[Federal Register: November 22, 2005 (Volume 70, Number 224)]
[Rules and Regulations]
[Page 70532-70548]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no05-13]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 418
[CMS-1022-F]
RIN 0938-AJ36
Medicare Program; Hospice Care Amendments
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This final rule revises existing regulations that govern
coverage and payment for hospice care under the Medicare program. These
revisions reflect the statutory changes required by the Balanced Budget
Act of 1997 (BBA), the Medicare, Medicaid, and SCHIP Balanced Budget
Refinement Act of 1999 (BBRA), and the Medicare, Medicaid, and SCHIP
Benefits Improvement and Protection Act of 2000 (BIPA). Additionally,
these revisions reflect current policy on the documentation needed to
support a certification of terminal illness, admission to Medicare
hospice, and a new requirement that allows for discharges from hospice
for cause under very limited circumstances.
This final rule does not address the requirement for hospice data
collection, the changes to the limitation of liability rules, or the
changes to the hospice conditions of participation that were included
in the BBA.
The intent of this final rule is to expand the hospice benefit
periods, improve documentation requirements to support certification
and recertification of terminal illness, provide guidance on hospice
admission procedures, clarify hospice discharge procedures, update
coverage and payment requirements, and address the changing needs of
beneficiaries, suppliers, and the Medicare program.
DATES: These regulations are effective on January 23, 2006.
FOR FURTHER INFORMATION CONTACT: Linda Smith, (410) 786-5650.
SUPPLEMENTARY INFORMATION:
I. Background
A. Hospice Care
Hospice care means a comprehensive set of services described in
1861(dd)(1) of the Social Security Act (the Act), identified and
coordinated by an interdisciplinary team to provide the physical,
psychosocial, spiritual, and emotional needs of a terminally ill
patient and family members or both as denoted in a specific patient
plan of care.
The emphasis of hospice care is on the control of pain and the
furnishing of services that enable the beneficiary to remain at home as
long as possible with minimal disruption to normal activities. A
hospice uses an interdisciplinary approach to deliver medical, social,
psychological, emotional, and spiritual services through the use of a
broad spectrum of professional and other caregivers, with the goal of
making the individual as physically and emotionally comfortable as
possible. Counseling and respite services are available to the family
of the hospice patient. Hospice programs consider both the patient and
the family as the unit of care.
B. Medicare Hospice Before the Balanced Budget Act of 1997
The Balanced Budget Act of 1997 changed and clarified numerous
aspects of the Medicare hospice benefit including the length of
available benefit periods, the amount of annual updates, how local
payment rates are determined, the time frame for physician
certification, and what is considered a covered Medicare hospice
service. Section 1861(dd) of the Act provides for coverage of hospice
care for terminally ill Medicare beneficiaries
[[Page 70533]]
who elect to receive care from a participating hospice. Beneficiaries
are eligible to elect the Medicare hospice benefit if they are eligible
for Medicare Part A; are certified as terminally ill by their personal
physician, if they have one, and by the hospice medical director; and
elect to receive hospice care from a Medicare-certified hospice.
Section 1861(dd)(3)(A) of the Act defines terminally ill as a medical
prognosis with a life expectancy of 6 months or less. This definition
was clarified to provide for a life expectancy of ``6 months or less if
the illness runs its normal course'' when we amended 42 CFR 418.3 in
our December 11, 1990 final rule with comment period titled ``Hospice
Care Amendments: Medicare'' (55 FR 50834).
A Medicare beneficiary who has elected the hospice benefit can
receive care for specific lengths of time referred to as benefit
periods. Under the Tax Equity and Fiscal Responsibility Act of 1982,
hospice care was made available in three distinct benefit periods, the
first two lasting 90 days, and the third lasting 30 days. The total
amount of Medicare hospice coverage was 210 days. Because of the
scientific difficulty in making a prognosis of 6 months or less, the
210-day limit was repealed by the Medicare Catastrophic Coverage Repeal
Act of 1989 for services furnished on or after January 1, 1990. The
benefit periods were restructured into two periods of 90 days duration,
one period of 30 days duration, and a fourth period of unlimited
duration. Prior to the BBA of 1997, if a beneficiary voluntarily left
the program or was discharged from it, he or she forfeited the
remaining days in the benefit period. When this occurred during the
fourth benefit period, the beneficiary could never again receive the
Medicare hospice benefit. A beneficiary in the fourth benefit period
who became ineligible for hospice care services because he or she no
longer met the eligibility requirements would then return to normal
Medicare coverage and would never be eligible for the Medicare hospice
program, even if his or her condition once again became terminal.
The BBA of 1997 amended the election and benefit period procedures
to state that once a patient elects the Medicare hospice benefit, the
patient gives up the right to have Medicare pay for hospice care
furnished by any hospice provider other than the one that he or she has
selected, unless the selected hospice provider arranges for services to
be furnished by another provider or if the patient elects to change
providers. Also during the benefit period, the beneficiary gives up the
right to receive any other Medicare payment for services that are
determined to be related to his or her terminal illness or other
related conditions or that are duplicative of hospice care. Medicare
would continue to pay for a beneficiary's covered medical needs
unrelated to the terminal condition.
The Medicare hospice benefit includes nursing services; medical
social services; physician services; counseling services, including
dietary and bereavement counseling; short-term inpatient care,
including respite care; medical appliances and drugs; home health aide
and homemaker services; physical therapy; occupational therapy; and
speech-language pathology services. Medicare-certified hospices furnish
care using an interdisciplinary team of people who assess the needs of
the beneficiary and his or her family and develop and maintain a plan
of care that meets those needs.
Under section 1814(i) of the Act, Medicare payment for hospice care
is based on one of four prospectively determined rates that correspond
to four different levels of care for each day a beneficiary is under
the care of the hospice. The four rate categories are routine home
care, continuous home care, inpatient respite care, and general
inpatient care. The prospective payment rates are updated annually and
are adjusted by a wage index to reflect geographic variation. The
payment rules are in our regulations at 42 CFR part 418, subpart G,
``Payment for Hospice Care.''
II. Hospice Provisions of the Balanced Budget Act of 1997, the Balanced
Budget Refinement Act of 1999, and the Medicare, Medicaid, and SCHIP
Benefits Improvement and Protection Act of 2000
The Balanced Budget Act of 1997 (BBA) included a number of
provisions affecting the Medicare hospice benefit. Additionally, the
Balanced Budget Refinement Act (BBRA) of 1999 and the Medicare,
Medicaid, and SCHIP Benefits Improvement and Protection Act (BIPA) of
2000 made additional changes to the Medicare hospice benefit. Program
Memorandum (PM A-97-11), released in September 1997, implemented most
of the hospice-related BBA provisions.
The limitation of liability rule changes were implemented through
the Program Memorandum (PM A-97-11), issued in September 1997. A
hospice cost report for the hospice data collection requirement was
developed and issued in April 1999.
A. Payments for Hospice Services (Section 4441 of the BBA)
Section 4441(b) of the BBA amended section 1814(i) of the Act to
require hospice management to submit cost data for each fiscal year
beginning with fiscal year 1999. A hospice cost report to collect this
information was issued in April 1999. To allow hospices enough time to
prepare for the new requirement, the implementation of the hospice cost
report was delayed until cost reporting periods beginning on or after
April 1, 1999.
B. Payment for Home Hospice Care Based on Location Where Care Is
Furnished (Section 4442 of the BBA)
Section 4442 of the BBA amended section 1814(i)(2) of the Act,
effective for services furnished on or after October 1, 1997, required
hospices to submit claims for payment for hospice care furnished in an
individual's home only on the basis of the geographic location at which
the service is furnished. Previously, local wage index values were
applied based on the geographic location of the hospice provider,
regardless of where the hospice care was furnished. Hospices were able
to inappropriately maximize reimbursement by locating their offices in
high-wage areas and actually delivering services in a lower-wage area.
Applying the wage index values for rate adjustments on the geographic
area where the hospice care is furnished provides a reimbursement rate
that is a more accurate reflection of the wages paid by the hospice for
the staff used to furnish care.
C. Hospice Care Benefit Periods (Section 4443 of the BBA)
Section 4443 of the BBA amended sections 1812(a)(4) and 1812(d)(1)
of the Act to provide for hospice benefit periods of two 90-day
periods, followed by an unlimited number of 60-day periods. This
amendment changed the previous hospice care benefit periods. Each
period requires a physician to certify at the beginning of the period
that the individual has a terminal illness with a prognosis that the
individual's life expectancy is 6 months or less, should the illness
run its normal course. Though it continues to be true that the
remaining days in a benefit period are lost once a beneficiary revokes
election of the hospice benefit or is discharged from the hospice, the
restructured benefit periods will allow the beneficiary, or the
hospice, to make this type of decision without placing the beneficiary
at risk of losing hospice benefit periods in the future.
[[Page 70534]]
Section 4449 of the BBA indicated that the benefit period change
applied to the hospice benefit regardless of whether or not an
individual had made an election of the benefit period before the date
of enactment. Therefore, beneficiaries who elected hospice before the
BBA and who, after the passage of the BBA, were discharged from hospice
care because they were no longer terminally ill, were able to avail
themselves of the benefit at some later date if they became terminally
ill again and otherwise met the requirements of the Medicare hospice
benefit. If the beneficiary had been discharged during the initial 90-
day period, he or she would enter the benefit in the second 90-day
period. If the discharge took place during the final 90-day period or
any subsequent 60-day period, the beneficiary would enter the benefit
in a new 60-day period. A beneficiary who had been discharged from
hospice during the fourth benefit period before the enactment of the
BBA would be eligible to access the benefit again, if certified as
being terminally ill, and would begin in a new 60-day period. The 90-
day periods would not be available again, as amended section 1812(d)(1)
of the Act still provides only for two 90-day periods during an
individual's lifetime. There is no limit on the number of 60-day
periods available as long as the beneficiary meets the requirements for
the hospice benefit.
D. Other Items and Services Included in Hospice Care (Section 4444 of
the BBA)
Section 1861(dd)(1) of the Act lists the specific services covered
under the Medicare hospice benefit. It has always been Medicare's
policy that Medicare hospice includes not only those specific services
listed in section 1861(dd)(1) of the Act, but also any service
otherwise covered by Medicare that is needed for the palliation and
management of the terminal illness. Section 4444 of the BBA reiterated
this policy by amending section 1861(dd)(1) of the Act to add a new
subparagraph ``I'' to the list of covered hospice services in section
1861(dd)(1) of the Act, effective April 1, 1998. This new provision
states that any other service that is specified in the plan of care,
and for which payment may otherwise be made under Medicare, is a
covered hospice service. This change underscores our previous
construction of the law as requiring that the hospice is responsible
for furnishing any and all services indicated as necessary for the
palliation and management of the terminal illness, and related
conditions, in the plan of care. A Medicare beneficiary, who elects
hospice care, gives up the right to have Medicare pay for services
related to the terminal illness or related conditions, outside of the
hospice benefit. Section 1861(dd)(1) of the Act contains a list of
services and therapies covered under the Medicare hospice benefit. This
list does not include services like radiation therapy, which are often
furnished by hospices for palliative purposes. This change clarifies
that these additional necessary services are covered under the hospice
benefit and cannot be billed separately to Medicare.
