REGULATORY INTELLIGENCE YEAR-END REPORT - 2021 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. 12/20/2021 I. BACKGROUND AND INTRODUCTION 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, says the APA. This has been caused in part, by 'the fact that the baby boom generation is increasingly dealing with end-of-life care for their parents and the prospect of their own mortality." Other factors, including increased longevity and the fact that 'the dying process and death have moved from taking place at home to medical settings" have impacted how end-of-life issues are presently addressed and handled by those confronting or experiencing a terminal : [FN2] illness. As might be expected, these issues continue to top the list of ethical dilemmas faced by hospitals. [FNS] Moreover, a Dartmouth Ailas of Health Care study pointed out tendencies toward overtreatment (based on assumptions that 'more" care equals 'better' care) and variations in treatment as well as a frequent disregard for patient wishes. The study suggested that hospital systems could impact ways in which treatment methods at the end of life are approached by 'moving the nation toward more organized, integrated care." [FN4 ty addition, many hospice care providers are confronting the moral pressures of serving patients who are outliving standard actuarial schedules: for example, The New York Times reported that those afflicted with either dementia or Alzheimer's disease 'now form a majority of hospice consumers, and their average stays are far longer." Because these longer stays often exceed Medicare reimbursement limits, hospice providers can potentially be hit with federally imposed assessments as a result of being unable, ethically, to discontinue care to those having 'outlived their profit potential." [FNS] On the other hand, a New England Journal of Medicine study concluded that a large number of Americans who could have been receiving hospice care were not, due mainly to the fact that 'many aspects of hospice care are misunderstood by both physicians and patients" [FNE] often resulting in delayed referrals and underutilization of services. A study IFN7] conducted by the Harvard Medical School and funded by the National Cancer Institute found that hospice and end-of life issues are not discussed by physicians or other health care providers with approximately 50 percent of patients deemed terminally ill. [FN8] aiden Huskamp, lead study author and a Harvard Medical School associate professor, cited several possible reasons for the delay, including patients' unrealistic expectations about life expectancy, the choice to believe in a better outcome, and lack of physician training in handling 'some delicate conversations." A study conducted by the Archives of Internal Medicine showed that doctors often choose to stop all further contact with patients once end-of-life care has begun. FNS] The year-long study, led by a University of Washington researcher and focusing on 31 physicians, 55 of their chronically ill patients, 36 family caregivers and 25 nurses, found that feelings of abandonment existed among caretakers and patients alike once hospice programs were initiated and doctor contact had ended. Another study carried out by the Dana-Farber Cancer Institute in Boston showed that advanced-cancer patients who did not talk with their doctors about end-of-life care had health care expenses in the last week of life that were 36 percent higher than those of patients who did have discussions concerning such care. IFN10] The study pointed out that 'higher costs were typically the result of more intensive, life-prolonging care, yet patients who received such intensive care usually didn't live longer." Only about 35 percent of people have actually had discussions with their loved ones about end-of-life care, according to a report coauthored by a University of Massachusetts Medical School professor. A survey found that a majority of those contacted-62 percent -hadn't spoken about their end-of-life care plans with either their healthcare agent or proxy, or their medical provider and just 10 THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. percent had spoken to both, the report stated. Also, 71 percent of respondents said that it was harder to plan for end-of-life care than to distribute their assets after death. However, once end-of-life conversations happened with doctors, 78 percent of respondents said they were 'not at all" difficult; two thirds of respondents said having the same conversation with someone other than a healthcare provider wasn't difficult. N11] In a recent study, researchers have found that making sure residents' care preferences are consistently recorded and updated in medical records is crucial to providing quality end-of-life care, in a recent study. 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 at the Indiana University Center for Aging Research and the Indiana University School of Nursing, and published online in the Journal of Pain and Symptom Management. 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 researchers recommend five best practices for providers to ensure consistency with their residents care preferences: 1) documenting each resident's specific treatment preferences, such as 'do not place feeding tube" instead of 'comfort care," in the medical record; 2) making sure treatment preferences are recorded in a consistent format and location in each medical record; 3) reviewing and updating preferences regularly as residents' clinical conditions change; 4) creating data collection strategies to document decisions to withhold medical interventions; and 5) implementing a consistent measurement approach, such as a required percentage for agreement with care preferences, that can be used to compare with other providers. [FN 12] 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-especially as they apply to the elderly as well as maturing baby boomers-developing trends and pending legislation will continue to be monitored by HPTS. For additional information on long-term, see Health Policy Tracking Service, Long-Term Care, a service of Thomson Reuters. According to the report, the medical advances of the past century have shifted the leading cause of death from infectious disease to chronic disease, resulting in longer life spans. Accordingly, it is expected that most people today will die at an advanced age following a period of chronic illness. Furthermore, the nation's oldest baby boomers turned 65 during 2001, causing the elderly to make up an even larger portion of the U.S. population. Thus, quality of life and quality of dying are increasingly important societal concerns. 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. IFN13] 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. Il. IMPACT OF COVID-19 Coronavirus cases are surging within nursing facilities in states hard hit by the latest onslaught of COVID-19. An analysis of federal data from 20 states for The Associated Press finds that resident deaths more than doubled, from 318 a week to 699, according to the study by University of Chicago health researchers Rebecca Gorges and Tamara Konetzka. [FN14] Equally concerning, weekly infection cases among nursing home staff in surge states more than quadrupled, from 855 the week ending May 31, to 4,050 the week ending October 25. Infected staffers not yet showing symptoms are seen as the most likely way the virus gets into facilities. Then, when those unwitting staffers test positive, they are sidelined from caring for residents, raising pressures on remaining staff. Although the Trump administration has allocated $5 billion to nursing homes, shipped nearly 14,000 fast-test machines with a goal of supplying every facility, and tried to boost stocks of protective equipment, the data calls into question broader White House policy, that pushes states to reopen, as the virus rebounds in communities surrounding the vulnerable nursing home populations. 'Trying to protect nursing home residents without controlling community spread is a losing battle," said Konetzka, co-researcher of the study, and nationally recognized expert on long-term care. 'Someone has to care for vulnerable nursing home residents, and those caregivers move in and out of the nursing home daily, providing an easy pathway for the virus to enter." Nursing homes and other long-term care facilities account for about 1% of the U.S. population, but represent 40% of COVID-19 deaths, according to the COVID Tracking Project. CMS noted different ways the administration has worked to help nursing homes, saying now that its focus is on ensuring that residents and staff would 'immediately' have access to a vaccine once approved. But Konetzka said her research has shown that nursing home quality has no significant effect on cases and deaths once community spread is factored in. 'It's not like the high-quality facilities have figured out how to do things better," she said. Other academic experts have reached similar conclusions. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. The 20 states analyzed in the study were Alaska, Arkansas, lowa, Idaho, Indiana, Kansas, Kentucky, Minnesota, Missouri, Montana, Nebraska, New Mexico, North Dakota, Ohio, Oklahoma, South Dakota, Utah, Wisconsin, West Virginia, and Wyoming. They were selected because they're now seeing their highest hospitalization rates for COVID-19. CMS Waives Some 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, IFN15] and the 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. IFN16] 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 has provided the following waivers: [FN17] « 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. Audits and Medical Reviews to Resume CMS will resume enforcement activities, including targeted probe and education audits, on August 3, regardless of the status of the federally declared COVID-19 national emergency, Hospice News reports. IFN18] The agency had suspended audits and medical reviews by Medicare Administrative Contractors (MACs) as of March 30. Hospice utilization among Medicare decedents rose to exceed 50% for the first time during 2018, according to CMS. As utilization climbs, so does the amount of dollars CMS spends on hospice care, spurring the agency to step up enforcement in an effort to control costs. Medicare hospice expenditures rise by about $1 billion annually. CMS indicated that hospices that are selected for review should discuss any hardships stemming from the outbreak with their contractor if their ability to respond to the audit in a timely fashion is uncertain. Nevertheless, hospice providers are uncertain about the prospect of facing an audit during a pandemic. This includes concerns about staff safety as they return to the office to pull documents. Audits can be triggered by issues such as longer lengths of stay, live discharges, and recertification of a patient for hospice. Documentation is a key component of each of these processes. Many hospice providers express uncertainty about their ability to weather an audit. Even prior to the pandemic, fewer than 50% of hospices indicated that they were ready for a federal audit or additional document request, according to a 2019 survey of 170 organizations by Optima Health. As MACs review hospices' compliance with CMS rules, some providers have also expressed concern that the contractors may not be up to speed regarding the evolving regulatory landscape brought on by the pandemic. CMS issued a number of 1135 waivers to relax regulations to allow hospices to focus on patient care rather than administrative compliance activities. 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, 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. [FN19] According to the CDC, Pfizer and Moderna shots administered to long-term care residents so far showed a high degree of safety, with no deaths attributed to the shots and few severe reactions reported in the first month of the rollout. Between December 14, 2020, and January 13, 2021, long-term care residents made up two-thirds of 113 post-vaccination deaths reported during this time. Half of the residents were in hospice or had do-not-resuscitate status. The incidence of death was split about evenly between people who had received the Pfizer-BioNTech vaccine and the Moderna vaccine. Significantly, in people for whom death certificates and autopsy information was available, the cause of death is consistent with expected all-cause mortality in this population, wrote Tom Shimabukuro, M.D., MPH, of the CDC's COVID-19 Response Team, and THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. colleagues. There is no indication of any unexpected pattern that might suggest a causal relationship with vaccination, he and his colleagues concluded. IFN20] The data was voluntarily reported to the agency's Vaccine Adverse Event Reporting System (VAERS). 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. [FN21] 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. On March 13, 2020, the Centers for Medicare & Medicaid Services (CMS) issued revised guidance for infection and control and prevention of coronavirus disease (COVID-19) for nursing homes, including specific guidance for visitation for certain compassionate care situations, such as end-of-life. Hospice guidance from CMS has not changed. The updated visitation guidance for nursing facilities, with the exception for end-of-life situations, is as follows: ¢ For all facilities nationwide: Facilities should restrict visitation of all visitors and non-essential health care personnel, except for certain compassionate care situations, such as an end-of-life situation. In those cases, visitors will be limited to a specific room only. Facilities are expected to notify potential visitors to defer visitation until further notice (through signage, calls, letters, etc.). Note: If a state implements actions that exceed CMS requirements, such as a ban on all visitation through a governor's executive order, a facility would not be out of compliance with CMS' requirements. In this case, surveyors would still enter the facility, but not cite for noncompliance with visitation requirements. ¢ Additional detail for compassionate situation entry: For individuals that enter in compassionate situations (e.g., end-of-life care), facilities should require visitors to perform hand hygiene and use Personal Protective Equipment (PPE), such as facemasks. Decisions about visitation during an end of life situation should be made on a case by case basis, which should include careful screening of the visitor (including clergy, bereavement counselors, etc.) for fever or respiratory symptoms. Those with symptoms of a respiratory infection (fever, cough, shortness of breath, or sore throat) should not be permitted to enter the facility at any time (even in end-of-life situations). Those visitors that are permitted, must wear a facemask while in the building and restrict their visit to the resident's room or other location designated by the facility. They should also be reminded to frequently perform hand hygiene. Hospice workers are considered health care workers and should be permitted to enter the facility. Additional guidance on exceptions for health care workers: Facilities should follow CDC guidelines for restricting access to health care workers. IFN22] This also applies to other health care workers, such as hospice workers, EMS personnel, or dialysis technicians, that provide care to residents. They should be permitted to come into the facility as long as they meet the CDC guidelines for health care workers. Facilities should contact their local health department for questions, and frequently review the CDC website dedicated to COVID-19 for health care professionals. [FN23] 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 © 2022 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," CMS Administrator Seema Verma wrote in the journal Health Affairs. [FN24] On the legislative front, a bipartisan group of representatives introduced the Protecting Access to Post-COVID-19 Telehealth Act on July 16, 2020, to help protect providers and patients who have benefited from telehealth services during the pandemic. The act expands the use of telehealth after the end of the crisis by eliminating most geographic and originating site restrictions in Medicare and establishing the patient's home as an eligible distant site so patients can receive telehealth care at home and doctors can still be reimbursed; authorizes CMS to continue Medicare reimbursement for telehealth for 90 days beyond the end of the public health emergency; makes the disaster waiver authority permanent, enabling HHS to expand telehealth in Medicare during all future emergencies and disasters; and requires a study on the use of telehealth during COVID-19, including its costs, uptake rates, measurable health outcomes and racial and geographic disparities. [FN25] 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). IFN26] 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. Deciding Who Gets Ventilators and Critical Care Resources As the COVID-19 pandemic intensifies, providers are encountering shortages of critical care resources, such as ventilators and ICU beds, and the real possibility that they may 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? IFN27] 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 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 THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. 