $7,254 in savings per individual. This was largely due to reduced hospitalization and emergency department visits in comparison to the control group. Those who were hospitalized spent fewer days in intensive care units and had shorter stays; they also were more likely to eventually accept the Medicare Hospice Benefit. About 83% of enrollees transitioned out of MCCM and into traditional hospice, which accounted for nearly 70% of the savings, the agency reported. A previous CMS report released in November 2020 found that the demonstration had reduced the agency's costs by $26 million, at that time. The agency plans to publish a final report in 2023. Medicaid Funding For those individuals who are dually eligible for Medicare and Medicaid who elect the Medicare hospice benefit, Medicare is financially responsible for the hospice care and the Medicaid program is the third-party payor responsible for the nursing facility room and board expense. For the nursing facility room and board care, the Medicaid program must provide for payment in an amount equal to at least 95% of the Medicaid daily nursing facility rate (the rate the state Medicaid program pays for nursing facility services furnished to an individual who has not elected to receive hospice care). Historically, the Medicaid program has paid the hospice provider for the nursing facility room and board expenses of dually eligible individuals who elect the hospice benefit, and the hospice provider has then passed through this payment to the nursing facility. ACO REACH Program Effective January 1, 2023, CMS is replacing the Global and Professional Direct Contracting (GPDC) model with the Realizing Equity, Access and Community Health (ACO REACH) program. According to CMS, the new program reflects its redesigned strategy for payment system demonstrations, with advancing health equity as a key tenet. ACO REACH will retain some features of GPDC, including flexibility of payment arrangements between ACOs and downstream providers. Within the direct contracting program, providers bear 100% of the risk associated with eligible patients for the global option or 50% risk with the professional option. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -19- Differences exist between the two programs. ACO REACH will focus more on addressing health care disparities, and emphasize screening and monitoring of model participants, in order to foster transparency and prevent inappropriate coding and risk score growth. The program also institutes a health equity benchmark adjustment for payments to ACOs serving higher numbers of beneficiaries from underserved populations. CMS will identify these providers using statistical manuals such as Area Deprivation Index and Dual Medicaid Status. Other new features include expansion of the services that nurse practitioners can provide and additional rules to tighten oversight, governance, and compliance. The flexibility that providers have to develop customized payment contracts began in earnest with the direct contracting program. The flexibility can apply not only to hospice itself, but also to the upstream services that many of those providers offer, such as palliative care, PACE, and home health, among others. There are regulations for different types of contracts, such as for skilled nursing facilities. These contracts can involve full capitation with a per-patient, per month rate, or they can be fee-for-service. Other possibilities include hybrid models in which the hospice or other post-acute provider will receive a portion of their reimbursement on a fee-for-service basis, as well as additional payments later determined by performance on quality metrics. Those metrics could include reductions in hospitalizations, readmissions. and emergency department visits. [FNS1] End-of-Life Care of Dementia Patients under Medicare, Medicare Advantage, or Accountable Care Organizations Medicare Advantage (MA) and Accountable Care Organizations (ACOs) operate under incentives to reduce burdensome and costly care at the end of life. A study conducted by Oregon Health and Science University researchers compared end-of-life care for persons with dementia who are in MA, ACOs, or traditional Medicare (TM). They found that nursing home dementia patients enrolled in MA plans had less burdensome care at the end of their lives than residents with an ACO. The study was based on data from more than 370,000 dementia patients who had a nursing home stay between 91 and 180 days prior to their death. Published in the Journal of the American Geriatrics Society, [FN52] findings revealed that residents enrolled in ACOs or TM were more likely to be hospitalized in the last 30 days of their life when compared to MA enrollees. Data showed that 20.5% of MA residents ended up in the hospital during the final days, while 27.9% of TM enrollees and 28.1% using ACOs were hospitalized in their final days. The study also found that dementia patients using MA were less likely to die in the hospital than those in ACOs; they also had a lower likelihood of being put on a ventilator. In sum, among decedents with dementia, MA enrollees but not decedents in ACOs experienced less costly and potentially burdensome care compared with those with TM. Policy changes are needed for ACOs, the researchers concluded. Recent Legislative Activity Federal ¢ 2021 CONG US HR 6870 and 2021 CONG US §S 3707, introduced February 28, 2022, to allow disabled individuals with incurable terminal illnesses listed on the Compassionate Allowance list to receive disability insurance benefits without a waiting period. «2021 CONG US S 2566, introduced July 29, 2021, to require the Centers for Medicare and Medicaid Innovation to test allowing blood transfusions to be paid separately from the Medicare hospice all-inclusive per diem payment. California ¢ 2021 CAA.B. 2516 (NS), amended/substituted April 18, 2022, providing expanded coverage of human papillomavirus under Medi-Cal in Medicare-certified hospice services. ¢ 2021 CAS.B. 1191 (NS), amended/substituted April 19, 2022, providing coverage of pharmacogenomic testing under Medi-Cal in Medicare-certified hospice services. Delaware 2021 DE S.B. 37 (NS), adopted June 3, 2021, relating to viatical settlements. Louisiana 2022 LA H.B. 1012 (NS), adopted June 18, 2022, providing for non-emergency medical transportation services within the Medicaid program. Massachusetts * 2021 MA H.D. 3850 (NS), filed February 19, 2021, to institute a pilot program to provide a one-time loan, up to and not in excess of ten thousand dollars to thirty individuals in the Commonwealth to assist them in the payment of expenses directly resulting from expenditures incurred due to a child being diagnosed with a terminal illness. ¢ 2021 MA S.D. 918 (NS), introduced February 9, 2021, establishing a tax credit for individuals paying for home health care and hospice. Minnesota ¢ 2021 MN H.F. 4062 (NS), introduced March 7, 2022, and 2021 MN S.F. 3699 (NS), introduced March 3, 2022, establishing Hospice respite and end-of-life care medical assistance benefit for individuals under the age of 22. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -20- ¢ 2021 MN S.F. 129 (NS), introduced January 14, 2021, would modify prescribed pediatric extended care (PPEC) center licensing requirements; PPEC basic services as services covered by medical assistance and setting medical assistance reimbursement rates establishment. New Hampshire 2021 NH S.B. 149 (NS), amended/substituted June 3, 2021, regarding Medicaid spend-down requirements, automated pharmacy systems for long-term care, hospice, and other residential facilities, and blanket CMS waivers for health care during a declared emergency. New Jersey ¢ 2022 NJ A.B. 4781 (NS), introduced October 17, 2022, requiring health insurance coverage for certain obesity treatments and providing for the medical assistance program to be expanded to include authorized services in various medical classifications, including hospice services. ¢ 2022 NJ S.B. 2936 (NS), introduced June 27, 2022, provides Medicaid coverage for certain home visitation program services, including hospice, under certain circumstances. New Mexico 2022 NM S.B. 138 (NS), adopted March 8, 2022, providing that receipts of a hospice or nursing home from payments by the United States government, or any agency thereof, or from a Medicare administrative contractor for medical and other health and palliative services provided by the hospice or nursing home to Medicare beneficiaries pursuant to the provisions of Title 18 of the Social Security Act may be deducted from gross receipts. New York ¢ 2021 NY A.B. 1060 (NS), introduced January 7, 2021, authorizes the commissioner of health to adjust medical assistance rates of payment for certified home health agencies, managed long-term care plans, hospices, long-term home health care programs, licensed home care services agencies and other entities for recruitment, training and retention of direct care workers for services in shortage areas and by shortage disciplines. ¢ 2021 NY S.B. 3748 (NS), introduced January 30, 2021, authorizes the commissioner of health to adjust medical assistance rates of payment for certified home health agencies, managed long term care plans, hospices, long term home health care programs, licensed home care services agencies and other entities for recruitment, training and retention of direct care workers for services in shortage areas and by shortage disciplines. Rhode Island ¢ 2021 RI H.B. 7446 (NS), introduced February 11, 2022, providing for Medicaid home care, home nursing care and hospice base rate adjustments for services delivered by professionals and paraprofessionals to meet the increasing demand for services for medically- complex and rural patients and to meet the need to grow and sustain the workforce. This act would support the state's long-term care rebalancing goals by keeping high-acuity or high medical necessity patients out of skilled nursing facilities and hospitals and remain safe at home and in the community with highly trained and stable long-term services and support. ¢ 2021 RI S.B. 2306 (NS), introduced February 15, 2022, would provide for Medicaid home care, home nursing care and hospice base rate adjustments for services delivered by professionals and paraprofessionals to meet the increasing demand for services for medically-complex and rural patients and to meet the need to grow and sustain the workforce. Vermont 2021 VT H.B. 153 (NS), engrossed March 25, 2021, to establish an annual inflation factor to be applied to the Medicaid rates for providers of home- and community-based service providers. It would also direct the Department of Vermont Health Access and the Department of Disabilities, Aging, and Independent Living to study the Medicaid reimbursement rates paid to home- and community- based service providers (including hospice), their adequacy, and the methodologies underlying the rates. V. ADVANCE CARE DIRECTIVES Most hospitals, nursing homes, home health agencies, and HMOs routinely provide information on advance directives at the time of admission. They are required to do so under a federal law called the Patient Self-Directed Determination Act of 1990 (PDSA). The PSDA simply requires that most health care institutions (but not individual doctors) do the following: ¢ Give patients at the time of admission a written summary of your health care decision-making rights. Each state has developed such a summary for hospitals, nursing homes, and home health agencies to use. * Provide the facility's policies with respect to recognizing advance directives. * Ask patients if they have an advance directive, and document that fact in their medical records. It is up to the individual patient to make sure providers get a copy of it. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -24- ¢ Educate their staff and community about advance directives. ¢ Never discriminate against patients based on whether or not they have an advance directive. Thus, it is against the law for them to require either that you have or not have an advance directive. [FN53] Definitions and Issues The terms 'advance directive" and 'advance care directive" refer to two types of legal documents that enable individuals to plan and communicate their end-of-life wishes in the event that the individuals are unable to communicate their wishes themselves. These are a health care proxy (also known as a medical power of attorney or durable power of attorney for health care) and a living will. A health care proxy allows an individual to appoint another person as the individual's health care agent, thus authorizing the agent to make medical decisions on the individual's behalf in the event that the individual is incapacitated and unable to make his or her own medical decisions. A health care proxy is typically a family member who accepts legal responsibility or medical power of attorney to make decisions on behalf of the incapacitated patient. Healthcare proxies are designated through a legal document, signed, and authorized by a patient prior to becoming incapacitated. A living will allows an individual to document his or her wishes concerning medical treatment at the end of life. A living will is also a legal document, but rather than assigning an individual to make decisions on behalf of a patient, a living will enumerates a patient's health wishes in writing. Such specifications may include the types of treatment a patient might wish to receive, as well as the duration of treatment. A living will may also contain 'do not resuscitate" (DNR) orders, which detail the circumstances under which a patient would not want medical professionals to go to great lengths to try to save the patient's life. People who do not have living wills with DNR clauses may opt to sign a DNR form with physician oversight while being treated at a health facility. A designated health care proxy also may instruct medical staff not to revive a patient, but such instructions do not require a written designation from the patient. The highly publicized story of Terri Schiavo in 2005 resulted in heightened public awareness of the importance of advance care directives. In 1990, Ms. Schiavo suffered a neurological injury and fell into a vegetative state. Ms. Schiavo, who was only 26 at the time, had not designated a health care proxy, nor had she authored a living will. Following her brain injury, she was able to breathe without respiratory assistance, but was unable to eat or drink on her own and received nourishment through a feeding tube. After more than a decade without noticeable improvement, Ms. Schiavo's husband wanted to remove the feeding device and allow her to pass away, but her parents wanted her to be kept alive by any possible means. Because Ms. Schiavo had not specified any advance care directives, the decision to remove her feeding tube led to a court battle between her husband and her parents. The Florida Legislature granted then Gov. Jeb Bush (R) the power to require that Ms. Schiavo continue to receive nourishment. At the start of 2005, Terri Schiavo's husband was granted a court order to remove her feeding tube, but her parents sought and won a temporary stay. The U.S. Congress passed a bill in mid-March 2005 that sent this and any similar future cases to federal court. [FNS4] Ultimately, the U.S. Supreme Court ruled that Mr. Schiavo could authorize the removal of Ms. Schiavo's feeding tube. IFNS55] Mis. Schiavo died March 31, 2005. Had Ms. Schiavo signed advance care directives prior to her injury, the ensuing family, moral, and legal battles might not have been necessary. All 50 states recognize advance care directives. However, the laws governing advance care directives and the forms for creating them vary from state to state. Laws governing the procedures and approved forms for advance care directives are continually in flux. Less than half of all Physician's Orders for Life-Sustaining Treatment (POLSTs) were concordant with current preferences, researchers found in a recent study. [FN56] POLSTs are widely used to document the treatment preferences of nursing facility residents as orders, but it is unknown how well previously completed POLST orders reflect current preferences (concordance) and what factors are associated with concordance, the study stated. The objective of the research was to describe POLST preference concordance and identify factors associated with concordance. The study was led by Susan E. Hickman, Ph.D., an expert on the subject and director of the Indiana University Center for Aging Research at Regenstrief Institute. It was conducted in 29 nursing homes in Indiana. Concordance was determined by comparing existing POLST orders for resuscitation, medical interventions, and artificial nutrition with current treatment preferences. Comfort focused POLSTs contained orders for do-not-resuscitate, comfort measures, and no artificial nutrition. Researchers found that while less than half of POLST orders were concordant with current preferences, they were over five times as likely to be concordant when they reflected preferences for comfort focused care. In conclusion, the findings suggest a clear need to improve the quality of POLST use in nursing facilities and focus its use among residents with stable, comfort focused preferences, the study said. In a published report released in 2016, researchers found that making sure residents' care preferences are consistently recorded and updated in medical records is crucial to providing quality end-of-life care. The report states that advanced care planning is an important step for patients and families to take, especially at a time when nearly a quarter of hospitalized older adults are not able to make their own end-of-life decisions. The study was conducted by a team of researchers from the Regenstrief Institute, Indiana University Center for Aging Research and the Indiana University School of Nursing, and published online in the Journal of Pain and Symptom Management. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -29- Inconsistencies in the way care preferences are documented and carried out by nursing homes and hospitals may mean a patient's preferences are not honored. The team's report, set out to measure care consistency with documented care practices, and how healthcare providers can improve that consistency. The team of researchers recommends five best practices for providers to ensure consistency with their residents care preferences: * Documenting each resident's specific treatment preferences, such as 'do not place feeding tube" instead of 'comfort care," in the medical record ¢ Making sure treatment preferences are recorded in a consistent format and location in each medical record ¢ Reviewing and updating preferences regularly as residents' clinical conditions change ¢ Creating data collection strategies to document decisions to withhold medical interventions ¢ Implementing a consistent measurement approach, such as a required percentage for agreement with care preferences, that can be used to compare with other providers. [FNS7] Awareness of Existence of Advance Care Directives The creation of advance care registries can give caregivers and others the ability to verify that advanced care directives have been put into place. Measures addressing the establishment of such registries have been initiated. A recent study explored the knowledge dementia caregivers have about advance care planning (ACP), how they learn to execute formal advance directives and how they understand their roles as decision makers for the patients. Researcher Mariette L. Klein identifies factors that contribute to the completion of an ACP process such as demographic, psychosocial, and situational factors. She found that caregivers understand ACP as having the power to shape the dying process for dementia patients; that it is not just about executing formal written ADs but how caregivers exercise that power. For the caregivers, the process of ACP occurs along a trajectory from years before dementia, to dementia diagnosis, to end stage and death. At each of these stages, actions taken by the caregivers and their motivation are identified. Three key features of the ACP process in all three stages are examined: conversations within the family and with trusted others, gaining knowledge of ACP, and keeping ACP documents. How caregivers use ACP is based on how they define their roles as decision makers for their patients by: accepting responsibility for making difficult decisions regarding treatment for the patients, using ACP as an effective tool to shape the dying process for their patients, and doing battle with health care professionals to honor patients' wishes. Klein concludes that some successful interventions could be adapted specifically for dementia families: Comprehensive Home-Based Options for Informed Consent about End State Services (CHOICES) for medically-fragile, home-bound older adults who do not meet criteria for the Medicare hospice benefit, and Palliative Excellence in Alzheimer Care Efforts (PEACE), a disease management model for dementia patients that includes ACP, patient-centered care, caregiver support, and palliative care." [FNS8] Advance Care Planning Goals Carried Out Patients who inform their loved ones and health care providers of their end-of-life care wishes find that those goals are carried out 85% to 95% of the time, according to recent research published in the JAMA Network Open. IFN58] Studies show that advance care planning can reduce hospitalizations by as much as 26%, reduce health care costs, increase community-based palliative care and hospice utilization, as well as significantly increase the likelihood that care will be delivered in accordance with the patient's wishes. Researchers surveyed 715 family members of Kaiser Permanente Southern California decedents aged 65 or older. About 84% percent of the decedents included in the study had an advance directive in place. Respondents noted that high percentages of decedents received treatment that was in line with their desires: 89% had their wishes met, 6% received a treatment they did not want, and 82.5% believed the amount of care was the right amount. Through advance care planning, patients relay their wishes and goals for end-of-life care, and communicate the information to their clinicians as well as their families. Advance care plans also typically include the patient's designated surrogate who can make health care decisions in their stead should the patient become incapacitated. Medicare Reimbursement for Physician Counseling Reimbursement of providers for talking to Medicare patients and their families about 'advance care planning" is among the recommendations to be issued by the AMA's Relative Value Scale Update Committee (RUC) to the CMS. Every year, the AMA makes such recommendations to the CMS on a broad range of procedures and services. CMS uses these recommendations, along with input from others, to set reimbursement rates. Counseling on advance care planning includes information on living wills and end-of-life treatment options and harkens back to an earlier provision in the Affordable Care Act. That provision was removed after former Republic vice-presidential candidate Sarah Palin accused President Obama of proposing 'death panels" to determine who deserved life-sustaining medical care and the public outcry that ensued. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -23- However, in 2016, the first year that health care providers were allowed to bill for the consultations, nearly 575,000 Medicare beneficiaries took part in conversations to discuss advance-care planning, Kaiser Health News reports. [FN6O] Nearly 23,000 providers submitted about $93 million in charges, including more than $43 million covered by the federal program for seniors and the disabled. Use was much higher than expected, nearly double the 300,000 people the American Medical Association projected would receive the service in the first year. Still, only a fraction of eligible Medicare providers - and patients - have used the benefit, which pays about $86 for the first 30-minute office visit and about $75 for additional sessions. Geriatricians, oncologists and other medical specialists who see gravely ill patients, however, say it's crucial to elicit a patient's wishes for treatment and other pastoral or psychological supports in a dire medical situation. If Medicare reimburses doctors for such discussions, as it pays them for examining patients and performing procedures, they are much more likely to happen. Some private insurers already reimburse doctors who help patients with advance care planning. Under Medicaid, states largely determine what medical services are covered, and at least two states, Oregon and Colorado, provide reimbursement for advance care planning. Studies show that when given a choice, patients often forgo invasive procedures at the end of life. Such procedures can be costly while doing little to extend or improve the quality of the patient's life. But some people fear that end-of-life conversations could lead to rationing health care or withholding it entirely. Research Reveals What to Discuss Near End of Life A study has identified the top five things health care teams should discuss with hospitalized patients and their families at the end of life. The research found gaps, however, between what patients would like and the care they receive. The team, led by a McMaster University researcher, with backgrounds in general internal medicine, critical care medicine and palliative care, surveyed 233 hospitalized older adults with serious illnesses and 205 family members about the importance of the 11 guideline-recommended elements of end-of-life care. The patients had been admitted to nine hospitals in British Columbia, Alberta, Ontario, and Quebec. In the study published in the Canadian Medical Association Journal (CMAJ), seriously ill hospitalized patients and their families say the most important aspects to discuss are: «Preferences for care in the event of life-threatening illness «Patient values «Prognosis of illness *Fears or concerns *Additional questions regarding care. 'However, we found that these elements are infrequently discussed and that concordance between preferred and prescribed goals of care is low," the authors stated. Current guidelines list 11 key elements for health care providers to discuss regarding end-of-life care that are based mainly on expert opinion, and not on patient and family feedback. [FN61] Noncompliance with DNR The state of New York has faulted a Syracuse nursing home for performing cardiopulmonary resuscitation on a resident even though she had a do-not-resuscitate order on file. The DNR stated that she did not want to be resuscitated or intubated, wanted limited medical interventions, and wished to be sent to the hospital only if necessary. When she was found not breathing, unresponsive, and without a pulse, nurses took all those emergency actions before realizing that the resident's chart contained the DNR order. According to the state inspection report, the nurse who called for help after finding the woman unresponsive said she was never trained how to determine if a resident has a DNR order. The nursing home said it would educate nurses on how to determine if a resident has a DNR order or other advance directives. '"N62I Simon's Law In 2010, Simon Crosier was diagnosed at birth with 'Trisomy 18," also known as Edward's syndrome. The condition is considered a 'lethal" anomaly and 'incompatible with life." After that clinical diagnosis, Simon's care and treatment began to be withheld, but the extent of the hospital's denial of care would not be known to his parents until after he died. [FNE3] After Simon passed away, his parents found out that because of Simon's medical condition a do-not-resuscitate (DNR) order had been placed on his medical file, and that the medical staff had only been feeding him drops of sucrose. All of this without their knowledge. Legislative efforts designed to guarantee parents their inalienable right to participate in the healthcare decisions of their disabled or severely ill children are supported by a number of pediatric and bioethic groups, including the American College of Pediatricians. Once inconceivable, the practice of hospital staff placing a Do Not Resuscitate (DNR) order on a child's chart, without the informed consent of the child's parents or legal guardian, is on the rise. 'It is first and foremost a physician's job to offer medical facts together with hope, and over time, if hope for survival becomes unwarranted, then physicians should discuss and reach understandings with the family regarding prognosis and interventions. This is how the doctor-patient relationship should proceed in all pediatric cases; this is what Simon's Law will codify. All states are encouraged to adopt similar legislation." FN64] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -24- Dubbed 'Simon's Law," Kansas was the first to enact legislation in 2017, followed by Missouri in 2019, that prevents doctors from putting do-not-resuscitate orders in children's medical charts without parental notification. The law also requires hospitals to give parents and prospective patients access to its denial of care policies, sometimes referred to as futility policies. Arizona and New Mexico, are considering similar legislation. Videos and Interventions Help Boost Use of Advance Care Planning Older patients showed greater interest in recording their end-of-life care wishes when engaged in an advance care planning (ACP) intervention during the pandemic, a new study finds. Documentation among Black patients increased the most, researchers found. In a study of over 42,000 participants in a large New York healthcare system, about 15,000 were given the opportunity to watch a video about ACP decision aids and interact with clinicians trained in ACP communication skills. The study revealed large post-intervention increases in ACP documentation and a dramatic shift in rates among patient populations when broken down by race and ethnicity. During the COVID pandemic, from March to September, 2020, rates of ACP documentation dropped to about 13% and lower for all groups. But participation in ACP shot up when the intervention began in mid-December. Fully 30% of Black patients documented their end-of-life wishes, surpassing whites (22.2%) and Hispanics (21.2%). The results suggest that advanced care planning may be one way to address disparities in care, the investigators concluded. [FN65] Recent Legislative Activity Federal * 2021 CONG US HR 5656, introduced October 21, 2021, to require providers of services and health maintenance organizations under the Medicare and Medicaid programs to provide for certain policies to be in place relating to do-not-resuscitate orders or similar physician's orders for unemancipated minors receiving services. ¢ 2021 CONG US HR 7608, introduced April 27, 2022, authorizing the Secretary of Health and Human Services to award grants to States to develop, improve, or maintain a State registry of advance directives. ¢ 2021 CONG US HR 9260, introduced October 31, 2022, the 'Stop Online Suicide Assistance Forums Act" would prohibit the use of mail or interstate communications to assist suicide. * 2021 CONG US S 4873, introduced September 15, 2022, 'Improving Access to Advance Care Planning Act," would waive cost- sharing for advance care planning services, promote increased education for providers on current advance care planning codes, and improve reporting on barriers to providing advance care planning services. Companion legislation was introduced in the U.S. House of Representatives by Congressman Earl Blumenauer (D-OR). [FN66] Specifically, the legislation would codify Medicare coverage of advance care planning services; expand eligible providers that can bill for such services to include clinical social workers with experience in care planning; remove beneficiary coinsurance and deductibles for advance care planning visits-including those that happen outside of an annual Medicare Annual Wellness Visit-to ensure that beneficiaries are not deterred from seeking these services, and providers are not deterred from offering them; require two reports: one that directs CMS to educate providers on the advance care planning codes and report to Congress on such activities, and one that directs MedPAC to study and report to Congress on (A) barriers to providing and receiving advance care planning services despite the ability to bill for them, and (B) barriers to billing the code itself. Alabama 2022 AL H.B. 191 (NS), introduced February 1, 2022, Natural Death Act, remove notarization requirement for certification of surrogate to make end of life health care decisions. Alaska ¢ 2021 AK H.B. 139 (NS), introduced March 17, 2021, relating to guardians, guardianships, successor guardians, incapacitated guardians, incapacitated individuals, and testamentary appointments of guardians; and relating to withholding or withdrawing life- sustaining procedures. * 2022 AK H.B. 155 (NS), approved June 29, 2022, relating to court-appointed visitors and experts to assist the court in investigating the issue of whether the patient has the capacity to give or withhold informed consent to the administration of psychotropic medication or any expressed wishes of the patient regarding medication, including wishes that may have been expressed in a power of attorney, a living will, or an advance health care directive. ¢ 2022 AK H.B. 362 (NS), adopted August 10, 2022, advanced practice registered nurses and physician assistants, relating to death certificates, do not resuscitate orders, and life sustaining treatment. California * 2021 CAA.B. 1234 (NS), amended/substituted April 8, 2021, would allow an electronic signature to be used for the purposes of advance health care directives and Physician Orders for Life Sustaining Treatment forms. The bill would enact the California POLST eRegistry Act, which would require the California Health and Human Services Agency to create a statewide electronic POLST registry system for the purpose of collecting a patient's POLST information received from a health care provider or the provider's designee and THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -25- disseminating the information therein to an authorized user, as defined; would require the agency to promulgate regulations necessary for the operation of the POLST eRegistry and set timelines for implementation; would allow an electronic representation of a POLST form and the electronic communication of the information contained in a POLST form to have the same legal standing as a paper hardcopy of a POLST form. ¢ 2021 CAA.B. 2338 (NS), adopted September 29, 2022, would authorize a patient to designate an adult as a surrogate to make health care decisions by also personally informing a designee of the health care facility caring for the patient; would authorize legally recognized health care decisionmakers, in an order of priority, to make health care decisions on a patient's behalf if the patient lacks the capacity to make a health care decision. If a patient does not have a legally recognized health care decisionmaker, the bill would specify individuals who may be chosen by a health care provider or a designee of the health care facility caring for the patient as a surrogate if the patient lacks the capacity to make a health care decision. The bill would require the patient's surrogate to be an adult who has demonstrated special care and concern for the patient, is familiar with the patient's personal values and beliefs to the extent known, and is reasonably available and willing to serve. * 2021 CA S.B. 1024 (NS), adopted September 27, 2022, would authorize specified parties to petition for the appointment of a professional fiduciary practice administrator, as defined, to act as a temporary professional fiduciary when a professional fiduciary (including an agent under a durable power of attorney for health care) either becomes incapacitated or dies and a vacancy exists. District of Columbia 2021 DC L.B. 121 (NS), adopted November 21, 2022, to enact the Uniform Power of Attorney Act, to repeal the Uniform Durable Power of Attorney Act and the Uniform Statutory Form Power of Attorney Act; to provide clear statutory guidance to individuals creating powers of attorney and to agents acting under powers of attorney; to clarify the fiduciary duties of agent to their principals; to protect individuals creating powers of attorney against fraud or other abuse by agents; to protect third parties who deal with agents exercising powers of attorney; and to provide a statutory power of attorney form that is easy to use, comprehensive, and legally effective. Illinois ¢ 2021 IL H.B. 704 (NS), adopted July 30, 2021, amended the Health Care Surrogate Act, removing the requirement that the attending physician or qualified physician be licensed specifically in Illinois. ¢ 2021 IL H.B. 4216 (NS), introduced January 5, 2022, providing that facilities licensed under the Nursing Home Care Act must offer to provide residents with the Department of Public Health Uniform POLST (Practitioner Orders for Life-Sustaining Treatment) form to existing and new residents. ¢ 2021 IL H.B. 5048 (NS), engrossed February 24, 2022, provides that facilities licensed under the Nursing Home Care Act must offer to provide POLST-appropriate residents or their representatives an opportunity to execute the Department of Public Health Uniform POLST form within specified time periods. ¢ 2021 IL S.B. 109 (NS), adopted July 23, 2021, amends the Health Care Surrogate Act; changes certain uses of the term 'qualified physician' to 'qualified health care practitioner'; provides that execution of a POLST form shall not be a requirement for admission to any facility or a precondition to the provision of services by any provider of health care services; provides that an individual may revoke a document directing that resuscitating efforts shall not be implemented. In a Section regarding Department of Public Health Uniform POLST forms, changes the definition of 'attending health care practitioner'; provides that a health care provider facility shall comply with a POLST form, National POLST form, another state's POLST Paradigm portable medical orders form, or an out-of-hospital Do Not Resuscitate (DNR) order sanctioned by a State in the United States that: has been executed by an adult; and is apparent and immediately available. Provides that before voiding or revoking a uniform practitioner orders for life-sustaining treatment (POLST) form, National POLST form, or another state's POLST Paradigm portable medical orders form consented to by the individual, that individual's legally authorized surrogate decision maker shall first: engage in consultation with the attending health care practitioner; consult the patient's advance directive, if available; and make a good faith effort to act consistently, at all times, with the patient's known wishes, or, if the patient's wishes are not known, using substituted judgment as the standard. Provides that when an individual's legally authorized surrogate is making a good faith effort to act consistently with the patient's known wishes to void or revoke a POLST form, if the patient's wishes are unknown and remain unknown after reasonable efforts to discern them, the decision shall be made on the basis of the patient's best interests as determined by the surrogate decision maker. Indiana 2022 IN H.B. 1208 (NS), adopted March 18, 2022, in the law on health care advance directives, changes the word 'testator' to 'declarant'; amends several provisions