E. Extending the Period for Physician Certification of an Individual's
Terminal Illness (Section 4448 of the BBA)
Section 4448 of the BBA amended section 1814(a)(7)(A)(i) of the Act
to eliminate the specific statutory time frame for the completion of a
physician's certification of terminal illness for admission to a
hospice for the initial 90-day benefit period. It requires only that
certification be done ``at the beginning of the period.'' In accordance
with our understanding of congressional intent, this change, (for
example, as indicated by the title of section 4448), was made to extend
the period for physician certification of the terminal illness by
allowing hospices the discretion to require that hospice certifications
are on file before a Medicare claim is submitted.
Before the BBA, hospices were required to obtain, no later than 2
calendar days after hospice care was initiated, written certification
that a person had a prognosis of a terminal illness with a life
expectancy of 6 months or less. For the first benefit period, if the
written certification could not be obtained within the 2 calendar days
following the initiation of hospice care, a verbal certification could
be made within 2 days following the initiation of hospice care, with a
written certification not later than 8 calendar days after care was
initiated. For subsequent benefit periods, written certification was
required no later than 2 calendar days after the first day of each
benefit period. Under the new certification requirement, certification
must be done ``at the beginning of the period.'' To protect the
beneficiaries, we are requiring that the hospice obtain written
certification before it submits a claim for payment.
This new certification requirement also applies to individuals who
had been previously discharged during a fourth benefit period and are
being certified for hospice care again to begin in a new 60-day benefit
period. Also, due to the restructuring of the benefit periods, any
individual who revoked, or was previously discharged from, the hospice
benefit, and then reelects to receive the hospice benefit in the next
available benefit period, will need to be recertified as if entering
the program in an initial benefit period. This means that the hospice
must obtain verbal certification of terminal illness no later than 2
days after care begins, and written certification before the submission
of a claim to the fiscal intermediary.
F. Effective Date (Section 4449 of the BBA)
The provisions of the BBA discussed above, unless noted otherwise,
became effective for services furnished on or after the date of
enactment of the BBA, or August 5, 1997. Section 4444 of the BBA, the
other services provision, was effective on April 1, 1998.
G. Clarification of the Physician Certification Requirement (Section
322 of BIPA)
Section 322 of BIPA amended section 1814(a) of the Act by
clarifying that the certification of an individual who elects hospice
``* * * shall be based on the physician's or medical director's
clinical judgment regarding the normal course of the individual's
illness.'' The amendment clarified that the certification is based on a
clinical judgment regarding the usual course of a terminal illness, and
recognizes the fact that making medical prognostications of life
expectancy is not always exact. This amendment at section 322 of BIPA
clarifies and supports our current policy. In the early 1990's, we
discovered that in many cases certification and recertification
occurred without the documentation that would support the terminal
illness prognosis. Accordingly, in 1995, we issued program memoranda
requiring clinical information and other documentation that support the
medical prognosis. This documentation must accompany a certification
and be filed in the patient's medical record.
We recognize that medical prognostications of life expectancy are
not always exact. However, the amendment regarding the physician's
clinical judgment does not negate the fact that there must be a basis
for a certification. A hospice needs to be certain that the physician's
clinical judgment can be supported by clinical information and other
documentation that provide a basis for the certification of 6 months or
less if the illness runs its normal course. A signed certification,
absent a medically sound basis that supports the clinical judgment, is
not sufficient for application of the hospice
[[Page 70535]]
benefit under Medicare. Section 322 of BIPA became effective for
certifications made on or after the date of enactment, December 21,
2000.
Requirements for Issuance of Regulations
Section 902 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) amended section 1871(a) of the Act and
requires the Secretary, in consultation with the Director of the Office
of Management and Budget, to establish and publish timelines for the
publication of Medicare final regulations based on the previous
publication of a Medicare proposed or interim final rule. Section 902
of the MMA also states that the timelines for these regulations may
vary but shall not exceed 3 years after publication of the preceding
proposed or interim final rule except under exceptional circumstances.
This final rule finalizes provisions set forth in the November 22,
2002 proposed regulation with some changes based on public comments (67
FR 70363). In addition, this final rule has been published within the
3-year time limit imposed by section 902 of the MMA. Therefore, this
final rule is in accordance with the Congress' intent to ensure timely
publication of final regulations.
III. Provisions of the Proposed Regulations
In the proposed rule published November 22, 2002 (67 FR 70363), we
proposed to amend 42 CFR Chapter IV by revising part 418. We proposed
to make conforming changes to the Medicare hospice regulations to
reflect the statutory changes, to revise the regulation to reflect
current policy and to clarify requirements regarding the documentation
needed to support a certification of terminal illness and the admission
to and discharge from a Medicare hospice. We proposed to add one new
requirement that would allow for discharges from hospice for cause
under very limited circumstances.
A. Duration of Hospice Care Coverage--Election Periods (Sec. 418.21)
In Sec. 418.21, we proposed to revise paragraph (a) to make
hospice benefit periods available in two 90-day periods followed by an
unlimited number of 60-day periods (requirement of section 4443 of the
BBA).
B. Certification of Terminal Illness (Sec. 418.22)
We proposed to revise the cross reference in Sec. 418.22(a)(1)
from ``Sec. 418.21'' to ``Sec. 418.21(a)'' and remove the phrase
``for two, three, or four periods'' and replace it with ``for an
unlimited number of periods'' to reflect the changes in the hospice
care election periods (requirement of section 4443 of the BBA). We
proposed to revise the basic requirement at paragraph (a)(2) to state
that the hospice must obtain written certification before it submits a
claim for payment (requirement of section 4448 of the BBA), and we
proposed to revise the exception at paragraph (a)(3) to state that, if
the hospice cannot obtain the written certification within 2 calendar
days, it must obtain an oral certification within 2 calendar days, and
the written certification before it submits a claim for payment.
Therefore, oral certifications, which are necessary only if the hospice
is unable to obtain written certification within 2 calendar days of the
start of the benefit period, would be required for each benefit period
rather than for just the initial 90-day period. We proposed to maintain
our requirement for verbal physician's certification no later than 2
days after hospice care begins because we continue to believe that
proper and timely assessment of a patient's condition is of critical
importance both to the hospice, which becomes responsible for the
patient, and to the patient, who must have a sound basis for choosing
palliative rather than curative care.
As a condition of eligibility for a Medicare hospice program, an
individual must be entitled to Medicare Part A and be certified as
terminally ill. The Act also requires that this certification be made
in writing by either the hospice medical director or the physician
member of the interdisciplinary group, and by the attending physician,
if the patient has one. However, the law does not explicitly discuss
what information a hospice physician needs to consider before making a
certification of terminal illness.
Operation Restore Trust (ORT), a joint effort among the Centers for
Medicare & Medicaid Services, the Office of the Inspector General, and
the Administration on Aging to identify vulnerabilities in the Medicare
program and to pursue ways to reduce Medicare's exposure to fraud and
abuse, identified several areas of weakness in the hospice benefit,
primarily in the area of hospice eligibility. In 1995, as a result of
early ORT findings, we issued a letter to all Regional Offices and
Regional Home Health Intermediaries (RHHIs) clarifying what should be
included in a patient's medical record to support the certification of
terminal illness. Subsequent ORT reports, and medical reviews conducted
by RHHIs, have raised concerns about inappropriate certifications and
recertifications and problems with a lack of documentation to support a
prognosis of terminal illness. These reports and reviews found that
certifications are being made for patients who are chronically ill but
who are without complications or other circumstances that indicate a
life expectancy of 6 months or less.
In response to these concerns, we proposed to revise Sec.
418.22(b) by adding introductory text, redesignating paragraph (b) as
paragraph (b)(1), and adding an additional requirement for the content
of certification as paragraph (b)(2). The introductory text would state
that certification for the hospice benefit would be based upon the
physician's or medical director's clinical judgment regarding the
normal course of the individual's illness. In paragraph (b)(2), we
proposed requiring that clinical information and other documentation
supporting the medical prognosis accompany the written certification
and be filed in the medical record as required under Sec. 418.22(d).
C. Election of Hospice Care (Sec. 418.24)
In Sec. 418.24, we proposed to add to paragraph (c), ``Duration of
election,'' a new paragraph (c)(3) to state that an election to receive
hospice care would be considered to continue through the initial
election period and through the subsequent election periods without a
break in care as long as the individual is not discharged from the
hospice under the provisions of Sec. 418.26. This addition would
clarify that only revocation by the beneficiary or discharge by the
hospice terminates an election.
D. Admission to Hospice Care (Sec. 418.25)
Also in response to concerns raised by ORT, we proposed to
establish general guidance on hospice admission procedures. Currently,
there is no guidance in manuals or regulations regarding admission
procedures. We proposed to add a new Sec. 418.25, ``Admission to
hospice care,'' which establishes specific requirements to be met
before a hospice provider admits a patient to its care.
Paragraph (a) would permit a hospice to admit a patient only on the
recommendation of the medical director in consultation with the
patient's attending physician, if any. We realize that many hospice
patients are referred to hospice from various ``nonmedical'' sources.
This is entirely appropriate; however, it is the responsibility of the
[[Page 70536]]
medical director, in concert with the attending physician, to assess
the patient's medical condition and determine if the patient can be
certified as terminally ill.
Paragraph (b) would require that the hospice medical director
consider at least the following information when making a decision to
certify that a patient is terminally ill: diagnosis of the patient's
terminal condition; any related diagnoses or comorbidities; and current
clinically relevant information supporting all diagnoses.
E. Discharge From Hospice Care (Sec. 418.26 and Sec. 418.28)
As with admission to hospice, the statute does not explicitly
address when it is appropriate to discharge an individual from hospice
care. The Internet Online Manual (IOM) Medicare Benefit Policy Manual,
Section 20.2.1 Hospice Discharge, explains that discharge is allowable
only if the patient is no longer terminally ill or if the patient moves
out of the service area.