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. [FN28] 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. California Reports More Deaths than Any Other State, With Over 50,000 Lost On February 24, 2021, California hit the grim milestone of reaching 50,000 deaths due to COVID, making the state the one with the highest number of deaths. By the next day, the deaths were nearing 51,000. At its peak in January, the state averaged more than 560 deaths a day. By contrast, for much of November, it reported fewer than 50 deaths a day, on average. Despite the high number of deaths, 30 other state have reported more total deaths per capita; New Jersey has recorded twice as many. The New York Times reports that 'Latinos, who are more likely than other Californians to work in essential industries and less likely to have the resources or space to isolate themselves if they get infected, have been sickened and have died at disproportionately high rates." With the surge from the holidays abating, coupled with rising vaccine administration, California is reporting half as many new cases a day as it did just two weeks ago, and some counties are beginning to lift restrictions. [FN28} Dementia Mortality Increases 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. '°° 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 § 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, Alabama 2021 AL H.B. 521 (NS), adopted May 18, 2021, to set minimum standards for visitation at a health care facility when visitation may be limited due to a public health emergency, subject to reasonable restrictions, and to provide civil immunity; allowing family or caregiver presence in end-of-life care situations. Arkansas THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. ¢ 2021 AR H.B. 1061 (NS), adopted March 10, 2021, to create the No Patient Left Alone Act, concerning visitation rights of patients. ¢ 2021 AR S.B. 301 (NS), introduced February 8, 2021, to require state agencies to return fines collected under ? 20-7-101 during the public health emergency for a failure to comply with rules, orders, or directives to mitigate or prevent the spread of Coronavirus 2019 (COVID-19). Arizona 2021 AZ H.B. 2575 (NS), introduced February 2, 2021, providing that in end-of-life situations, a hospital must allow clergy visitation regardless of the time of day. Connecticut 2021 CT H.B. 6470 (NS), adopted July 7, 2021, To ease health care access by making permanent certain changes related to hospice home health care agency and home care agency services, telehealth and utilization review in the medical assistance program that were implemented by executive order during the COVID-19 public health emergency. 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. 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. Indiana ¢ 2021 IN S.B. 202 (NS), adopted April 29, 2021, allows a person admitted as a patient to a hospital or ambulatory outpatient surgical center (facility) to receive visitation by specified individuals during a declared emergency or public health emergency. Requires visitors to comply with applicable disease control or prevention guidelines issued by CMS or the CDC when visiting a patient. Requires a facility to permit the visitation of a person admitted as a patient in a facility during specified compassionate care scenarios, including hospice and end-of-life situations. ¢ 2021 IN S.B. 229 (NS), introduced January 7, 2021, Establishes essential family caregiver status; requires each health facility and residential care facility to permit visitation by an essential family caregiver despite restricted visitation during compassionate care situations, including end-of-life situations; specifies eligibility requirements for caregiver status; allows the administrator of a facility or the administrator's designee to determine whether or not to award caregiver status to a selected individual. 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. Kentucky 2021 KY S.B. 2 (NS), adopted September 10, 2021, to require visitation in long-term care facilities and residential long-term care facilities to be allowed by family members, legal guardians, outside caregivers, friends, or volunteers who provided regular care and support to the resident prior to the pandemic, who are designated as being important to the mental, physical, or social well-being of a resident in critical situations, such as end of life. Maine 2021 ME H.P. 822 (NS), adopted July 13, 2021, regarding advance health care directives. Minnesota THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. ¢ 2019 MN H.F. 20 (NS), introduced December 14, 2020, would modify long-term care infection control requirements, modify hospice and assisted living bill of rights, and prohibit termination of assisted living services during a peacetime emergency. ¢ 2019 MN S.F. 23 (NS), introduced December 14, 2020, would modify long-term care and assisted living provisions regarding health- related electric monitoring requirements, create a SARS-CoV-2 infections state plan; and create a long-term care COVID-19 task force. 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 ¢ 2020 NJ A.B. 3999 (NS) and 2020 NJ S.B. 2380 (NS), amended/substituted on July 27, 2020, concerning employment benefits and coronavirus disease 2019 infections contracted by essential employees, including hospice employees. ¢ 2020 NJ A.B. 4485 (NS) and 2020 NJ S.B. 2784 (NS), amended/substituted September 24, 2020, would dedicate personal protective equipment to long-term care facilities, home health agencies, hospice care providers, and certain community-based providers during a public health emergency. * 2020 NJ A.B. 4767 (NS) and 2020 NJ S.B. 3006 (NS), introduced October 8, 2020, would restore civil liability of nursing homes and related facilities, including hospice, during public health emergency. ¢ 2020 NJ A.B. 4861 (NS), adopted November 8, 2021, requires the Department of Health to publish total number of COVID-19 deaths and cases in long-term care facilities. ¢ 2020 NJ S.B. 3041 (NS), amended/substituted December 7, 2020, would require the department of health to publish the total number of COVID-19 deaths in long-term care facilities. * 2020 NJ A.B. 5129 (NS), introduced December 10, 2020, and 2020 NJ S.B. 3269 (NS), introduced December 14, 2020, would provide gross income tax credit to essential employees working during the COVID-19 pandemic, including hospice workers. 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. 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. 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. Oregon 2021 OR S.B. 199 (NS), adopted June 15, 2021, adopting an advance directive form, providing for appointment of and instructions for health care representatives. 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 Dakota THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. 2021 SD H.B. 1046 (NS), approved February 17, 2017, to limit liability of health care providers, including hospice programs, for certain exposures to COVID?19. Texas ¢ 2021 TX H.B. 797 (NS), prefiled December 10, 2020, allowing home and hospice agencies to administer certain vaccines. ¢ 2021 TX H.B. 1354 (NS), introduced January 26, 2021, relating to members of the clergy who are employed or voluntarily enter inpatient health care facilities to minister during a state of disaster, emergency, or epidemic. Special consideration shall be given to patients or residents receiving end - of-life care. ¢ 2021 TX S.B. 87 (NS), introduced August 23, 2021, relating to health care facility reporting of COVID-19 data. ¢ 2021 TX S.B. 572 (NS), adopted June 14, 2021, relating to in-person visitation of religious counselors with certain health care facility patients and residents during stressful and end-of-life situations in the course of a public health emergency. Virginia * 2020 VA H.B. 5121 (NS), introduced August 24, 2020, and 2020 VA S.B. 5042 (NS), amended/substituted August 27, 2020, would require each nursing home, certified nursing facility, and hospice facility to allow every patient to receive visits, either virtually or in person, at least once per week from family or any person designated by the patient. If such visits are conducted virtually, each such facility shall provide access to equipment and staff support that (i) allows each patient the ability to schedule and receive no less than one virtual visit per week and (ii) provides both visual and sound technology allowing the patient to interact with persons outside the facility, unless the patient or power of attorney of the patient waives such rights to virtual visitation and such waiver is noted in the care plan for the patient. Any person visiting a patient in person may be required to comply with all reasonable requirements of such facility adopted to protect the health and safety of patients and staff of the facility. Each such facility shall publish on its website or provide written communication of its plan for providing virtual or in-person family visits. ¢ 2020 VA H.B. 5140 (NS), introduced August 26, 2020, would provide that during a declared public health emergency related to a communicable disease of public health threat, every hospital, nursing home, nursing facility, hospice, and assisted living facility shall allow visits from a patient's or resident's family members or any person designated by the patient when the patient has been diagnosed with a terminal condition or illness and the patient's death is expected to be imminent. ¢ 2020 VA S.B. 1356 (NS), adopted April 7, 2021, requires the Board of Health to include in regulations governing hospitals, nursing homes, certified nursing facilities, and hospices and the Board of Social Services to include in regulations governing assisted living facilities a requirement that, during a public health emergency related to a communicable disease of public health threat, each such facility establish a protocol to allow patients to receive visits from a rabbi, priest, minister, or clergy of any religious denomination or sect consistent with guidance from the CDC and CMS and subject to compliance with any executive order, order of public health, Department of Health guidance, or any other applicable federal or state guidance having the effect of limiting visitation. The measure provides that such protocol may restrict the frequency and duration of visits and may require visits to be conducted virtually using interactive audio or video technology when use of interactive audio or video technology is determined to be necessary to comply with any applicable federal or state guidance or to protect the health and safety of the person, patients or staff. Additionally, the protocol may require the person visiting a patient to comply with all reasonable requirements of the facility adopted to protect the health and safety of the person, patients, and staff. 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 IFN31] 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: THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. ¢ 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. Researchers at Boston's Massachusetts General Hospital have determined that videos depicting the effects of dementia at life's final stages could help seniors with choosing options for end-of-life care, McKnight's Long-Term Care News and Assisted Living reported. [FNS2] 9 study of 200 healthy seniors split into two groups showed that those who viewed a video presentation portraying advanced dementia were more likely to choose the option of comfort/palliative care rather than 'care to prolong life at all costs" or 'limited care to maintain physical function." In the study, 86 percent of seniors participating in the video group chose the comfort/palliative care option. As reported by USA Today, hospital ethics panels often serve as intermediaries between family members and healthcare personnel when end-of-life decisions must be faced in various hospital settings." IFN33] Often serving on a volunteer basis, ethicists are said to help when patients and their families must 'make the choices of a lifetime." As noted by USA Today, only 25 percent of the U.S. population has written, advance care directives determining treatment protocol at life's end. Others, it says, must make last-minute choices or let choices be made for them. And, says USA Today, 'the sticking points are almost never cost or insurance," even in the middle of the current health reform debate and rumors of so-called 'death panels." In some hospitals, such as the Rochester, Minn. Mayo Clinic, one physician becomes the contact person for the ethics team through whom the patient, family, and staff must communicate. This, said the clinic, helps eliminate 'the blizzard of messages from a constantly shifting medical staff [that] left some families locked in indecision." A study undertaken by University of Michigan researchers has shown that a group of colostomy patients who were told they had 'no hope for getting better reported greater levels of happiness since they had gotten on with their lives. " [FN34] Wiembers of another control group who were told their colostomies would be reversed 'believed their condition to be temporary [and] had a more difficult time adjusting to their new situation." As documented by McKnight's Long-Term Care News & Assisted Living, physicians need to be 'mindful of the dichotomy" of providing hope versus presenting an illness in more realistic terms. Otherwise, said Peter A. Ubel, M.D., who led the research, hope may be built up to the point that patients 'put off living their lives." Improving and exercising proper and effective end-of-life care is beginning to be addressed at various levels. For example, a Web site created by doctors affiliated with the American Academy of Hospice and Palliative Medicine (AAHPM) and specializing in palliative care seeks to raise awareness of the roles of hospice care as well as palliative medicine in the management of terminal illness. IFNS5] The Web site, PalliativeDoctors.org, provides an overview of end-of-life options and a clear definition of what palliative care is and what it is not. As documented by The Medical News, Gail Austin Cooney, MD., a palliative doctor and president of AAHPM, feels that myths and untruths about the practices of palliative and hospice care need to be dispelled. 'There is enormous misunderstanding about palliative medicine," said Dr. Cooney, 'and tremendous fear associated with it." While Americans generally agree that discussing end-of-life care with their loved ones is important, a recent study conducted by Bestow IFN36] looked 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. IFNS7] in 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. End-of-life Planning Does Not Make Cancer Patients Hopeless or Anxious For a small group of advanced cancer patients, using an online tool-called 'Making Your Wishes Known: Planning Your Medical Future," (MYWK)}-for learning about end-of-life medical decisions and developing an advance directive document, did not lead to psychological distress, according to a new study. [FN] 'One thing we noticed is that many patients with advanced cancer had not had these conversations," said lead author Dr. Michael J. Green of the humanities and medicine departments at Penn State College of Medicine in Hershey, Pennsylvania. He and his team set out to see if it was true that working through end of life planning took away cancer patients' hope or raised their anxiety levels. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -10- MYWK includes education modules on common medical conditions that can result in decisional incapacity, as well as medical treatments often introduced in life or death situations. Patients can choose a spokesperson, prioritize values and goals, match treatment options with priorities, and generate a printable advance directive document articulating their wishes. For the study, the researchers divided 200 advanced-stage cancer patients with anticipated life expectancy of two years or less into two groups. One engaged in advanced care planning with the online tool, while the other used only a state-approved advance directive form and American Hospital Association educational materials. Those who used the MYWK online tool spent an average of 70 minutes in their advance care planning, compared to 26 minutes in the comparison group. Neither group had a decrease in hope or an increase in hopelessness after their advance care planning sessions, according to results in the Journal of Pain and Symptom Management. Anxiety levels decreased slightly for the MYWK group and stayed the same for the comparison group. Knowledge of advance care planning and feelings of self-determination increased slightly for both groups. Doctors who initiate these conversations can do a lot to decrease patient stress and anxiety, but many physicians are hesitant and are also pressed for time, he said. The MYWK decision aid was modeled on what a conversation with your doctor should look like, he said. End-of-Life Care Differs Depending on Hospital A report released by the Dartmouth Atlas of Health Care found that the care provided to patients at the end of their lives differs significantly based on the hospital. The lead author of the study, Dr. David Goodman, stated, 'Unfortunately the care that patients get is much more about where they happen to be treated rather than care that follows their preferences." Whereas some doctors prefer aggressive treatments, many other prefer hospice. The study suggests that more patients would choose hospice. However, this report and previous ones have been criticized. Some say that the care provided was intended to prolong life and that imminent death was not obvious. /FN%9! In 2011, researchers at Dartmouth College released a report showing that at the end of life, people with chronic diseases get more aggressive medical care in the New York area than any place else in the country. The study, which looked at federal data from 2007 (the most recent available), found that 46 percent of chronically ill patients in the Manhattan hospital region were being treated at hospitals-as opposed to at home, in hospices, or nursing homes-when they died. That rate was the highest in the country. Nationally, 28 percent of chronic patients were being treated at hospitals when they died. Dr. Elliott S. Fisher, a co-author of the study, said that some of the disparity might be driven by financial incentives for keeping patients in New York-area hospitals while neglecting the true wishes of the patients. Colleague Dr. David C. Goodman pointed out that Medicare generally paid better for hospital-based care, including procedures and specialists, than for palliative care or community-based medical services. [FN40] 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, IFN41] 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 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. " [FN42] 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 THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -11- 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. 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. [FN43] 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. Dementia Patients' Receipt of Hospice Care An analysis of nursing home records in 2010 found that many dementia patients are seeking hospice care. The analysis also found that approximately 40% of nursing home residents also suffer from some level of dementia. The study's authors fear that 'Medicare policymakers will see this as a reason to cut costs. . . . Initiatives focusing on reducing long hospice stays could disproportionately and adversely affect the timing of hospice referral for persons with dementia. It is critical that the creation of any new policy explicitly consider the challenges inherent in the time of hospice referral for nursing home residents dying with dementia." [FN44] According to researchers, many people who suffer from advanced dementia are not receiving hospice care because they cannot meet the admission criteria. Researchers claim that the admission criteria are flawed because the guidelines suggest that practitioners should wait until the resident has an estimated six months left to live. It is extremely difficult to make this determination in certain dementia cases. The researchers suggest that 'instead of using life expectancy as the requirement for admission, hospice care for dementia patients should be offered based on the patient's and family's desire for comfort care." In an attempt to improve the chances of dementia patients getting palliative care, the researchers developed a new method of determining how long a patient has left to live. The Advanced Dementia Prognostic Tool (ADEPT) looks at 'body mass index, ability to perform tasks of daily living like self-feeding, bowel incontinence, shortness of breath and oral food intake" among other things. The study was published in the November 3, 2010 issue of the Journal of the American Medical Association. "4°! A new study finds that most people with dementia don't die in nursing homes after all, but are more likely to spend their final days at home. 1,500 elderly adults with dementia were studied by investigators from the Indiana University School of Medicine and the Regenstrief Institute as they transitioned through various care settings. Researchers found that while 74% of the dementia patients were placed in nursing homes after a hospitalization, they did not stay there. In fact, only 19% died in facilities, compared to 46% that died at home. Lead researcher Christopher Callahan, M.D., said this finding runs counter to a common belief that such residents typically die in facilities. He added that 'a better understanding of the relationships between sites of care for older adults with dementia is fundamental to building better models of care for these vulnerable elders." [FN48] Full findings were published on May 15, 2012, in the Journal of the American Geriatrics Society. [FN47] 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. [FN48] 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 THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -12- 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 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. [FN48} Citing a recent CDC report that found that more persons die at home, a study reported in JAMA examined the changes in site of death, place of care, and health care transitions between 2000, 2005, and 2009. Researchers used a random 20% sample of fee-for-service Medicare beneficiaries, aged 66 years and older, who died in 2000, 2005, or 2009. Based on billing data, patients were classified as having a medical diagnosis of cancer, chronic obstructive pulmonary disease, or dementia in the last 180 days of life. Comparing 2000, 2005, and 2009, the results indicate that the proportion of deaths in acute care hospitals decreased from 32.6% to 26.9% to 24.6% in 2000, 2005, and 2009, respectively. However, intensive care unit (ICU) use in the last month of life increased from 24.3% to 26.3% to 29.2%. Hospice use at the time of death increased from 21.6% to 32.3% to 42.2%, with 28.4% using a hospice for 3 days or less in 2009. The researchers concluded that among Medicare beneficiaries who died in 2009 and 2005 compared with 2000, a lower proportion died in an acute care hospital, although both ICU use and the rate of health care transitions increased in the last month of life. In addition, the author states that the results confirm the CDC finding based on death certificate data that more persons aged 65 years and older are dying at home, but the rate of ICU use in the last month of life has increased, that 11.5% of 2009 decedents had 3 or more hospitalizations in the last 90 days of life, that hospice use increased, but 28.4% of those decedents used a hospice for 3 days or less in 2009. [FN5O] 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." 'FN51] 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. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -13- In a study reported in Health Affairs [FNS2] vesearchers 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. IFN53] 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. [FNS4] Nurses May Be Key to Improving the Quality of End-of-Life Care A recent study [FNS] from the University of Pennsylvania School of Nursing's Center for Health Outcomes and Policy Research (CHOPR) looked at the quality of end-of-life care in nearly 500 hospitals in the U.S., utilizing nearly 13,000 bedside nurses as informants of quality. The majority of nurses (58%) rate their hospital's end of life care unfavorably. The most common quality problem cited by nurses (53%) is that patients often experience painful procedures that are not likely to change their clinical outcome. This finding is consistent with growing trends towards aggressive medical intervention in the final days of life, which is widely recognized as inappropriate for terminally ill individuals. Further, over a third of nurses (37.7%) report being discouraged from discussing alternative care options with patients and their families. A similar percentage of nurses say they often disagree with their physician colleagues about end-of-life care decisions, and feel decisions are not made as a team. The study found that end-of-life care is best in hospitals characterized by effective nurse-physician teamwork, where authority is devolved to nurses to act in their areas of expertise, where nurses have manageable workloads, and where they are highly engaged in hospital decision-making. 'For patients and families, making health care decisions at the end of life is stressful. They want to be cared for by a team of providers that elicit and respect their care preferences. They want information about disease progression, symptom management, and the full array of care options. They want to be acknowledged as a whole person-with goals beyond prolonging life. This is at the heart of nurses' work,' says says lead-author Karen Lasater, PhD, RN, Assistant Professor of Nursing. OIG Report Cites Hospice Quality Problems According to a recent audit IFNS6] 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); THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -14- ¢ 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. ""°"] 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. 'FN58l 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. Recent Legislative Activity Federal 2021 CONG US § 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. Arizona 2021 AZ S.B. 1418 (NS), introduced January 27, 2021, provides that chronically ill patients and terminally ill patients have the right to determine, with the assistance and guidance of their health care providers, individual courses of treatment through the use of medications and treatments obtained from a compounding pharmacy. Arkansas 2021 AR H.B. 1585 (NS), adopted April 19, 2021, requiring employees of certain healthcare providers, including hospice, to have a criminal background check. California * 2021 CAA.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 THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -15- hospice to provide verbal and written notice of the patient's rights and responsibilities to the patient or the patient's representative, in a language and manner the person understands, before providing care. * 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 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. Florida 2022 FL S.B. 748 (NS), filed November 2, 2021, prohibiting specified insurer practices related to reimbursements, payment, access, dispensing, or coverage of clinician-administered drugs in hospices and other health care facilities. 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. 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 2021 MD S.B. 891 (NS), introduced February 9, 2021, and 2021 MD H.B. 1112 (NS), introduced February 5, 2021 regarding review of maternal and child mortality and perinatal hospice services. 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 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. 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 * 2021 MS H.B. 98 (NS), introduced January 7, 2021, to extend the date of the repealer on the authority of a hospice medical director to prescribe controlled substances for a patient of the hospice for terminal disease pain without having an in-person face-to-face visit with the patient before issuing the prescription. * 2021 MS H.B. 294 (NS), approved March 22, 2021, to delete the repealer on the section that authorizes medical directors of hospices to prescribe controlled substances for patients of the hospice for terminal disease pain without having an in-person face-to-face visit with a patient before issuing a prescription; to authorize the state department of health to issue up to two new pediatric palliative care hospice licenses during a certain period of time; to require that at least one of the new hospice licenses be issued to an applicant that is located within the Second United States Congressional District; and to extend the date of the repealer on the moratorium on the issuance of new hospice licenses. ¢ 2021 MS H.B. 1309 (NS), introduced January 18, 2021, to provide 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. Missouri ¢ 2021 MO H.B. 632 (NS), introduced January 6, 2021, creates provisions relating to end-of-life care homes. ¢ 2021 MO S.B. 342 (NS), introduced January 6, 2021, modifies provisions relating to hospice inspections. Montana THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -16- ¢ 2021 MT H.B. 43 (NS), introduced March 15, 2021, expanding the practice of telemedicine in health care facilities, including long-term care and hospice facilities. Nevada 2021 NV A.B. 217 (NS), adopted May 25, 2021, requiring the State Board of Health to adopt regulations requiring unlicensed caregivers at designated facilities (including hospice) to receive certain training. New Jersey ¢ 2020 NJ A.B. 576 (NS), introduced January 14, 2020, would make it a crime of the first degree to coerce a patient to request medication pursuant to the 'Medical Aid in Dying for the Terminally Ill Act' or to forge a patient's request for such medication. ¢ 2020 NJ A.B. 577 (NS), introduced January 14, 2020, would repeal the 'Medical Aid in Dying for the Terminally Ill Act.' * 2020 NJ A.B. 830 (NS) and 2020 NJ S.B. 361 (NS), introduced January 14, 2020, would provide Medicaid coverage for certain home visitation program services, including hospice services. * 2020 NJ A.B. 2648 (NS), introduced February 13, 2020, would establish a Medicaid demonstration project to cover room and board services for certain terminally ill patients in the home or other non-institutional setting. ¢ 2020 NJ S.B. 1894 (NS), introduced on February 24, 2020, 'Linnette Lebron's Law'; would modify procedures for marriage or civil union where a party is terminally ill. ¢ 2020 NJ S.B. 2086 (NS), introduced March 16, 2020, would establish a Medicaid demonstration project to cover room and board services for certain terminally ill patients in the home or other non-institutional setting. * 2020 NJ S.B. 3833 (NS), amended/substituted November 8, 2021, 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 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. North Dakota 2021 ND S.B. 2226 (NS), approved March 29, 2021, relating to regulation of residential end-of-life facilities. 