[Title 42 CFR 418]
[Code of Federal Regulations (annual edition) - October 1, 2007 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter IV - CENTERS FOR MEDICARE]
[Subchapter A - GENERAL PROVISIONS]
[Part 418 - HOSPICE CARE]
[From the U.S. Government Printing Office]


42PUBLIC HEALTH32007-10-012007-10-01falseHOSPICE CARE418PART 418PUBLIC HEALTHCENTERS FOR MEDICAREGENERAL PROVISIONS
PART 418_HOSPICE CARE--Table of Contents




               Subpart A_General Provision and Definitions

Sec.
418.1 Statutory basis.
418.2 Scope of part.
418.3 Definitions.

        Subpart B_Eligibility, Election and Duration of Benefits

418.20 Eligibility requirements.
418.21 Duration of hospice care coverage--Election periods.
418.22 Certification of terminal illness.
418.24 Election of hospice care.
418.25 Admission to hospice care.
418.26 Discharge from hospice care.

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418.28 Revoking the election of hospice care.
418.30 Change of the designated hospice.

      Subpart C_Conditions of Participation_General Provisions and 
                             Administration

418.50 Condition of participation--General provisions.
418.52 Condition of participation--Governing body.
418.54 Condition of participation--Medical director.
418.56 Condition of participation--Professional management.
418.58 Condition of participation--Plan of care.
418.60 Condition of participation--Continuation of care.
418.62 Condition of participation--Informed consent.
418.64 Condition of participation--Inservice training.
418.66 Condition of participation--Quality assurance.
418.68 Condition of participation--Interdisciplinary group.
418.70 Condition of participation--Volunteers.
418.72 Condition of participation--Licensure.
418.74 Condition of participation--Central clinical records.

          Subpart D_Conditions of Participation: Core Services

418.80 Condition of participation--Furnishing of core services.
418.82 Condition of participation--Nursing services.
418.83 Nursing services--Waiver of requirement that substantially all 
          nursing services be routinely provided directly by a hospice.
418.84 Condition of participation--Medical social services.
418.86 Condition of participation--Physician services.
418.88 Condition of participation--Counseling services.

          Subpart E_Conditions of Participation: Other Services

418.90 Condition of participation--Furnishing of other services.
418.92 Condition of participation--Physical therapy, occupational 
          therapy, and speech-language pathology.
418.94 Condition of participation--Home health aide and homemaker 
          services.
418.96 Condition of participation--Medical supplies.
418.98 Condition of participation--Short term inpatient care.
418.100 Condition of participation--Hospices that provide inpatient care 
          directly.

                       Subpart F_Covered Services

418.200 Requirements for coverage.
418.202 Covered services.
418.204 Special coverage requirements.
418.205 Special requirements for hospice pre-election evaluation and 
          counseling services.

                   Subpart G_Payment for Hospice Care

418.301 Basic rules.
418.302 Payment procedures for hospice care.
418.304 Payment for physician and nurse practitioner services.
418.306 Determination of payment rates.
418.307 Periodic interim payments.
418.308 Limitation on the amount of hospice payments.
418.309 Hospice cap amount.
418.310 Reporting and recordkeeping requirements.
418.311 Administrative appeals.

                          Subpart H_Coinsurance

418.400 Individual liability for coinsurance for hospice care.
418.402 Individual liability for services that are not considered 
          hospice care.
418.405 Effect of coinsurance liability on Medicare payment.

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 
1302 and 1395hh).

    Source: 48 FR 56026, Dec. 16, 1983, unless otherwise noted.



               Subpart A_General Provision and Definitions



Sec. 418.1  Statutory basis.

    This part implements section 1861(dd) of the Social Security Act. 
Section 1861(dd) specifies services covered as hospice care and the 
conditions that a hospice program must meet in order to participate in 
the Medicare program. The following sections of the Act are also 
pertinent:
    (a) Sections 1812(a) (4) and (d) of the Act specify eligibility 
requirements for the individual and the benefit periods.
    (b) Section 1813(a)(4) of the Act specifies coinsurance amounts.
    (c) Sections 1814(a)(7) and 1814(i) of the Act contain conditions 
and limitations on coverage of, and payment for, hospice care.

[[Page 195]]

    (d) Sections 1862(a) (1), (6) and (9) of the Act establish limits on 
hospice coverage.

[48 FR 56026, Dec. 16, 1983, as amended at 57 FR 36017, Aug. 12, 1992]



Sec. 418.2  Scope of part.

    Subpart A of this part sets forth the statutory basis and scope and 
defines terms used in this part. Subpart B specifies the eligibility 
requirements and the benefit periods. Subpart C specifies conditions of 
participation for hospices. Subpart D describes the covered services and 
specifies the limits on services covered as hospice care. Subpart E 
specifies the reimbursement methods and procedures. Subpart F specifies 
coinsurance amounts applicable to hospice care.



Sec. 418.3  Definitions.