relating to the filing of notices to make those provisions consistent with Rules of Trial Procedure concerning electronic filing; provides that a video or audio recording of a principal who executes a power of attorney may be admissible as evidence of matters relevant to the validity or enforceability of the power of attorney. Kansas 2021 KS H.B. 2650 (NS), introduced February 8, 2022, allowing advanced practice registered nurses to sign do not resuscitate orders. Kentucky THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -26- 2022 KY S.B. 173 (NS), adopted April 8, 2022, to require an electronically-fillable version of the MOST (Medical Orders for Scope of Treatment) form to be accessed online; allow for an electronic signature; require a Spanish translation of the MOST form; allow the MOST form to be printed on any color of paper. Maine 2021 ME H.P. 822 (NS), introduced March 18, 2021, amending the law regarding advance health care directives. Maryland 2022 MD H.B. 1073 (NS), adopted May 12, 2022, requiring the Maryland Health Care Commission to coordinate the accessibility of electronic advance care planning documents in the State. Massachusetts ¢ 2021 MA H.D. 2921 (NS), filed March 1, 2021, establishing a Durable Power of Attorney Review Commission. * 2021 MA H.D. 3050 (NS), filed February 18, 2021, relative to do-not-resuscitate orders. ¢ 2021 MA H.D. 3518 (NS), filed February 19, 2021, 2021 MA H.D. 2562 (NS), filed February 18, 2021, and 2021 MAS.D. 1241 (NS), filed February 12, 2021, improving medical decision making; while all persons have a right to make a written directive, not all take advantage of that right, and it is the purpose of the surrogacy provisions of this chapter to ensure that health care decisions can be made in a timely manner by a person's next of kin, friend or other qualified individual without involving court action. This chapter specifies a process to establish a surrogate decision-maker when there is no valid advance directive or a guardian to make health care decisions. Michigan ¢ 2021 MI S.B. 1148 (NS), introduced September 7, 2022, to make uniform the law relating to the designation of agents to act for principals under powers of attorney; to provide for the powers of designated agents; to provide for an optional form for powers of attorney; and to provide remedies. ¢ 2021 MI S.B. 1149 (NS), introduced September 7, 2022, to revise provisions regarding advance health care directives to reflect adoption of the Uniform Power of Attorney Act. Minnesota ¢ 2021 MN H.F. 1087 (NS), introduced February 15, 2021, modification of hospice and assisted living bill of rights. ¢ 2021 MN H.F. 4665 (NS) and 2021 MN S.F. 4333 (NS), introduced March 28, 2022, establishment of procedures to be followed if a physician refuses to comply with a patient's health care directive. Missouri 2022 MO H.B. 2741 (NS), introduced February 22, 2022, modifying provisions related to outside the hospital do-not-resuscitate orders. New Hampshire 2021 NH S.B. 74 (NS), amended/substituted June 3, 2021, relative to advance directives for health care decisions. New Jersey ¢ 2022 NJ A.B. 2796 (NS), introduced February 28, 2022, requiring hospitals to provide resources to certain patients and to ask them if they have completed an advance directive or practitioner orders for life-sustaining treatment form. ¢ 2022 NJ A.B. 2837 (NS), introduced February 28, 2022, requiring long-term care facilities to annually review residents' proxy directives. ¢ 2022 NJ S.B. 1036 (NS), introduced January 31, 2022, requiring hospitals to provide certain resources to certain patients and to ask patients if patients have completed advance directive or practitioner orders for life-sustaining treatment form. New York ¢ 2021 NY A.B. 175 (NS), introduced January 6, 2021, relating to health care agents and proxies, decisions under the family health care decisions act and non-hospital orders not to resuscitate. ¢ 2021 NY A.B. 204 (NS), introduced January 6, 2021, restoring medical futility as a basis for a do not resuscitate order. ¢ 2021 NY A.B. 8880 (NS), adopted July 21, 2022, establishing a statewide advanced care planning campaign to promote public awareness of hospice and palliative care services. * 2021 NY S.B. 4685 (NS), introduced February 8, 2021, relates to restoring medical futility as a basis for DNR. ¢ 2021 NY S.B. 5327 (NS), introduced March 2, 2021, relating to health care agents and proxies, decisions under the family health care decisions act and non-hospital orders not to resuscitate. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -27- ¢ 2021 NY S.B. 6782 (NS), introduced May 17, 2021, establishing a frontline healthcare workers tax credit for clinical and non-clinical frontline healthcare workers and certain long-term care facility workers, including hospice care, during the novel coronavirus, COVID-19 pandemic. ¢ 2021 NY S.B. 8205 (NS), introduced February 2, 2022, establishing a statewide advanced care planning campaign to promote public awareness of hospice and palliative care services. North Carolina 2021 NC S.B. 666 (NS), amended/substituted April 27, 2021, updating requirements for health care powers of attorney and advance health care directives; and authorizing the secretary of state to receive electronic filings of advance health care directives. Ohio ¢ 2021 OH H.B. 339 (NS), introduced June 7, 2021, providing for electronic execution of wills, declarations or living wills, durable powers of attorney for health care, and transfer on death designation affidavits. ¢ 2021 OH S.B. 230 (NS), introduced September 15, 2021, to expand the laws on wills, declarations, or living wills, durable powers of attorney for health care, and transfer on death designation affidavits by providing for their execution electronically. Oklahoma ¢ 2021 OK H.B. 3343 (NS), introduced February 7, 2022, relating to power of attorney; enacting the Medical Uniform Durable Power of Attorney Act of 2022; providing applicability to all powers of attorney conceming health and medical care decisions executed in conformity with the requirements of this act; providing that all powers of attorney concerning health and medical care decisions validly executed prior to the effective date are valid and enforceable according to the statutory provisions in effect at the time of execution. ¢ 2021 OK H.B. 3815 (NS), engrossed March 21, 2022, creating the Health Care Agent Act, relating to health care power of attorney, authorizing execution of power of attorney for health care; establishing requirements for execution of power of attorney for health care; specifying when power of attorney for health care is effective; establishing requirements for revocation of power of attorney for health care. ¢ 2021 OK S.B. 1596 (NS), adopted April 29, 2022, creating the Oklahoma Health Care Agent Act; authorizing and establishing requirements for the execution of power of attorney for health care; when power of attorney for health care is effective; establishing requirements for revocation; creating optional form for execution of; requiring compliance and certain communication by health care provider; requiring record of certain information; exceptions; requiring notice of noncompliance; authorizing access to certain information; establishing immunity from liability for certain actions; providing for judicial relief; requiring retroactive application of provisions to certain documenis. Pennsylvania 2021 PA H.B. 2394 (NS), introduced March 9, 2022, in living wills, further providing for emergency medical services; in out-of-hospital nonresuscitation, further providing for definitions, for orders, bracelets and necklaces. South Carolina 2021 SC S.B. 508 (NS), adopted March 14, 2022, to allow a parent or legal guardian of a medically eligible child to request and revoke a do not resuscitate order for emergency services for the child. Vermont 2021 VT S.B. 117 (NS), adopted March 29, 2021, allows remote witnesses for advance directives through June 30, 2022. Virginia 2022 VA H.B. 286 (NS), adopted April 7, 2022, authorizes autonomous nurse practitioners, defined in the bill, to declare death and determine cause of death; allows nurse practitioners who are not autonomous nurse practitioners to pronounce the death of a patient in certain circumstances; and eliminates the requirement for a valid Do Not Resuscitate Order for the deceased patient for declaration of death by a registered nurse, physician assistant, or nurse practitioner who is not an autonomous nurse practitioner. West Virginia ¢ 2022 WV S.B. 470 (NS), adopted March 23, 2022, relating to health care decisions; defining terms; renaming the physician orders for scope of treatment as portable orders for scope of treatment and indicating that advanced practice registered nurses and physician assistants may complete them within their scope of practice; revising forms of a living will, medical power of attorney, and combined medical power of attorney and living will; providing clarifying language regarding the effect of signing a living will on the availability of medically-administered food and fluids; requiring oral food and fluids be provided as desired and tolerated; providing reciprocity for portable orders for scope of treatment or similar medical orders validly executed in another state. ¢ 2021 WV S.B. 551 (NS), introduced March 3, 2021, revising forms of living will, medical power of attorney, and combined medical power of attorney and living will. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -28- Vi. PALLIATIVE CARE Palliative care is specialized medical care for people living with a serious illness, such as cancer or heart failure. Patients in palliative care may receive medical care for their symptoms, or palliative care, along with treatment intended to cure their serious illness. Palliative care is meant to enhance a person's current care by focusing on quality of life for them and their family. [FN67] According to a recent report by the nonprofit economic research group Florida TaxWatch, palliative care could reduce health care costs by $103 billion within the next 20 years. [FNE8] The group recommended that policymakers take action to expand palliative care utilization in the state. In general, palliative care can reduce health care costs by more than $4,000 per patient, a July 2017 study in Health Affairs FFNEST found. It can also reduce the frequency of 911 calls, emergency department visits, and unnecessary hospitalizations. Many hospice providers offer palliative care in addition to their other services. Payors often treat it as a precursor to hospice, allowing patients to receive similar services until they become eligible for the hospice benefit. Hospice and related palliative care is covered by Medicare Part A (Hospital Insurance) if your physician certifies that you are terminally ill with a life expectancy of 6 months or less; you want palliative care for comfort rather than treating your illness; and you sign a statement declaring that you choose hospice care rather than other benefits covered by Medicare which may treat your terminal illness. However, if you are not in hospice, Medicare Part B (Medical Insurance) may help cover the costs of palliative care, including medically necessary services and supplies, mental health care, and durable medical equipment. If you have Medicare coverage through a Medicare Advantage plan, you will have at least the same benefits as Original Medicare, although many Medicare Advantage plans include additional coverage. IFN70] End-of-Life Care Guidelines The American College of Physicians (ACP) released updated guidelines addressing the three most common end-of-life (EOL) symptoms: pain, difficulty breathing, and depression. [FN71] According to Drug Week, the ACP recommended that 1) clinicians should regularly assess people with serious illness at the end of life for these symptoms; 2) clinicians should use proven therapies to treat these conditions; and 3) clinicians should ensure that advanced care planning occurs for all patients with serious illness. Drug treatment recommendations for relieving symptoms were also included in the newly released directives. As reported by Drug Week, '[alll of the ACP recommendations on EOL care are considered strong recommendations, meaning that benefits clearly outweigh the risks." The National Consensus Project for Quality Palliative Care has released The Clinical Practice Guidelines for Quality Palliative Care, 4th edition, which seeks 'to improve access to quality palliative care for all people with serious illness regardless of setting, diagnosis, prognosis, or age." [FN72] The NCP Guidelines are intended to encourage and guide health care organizations and clinicians, including non-palliative care specialists, across the care continuum to integrate palliative care principles and best practices into their routine assessment and care of all seriously ill patients. Importantly, the NCP Guidelines formalize and delineate available evidence-based processes and practices as well as consensus recommendations for the provision of safe and reliable high-quality palliative care for adults, children, and families with serious illness in all care settings. Specifically, the purpose of the 4th edition is to promote access to quality palliative care, foster consistent standards and criteria, and encourage continuity of palliative care across settings. Because there is shared responsibility for delivery and quality of palliative care across health care settings and over time, the emphasis is on collaborative partnerships within and between all care providers to ensure access, quality, and continuity of palliative care. This revision addresses best practices for both palliative care specialists, as well as all clinicians who care for people with serious illness, according to the Foreword. The expectation is that other clinicians caring for seriously ill patients will integrate palliative care competencies (such as safe and effective pain and symptom management, and expert communication skills) in their practice and palliative care specialists will provide expertise for those with the most complex needs. The 4th edition, therefore, is intended for specialty hospice and palliative care practitioners and teams, as well as health systems, primary care and specialist physician practices, cancer centers, dialysis units, long-term care facilities, assisted living facilities, Veterans Health Administration providers, home health and hospice agencies, prisons, and other care providers. The Guidelines are also applicable to social service agencies, homeless shelters, and any other community organizations serving seriously ill individuals. The guidelines also seek to improve continuity and coordination of care and, as a consequence, reduce expenses related to duplicative or non-beneficial interventions or waste. While hospital-based palliative care and hospice are widely available in the United States, access to palliative care in other settings is often unavailable. Reliable access to palliative care in community-based settings is essential to the delivery of expert care and symptom management, as well as psychological, practical, and social support, helping patients and families remain safely in their care setting of choice, according to the guidelines. The guidelines were developed by the National Consensus Project for Quality Palliative Care, comprised of 16 national organizations with extensive expertise in palliative care and hospice. Defining 'Palliative Care" THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -29- Efforts to build care and payment models are hitting a wall due to the lack of a standardized definition of palliative care services, an article in Hospice News reports. [FN73] Interest in palliative care has been growing among hospices and other health care providers, payers, and policymakers, due to the substantial savings that can be realized in overall health care costs. Studies have found that direct hospital costs can be cut by $3,000 to $4,800 per patient IFN74] and that home-based palliative care could reduce societal health care costs by $103 billion within the next 20 years. IFN75] Patients and families who are facing serious illness need palliative care, and providers need sustainable payment and clinical models. The lack of a definition can have serious business implications for hospices, who are increasingly diversifying their services to include palliative care but struggle to make their programs profitable or even sustainable. Patients and families not yet facing end-of-life may be put off from choosing palliative care due to misplaced fears that they would have to end curative treatment. A number of definitions have been adopted by various organizations. Some consider palliative care to be transitional care that takes place when curative treatment is no longer effective, but the patient has not reached the point where they are are hospice eligible. Others recognize that patients can benefit from this care at any point in the course of their illness without interrupting other treatments, particularly when it comes to serious or chronic illness. COVID-19 Patients In the midst of the COVID-19 pandemic, palliative care is a pressing need for patients for whom mechanical ventilation is not suitable. Emergency-style palliative care is necessary to meet the needs of patients who won't benefit from a ventilator, say researchers in Switzerland. "76 The investigators based their recommendations on the experience of those caring for severely ill patients in a Swiss hospital bordering Italy, where treatment depends on workers inexperienced in palliative care, and resources scarce. Hence, palliative care assessment and treatment plans need to be clear and simple to implement, and decision-making done rapidly as patients deteriorate quickly. Most patients with COVID-19 need some palliative care due to the large symptom burden and the need for clear and open communication with patients and their families, wrote Professor Nancy Preston, one of the researchers. A conservative approach to treatment is ideal, one that provides maximum support for physical, emotional, and spiritual needs. The authors recommend an initial assessment to identify patients who are stable, unstable, or at the end of life using the early warning parameters for COVID-19. Palliative care management is then formulated with the help of an assessment tool focusing on key symptoms, assessing dyspnoea, distress, and discomfort. The researchers concluded that during the COVID-19 pandemic palliative care needs to adapt to an emergency style of care as patients can deteriorate rapidly and require quick decisions and clear treatment plans. These need to be easily followed up by generalist staff members caring for these patients. Furthermore, palliative care should be at the forefront to help make the best decisions, give care to families, and offer spiritual support. Senate Takes Up Hospice, Palliative Care Staffing Bill Designed to bolster the shrinking workforce in the fields of hospice and palliative care with federal support, Senators Tammy Baldwin (D-Wis.) and Shelley Moore Capito (R-W.Va.) have reintroduced the Palliative Care and Hospice Education Training Act (PCHETA). [FN77] 1 enacted, PCHETA would support hospice and palliative care training programs for physicians, nurses, pharmacists, social workers, and chaplains. The bill would also expand continuing education and career development programs and incentives in these fields. The legislation would establish fellowships through new palliative care and hospice education centers to provide short-term, intensive training, as well as incentivized award programs across all the relevant disciplines. It includes provisions for additional training for medical school faculty and other health care educators as well as provider resources for workforce development, and nurse retention projects. Eight other senators have signed on to co-sponsor the bill, which has received endorsements from over 50 industry organizations. Senators Support Palliative Care Access On June 16, 2022, Senators Rosen (D-NV), Barrasso (R-WY), Fischer (R-NE), and six other senators sent a letter to CMS requesting that the Innovation Center support access to palliative care wherever the patient is located, 'be it at home, at a caregiver's home, in the hospital, in a nursing or assisted living facility, or through telemedicine." [FN78] The senators note that, to be most effective, palliative care should be provided as close to time of diagnosis as possible, underscoring the importance of concurrent treatment models. Under the current Medicare benefit, however, those with serious illness can only receive Medicare reimbursement for palliative care when nearing the end of life, through hospice, and not concurrently with curative treatment. While the senators support the current model as one option, they recognize the difference and the need for older adults with serious illness or injury to have integrated palliative care, while still receiving curative treatment and health maintenance care. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -30- Although demand for such services has risen over the last two years of the COVID-19 pandemic, the senators observe, palliative services in both skilled nursing facilities and assisted living residences remains 'woefully' under-utilized. They cite samples from medical records revealing that while 69% of nursing home patients and residents are in need of palliative care, and a recent study found that only 4% had received a related consult prior to death. They urge the Innovation Center to expand the palliative care model through a demonstration project that would access the need for concurrent care, which would both improve the patient experience and reduce costs. Accreditation Program The Accreditation Commission for Health Care (ACHC) has launched a palliative care accreditation program for community-based providers that offer 'a robust palliative care program." The program's accreditation standards are based on the National Consensus Project Clinical Practice Guidelines for Quality Palliative Care. According to the Center to Advance Palliative Care, about 50% of community-based palliative care providers in the United States are hospices. Hospice providers nationwide have been working to diversify their service lines to extend beyond the expected last six months of life, with palliative care as the most common new offering. Community-based providers that offer palliative care in the home are eligible to receive accreditation, according to ACHC. The program has a three-year accreditation cycle, and surveys last one day. Virtual surveys are now an option due to the COVID-19 pandemic. [FN79] Music Therapy The benefits of music therapy in palliative care have become increasingly recognized by health care professionals in North America, since end-of-life treatment is designed to meet the psychosocial, physical, and spiritual needs of patients. A music therapy professor in the Concordia University Department of Creative Arts Therapies, Sandi Curtis, has published a new study on the topic in the journal Music and Medicine. Her findings are based on a collaboration of music therapy students, professional symphony orchestra musicians and a hospital palliative care ward. 'Our study showed how music therapy was effective in enhancing pain relief, comfort, relaxation, mood, confidence, resilience, life quality and well-being in patients," she said. Curtis, who is vice-president elect of the American Music Therapy Association, divided undergraduates and musicians into pairs supervised by an accredited music therapist. The 371 participants were male and female palliative care patients between 18 and 101 years old, all patients who had a terminal illness and most with a diagnosis of cancer. Participants were seen for a single music therapy session, lasting from 15 to 60 minutes, designed to address four areas: pain relief, relaxation, mood, and quality of life. [FN60] Further, a recent study found that 'an evidence-based protocol known as individualized music (IM) offers a non-pharmacological intervention to reduce agitation." This project, using a one-group pre-test/post-test design, was implemented by training a self-selected sample of 24 hospice professionals to use the IM protocol with dementia patients. The effectiveness of the training on increasing the participants' knowledge of and confidence in using IM was explored. Paired t-tests were employed to analyze the data and the results of the analysis were encouraging, suggesting that it is feasible to educate multidisciplinary hospice staff in implementing the IM protocol," wrote M. Gallagher and colleagues. The researchers concluded that there is potential for using IM in the palliative treatment of persons with advanced dementia. The study was published in International Journal of Palliative Nursing. [FN81] Online Calculator Predicts Older Adults' Life Expectancy and Palliative Care Needs Researchers in Canada have developed a new online tool to help frail older adults and their clinicians calculate six-month life expectancy, in order to plan palliative care. The Risk Evaluation for Support: Predictions for Elder-life in the Community Tool (or RESPECT), was developed to understand the changing care needs of older adults as they age. [FN82] The researchers studied 491 ,000 home care recipients in Ontario having similar characteristics. Users were guided through the tool's short questionnaire about their health and the ability for self-care. Using the responses, the RESPECT's algorithm provided an estimate of survival based on data gathered from the administrative data. Although most people die of causes that are progressive with a predictable course, the researchers found that the best predictors of impending palliative care needs are declines in a person's ability to carry out activities of daily living. The need for help with hygiene, using the toilet and locomotion, were stronger predictors of six-month mortality than disease, reported researcher Amy Hsu, M.D. The researchers concluded that the RESPECT model 'showed good performance" and provides useful survival information to help inform when palliative care should be started. According to the researchers, the model 'could be readily implemented at the health system level as a care planning tool and at the patient level as a risk communication aid. The tool ... can be easily self-reported by patients or their caregivers to support their decision-making and, potentially, allows them to advocate for their care needs to achieve the appropriate balance of life-prolonging and comfort care." Recent Legislative Activity Federal * 2021 CONG US §S 2565, introduced July 29, 2021, to provide for the testing of a community-based palliative care model. * 2021 CONG US S 4862, introduced September 15, 2022, would establish the Commission on Long-Term Care to submit policy recommendations with respect to access to palliative care as needed, including both concurrently with curative treatment for serious illness or injury and as hospice end-of-life care, among other issues. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -31- California ¢ 2021 CA S.B. 311 (NS), adopted September 28, 2021, the Compassionate Access to Medical Cannabis Act or Ryan's Law, requires specified types of health care facilities to allow a terminally ill patient's use of medicinal cannabis within the health care facility, subject to certain restrictions; requires a patient to provide the health care facility with a copy of their medical marijuana card or written documentation that the use of medicinal cannabis is recommended by a physician; requires a health care facility to reasonably restrict the manner in which a patient stores and uses medicinal cannabis to ensure the safety of other patients, guests, and employees of the health care facility, compliance with other state laws, and the safe operations of the health care facility; provides that compliance with the bill would not be a condition for obtaining, retaining, or renewing a license as a health care facility; requires that health care facilities permitting patient use of medical cannabis comply with other drug and medication requirements, as specified, and would make those facilities subject to enforcement actions by the State Department of Public Health; and authorizes a health care facility to suspend compliance with these provisions if a regulatory agency, the United States Department of Justice, or the federal Centers for Medicare and Medicaid Services takes specified actions, including initiating an enforcement action against a health care facility related to the facility's compliance with a state-regulated medical marijuana program. ¢ 2021 CA S.B. 353 (NS), adopted October 4, 2021, extending to January 1, 2027, the requirement of hospices to provide interdisciplinary health care, including palliative care, to individuals experiencing the last phases of life due to the existence of a terminal disease and supportive care to the primary caregiver and family of the hospice patient. «2021 CA S.B. 988 (NS), adopted September 2, 2022, requires specified types of health care facilities to allow a terminally ill patient's use of medicinal cannabis within the health care facility, subject to certain restrictions. Illinois ¢ 2021 IL H.B. 4288 (NS), introduced January 5, 2022, amending the Nursing Home Care Act, to provide that a resident who is an end- of-life hospice patient, and who does not receive palliative care, has the right to a private room in the resident's facility, regardless of the resident's method of payment for residency at the facility; provides that the resident's facility shall ensure that the resident's family members have full access to visit the resident at the facility. ¢ 2021 IL S.B. 3819 (NS), adopted May 13, 2022, provides that a group or individual policy of accident and health insurance or a managed care plan amended, delivered, issued, or renewed on or after the effective date of the Act shall provide coverage for community-based pediatric palliative or hospice care; provides that the care shall be delivered to any qualifying child by a trained interdisciplinary team in accordance with all the terms of the Pediatric Palliative Care Act, which allows a child to receive community- based pediatric palliative and hospice care while continuing to pursue curative treatment and disease-directed therapies for the qualifying illness. lowa 2021 IA H.F. 2444 (NS), introduced February 16, 2022, relating to the definition and provision of palliative care. Louisiana 2022 LA S.B. 22 (NS), adopted June 18, 2022, extends the termination date of the Palliative Care Interdisciplinary Advisory Council for three years. Maine 2021 ME H.P. 793 (NS), adopted July 9, 2021, to advance palliative care utilization in the state. Maryland 2022 MD H.B. 378 (NS), adopted May 12, 2022, requiring the Maryland Health Care Commission to convene a workgroup to study palliative care services and make recommendations to improve palliative care services. Massachusetts 2021 MA H.D. 2044 (NS), filed February 16, 2021, and 2021 MA S.D. 2284 (NS), filed February 19, 2021, regarding the pediatric palliative care program. Minnesota ¢ 2021 MN H.F. 2517 (NS), introduced April 13, 2021, and 2021 MN S.F. 2400 (NS), introduced April 12, 2021, Palliative Care Advisory Council funding provided, and money appropriated. ¢ 2021 MN S.F. 2786 (NS), engrossed March 23, 2022, provisions and appropriation for bonuses of medical assistance provider employees, including hospice providers. ¢ 2021 MN S.F. 2912 (NS), introduced February 7, 2022, modifying the definition of palliative care. Mississippi THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -32- 2022 MS H.B. 1298 (NS), introduced January 17, 2022, to provide hospice services to individuals who are not terminally ill but who can benefit from palliative care and supportive care services, if such expansion of the minimum qualifications of individuals who are eligible to receive hospice services is approved by CMS. New Jersey ¢ 2022 NJ A.B. 3210 (NS), introduced March 7, 2022, establishing the Working Group on End-of-Life Care and Palliative Care in the Department of Health. * 2022 NJ A.C.R. 111 (NS), introduced February 28, 2022, urging Congress to pass the 'Palliative Care and Hospice Education and Training Act" and fund initiatives to expand palliative care. ¢ 2022 NJ S.B. 1012 (NS), introduced January 31, 2022, establishing the Working Group on End-of-Life Care and Palliative Care in the Department of Health. ¢ 2022 NJ S.C.R. 46 (NS), introduced January 31, 2022, urges Congress to pass 'Palliative Care and Hospice Education and Training Act' and fund initiatives to expand palliative care. New Mexico 2022 NM S.B. 138 (NS), adopted March 8, 2022, providing that receipts of a hospice or nursing home from payments by the United States government, or any agency thereof, or from a Medicare administrative contractor for medical and other health and palliative services provided by the hospice or nursing home to Medicare beneficiaries pursuant to the provisions of Title 18 of the Social Security Act may be deducted from gross receipts. New York ¢ 2021 NY A.B. 8569 (NS), amended/substituted April 29, 2022, relating to the medical use of psilocybin for palliative care, and for mental health conditions including end-of-life psychological distress. ¢ 2021 NY A.B. 8881 (NS), introduced January 19, 2022, establishing the office of hospice and palliative care access and quality. * 2021 NY S.B. 8206 (NS), introduced February 2, 2022, establishing the office of hospice and palliative care access and quality. Oklahoma 2021 OK H.B. 4396 (NS), introduced February 7, 2022, relating to pediatric palliative care; creating program; defining program qualifications; authorizing standards; allowing State Department of Health to promulgate rules. Pennsylvania 2021 PA H.B. 1972 (NS), introduced October 13, 2021, would establish and fund the Veterans' Affairs Community-Based Palliative Care Program to provide nonhospital specialized medical care for people living with a serious illness provided through clinics, nursing and other assisted care facilities and in private homes focusing on providing patients with relief from the symptoms and stress of the illness to improve quality of life for both the patient and the family. Rhode Island ¢ 2021 RI H.B. 7926 (NS), introduced March 7, 2022 and 2021 RI S.B. 2470 (NS), introduced March 1, 2022, raising the maximum age of eligibility for pediatric palliative services from eighteen (18) to twenty-six (26) and raises the eligibility for enhanced services from age eight (8) to age twenty-six (26). ¢ 2021 RI S.B. 2470 (NS), amended/substituted May 19, 2022, raises the maximum age of eligibility for pediatric palliative services from 18 to 26 and raises the eligibility for enhanced services from age 8 to age 26. Washington 2021 WA S.B. 5848 (NS), introduced January 13, 2022, relating to licensure for music therapists. West Virginia 2021 WV S.C.R. 53 (NS), adopted April 10, 2021, encouraging certain facilities to improve palliative care programs. Vil. AID IN DYING Adoption by States and the District of Columbia To date, ten states and the District of Columbia have legalized physician-assisted suicide. [FN83] Eight states (California, Colorado, Hawaii, Maine, New Jersey, New Mexico, Oregon, Vermont, and Washington) and the District of Columbia legalized physician- assisted suicide through legislation. Montana has legal physician-assisted suicide through a court ruling. Oregon was the first to legalize assisted suicide, in 1994; an injunction delayed implementation of its Death with Dignity Act [FN84] until October 1997. It remained the only state to have enacted such legislation until Nov. 4, 2008 when Washington voters passed THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -33- Initiative 1000, a ballot measure allowing for physician-assisted suicide. [FN85I | ike Oregon's Death with Dignity Act, it allows terminally ill patients to request lethal prescription medications from their physicians. Under the Oregon act, patients must express a desire for suicide assistance in writing, and two witnesses must attest to the request. In addition to the written note, patients must voice their requests aloud to their physicians. The Oregon law specifically prohibits 'lethal injection, mercy killing, or active euthanasia," but it allows mentally competent adults who declare their intentions in writing and who have been diagnosed as terminally ill to take a doctor- prescribed lethal drug themselves, orally, after a waiting period. In Washington, provisions of the newly approved initiative require that two doctors must declare that a patient requesting such a prescription has a terminal illness and is expected to die within six months. The state's 2008 measure was exercised for the first time when Linda Fleming, 66, of Sequim, Washington, suffering from stage 4 pancreatic cancer, chose to end her life with prescribed medication now allowed by the state's assisted suicide law, The New York Times reported. [FN86] The Washington State Department of Health is required, under the Act, to collect information and make available to the public an annual statistical report. IFN87] Use of the state's Death with Dignity law grew slightly in the law's second year, with at least 51 terminally ill patients dying from lethal doses of legally prescribed medication, compared to 36 in 2009. From 2009 to 2015, the number of patients who have died from ingesting the medication has gradually increased. In June 2016, the department reports that 213 people requested and received lethal doses of medication in 2015, written by 142 different physicians and dispensed by 49 different pharmacists. Of the 213 people who received lethal doses of prescription medication, 202 are known to have died; 166 died from ingesting the medication and 24 died for other reasons. Those who died were between the ages of 20 and 97 years old. Most had cancer. According to prescribing physicians, many of the patients who received medication expressed concem about loss of autonomy as a reason for requesting a prescription. N®*! During the past decade, the Supreme Court has ruled on two assisted suicide cases and upheld the constitutionality of the Oregon law. In 2006, the Supreme Court again ruled in favor of Oregon in Gonzales v. Oregon. [FN89] Since Oregon originally legalized assisted suicide, many lawmakers in other states have sought to criminalize the practice. Opponents claim it disrespects human life and presents many public policy implications. They also fear the enormous potential for abuse and contend that it violates a doctor's Hippocratic Oath to heal those who are ill. In addition, some argue that legalizing assisted suicide could grant too much power to doctors to 'play God" or encourage medical staff to avoid costly, heroic measures to save critically ill patients. Proponents of legalized assisted suicide argue that individuals with terminal illnesses should have the right to choose a peaceful passing rather than suffering through the final months of terminal disease. They emphasize that planning for death in advance can guarantee family members an opportunity to say goodbye to ailing loved ones. Additionally, those in favor of the practice argue that physician-assisted suicide reduces the cost of providing end-of-life care to terminal patients who would prefer not to receive it. They claim that reasonable laws can be constructed to prevent abuse while still protecting the value of human life. In the first decade since Oregon