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. Ohio 2021 OH S.B. 160 (NS), introduced April 13, 2021, the Veteran Information Act, requiring certain entities to inform veterans about available health care benefits, including hospice services. Oregon 2021 OR S.B. 556 (NS), adopted June 15, 2021, relating to in-person inspections of hospice and other health care facilities. South Dakota 2021 SD S.B. 83 (NS), adopted March 9, 2021, to require the provision of information regarding perinatal hospice. Texas * 2021 TX H.B. 4295 (NS), engrossed May 8, 2021, relating to the authorized release and confidentiality of an autopsy report. ¢ 2021 TX S.B. 41 (NS), introduced September 27, 2021, relating to the development and implementation of the Live Well Texas program to provide health benefit coverage, including hospice and skilled nursing care, to certain individuals. Utah THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -17- 2021 UT H.B. 226 (NS), adopted March 16, 2021, relating to long-term care patient and consumer rights protection, requires facilities (including hospice) to make disclosures. Virginia ¢ 2020 VA H.B. 471 (NS) and 2020 VA S.B. 540 (NS), introduced January 8, 2020, would require the director of every hospice organization and heads of other health care organizations to report to the Department of Health Professions any information of which they may become aware in their professional capacity that they have determined, in good faith, after investigation, review, or consultation, if and as needed, with the appropriate internal boards or committees authorized to impose disciplinary action on a health professional, indicates that there is a reasonable probability that such health professional may have engaged in unethical, fraudulent, or unprofessional conduct. * 2020 VA H.B. 2162 (NS), adopted March 18, 2021, requires every general hospital, outpatient surgical hospital, or hospice licensed by the Department of Health to allow a person with a disability who requires assistance as a result of such disability to be accompanied by a designated support person at any time during which health care services are provided. 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 'Build Back Better" Funding After a series of negotiations with lawmakers, the White House has announced a 'framework' for drafting the Build Back Better Act that would include $100 million to grow the hospice and palliative care nursing workforce and educate the public about those services. IFN5®] Provisions of the forthcoming legislation include $30 million for hospice and palliative care education, $20 million for physician training in that specialty, and $10 million for dissemination of palliative care information. The framework would also allocate $20 million for hospice and palliative care academic career awards. Enhanced services for seniors is one of the cornerstones of the proposal. 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. The rule also updates the Hospice Quality Reporting Program and finalizes changes, beginning with the January 2022 public reporting, for the Home Health Quality Reporting Program to address exceptions related to the COVID-19 PHE. 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. The regulations take effect October 1, 2021. [FN6O] 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 THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -18- October 1, 2021. [FN61] 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. In 2021, hospice and palliative care will be offered by 53 Medicare Advantage plans through the value-based insurance design (VBID) model, according to CMS. Payers and hospice providers will have 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&2 The Medicare Payment Advisory Commission (MedPAC) has voted unanimously to eliminate the update to the FY 2021 Medicare base payment rates for hospice for FY 2022. It also voted to reduce, by 20%, the hospice aggregate cap. The payment cap is the upper limit of funds a hospice can collect from Medicare in a single year. If a hospice exceeds the payment cap, it must refund that amount to CMS. For FY 2021, the hospice cap is $30,684 per patient. About 16% of hospices exceeded the cap in 2019, according to MedPAC. For a cap reduction to take place, Congress would have to accept the recommendation and legislate accordingly. Historically lawmakers have not pursued recommended cuts to hospice payments. [FN63] 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. IFN@4] 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. [FN65] 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). IFN66] 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 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 In a final rule published by CMS in 2011, [FN67] hospices are required to report on the quality of care received by Medicare patients. The final 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: THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -19- ¢ 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. [FN68] Hospice Compare Website CMS unveiled the Hospice Compare [FNE9] Website on August 16, 2017. The goal of Hospice Compare is to help consumers compare hospice providers on their performance and assist consumers in making decisions that are right for them. According to CMS, [FN70} providers can start a conversation with their patients and family members about how the new Hospice Compare website impacts them by: ¢ 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. [FN71] 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. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -20- 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. '*N72I 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. IFN73] 4 2011 study, reported in The Lancet, researched 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. OIG Finds Medicare Hospices Have Financial Incentives to Provider Care in Assisted Living Facilities In a report released January 13, 2015, the OIG recommends that CMS reform the hospice payment system, collect data, and develop quality measures for hospices. [FN74] Although focused on assisted living facilities (ALFs), the OIG notes its recommendations pertain to the hospice benefit more broadly. The OIG report analyzed all Medicare hospice claims from 2007 through 2012, using Certification and Survey Provider Enhanced Reports data and Healthcare Cost Report Information System reports for supplementary information on hospice characteristics. The OIG found Medicare payments for hospice care in ALFs more than doubled in 5 years, totaling $2.1 billion in 2012. Hospices provided care much longer and received much higher Medicare payments for beneficiaries in ALFs than for beneficiaries in other settings. Hospice beneficiaries in ALFs often had diagnoses that usually require less complex care. Hospices typically provided fewer than 5 hours of visits and were paid about $1,100 per week for each beneficiary receiving routine home care in ALFs. Also, for-profit hospices received much higher Medicare payments per beneficiary than nonprofit hospices. The report raises concerns about the financial incentives created by the current payment system and the potential for hospices to target beneficiaries in ALFs because they may offer the hospices the greatest financial gain. Together, the findings in this and previous OIG reports show that payment reform and more accountability are needed to reduce incentives for hospices to focus solely on certain types of diagnoses or settings. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -24- The OIG recommends that CMS, as part of its ongoing hospice reform efforts: (1) reform payments to reduce the incentive for hospices to target beneficiaries with certain diagnoses and those likely to have long stays, (2) target certain hospices for review, (3) develop and adopt claims-based measures of quality, (4) make hospice data publicly available for beneficiaries, and (5) provide additional information to hospices to educate them about how they compare to their peers. CMS agreed with all five recommendations. Effect of Hospice Care on Medicare Hospitalizations and Costs Medicare patients with poor-prognosis cancers who received hospice care had significantly lower rates of hospitalization, ICU admissions, and invasive procedures than those without at the end of life, a study published in JAMA finds. [FN75] During the last year of life, significantly lower health care expenditures were reported as well. The article states that uncertainties regarding how hospice affects health care utilization and costs have hampered efforts to promote it. While more patients with cancer use hospice now than ever before, there are indications that the intensity of care outside of hospice is increasing, and the length of hospice stay decreasing. This study, led by Ziad Obermeyer of Brigham and Women's Hospital and Harvard Medical School, used data from Medicare beneficiaries with poor-prognosis cancers (including, brain, pancreatic, and metastatic malignancies) and matched those enrolled in hospice before death to those who died without hospice care. A nationally representative 20% sample of Medicare fee-for-service beneficiaries who died in 2011 was studied. Matching patients based on various criteria produced a hospice and nonhospice group, with 18,165 in each. The median duration of hospice care was 11 days. Significantly greater health care utilization was found in the nonhospice group, largely for acute conditions not directly related to cancer and higher overall costs. Rates of hospitalizations (65% vs 42%), ICU admissions (36% vs 15%), invasive procedures (51% vs 27%), and death in a hospital or nursing facility (74% vs 14%) were higher for nonhospice beneficiaries compared to hospice patients. In addition, costs during the last year of life were $62,819 for hospice beneficiaries and $71,517 for nonhospice beneficiaries. [FN76] 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. [FN77] Lengthier Hospice Stays and Rising Profits The Washington Post reports that over the past decade, the number of 'hospice survivors" in the U.S. has risen dramatically, in part because hospice businesses earn more by recruiting patients who aren't actually dying. Hospice patients are expected to die; to enroll a patient, two doctors certify a life expectancy of six months or less. But healthier patients are more profitable because they require fewer visits and stay enrolled longer, the Posf's investigation found. Between 2002 and 2012, the proportion of patients who were discharged alive from hospice care rose about 50 percent according to the Post analysis of more than 1 million hospice patients' records over 11 years in California. The average length of a stay in hospice care also jumped substantially over that time, in California and nationally, according to the analysis, and profit per patient quintupled, to $1,975, California records show, according to the analysis. Hospice care has evolved into a $17 billion industry dominated by for-profit companies, and roughly $15 billion of industry revenue came from Medicare last year. The Post cites AseraCare, one of the nation's largest for-profit chains, as an example: about 78 percent of patients who enrolled at the Mobile, Ala., branch left the hospice's care alive, and as many as 59 percent of patients left the AseraCare branch in nearby Foley, Ala., alive, according to company records. There is financial incentive for hospice firms to enroll healthier patients. Medicare pays a hospice about $150 a day per patient for routine care, regardless of whether the company sends a nurse or any other worker out on that day. That means healthier patients, who generally need less help and live longer, yield more profits, which may be costing Medicare billions of dollars a year, the Post reports. In fact, MedPAC, the Medicare watchdog group created by Congress, has reported that in 2011, nearly 60 percent of Medicare's hospice expenditure of $13.8 billion went toward patients who stay on hospice care longer than six months. Furthermore, data suggests that the trend toward longer stays is a response to the financial incentive: while the average nonprofit serves a patient for 69 days, the average for-profit hospice serves a patient for an average of 102 days, according to MedPAC. MedPAC has been recommending that the payments to hospice companies be revised to eliminate the financial incentive for improper care, but Medicare has not yet done so. The hospice industry is opposed to fundamental changes to the payment system; an official with a hospice industry group says that the current payment system is sound and that tampering with it could have unintended consequences, noting that two doctors certify a life expectancy of six months or less for hospice patients, the Post reports. [FN78] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -29- 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. 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, [FN79}] 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. Hospice Use Does Not Increase Long-Stay Nursing Home Costs According to a study conducted by University of Indiana Center for Aging Research and the Regenstrief Institute, use of hospice services does not increase care costs in the last six months of life for long-stay nursing home residents. Investigators found that avoidance of costly hospitalization and subsequent post-acute care in the nursing home appears to offset hospice services costs, even when hospice services are provided over a prolonged period of time. The study looked at 2,510 long-stay nursing home decedents in Indiana, a third of whom received hospice services. Medicare costs were calculated for 2, 7, 14, 30, 90, and 180 days before death; Medicaid costs were calculated for dual-eligible beneficiaries. Total costs and costs for hospice, nursing home, and inpatient care are reported. The mean length of hospice was 103 days (median 34 days); hospice users were more likely to have cancer, a do-not-resuscitate order in place, greater cognitive impairment, and worse activity of daily living (ADL) function, and were less likely to have had a hospitalization in the year before death. In propensity score analyses, hospice users had lower total Medicare costs for all time periods up to and including 90 days before death. For dually eligible beneficiaries, overall costs and Medicare costs were significantly lower for hospice users up to 30 days before death. Medicaid costs were not different between the groups except for the 2-day time period. Age, race, or gender had no effect on the findings. The study found few significant differences in clinical or demographic characteristics between long stay nursing home decedents who did and did not receive hospice services near the end of life. The exception was residents with a cancer diagnosis, who were more likely to receive hospice than those with other diagnoses, also true of hospice use by those not in nursing homes. Advanced dementia also was associated with increased hospice use. The long-stay nursing home residents whose records were reviewed for this study were disproportionately poor, non-white and characterized by high health care costs-individuals often not included in healthcare utilization studies. [FN80] Recent Legislative Activity Federal 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. Arizona 2021 AZ S.B. 1466 (NS), introduced January 28, 2021, provides for the family caregiver grant program. Colorado * 2021 CO H.B. 1187 (NS), adopted May 1, 2021, concerning the implementation of case management redesign to ensure conflict-free case management for members eligible for long-term services and supports under the Medicaid program, including hospice services. * 2021 CO S.B. 214 (NS), adopted May 4, 2021, concerning state payments to licensed hospice facilities for house residential care provided to certain persons enrolled in the medical assistance program, and making an appropriation. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -23- Delaware 2021 DE S.B. 37 (NS), adopted June 3, 2021, relating to viatical settlements. Indiana 2021 IN S.B. 235 (NS), introduced January 7, 2021, requires a provider to include the service facility location in order to obtain Medicaid reimbursement from the office of the secretary of family and social services or a managed care organization. 