We proposed to add a new Sec. 418.26, ``Discharge from hospice
care,'' to specify when a hospice may discharge a patient from its
care. Paragraph (a), ``Reasons for discharge,'' would specify that a
hospice may discharge a patient if--
1. The patient moves out of the hospice's service area or transfers
to another hospice;
2. The hospice determines that the patient is no longer terminally
ill; or
3. The hospice determines, under a policy set by the hospice for
the purpose of addressing ``discharge for cause'' that also meets the
requirements discussed in the remainder of the new paragraph (a), that
the patient's behavior is disruptive, abusive, or uncooperative to the
extent that delivery of care to the patient or the ability of the
hospice to operate effectively is seriously impaired. Before the
hospice seeks to discharge a patient, we would require it to make a
serious effort to resolve the problem(s) presented by the patient's
behavior or situation; ascertain that the patient's proposed discharge
is not due to the patient's use of necessary hospice services; document
the problem(s) and efforts made to resolve the problem(s) and enter
this documentation into the patient's medical records; and obtain a
written physician's order from the patient's attending physician and
hospice medical director concurring with the discharge from the
hospice.
Since the inception of the Medicare hospice program, we have
received inquiries from hospices regarding patients and their family
members or primary caregivers who elected hospice but subsequently
became uncooperative or hostile (including threats of physical harm and
to the extent that hospice staff could not provide care to the patient)
when the facilities attempted to provide care. In the absence of
regulations or guidance from Medicare regarding these situations,
hospices were uncertain as to their authority to act to resolve this
type of problem. We offered informal guidance that if the hospice had
made a conscientious effort to resolve the problem and had documented
that effort, and the patient refused to revoke the benefit voluntarily,
a discharge would be indicated. Failure to revoke the benefit could
place the patient in a compromised position in which the patient would
not be able to receive services from the hospice but would at the same
time be unable to obtain services under the standard Medicare program
because of his or her hospice status. An additional concern is the
issue of daily payments being made to a hospice when no services are
being provided.
Paragraph (b), ``Effect of discharge,'' specifies that an
individual, upon discharge from the hospice during a particular
election period for reasons other than immediate transfer to another
hospice, is no longer covered under Medicare for hospice care and
resumes Medicare coverage of the benefits waived under Sec. 418.24(d).
If the beneficiary becomes eligible for the hospice benefit at a future
time, he or she would be able to elect to receive this benefit again.
Although the statute does not explicitly address when a hospice may
discharge a patient from its care, we realize that there are certain
instances in which it is no longer appropriate for a hospice to provide
care to a patient. A decision that a hospice patient is no longer
terminally ill is generally not made during one assessment. However,
once it is determined that the patient is no longer terminally ill, the
patient is no longer eligible to receive the Medicare hospice benefit.
Currently, the regulations do not provide any time for discharge
planning between the determination that the patient is no longer
terminally ill and discharge from the benefit. Since the BBA has ended
the limitation on available benefit periods during a beneficiary's
lifetime, we expect to see an increase in the number of beneficiaries
being discharged from, or revoking, the hospice benefit because they
can no longer be certified as terminally ill. However, it is common for
these beneficiaries to remain in medically fragile conditions and in
need of some type of medical services in order to remain at home. It is
important that hospice providers consider these needs so that support
structures can quickly be put into place should the patient's prognosis
improve.
Therefore, we proposed to add a paragraph (c), ``Discharge
planning,'' in the new requirement at Sec. 418.26. We require at
paragraph (c)(1) that the hospice have in place a discharge planning
process that takes into account the prospect that a patient's condition
might stabilize or otherwise change that the patient cannot continue to
be certified as terminally ill. Additionally, we proposed at paragraph
(c)(2) that the discharge planning process must ensure that planning
for the potential of discharge includes consideration of plans for any
necessary family counseling, patient education, or other services
before the patient is discharged because he or she is no longer
terminally ill.
Finally, we proposed to revise Sec. 418.28(b)(1) to permit
discharges for cause (under proposed Sec. 418.26(a)) if a patient
refuses to sign a revocation statement. A signed revocation statement
serves to protect hospice patients whose hospice may seek to discharge
them because of possible higher costs associated with use of necessary
services. Under current regulations, if a patient, who otherwise would
be discharged for cause, were to refuse to sign a revocation statement,
the hospice would be in the position of receiving daily payments from
Medicare for a person who cannot receive services. Paragraph (b)(1)
would permit waiver of a signed revocation if one were not obtainable
in cases of discharge for cause. Our utmost concern is that there are
sufficient patient protections in place to ensure appropriate delivery
of care and, if needed, discharge planning.
F. Covered Services (Sec. 418.202)
We proposed to add a new paragraph (i) to Sec. 418.202 to state
that any other service that is specified in the patient's plan of care
as reasonable and necessary for the palliation and management of the
patient's terminal illness and related conditions, and for which
payment may otherwise be made under Medicare, is a covered hospice
service. This change was made by section 4444 of the BBA and was a
clarification of long-standing Medicare policy.
G. Payment for Hospice Care (Sec. 418.301, Sec. 418.302, Sec.
418.304, and Sec. 418.306)
In addition to reflecting the payment changes required by the BBA,
we proposed to add a new paragraph (c) to Sec. 418.301, ``Basic
rules.'' This paragraph
[[Page 70537]]
would restate the basic requirement, included in the provider
agreement, that the hospice may not charge a patient for services for
which the patient is entitled to have payment made under Medicare or
for services for which the patient would be entitled to payment if the
provider had completed all of the actions described in Sec. 489.21.
Since this requirement is currently included in the provider agreement,
we would restate it in this part for clarification only.
We proposed to add a new paragraph (g) to Sec. 418.302, ``Payment
procedures for hospice care,'' to provide that payment for routine home
care and continuous home care would be made based on the geographic
location where the service is provided (requirement of section 4442 of
the BBA).
We proposed to update the rules found at Sec. 418.304, ``Payment
for physician services,'' to reflect current payment methodology for
physician services under Medicare Part B. References to reimbursement
based on reasonable charges would be replaced with references to the
physician fee schedule. We proposed to revise the first sentence of
paragraph (b) to clarify that a specified Medicare contractor pays the
hospice an amount equivalent to 100 percent of the physician fee
schedule, rather than 100 percent of the physician's reasonable charge,
for those physician services furnished by hospice employees or those
under arrangement with the hospice. We also proposed to revise the
second sentence of paragraph (c) to specify that services of the
patient's attending physician, if he or she is not an employee of the
hospice or providing services under arrangements with the hospice, are
paid by the carrier under the provisions in 42 CFR Part 414 Subpart B.
Finally, in Sec. 418.306, ``Determination of payment rates,'' we
proposed to revise paragraph (b)(3) and to add new paragraphs (b)(4)
and (b)(5) to set the payment rate in Federal fiscal years 1998 through
2002 as the payment rate in effect during the previous fiscal year
increased by a factor equal to the market basket percentage increase
minus 1 percentage point, with the exception that the payments for the
first half of FY 2001 shall be increased 0.5 percent, and then
increased an additional 5 percent over the above calculation. Payments
for all of FY 2002 were increased by 0.75 percent.
IV. Analysis of and Responses to Public Comments
We received a total of 27 timely public comments in response to the
November 22, 2002 proposed rule (67 FR 70363). Some of the
organizations we received letters from were hospice providers, national
stakeholder and advocacy groups, national and State hospice
associations, and other health care providers and suppliers. All public
comments were reviewed and grouped by the same or related topics. The
comments and our responses are summarized below.
A. Duration of Hospice Care Coverage--Election Periods (Sec. 418.21)
Comment: A commenter stated that the regulations should make clear
that if a beneficiary revokes the benefit and there are unused days
remaining in the benefit period, the beneficiary is free to re-elect
hospice before those unused days pass.
Response: Section 418.26(b)(3) specifically states that the
individual ``may at any time elect to receive hospice care if he or she
is again eligible to receive the benefit.'' Section 418.28(c)(3) also
contains similar language.
Comment: One commenter requested that the new benefit period rules
apply to State Medicaid programs that offer hospice.
Response: This would be up to individual States, who generally
follow Medicare hospice rules.
Comment: A commenter asked us to state in the final rule that there
is no 6-month limit on hospice eligibility as long as there is
documentation to support medical reviews of cases when this happens.
Response: We do not believe this language needs to be included in
the final rule. The 6-month rule applies to eligibility for the hospice
benefit, including a patient's prognosis and life expectancy. Medical
reviews are not automatic in the event that a patient lives longer than
6 months, and could occur at any point during an individual's time in
hospice including less than 6 months if this review were indicated.
B. Certification of Terminal Illness (Sec. 418.22)
Comment: A few commenters believe that the proposed rule would
require oral certifications for each benefit period, and that oral
certification is required from the medical director and the attending
physician for all benefit periods, a new and unnecessary burden.
Response: This is not correct. An oral certification is only needed
if no written certification is obtained within 2 days. This change in
regulations implements a BBA provision that the Congress intended to
ease the burden of obtaining a written certification within 2, or at
the latest, 8 days after the start of the initial benefit period. Now,
the written certification is required before a hospice submits a claim
for payment. Therefore, oral certification will be required if the
written certification cannot be obtained within 2 days following the
start of the benefit period. In fact, the rules for certification for
periods following the initial period are unchanged. Section Sec.
418.22(c), the regulation concerning the initial certification and
those that followed, was not part of the proposed changes published on
November 22, 2002 (67 FR 70363). This regulation requires the attending
physician's (if there is one) certification for the initial period.
Subsequent periods only require certification by the hospice's medical
director or the physician member of the hospice IDG.
Comment: Several commenters are concerned that language calling for
``specific clinical findings and other documentation'' at Sec.
418.22(3)(b)(2) could end up with requirements that would become
excessively specific and cause access problems due to a perception that
exacting documentation requirements must be met; or that additional
tests must be performed, beyond what already will have sufficiently
established that eligibility is met. Commenters suggested that
physician experience and not simply lab or pathology reports be
recognized.
Response: It appears that the word ``specific'' may be skewing the
intention of the regulation. This rule is being added to formalize
policy that came in response to OIG/ORT findings in the mid-1990s, when
a number of admissions to hospices were happening with little or no
documentation that supported a certification for hospice. We expect
that a hospice patient's medical record would contain sufficient
information to support the certification of the individual as having a
terminal illness with a life expectancy of 6 or fewer months, if the
illness runs its normal course. We believe it is reasonable to expect
documentation to support the certification. We are removing the word
``specific'' and changing ``findings'' to ``information'' so that the
phrase would read ``clinical information and other documentation.''
Section 322 of BIPA called for the physician's ``clinical judgment,''
and this regulation simply asks that it be supported.
Comment: A commenter stated that the best approach to certification
might be for the attending physician to refer patients he or she
believes eligible, and for the medical director to exercise his or her
best judgment regarding concurrence.
[[Page 70538]]
Response: The Medicare statute is clear about the responsibility of
the hospice's medical director to certify, along with the attending
physician for the initial benefit period, the individual as eligible
for hospice.
Comment: Two commenters believe we were compromising the intent of
BIPA by requiring oral certifications for each benefit period,
requiring a hospice to expend additional resources without any obvious
benefit. One commenter believes this is a new requirement. Another
commenter indicated that it ignores Congressional intent.