    For purposes of this part--
    Attending physician means a--(1)(i) Doctor of medicine or osteopathy 
legally authorized to practice medicine and surgery by the State in 
which he or she performs that function or action; or
    (ii) Nurse practitioner who meets the training, education, and 
experience requirements as described in Sec. 410.75 (b) of this 
chapter.
    (2) Is identified by the individual, at the time he or she elects to 
receive hospice care, as having the most significant role in the 
determination and delivery of the individual's medical care.
    Bereavement counseling means counseling services provided to the 
individual's family after the individual's death.
    Cap period means the twelve-month period ending October 31 used in 
the application of the cap on overall hospice reimbursement specified in 
Sec. 418.309.
    Employee means an employee (defined by section 210(j) of the Act) of 
the hospice or, if the hospice is a subdivision of an agency or 
organization, an employee of the agency or organization who is 
appropriately trained and assigned to the hospice unit. ``Employee'' 
also refers to a volunteer under the jurisdiction of the hospice.
    Hospice means a public agency or private organization or subdivision 
of either of these that--is primarily engaged in providing care to 
terminally ill individuals.
    Physician means physician as defined in Sec. 410.20 of this 
chapter.
    Representative means an individual who has been authorized under 
State law to terminate medical care or to elect or revoke the election 
of hospice care on behalf of a terminally ill individual who is mentally 
or physically incapacitated.
    Social worker means a person who has at least a bachelor's degree 
from a school accredited or approved by the Council on Social Work 
Education.
    Terminally ill means that the individual has a medical prognosis 
that his or her life expectancy is 6 months or less if the illness runs 
its normal course.

[48 FR 56026, Dec. 16, 1983, as amended at 52 FR 4499, Feb. 12, 1987; 50 
FR 50834, Dec. 11, 1990; 70 FR 45144, Aug. 4, 2005; 72 FR 50227, Aug. 
31, 2007]



        Subpart B_Eligibility, Election and Duration of Benefits



Sec. 418.20  Eligibility requirements.

    In order to be eligible to elect hospice care under Medicare, an 
individual must be--
    (a) Entitled to Part A of Medicare; and
    (b) Certified as being terminally ill in accordance with Sec. 
418.22.



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.
    (b) The periods of care are available in the order listed and may be 
elected separately at different times.

[55 FR 50834, Dec. 11, 1990, as amended at 57 FR 36017, Aug. 12, 1992; 
70 FR 70546, Nov. 22, 2005]

[[Page 196]]



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.
    (c) Sources of certification. (1) For the initial 90-day period, the 
hospice must obtain written certification statements (and oral 
certification statements if required under paragraph (a)(3) of this 
section) from--
    (i) The medical director of the hospice or the physician member of 
the hospice interdisciplinary group; and
    (ii) The individual's attending physician, if the individual has an 
attending physician. The attending physician must meet the definition of 
physician specified in Sec. 410.20 of this subchapter.
    (2) For subsequent periods, the only requirement is certification by 
one of the physicians listed in paragraph (c)(1)(i) of this section.
    (d) Maintenance of records. Hospice staff must--
    (1) Make an appropriate entry in the patient's medical record as 
soon as they receive an oral certification; and
    (2) File written certifications in the medical record.

[55 FR 50834, Dec. 11, 1990, as amended at 57 FR 36017, Aug. 12, 1992; 
70 FR 45144, Aug. 4, 2005; 70 FR 70547, Nov. 22, 2005]



Sec. 418.24  Election of hospice care.

    (a) Filing an election statement. An individual who meets the 
eligibility requirement of Sec. 418.20 may file an election statement 
with a particular hospice. If the individual is physically or mentally 
incapacitated, his or her representative (as defined in Sec. 418.3) may 
file the election statement.
    (b) Content of election statement. The election statement must 
include the following:
    (1) Identification of the particular hospice that will provide care 
to the individual.
    (2) The individual's or representative's acknowledgement that he or 
she has been given a full understanding of the palliative rather than 
curative nature of hospice care, as it relates to the individual's 
terminal illness.
    (3) Acknowledgement that certain Medicare services, as set forth in 
paragraph (d) of this section, are waived by the election.
    (4) The effective date of the election, which may be the first day 
of hospice care or a later date, but may be no earlier than the date of 
the election statement.
    (5) The signature of the individual or representative.
    (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.
    (d) Waiver of other benefits. For the duration of an election of 
hospice care,

[[Page 197]]

an individual waives all rights to Medicare payments for the following 
services:
    (1) Hospice care provided by a hospice other than the hospice 
designated by the individual (unless provided under arrangements made by 
the designated hospice).
    (2) Any Medicare services that are related to the treatment of the 
terminal condition for which hospice care was elected or a related 
condition or that are equivalent to hospice care except for services--
    (i) Provided by the designated hospice:
    (ii) Provided by another hospice under arrangements made by the 
designated hospice; and
    (iii) Provided by the individual's attending physician if that 
physician is not an employee of the designated hospice or receiving 
compensation from the hospice for those services.
    (e) Re-election of hospice benefits. If an election has been revoked 
in accordance with Sec. 418.28, the individual (or his or her 
representative if the individual is mentally or physically 
incapacitated) may at any time file an election, in accordance with this 
section, for any other election period that is still available to the 
individual.