passed its controversial law, 541 Oregonians received prescriptions for a lethal dose of medication. To date, 341 have died after ingesting a lethal dose. IFN90] Partly due to the raised awareness about terminal illness brought about by the controversial Oregon law, palliative and hospice care have increased markedly in Oregon, and the state ranks among the best in the nation in end-of-life care. On October 5, 2015, California approved 2015 CA S.B. 128 (NS), the 'End of Life Option Act," authorizing an adult who meets certain qualifications and who has been determined by his or her attending physician to be suffering from a terminal illness, as defined, to make a request for medication prescribed pursuant to these provisions for the purpose of ending his or her life. The measure establishes the procedures for making these requests. It also establishes the forms to request aid-in-dying medication and under specified circumstances an interpreter declaration to be signed subject to penalty of perjury, thereby creating a crime and imposing state-mandated local program. S.B. 128 provides immunity from civil or criminal liability or professional disciplinary action for participating in good faith compliance with the act and provides that participation in activities authorized pursuant to this bill shall be voluntary. The measure also 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 to conceal or destroy a rescission of a request for medication, if it is done with the intent or effect of causing the individual's death. It also 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. By creating a new crime, the bill imposes a state-mandated local program; provides that nothing in its provisions be construed to authorize ending a patient's life by lethal injection, mercy killing, or active euthanasia; and provides that action taken in accordance with the act shall not constitute, among others, suicide or homicide. After it passed the California Senate 23-13 on June 4 and the state Assembly 43-34 on Sept. 9, Governor Jerry Brown signed it into law on Oct. 5, 2015. Valeant Pharmaceuticals, the drugmaker that acquired the rights to Seconal, doubled the cost, from $1,500 to more than $3,000 - and up to $5,000 following passage of California's right-to-die/death with dignity legislation last fall. Seconal is the trade name of secobarbital sodium, the most commonly prescribed drug for aid-in-dying patients. The price increase came on top of previous retail price increases for the nearly 90-year-old sedative that once sold for $150 for a lethal 10-gram dose. California's Medicaid program THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -34- plans to cover the drug although health insurance often doesn't pay for aid-in-dying drugs, and they are not covered under Medicare. In Washington, the drugs aren't covered under the state Medicaid plan or by several Catholic health systems that prohibit doctor-aided death based on religious objections. Washington State decided to seek an alternative to the high-priced Seconal and turned to a compounding pharmacist. The result was a less-expensive mix of three medications: phenobarbital, chloral hydrate, and morphine sulfate, all in powdered form to be mixed with water, alcohol, applesauce, or juice. The new mix of medications sells for about $500. Now doctors in Oregon have adopted the drug mix, too, as a way to ensure that cost doesn't prevent terminally ill patients from making the choice they want under the state's right-to- die law. California officials are considering it as well. Colorado voters on November 8, 2016 approved Proposition 106 to allow a terminally ill adult to take a prescribed drug to cause his or her death. The measure, called 'Medical Aid in Dying," restricts the drugs to those who are at least 18, have a terminal illness with less than six months to live, and are able to self-administer the medications. Two physicians would have to sign off on the terminal diagnosis, and the patient would have to be mentally competent. Colorado became the sixth state in the U.S. (after Washington, Vermont, Oregon, California, and Montana) to allow patients to take drugs to end their lives. On December 20, 2016, District of Columbia mayor Muriel Bowser signed the Death with Dignity Act of 2015, bringing the District one step closer to making assisted dying available to terminally ill patients. City council approved the bill on November 15, 2016, by an 11 to 2 margin. The measure would allow terminally ill patients 18 years or older and with six months or less to live the ability to obtain life- ending, physician-prescribed medicine. Two witnesses have to verify that the patient's decision is voluntary, and the medication must be self-administered. Since Congress failed to disapprove the Act with a joint resolution, the District became the seventh jurisdiction with an assisted dying statute. [FN91] After decades of debate, Hawaii became the sixth state, along with the District of Columbia, to enact legislation (2017 HI H.B. 2739 (NS)) allowing a mentally competent adult resident who has a terminal illness to voluntarily request and receive a prescription medication to die in a peaceful, humane, and dignified manner. Dubbed the 'Our Care, Our Choice Act," the legislation contains the following safeguards, to protect patients and their loved ones from any potential abuse: * Confirmation by two health care providers of the patient's diagnoses, prognosis, and medical decision-making capacity, and the voluntariness of the patient's request; ¢ Determination by a counselor that the patient is capable, and does not appear to be suffering from undertreatment or nontreatment of depression or other conditions which may interfere with the patient's ability to make an informed decision; ¢ Two oral requests from the patient, separated by not less than twenty days; one signed written request that is witnessed by two people, one of whom must be unrelated to the patient; and one signed final attestation; * An additional waiting period between the written request and the writing of the prescription; and ¢ The creation of strict criminal penalties for any person who tampers with a person's request for a prescription pursuant to this Act, or coerces a person with a terminal illness to request a prescription. In addition, the patient at all times retains the right to rescind the request for medication and be under no obligation to fill the prescription or use the medication. New Jersey adopted the Medical Aid in Dying for the Terminally III Act (2018 NJ A.B. 1504 (NS)) on April 12, 2019. One week after the law originally took effect, a physician who opposes the law on religious grounds filed suit in Superior Court to enjoin the law. Superior Court Judge Paul Innes in Mercer County granted a temporary restraining order on August 14, preventing doctors from writing prescriptions. The temporary restraining order had suspended the Act because although the state statute contains regulations, there are no administrative rules yet. On August 27, a state appellate court ruled that agencies and regulatory boards did not need to establish rules before the law could go into effect, and overturned the restraining order. Subsequently, the Supreme Court of New Jersey denied the plaintiffs emergency application to reverse the appellate court's ruling. In June 2019, Maine became the eighth state to legalize medically assisted suicide. Governor Janet Mills signed the Maine Death with Dignity Act (ME H.P. 948 (NS)) on June 12, 2019, which lays out the steps a patient and physician must take before a person can legally end their life. The law requires the patient to undergo two waiting periods and one written and two oral requests and obtain opinions from at least two physicians that a medically assisted suicide is appropriate. The patient must be 18 years of age or older, meet certain qualifications, has been determined by the person's attending physician to be suffering from a terminal disease to make a request for medication to end the person's life. The bill criminalizes coercing a patient into requesting life-ending medication and falsifying a request for the procedure. Veterans Although California voters approved a law two years ago that allows terminally ill people to take lethal drugs to end their lives, controversy is growing over a newer rule that effectively bans that option in the state's eight veterans homes. According to Kaiser Health News, proponents of medical aid-in-dying and residents of the Veterans Home of California-Yountville (the largest in the nation) THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -35- are protesting a regulation passed last year by the California Department of Veterans Affairs ('CalVet") that requires that anyone living in the facilities be discharged if they intend to use the law. That's a position shared three other states-Oregon, Colorado, and Vermont-that prohibit use of lethal medication in state-run veterans homes. A CalVet official said the agency adopted the rule to avoid violating a federal statute (42 U.S.C. 714402) that prohibits using U.S. government resources for physician-assisted death. Otherwise, the agency would jeopardize nearly $68 million in federal funds that helps run the facilities, said June lIljana, CalVet's deputy secretary of communications. [FN92] Recent Legislative Activity Federal 2021 CONG US HCON 68, introduced February 4, 2022, expressing the sense of the Congress that assisted suicide (sometimes referred to using other terms) puts everyone, including those most vulnerable, at risk of deadly harm. Alaska 2021 AK H.B. 252 (NS), introduced January 18, 2022, No Patient Left Alone Act, relating to the right of patients to have a support person present during treatment and during stays at hospices and other facilities. California 2021 CA S.B. 380 (NS), adopted October 5, 2021, would allow for an individual to qualify for aid-in-dying medication by making 2 oral requests a minimum of 48 hours apart; would eliminate the requirement that an individual who is prescribed and ingests aid-in-dying medication make a final attestation; would require that the date of all oral and written requests be documented in an individual's medical record and would require that upon a transfer of care, that record be provided to the qualified individual; would extend the operation of the act until January 1, 2031, thereby imposing a state-mandated local program by extending the operation of crimes for specified violations of the act; would require a health care provider who is unable or unwilling to participate under the act to inform the individual seeking an aid-in-dying medication that they do not participate, document the date of the individual's request and the provider's notice of their objection, and transfer their relevant medical record upon request; would authorize a health care entity to prohibit employees and contractors, as specified, from participating under the act while on the entity's premises or in the course of their employment; would prohibit a health care provider or health care entity from engaging in false, misleading, or deceptive practices relating to their willingness to qualify an individual or provide a prescription for an aid-in-dying medication to a qualified individual; would require a health care entity to post its current policy regarding medical aid in dying on its internet website. Connecticut 2022 CT S.B. 88 (NS), amended/substituted March 22, 2022, to provide aid in dying to terminally ill patients. Delaware 2021 DE H.B. 140 (NS), introduced June 30, 2021, relating to end-of-life options, providing that a terminally ill adult individual who has decision-making capacity has the right to request and self-administer medication to end their life in a humane and dignified manner. Hawaii ¢ 2021 HI H.B. 1823 (NS), amended/substituted March 24, 2022, amending the Our Care, Our Choice Act, to authorize advanced practice registered nurses and physician assistants to practice medical aid in dying or provide counseling to a qualified patient; requires a prescribing provider to conduct an initial visit in-person; amends the mandatory waiting period between oral requests and the provision of a prescription; prohibits the disclosure, discovery, or compelled production of information collected or retained pursuant to incidental or routine communication between DOH and qualified patients or providers. ¢ 2021 HI S.B. 839 (NS), amended/substituted February 18, 2021, authorizes advanced practice registered nurses, in addition to physicians, to practice medical aid in dying in accordance with their scope of practice and prescribing authority; authorizes psychiatric mental health nurse practitioners and clinical nurse specialists, in addition to psychiatrists, psychologists, and clinical social workers, to provide counseling to a qualified patient; reduces the mandatory waiting period between oral requests from twenty days to fifteen days; waives the mandatory waiting period for those terminally ill individuals not expected to survive the mandatory waiting period. ¢ 2021 HI S.B. 2680 (NS), amended/substituted February 17, 2022, authorizing advanced practice registered nurses, in addition to physicians, to practice medical-aid-in-dying in accordance with their scope of practice and prescribing authority; authorizing licensed psychiatric mental health nurse practitioners, clinical nurse specialists, and marriage and family therapists, in addition to psychiatrists, psychologists, and clinical social workers, to provide counseling to a qualified patient; strengthening nondisclosure protections; reducing the mandatory waiting period between oral requests from twenty days to fifteen days; waiving the mandatory waiting period for those terminally ill individuals not expected to survive the mandatory waiting period Indiana 2022 IN H.B. 1020 (NS), introduced January 4, 2022, allowing individuals with a terminal illness who meet certain requirements to make a request to an attending provider for medication that the individual may take to bring about death; specifies requirements a provider THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -36- must meet in order to prescribe the medication to a patient; prohibits an insurer from denying payment of benefits under a life insurance policy based upon a suicide clause in the life insurance policy if the death of the insured individual is the result of medical aid in dying. lowa 2021 IA H.F. 475 (NS), introduced February 10, 2021, and 2021 IA S.F. 212 (NS), introduced February 2, 2021, the 'lowa Our Care, Our Options Act" making medical aid in dying available as an additional palliative care option for terminally ill individuals. Kansas 2021 KS H.B. 2202 (NS), introduced February 2, 2021, the Kansas Death with Dignity Act, would allow certain terminally ill adults to request and receive life-ending medication. Kentucky 2022 KY H.B. 534 (NS), introduced February 17, 2022, would establish a qualified terminally ill patient's right to voluntarily request medication to self-administer to cause death; require conditions for making the request; permit a patient to rescind the request at any time; permit an attending physician to provide medication; establish requirements for the attending physician to inform patients and document request; require disposal of unused medications; establish residency requirements for qualified patients. Massachusetts 2021 MA S.D. 801 (NS) and 2021 MA H.D. 1456 (NS), introduced February 8, 2021, End of Life Options Act, providing for aid in dying options for terminally ill patients. Minnesota 2021 MN H.F. 1358 (NS) and 2021 MN S.F. 1352 (NS), introduced February 22, 2021, establishing an end-of-life option for terminally ill adults, allowing a qualified individual to request and obtain a prescription for medication that the individual may self-administer to bring about a peaceful death. New York ¢ 2021 NY A.B. 198 (NS), introduced January 6, 2021, requiring the commissioner of health to conduct a study relating to medical aid in dying. ¢ 2021 NY A.B. 4321 (NS), amended/substituted April 1, 2021, relating to the medical aid in dying act; relates to a terminally ill patient's request for and use of medication for medical aid in dying. ¢ 2021 NY S.B. 6471 (NS), introduced April 30, 2021, relates to the medical aid in dying act; relates to a terminally ill patient's request for and use of medication for medical aid in dying. North Carolina 2021 NC H.B. 780 (NS), introduced May 4, 2021, establishing an end-of-life option act to allow qualified individuals diagnosed with a terminal disease to end life ina humane and dignified manner. Pennsylvania ¢ 2021 PA H.B. 1453 (NS), introduced May 21, 2021, providing for compassionate assisted dignified death. * 2021 PA 8S.B. 405 (NS), introduced March 11, 2021, providing for end-of-life options, for duties of attending physicians, for duties of consulting physicians and for insurance or annuity policies; imposing duties on the Department of Health; providing for immunities; and imposing penalties. Rhode Island ¢ 2021 RI H.B. 6600 (NS), creating the Lila Manfield Sapinsley Compassionate Care Act, to provide a legal mechanism whereby a terminally ill patient may choose to end their life using drugs prescribed by a physician. ¢ 2021 RI S.B. 21112 (NS), introduced January 25, 2022, creating the Lila Manfield Sapinsley Compassionate Care Act, to provide a legal mechanism whereby a terminally ill patient may choose to end their life using drugs prescribed by a physician. South Carolina 2021 SC S.B. 688 (NS), introduced March 23, 2021, to provide that an accident or health insurer must provide a discount to a policy holder who has and maintains a declaration pursuant to the death with dignity act. Utah 2022 UH H.B. 74 (NS), introduced January 18, 2022, would enact the End of Life Options Act, establishing a procedure for an individual with a terminal disease to obtain a prescription to end the individual's life; describes when an individual may make a request for a prescription for aid-in-dying medication; establishes attending and consulting physician responsibilities if an individual requests a prescription for aid-in-dying medication; includes documentation and reporting requirements; establishes the effect of the decision to utilize aid-in-dying medication on an individual's will, contracts, and insurance and annuity contracts; provides limited immunities THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -37- for good faith application of the Act; prohibits euthanasia or mercy killing; establishes criminal penalties and civil liability for certain actions; clarifies that a health care provider does not commit manslaughter by following the procedure established in the Act; provides a uniform form for an individual's written request for a prescription for aid-in-dying medication; and provides safe disposal requirements for unused aid-in-dying medication. Vermont 2021 VT S.B. 74 (NS), adopted April 27, 2022, proposes to eliminate a requirement in Vermont's patient choice at end-of-life laws that both oral requests required of the patient with a terminal condition for medication to be self-administered to hasten the patient's death must have been made in the physical presence of the physician to whom the patient made the request. It would eliminate a requirement that the prescribing physician have conducted a physical examination of the patient in order to determine that the patient was suffering a terminal condition and a requirement that the physician must have waited at least 48 hours after the occurrence of certain required events before writing the prescription. The bill would also provide immunity for any person who acts in good faith compliance with the provisions of Vermont's patient choice at end-of-life laws. Virginia 2022 VA S.B. 668 (NS), introduced January 20, 2022, allowing an adult who has been determined by an attending physician and consulting physician to be suffering from a terminal condition to request medication for the purpose of ending his life in a humane and dignified manner; requires that a patient's request for medication to end his life be given orally on two occasions, that such request be in writing, signed by the patient and two witnesses, and that the patient be given an express opportunity to rescind his request; requires that before a patient is prescribed medication to end his life, the attending physician must (i) confirm that the patient is making an informed decision, (ii) refer the patient to a capacity reviewer if the physician is uncertain as to whether the patient is making an informed decision, (iii) refer the patient to a consulting physician for confirmation or rejection of the attending physician's diagnosis, and (iv) inform the patient that he may rescind the request at any time; provides that neither a patient's request for medication to end his life ina humane and dignified manner nor his act of ingesting such medication shall have any effect upon a life, health, or accident insurance policy or an annuity contract; makes it a Class 2 felony (a) to willfully and deliberately alter, forge, conceal, or destroy a patient's request, or rescission of request, for medication to end his life with the intent and effect of causing the patient's death or (b) to coerce, intimidate, or exert undue influence on a patient to request medication for the purpose of ending his life or to destroy the patient's rescission of such request with the intent and effect of causing the patient's death; grants immunity from civil or criminal liability and professional disciplinary action to any person who complies with the provisions of the bill and allows health care providers to refuse to participate in the provision of medication to a patient for the purpose of ending the patient's life. Washington 2021 WA H.B. 1141 (NS), engrossed February 25, 2021, increasing access to the death with dignity act. Wisconsin ¢ 2021 WI A.B. 1078 (NS), introduced March 7, 2022, permitting certain qualified individuals to make a request for medication for the purpose of ending their lives and providing a penalty. ¢ 2021 WI S.B. 1013 (NS), introduced February 23, 2022, permitting certain qualified individuals to make a request for medication for the purpose of ending their lives, and providing a penalty. VII. 