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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_2593_Библиотеки_им_академика_М_И_Перельмана
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review of the medication profile as part
of the initial assessment of new
patients. The medication regimens of
hospice patients should be continually
reviewed and updated, with
unnecessary, ineffective, or duplicative
medications discontinued.
Patients near end of life can experience
a number of distressing symptoms.
These should be anticipated and treated
in a timely manner that is acceptable to
the patients and their families.
Case 6-1 (Question 3),
Table 6-3
Well-trained pharmacists can improve
medication management for hospice
patients, while helping the hospice
manage their drug costs.
Case 6-1 (Question 2)
Many barriers exist regarding pain
management and the use of opioids.
Case 6-1 (Question 4)
Effective pain management uses a
variety of approaches.
Case 6-2 (Question 1)
Pain and symptom management may at
times require an aggressive approach.
Case 6-3 (Questions
1–3)
INTRODUCTION
Hospice and Palliative Care
End-of-life care is care provided in the period leading up to an
inevitable death and can be provided under hospice or palliative care
or outside of a formal program.1 Hospice care and palliative care are
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similar, but distinct terms sharing the common belief that the relief of
suffering is a long-standing, central, and fully legitimate aim of
medicine. The basic principle of end-of-life care is to optimize the
quality of life for the patient and family in the last weeks and months
of life as well as to provide support for the family beyond the end of
life into bereavement.
Palliative care, which includes hospice care, is ideally introduced
early in the disease progression to provide support to patients of all
ages with a serious chronic or life-threatening illness. It can be
provided concurrently with other treatments to cure or reduce
disease or it can be provided independently. The word palliation,
derived from the Latin word pallium (a cloak), has been defined as
“treatment to reduce the violence of a disease.”
2,3
The World Health
Organization and the National Consensus Project for Quality
Palliative Care define palliative care as a patient- and familycentered approach that improves the quality of life of patients and
their families who are facing a life-threatening illness, by preventing
and relieving suffering through early identification, assessment, and
management of pain and other physical, psychosocial, and spiritual
problems while affirming life and regarding death as a normal
process.
4,5
Palliative care can be provided wherever patients receive
care: in the hospital, physician practice sites, ambulatory clinics,
community pharmacies, and long-term care facilities.
Hospice and palliative medicine became a recognized
subspecialty of internal medicine in 2006, awarded by the American
Board of Medical Specialties and is currently a subspecialty
certification for nine other specialty areas, including anesthesiology,
emergency medicine, and pediatrics.6 The Joint Commission offers
an Advanced Certification Program for Palliative Care to recognize
hospitals that provide high-quality palliative care services.7 There is
currently no specialty certification available for pharmacists in
hospice or palliative care, although there are 26 American Society of
Health-System Pharmacists (ASHP)-accredited PGY2 (postgraduate year 2) residencies in palliative care and pain
management.
8,9
A small number of advanced degree programs are
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available, offering additional training for pharmacists in palliative
care, and ASHP offers a certificate program in pain management.
Hospice, originally a place or way station for people making a
pilgrimage, is considered both a philosophy of care and a place to
deliver care. Hospice care focuses on the palliation of pain and other
symptoms when active treatment to cure a terminal illness ends.
Hospice care can be delivered in a building designated as a hospice,
in the patient’s home, or in a facility where the patient resides. As a
programmatic model for delivering palliative care, hospice care
provides an interdisciplinary team approach to individualized
symptom management (eg, pain), as well as psychosocial,
emotional, spiritual, and bereavement support for the patient and his
or her family and caregivers during the last months of life while no
longer pursuing active or curative treatment.
10
Hospice Care in the United States
Most hospice care in the United States is provided under the
Medicare Hospice Benefit by hospice programs certified by the
Centers for Medicare and Medicaid Services (CMS). According to
estimates of the National Hospice and Palliative Care Organization
(NHPCO), there were approximately 4639 Medicare-certified hospice
programs in the United States in 2018.10 Of all deaths of Medicare
recipients in the United States, 50.7% occurred under hospice care,
with 1.55 million beneficiaries enrolled in a hospice program for 1
day or more during 2018. During the Medicare demonstration project
(1980–1982, just before the creation of the Medicare Hospice Benefit
as part of the Social Security Act), 93% of home hospice patients
had cancers of various types.11 In 2018, hospices provided care for
patients with a wider variety of terminal illnesses (eg, cancer [29.6%
of all admissions], circulatory or heart disease [17.4%], dementia
[15.6%], respiratory disease [11%], stroke [9.5%], chronic kidney
disease [2.2%], and other [14.7%]).10 This care was provided
primarily in the patient’s home (55.6%), in an inpatient facility (0.8%),
or in another unspecified location (6.6%).