[55 FR 50834, Dec. 11, 1990, as amended at 70 FR 70547, Nov. 22, 2005]



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.

[70 FR 70547, Nov. 22, 2005]



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

[[Page 198]]

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.

[70 FR 70547, Nov. 22, 2005]



Sec. 418.28  Revoking the election of hospice care.

    (a) An individual or representative may revoke the individual's 
election of hospice care at any time during an election period.
    (b) To revoke the election of hospice care, the individual or 
representative must file a statement with the hospice that includes the 
following information:
    (1) A signed statement that the individual or representative revokes 
the individual's election for Medicare coverage of hospice care for the 
remainder of that election period.
    (2) The date that the revocation is to be effective. (An individual 
or representative may not designate an effective date earlier than the 
date that the revocation is made).
    (c) An individual, upon revocation of the election of Medicare 
coverage of hospice care for a particular election period--
    (1) Is no longer covered under Medicare for hospice care;
    (2) Resumes Medicare coverage of the benefits waived under Sec. 
418.24(e)(2); and
    (3) May at any time elect to receive hospice coverage for any other 
hospice election periods that he or she is eligible to receive.



Sec. 418.30  Change of the designated hospice.

    (a) An individual or representative may change, once in each 
election period, the designation of the particular hospice from which 
hospice care will be received.
    (b) The change of the designated hospice is not a revocation of the 
election for the period in which it is made.
    (c) To change the designation of hospice programs, the individual or 
representative must file, with the hospice from which care has been 
received and with the newly designated hospice, a statement that 
includes the following information:
    (1) The name of the hospice from which the individual has received 
care and the name of the hospice from which he or she plans to receive 
care.
    (2) The date the change is to be effective.



      Subpart C_Conditions of Participation_General Provisions and 
                             Administration



Sec. 418.50  Condition of participation--General provisions.

    (a) Standard: Compliance. A hospice must maintain compliance with 
the conditions of this subpart and subparts D and E of this part.
    (b) Standard: Required services. A hospice must be primarily engaged 
in providing the care and services described in Sec. 418.202, must 
provide bereavement counseling and must--
    (1) Make nursing services, physician services, and drugs and 
biologicals routinely available on a 24-hour basis;
    (2) Make all other covered services available on a 24-hour basis to 
the extent necessary to meet the needs of individuals for care that is 
reasonable and necessary for the palliation and management of terminal 
illness and related conditions; and
    (3) Provide these services in a manner consistent with accepted 
standards of practice.
    (c) Standard: Disclosure of information. The hospice must meet the 
disclosure of information requirements at Sec. 420.206 of this chapter.

[48 FR 56026, Dec. 16, 1983, as amended at 55 FR 50834, Dec. 11, 1990]



Sec. 418.52  Condition of participation--Governing body.

    A hospice must have a governing body that assumes full legal 
responsibility for determining, implementing and monitoring policies 
governing the hospice's total operation. The governing body must 
designate an individual who is responsible for the day to day management 
of the hospice program. The governing body must also ensure that all 
services provided are

[[Page 199]]

consistent with accepted standards of practice.



Sec. 418.54  Condition of participation--Medical director.

    The medical director must be a hospice employee who is a doctor of 
medicine or osteopathy who assumes overall responsibility for the 
medical component of the hospice's patient care program.



Sec. 418.56  Condition of participation--Professional management.

    Subject to the conditions of participation pertaining to services in 
Sec. Sec. 418.80 and 418.90, a hospice may arrange for another 
individual or entity to furnish services to the hospice's patients. If 
services are provided under arrangement, the hospice must meet the 
following standards:
    (a) Standard: Continuity of care. The hospice program assures the 
continuity of patient/family care in home, outpatient, and inpatient 
settings.
    (b) Standard: Written agreement. The hospice has a legally binding 
written agreement for the provision of arranged services. The agreement 
includes at least the following:
    (1) Identification of the services to be provided.
    (2) A stipulation that services may be provided only with the 
express authorization of the hospice.
    (3) The manner in which the contracted services are coordinated, 
supervised, and evaluated by the hospice.
    (4) The delineation of the role(s) of the hospice and the contractor 
in the admission process, patient/family assessment, and the 
interdisciplinary group care conferences.
    (5) Requirements for documenting that services are furnished in 
accordance with the agreement.
    (6) The qualifications of the personnel providing the services.
    (c) Standard: Professional management responsibility. The hospice 
retains professional management responsibility for those services and 
ensures that they are furnished in a safe and effective manner by 
persons meeting the qualifications of this part, and in accordance with 
the patient's plan of care and the other requirements of this part.
    (d) Standard: Financial responsibility. The hospice retains 
responsibility for payment for services.
    (e) Standard: Inpatient care. The hospice ensures that inpatient 
care is furnished only in a facility which meets the requirements in 
Sec. 418.98 and its arrangement for inpatient care is described in a 
legally binding written agreement that meets the requirements of 
paragraph (b) and that also specifies, at a minimum--
    (1) That the hospice furnishes to the inpatient provider a copy of 
the patient's plan of care and specifies the inpatient services to be 
furnished;
    (2) That the inpatient provider has established policies consistent 
with those of the hospice and agrees to abide by the patient care 
protocols established by the hospice for its patients;
    (3) That the medical record includes a record of all inpatient 
services and events and that a copy of the discharge summary and, if 
requested, a copy of the medical record are provided to the hospice;
    (4) The party responsible for the implementation of the provisions 
of the agreement; and
    (5) That the hospice retains responsibility for appropriate hospice 
care training of the personnel who provide the care under the agreement.