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 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 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. 5112 (NS), introduced January 25, 2021, requires that the rate for hospice providers, delivering hospice care in a skilled nursing facility, not exceed ninety-five percent (95%) of the rate paid for non-hospice care in a skilled nursing facility. ¢ 2021 RI S.B. 972 (NS), amended/substituted June 29, 2021, would increase wages for direct care workers employed by home nursing care, home care, and hospice providers licensed by the Rhode Island department of health, under the state Medicaid program. 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. Virginia 2020 VA H.B. 2022, introduced January 13, 2021, directs the Department of Medical Assistance Services to include provisions in any agreement with a managed care organization related to communication of information to participating hospice and home care providers about specific requirements for participation in such managed care organization's provider network, including communicating changes to such requirements, developing an audit process for identifying violations of such requirements, and providing training and technical assistance regarding compliance. The bill requires the managed care organization to provide an opportunity for a hospice or home care provider to correct any violations of such requirements that are not related to adherence to a plan of care and a process by which a finding by the managed care organization that a hospice or home care organization has violated such requirements may be appealed to the Department. The bill also directs the Department to develop a process for review of any appeal made of a finding by the managed care organization that a hospice or home care organization has violated requirements for participation in the managed care organization's provider network. V. ADVANCE CARE DIRECTIVES THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -24- 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. ¢ 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. [FN81] 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. [FN82] Ultimately, the U.S. Supreme Court ruled that Mr. Schiavo could authorize the removal of Ms. Schiavo's feeding tube. [FN83] Ms. 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. An AARP Bulletin Poll, conducted in 2007, entitled 'Getting Ready to Go," investigated related to end-of-life decisions and advance care directives, /FN®4I Among the findings: ¢ Most people have some knowledge of the steps involved with completing advance directives, but few have taken action. ¢ Older individuals are more prone to take action than those who are younger. ¢ Healthy individuals' actions differ from those who are less healthy. * As individuals age, differences in actions with regard to health status disappear. ¢ Parents take action more often than their children do. 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. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -25- Less than half of all Physician's Orders for Life-Sustaining Treatment (POLSTs) were concordant with current preferences, researchers found in a recent study. [FN85] BOLSTs 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. 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. [FN86] Researchers at the University of California at San Francisco find that current legal restrictions significantly compromise the clinical effectiveness of advance directives. The study, which surveys medical and legal literature from across the United States, appears in the January 18, 2010 issue of the Annals of Internal Medicine. Advance directives allow patients to designate health care decision-makers and specify health care preferences for future medical needs. The authors recommend that advance directive law and advance care planning evolve into a more flexible, relationship-and communication-based model, in which any type of advance care planning tool or discussion can help guide clinical care. Authors of the study list a number of legal barriers to the clinical effectiveness of advance directives; to improve the clinical efficacy of advance directives, the researchers suggest: ¢ doing away with mandatory legal language to improve readability; * expanding the potential pool of medical decision-makers to include non-medical professionals who may be close to unbefriended adults; * promoting universal acceptance of oral advance directives; ¢ eliminating witness and notary requirements; * adoption by all states of reciprocity laws for directives from other states, regardless of the location or type of planning tool used; and ¢ allowing patients to document their religious, social, and cultural values and preferences for end-of-life care. [FN87] The general themes of recent advance care directive legislative initiatives can be categorized as: * general advance care directive legislation; * simplifying advance care directives; ¢ awareness of advance care directives; THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -26- « providing or withholding life-sustaining treatment; and ¢ the role of surrogates in end-of-life decision-making. 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." [FN88] 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. IFN89] 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. Providing or Withholding Life-Sustaining Treatment A study performed by researchers at Queen Mary University of London found that the religious views of the patient's treating physician could affect the end of life care that a patient receives. The United Kingdom study found that the physicians 'who described themselves as very or extremely religious were less likely to discuss treatment options that could hasten death." At the other end of the spectrum, physicians without strong religious beliefs were more likely to discuss all options with their patients, including providing treatment that would hasten death. The lead researcher, Dr. Clive Seale, concluded that 'Physicians who deal with terminal patients at the end of life should be more aware of how their religious views affect the treatment decisions they make. " [FNS0} As reported by The Philadelphia Inquirer, Kaiser Health News has suggested that a new approach may combine palliative and hospice care to allow active treatment and end-of-life care to occur simultaneously for the terminally ill. IFNST] As opposed to standard Medicaid/ Medicare protocols stipulating that one 'must give up aggressive treatment to get end-of-life counseling and care," the new initiative, says KHN, 'may be especially useful for people using dialysis to extend their lives, and those waiting for organ transplants that may not come in time." In addition, 'the change may encourage people with any kind of terminal illness to take advantage of hospice care earlier." As documented by KHN: The new law instructs Medicaid, the state-federal program for the poor, to cover simultaneous hospice and curative care for children with terminal illnesses immediately. And it directs the federal Medicare program, which covers seniors and disabled people, to launch up to 15 pilot projects around the country to test the concept. If the experiment is deemed successful and doesn't increase costs, then Medicare could make the benefit available to everyone in hospice. Additionally, a panel of experts gathered by doctors from the Mayo Clinic and the Yale University School of Medicine has created guidelines for proceeding with end-of-life treatments for those who are terminally ill and have implanted defibrillators. IFN92] According to McKnight's Long-Term Care News & Assisted Living, the new guidelines include the following recommendations: THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -27- * All patients with implanted electronic devices are encouraged to make advance directives, and to decide on their own whether or not to remove the device. ¢ Adult patients should be assumed to be competent, but if they are incapacitated, a health care proxy should make a decision. In submitting the guidelines, the panel emphasized that neither physicians nor caregivers should 'be compelled to perform tasks that conflict with their ethical values." Effect of Advance Directives on Palliative Care Researchers from the University of Michigan have found that individuals who have advance directives are more likely to receive palliative care and are less likely to die in a hospital. Medicare expenditures for enrollees with advance directives also are lower, especially in higher-spending regions of the United States, the study noted. The study is one of the first to look at national data linking end-of-life spending, treatments and advance directives. Researchers analyzed records of health and retirement study participants who died between 1998 and 2007, including their Medicare claims, and interviews were conducted with beneficiaries' next of kin. The study was published in the October 5 issue of the Journal of the American Medical Association. [FNS3] Caregivers in nursing home and hospitals may forgo palliative and comfort care for patients with 'do not resuscitate" orders, a new study in Oregon suggests. 'The risk is that you make assumptions about the patient because of their DNR. You assume they may not want this treatment or that treatment," says Dr. Erik Fromme, a palliative care specialist at the Oregon Health & Science University. Fromme and his colleagues used a unique registry in Oregon to compare detailed treatment references of more than 25,000 people. Since 2009, Oregon has kept an electronic registry of preferences residents recorded with a document called Physician Orders for Life- Sustaining Treatment, or POLST. The researchers found that 18,000 people, or 72 percent of those in the registry, did not want CPR, but many wanted other treatment, including hospital care. About 55 percent wanted the option of antibiotics for infections. Nearly one- quarter considered a temporary feeding tube appropriate. Previous studies found evidence doctors make assumptions and withhold many kinds of care beyond CPR when patients have a DNR order. Nursing home residents with DNR orders who came down with pneumonia, for example, were 30 percent less likely to be hospitalized than comparable nursing home residents with no DNR, University of Missouri researchers found. Researchers at Johns Hopkins University found a DNR order made doctors significantly less likely to order blood cultures, central lines, transfusions and other treatments when responding to hypothetical cases. [FNO94] 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 Centers for Medicare and Medicaid Services (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. 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. [FN95] 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 THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -28- 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. [FN96] 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. !FN971 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. [FNS8] 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." FN99] Dubbed 'Simon's Law," Kansas was the first to enact legislation, in 2017, 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, Missouri, and New Mexico, are considering similar legislation. Recent Legislative Activity Federal 2021 CONG US HR 5656, introduced October 21, 2021, to amend titles XVIII and XIX of the Social Security Act 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. Alabama 2021 AL H.B. 224 (NS), adopted May 25, 2021, requires doctors to obtain consent of parent or legal guardian of minor prior to entering 'do not attempt resuscitation order' order. 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. Arkansas THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -29- ¢ 2021 AR H.B. 1116 (NS), adopted March 2, 2021, to establish Simon's Law; to clarify the requirement for parent or legal guardian consent for end-of-life medical procedures for minors; to prohibit healthcare facilities or healthcare professionals from instituting end-of- life medical procedures on a minor without consent of a parent or legal guardian. ¢ 2021 AR H.B. 1685 (NS), engrossed April 5, 2021, to amend the Arkansas Healthcare Decisions Act. ¢ 2021 AR H.B. 1686 (NS), engrossed April 12, 2021, amending the Arkansas Physician Order for Life-Sustaining Treatment Act. California 2021 CA A.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 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. 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 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. Maine 2021 ME H.P. 822 (NS), introduced March 18, 2021, amending the law regarding advance health care directives. Maryland ¢ 2021 MD H.B. 203 (NS), introduced January 13, 2021, for the purpose of providing that a will may be made self-proved in a certain manner; altering the requirements of an advance medical directive; requiring a declarant to acknowledge a certain advance medical directive before a notary public; authorizing a notary public to serve as a certain witness for a certain advance medical directive; and generally relating to the execution of wills and advance medical directives. ¢ 2021 MD H.B. 1261 (NS), adopted May 30, 2021, regarding electronic execution of wills, powers of attorney, and advance directives. ¢ 2021 MD S.B. 820 (NS), introduced February 9, 2021, and 2021 MD H.B. 1261 (NS), introduced February 8, 2021, generally relating to the execution of wills, powers of attorney, and advance directives, altering certain provisions of law related to the execution of advance directives to authorize certain witnesses to sign an advance directive in either certain physical or electronic presence of the declarant; providing that a will, a power of attorney, a notarization of a power of attorney, or an advance directive executed in conformance with the provisions of certain executive orders shall be deemed to satisfy certain requirements under this Act; altering certain definitions; defining certain terms; making certain clarifying changes; providing for the retroactive application of this Act. ¢ 2021 MD S.B. 837 (NS), introduced February 9, 2021, generally relating to advance care planning and advance directives, requiring the Maryland Health Care Commission to coordinate the implementation of advance care planning programs in the State; requiring that the coordination include adoption and implementation of certain measures and development and implementation of certain quality metrics; requiring each health insurance carrier to offer electronic advance directives to its members and enrollees at certain times and make arrangements to receive certain notifications; requiring the Maryland Department of Health, in collaboration with local jurisdictions in the State, to develop and implement, for certain years, a plan to provide information about advance care planning and the State- designated electronic advance directive system, and the opportunity to upload certain documents to a certain system or create a certain plan, to certain individuals. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -30- 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 MA S.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 ¢ 2019 MI H.B. 5417 (NS), adopted December 31, 2020, allows parent or guardian to execute do-not-resuscitate order on behalf of certain children. ¢ 2019 MI H.B. 5418 (NS), adopted December 31, 2020, provides for filing, storage, and notice rules for school districts regarding do- not-resuscitate orders and POST forms, and limitation of liability for certain persons. ¢ 2019 MI H.B. 5419 (NS), adopted December 31, 2020, authorizes a guardian or a minor to execute do-not-resuscitate orders. Minnesota 2021 MN H.F. 1087 (NS), introduced February 15, 2021, modification of hospice and assisted living bill of rights. Missouri 2021 MO H.B. 585 (NS), amended/substituted April 27, 2021, authorizing the next-of-kin of a deceased person to delegate control of the final disposition of the remains. Montana 2021 MT H.B. 43, introduced December 13, 2020, would expand the practice of telemedicine, providing that a previously established patient-health care provider relationship is not required to receive services by telemedicine; revising the definition of telemedicine. New Hampshire 2021 NH S.B. 74 (NS), amended/substituted June 3, 2021, relative to advance directives for health care decisions. New Jersey 2020 NJ A.B. 2472 (NS), introduced February 3, 2020, concerning Practitioner Orders for Life-Sustaining Treatment forms. 