10
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Adults age younger than 65 years account for <5.1% of the
hospice population under the Medicare benefit.10 Pediatric patients,
who may range in age from prenatal to young adults, represent a
unique challenge for hospice care. Regulatory, financial, cultural, and
educational barriers play a role in diminished access to hospice care
for pediatric patients because treatment is often pursued late in the
progression of disease.
12–14
Referrals for pediatric oncology patients
to palliative care often occurs late in the course of illness.15 Although
states are required to offer hospice care to pediatric patients under
Medicaid and other state programs as part of the Affordable Care
Act expanding benefits to improve coordination of care,
16
community-based pediatric palliative care may be a better initial
alternative for these patients and can serve as a bridge to
subsequent hospice admission.
14
Medicare Hospice Benefit
The regulatory framework for the provision of hospice care under
Medicare is defined in 42 CFR (Code of Federal Regulations) Part
418, Medicare and Medicaid Programs: Hospice Conditions of
Participation and is funded from Part A (the hospital portion) of
Medicare.
17,18
Patients are eligible for this benefit if, in the opinion of
two physicians (ie, patient’s primary care physician and hospice
medical director), the natural course of their disease will result in
death within 6 months. The hospice medical director determines and
documents the terminal diagnosis and any other conditions
contributing to the terminal prognosis. Eligibility for hospice can
continue beyond the initial certification if the hospice medical director
recertifies eligibility at defined intervals, called certification periods.
Other insurance payers generally follow this criterion. In electing this
benefit when signing the hospice election form, patients accept the
palliative rather than the curative approach provided by hospice. All
care related to these diagnoses is coordinated, provided, and paid
for by the Medicare-certified hospice program. CMS has clarified that
virtually all diagnoses are related to the terminal diagnosis and
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prognosis; if a program disagrees, the hospice medical director must
specifically document why a diagnosis is not related.
19,20
Hospice care is provided (and reimbursed) under Medicare at four
levels, all of which can be modified at any time based on a patient’s
condition or caregiving needs:
assisted living facility)
required owing to symptom management or a caregiving crisis)
where a nurse or home health aide provides care for at least 8
hours in a day (ending at midnight); 50% of this care must be
provided by a nurse.
hospital or skilled nursing facility related to symptoms that cannot
be managed in the home)
give the caregiver a break or respite
Most care, consisting of pain and symptom management and
assistance with activities of daily living, as well as psychosocial
support, is provided to hospice patients at the routine level of care.
Unlike home health care under Medicare, patients in hospices do
not have to be homebound. They may freely visit their primary care
provider (ie, physician or nurse practitioner) for any reason, including
reasons that are documented as unrelated to their terminal illness.
The primary care provider will be paid directly by Medicare. Patients
may use their regular Medicare benefits for the documented
unrelated illnesses; visits to providers for care or treatments
unrelated to the primary hospice diagnosis are not limited or
restricted. Patients may revoke (terminate) their election of the
Medicare Hospice Benefit at any time (eg, end hospice care to
pursue curative treatment or seek treatment outside the hospice plan
of care [POC] or if they move outside of the hospice service area).
Patients may, at a later date, choose to return to hospice care or
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change to a different hospice program, without restrictions or loss of
benefits.
18
It is common for patients to be referred to hospice when death is
imminent. Median lengths of stay have declined, from 37.1 days
during the Medicare demonstration project (1980–1982) to 26 days
in 2005 and to 18 days in 2018.
10,11
Approximately 27.9% of patients
admitted to a hospice program in 2018 died or were discharged
within 7 days; 40% received services for ≤14 days.