Response: In a sense, this is a new requirement, but it protects
and ensures timely medical care for the beneficiary as well as
significantly eases the written certification burden on the hospice.
The hospice regulations have always required written certification at
the start of each benefit period. The Congress made no indication that
this rule should end. Now, all that is required, if a written physician
certification cannot be completed within 2 calendar days after a period
begins, is that an oral certification be obtained. Previously a written
certification was required within 2 days for every period after the
initial benefit period, or the hospice would be faced with the
possibility of a claim being denied. We are following Congressional
intent, in that the Congress indicated that the written hospice
certification rule should follow the home health rule, and be on file
before a claim is submitted.
Comment: A commenter believes that clinical information and
documentation do not need to accompany the certification, and urged
that we delete ``accompany'' in the requirement at Sec. 418.22(b)(2),
replacing it with simply a requirement that the information be in the
medical record. The commenter believes that if documentation had to
accompany the certification, care could be delayed or even denied, and
an unnecessary burden would be placed upon the hospice and other
providers. Several commenters pointed out that frequently hospices
obtain certifying information over the phone from the referring
physician, which is then recorded and placed in the patient's medical
record.
Response: We believe that clinical information and documentation
are critical to the certification decision. We recognize that some
documentation may physically arrive at the hospice and be placed in the
medical record after the start of care; however, that should not mean
that the information does not come to the attention of the hospice and
be included in the certification and admission process. The attending
physician may well report clinical information by telephone or
interview, with written documents to arrive later. It is the
information needed for the hospice's IDG to develop the initial plan of
care for the new patient, and therefore we would expect the information
to accompany, in some fashion, the certification, although some of it
may not arrive physically at the hospice until later. We are revising
this final rule to indicate that clinical information may initially
arrive verbally and is documented in the patient's medical record as
part of the hospice's assessment of eligibility for hospice.
Comment: A commenter objected to oral certification within 2 days
after the start of each benefit period, believing it is unnecessary
record keeping.
Response: Certification no later than 2 days after the start of
each benefit period is not a new requirement. Past regulations required
that certification be in writing no later than 2 days after the start
of care for all periods after the initial period. The oral
certification is a way to protect and ensure timely medical care for
the beneficiary as well as easing the written certification burden on
the hospice. This final rule requires oral certification (if needed)
for all benefit periods, and in writing before a claim for the period
is submitted.
Comment: A few commenters stated that it was burdensome and
unnecessary to require clinical information and documentation as part
of the certification that supports the physician's clinical judgment
that the individual is terminally ill with a prognosis of 6 months or
less to live if the illness runs its normal course. There were
suggestions that BIPA's amendment of the statute, which provides for
``certification based on the physician's or medical director's clinical
judgment * * *'' was sufficient, without any supporting documentation
at the time of certification. It was noted that prognosis is inexact at
best, and that we seemed to be requiring accurate predictions (with
possible penalties for failure to be precise).
Response: As discussed in the preamble of the November 22, 2002
proposed rule (67 FR 70363), the Medicare statute does not explicitly
describe what a physician needs to consider before certifying a patient
for hospice. In that preamble, we cited early ORT findings (which were
partly based upon other OIG and intermediary medical reviews of patient
records) as clearly indicating a need for requirements that
certifications be supported by clinical findings and documentation.
(Elsewhere in this preamble, we discuss the replacing of the word
``findings'' with ``information'' in the final rule.) Our 1995 letters
to RHHIs clarified expectations for supporting documentation, and this
information was widely disseminated to the hospices and the hospice
industry. Response to our effort was positive. At that time, claims
were coming under closer scrutiny, and failure to find documentation in
medical records that supported certification and the need for hospice
caused denial of claims. CMS has sent out widely disseminated letters
that made it clear that Medicare supports accessibility to the hospice
benefit. The letters recognized that prognosis is not an exact science,
and that the impact of a hospice's services may sometimes lead to brief
periods of improvement. Nevertheless, it is reasonable to expect that
information supporting physician certifications be provided to ensure
that patients beginning hospice are appropriate for this type of care.
Comment: One commenter stated that written certifications did not
need to be obtained by the hospice before submission of claims for
periods following the initial period and could be obtained later.
Response: A written certification has been required by statute
since the inception of the Medicare hospice program.
Comment: There was a comment that certification of the terminal
illness should be based on either the attending physician's
certification or the hospice's medical director's certification.
Response: This is a statutory requirement. Section 1814(a)(7)(A) of
the Social Security Act requires that both the hospice's physician
(either the medical director or physician member of the
interdisciplinary group) and the attending physician (if the patient
has one) must certify patients for the Medicare hospice benefit for the
initial period. For subsequent benefit periods, the hospice physician
alone may certify patients for the hospice benefit. The attending
physician does not have sole or surrogate power to certify for
admission for any benefit period.
C. Election of Hospice Care (Sec. 418.24)
No comments were received.
D. Admission to Hospice Care (Sec. 418.25)
Comment: A commenter suggested that the medical director alone
certify patients for hospice.
Response: Though the medical director or physician member of the
hospice interdisciplinary group must certify for each election period,
the attending physician (if any) is also
[[Page 70539]]
required, by statute, to do so for the first election period.
Comment: Some commenters believe the regulation would require the
attending physician to participate in all certifications that may be
required, and that it imposes a barrier to obtaining hospice care.
Further, it would subvert the role of the IDG. It would also increase
costs unnecessarily, since some patients are near death by time of
admission.
Response: This is not correct. An attending physician (if the
patient has one) does certify for the initial period, but is not
required or expected to do any subsequently needed certifications. We
would expect the attending physician to be consulted by the medical
director or IDG if he or she has maintained significant involvement in
the case.
Comment: A commenter believes this rule negates the role of the IDG
in the admission process.
Response: The role of the IDG is not changed by this rule.
Regulations at Sec. 418.22(c)(1)(i), which includes the physician
member of the interdisciplinary group as a party who may certify
terminal illness, remain the same.
Comment: A commenter believes that the November 22, 2002 proposed
rule requires excessive involvement by the Medical Director in the
patients' admission to hospice, such as physically seeing the patient
before admission, making telephone calls to the attending physician,
and obtaining original history and physical reports.
Response: Currently, to be admitted to hospice, the patient must
meet the eligibility requirements at Sec. 418.20(b) ``certified as
being terminally ill in accordance with Sec. 418.22.'' It is the
physician's responsibility to assess the patient's medical condition
and determine if the patient can be certified as terminally ill. This
is reflected in Section 418.22(c)(i) and (ii), Sources of
Certification, which states that for the initial 90-day period,
certification statements must be obtained from ``the medical director
of the hospice or the physician member of the hospice interdisciplinary
group; and the individual's attending physician if the individual has
an attending physician.'' The new requirements at Sec. 418.25 provides
clarification of the physician's responsibilities as it relates to the
admission process.
Comment: Some commenters suggested that this final rule would
require the medical director to consult directly with the attending
physician, and that it would be a poor and expensive use of the
director's time. Some commenters stated that it would be a needless
impediment that would add delays to the start of hospice care. One
commenter stated that the final rule required every piece of medical
documentation be in the hands of the medical director before an
admission decision is made. One commenter stated that the hospice
nurse, while obtaining pre-admission information, would be the more
appropriate individual to obtain an attending physician's input in the
admission process.
Response: It is not our intent to require a face-to-face or any
type of direct consultation between the Director and the attending
physician. We are revising the language to indicate that the medical
director has considered patient information from the attending
physician that may be obtained through consultation, or through
information obtained indirectly. Information could be obtained through
the hospice nurse or others who would bring the attending physician's
knowledge of the patient to the medical director when the admission
decision is being made. We also note that the medical documentation
does not necessarily need to be physically in the hands of the medical
director, but that the information presented is considered in the
decision. The medical reports may arrive later for retention in the
patient's medical record.
Comment: A commenter suggested that the proposed rule required an
attending physician to be consulted, which would be impossible if the
patient did not have one.
Response: The proposed rule included the phrase ``if any''
following ``attending physician'' but preceded by a comma. We have made
``if any'' a parenthetical phrase after attending physician to make it
clearer that we recognize that there may not be an attending physician
in all cases.
Comment: One commenter is concerned that small hospices that use
volunteer medical directors would be forced to hire a Medical Director
at a big expense. The commenter believes that volunteers would be
reluctant to offer their time because consultation with attending
physicians at the time of admission would require more time than they
would be willing to provide. Other commenters believe that hospices,
especially small ones with part-time medical directors with separate
private practices, will face considerable increased costs if medical
directors were forced to consult with attending physicians.
Response: We cannot know whether this final rule would cause
volunteer physicians to cease participating in any particular hospice
program, or what additional costs a hospice would face with respect to
its part-time medical directors. However, no matter what the status of
the hospice medical director--employee or volunteer--that individual
(or the physician member of the IDG) has always had a responsibility to
review the appropriateness of admission of new patients to hospice. The
ORT/OIG reports from the mid-1990s investigations made it clear that we
need to make sure that certifications were not simply a physician
signature upon a document alone, but that there was documentation
supporting the admission decision that had been considered. The medical
director's certification is an essential part of the admission
procedure, and the director considering the attending physician's
knowledge of the patient is part of the certification decision. As we
discussed elsewhere in the preamble, the consultation need not be
direct, but the attending physician's input should be considered in the
admission process.
Comment: A commenter stated that the medical director must submit
documentation regarding his or her consideration of the documentation.
Response: The medical director would only need to document that the
pertinent clinical information had been considered in the certification
process. The documentation includes a diagnosis of the patient's
terminal condition; any related diagnoses or comorbidities; and current
clinically relevant findings supporting all diagnoses.
Comment: A commenter objected to Sec. 418.25(b) describing the
information that should be considered by the medical director when
certifying a patient.
Response: We believe that this final rule clarifies the expectation
that underlies the basis for making a significant decision about an
individual accepting his or her terminal condition and the treatment
plans that are to come. It is information that should be considered,
and we do not think that the final rule should be modified.
Comment: One commenter opposes this admission section of the
proposed regulations entirely, citing election and certification as the
only requirements for beginning hospice. The commenter believes that
the admission rules would make it impossible for a hospice to admit
certain individuals for care for a terminal illness that does not meet
the Medicare eligibility requirements for the benefit, but for whom the
hospice would not submit claims to Medicare.
Response: As we explained in the preamble to the proposed rule (67
FR 70367), this regulation would establish guidance on hospice
admission
[[Page 70540]]
procedures. It clarifies and supports the election and certification
rules by describing the process by which a medical director must
certify that a patient is terminally ill and, thus, admit that patient
to the hospice. In addition, the admission rules, along with election
and certification rules would not necessarily pertain to an individual
that does not meet Medicare eligibility rules but whom the hospice
otherwise decides to offer services to without cost to Medicare.