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 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. ¢ 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. 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. North Dakota 2021 ND H.B. 1415 (NS), introduced January 18, 2021, relating to end-of-life health care decisions; and to provide a penalty. 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. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -31- Oregon * 2021 OR S.B. 219 (NS), engrossed April 30, 2021, related to recommendations for development, adoption and administration of statewide advance directive registry for collection and dissemination of advance directives. * 2021 OR S.B. 818 (NS), introduced March 3, 2021, relating to ratification of the advance directive form adopted by the Advance Directive Adoption Committee. South Carolina 221 SC S.B. 508 (NS), amended/substituted May 5, 2021, relating to do-not-resuscitate orders, 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. Texas ¢ 2021 TX H.B. 102 (NS), relating to an advance directive and do-not-resuscitate order of a pregnant woman and information provided for an advance directive. ¢ 2021 TX H.B. 2183 (NS), engrossed May 14, 2021, relating to durable powers of attorney and the construction of certain powers conferred in those powers of attorney. Utah 2021 UT S.B. 83 (NS), adopted March 16, 2021, renames the life with dignity order as the POLST order; applies the provisions of the Uniform Electronic Transactions Act to signatures that are required on a POLST order; and allows a verbal confirmation, under limited circumstances, to satisfy the requirement for a signature on a POLST order. Vermont 2021 VT S.B. 117 (NS), adopted March 29, 2021, allows remote witnesses for advance directives through June 30, 2022. Virginia 2020 VA S.B. 1190 (NS), adopted March 18, 2021, health standards of learning, advanced directive education for high school students. West Virginia 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. Vi. PALLIATIVE CARE 'Palliative care" may be described as care that seeks to treat symptoms and improve the quality of life in patients with cancer and other serious illnesses. "N1°°l palliative care adapts aspects of the hospice philosophy without requiring patients to forgo curative care or to have a life expectancy of six months or less. [FN101] 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. IFN102] 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 [FN103] 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. In 2021, hospice and palliative care will be offered by 53 Medicare Advantage plans in 2021 through the value-based insurance design (VBID) model, according to CMS. Payers and hospice providers will have 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. [141 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. [FN105] 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." THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -32- 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. " IFN108] 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. As stated in the guidelines, '[mJost importantly, the goal of the NCP Guidelines is to improve the care that patients and families receive by defining and supporting access to high-quality palliative care in all care settings." All practitioners are encouraged to use the NCP Guidelines to strengthen knowledge and skills to better meet the needs of people living with serious illness. 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. New community-based palliative care models are meeting the needs of those with a serious illness who are neither hospitalized nor hospice-eligible, through provision of care in patient homes, physician offices/clinics, cancer centers, dialysis units, assisted and long- term care facilities, and other community settings. Community-based palliative care services are delivered by clinicians in primary care and specialty care practices (such as oncologists), as well as home-based medical practices, private companies, home health agencies, hospices, and health systems. 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. The Fourth Edition was endorsed and supported by more than 80 national organizations. Defining 'Palliative Care" 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. [FN107] 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 IFN108] ond that home-based palliative care could reduce societal health care costs by $103 billion within the next 20 years. [FN109] 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 growing COVID-19 pandemic, palliative care becomes 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 THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -33- researchers in Switzerland. "\""°! 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. Medicare Palliative Benefit Urged by Congress Members Members of the congressional physician's caucus advocated for a Medicare palliative care benefit demonstration in a letter to CMS Administrator Seema Verma. CMS uses demonstration projects to test the viability and functionality of new payment models and other initiatives. Signed by Reps. Neal Dunn, M.D. (R-Fla), Phil Roe, M.D. (R-Tenn.), Jeff VanDrew (D-N.J.), and Sen.-Elect Roger Marshall (R-Kan.), the members noted the significant evidence supporting the need for a CMS-supported community-based palliative care effort 'that would lead to improved quality and cost outcomes for [Medicare] beneficiaries experiencing serious illness." Hospices provide about 50% of community-based palliative care in the United States, according to the Center to Advance Palliative Care. Medicare typically reimburses for palliative care physician services via fee-for-service payment (which generally does not pay for the entire range of interdisciplinary care). Medicare Advantage plans have the option to cover palliative care as a supplemental benefit. [FN111] 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. [FN112] 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. [FN113] 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. [FN114] 'Palliative Care" Triggers Negative Feelings, Study Finds The term 'palliative care" is perceived negatively by cancer patients in a study conducted by researchers at the Princess Margaret Cancer Center in Toronto. "N""5! The researchers analyzed interviews with 48 patients who had advanced cancer and an estimated survival of between 6 and 24 months. Half the patients received early palliative care in an outpatient clinic along with standard cancer THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -34- care, while the other half received standard cancer care only. Quality of life improved for those who received early palliative care, the study found. At first, 'both groups perceived palliative care as synonymous with death; as care at the end of life in a setting where they would die, and in general as a frightening, anxiety-provoking thing they wanted to avoid," said Dr. Camilla Zimmermann, head of palliative care for the hospital and the University Health Network. But that perception changed among those in the palliative care group, the researchers found. She feels that palliative care has a 'branding issue." 'Patients told us if palliative care were called something else, they wouldn't feel so stigmatized." The study was published April 18, 2016, in the Canadian Medical Association Journal. Telehealth Care for Rural Communities: Study Studies have found that African-Americans living in rural areas are more likely to receive medically ineffective, poor quality care than are Caucasians, according to researchers at the University of Alabama at Birmingham. IFN116] To provide adequate palliative care, the researchers will provide a culturally based palliative care program provided through telehealth in three rural hospitals in the Southeast, and compare that to patients receiving regular care, to see if it helps reduce suffering for patients, increases patient and family quality of life, and reduces the burden of care for caregivers. Researchers will study 352 hospitalized African-American and white older adults with life-limiting illnesses in three rural, community hospitals in Aiken, South Carolina, Alexander City, Alabama, and Picayune, Mississippi. None of the hospitals have palliative care resources or palliative team members. The care via telehealth will be provided by three different palliative care physicians, including Rodney Tucker, M.D., director of the Center for Palliative and Supportive Care at UAB. The physicians will not be the only ones involved in this process. The researchers will take a team approach to care, including a community advisory group, the hospitalist from each hospital and the patient's on-site care providers. According to Ronit Elk, Ph.D., the study's co-principal investigator and associate director of the Southeast Institute for Innovation in Palliative and Supportive Care at UAB, even when palliative and hospice services are available, numerous studies have shown that African-Americans underutilize it. The reasons for this include a lack of exposure to hospice and palliative care and a different cultural perspective when it comes to end-of-life care and support. 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. IFN117] 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 § 2565, introduced July 29, 2021, to provide for the testing of a community-based palliative care model. Califomia * 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. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -35- ¢ 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. Connecticut ¢ 2021 CT H.B. 6213 (NS), introduced January 29, 2021, to only require qualifying patients issued a written certification for the palliative use of marijuana to pay the Department of Consumer Protection registration fee, and to waive such fee for qualifying caregivers. ¢ 2021 CT S.B. 861 (NS), introduced February 10, 2021, to exempt veterans issued a written certification for the palliative use of marijuana from the registration and administration fees for medical marijuana. Maine 2021 ME H.P. 793 (NS), adopted July 9, 2021, to advance palliative care utilization in the state. 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. Mississippi * 2021 MS H.B. 296 (NS), engrossed February 3, 2021, to authorize the state Department of Health to issue up to two new pediatric palliative care hospice licenses during a certain period of time; to require that at least one of the new hospice licenses be issued to an applicant that is located within the Second United States Congressional District; to extend the date of the repealer on the moratorium on the issuance of new hospice licenses. ¢ 2021 MS H.B. 910 (NS) and 2021 MS S.B. 2754 (NS), introduced January 18, 2021, to provide that the state department of health may authorize hospice licensees 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 ¢ 2020 NJ A.C.R. 53 (NS), introduced January 14, 2020, would urge Congress to pass the 'Palliative Care and Hospice Education and Training Act' and fund initiatives to expand palliative care. * 2020 NJ A.B. 1072 (NS), introduced January 14, 2020, would establish the Working Group on End-of-Life Care and Palliative Care in the Department of Health. ¢ 2021 NJ S.B. 619 (NS), adopted June 24, 2021, permits use of telemedicine and telehealth to authorize patients for medical cannabis and to issue written instructions for dispensing medical cannabis, for terminally ill patients receiving hospice care. ¢ 2020 NJ S.B. 1816 (NS), introduced on February 24, 2020, would establish the Working Group on End-of-Life Care and Palliative Care in DOH. Oregon 2021 OR H.B. 2981 (NS), adopted July 14, 2021, relating to palliative care. 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. Texas ¢ 2021 TX H.B. 4304 (NS), introduced March 12, 2021, relating to information regarding perinatal palliative care. ¢ 2021 TX S.B. 292 (NS), introduced March 3, 2021, relating to supportive palliative care services. ¢ 2021 TX S.B. 1173 (NS), engrossed March 30, 2021, relating to the regulation of abortion, including information regarding perinatal palliative care and prohibiting discriminatory abortions; authorizing disciplinary action; providing a civil remedy; creating a criminal offense. West Virginia 2021 WV S.C.R. 53 (NS), adopted April 10, 2021, encouraging certain facilities to improve palliative care programs. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -36- Vil. AID IN DYING Adoption by States and the District of Columbia To date, nine states and the District of Columbia have legalized physician-assisted suicide. [FN118] Eight states (California, Colorado, Hawaii, Maine, New Jersey, 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 [FN119] until October 1997. It remained the only state to have enacted such legislation until Nov. 4, 2008 when Washington voters passed Initiative 1000, a ballot measure allowing for physician-assisted suicide. [FN1201 | 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. [FN121] The Washington State Department of Health is required, under the Act, to collect information and make available to the public an annual statistical report. IFN122] 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 concern about loss of autonomy as a reason for requesting a prescription. [FN123] 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. IFN124] 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. IFN125] 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. However, a 2010 survey in the Hastings Center Report found that many hospices in Oregon did not participate in requests by patients for physician-assistance in dying. The survey compiled the responses from 55 hospice program in Oregon (86% of the total number of hospices in Oregon). The report found that hospices' 'role is largely confined to providing information about the law in a neutral manner . . . . Patients must then work on their own to find physicians who are willing to help them die." Of the 55 programs, 52% either did not participate in the law at all, or had very limited participation. In all situations, staff members are forbidden from assisting patients in obtaining or taking medications that will end the patient's life. The study found both legal and moral reasons for the lack of assistance being offered to patients. [FN126] 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 THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -37- 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, despite intense opposition from some religious and disability rights groups. [FN127] th @ rare statement accompanying the signing notice, Brown, a former Roman Catholic seminarian, said he closely considered arguments on both sides of the controversial measure, which makes California only the fifth U.S. state to legalize assisted suicide for terminally ill patients. The law, which took effect Jan. 1, 2016, makes it a felony to pressure anyone into requesting or taking assisted suicide drugs. Advocates for physician-assisted suicide have tried for decades to persuade California to legalize the practice as a way to help end- stage cancer and other patients to die with less pain and suffering, failing six times in the legislature or the ballot box before finally winning passage last month. 