10
Hospice programs have historically received a fixed daily payment
to provide all care related to the terminal diagnosis (eg, medications,
supplies, durable medical equipment, procedures, home health
aides, provider visits, spiritual care, bereavement services). The
reimbursement rates for the four levels of hospice care under the
Medicare Hospice Benefit are established each summer for the
following fiscal year, effective October 1. A baseline reimbursement
rate is set, along with an adjustment for wage differentials (the wage
index) based on the local cost of living. There are additional
adjustments made for rural hospices and for the submission of
quality data. Effective in fiscal year 2014, hospices that do not
submit quality data receive a 2% reduction in reimbursement for all
levels of care.
21
Programs generally have high costs at the start of care due to
personnel costs involved in the admission, assessment, and
development of the initial POC, as well as obtaining medications,
medical equipment, and medical supplies. High costs are also
encountered nearer to the end of a patient’s life, when new problems
can appear and symptoms often intensify. In recognition of this, CMS
implemented a tiered hospice payment system in January 2016. This
system consists of higher payments at the start of care (for days 1–
60) and for the 5 days before death near the end of life via a service
intensity add-on (SIA) to account for greater care needs during these
periods.
22
Hospice reimbursement rates have not kept pace with rising costs.
The total unadjusted hospice daily payment rate for routine level of
care increased from $146.63 to $161.89 per day from 2011 to the
first quarter of 2016 (just before when rates moved to the two-tier
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model), an increase of 2.1% annually.
22,23
For fiscal year 2021, the
rate for days 1 to 60 has been increased to $199.25 per day for
hospices that submit quality data from $194.50 in 2020, a 2.44%
increase.
24,25
In 2018, drug prices for the 267 top products used by
older adults in the United States increased on average by 5.8%. In
the period from 2010 to 2018, these drug price increases peaked at
a 15.8% rise with a 1.6% general inflation rate in 2014.26 In addition,
prices have increased for generic drugs because of fewer generic
drug manufacturers (less competition), drug shortages, and the U.S.
Food and Drug Administration (FDA) Unapproved Drug Initiative,
which converted some generic drugs back to branded products.
27–31
Prices for drugs for pain and inflammation increased by 15.7% in
2014. This resulted in some generic drugs traditionally used
extensively for palliation (eg, atropine, chlorpromazine,
promethazine, prochlorperazine) no longer being used as first-choice
agents by many hospice programs.
In reviewing hospice beneficiary use of Medicare Part D, CMS has
reminded Medicare Part D Plans, pharmacies, and hospices that
hospices are required to pay for virtually all care (including all related
medications) for patients in hospices (via Part A). An initiative to
block Part D access to such patients was subsequently reversed by
CMS with the clear expectation that hospices provide analgesics,
antiemetics, laxatives, and anxiolytics and to coordinate drug
coverage with the Part D plans.
32–34
Hospices are allowed to
establish formularies, but if the hospice does not provide a related
medication for any reason, the beneficiary may not use their Part D
plan to obtain it. The result has been hospices paying for many more
medications than they did in the past (ie, covering medications used
to treat rather than just palliate related conditions). Effective October
1, 2020, an addendum must be submitted as part of the hospice
election at admission and subsequently if requested by the patient
(or their representative) that specifically identifies noncovered items,
services, and drugs.25 This must be submitted at the start of care
(within 5 days) and thereafter within 72 hours of the request.
These variables (ie, referrals to hospice later in the course of
terminal illness, higher costs at the start of care, shortened lengths of
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stay, higher drug costs, providing more medications) have placed
intense pressure on hospice programs to manage expenses.
Because it is difficult to influence the time when patients are referred
to hospice, the duration of time in hospice care, or the inherently
higher costs when patients are first enrolled into hospice, the
management of drug costs has taken a high priority in providing
cost-effective hospice care.
Improving Patient Care and Managing Drug Costs
In 2008, the Hospice Conditions of Participation were updated to be
more patient centered and outcome oriented.18 Coverage of
medications is mandated as described in 42 CFR §418.106 Drugs
and biologicals, medical supplies, and durable medical equipment: “.
. .drugs and biologicals related to the palliation and management of
the terminal illness and related conditions, as identified in the
hospice POC, must be provided by the hospice while the patient is
under hospice care.” CMS has stated that it will be the rare
exception that a hospice patient is taking a medication that is not
paid for by the hospice.