[48 FR 56026, Dec. 16, 1983; 48 FR 57282, Dec. 29, 1983]



Sec. 418.58  Condition of participation--Plan of care.

    A written plan of care must be established and maintained for each 
individual admitted to a hospice program, and the care provided to an 
individual must be in accordance with the plan.
    (a) Standard: Establishment of plan. The plan must be established by 
the attending physician, the medical director or physician designee and 
interdisciplinary group prior to providing care.
    (b) Standard: Review of plan. The plan must be reviewed and updated, 
at intervals specified in the plan, by the attending physician, the 
medical director or physician designee and interdisciplinary group. 
These reviews must be documented.
    (c) Standard: Content of plan. The plan must include an assessment 
of the individual's needs and identification of the

[[Page 200]]

services including the management of discomfort and symptom relief. It 
must state in detail the scope and frequency of services needed to meet 
the patient's and family's needs.



Sec. 418.60  Condition of participation--Continuation of care.

    A hospice may not discontinue or diminish care provided to a 
Medicare beneficiary because of the beneficiary's inability to pay for 
that care.



Sec. 418.62  Condition of participation--Informed consent.

    A hospice must demonstrate respect for an individual's rights by 
ensuring that an informed consent form that specifies the type of care 
and services that may be provided as hospice care during the course of 
the illness has been obtained for every individual, either from the 
individual or representative as defined in Sec. 418.3.



Sec. 418.64  Condition of participation--Inservice training.

    A hospice must provide an ongoing program for the training of its 
employees.



Sec. 418.66  Condition of participation--Quality assurance.

    A hospice must conduct an ongoing, comprehensive, integrated, self-
assessment of the quality and appropriateness of care provided, 
including inpatient care, home care and care provided under 
arrangements. The findings are used by the hospice to correct identified 
problems and to revise hospice policies if necessary. Those responsible 
for the quality assurance program must--
    (a) Implement and report on activities and mechanisms for monitoring 
the quality of patient care;
    (b) Identify and resolve problems; and
    (c) Make suggestions for improving patient care.



Sec. 418.68  Condition of participation--Interdisciplinary group.

    The hospice must designate an interdisciplinary group or groups 
composed of individuals who provide or supervise the care and services 
offered by the hospice.
    (a) Standard: Composition of group. The hospice must have an 
interdisciplinary group or groups that include at least the following 
individuals who are employees of the hospice:
    (1) A doctor of medicine or osteopathy.
    (2) A registered nurse.
    (3) A social worker.
    (4) A pastoral or other counselor.
    (b) Standard: Role of group. The interdisciplinary group is 
responsible for--
    (1) Participation in the establishment of the plan of care;
    (2) Provision or supervision of hospice care and services;
    (3) Periodic review and updating of the plan of care for each 
individual receiving hospice care; and
    (4) Establishment of policies governing the day-to-day provision of 
hospice care and services.
    (c) If a hospice has more than one interdisciplinary group, it must 
designate in advance the group it chooses to execute the functions 
described in paragraph (b)(4) of this section.
    (d) Standard: Coordinator. The hospice must designate a registered 
nurse to coordinate the implementation of the plan of care for each 
patient.



Sec. 418.70  Condition of participation--Volunteers.

    The hospice in accordance with the numerical standards, specified in 
paragraph (e) of this section, uses volunteers, in defined roles, under 
the supervision of a designated hospice employee.
    (a) Standard: Training. The hospice must provide appropriate 
orientation and training that is consistent with acceptable standards of 
hospice practice.
    (b) Standard: Role. Volunteers must be used in administrative or 
direct patient care roles.
    (c) Standard: Recruiting and retaining. The hospice must document 
active and ongoing efforts to recruit and retain volunteers.
    (d) Standard: Cost saving. The hospice must document the cost 
savings achieved through the use of volunteers. Documentation must 
include--
    (1) The identification of necessary positions which are occupied by 
volunteers;

[[Page 201]]

    (2) The work time spent by volunteers occupying those positions; and
    (3) Estimates of the dollar costs which the hospice would have 
incurred if paid employees occupied the positions identified in 
paragraph (d)(1) for the amount of time specified in paragraph (d)(2).
    (e) Standard: Level of activity. A hospice must document and 
maintain a volunteer staff sufficient to provide administrative or 
direct patient care in an amount that, at a minimum, equals 5 percent of 
the total patient care hours of all paid hospice employees and contract 
staff. The hospice must document a continuing level of volunteer 
activity. Expansion of care and services achieved through the use of 
volunteers, including the type of services and the time worked, must be 
recorded.
    (f) Standard: Availability of clergy. The hospice must make 
reasonable efforts to arrange for visits of clergy and other members of 
religious organizations in the community to patients who request such 
visits and must advise patients of this opportunity.