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 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. As of December 31, 2016, 111 California residents died with the help of doctor-prescribed drugs under the state's new aid-in-dying law, according to a first-of-its-kind report released Tuesday. Nearly 200 received the drugs under the law, the report said. The End of Life Option Act went into effect on June 9, 2016, ending years of debate over whether the state should allow a mentally competent adult, diagnosed with less than six months to live, to end their life with a lethal drug prescription from their doctor. The law also mandated publication of an annual report by the California Department of Public Health that provides specific details about anyone who requested and may have ingested the drugs. Released on June 27, 2017, the report analyzes statistics from June 9 through December 31, 2016, based on information contained in physicians' forms and California death certificates. Highlights of the report include: ¢ Of the 191 individuals who were prescribed the drugs, 111 (or 58.1 percent), were reported to have died following ingestion of the drugs; and 21 individuals (11.0 percent) died without ingestion of the drugs. The outcome of the remaining 59 individuals, or 30.9 percent, who had been prescribed aid-in-dying drugs, was undetermined, as there had been no outcome reported as of Dec. 31, 2016. * Nearly 60 percent were suffering from cancer; 18 percent had been diagnosed with a neuromuscular disorder like ALS or Parkinson's disease; 9 percent from heart disease; 7% percent from respiratory diseases. * The median age of people who used the new law was 73; 42 percent were aged 80 and over. ¢ The decedents were 89.5 percent white, 6 percent Asian, 3 percent black, and 3 percent Hispanic; 54.1 percent were female. ¢ 83.8 percent were receiving hospice and/or palliative care, and 72.1 percent had at least some level of college education On May 15, 2018, a Riverside County Superior Court judge overturned California's physician-assisted suicide law, which allows terminally ill patients to request lethal medications from their doctors. Judge Daniel A. Ottalia said that the California Legislature violated the law by passing the End of Life Option Act during a special session dedicated to healthcare issues. The state attorney general has five days to file an appeal to keep the law in place. An attorney representing Compassion and Choices, which advocated for the law, said he believes the passage of the law was constitutional because aid in dying is a healthcare issue. Alexandra Snyder, head of the Life Legal Defense Foundation, one of the groups that filed the lawsuit said 'We're very happy with the decision today. We will now wait and see what the attorney general does.' THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -38- In a statement sent to the Los Angeles Times, California Attomey General Xavier Becerra said: 'We strongly disagree with this ruling and the state is seeking expedited review in the court of Appeal." [FN 128] 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. [FN128] A House subcommittee has added a policy rider to a government appropriations bill (2017 US HR 6147) that would repeal the medical aid in dying bill in the District of Columbia. The rider was not approved in the Senate subcommittee version of the bill. D.C. Congresswoman Eleanor Holmes Norton authored an amendment to eliminate the rider, but the House Rules Committee refused to allow debate on it. The D.C. City Council passed the Death with Dignity Act with an overwhelming majority in 2016, with the support of most D.C. residents. After decades of debate, Hawaii has become 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 shall retain 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. Public Support A Gallup poll in 2015 found that 68% of Americans feel doctors should be legally allowed to assist terminally ill patients to commit suicide. This a marked increase of 10% over the finding in 2014 and, support for euthanasia has risen nearly 20 percentage points over the last two years and stands at the highest level in over a decade. Gallup reports that most of the increased support came from 18- THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -39- to 34-year-olds. Unlike earlier polls, use of the word 'suicide" did not appear to temper support of doctor-assisted suicide. Further, a majority of Americans (56%) now say that doctor-assisted suicide is 'morally acceptable, an increase of seven points since 2001. [FN130] Faith-based Hospitals Oppose Aid-in-Dying Laws When Colorado veteran geriatrician Dr. Barbara Morris went to court to fight for the right of her patient to use the state's medical aid- in-dying law, her employer, Christian-run Centura Health Corp. fired her, citing religious doctrine that describes 'assisted suicide" as 'intrinsically evil." [FN131] According to Definitive Healthcare, 5 of the top 10 hospital systems by net patient revenue are associated with the Roman Catholic Church, including hospitals that did not previously have any religious affiliation. [FN132] At the same time, there are 10 jurisdictions in the U.S. where aid-in-dying has been approved, and public support for the option is increasing. Centura claims that Morris violated the firm's governing rules, the Ethical and Religious Directives for Catholic Health Care Services. The directives state that Catholic health care providers 'may never condone or participate in euthanasia or assisted suicide in any way." According to a spokeswoman, Centura believes that the freedom of religion doctrine 'at the heart of the First Amendment to the U.S. Constitution supports our policies as a Christian health-care ministry." According to the KHN article, the argument based on the First Amendment has gained support recently in conservative circles. Support for provider resistance in the Trump Administration is evidenced by adoption in May 2019 of the so-called 'conscience rule" that strengthens the rights of hospitals and health workers to refuse to participate in patient care based on religious or moral grounds. [FN133] 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) 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. [FN134] Recent Legislative Activity Arizona ¢ 2021 AZ H.B. 2254 (NS), introduced January 21, 2021, relating to end-of-life decisions for terminally ill patients, providing for medical aid in dying. ¢ 2021 AZ S.B. 1775 (NS), introduced February 3, 2021, relating to end-of-life decisions for terminally ill patients, providing for medical aid in dying. * 2021 AZ S.B. 1781 (NS), introduced February 3, 2021, relating to end-of-life decisions, care choices for terminally ill patients. 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 2021 CT H.B. 6425 (NS), introduced February 10, 2021, 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 THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -40- 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. Indiana 2021 IN H.B. 1074 (NS), introduced January 4, 2021, allows 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 a peaceful death; specifies requirements a provider 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; establishes a Level 1 felony if a person: (1) without authorization of the patient, willfully alters, forges, conceals, or destroys a request for medication or a rescission of a request for medication with the intent or effect of causing the individual's death; or (2) knowingly or intentionally coerces or exerts undue influence on an individual to request medication to bring about a peaceful death or to destroy a rescission of a request for medication to bring about a peaceful death; establishes a Class A misdemeanor if a person, without authorization of the patient, willfully alters, forges, conceals, or destroys a request for medication or a rescission of a request for medication in order to affect a health care decision by the individual; establishes certain criminal and civil immunity for health care providers. 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. 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. Nevada 2021 NV A.B. 351 (NS), introduced March 22, 2021, revising provisions concerning medical certificates of death relating to a person who self-administers a medication that is designed to end his or her life; authorizing a physician to prescribe a medication that is designed to end the life of a patient under certain circumstances; prohibiting persons other than a patient from administering a medication that is designed to end the life of the patient; imposing requirements on certain providers of health care and health care facilities relating to the records of a patient who requests a medication that is designed to end his or her life; providing immunity to certain providers of health care and health care facilities that take certain actions relating to prescribing or dispensing a medication that is designed to end the life of a patient; prohibiting certain fraudulent, deceptive or coercive acts relating to prescribing or dispensing a medication that is designed to end the life of a patient; authorizing the owner or operator of a health care facility to prohibit certain persons from providing certain services relating to a medication that is designed to end the life of a patient; prohibiting a person from conditioning provisions of a will, contract, agreement or policy of life insurance on the request for or acquisition or administration of a medication that is designed to end the life of the person; prohibiting a person from refusing to sell or provide life insurance or denying benefits to or imposing additional charges against a policyholder or beneficiary because the insured requested or revoked a request for a medication that is designed to end the life of the person; and providing penalties. New Mexico «2021 NM H.B. 47 (NS), adopted April 8, 2021, enacting the Elizabeth Whitefield End-of-life Options Act; establishing rights, procedures and protections relating to medical aid in dying; establishing reporting requirements; removing criminal liability for providing assistance pursuant to Act. ¢ 2021 NM S.B. 308 (NS), introduced February 1, 2021, enacting the Elizabeth Whitefield End-of-Life Options Act; to establish rights, procedures and protections relating to medical aid in dying; establishing reporting requirements; removing criminal liability for providing assistance pursuant to the Act. New York THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -41- ¢ 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. 5572 (NS), introduced February 12, 2021, creates 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. 775 (NS), introduced April 1, 2021, establishes detailed steps and safeguards to create 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. Texas 2021 TX H.J.R. 15 (NS), introduced January 12, 2021, applying to the Congress of the United States to call a convention under Article V of the United States Constitution for the limited purpose of proposing an amendment to the constitution to prohibit abortion, euthanasia, and certain other acts. Vermont 2021 VT S.B. 74 (NS), introduced February 9, 2021, 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 2020 VA H.B. 1649 (NS), introduced January 16, 2020, would allow an adult diagnosed with a terminal condition to request, and an attending health care provider to prescribe, a self-administered controlled substance for the purpose of ending the patient's life in a humane and dignified manner. The bill requires that a patient's request for a self-administered controlled substance to end his life must be given orally on two occasions and in writing, signed by the patient and one witness, and that the patient be given an express opportunity to rescind his request at any time. The bill makes it a Class 2 felony (i) to willfully and deliberately alter, forge, conceal, or destroy a patient's request, or rescission of request, for a self-administered controlled substance to end his life with the intent and effect of causing the patient's death; (ii) to coerce, intimidate, or exert undue influence on a patient to request a self-administered controlled substance 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; or (iii) to coerce, intimidate, or exert undue influence on a patient to forgo a self-administered controlled substance for the purpose of ending the patient's life. The bill also 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 a self-administered controlled substance 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. VII. 'RIGHT TO TRY" THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -42- 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. IFN135] 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. 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 Actions Rhode Island 2021 RI H.B. 5077 (NS), introduced January 22, 2021, creates the 'Neil Fachon Terminally Ill Patients' Right To Try Act of 2021,' which establishes the conditions for the use of experimental treatments for terminally ill patients. IX. ORGAN DONATION AND TRANSPLANTATION 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 comeas. 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 the U.S. Department of Health and Human Services (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 [FN136] provided by HRSA supplies extensive and detailed information on state legislation. Recent Legislative Activity THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -43- Alabama 2021 AL H.B. 263 (NS), introduced February 2, 2021, would prohibit discrimination against an individual from receiving an organ transplant based on the individual having a disability. The bill would also require health care practitioners, hospitals and other health care facilities, and organ transplant centers to provide reasonable accommodations to an individual with a disability in medical need of an anatomical gift or organ transplant. Arkansas 2021 AR S.B. 155 (NS), adopted April 26, 2021, to establish Lila's law; to prohibit discrimination against individuals with disabilities regarding access to organ transplantation; to require covered entities to make reasonable modifications to policies, practices, and procedures; to provide auxiliary aids and services during the organ transplantation process. 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. Colorado * 2021 CO H.B. 1169 (NS), adopted May 6, 2021, prohibiting discrimination against a potential organ transplant recipient based solely on the person's disability. ¢ 2021 CO S.B. 195 (NS), adopted May 7, 2021, concerning permitted notarization of certain probate documents, including anatomical gift donations. Connecticut 2021 CT H.B. 6387 (NS), adopted July 12, 2021, prohibits certain insurers from engaging in certain discrimination against living organ donors; and provides that prohibited discrimination against living organ donors constitutes a violation of the Connecticut Unfair Insurance Practices Act. Delaware 2021 DE S.B. 87 (NS), adopted September 10, 2021, relating to anatomical gifts and the Delaware Health Information Database. 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. 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 THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -44- 2021 IN S.B. 295 (NS), introduced January 11, 2021, prohibits 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. Maryland ¢ 2021 MD H.B. 301 (NS) and 2021 MD S.B. 265 (NS), adopted May 30, 2021, relating to the Maryland Revised Uniform Anatomical Gift Act, authorizing a person who chooses to be an organ donor to designate if the anatomical gift is to be used for certain purposes; requiring the Organ Procurement Organization or its designee to produce and provide to each Motor Vehicle Administration location educational materials; requiring each Motor Vehicle Administration location to prominently display and make available to prospective donors on request the educational materials; altering the purposes for which certain anatomical gifts may be used; requiring that a certain gift registered before a certain date be used only for certain purposes; repealing provisions of law that require certain persons to search certain individuals for a document of gift or any other information identifying the individual as a donor, that specify certain procedures to be taken if a document is located, and that concern certain administrative sanctions; requiring a certain procurement organization to make a certain search of certain registries under certain circumstances. ¢ 2021 MD S.B. 265 (NS), enrolled March 14, 2021, authorizing a person who chooses to be an organ donor on or after a certain date to designate if the anatomical gift is to be used for certain purposes; requiring the Organ Procurement Organization or its designee to produce and provide to each Motor Vehicle Administration location educational materials that include certain information; requiring each Motor Vehicle Administration location to prominently display and make available to prospective donors on request the educational materials. 