E. Discharge From Hospice Care (Sec. 418.26)
We received some comments that indicated that a discharge for cause
rule offered helpful guidance in cases where patients consistently
refused to permit the hospice to visit or deliver care, or it was
dangerous for staff to visit the home, or when the patient repeatedly
left the service area. Other commenters asked for specificity in the
regulations regarding circumstances when the discharge for cause rule
might apply. We do not believe it is possible to do this without
creating either an excessively lengthy regulation or one that due to
over-specificity would unintentionally take the flexibility that the
hospice may need to act. We do plan to offer some guidance and examples
in the hospice manual.
Comment: Some commenters want family added along with the patient
as a source of problems that could be a reason to consider a discharge
for cause. Commenters cited examples such as threats from the patient's
family, or drug stealing and drug dealing by members of the patient's
household.
Response: We agree, and have amended the proposed rule to take
other persons (which would include family) in the patient's home into
account. To the extent that the situation interferes with the ability
of the hospice staff to provide care efficaciously, it may be
appropriate to discharge the patients. However, we would expect the
hospice to make every effort to rectify the situation before ending its
services, with documentation of what transpired in the case.
Alternative suggestions and referrals for care should be presented to
the patient and his or her caregiver before ending services.
Comment: A commenter suggested that failure on the part of the
patient to follow the plan of care be identified as a reason for
discharge. Instances of the patient going to the emergency room without
first contacting the hospice were cited, particularly with respect to
financial issues where the patient would be responsible for care not
arranged for through the hospice.
Response: We do not think that single instances of the patient/
family going to the emergency room without prior authorization from the
hospice would necessarily be a valid reason for discharge. Failure to
follow important clinical features of the POC may be a reason to
consider discharge, but a panicked reaction to an emergency should not
be, by itself, a reason to terminate services. It is important for the
patient and family to be educated before the start of care that hospice
entails certain limits in the way care will be provided once hospice
services begin, among them being restrictions on obtaining care outside
those provided or arranged for by the hospice, and the patient's
potential liability for care received without the hospice's
involvement. It is particularly important that the patient and
caregiver be instructed on what to do in a crisis or emergency.
Comment: Some commenters believe that it would be very difficult to
obtain a patient's attending physician's signature when discharging a
patient for cause, and that in any event many attending physicians
cease following their patients after hospice begins. Some patients
never had an attending physician. Other commenters worry that an
attending physician could override an IDG decision, when the attending
physician's opinion was not needed or that in the case of an attending
physician who disagreed with discharge, it would place him or her in a
compromised position with his or her patient. Further, the commenter
stated that it is ultimately the hospice's responsibility to decide
upon discharge of patients.
Response: If there is no attending physician involved in a
patient's care, then such a requirement would seem to create a problem.
At the same time, a discharge for cause is a serious matter where we
believe the patient needs some protection from a hospice that may
behave unethically and try to discharge a patient because he or she may
require more attention or care than the hospice wished to offer. If
there is an attending physician, his or her opinion matters. However,
to reduce a burden that the proposed rule might have created if it were
finalized, we are revising the requirement at Sec. 418.26(b) to read,
``Prior to discharging a patient for any reason listed in subsection
(a), the hospice must obtain a written physician's discharge order from
the hospice medical director. If the patient has an attending physician
involved in his or her care, the physician should be consulted before
discharge and his or her view included in the discharge note.'' This
would help ensure that the attending physician's position on discharge
for cause is taken into account, as well as giving the attending
physician an opportunity to participate in post-discharge planning for
the patient.
Comment: Some commenters suggested that either the attending
physician or medical director could sign a discharge order.
Response: We cannot accept this suggestion. It is the
responsibility of the hospice to make this decision, just as it is the
hospice's decision to admit the new patient. Elsewhere in this
preamble, we have indicated that the final rule has been revised to
indicate that the attending physician is to be consulted and his or her
views included in the discharge note.
Comment: Commenters want the discharge-planning rule made
conditional upon the possibility that there will be time to plan, or
that planning only be done when possible, since some patients may need
immediate discharge because they are no longer terminally ill. Requests
were made for a time frame for determining stability requiring
discharge.
Response: The rule requires that the hospice have in place a
process ``that takes into account the prospect that a patient's
condition might stabilize or otherwise change''. We do not expect that
a discharge would be the result of a single moment that does not allow
time for some post-discharge planning. Rather, we would expect that the
hospice's IDG is following their patient, and if there are indications
of improvement in the individual's condition such that hospice may soon
no longer be appropriate, then planning should begin. If the patient
seems to be stabilizing and the disease progression has halted, then it
could be the time to begin preparing the patient for alternative care.
Discharge planning should be a process, and planning should begin
before the date of discharge. We have tried to avoid prescriptive time
frames for discharge planning, since we have long been aware that
merely the attention that hospice services give to a patient can have a
beneficial effect, creating the impression that the individual may no
longer be ``actively dying'' and therefore ineligible for the Medicare
hospice benefit. Therefore, we cannot offer a specific number of days
or weeks that a patient may be stable and thus not eligible. We see
this issue as one requiring physician/IDG judgment and would only ask
that the judgment be supported by documentation in the medical record
indicating the reason
[[Page 70541]]
why hospice should continue if there seems to be improvement such that
discharge is under consideration.
Comment: A commenter wanted the discharge of a patient who moves
out of the service area or who transfers to another hospice to include
patients who temporarily leave the hospice's service area without
notifying or making arrangements with the hospice.
Response: If the patient transfers to another hospice, then the
assumption is that arrangements have been made, and end and start dates
of care have been worked out. This is not a temporary move, and
discharge issues should not arise. Concerning patients who leave the
hospice service area temporarily, this issue should have been addressed
by the hospice at the time of admission when the hospice explains to
the patient the waiver of benefits that occur upon election of the
hospice benefit. If the hospice patient leaves the service area and
attempts to obtain care for his or her terminal condition for which
hospice was elected, then the patient assumes financial responsibility
for this care. It is not necessarily a reason to discharge a patient
unless there is a repeated pattern of such activity and it interferes
with the care that the hospice plan of care calls for. The hospice
should counsel the patient regarding the consequences of obtaining care
from sources other than the hospice. The patient may even decide to
revoke the benefit under the circumstances.
Comment: A commenter does not believe a discharge plan should be
required for all patients, since live discharges are rare. Imposing
this requirement for every patient would be an unnecessary and costly
burden.
Response: We believe that the commenter may have misunderstood the
purpose of the proposed rule. A hospice would need to have a process in
place should the condition of a patient show indications that hospice
possibly may no longer be the appropriate treatment for that
individual. We do not expect that every patient will have a discharge
plan prepared. However, should a hospice patient's condition seem to be
improving (beyond just brief periods of improvement that sometimes
occur simply because the individual is receiving attention and some
symptom relief), the hospice IDG should have a discharge planning
process available in order to help make plans for the individual's
discharge and follow-up care as may be needed. We would expect most
patients would not have a discharge plan ever; however, when indicated,
the hospice would have the ability to begin the process timely.
Comment: A commenter believes that requiring a written physician's
order for discharge of a patient, ignored the role of the IDG,
including the attending physician if he or she is participating.
Response: We agree about the essential role of the IDG, and we
would expect their participation in any discharge decisions. However,
it is the commonly accepted practice for a physician to sign an
admission or discharge order in hospitals. Similarly, it is the hospice
physician who signs a certification for hospice care in order to begin
care, and that individual also would consequently be the one to sign
the discharge order. Elsewhere in this preamble, we have advised that
an attending physician would not be required to sign discharge papers.
Comment: A commenter urged that in cases of discharge for cause the
patient should be notified of this possible action.
Response: We agree, and have revised the regulation to reflect this
suggestion.
Comment: A commenter wants the beneficiary advised of appeal rights
when a discharge for cause is being considered. One commenter noted the
potential for misuse of the discharge for cause rule to discharge high-
cost patients.
Response: There are no specific appeal rights for the beneficiary
regarding such considerations. However, for the protection of the
beneficiary, we added to the regulation, a provision that the
beneficiary must be notified, by the hospice, that discharge for cause
is being considered.
Comment: A commenter suggested that we monitor, analyze, and
identify ways to reduce discharge for cause, and perhaps then establish
a forum for sharing best practices on maintaining hospice care for
difficult patients.
Response: We appreciate the suggestion and will consider it for
future program evaluations.
Comment: A commenter complained that having a physician sign a
discharge order was creating an additional paperwork burden.
Response: We see the signing of a discharge order in the patient's
medical record as part of the physician's administrative activities.
Signing the order would simply be the final action at the end of
discharge process.
Comment: Some commenters believe that it was inappropriate to ask
the hospice, in considering a discharge for cause, to ``ascertain that
* * * is not due to * * * use of necessary hospice services,'' and that
it would be difficult to prove a negative that the use of services was
not a factor in discharge. Commenters did agree that use of necessary
services would not be an appropriate reason to discharge.
Response: We believe that this requirement is appropriately in this
section of the rule. It is one of our concerns that discharge for cause
could be a rule that offers opportunity for abuse, and we want to make
it clear that the hospice needs to make sure that it is planning to
discharge a patient because of behavior issues, not time or effort or
cost factors in providing services to a particular individual. We
believe that ascertaining that discharge is not due to the use of
necessary services is simply a reminder that some of a hospice's
patients require more services. This fact should not influence a
discharge decision.
Comment: One commenter suggested that the regulations should not
list any reasons for a cause discharge and instead the hospice should
set its own policy for discharge for cause. This was based upon the
assertion that it is impossible to set forth rules that could address
every possible circumstance that would be a reason to seek a cause
discharge.
Response: We agree that it is impossible to list every possible
reason that an individual might be discharged under this rule. That
being said, we believe that the circumstances under which this type of
discharge could be considered are adequately addressed by the rule we
published. The types of behavior discussed in the rule that seriously
impair the hospice's ability to operate effectively and provide care to
the patient and the requirements imposed on the hospice are necessary
to place some parameters on discharges for cause.
Comment: One commenter is concerned that the hospice would be
responsible for post-discharge care of patients discharged for cause,
when generally these would be patients that it had already found to be
a problem to the extent that it could not provide needed services.
Response: We recognize that it may be very difficult to implement
post-discharge care plans for a patient that has proven to be
disruptive, abusive, or uncooperative to the extent that services
cannot be provided, but post-discharge care would not be the
responsibility of the hospice. The hospice would engage in and prepare
for after hospice care, but it is up to the patient (and the patient's
supporters) to take advantage of other sources of care after discharge.
Though not entirely analogous, it is similar to a physician prescribing
medication, but it is the responsibility of the patient to take the
medication, even after the
[[Page 70542]]
physician has fully informed the patient of the importance of doing so.