Sec. 418.72  Condition of participation--Licensure.

    The hospice and all hospice employees must be licensed in accordance 
with applicable Federal, State and local laws and regulations.
    (a) Standard: Licensure of program. If State or local law provides 
for licensing of hospices, the hospice must be licensed.
    (b) Standard: Licensure of employees. Employees who provide services 
must be licensed, certified or registered in accordance with applicable 
Federal or State laws.



Sec. 418.74  Condition of participation--Central clinical records.

    In accordance with accepted principles of practice, the hospice must 
establish and maintain a clinical record for every individual receiving 
care and services. The record must be complete, promptly and accurately 
documented, readily accessible and systematically organized to 
facilitate retrieval.
    (a) Standard: Content. Each clinical record is a comprehensive 
compilation of information. Entries are made for all services provided. 
Entries are made and signed by the person providing the services. The 
record includes all services whether furnished directly or under 
arrangements made by the hospice. Each individual's record contains--
    (1) The initial and subsequent assessments;
    (2) The plan of care;
    (3) Identification data;
    (4) Consent and authorization and election forms;
    (5) Pertinent medical history; and
    (6) Complete documentation of all services and events (including 
evaluations, treatments, progress notes, etc.).
    (b) Standard; Protection of information. The hospice must safeguard 
the clinical record against loss, destruction and unauthorized use.



          Subpart D_Conditions of Participation: Core Services



Sec. 418.80  Condition of participation--Furnishing of core services.

    Except as permitted in Sec. 418.83, a hospice must ensure that 
substantially all the core services described in this subpart are 
routinely provided directly by hospice employees. A hospice may use 
contracted staff if necessary to supplement hospice employees in order 
to meet the needs of patients during periods of peak patient loads or 
under extraordinary circumstances. If contracting is used, the hospice 
must maintain professional, financial, and administrative responsibility 
for the services and must assure that the qualifications of staff and 
services provided meet the requirements specified in this subpart.

[52 FR 7416, Mar. 11, 1987, as amended at 55 FR 50835, Dec. 11, 1990]



Sec. 418.82  Condition of participation--Nursing services.

    The hospice must provide nursing care and services by or under the 
supervision of a registered nurse.
    (a) Nursing services must be directed and staffed to assure that the 
nursing needs of patients are met.
    (b) Patient care responsibilities of nursing personnel must be 
specified.
    (c) Services must be provided in accordance with recognized 
standards of practice.

[[Page 202]]



Sec. 418.83  Nursing services--Waiver of requirement that substantially all nursing services be routinely provided directly by a hospice.

    (a) CMS may approve a waiver of the requirement in Sec. 418.80 for 
nursing services provided by a hospice which is located in a non-
urbanized area. The location of a hospice that operates in several areas 
is considered to be the location of its central office. The hospice must 
provide evidence that it was operational on or before January 1, 1983, 
and that it made a good faith effort to hire a sufficient number of 
nurses to provide services directly. CMS bases its decision as to 
whether to approve a waiver application on the following:
    (1) The current Bureau of the Census designations for determining 
non-urbanized areas.
    (2) Evidence that a hospice was operational on or before January 1, 
1983 including:
    (i) Proof that the organization was established to provide hospice 
services on or before January 1, 1983;
    (ii) Evidence that hospice-type services were furnished to patients 
on or before January 1, 1983; and
    (iii) Evidence that the hospice care was a discrete activity rather 
than an aspect of another type of provider's patient care program on or 
before January 1, 1983.
    (3) Evidence that a hospice made a good faith effort to hire nurses, 
including:
    (i) Copies of advertisements in local newspapers that demonstrate 
recruitment efforts;
    (ii) Job descriptions for nurse employees;
    (iii) Evidence that salary and benefits are competitive for the 
area; and
    (iv) Evidence of any other recruiting activities (e.g., recruiting 
efforts at health fairs and contacts with nurses at other providers in 
the area);
    (b) Any waiver request is deemed to be granted unless it is denied 
within 60 days after it is received.
    (c) Waivers will remain effective for one year at a time.
    (d) CMS may approve a maximum of two one-year extensions for each 
initial waiver. If a hospice wishes to receive a one-year extension, the 
hospice must submit a certification to CMS, prior to the expiration of 
the waiver period, that the employment market for nurses has not changed 
significantly since the time the initial waiver was granted.