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 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 * 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. 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 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. Mississippi 2021 MS H.B. 191 (NS), introduced January 8, 2021, to enact Cole's Law to prohibit discrimination against recipients of an anatomical gift or organ transplant based on disability. Montana ¢ 2021 MT H.B. 641 (NS)S, adopted May 7, 2021, authorizing a search and rescue unit to possess human remains for training search and rescue canines; revising laws related to anatomical gifts to allow search and rescue units as authorized donees in certain circumstances; allowing monetary donations for the support and training of search and rescue units. ¢ 2021 MT S.B. 155 (NS), adopted May 12, 2021, providing for nondiscrimination in access to anatomical gifts and organ transplantation on the basis of disability; providing a cause of action for alleged violation of nondiscrimination provisions; prohibiting insurers from denying coverage solely on the basis of disability. Nebraska 2021 ND L.B. 251 (NS), introduced January 11, 2021, would change the age for organ and tissue donation. Nevada ¢ 2021 NV S.B. 134 (NS), introduced February 18, 2021, relating to anatomical gifts, revising provisions governing the indication of a person's intent on a driver's license or identification card. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -45- ¢ 2021 NV S.B. 305 (NS), adopted May 31, 2021, prohibiting certain providers of medical or related services from taking certain actions relating to organ transplants solely on the basis of a person's disability; limiting the extent to which such a provider is authorized to consider a person's disability wnen making recommendations or decisions concerning an organ transplant; requiring such a provider to take certain actions to provide a person with a disability access to any service provided by the provider related to an organ transplant; authorizing a person aggrieved by the failure of such a provider to comply with certain requirements to institute a civil action for injunctive or other appropriate relief; prohibiting an insurer from taking certain actions related to an organ transplant because the insured is a person with a disability. 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 ¢ 2020 NJ A.B. 2217 (NS), introduced January 14, 2020, would provide for opting out of organ and tissue donation. ¢ 2020 NJ A.B. 2218 (NS), introduced January 14, 2020, would provide that the organ donor designation on a driver's license or identification card remains upon renewal of a license or card under certain circumstances. * 2020 NJ A.B. 3199 (NS), 2020 NJ S.B. 2315 (NS), amended/substituted January 11, 2021, prohibits discrimination against living organ donors in relation to life, health, and long-term care insurance. ¢ 2020 NJ A.B. 3558 (NS), introduced on February 25, 2020, would require insurers to provide information about organ donation and allow insurers to limit reimbursement for organ transplant if recipient has not made gift pursuant to Revised Uniform Anatomical Gift Act. ¢ 2020 NJ S.B. 510 (NS), introduced January 14, 2020, would require insurers to provide information about organ donation and allow insurers to limit reimbursement for organ transplant if recipient has not made the gift pursuant to Revised Uniform Anatomical Gift Act. ¢ 2020 NJ S.B. 2315 (NS), introduced April 9, 2020, would prohibit discrimination against living organ donors in relation to life, health, and long-term care insurance. New York ¢ 2021 NY A.B. 6392 (NS), introduced March 17, 2021, and 2021 NY S.B. 5973 (NS), introduced March 24, 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. North Carolina ¢ 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), engrossed June 25, 2021, prohibiting insurers from discriminating against living organ donors. Oklahoma ¢ 2021 OK S.B. 170 (NS), engrossed March 2, 2021, relating to judicial authorization for anatomical gifts under certain circumstances. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -46- ¢ 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. Rhode Island ¢ 2021 RI H.B. 6079 (NS), introduced March 3, 2021, prohibits discrimination against a potential organ transplant recipient based solely on a physical or mental disability. ¢ 2021 RI S.B. 126 (NS), introduced January 26, 2021, require that all applicants for driver's licenses and registry-issued identification cards automatically become organ donors unless they execute a declination card. ¢ 2021 RI H.B. 5388 (NS), introduced February 5, 2021, requiring that all applicants for driver's licenses and registry-issued identification cards automatically become organ donors unless they execute a declination card. South Carolina * 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), introduced March 24, 2021, relating to the jurisdiction of a coroner over a body that is the subject of an anatomical gift, 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. 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. ¢ 221 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. Texas ¢ 2021 TX H.B. 317 (NS), adopted May 24, 2021, prohibiting discrimination against living organ donors by certain insurers, including long-term care insurers. ¢ 2021 TX H.B. 3701 (NS), introduced March 11, 2021, relating to publication of national organ transplant waiting list information on the Department of State Health Services' Internet website and donors included in the anatomical gift registry. ¢ 2021 TX S.B. 212 (NS), relating to the making of an anatomical gift. Virginia ¢ 2020 VA H.B. 1856 (NS), introduced January 13, 2021, would permit trusts, advance medical directives, and refusals to make anatomical gifts to be signed and notarized, as appropriate, by electronic means. The bill also codifies the Uniform Electronic Wills Act, which permits a testator to execute a will by electronic means. The Act requires that the will be signed by two witnesses who are in the physical or electronic presence of the testator and acknowledged by the testator and attesting witnesses in the physical or electronic presence of a notary public. * 2020 VA S.B. 1435 (NS), amended/substituted February 3, 2021, and 2020 VA H.B. 1856 (NS), amended/substituted January 29, 2021, providing for electronic execution of estate planning documents and codification of the Uniform Electronic Wills Act; permits trusts, advance medical directives, and refusals to make anatomical gifts to be signed and notarized, as appropriate, by electronic means. 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. ¢ 2021 WV S.B. 73 (NS), introduced February 10, 2021, prohibiting discrimination in access to organ transplants based on physical or mental disability. Wisconsin THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -47- 2021 WI S.B. 538 (NS), adopted December 3, 2021, prohibiting discrimination in organ transplantation on the basis of disability. Wyoming 2021 WY H.B. 111 (NS), adopted March 30, 2021, prohibiting discrimination in the provision of health care services and insurance for organ transplants and related procedures based on a person's disability. X. TERMINALLY ILL INMATES AND PRISONERS Recent Legislative Activity Federal 2021 CONG US § 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, Arizona ¢ 2021 AZ H.B. 2776 (NS), introduced February 2, 2021, providing for release of a prisoner on medical parole if the prisoner has been examined by a physician and has received a written diagnosis that includes prognosis that the prisoner is terminally ill. * 2021 AZ S.B. 1478, introduced January 28, 2021, provides medical parole for a prisoner that is terminally ill and is not reasonably expected to live for more than two years. California ¢ 2021 CAA.B. 124 (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 CAA.B. 960 (NS), amended/substituted April 22, 2021, would require a designated medical representative from the State Department of Public Health to participate in the evaluation of prisoners for compassionate release or for medical parole. * 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 2021 CT S.B. 1058 (NS), amended/substituted April 26, 2021, to modify standards used by the Board of Pardons and Paroles to determine when an inmate may be eligible for compassionate parole release and to clarify that whistle blower protections apply to staff of the Department of Correction who report suspected unlawful uses of force by other staff members. Florida 2022 FL S.8. 784 (NS), filed November 2, 2021, establishing the conditional medical release program within the Department of Corrections for inmates who are terminally ill or suffering from a permanently incapacitating medical condition; authorizing certain inmates be released on conditional medical release before serving 85 percent of their term of imprisonment; specifying that inmates do not have a right to conditional medical release or to a certain medical evaluation; providing that inmates are considered medical releases upon release from the department into the community. 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. Louisiana 2021 LA H.R. 51 (NS), adopted June 2, 2021, to urge and request the Department of Public Safety and Corrections, the Louisiana Department of Health, physicians at private and state medical facilities who treat incarcerated patients, and other community members and stakeholders to study the current eligibility, recommendation, and approval processes for the medical parole program and the medical treatment furlough program as well as for compassionate release as provided by the policy of the Department of Public Safety and Corrections for persons who are terminally ill. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -48- 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 2021 MS H.B. 1174 (NS), engrossed Feb 4, 2021, to authorize the department of corrections to provide for hospice care services for inmates who are confined in facilities under the jurisdiction of the department and who are terminally ill. New Jersey 2020 NJ S.B. 2594 (NS), introduced June 22, 2020, would establish a compassionate release program for inmates diagnosed with a terminal condition, disease, or syndrome. 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. 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. Pennsylvania 2021 PA S.B. 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. 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. Virginia ¢ 2020 VA H.B. 782 (NS) and 2020 VA S.B. 493 (NS), introduced January 8, 2020, would provide for the conditional release of geriatric, terminally ill, or permanently physically disabled prisoners serving a sentence imposed upon a conviction for a felony offense, other than a Class 1 felony. * 2020 VA H.B. 2167 (NS), adopted April 7, 2021, providing for earlier release date for terminally ill inmates. * 2020 VA H.B. 5053 (NS) and 2020 VA S.B. 5018, introduced August 18, 2020, would provide that any person serving a sentence imposed upon a conviction for a felony offense, other than a Class 1 felony, who is terminally ill or permanently physically disabled is eligible for consideration by the Parole Board for conditional release. The bill also provides that any person serving such sentence (i) who is 65 years of age or older and has served at least five years of the sentence imposed or (ii) who is 60 years of age or older and has served at least 10 years of the sentenced imposed is eligible for consideration by the Parole Board for conditional release without the need to petition the Parole Board. ¢ 2020 VA S.B. 1397 (NS), adopted March 18, 2021, providing for conditional release of geriatric or terminally ill inmates. ¢ 2020 VA S.B. 5034 (NS), introduced August 18, 2020, would provide that any person serving a sentence imposed upon a conviction for a felony offense, other than a Class 1 felony, who is terminally ill or permanently physically disabled is eligible for consideration by the Parole Board for conditional release. The bill also provides that any person serving such sentence (i) who is 65 years or age or older and has served at least five years of the sentence imposed or (ii) who is 60 years of age or older and has served at least 10 years of the sentenced imposed is eligible for consideration by the Parole Board for conditional release without the need to petition the Parole Board; establishes a four-level classification system for the awarding and calculation of earned sentence credits; and requires the calculation of earned sentence credits to apply retroactively to the entire sentence of any inmate who is confined in a state correctional facility and participating in the earned sentence credit system. XI. CONCLUSION End-of-life issues remain at the forefront in 2021 as hospitals deal with the onslaught of 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 later years. Meanwhile, related issues involving the definition and compliance requirements of advance care directives as well as improving THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -49- the awareness of their existence through registries or other means remain under scrutiny in many states. Throughout 2021, HPTS will continue to monitor legislative and regulatory activity pertaining to COVID-19, hospice, palliative care, death with dignity initiatives, advance care directives, and other end-of-life care issues. © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service [FN2] . Report from: APA Working Group on Assisted Suicide and End-of-Life Decisions, available at: http:/Avww.apa.org/pubs/info/reports/ aseol.aspx#. 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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. [FN14] . Ricardo Alonso-Zaldivar, "Nursing home COVID-19 cases rise four-fold in surge states," AP (Nov. 8, 2020), available at: https:// apnews.com/article/virus-outbreak-only-on-ap-chicago-nursing-homes-596ef4bfe1 8313ae72368e2c86e85i27. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -50- [FN15] . Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. ?? 512175207. [FN16] . 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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_328&utm_medium=email&utm_term=0_9b5a8c75fe- dbaGa3df80-150888080&. [FN25] . Kristin Easterling, 'What is the Protecting Access to Post-COVID-19 Telehealth Act?,' HomeCare (July 28, 2020), available at: https:// www.homecaremag.com/august-2020/protecting-access-post-covid 1 9-telehealth-act. [FN26] . 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/. [FN27] . Douglas B. 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Available at: http:/Avww.mcknights.com/people-with-dementia-more-likely-to-die-at-home-than-a-facility/article/240869/? DCMP=EMC- MCK_Weekly. [FN47] . Available at: http://onlinelibrary.wiley.com/doi/10.1 11 1/j.1532-5415.2012.03905.x/abstract. [FN48] . 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:/Awww.cms.gov/newsroom/fact-sheets/cms-finalizes-calendar-year-2022- home-health-prospective-payment-system-rate-update-home-health. [FN49] . 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. [FN50] . Joan M. Teno, et al., "Change in End-of-Life Care for Medicare Beneficiaries-Site of Death, Place of Care, and Health Care Transitions in 2000, 2005, and 2009." 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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/. [FN55] . "End-of-life care quality remains a problem-nurses may be a solution," University of Pennsylvania School of Nursing, Public Release, EurekaAlert! (Dec. 17, 2018), available at: https:/Avww.eurekalert.org/pub_releases/2018-12/uops-eol121718.php. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -53- [FN56] . '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. [FN57] . 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