F. Revoking Election of Hospice Care (Sec. 418.28)
Comment: A commenter believes that the waiver of a signed
revocation when a patient revocation cannot be obtained in cases of
discharge for cause should be placed in the section of regulations
addressing discharge. The commenter stated that it is confusing to have
it in its present location as it mixes discharge and revocation. The
commenter also pointed out that a discharge for cause is not
revocation. Revocation is voluntary, and mixing it with discharge for
cause is confusing and unnecessary.
Response: We agree that this proposal is unneeded, and it has been
deleted from the final rule.
G. Covered Services (Sec. 418.202)
Comment: Commenters objected to ``other covered services'' applying
to ``related conditions'' (to the terminal illness), and asked that it
be removed from the proposed rule. The commenters feared it would be
misinterpreted to mean that the hospice would be responsible for
services not related to the terminal illness.
Response: A hospice has always been responsible for the care of the
patient's terminal illness and related conditions, and this rule should
not be interpreted to mean what the commenter fears, that is, that the
hospice provides care unrelated to the terminal illness. At the same
time, if the hospice staff notices, for example, that the patient has
an eye infection that is unrelated to the terminal illness, then sound
health care practices suggest that the hospice staff refer that person
to his or her doctor for treatment. Commenters should review the
hospice regulation at 42 CFR 418.402, which addresses this concern when
it states that ``* * * services not considered hospice care include * *
* treatment of an illness or injury not related to the individual's
terminal condition.''
Comment: One commenter asked how ``covered services'' might be
interpreted by contractors reviewing claims, and whether the lack of
specificity defining these services could cause denial of payment if
``covered services'' were determined to be non-covered.
Response: As we discussed in the preamble to the proposed rule, the
BBA clarified and codified what had been a Medicare rule, but had not
always been well understood: that a ``service that is specified in the
patient's plan of care as reasonable and necessary for the palliation
and management of the terminal illness and related conditions, and for
which payment may otherwise be made under Medicare, is a covered
hospice service.'' The decision as to whether a patient requires and
receives any particular service from the hospice is, as before, the
responsibility of the hospice. A medical review by a contractor would
not necessarily consider whether an item was not required and therefore
subject to a denial or payment, but rather whether the patient had
received the appropriate necessary care for his or her particular
terminal condition. Hospice payment is a prospectively-set daily
payment to the hospice, and is made without regard to the cost of care
on any particular day, nor with regard to the total cost of care during
the entire time period that the hospice cares for the patient.
Comment: One commenter believes that the phrase ``otherwise covered
by Medicare'' would result in limitations on what patients could
receive by way of care, since items not covered by the regular Medicare
program would not be available due to this phrase.
Response: The BBA expressly used the cited phrase in amending the
law and in a congressional document, indicating that Medicare services
that had not previously been specified in section 1861(dd)(1) of the
Act were indeed to be made available under the hospice benefit if
determined to be medically necessary and ordered in the plan of care.
Comment: A commenter believes that hospices would use this phrase
to use unqualified and untrained persons to provide services.
Response: Hospices must meet conditions of participation, which
require that their staff be qualified to provide the particular service
the patient needs.
Comment: The American Association for Respiratory Care asked
whether respiratory therapy, when part of a hospice patient's plan of
care, is a Medicare covered hospice service.
Response: Respiratory therapy would be a covered hospice service if
the hospice decides its patient requires the service. Provision of the
service would be paid for out of the hospice daily rate made to the
hospice.
Comment: One commenter suggested that psychologists be recognized
as equivalent practitioners to physicians for purposes of payment for
mental health services required by a hospice patient. The commenter
argued that as an otherwise covered Medicare service, certain patients
could benefit from a psychologist's specialized training, but because
of the high cost of these services, a hospice would avoid arranging for
them. This would be due to the fact that payment would come out of the
hospice's daily rate, a limited source of payment for all needed
hospice services for individual patients.
Response: The Medicare law, with respect to hospice, only
recognizes physicians as defined by statute, that is, medical doctors
and osteopaths, and we therefore limit separate additional payments to
those practitioners. If a hospice recognizes that its terminally ill
patient requires the services of a psychologist, it is free to arrange
for it.
H. Payment for Hospice Care (Sec. 418.301, Sec. 418.302, Sec.
418.304 and Sec. 418.306)
Comment: A commenter requested that Sec. 418.301(c) indicate that
hospices pay for medical services not related to the hospice-covered
terminal illness. Another commenter asked that we clarify that hospices
are only responsible for the care and services related to the terminal
illness.
Response: Conditions not related to the terminal illness may be
covered under the regular Medicare program, a right that the
beneficiary does not lose when hospice is elected. Even though other
non-hospice care may be written into the hospice's plan of care to
address care and services not related to the terminal illness, which
help assure proper care to the patient, the hospice's responsibility is
for care and services related to the terminal illness. Of course, the
hospice would be expected to make the proper referrals when needed.
Comment: One commenter asked about the change proposed in Sec.
418.304(b), where the phrase ``physician's reasonable charge'' is
replaced by ``physician fee schedule''. The commenter wanted to know if
this change was the change discussed in the preamble of the proposed
rule.
Response: The change in the regulation is the same one discussed in
the preamble of the proposed rule.
I. Miscellaneous Comments
Comment: Some commenters believe that we were tightening up the 6-
month prognosis, and that it would make physicians more reluctant to
refer patients to hospice. Commenters stated that physicians are
``terrible'' at determining prognoses. They feared they would be
exposed to scrutiny and penalty if they failed to make accurate
prognoses.
Response: As we have noted elsewhere in this section, we know that
``prognosis'' indicates expectancy. It does not connote exact
predictions regarding the expected date of death of an individual with
a terminal illness. We merely want the certification of the
[[Page 70543]]
patient for hospice care to be accompanied by documentation that
supports the appropriateness of the hospice benefit.
Comment: One commenter seems concerned by references to ORT, and
what was perceived as a disregard for the intent of Congress to make
hospice more accessible.
Response: We believe that ORT and other investigations by the OIG
are what helped guide the Congress in changes affecting the Medicare
hospice benefit, and that we adhered to this effort to make the benefit
more accessible. Payments for hospice care increased in response to
industry complaints that payments were inadequate, but payment based
upon the location at which the services were provided (the individual's
home) made it more appropriate in that it reflected the wages paid in
the home's location rather than the high cost area where the hospice's
home office might be located. The unlimited number of benefit periods
permitted the hospice industry and all potential patients to no longer
worry that an individual might live into a fourth but final benefit
period and then be forced out of hospice care because of improvement in
health, only to face permanent loss of access to hospice care in the
future because of pre-BBA rules. Physician certification rules were
eased, but as discussed elsewhere, the Congress gave no indication that
it was dissatisfied with our clarification of requirements that a
physician certification of terminal illness be supported by
documentation. In addition, the growth of hospice since the ORT/OIG
investigations indicates that our clarification has not adversely
affected the industry, considering the increases in patient enrollment
and Medicare payments for the care.
Comment: A commenter asked about relief from the 24-hour registered
nurse requirement for respite care.
Response: This issue is being taken into consideration as CMS
drafts the new Hospice Conditions of Participation.
V. Provisions of the Final Regulations
For the most part, this final rule incorporates the provisions of
the proposed rule. The provisions of this final rule that differ from
the proposed rule are as follows and changes are based on public
comments to provide clarifying language:
Certification of Terminal Illness (Sec. 418.22)
(a) Timing of certification: (3) Exception. Added, ``after a period
begins'' to clarify timeframe for written certification within 2 days.
(b) Content of certification: Deleted the term ``specific'' and
changed ``findings'' to ``information.'' Also added, ``Initially, the
clinical information may be provided verbally, and must be documented
in the medical record and included as part of the hospice's eligibility
assessment.''
Admission To Hospice Care (Sec. 418.25)
(a) Added clarifying language ``or with input from'' the patient's
attending physician and added parentheses around the phrase ``if any.''
Discharge From Hospice Care (Sec. 418.26)
(a) Reasons for discharge.
(3) Added clarifying language ``(or other persons in the patient's
home)'' to address public comment that the patient's family may be the
problem necessitating a discharge for cause. Also added the following
language ``(i) Advise the patient that a discharge for cause is being
considered'' to address the public comment that there should be
requirements for notification to beneficiaries.
(b) Renumbered and revised proposed paragraph (a)(3)(iv) for
clarity as follows ``Prior to discharging a patient for any reason
listed in subsection (a), the hospice must obtain a written physician's
discharge order from the hospice medical director. If a patient has an
attending physician involved in his or her care, this physician should
be consulted before discharge and his or her review and decision
included in the discharge note.''
Revoking the Election of Hospice Care (Sec. 418.28)
Deleted proposed change to Sec. 418.28(b)(1).
Payment for Physician Services (Sec. 418.304)
As a technical correction we are replacing the language
``reasonable charges'' with physician fee schedule: to reflect the
current payment methodology. Additionally, the cross-reference to
``subparts D or E, Part 405 of this chapter'' will be changed to
``subpart B, Part 414 of this chapter.''
VI. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), we are required to
provide 30-day notice in the Federal Register and solicit public
comment when a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection report
should be approved by OMB, section 3506(c)(2)(A) of the PRA requires
that we solicit comments on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements:
Sections 418.22 and 418.26 of this final regulation contain
information collection requirements that are subject to review by OMB
under the PRA.
Certification of Terminal Illness (Sec. 418.22)
The current collection requirements referenced in Sec. 418.22 have
been approved by OMB under approval number 0938-0302, with a current
expiration date of September 30, 2006. However, this rule imposes a new
collection requirement, which requires CMS to solicit comment on the
new information collection requirement and resubmit 0938-0302 to OMB
for review and approval, as a revision to a currently approved
collection.
The newly imposed requirement as referenced under paragraph (b)(2)
of this section stipulates that clinical information and other
documentation that support the medical prognosis must accompany the
certification of terminal illness and must be filed in the medical
record with the written certification as set forth in paragraph (b)(2)
of this section.
While this requirement is subject to the PRA, we believe the burden
associated with this requirement is exempt from the PRA as stipulated
under 5 CFR 1320.3 (b)(2) and (b)(3) because the requirement is
considered a reasonable and customary business practice and/or is
required under State or local laws and/or regulations.
Discharge From Hospice Care (Sec. 418.26)
Paragraph (a)(3)(iv) of this section requires documentation of the
problem(s) related to the patient and efforts made to resolve the
problem(s) into the patient's medical records.
Paragraph (b) of this section requires that a written physician's
discharge order from the hospice medical director and the decision of
the patient's attending physician (if any) concurring with discharge
from hospice care be
[[Page 70544]]
obtained and included in the patient's medical record.
While these requirements are subject to the PRA, we believe the
burden associated with these requirements is exempt from the PRA as
stipulated under 5 CFR 1320.3(b)(2) and (b)(3) because the requirements
are considered reasonable and customary business practices and/or are
required under State or local laws and/or regulations.
We have submitted a copy of this final rule to OMB for its review
of the information collection requirements described above. These
requirements are not effective until they have been approved by OMB.