[52 FR 7416, Mar. 11, 1987]



Sec. 418.84  Condition of participation--Medical social services.

    Medical social services must be provided by a qualified social 
worker, under the direction of a physician.



Sec. 418.86  Condition of participation--Physician services.

    In addition to palliation and management of terminal illness and 
related conditions, physician employees of the hospice, including the 
physician member(s) of the interdisciplinary group, must also meet the 
general medical needs of the patients to the extent that these needs are 
not met by the attending physician.



Sec. 418.88  Condition of participation--Counseling services.

    Counseling services must be available to both the individual and the 
family. Counseling includes bereavement counseling, provided after the 
patient's death as well as dietary, spiritual and any other counseling 
services for the individual and family provided while the individual is 
enrolled in the hospice.
    (a) Standard: Bereavement counseling. There must be an organized 
program for the provision of bereavement services under the supervision 
of a qualified professional. The plan of care for these services should 
reflect family needs, as well as a clear delineation of services to be 
provided and the frequency of service delivery (up to one year following 
the death of the patient). A special coverage provision for bereavement 
counseling is specified Sec. 418.204(c).
    (b) Standard: Dietary counseling. Dietary counseling, when required, 
must be provided by a qualified individual.
    (c) Standard: Spiritual counseling. Spiritual counseling must 
include notice to patients as to the availability of clergy as provided 
in Sec. 418.70(f).
    (d) Standard: Additional counseling. Counseling may be provided by 
other members of the interdisciplinary group

[[Page 203]]

as well as by other qualified professionals as determined by the 
hospice.



          Subpart E_Conditions of Participation: Other Services



Sec. 418.90  Condition of participation--Furnishing of other services.

    A hospice must ensure that the services described in this subpart 
are provided directly by hospice employees or under arrangements made by 
the hospice as specified in Sec. 418.56.

[48 FR 56026, Dec. 16, 1983, as amended at 55 FR 50835, Dec. 11, 1990]



Sec. 418.92  Condition of participation--Physical therapy, occupational therapy, and speech-language pathology.

    (a) Physical therapy services, occupational therapy services, and 
speech-language patholgy services must be available, and when provided, 
offered in a manner consistent with accepted standards of practice.
    (b)(1) If the hospice engages in laboratory testing outside of the 
context of assisting an individual in self-administering a test with an 
appliance that has been cleared for that purpose by the FDA, such 
testing must be in compliance with all applicable requirements of part 
493 of this chapter.
    (2) If the hospice chooses to refer specimens for laboratory testing 
to another laboratory, the referral laboratory must be certified in the 
appropriate specialties and subspecialties of services in accordance 
with the applicable requirements of part 493 of this chapter.

[57 FR 7135, Feb. 28, 1992]



Sec. 418.94  Condition of participation--Home health aide and homemaker services.

    Home health aide and homemaker services must be available and 
adequate in frequency to meet the needs of the patients. A home health 
aide is a person who meets the training, attitude and skill requirements 
specified in Sec. 484.36 of this chapter.
    (a) Standard: Supervision. A registered nurse must visit the home 
site at least every two weeks when aide services are being provided, and 
the visit must include an assessment of the aide services.
    (b) Standard: Duties. Written instructions for patient care are 
prepared by a registered nurse. Duties include, but may not be limited 
to, the duties specified in Sec. 484.36(c) of this chapter.

[48 FR 56026, Dec. 16, 1983, as amended at 55 FR 50835, Dec. 11, 1990]



Sec. 418.96  Condition of participation--Medical supplies.

    Medical supplies and appliances including drugs and biologicals, 
must be provided as needed for the palliation and management of the 
terminal illness and related conditions.
    (a) Standard: Administration. All drugs and biologicals must be 
administered in accordance with accepted standards of practice.
    (b) Standard: Controlled drugs in the patient's home. The hospice 
must have a policy for the disposal of controlled drugs maintained in 
the patient's home when those drugs are no longer needed by the patient.
    (c) Standard: Administration of drugs and biologicals. Drugs and 
biologicals are administered only by the following individuals:
    (1) A licensed nurse or physician.
    (2) An employee who has completed a State-approved training program 
in medication administration.
    (3) The patient if his or her attending physician has approved.
    (4) Any other individual in accordance with applicable State and 
local laws. The persons, and each drug and biological they are 
authorized to administer, must be specified in the patient's plan of 
care.



Sec. 418.98  Condition of participation--Short term inpatient care.

    Inpatient care must be available for pain control, symptom 
management and respite purposes, and must be provided in a participating 
Medicare or Medicaid facility.
    (a) Standard: Inpatient care for symptom control. Inpatient care for 
pain control and symptom management must be provided in one of the 
following:
    (1) A hospice that meets the condition of participation for 
providing inpatient care directly as specified in Sec. 418.100.