The regulations state that the comprehensive assessment must
“take into consideration” the drug profile (42 CFR §418.54). This is
defined as “[a] review of all of the patient’s prescription and over-thecounter drugs, herbal remedies and other alternative treatments that
could affect drug therapy” and is to include the following:
Effectiveness of drug therapy
Drug side effects
Actual or potential drug interactions
Duplicate drug therapy
Drug therapy currently associated with laboratory monitoring
Although the regulations specify that the hospice registered nurse
complete the initial and comprehensive assessments, pharmacists
are uniquely qualified, as part of the hospice interdisciplinary team,
to perform or provide input on the medication assessment.
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Well-trained pharmacists can improve patient care and positively
affect the fiscal margins of hospice programs by discouraging
inappropriate use of medications, establishing evidence-based
formularies, promulgating prior authorization policies for specific
targeted drugs, establishing policies for adhering to the use of
generic drugs, and managing the quantities of medications to be
dispensed. In addition to managing drug expenditures, pharmacists
provide drug information both to patients and providers and work
integrally with other members of the hospice health care team to
improve the safe and effective use of medications and collaborate in
providing pain and symptom management.
35–52
In 2016, ASHP
published a comprehensive guideline detailing the role and
contribution of the palliative and hospice care pharmacist (PHP).
53
Referral to Hospice
ELIGIBILITY
CASE 6-1
QUESTION 1: M.P. is an 89-year-old female referred to hospice for end-stage
Alzheimer dementia. She lives in a residential care home for the elderly with a
hired caregiver. Her husband has been unable to care for her at home for some
time because she requires full assistance with all activities of daily living. She
was recently hospitalized with aspiration pneumonia and a urinary tract infection
(UTI) and completed a course of intravenous (IV) vancomycin and
piperacillin/tazobactam. Her medical history includes osteoporosis, coronary
artery disease (CAD), chronic obstructive pulmonary disease (COPD),
hypercholesterolemia, and hypothyroidism. She is not oriented to person, place,
or date. Her speech is unintelligible or nonsensical. She cannot feed herself, but
will eat the thick pureed food that is fed to her. She is bedbound and incontinent
of urine and stool. She is restless and irritable at times, especially at night. Her
Palliative Performance Scale Version 2 (PPS) is 30%. Weight is 112 pounds
(50.80 kg), decreased from 135 pounds (61.23 kg) a year ago, and a recent
serum albumin is 2.2 g/dL.
What criteria does M.P. meet for eligibility for hospice services under the
Medicare Hospice Benefit?
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Patients with chronic diseases (eg, Alzheimer disease, Parkinson
disease, stroke, heart failure, lung disease) can be sufficiently ill and
debilitated to need custodial care, but might not be sufficiently ill to
meet the definition of a terminal illness. This differentiation between
terminally ill versus chronically ill requiring custodial care is important
because to qualify for hospice services under the Medicare Hospice
Benefit, patients must be at a stage where death is expected within
the next 6 months. For cancer diagnoses, the presence of
widespread metastatic disease may make this prognosis more easily
evident. However, for other chronic diseases, this is not as clear.
Further, a cancer diagnosis will have a different disease trajectory
than do chronic debilitating diseases. There are three primary
models for decline in the face of serious illness that must be
considered in determining hospice eligibility as well as in creating a
treatment plan. In cancer, patients typically show steady disease
progression followed by a sudden steep decline leading to death.
Patients with respiratory and cardiac disease may show a long
decline with acute exacerbations and deterioration followed by
sudden death. Chronic debilitating diseases such as Parkinson
disease, amyotrophic lateral sclerosis (ALS), and dementia generally
show a prolonged gradual decline, with death often attributed to an
intervening comorbidity such as pneumonia, sepsis, or malnutrition.
54
The Medicare Administrative Contractors (MACs) have issued
criteria to assist in the determination of eligibility for hospice care, as
well as criteria to meet a 6-month terminal prognosis for a number of
diseases. These criteria, or local coverage determinations (LCDs),
provide guidelines for meeting an overall decline in clinical status, for
meeting non–disease-specific data to establish a baseline, for
establishing the effect of comorbidities (eg, renal failure, liver
disease), and for the submission of documentation for having met
criteria. Criteria have been established for patients with cancer and
noncancer diagnoses, and these criteria are used in the
determination of eligibility for service and reimbursement.55 Criteria
for the noncancer diagnoses have been developed for ALS,
dementia as a result of Alzheimer disease and related disorders,
heart disease, human immunodeficiency virus disease, liver disease,
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