If you comment on any of these information collection and record
keeping requirements, please mail copies directly to the following:
Centers for Medicare & Medicaid Services, Office of Strategic
Operations and Regulatory Affairs, Regulations Development Group, Attn:
Melissa Musotto, CMS-1022-F, Room C5-11-04, 7500 Security Boulevard,
Baltimore, MD 21244-1850; and Office of Information and Regulatory
Affairs, Office of Management and Budget, Room 10235, New Executive
Office Building, Washington, DC 20503, Attn: Carolyn Lovett, CMS Desk
Officer. Comments submitted to OMB may also be e-mailed to the
following address: e-mail: Carolyn_Lovett@omb.eop.gov or faxed to OMB
at (202) 395-6974.
VII. Regulatory Impact
The provisions of this final rule are based upon provisions in the
BBA, BBRA, and BIPA, with statutorily-set timeframes, and have already
been implemented through program memoranda. These include changes in
election periods; timing requirements for written certification;
covered services; payment based upon site of service; and annual
payment update amounts. Other proposed provisions address documentation
supporting certification; admission requirements; discharge from
hospice; and clarification of current policy that has not previously
been captured in regulations.
A. Overall Impact
We have examined the impacts of this final rule as required by
Executive Order 12866 (September 1993, Regulatory Planning and Review),
the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-
354), section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 (as amended by Executive Order 13258, which
merely reassigns responsibility of duties) directs agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
We have determined that this rule is not a major rule for the reasons
discussed below.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and government agencies.
Most hospitals and most other providers and suppliers are small
entities, either by nonprofit status or by having revenues of $6
million to $29 million in any 1 year. Individuals and States are not
included in the definition of a small entity. For purposes of the RFA,
in 2001, there were approximately 2,277 Medicare-certified hospices. Of
those 2,277, approximately 73 percent can be considered small entities
because they were identified as being voluntary, government, or other
agency.
Given the general lack of hospice data and the unpredictable nature
of hospice care, it is extremely difficult to predict the savings or
costs associated with the changes contained in this final rule.
Originally, we estimated the Medicare hospice rate reductions required
by section 4441 of the BBA would result in a $120 million savings to
the Medicare program in FY 2002. Increases required by section 321 of
BIPA, however, added $150 million to Medicare program costs, and
increases required by section 131 of BBRA added another $20 million in
costs, for a net of $50 million in costs for that fiscal year. While it
is likely that all of the Medicare-certified hospices considered to be
small entities have been required to make changes in their operations
in some way due to the implementation of these statutory provisions and
proposed changes, this final rule does not set forth any additional
changes that are likely to significantly impact the operations of
hospice providers. For these reasons, we certify that this final rule
will not have a significant effect on a substantial number of small
entities. However, we have prepared the following analysis to describe
the impacts of this rule. This analysis, in combination with the rest
of the preamble, is consistent with the standards for analysis set
forth by the RFA and Executive Order 12866.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. This final rule largely
codifies existing hospice requirements and will not result in a
significant impact on a substantial number of small rural hospitals.
Therefore, no analysis is required.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditure in any 1 year by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $110 million. This final rule does not impose unfunded
mandates, as defined by section 202 of UMRA, as it will not result in
the expenditure in any 1 year by either State, local or tribal
governments, or by the private sector of $110 million.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. This final rule has no impact on State or local
governments. We have reviewed this final rule under the threshold
criteria of Executive Order 13132 and we believe that it will not have
substantial Federalism implications.
Section 1902(a)(13)(B) of the Act requires the Medicaid payment
methodology for hospice care to be determined using the same
methodology that is used for Medicare. State Medicaid programs with the
optional Medicaid hospice benefit would be required to implement
sections 4441(a) and 4442 of the BBA. We remain unaware of any impact
of these provisions on State Medicaid programs since these provisions
became effective. Nevertheless, it is possible that these payment-
related provisions could impact particular State Medicaid programs.
However, because each State Medicaid program is unique, it is
impossible to quantify meaningfully an estimate of the effect of the
costs on State and local governments.
[[Page 70545]]
B. Anticipated Effects
1. Effects on Hospice Providers
Given the general lack of hospice data and the unpredictable nature
of hospice care, it is extremely difficult to quantify the impact this
final rule will have on hospice providers. Nevertheless, we have tried
to estimate the impact of the following changes on hospice providers.
In general, we believe that the effect of the final rule will have
minimal economic impact on hospice providers or on the regulatory
burden of small business. In the following sections, we have indicated
implementation actions already taken, and anticipated effects the final
rule may have.
2. Effects on Payments
The BBA required hospice providers to bill for routine and
continuous home care based on the geographic location where the service
was provided. We expect that Medicare would experience some savings
with this provision; however, it is impossible to predict the size of
the savings attributable to this provision. These Medicare savings may
reflect a cost to hospice providers. This BBA change has been
implemented through program memoranda. This final rule merely codifies
this statutorily required change.
3. Effects on Benefit Period Change
Medicare hospice is now available in two 90-day periods and an
unlimited number of 60-day benefit periods. Because there is no longer
a limit on the number of benefit periods available to a beneficiary, it
is possible that this change will result in an increase in the number
of revocations and re-elections. However, we anticipate that this
change will have a negligible effect on hospice providers. The change
in benefit periods was implemented by a program memorandum issued
shortly after passage of the BBA and has already been incorporated into
hospice program operations.
4. Effects on Covered Services
The BBA clarified that the Medicare hospice benefit covers any
service otherwise covered by Medicare and listed in the hospice plan of
care as reasonable and necessary for the palliation and management of a
terminal illness. This change should not generate any additional costs
for Medicare hospices because it is merely a statutory clarification of
existing Medicare policy. This clarification of covered hospice
services was implemented through a program memorandum issued before the
April 1, 1998 effective date set by the BBA and is merely being
codified by this regulation. It helped providers to better determine
the services they must provide.
5. Effects of Physician Certification
The requirement that a written certification of terminal illness
for admission to a hospice for the initial 90-day benefit period be on
file before a claim for payment is submitted will not impose any
additional costs on hospice providers and removes the problem of
obtaining the written certification according to a rigid timeframe.
This requirement will provide hospices with more flexibility to
establish cost-efficient procedures for obtaining the required
certifications. However, the expansion of the requirement for verbal
certifications to every benefit period may impose costs on hospice
providers. Before enactment of the BBA, verbal certifications were
required within 2 days of the start of care during the first benefit
period if a written certification could not be obtained within those 2
days. We are requiring that, absent written certification, verbal
certifications of terminal illness be obtained within those 2 days for
each benefit period. Although we believe the impact of this requirement
would be negligible, it is difficult to estimate the exact size of the
impact of this requirement because some costs may be negated by the
increased flexibility, and time, a hospice provider has in obtaining
the required written certifications.
Additionally, we believe that requiring that written certifications
of terminal illness be accompanied by clinical information and
documentation supporting the prognosis will not impose any new costs on
hospice providers. We released a policy memorandum in 1995 to all
hospice providers, through the fiscal intermediaries, requesting that
all hospices maintain documentation demonstrating a beneficiary's
terminal status. Because it has been 10 years since we issued the
policy calling for clinical information and other documentation
supporting the terminal prognosis, we do not anticipate that the
requirement will alter hospices' current practices.
6. Effects on Admission to Hospice Care
We believe that the final rule describing admission
responsibilities will impose no additional burden upon hospices. The
responsibilities were referred to in various regulations, manuals,
program memoranda, and other correspondence; this regulation brings
them together in an organized rule. ORT and OIG investigations and
reviews found that admission activities were not always executed fully,
or when done, they were not always documented. This final rule
specifies the consultation between the attending physician and the
hospice and its medical director that normally does or should take
place when a physician seeks hospice care for his or her patient. The
final rule also describes the consideration that the medical director
gives when deciding upon certification, to the patient's diagnosis,
related diagnoses, medical information that support those diagnoses,
the overall medical management needs of the patient, and the attending
physician's future plans for the patient. We do not believe any new
costs are associated with these requirements, and the 1995 policy
memorandum had made clear the hospice admission responsibilities and
the need to document their execution. We found that the hospice
provider community was generally pleased that we had issued the
guidance, which alleviated previous problems associated with admission
of beneficiaries to hospice care.
7. Effects on Discharge and Discharge Planning
This final rule may add a small additional burden to hospices
providing services to Medicare beneficiaries, but at the same time, it
also should reduce certain other burdens they may currently experience,
particularly with respect to making appropriate discharges. In the
absence of specific regulations, hospices have often been uncertain
what to do when a patient appeared appropriate for discharge from the
program. There was limited manual guidance, although following the ORT
and OIG investigations, some additional information on the appropriate
time to discharge patients was communicated to the hospice industry.
Our final rule would incorporate discharge planning, a normal part of
health care provision, into the hospice's care planning procedures.
Regular, ongoing care planning, including the potential for discharge,
has always been part of a hospice's responsibilities, and the
regulation would simply recognize this responsibility. It is not a new
additional burden.
Discharge for certain disruptive, abusive, or uncooperative
patients will entail a small additional burden upon very few hospices,
based on past discussions with some providers before preparation of
this final rule. We believe the burden is small, because we have rarely
received requests from hospices over the years for relief in cases
involving this type of behavior. In the
[[Page 70546]]
preamble to the proposed rule, we elicited input on this particular
final rule, particularly with respect to protection of patients. We are
aware of the burden that individual providers have had when faced with
difficult patients, and this regulation would provide a way for them to
resolve it, and, we believe, also lessen burdens currently experienced
when trying to provide care to this type of patient.
The section of this final rule that discusses the effect of
discharge, that is, that a beneficiary discharged from hospice care
immediately resumes full coverage under the regular Medicare program,
has always been the law. However, it has not been stated in regulation
in a straightforward manner, and doing so offers reassurance to both
the beneficiary and the hospice that discharge from the hospice does
not mean the loss of Medicare benefits. This section also assures a
beneficiary that he or she may again elect hospice at any future time
if he or she meets eligibility requirements.
8. Effects on Other Providers
We do not anticipate that this rule will have any effects on other
provider types.
9. Effects on the Medicare and Medicaid Programs
As discussed above, it is very difficult to estimate the size of
any savings to the Medicare program attributable to this final rule. We
have estimated that the hospice rate reduction as required by section
4441 of the BBA, temporary increases in hospice care payments for FY
2001 and FY 2002 due to section 131 of BBRA, and a 5 percent increase
in hospice payments due to section 321 of BIPA, would result in a net
savings of $80 million for FY 1998-2002 and an overall net cost of $120
million for FY 1998-2007. Given that after FY 2001 the annual costs
attributable to section 321 of BIPA exceed the annual savings
attributable to section 4441 of BBA, there are net costs in the out-
years attributable to these two provisions. Below is a table indicating
the year-by-year costs and savings attributable to the various
provisions.