[[Page 204]]

    (2) A hospital or an SNF that also meets the standards specified in 
Sec. 418.100 (a) and (e) regarding 24-hour nursing service and patient 
areas.
    (b) Standard: Inpatient care for respite purposes. Inpatient care 
for respite purposes must be provided by one of the following:
    (1) A provider specified in paragraph (a) of this section.
    (2) An ICF that also meets the standards specified in Sec. 418.100 
(a) and (e) regarding 24-hour nursing service and patient areas.
    (c) Standard: Inpatient care limitation. The total number of 
inpatient days used by Medicare beneficiaries who elected hospice 
coverage in any 12-month period preceding a certification survey in a 
particular hospice may not exceed 20 percent of the total number of 
hospice days for this group of beneficiaries.
    (d) Standard: Exemption from limitation. Until October 1, 1986, any 
hospice that began operation before January 1, 1975 is not subject to 
the limitation specified in paragraph (c).

[48 FR 56026, Dec. 16, 1983, as amended at 55 FR 50835, Dec. 11, 1990]



Sec. 418.100  Condition of participation Hospices that provide inpatient care directly.

    A hospice that provides inpatient care directly must comply with all 
of the following standards.
    (a) Standard: Twenty-four-hour nursing services. (1) The facility 
provides 24-hour nursing services which are sufficient to meet total 
nursing needs and which are in accordance with the patient plan of care. 
Each patient receives treatments, medications, and diet as prescribed, 
and is kept comfortable, clean, well-groomed, and protected from 
accident, injury, and infection.
    (2) Each shift must include a registered nurse who provides direct 
patient care.
    (b) Standard: Disaster preparedness. The hospice has an acceptable 
written plan, periodically rehearsed with staff, with procedures to be 
followed in the event of an internal or external disaster and for the 
care of casualties (patients and personnel) arising from such disasters.
    (c) Standard: Health and safety laws. The hospice must meet all 
Federal, State, and local laws, regulations, and codes pertaining to 
health and safety, such as provisions regulating--
    (1) Construction, maintenance, and equipment for the hospice;
    (2) Sanitation;
    (3) Communicable and reportable diseases; and
    (4) Post mortem procedures.
    (d) Standard: Fire protection. (1) Except as otherwise provided in 
this section--
    (i) The hospice must meet the provisions applicable to nursing homes 
of the 2000 edition of the Life Safety Code of the National Fire 
Protection Association. The Director of the Office of the Federal 
Register has approved the NFPA 101 [reg] 2000 edition of the 
Life Safety Code, issued January 14, 2000, for incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy 
of the Code is available for inspection at the CMS Information Resource 
Center, 7500 Security Boulevard, Baltimore, MD or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html. Copies may be obtained from the 
National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 
02269. If any changes in this edition of the Code are incorporated by 
reference, CMS will publish notice in the Federal Register to announce 
the changes.
    (ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition 
of the LSC does not apply to a hospice.
    (2) In consideration of a recommendation by the State survey agency, 
CMS may waive, for periods deemed appropriate, specific provisions of 
the Life Safety Code which, if rigidly applied would result in 
unreasonable hardship for the hospice, but only if the waiver would not 
adversely affect the health and safety of the patients.
    (3) The provisions of the adopted edition of the Life Safety Code do 
not apply in a State if CMS finds that a fire and safety code imposed by 
State

[[Page 205]]

law adequately protects patients in hospices.
    (4) Beginning March 13, 2006, a hospice must be in compliance with 
Chapter 9.2.9, Emergency Lighting.
    (5) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 
does not apply to hospices.
    (6) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, a hospice may place alcohol-based hand rub 
dispensers in its facility if--
    (i) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (ii) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (iii) The dispensers are installed in a manner that adequately 
protects against inappropriate access;
    (iv) The dispensers are installed in accordance with chapter 
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety 
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued 
by the Standards Council of the National Fire Protection Association on 
April 15, 2004. The Director of the Office of the Federal Register has 
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy 
of the amendment is available for inspection at the CMS Information 
Resource Center, 7500 Security Boulevard, Baltimore, MD and at the 
Office of the Federal Register, 800 North Capitol Street NW., Suite 700, 
Washington, DC. Copies may be obtained from the National Fire Protection 
Association, 1 Batterymarch Park, Quincy, MA 02269; and
    (v) The dispensers are maintained in accordance with dispenser 
manufacturer guidelines.
    (e) Standard: Patient areas. (1) The hospice must design and equip 
areas for the comfort and privacy of each patient and family members.
    (2) The hospice must have--
    (i) Physical space for private patient/family visiting;
    (ii) Accommodations for family members to remain with the patient 
throughout the night;
    (iii) Accommodations for family privacy after a patient's death; and
    (iv) Decor which is homelike in design and function.
    (3) Patients must be permitted to receive visitors at any hour, 
including small children.
    (f) Standard: Patient rooms and toilet facilities. Patient rooms are 
designed and equipped for adequate nursing care and the comfort and 
privacy of patients.
    (1) Each patient's room must--
    (i) Be equipped with or conveniently located near toilet and bathing 
facilities;
    (ii) Be at or above grade level;
    (iii) Contain a suitable bed for each patient and other appropriate 
furniture;
    (iv) Have closet space that provides security and privacy for 
clothing and personal belongings;
    (v) Contain no more than four beds;
    (vi) Measure at least 100 square feet for a single patient room or 
80 square feet for each patient for a multipatient room; and
    (vii) Be equipped with a device for calling the staff member on 
duty.
    (2) For an existing building, CMS may waive the space and occupancy 
requirements of paragraphs (f)(1) (v) and (vi) of this section for as 
long as it is considered appropriate if it finds that--
    (i) The requirements would result in unreasonable hardship on the 
hospice if strictly enforced; and
    (ii) The waiver serves the particular needs of the patients and does 
not adversely affect their health and safety.
    (g) Standard: Bathroom facilities. The hospice must--
    (1) Provide an adequate supply of hot water at all times for patient 
use; and
    (2) Have plumbing fixtures with control valves that automatically 
regulate the temperature of the hot water used by patients.
    (h) Standard: Linen. The hospice has available at all times a 
quantity of linen essential for proper care and comfort of patients. 
Linens are handled, stored, processed, and transported in such a manner 
as to prevent the spread of infection.