'RIGHT TO TRY" U.S. 'Right to Try" Laws May Not Help Dying Get Unapproved Drugs So-called 'right to try" laws, intended to expand dying patients' access to experimental treatments, may not work as expected ? and might strip patients of federal safety protections, some experts say. IFNS3] The laws, enacted in at least 24 states, have been promoted as a way to help dying patients get hold of medicines and devices that haven't been approved by the U.S. Food and Drug Administration (FDA). But the laws haven't yet helped patients gain access to experimental therapies, Alison Bateman-House, an ethicist at New York University Langone Medical Center, and colleagues argue in an article in Annals of Internal Medicine. The state laws may also cover access only for terminally ill patients, excluding people with serious or rare diseases with limited treatment options that are not immediately life-threatening, the authors note. And the laws may disrupt the current system for granting so-called 'compassionate use" of unproven treatments to dying or seriously ill patients, which includes FDA oversight to track any safety issues, Bateman-House said by email. Under current federal policy, when terminally ill patients want to use drugs and devices that are too early in their development to be approved by the FDA, their doctors typically ask for the drug or device companies to grant expanded access to the experimental therapies. If the company agrees, the FDA and a review board where the physician works would also vet the request. Among other things, reviewers might assess whether the patient has exhausted other options and understands the potential risks and benefits of therapies that generally haven't yet been tested in large-scale human trials. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -38- The FDA has not taken a position on right to try legislation, Sarah Peddicord, an FDA spokeswoman, said by email. The FDA approved more than 99 percent of compassionate use applications, also known as expanded access requests, received during the 2010 to 2014 fiscal years, she said. The FDA is required to respond to these requests within 30 days, but often does so much more quickly, she added. States have approved right to try laws, however, because the current system doesn't move quickly enough for terminally ill patients who seek experimental treatments as a last resort, said Kurt Altman, director of national affairs at the Goldwater Institute, which has drafted model legislation and helped promote the laws. He doesn't dispute the FDA's 99 percent approval rate for compassionate use requests. Instead, Altman argues that these requests represent only a fraction of the patients who might have benefited from getting experimental treatments. 'What the 99 percent figure does not tell us is how many terminal patients didn't know about expanded access, had a doctor with insufficient time to complete the process, etc.," Altman said by email. The application can take doctors more than 100 hours to complete, he said. Though the FDA announced plans to streamline this process so it takes only 45 minutes, Altman said he isn't aware of this being implemented yet. 'Overall, | think right to try is a first step that will lead to reforms that not only speed some FDA processes but also make their processes more transparent and understandable," Altman said. Recent Legislative Activity Federal 2021 CONG US HR 8440, introduced July 20, 2022, to clarify that the Federal Right to Try law applies to schedule | substances for which a phase | clinical trial has been completed and to provide access for eligible patients to such substances pursuant to the Federal Right to Try law. Hawaii 2021 HI H.B. 1918 (NS), filed January 21, 2022, codifying a terminally ill patient's right to try experimental treatment options. lowa 2021 IA H.F. 2203 (NS), introduced February 1, 2022, relating to experimental treatments for terminally ill persons. Michigan 2021 MI H.B. 5637 (NS), introduced December 14, 2021, modifying the Right to Try Act to include certain drugs and treatments during the COVID-19 pandemic emergency. Minnesota 2021 MN S.F. 4332 (NS), introduced March 28, 2022, the William Shegstad Healthcare Advocates Act, providing for right of patient to try alternative early treatment and procedures for a medical condition; options for patient to complete care at home or hospice as alternative to a hospital death. New Jersey * 2022 NJ A.B. 3034 (NS), introduced February 28, 2022, establishing the 'Right to Try Act" permitting terminally ill patients to access investigational drugs and treatment. * 2022 NJ A.B. 3487 (NS), introduced March 8, 2022, permitting terminally ill patients access to certain investigational and off-label treatments. ¢ 2022 NJ S.B. 1166 (NS), introduced January 31, 2022, establishing 'Right to Try Act" permitting terminally ill patients to access investigational drugs and treatment. Rhode Island 2021 RI H.B. 7393 (NS), introduced February 9, 2022, creating the 'Neil Fachon Terminally Ill Patients' Right To Try Act of 2022,' which establishes the conditions for the use of experimental treatments for terminally ill patients. South Dakota 2022 SD H.B. 1228 (NS), introduced January 27, 2022, expanding the ability for patients to seek investigational drugs, biological products, or devices. Wisconsin 2021 WI A.B. 979 (NS), introduced February 15, 2022, providing the right to try off-label therapies. IX. ORGAN DONATION AND TRANSPLANTATION THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -39- Organ donation takes place when a person allows healthy transplantable organs and tissues to be removed, either after death or while the donor is alive, and transplanted into another person. Common transplantations include: kidneys, heart, liver, pancreas, intestines, lungs, bones, bone marrow, skin, and corneas. The field of organ donation and transplantation is one of the most regulated areas of health care today. Both state and federal legislation has been put in place to provide the safest and most equitable system for allocation, distribution, and transplantation of donated organs. To address the nation's critical organ donation shortage and improve the organ matching and placement process, the U.S. Congress passed the National Organ Transplant Act in 1984. The act established the Organ Procurement and Transplantation Network (OPTN) to maintain a national registry for organ matching. The Act also called for the network to be operated by a private, nonprofit organization under federal contract. The United Network for Organ Sharing (UNOS), based in Richmond, Virginia, administers the OPTN under contract with the Health Resources and Services Administration (HRSA) of HHS. On the state level, laws facilitate organ and tissue donation commitments, including revenue sources and funding, legal consent for donation, donation education, and living donor support. A website [FN@4] provided by HRSA supplies extensive and detailed information on state legislation. Recent Legislative Activity Alaska 2021 AK S.B. 147 (NS), introduced January 18, 2022, requiring the Department of Administration to allow individuals to execute an anatomical gift when renewing a driver's license. Arizona ¢ 2022 AZ H.B. 2284 (NS), adopted July 6, 2022, regarding persons who may received anatomical gifts. ¢ 2022 AZ H.B. 2659 (NS), engrossed February 23, 2022, prohibiting discrimination against recipients of an anatomical gift or organ transplant based on disability. California * 2021 CAA.B. 1374 (NS), adopted September 22, 2021, revises and recasts the requirements relating to providing for enrollment for organ or tissue donation through the process of obtaining a driver's license or identification card from the department, including deleting an outdated reporting requirement and making conforming changes to related provisions; requires the department instead to enter into a memorandum of understanding (MOU) with the Donate Life California Organ and Tissue Donor Registry to mutually agree upon the language providing for enrollment in organ or tissue donation; authorizes a person who applies for an original or renewal driver's license or identification card to designate a voluntary contribution of $2 or more, as specified. ¢ 2021 CA A.B. 1800 (NS), adopted September 30, 2022, enacts Charlie's Law to require, beginning January 1, 2027, an electronic application for an original or renewal driver's license or identification card to contain a solicitation for the applicant to enroll in the National Marrow Donor Program's (NMDP) registry as a bone marrow or blood stem cell donor. The bill provides that an applicant's election to enroll in the NMDP's registry constitutes consent to their information being transmitted to the NMDP for the purposes of completing enrollment in the registry. The bill also requires the Department of Motor Vehicles to enter into a memorandum of understanding with the NMDP, as specified, and to transmit weekly specified applicant information to the NMDP. ¢ 2021 CAA.B. 2725 (NS), introduced February 18, 2022, relating to anatomical gifts, would make it the duty of the procurement organization, upon referral, to inform the appropriate person of the donor's gift, or the appropriate person's ability to make an anatomical gift; would require a reasonable effort to locate a person with authority over the remains to include fingerprinting, as specified, and would require the coroner to assist a procurement organization in the search for a person authorized to make an anatomical gift; would authorize the coroner or designee to attend the recovery procedure if they cannot complete the examination prior to recovery of the gift and would require the county coroner to cause a licensed forensic pathologist to be present at the recovery procedure in order to restrict recovery of a donated part; would authorize the procurement organization and the county coroner to establish a collaborative procurement protocol for anatomical gifts and would authorize that protocol to delineate items of information that may be provided by the procurement organization to the coroner and to identify a liaison with the coroner's office who shall be available 24 hours per day, seven days a week, for the receipt of that information. Connecticut 2022 CT S.B. 330 (NS), amended/substituted March 29, 2022, prohibiting discrimination against persons with a disability who are candidates to receive an anatomical gift. Delaware 2021 DE S.B. 87 (NS), adopted September 10, 2021, relating to anatomical gifts and the Delaware Health Information Database. Florida ¢ 2022 FL H.B. 1099 (NS), adopted April 6, 2022, prohibiting insurers under certain policies from declining or limiting coverage and discriminating against persons based solely on their status as living organ donors. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -40- ¢ 2022 FL S.B. 1026 (NS), introduced January 11, 2022, prohibiting insurers under life insurance policies, industrial life insurance policies, group life insurance policies, individual health insurance policies, group, blanket, and franchise health insurance policies, credit life and disability insurance policies, and long-term care insurance policies, health maintenance organizations, and prepaid health clinics under specified policies from declining or limiting coverages and discriminating against persons based solely on their status as living organ donors, and from precluding insureds or subscribers from donating organs. Georgia 2021 GA H.B. 128 (NS), adopted May 6, 2021, prohibiting providers from discriminating against potential organ transplant recipients due solely to the physical or mental disability of the potential recipient. Hawaii 2021 HI S.B. 2692 (NS), introduced January 21, 2022, requiring an applicant for a driver's license or renewal of a driver's license to designate whether the applicant wishes to be an organ donor in the event of the applicant's death by providing a 'yes' or 'no' response; requires the examiner of drivers to design and provide an informational brochure about organ donation to each applicant for driver's license or driver's license renewal. Illinois ¢ 2021 IL S.B. 363 (NS), introduced February 19, 2021, creates the Non-Transplant Organ Donation Regulation Act; requires non- transplant organ donation organizations that acquire or transfer human bodies or human body parts for education, research, or the advancement of medical, dental, or mortuary science to register with the office of the Secretary of State and be licensed by the Department of Public Health; contains requirements for license application, accreditation, renewal, and fees; provides that the Department may deny, suspend, or revoke a license; assess civil penalties; and perform inspections under the Act. ¢ 2021 IL S.B. 500 (NS), adopted July 23, 2021, amends the Illinois Anatomical Gift Act; deletes language providing that no hospital, physician and surgeon, procurement organization, or other person shall determine the ultimate recipient of an anatomical gift based upon a potential recipient's physical or mental disability, except to the extent that the physical or mental disability has been found by a physician and surgeon, following a case-by-case evaluation of the potential recipient, to be medically significant to the provision of the anatomical gift; provides instead that a hospital, physician and surgeon, procurement organization, or other person shall not, solely on the basis of an individual's mental or physical disability: deem an individual ineligible to receive an anatomical gift or organ transplant, deny medical and other services related to organ transplantation, including evaluation, surgery, counseling, postoperative treatment, and services, refuse to refer the individual to a transplant center or other related specialist for the purpose of evaluation for or receipt of an organ transplant, refuse to place an individual on an organ transplant waiting list or place an individual at a lower priority position on the waiting list than the position at which the individual would have been placed if not for the individual's disability, or decline insurance coverage for any procedure associated with the receipt of the anatomical gift, including post-transplantation care. Provides that a hospital, physician and surgeon, procurement organization, or other person may take an individual's disability into account when making treatment or coverage recommendations or decisions solely to the extent that the physical or mental disability has been found by a physician or surgeon, following an individualized evaluation of the potential recipient, to be medically significant to the provision of the anatomical gift. Indiana 2022 IN S.B. 95 (NS), amended/substituted January 7, 2022, prohibiting an insurer that issues a policy of life insurance, disability insurance, or long term care insurance from taking certain actions with respect to the coverage of individuals who are living organ donors; specifies that certain actions constitute an unfair and deceptive act and practice in the business of insurance when taken against a living organ donor by an insurer. Louisiana 2022 LA H.B. 307 (NS), adopted May 25, 2022, prohibiting insurers from denying or conditioning certain policies based on the policyholder's status as a living organ donor. Michigan ¢ 2021 MI H.B. 4521 (NS), introduced March 16, 2021, HIV positive organ donations, allowing when recipient is HIV positive. ¢ 2021 MI H.B. 4762 (NS), introduced April 29, 2021, prohibiting discrimination against an organ transplant recipient based on physical or mental disability. ¢ 2021 MI H.B. 6068 (NS) and 2021 MI S.B. 1025 (NS), introduced May 3, 2022, allowing certain private practice offices and urgent care clinics to provide information on the donor registry and donating bone marrow. ¢ 2021 MI S.B. 584 (NS), introduced June 30, 2021, prohibiting insurers from denying or limiting insurance to living organ donors. ¢ 2021 MI S.B. 588 (NS), introduced June 30, 2021, and 2021 MI H.B. 4762 (NS), engrossed June 17, 2021, prohibiting discrimination against organ plant recipients based on physical or mental disability. Minnesota THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -41- ¢ 2021 MN H.F. 1080 (NS), introduced February 15, 2021, an act relating to human rights; requiring nondiscrimination in access to transplants; prescribing penalties. ¢ 2021 MN H.F. 1829 (NS), engrossed May 25, 2022, prohibiting organ or bone marrow donor discrimination by insurers. ¢ 2021 MN H.F. 2064 (NS), introduced March 9, 2021, prohibiting the direct or indirect distribution of the anatomical gift of an eye or parts of an eye by a for-profit entity. ¢ 2021 MN H.F. 3972 (NS), introduced March 3, 2022, prescribing nondiscrimination and equity required in access to organ transplants. * 2021 MN S.F. 875 (NS), engrossed March 17, 2021, relating to human rights, requiring nondiscrimination in access to transplants. ¢ 2021 MN S.F. 1862 (NS), introduced March 8, 2021, prohibiting an anatomical gift of an eye or parts of an eye from being directly or indirectly distributed by a for-profit entity. ¢ 2021 MN S.F. 3790 (NS), introduced March 7, 2022, authorizing nondiscrimination and equity in access to organ transplants. ¢ 2021 MN S.F. 4231 (NS), introduced March 23, 2022, requiring nondiscrimination and equity in access to organ transplants. Mississippi ¢ 2022 MS H.B. 20 (NS), adopted March 3, 2022, prohibiting discrimination against recipient of anatomical gift based on disability. * 2022 MS H.B. 942 (NS), engrossed January 25, 2022, allowing online applicants for a hunting or fishing license to elect to be an organ donor. * 2022 MS H.B. 964 (NS), S.B. 2458 (NS), introduced January 17, 2022, to enact Cole's Law to prohibit discrimination against recipients of an anatomical gift or organ transplant based on disability; to define certain terms used in the act; to provide requirements for covered entities; to provide civil remedies for violations of the act. Missouri 2022 MO H.B. 2680 (NS), introduced February 10, 2022, and 2022 MO S.B. 1146 (NS), introduced February 11, 2022, modifying provisions related to organ donation. Nebraska ¢ 2021 ND _L.B. 251 (NS), introduced January 11, 2021, would change the age for organ and tissue donation. ¢ 2021 NE L.B. 1082 (NS), adopted April 18, 2022, requiring the Game and Parks Commission to provide certain organ and tissue donation information on applications for certain hunting and fishing permits. New Hampshire ¢ 2021 NH H.B. 421 (NS), introduced January 6, 2021, clarifies that a person's decision to donate his or her own body, organ, or tissue upon death is not subject to amendment or revocation after such person's death. ¢ 2021 NH H.B. 583 (NS), introduced January 6, 2021, allows for applicants of drivers' licenses and nondrivers' picture identification cards who are organ donors to indicate on such licenses or cards their intent to have their kidneys donated to New Hampshire residents on the kidney waiting list prior to out-of-state residents. New Jersey ¢ 2022 NJ A.B. 3163 (NS), introduced March 7, 2022, providing that organ donor designation on driver's license or identification card remains upon renewal of license or card under certain circumstances. ¢ 2022 NJ A.B. 3193 (NS), introduced March 7, 2022, providing for opting out of organ and tissue donation. * 2022 NJ S.B. 2433 (NS), introduced May 9, 2022, providing that organ donor designation on driver's license or identification card remains upon renewal of license or card under certain circumstances. New York ¢ 2021 NY A.B. 6392 (NS), adopted December 22, 2021, allows donate life registration on electronic applications administered by the office of temporary disability assistance, the higher education services corporation, and on mandatory electronic tax filings. ¢ 2021 NY S.B. 3047 (NS), introduced January 27, 2021, requires election for registration for organ, eye and tissue donations to be included upon certain state forms. ¢ 2021 NY S.B. 3203 (NS), introduced January 28, 2021, ensures fairness in organ donations to persons with physical or mental disabilities. ¢ 2021 NY S.B. 7890 (NS), introduced January 18, 2022, relating to donate life registrations. ¢ 2021 NY S.B. 8805 (NS), introduced April 19, 2022, requiring space for donate life registration on certain health insurance forms. North Carolina THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -42- ¢ 2021 NC H.B. 71 (NS), amended/substituted June 3, 2021, The Living Donor Protection Act, to protect living donors from potential insurance discrimination, to provide an income tax credit for unreimbursed medical expenses resulting from certain organ and marrow donations, and to provide up to thirty days' paid leave to state employees and other state-supported personnel who serve as living organ donors and up to seven days' paid leave for bone marrow donors. ¢ 2021 NC H.B. 642 (NS), adopted July 1, 2021, Down Syndrome Organ Transplant Nondiscrimination Act, prohibiting organ transplant discrimination on the basis of disability by health care providers and health insurers. * 2021 NC S.B. 135 (NS), adopted June 14, 2021, improving the efficiency of organ, eye, and tissue donation at the department of motor vehicles by requiring donors who originally became donors in another jurisdiction to consent to the imprinting of an anatomical gift statement or symbol on the donor's North Carolina drivers license or identification card and by clarifying when an anatomical gift made by authorizing that a statement or symbol be imprinted on the donor's drivers license or identification card will be considered revoked. Ohio 2021 OH H.B. 188 (NS), adopted April 6, 2022, prohibiting insurers from discriminating against living organ donors. Oklahoma * 2021 OK H.B. 3464 (NS) and 2021 OK S.B. 1349 (NS), introduced February 7, 2022, relating to anatomical gifts; prohibiting for-profit entity from engaging in certain acts. * 2021 OK H.B. 3623 (NS), introduced February 7, 2022, relating to driver license organ donation procedures. ¢ 2021 OK S.B. 170 (NS), engrossed March 2, 2021, relating to judicial authorization for anatomical gifts under certain circumstances. ¢ 2021 OK S.B. 378 (NS), adopted April 20, 2021, organ donation and anatomical gifts; creating Everett's Law; prohibiting and requiring certain actions by covered entity; prohibiting certain actions by health carrier. ¢ 2021 OK S.B. 675 (NS), introduced February 1, 2021, relating to organ donation and anatomical gifts; prohibiting harvest of organs or tissue without consent; prohibiting commercialization of certain organs or tissue. South Carolina ¢ 2021 SC H.B. 4537 (NS), introduced January 11, 2022, to prohibit issuers of group and individual life insurance policies and long-term care insurance policies from discriminating against living kidney donors. ¢ 2021 SC H.B. 4597 (NS), adopted May 13, 2022, prohibiting discrimination against individuals with disabilities in accessing anatomical gifts and organ transplants; to establish requirements and prohibited conduct for covered entities, including hospitals and organ procurement organizations, with regard to the organ transplant process; to create civil remedies for violations; to establish requirements applicable to health insurers that provide coverage for anatomical gifts and organ transplants. * 2021 SC H.B. 4839 (NS), amended/substituted March 1, 2022, to prohibit issuers of life insurance, disability income, and long-term care insurance policies from discriminating against living organ donors. * 2021 SC S.B. 646 (NS), introduced March 9, 2021, to provide that a for-profit entity shall not engage, directly or indirectly, in the procurement, transfer, or distribution of any human eye, cornea, eye tissue, corneal tissue, or portion of an eye. ¢ 2021 SC S.B. 697 (NS), amended/substituted April 5, 2022, to clarify that the coroner must cooperate expeditiously with a procurement organization to maximize the opportunity to recover anatomical gifts for the purpose of transplantation, therapy, research, or education, even when performing an investigation. South Dakota ¢ 2022 SD H.B. 1129 (NS), adopted March 18, 2022, prohibiting forms of discrimination in access to organ transplantation. * 2022 SD S.B. 107 (NS), approved March 25, 2022, providing for the remote witnessing of certain legal instruments including durable power of attorney for health care and anatomical gift or refusal to make an anatomical gift. Tennessee ¢ 2021 TN H.B. 860 (NS), introduced February 10, 2021, requires an organ procurement organization to contact family members of a decedent within five hours of the decedent's death to inquire about organ donation. ¢ 2021 TN H.B. 2080 (NS) and 2021 TN S.B. 2058 (NS), introduced January 31, 2022, requiring a procurement organization or hospital contacting an individual following the death of the decedent for purposes of allowing the individual to make an anatomical gift to explain to the individual that the individual can designate the decedent's whole body or a part, and the process of making an anatomical gift and the condition the decedent's body will be in after the completion of the process. ¢ 2021 TN S.B. 488 (NS), adopted May 13, 2021, prohibits certain healthcare providers and entities from discriminating against qualified persons for receipt of transplantations or anatomical gifts based solely on disability; prohibits insurers that offer plans covering transplantations from denying coverage solely on disability. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -43- ¢ 2022 NJ S.B. 1146 (NS), introduced January 31, 2022, requiring insurers to provide information about organ donation, allowing insurers to limit reimbursement for organ transplant if recipient has not made gift pursuant to Revised Uniform Anatomical Gift Act. Virginia * 2022 VA H.B. 421 (NS), amended/substituted February 21, 2022, prohibiting any person from refusing to insure, refusing to continue to insure, or limiting the amount or extent of life insurance, disability insurance, or long-term care insurance coverage available to an individual, or to charge an individual a different rate for the same coverage based solely and without any additional actuarial risks upon the status of such individual as a living organ donor. * 2022 VA S.B. 271 (NS), amended/substituted January 17, 2022, prohibiting any person from refusing to insure, refusing to continue to insure, or limiting the amount or extent of life insurance, disability insurance, or long-term care insurance coverage available to an individual or to charge an individual a different rate for the same coverage based solely and without any additional actuarial risks upon the status of such individual as a living organ donor. The bill requires that an employer that employs 15 or more employees provide eligible employees with (i) up to 60 business days of unpaid organ donation leave in any 12-month period to serve as an organ donor and (ii) up to 30 business days of unpaid organ donation leave in any 12-month period to serve as a bone marrow donor. The bill requires the employer to restore the employee's position following the leave, to continue to provide coverage for the employee under any health benefit plan, and to pay the employee any commission earned prior to the leave. Washington 2021 WA S.B. 5003 (NS), adopted May 3, 2021, enacting the Living Donor Act, prohibiting all insurers and health care service contractors from declining or limiting coverage of a person solely due to the person's status as a living organ donor. West Virginia * 2021 WV H.B. 3032 (NS), introduced March 10, 2021, prohibiting discrimination based on an individual's mental or physical disability in access to organ transplantation. ¢ 2021 WV H.B. 3074 (NS), introduced March 11, 2021, relating to information on organ and tissue donations. ¢ 2022 WV H.B. 4340 (NS), adopted March 30, 2022, relating to maximizing the opportunity to recover anatomical gifts for the purpose of transplantation, therapy, research, or education: clarifying wno may make an anatomical gift of decedent's body or part; clarifying the duties of procurement organization with regard to state medical examiner; requiring the state medical examiner to cooperate with procurement organizations to maximize the opportunity to recover anatomical gifts; authorizing procurement organizations to conduct a test to evaluate the medical suitability of the body part; and authorizing the state's chief medical examiner to enter into agreements with a procurement organization to facilitate the recovery of anatomical gifts. * 2022 WV H.B. 4767 (NS), introduced February 15, 2022, to prohibit vaccine requirements as a condition of being eligible for an organ transplant. * 2022 WV H.B. 4777 (NS), introduced February 15, 2022, State Living Donor Protection Act, prohibiting an insurer from declining or limiting coverage on a person under any life insurance policy, major medical coverage policy, disability insurance policy, or long-term care insurance policy solely due to the status of that person as a living organ donor. ¢ 2021 WV S.B. 73 (NS), introduced February 10, 2021, prohibiting discrimination in access to organ transplants based on physical or mental disability. * 2022 WV S.B. 623 (NS), introduced February 14, 2022, State Living Donor Protection Act, setting forth prohibited acts related to insurance coverage for living organ donors. ¢ 2022 WV S.B. 647 (NS), approved March 21, 2022, prohibiting discrimination based on an individual's mental or physical disability in access to organ transplantation; and providing enforcement mechanisms. Wisconsin 2021 WI S.B. 538 (NS), adopted December 3, 2021, prohibiting discrimination in organ transplantation on the basis of disability. X. TERMINALLY ILL INMATES AND PRISONERS Recent Legislative Activity Federal * 2021 CONG US HR 6296, introduced December 16, 2021, establishing Federal policies and procedures to notify the next-of-kin or other emergency contact upon the death, or serious illness or serious injury, of an individual in Federal custody, to provide model policies for States, units of local government, and Indian Tribes to implement and enforce similar policies and procedures. * 2021 CONG US §S 312, reported in Senate June 8, 2021, to expand eligibility for and provide judicial review for the Elderly Home Detention Pilot Program for eligible elderly or terminally ill offenders, provide for compassionate release based on COVID-19 vulnerability, shorten the waiting period for judicial review during the COVID-19 pandemic, THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -44- California ¢ 2021 CAA.B. 124 (NS), adopted October 8, 2021, provides for the resentencing or recall by the court of a prisoner who is terminally ill with an incurable condition caused by an illness or disease that would produce death within 12 months. * 2021 CAA.B. 960 (NS), adopted September 29, 2022, would require the Department of Corrections and Rehabilitation to make a recommendation for recall or resentencing of an incarcerated person if an incarcerated person has a serious and advanced illness with an end-of-life trajectory or who is found to be permanently medically incapacitated. * 2021 CAA.B. 1540 (NS), adopted October 8, 2021, would provide for the resentencing or recall by the court of a prisoner who is terminally ill with an incurable condition caused by an illness or disease that would produce death within 12 months. ¢ 2021 CA S.B. 567 (NS), adopted October 8, 2021, would provide for the resentencing or recall by the court of a prisoner who is terminally ill with an incurable condition caused by an illness or disease that would produce death within 12 months. Connecticut 2022 CT S.B. 460 (NS), amended/substituted April 19, 2022, to create a release panel for determinations of medical and compassionate release, modify standards used to determine when an inmate may be eligible for compassionate parole release and establish a system for credits to be awarded to terminally ill inmates toward release from imprisonment in the time of an emergency declaration. Illinois 2021 IL H.B. 3665 (NS), adopted August 20, 2021, amends the Unified Code of Corrections; provides that the Prisoner Review Board may grant a person committed to the Department of Corrections early release for medical incapacity or terminal illness; establishes the procedures for applying for that release and the considerations the Prisoner Review Board must make in determining whether to grant the release; provides that a committed person granted medical release shall be released on mandatory supervised release for a period of 5 years subject to the Code provisions concerning mandatory supervised release, which shall operate to discharge any remaining term of years imposed upon him or her; however, the person shall not serve a period of mandatory supervised release greater than the aggregate of the discharged underlying sentence and the mandatory supervised release period; provides that a grant of medical release shall be an act of executive and legislative grace and shall be at the sole discretion of the Prisoner Review Board. Massachusetts 2021 MA H.D. 3975 (NS) and 2021 MA S.D. 2163 (NS), filed February 19, 2021, to remove barriers to medical parole for prisoners who are permanently cognitively or physically incapacitated or terminally ill. Mississippi 2022 MS S.B. 2817 (NS), engrossed February 2, 2022, authorizing the provision of hospice care services to inmates with a terminal illness. New Hampshire 2021 NH H.B. 1335 (NS), introduced January 5, 2022, relative to the parole board and the procedure for medical parole of terminally ill prisoners. New York ¢ 2021 NY A.B. 4347 (NS), introduced February 1, 2021, relates to medical parole and determinations of whether a person released on medical parole is physically or cognitively incapable of presenting a danger to society. ¢ 2021 NY S.B. 2907 (NS), introduced January 26, 2021, relates to medical parole and determinations of whether a person released on medical parole (including terminally ill inmates) is physically or cognitively incapable of presenting a danger to society. ¢ 2021 NY S.B. 9423 (NS), introduced May 25, 2022, relating to the establishment of emergency management release plans for terminally ill, mentally ill, or disabled inmates, to be developed for use in correctional facilities in the event of a state disaster emergency declared pursuant to executive order. North Carolina 2021 NC S.B. 889 (NS), introduced May 27, 2022, to expand the eligibility for the medical release of inmates who are permanently and totally disabled, terminally ill, or geriatric, and to appropriate funds to support chronic care units in state prisons and improve screening and training of incoming prison staff. Oklahoma ¢ 2021 OK S.B. 686 (NS), introduced February 1, 2021, relating to a prison system hospice care training program. * 2021 OK H.B. 2567 (NS), introduced February 1, 2021, providing for development of a hospice care training program within the Department of Corrections and inmate training. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -45- ¢ 2022 OK S.B. 14 (NS), approved May 26, 2022, would allow the Department of Corrections to establish a Hospice Care and Certified Nurse Assistant training program administered through the Health Services Division under the direction of the Chief Medical Officer, to provide inmate education, training, and clinical experience to adequately prepare the participants for related career opportunities upon release from incarceration. Pennsylvania * 2021 PA H.B. 2347 (NS), introduced March 8, 2022, providing for parole for reasons of age or terminal illness of inmate. * 2021 PA H.B. 2634 (NS), introduced June 13, 2022, provides for modification of sentence by court that imposed it in cases of terminal illness and other circumstances. * 2021 PA S.8. 835 (NS), introduced August 11, 2021, would allow the parole board to grant parole to an incarcerated individual who has a substantially diminished ability to function in a correctional institution due to a terminal illness, among other conditions. Rhode Island 2021 RIH.B. 7191 (NS), introduced January 26, 2022, allowing the parole board to grant medical parole release of a prisoner who is determined to be terminally ill, severely ill, or permanently physically or cognitively incapacitated. Tennessee 2021 TN H.B. 32 (NS), introduced January 12, 2021, makes eligible for parole an inmate who is 65 years of age or older or is terminally ill. XI. CONCLUSION End-of-life issues remain at the forefront in 2022 as hospitals continue to deal with COVID-19 cases and efforts to provide compassionate care visits for family and clergy. More and more states consider legislation to allow terminally ill patients to end their lives in a humane and dignified manner. More attention is focused on an aging population as baby boomers advance toward their twilight years. Meanwhile, related issues involving the definition and compliance requirements of advance care directives as well as improving the awareness of their existence through registries or other means remain under scrutiny in many states. Throughout 2023, HPTS will continue to monitor legislative and regulatory activity pertaining to COVID-19, hospice, palliative care, death with dignity initiatives, advance care directives, organ donation, and other end-of-life care issues. © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service [FN2] Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. ?? 