Costs Associated With the Various Hospice Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
--------------------------------------------------------------------------------------------------------------------------------------------------------
BBA Sec. 4441................................................. -20 -40 -70 -90 -120 -130 -140 -140 -150 -160
BBRA Sec. 131................................................. ....... ....... ....... 10 20 ....... ....... ....... .......
BIPA Sec. 321................................................. ....... ....... ....... 80 150 160 170 180 200 210
Total Costs............................................... -20 -40 -70 0 50 30 30 40 50 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
All dollar figures are in millions and rounded to the nearest $10 million. Costs are shown as positive, savings as negative.
BBA Sec. 4441: Payments for Hospice Services.
BBRA Sec. 131: Temporary increase in payment for hospice care.
BIPA Sec. 321: 5% Increase in Payment.
Also, as discussed above, it is very difficult to estimate the size
of any implementation costs to State Medicaid programs with optional
Medicaid hospice benefits. However, it should be noted that the BBA
provisions that State Medicaid programs are required to implement
(rates of payment, payment based on location where care is furnished,
other items and services, physician contracting) have been effective
since August 5, 1997. Since that time, we have not received any
correspondence from State Medicaid programs indicating that these
provisions have had significant costs associated with implementation.
C. Alternatives Considered
Most sections of this final rule are mandated requirements of the
BBA, BBRA, and BIPA, and have already been implemented by CMS Program
Memoranda, published in the month after passage of the BBA, and the
month after the passage of BIPA. BBRA changes only concerned hospice
payment amounts but did not affect the basic law. Discharge for cause
will enable us to implement policies that permit hospices to act in
those rare events that indicate the need, but with protection for the
beneficiary included in the rules. Alternatively, hospices may continue
to address this particular problem without certainty as to their
authority in these special situations. Other sections of this final
rule represent current policies that have been implemented and
recognized by the industry, clarification of current regulations, or
suggested policies that the industry and CMS believe may help improve
the Medicare hospice program.
D. Conclusion
For these reasons, we are not preparing analyses for either the RFA
or section 1102(b) of the Act because we have determined that this
final rule will not have a significant economic impact on a substantial
number of small entities or a significant impact on the operations of a
substantial number of small rural hospitals.
The general lack of hospice data and the unpredictable nature of
hospice care have made it extremely difficult to predict the savings or
costs associated with the changes contained in this final rule.
However, we believe that these changes will create very little, if any,
new economic or regulatory burdens on hospice providers. These changes
are either statements of current policy or clarifications of policy
that would benefit hospice providers. We believe that we have made
every effort to mitigate the effects of these changes on hospice
providers.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 418
Health facilities, Hospice care, Medicare, Reporting and
recordkeeping requirements.
0
For reasons set forth in this preamble, the Centers for Medicare &
Medicaid Services amend 42 CFR chapter IV as follows:
PART 418--HOSPICE CARE
0
1. The authority citation for part 418 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart B--Eligibility, Election and Duration of Benefits
0
2. In Sec. 418.21, paragraph (a) is revised to read as follows:
Sec. 418.21 Duration of hospice care coverage--Election periods.
(a) Subject to the conditions set forth in this part, an individual
may elect to receive hospice care during one or more of the following
election periods:
(1) An initial 90-day period;
(2) A subsequent 90-day period; or
(3) An unlimited number of subsequent 60-day periods.
* * * * *
[[Page 70547]]
0
3. In Sec. 418.22, paragraphs (a) and (b) are revised to read as
follows:
Sec. 418.22 Certification of terminal illness.
(a) Timing of certification--(1) General rule. The hospice must
obtain written certification of terminal illness for each of the
periods listed in Sec. 418.21, even if a single election continues in
effect for an unlimited number of periods, as provided in Sec.
418.24(c).
(2) Basic requirement. Except as provided in paragraph (a)(3) of
this section, the hospice must obtain the written certification before
it submits a claim for payment.
(3) Exception. If the hospice cannot obtain the written
certification within 2 calendar days, after a period begins, it must
obtain an oral certification within 2 calendar days and the written
certification before it submits a claim for payment.
(b) Content of certification. Certification will be based on the
physician's or medical director's clinical judgment regarding the
normal course of the individual's illness. The certification must
conform to the following requirements:
(1) The certification must specify that the individual's prognosis
is for a life expectancy of 6 months or less if the terminal illness
runs its normal course.
(2) Clinical information and other documentation that support the
medical prognosis must accompany the certification and must be filed in
the medical record with the written certification as set forth in
paragraph (d)(2) of this section. Initially, the clinical information
may be provided verbally, and must be documented in the medical record
and included as part of the hospice's eligibility assessment.
* * * * *
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4. In Sec. 418.24, paragraph (c) is revised to read as follows:
Sec. 418.24 Election of hospice care.
* * * * *
(c) Duration of election. An election to receive hospice care will
be considered to continue through the initial election period and
through the subsequent election periods without a break in care as long
as the individual--
(1) Remains in the care of a hospice;
(2) Does not revoke the election; and
(3) Is not discharged from the hospice under the provisions of
Sec. 418.26.
* * * * *
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5. New Sec. 418.25 and Sec. 418.26 are added to read as follows:
Sec. 418.25 Admission to hospice care.
(a) The hospice admits a patient only on the recommendation of the
medical director in consultation with, or with input from, the
patient's attending physician (if any).
(b) In reaching a decision to certify that the patient is
terminally ill, the hospice medical director must consider at least the
following information:
(1) Diagnosis of the terminal condition of the patient.
(2) Other health conditions, whether related or unrelated to the
terminal condition.
(3) Current clinically relevant information supporting all
diagnoses.
Sec. 418.26 Discharge from hospice care.
(a) Reasons for discharge. A hospice may discharge a patient if--
(1) The patient moves out of the hospice's service area or
transfers to another hospice;
(2) The hospice determines that the patient is no longer terminally
ill; or
(3) The hospice determines, under a policy set by the hospice for
the purpose of addressing discharge for cause that meets the
requirements of paragraphs (a)(3)(i) through (a)(3)(iv) of this
section, that the patient's (or other persons in the patient's home)
behavior is disruptive, abusive, or uncooperative to the extent that
delivery of care to the patient or the ability of the hospice to
operate effectively is seriously impaired. The hospice must do the
following before it seeks to discharge a patient for cause:
(i) Advise the patient that a discharge for cause is being
considered;
(ii) Make a serious effort to resolve the problem(s) presented by
the patient's behavior or situation;
(iii) Ascertain that the patient's proposed discharge is not due to
the patient's use of necessary hospice services; and
(iv) Document the problem(s) and efforts made to resolve the
problem(s) and enter this documentation into its medical records.
(b) Discharge order. Prior to discharging a patient for any reason
listed in paragraph (a) of this section, the hospice must obtain a
written physician's discharge order from the hospice medical director.
If a patient has an attending physician involved in his or her care,
this physician should be consulted before discharge and his or her
review and decision included in the discharge note.
(c) Effect of discharge. An individual, upon discharge from the
hospice during a particular election period for reasons other than
immediate transfer to another hospice--
(1) Is no longer covered under Medicare for hospice care;
(2) Resumes Medicare coverage of the benefits waived under Sec.
418.24(d); and
(3) May at any time elect to receive hospice care if he or she is
again eligible to receive the benefit.
(d) Discharge planning. (1) The hospice must have in place a
discharge planning process that takes into account the prospect that a
patient's condition might stabilize or otherwise change such that the
patient cannot continue to be certified as terminally ill.
(2) The discharge planning process must include planning for any
necessary family counseling, patient education, or other services
before the patient is discharged because he or she is no longer
terminally ill.
Subpart F--Covered Services
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6. In Sec. 418.202, the introductory text is republished, and a new
paragraph (i) is added to read as follows:
Sec. 418.202 Covered services.
All services must be performed by appropriately qualified
personnel, but it is the nature of the service, rather than the
qualification of the person who provides it, that determines the
coverage category of the service. The following services are covered
hospice services:
* * * * *
(i) Effective April 1, 1998, any other service that is specified in
the patient's plan of care as reasonable and necessary for the
palliation and management of the patient's terminal illness and related
conditions and for which payment may otherwise be made under Medicare.
Subpart G--Payment for Hospice Care
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7. Section 418.301 is amended by adding a new paragraph (c) to read as
follows:
Sec. 418.301 Basic rules.
* * * * *
(c) The hospice may not charge a patient for services for which the
patient is entitled to have payment made under Medicare or for services
for which the patient would be entitled to payment, as described in
Sec. 489.21 of this chapter.
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8. Section 418.302 is amended by adding a new paragraph (g) to read as
follows:
Sec. 418.302 Payment procedures for hospice care.
* * * * *
(g) Payment for routine home care and continuous home care is made
on the basis of the geographic location where the service is provided.
Sec. 418.304 [Amended]
0
9. In Sec. 418.304, the following changes are made:
0
a. In paragraph (b), the phrase ``physician's reasonable charge'' is
[[Page 70548]]
removed and is replaced with ``physician fee schedule.''
0
b. In paragraph (c), the phrase ``subparts D or E, part 405 of this
chapter'' is removed and the phrase ``subpart B, part 414 of this
chapter'' is added in its place.
0
10. In Sec. 418.306, the introductory text of paragraph (b) is
republished, paragraph (b)(3) is revised, and new paragraphs (b)(4) and
(b)(5) are added to read as follows:
Sec. 418.306 Determination of payment rates.
* * * * *
(b) Payment rates. The payment rates for routine home care and
other services included in hospice care are as follows:
* * * * *
(3) For Federal fiscal years 1994 through 2002, the payment rate is
the payment rate in effect during the previous fiscal year increased by
a factor equal to the market basket percentage increase minus--
(i) 2 percentage points in FY 1994;
(ii) 1.5 percentage points in FYs 1995 and 1996;
(iii) 0.5 percentage points in FY 1997; and
(iv) 1 percentage point in FY 1998 through FY 2002.
(4) For Federal fiscal year 2001, the payment rate is the payment
rate in effect during the previous fiscal year increased by a factor
equal to the market basket percentage increase plus 5 percentage
points. However, this payment rate is effective only for the period
April 1, 2001 through September 30, 2001. For the period October 1,
2000 through March 31, 2001, the payment rate is based upon the rule
under paragraph (b)(3)(iv) of this section. The payment rate in effect
during the period April 1, 2001 through September 30, 2001 is
considered the payment rate in effect during fiscal year 2001.
(5) The payment rate for hospice services furnished during fiscal
years 2001 and 2002 is increased by an additional 0.5 percent and 0.75
percent, respectively. This additional amount is not included in
updating the payment rate as described in paragraph (b)(3) of this
section.
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: May 24, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: October 11, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-23078 Filed 11-21-05; 8:45 am]
BILLING CODE 4120-01-P