512175207. [FN3] Trump Administration Makes Sweeping Regulatory Changes to Help U.S. Healthcare System Address COVID-19 Patient Surge, CMS. gov (press release, Mar. 30, 2020), available at: https:/Awww.cms.gov/newsroom/press-releases/trump-administration-makes- sweeping-regulatory-changes-help-us-healthcare-system-address-covid-19. [FN4] COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (fact sheet), CMS.gov (Apr. 3, 2020), available at: https:// www.cms.gov/files/document/covid19-emergency-declaration-health-care-providers-fact-sheet. pdf. [FN5] David Leonhardt, "Nursing Home Deaths Plummet," The New York Times (Feb. 25, 2021), https:/Avww.nytimes.com/2021/02/25/ briefing/covid-variant-new-york-postal-service-smith-college.html. [FN6] "CMS Updates Nursing Home Guidance with Revised Visitation Recommendations," CMS.gov (Press Release, Mar. 10, 2021), https:// www.cms.gov/newsroom/press-releases/cms-updates-nursing-home-guidance-revised-visitation-recommendations. [FN7] Seema Verma, 'Early Impact Of CMS Expansion Of Medicare Telehealth During COVID-19,' Health Affairs (July 15, 2020), available at: https:/Avww.healthaffairs.org/do/10.1377/hblog202007 15.454789/full/?utm_source=Master+Segment+List&utm_campaign =dba6a3df80-EMAIL_CAMPAIGN_2020_07_16_07_32&utm_medium=email&utm_term=0_9b5a8c75fe-dba6a3df80-1508880808. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -46- [FN8] Hospice in the Time of COVID-19: Findings from the NAHC National Survey, National Association for Home Care & Hospice (press release, May 27, 2020), available at: https:/Avww.nahc.org/2020/05/27/hospice-in-the-time-of-covid-1 9-findings-from-the-nahc-national- survey/. [FN9] COVID-19: U.S. Impact on Antimicrobial Resistance, 2022 Special Report, Centers for Disease Control and Prevention (June 2022), https:/Avww.cdc.gov/drugresistance/pdf/covid19-impact-report-508. pdf. [FN10] Douglas B. White, MD, MAS, and Bernard Lo, MD, 'A Framework for Rationing Ventilators and Critical Care Beds During the COVID-19 Pandemic,' JAMA Network, (Mar. 27, 2020), available at: https://jamanetwork.com/journals/jama/fullarticle/2763953. [FN11] Rebecca J. Gorges and R. Tamara Konetzka, "Factors Associated with Racial Differences in Deaths Among Nursing Home Residents With COVID-19 Infection in the US," JAMA Network (Feb. 10, 2021), https://jamanetwork.com/journals/jamanetworkopen/ fullarticle/2776102. [FN12] William Wan, 'Pandemic isolation has killed thousands of Alzheimer's patients while families watch from afar,' The Washington Post (Sept. 16, 2020), https:/Avww.washingtonpost.com/health/2020/09/1 6/coronavirus-dementia-alzheimers-deaths/?arc404=true. [FN13] "Nonprofit Hospice Services: Where Mission and Community Meet," LeadingAge, LeadingAge Ohio, and the National Partnership for Hospice Innovation. (January 2019), available at: https://www.leadingage.org/sites/default/files/Nonprofit Hospice Services_FINAL 5. pdf. [FN14] Bestow Team, "What States Are Most Concerned About End-of-Life Issues?," Bestow (Dec. 14, 2018), available at: https:// hellobestow.com/blog/states-concerned-about-end-of-life/. [FN15] Lucas Morin, et al., "Discussing end-of-life issues in nursing homes: a nationwide study in France, Age and Ageing (3/24/2016), available at: http://ageing.oxfordjournals.org/content/early/201 6/03/24/ageing.afw046.abstract?sid=4a860ed7-cdb0-4b97-9088- cd858303a17e. [FN16] Stephanie Deeb et al., "Disparities in Care Management During Terminal Hospitalization Among Adults With Metastatic Cancer From 2010 to 2017," JAMA Network Open (Sept. 22, 2021), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784430. [FN17] Fredrick Kunkle, Ethnicity complicates patient-doctor discussion of death, WashingtonPost.com (April 22, 2015) at 2015 WLNR 11726999. [FN18] Ruth Palan Lopez et al., "Association of Nursing Home Organizational Culture and Staff Perspectives With Variability in Advanced Dementia Care: The ADVANCE Study," JAMA Intern Med. (Jan. 24, 2022), https://jamanetwork.com/journals/jamainternalmedicine/ article-abstract/2788469. [FN19] Katherine A. Ornstein, et al., Evaluation of Racial Disparities in Hospice Use and End-of-Life Treatment Intensity in the REGARDS Cohort, JAMA Network Open (Aug. 24, 2020), available at: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2769692. [FN20] Lauren B. Gerlach et al., "State variation in antipsychotic and benzodiazepine prescribing among hospice beneficiaries in the United States," Journal of the American Geriatrics Society (Aug. 9, 2022), https://agsjournals.onlinelibrary.wiley.com/doi/full/10.1 11 1/jgs.17992. [FN21] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -47- CMS Finalizes Calendar Year 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Expansion (fact sheet), CMS.gov (Nov. 2, 2021), https:/Avww.cms.gov/newsroom/fact-sheets/cms-finalizes-calendar-year-2022- home-health-prospective-payment-system-rate-update-home-health. [FN22] .Zhang B, Nilsson ME, Prigerson HG, "Factors Important to Patients; Quality of Life at the End of Life," Archives of Internal Medicine (July 9, 2012). Available at: http://archinte.jamanetwork.com/article.aspx?articleid=1212635. [FN23] Anna Gorman, "?Pre-Hospice' Saves Money By Keeping People At Home Near The End of Life," Kaiser Health News (March 27, 2017), available at: khn.org/news/pre-hospice-saves-money-by-keeping-people-at-home-near-the-end-of-life/. [FN24] Susan C. Miller et al., "Increasing Veterans' Hospice Use: The Veterans Health Administration's Focus On Improving End-Of-Life Care," Health Affairs, vol. 36, no. 7, 1274782 (July 2017), available at: http://content.healthaffairs.org/content/36/7/1274.abstract?=right. [FN25] Orna Intrator, et al., Benchmarking Site of Death and Hospice Use: A Case Study of Veterans Cared by Department of Veterans Affairs Home-based Primary Care, Medical Care (Sept. 2020), available at: https://journals.lww.com/lww-medicalcare/Abstract/2020/09000/ Benchmarking_Site_of_Death_and_Hospice_Use__A_Case.8.aspx. [FN26] Holly Vossol, More Veterans Gravitating Toward Home-Based Hospice Care, Hospice News (Oct. 29, 2020), available at: https:// hospicenews.com/2020/10/29/more-veterans-gravitating-toward-home-based-hospice-care/. [FN27] Matthew A. Davis et al., Trends in US Medicare Decedents' Diagnosis of Dementia From 2004 to 2017, JAMA Health Forum (Apr. 1, 2022), https://jamanetwork.com/journals/jama-health-forum/fullarticle/2790757. [FN28] Jacob D. Hill ND, et al., "Emergency and post-emergency care of older adults with Alzheimer's disease/Alzheimer's disease related dementias," Journal of the American Geriatrics Society (May 25, 2022), https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/ jgs.17833?af=R. [FN29] Alicia Lasek, ?Ds rarely send seniors with dementia to hospice care: study," McKnights Long-Term Care News (June 9, 2022), https:// www.mcknights.com/news/clinical-news/eds-rarely-send-seniors-with-dementia-to-hospice-care-study/. [FN30] "Hospice Deficiencies Pose Risks to Medicare Beneficiaries," U.S. Department of Health and Human Services Office of Inspector General (OEI-02-17-00020, July 2019), available at: https://oig.hhs.gov/oei/reports/oei-02-17-00020.pdf?utm_source=summary- page&utm_medium=web&utm_campaign=OEI-02-17-00020-PDF. [FN31] Hospice Performance on Health and Safety Surveys-Concerns and Considerations, A NAHC Information Brief, National Association for Home Care & Hospice, available at: https://www.nahc.org/wp-content/uploads/201 9/09/HOSPICE-PERFORMANCE-ON-HEALTH- SAFETY-SURVEYS-Concerns-Recommendations.pdf. [FN32] The study was published in the New England Journal of Medicine, 381:2369-2370 (Dec. 12, 2019), available at: https://2019 / cwww.nejm.org/doi/full/10.1056/NEJMc191 1892. [FN33] Nauzley C. Abedini et al., "The Relationship of Loneliness to End of Life Experience in Older Americans: A Cohort Study," Journal of the American Geriatrics Society, Wiley Online Library (Mar. 3, 2020), available at: https://onlinelibrary.wiley.com/doi/abs/10.1111/ jgs.16354. [FN34] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -48- Jim Parker, '53 Medicare Advantage Plans to Offer Hospice in 2021, Palliative Care to Grow,' Hospice News (Sept. 25, 2020), available at: https://nospicenews.com/2020/09/25/53-medicare-advantage-plans-to-offer-hospice-in-2021 -palliative-care-to-growRk°_/. [FN35] Jim Parker, "OIG Planning National Audit for Hospice Eligibility for 2023," Hospice News (Jan. 19, 2022), https:// hospicenews.com/2022/01/19/oig-planning-national-audit-for-hospice-eligibility-for-2023/. [FN36] Kan Z. Gianattasio, M.P.P., et al., "Evaluation of Federal Policy Changes to the Hospice Benefit and Use of Hospice for Persons With ADRD," JAMA Health Forum (May 6, 2022), https://jamanetwork.com/journals/jama-health-forum/fullarticle/2791963. [FN37] Value-Based Insurance Design (VBID) Model: Hospice Benefit Component, CMS.gov (Jan. 28, 2021), https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/Hospice. [FN38] VBID Model Hospice Benefit Component Overview, CMS.gov (Oct. 28, 2020), https://innovation.cms.gov/innovation-models/vbid- hospice-benefit-overview. [FN39] Medicare Advantage: Beneficiary Disenrollments to Fee-for-Service in Last Year of Life Increase Medicare Spending, United States Government Accountability Office Report to Congressional Requesters, GAO-21-482 (June 2021), https:/Avww.gao.gov/assets/ gao-21-482.pdf. [FN40] . 76 FR 47302, 2011 WL 3322765. [FN41] Medicare Program; FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements, Centers for Medicare & Medicaid Services, 82 Fed. Reg. 36638 (Aug. 4, 2017). 2017 WL 3311409. [FN42] Medicare Program; FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements (Final Rule), Department of Health and Human Services (filed July 29, 2021), https://public-inspection.federalregister.gov/2021-16311 .pdf. [FN43] Jim Parker, "CMS Details Two New Claims-Based Hospice Quality Measures," Hospice News (Oct. 12, 2021), https:// hospicenews.com/2021/10/12/cms-details-two-new-claims-based-hospice-quality-measures/. [FN44] The website is available at: https:/Avwww.medicare.gov/hospicecompare/. [FN45] Hospice Quality Reporting, CMS.gov, https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice- Quality-Reporting/Hospice-Quality-Public-Reporting.html. [FN46] Study: Nursing Homes Increasingly Pushing Patients into Rehab at End-of-Life, University of Rochester Medical Center (Newsroom, Oct. 3, 2018), available at: https:/Avww.urmc.rochester.edu/news/story/5434/study-nursing-homes-increasingly-pushing-patients-into- rehab-at-end-of-life.aspx. [FN47] Rachel Bluth, "Younger Seniors Amass More End-Of-Life Care Than Oldest Americans, Study Finds," Kaiser Health News (July 14, 2016), available at: http://khn.org/news/younger-seniors-amass-more-end-of-life-care-than-oldest-americans-study-finds/. [FN48] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -49- Liz Szabo, "Treatment Overkill: Never Too Late To Operate? Surgery Near End of Life Is Common, Costly," Kaiser Healfh News (Feb. 28, 2018), available at: https://khn.org/news/never-too-late-to-operate-surgery-near-end-of-life-is-common-costly/, citing Alvin C. Kwok, et al., "The intensity and variation of surgical care at the end of life: a retrospective cohort study," The Lancet (Oct. 6, 2011), available at: http:/Avww.thelancet.com/journals/lancet/article/PIISO 140-6736(1 1)61268-3/fulltext. [FN49] Jim Parker, "Congress Prolongs Medicare Sequestration Moratorium for Hospices, Other Providers," Hospice News (Apr. 14, 2021), https://hospicenews.com/2021/04/14/congress-prolongs-medicare-sequestration-moratorium-for-hospices-other-providers/. [FN50] Jim Parker, "CMS Report: Concurrent Hospice, Curative Care and Winning Proposition," Hospice News (Apr. 29, 2022), https:// hospicenews.com/2022/04/29/cms-report-concurrent-hospice-curative-care-a-winning-proposition/?itm_source=parsely-api. [FN51] Jim Parker, "Customizing Hospice, Palliative Care Payment Contracts in ACO REACH," Hospice News (Oct. 12, 2022), https:// hospicenews.com/2022/10/12/customizing-hospice-palliative-care-payment-contracts-in-aco-reach/?itm_source =parsely-api. [FN52] Joan M. Teno et al., "Dying with dementia in Medicare Advantage, Accountable Care Organizations, or traditional Medicare," Journal of the American Geriatrics Society (May 14 2021), https://agsjournals.onlinelibrary.wiley.com/doi/abs/10.11 1 1/jgs.17225. [FN53] . Law for Older Americans: Health Care Advance Directives, American Bar Association, Division for Public Education, available at: https:/Avww.americanbar.org/groups/public_education/resources/law_issues_for_consumers/patient_self_determination_act.html. [FN54] . Pub. L. 109-3 (March 21, 2005). [FN55] . See Bush v. Schiavo, 885 So.2d 321 (Fla. 2004), cert. denied, 125 S.Ct. 1086 (2005); Schiavo ex rel. Schindler v. Schiavo, 403 F.3d 1223 (11th Cir. 2005), cert. denied, 125 S.Ct. 1692 (2005); Schiavo ex rel. Schindler v. Schiavo, 403 F.3d 1289 (11th Cir. 2005), cert. denied, 125 S.Ct. 1722 (2005). [FN56] Susan E. Hickman et al., "Factors associated with concordance between POLST orders and current treatment preferences," Journal of the American Geriatrics Society (Mar. 24, 2021), https://agsjournals.onlinelibrary.wiley.com/doi/abs/10.1111/igs.17095. [FN57] Emily Mongan, "Researchers dissect end-of-life care practices, issue best practices," McKnights (November 14, 2016), available at: http:/Awww.mcknights.com/news/researchers-dissect-end-of-life-care-practices-issue-best-practices/article/572877/. [FN58] -Mariette L. Klein, "Dementia Caregivers: An Exploration of Their Knowledge, Beliefs, and Behavior Regarding Advance Care Planning for End-of-Life Care" (dissertation), Virginia Commonwealth University, Richmond, Va., May 2014, available at: https:// digarchive .library.vcu.edu/handle/10156/4665. [FN59] David P. Glass et al., "Concordance of End-of-Life Care with End-of-Life Wishes in an Integrated Health Care System," JAMA Network Open (Apr. 6, 2021), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2778182. [FN60] JoNel Aleccia, "End-Of-Life Advice: More Than 500,000 Chat On Medicare's Dime," Kaiser Health News (Aug. 14, 2017), available at: http://khn.org/news/end-of-life-advice-more-than-500000-chat-on-medicares-dime/. [FN61] . 'New Research Reveals What to Discuss Near Life's End," McMaster University, NewsRx Health & Science (Nov. 23, 2014). 2014 WLNR 3196054. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -50- [FN62] James T. Mulder, "Syracuse nursing home faulted for saving woman who did not want to be saved," syracuse.com (Jan. 9, 2018), available at: http:/Avww.syracuse.com/health/index.ssf/2018/01/ syracuse_nursing_home_censured_for_saving_woman_who_did_not_want_to_be_saved.html. [FN63] Sheryl Crosier, "The Story Behind Simon's Law and Parental Rights Over DNRs," Pro-Life Healthcare Alliance (July 2, 2018), available at: https:/Avww.prolifehealthcare.org/story-simons-law-parental-rights-dnrs/. [FN64] "Simon's Law," American College of Pediatricians, available at: https://www.acpeds.org/the-college-speaks/for-policy-makers/sanctity- of-life/simons-law. [FN65] Angelo E. Volandes et al., "Association of an Advance Care Planning Video and Communication Intervention with Documentation of Advance Care Planning among Older Adults-A Nonrandomized Controlled Trial," JAMA Network Open (Feb. 24, 2022), https:// jamanetwork.com/joumals/jamanetworkopen/fullarticle/27 89397. [FN66] Collins, Warner Introduce Bipartisan, Bicameral Legislation to Expand Access to Advance Care Planning, Susan Collins (Newsroom) (Nov. 4, 2022), https:/Awww.collins.senate.gov/newsroom/collins-warner-introduce-bipartisan-bicameral-legislation-to-expand-access-to- advance-care-planning. [FN67] . "What Are Palliative Care and Hospice Care?", National Institute on Aging, https:/Awww.nia.nih.gov/health/what-are-palliative-care- and-hospice-care (last visited Dec. 10, 2022). [FN68] Jim Parker, "Palliative Care Could Cut Health Care Costs by $103 Billion," Hospice News (Apr. 4, 2019), available at: https:// hospicenews.com/2019/04/04/palliative-care-could-cut-health-care-costs-by-103-billion/. [FN69] Diane E. Meier et al., "A National Strategy for Palliative Care," Health Affairs (July 2017) (abstract), available at: https:/Avww.healthaffairs.org/doi/abs/10.1377/hlthaff.201 7.0164? rfr_dat=cr_pub#pubmed&url_ver=Z39.88-2003&rir_id=ori#rid#crossref.org&journalCode=hithaff. [FN70] "Does Medicare Cover Palliative Care?", Medicare.org, https:/Awww.medicare.org/articles/does-medicare-cover-palliative-care/ (last visited Dec. 10, 2022). [FN71] . 'Internal Medicine Organization Issues Guidelines to Improve Care of 3 Symptoms at End of Life," Drug Week, Feb. 1, 2008. 2008 WLNR 1420102. 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No claim to original U.S. Government Works. -51- "Palliative Care in Florida: Challenges and Options for Florida's Future," Florida TaxWatch (Mar. 12, 2019), available at: https:// floridataxwatch.org/Research/Full-Library/ArtMID/34407/Article|D/18688/Palliative-Care-in-Florida-Challenges-and-Options-for-Floridas- Future. [FN76] Tanja Fusi-Schmidhauser, et al., 'Conservative Management of COVID-19 Patients-Emergency Palliative Care in Action, Journal of Pain and Symptom Management (Mar. 27, 2020), available at: https:/Avww.jpsmjournal.com/article/S0885-3924 (20)30183-4/pdf. [FN77] Jim Parker, "Senate Again Takes Up Hospice, Palliative Staffing Bill," Hospice News (May 20, 2022), https:// hospicenews.com/2022/05/20/senate-again-takes-up-hospice-palliative-staffing-bill/. [FN78] Letter to Chiquita Brooks-LaSure, Administrator, Centers for Medicare and Medicaid Services from Sens. Jacky Rosen, John Barrasso, et al. (June 16, 2022), https:/Awww.rosen.senate.gov/sites/default/files/2022-06/Letter to CMS on Palliative Care Demonstration Project FINAL w. Signatures.pdf. [FN79] Jim Parker, "ACHC Launches Palliative Care Accreditation Program," Hospice News (Apr. 19, 2021), https:// hospicenews.com/2021/04/19/achc-launches-palliative-care-accreditation-program/?itm_source=parsely-api. [FN80] . 'A Comforting Swan Song-Palliative and Supportive Care," Drug Week, May 27, 2011. 2011 WLNR 10000117. [FN81] Gallagher, M., "Evaluating a protocol to train hospice staff in administering individualized music," International Journal of Palliative Nursing, 2011 Apr; 17(4): 1957201. [FN82] Amy T. Hsu et al., "Predicting death in home care users: derivation and validation of the Risk Evaluation for Support: Predictions for Elder-Life in the Community Tool (RESPECT)," CMAJ Vol. 193, Issue 26 (July 5, 2021), https:/Avww.cmaj.ca/content/193/26/E997. [FN83] States Where Medical Aid in Dying is Authorized, Compassion & Choices, https://compassionandchoices.org/resources/states-or- territories-where-medical-aid-in-dying-is-authorized (last visited March 20, 2022). [FN84] . O.R.S. ?? 127.800 et seq. [FN85] . John Iwasaki, "State Second in Nation to Allow Lethal Prescriptions," Seattle Post-intelligencer, Nov. 5, 2008, at A15. 2008 WLNR 21175843. [FN86] . William Yardley, "In Washington, First Death Using Assisted-Suicide Law," The New York Times, May 22, 2009, at A10. 2009 WLNR 9828712. [FN87] Revised Code of Washington (RCW) 70.245.150. [FN88] . The 2015 Death with Dignity Act Report is available on the Washington State Department of Health's website, at http:// www.doh.wa.gov/portals/1/Documents/Pubs/422-109-DeathWithDignityAct2015.pdf. [FN89] . Gonzales v. Oregon , 546 U.S. 243, 126 S.Ct. 904, 163 L.Ed.2d 748 (2006). [FN90] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -52- . 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No claim to original U.S. Government Works. -53-