[[Page 206]]

    (i) Standard: Isolation areas. The hospice must make provision for 
isolating patients with infectious diseases.
    (j) Standard: Meal service, menu planning, and supervision. The 
hospice must--
    (1) Serve at least three meals or their equivalent each day at 
regular times, with not more than 14 hours between a substantial evening 
meal and breakfast;
    (2) Procure, store, prepare, distribute, and serve all food under 
sanitary conditions;
    (3) Have a staff member trained or experienced in food management or 
nutrition who is responsible for--
    (i) Planning menus that meet the nutritional needs of each patient, 
following the orders of the patient's physician and, to the extent 
medically possible, the recommended dietary allowances of the Food and 
Nutrition Board of the National Research Council, National Academy of 
Sciences (Recommended Dietary Allowances (9th ed., 1981) is available 
from the Printing and Publications Office, National Academy of Sciences, 
Washington, DC 20418); and
    (ii) Supervising the meal preparation and service to ensure that the 
menu plan is followed; and
    (4) If the hospice has patients who require medically prescribed 
special diets, have the menus for those patients planned by a 
professionally qualified dietitian and supervise the preparation and 
serving of meals to ensure that the patient accepts the special diet.
    (k) Standard: Pharmaceutical services. The hospice provides 
appropriate methods and procedures for the dispensing and administering 
of drugs and biologicals. Whether drugs and biologicals are obtained 
from community or institutional pharmacists or stocked by the facility, 
the facility is responsible for drugs and biologicals for its patients, 
insofar as they are covered under the program and for ensuring that 
pharmaceutical services are provided in accordance with accepted 
professional principles and appropriate Federal, State, and local laws. 
(See Sec. 405.1124(g), (h), and (i) of this chapter.)
    (1) Licensed pharmacist. The hospice must--
    (i) Employ a licensed pharmacist; or
    (ii) Have a formal agreement with a licensed pharmacist to advise 
the hospice on ordering, storage, administration, disposal, and 
recordkeeping of drugs and biologicals.
    (2) Orders for medications. (i) A physician must order all 
medications for the patient.
    (ii) If the medication order is verbal--
    (A) The physician must give it only to a licensed nurse, pharmacist, 
or another physician; and
    (B) The individual receiving the order must record and sign it 
immediately and have the prescribing physician sign it in a manner 
consistent with good medical practice.
    (3) Administering medications. Medications are administered only by 
one of the following individuals:
    (i) A licensed nurse or physician.
    (ii) An employee who has completed a State-approved training program 
in medication administration.
    (iii) The patient if his or her attending physician has approved.
    (4) Control and accountability. The pharmaceutical service has 
procedures for control and accountability of all drugs and biologicals 
throughout the facility. Drugs are dispensed in compliance with Federal 
and State laws. Records of receipt and disposition of all controlled 
drugs are maintained in sufficient detail to enable an accurate 
reconciliation. The pharmacist determines that drug records are in order 
and that an account of all controlled drugs is maintained and 
reconciled.
    (5) Labeling of drugs and biologicals. The labeling of drugs and 
biologicals is based on currently accepted professional principles, and 
includes the appropriate accessory and cautionary instructions, as well 
as the expiration date when applicable.
    (6) Storage. In accordance with State and Federal laws, all drugs 
and biologicals are stored in locked compartments under proper 
temperature controls and only authorized personnel have access to the 
keys. Separately locked compartments are provided for storage of 
controlled drugs listed in Schedule II of the Comprehensive Drug Abuse 
Prevention & Control Act of 1970 and other drugs subject to abuse, 
except under single unit package drug

[[Page 207]]

distribution systems in which the quantity stored is minimal and a 
missing dose can be readily detected. An emergency medication kit is 
kept readily available.
    (7) Drug disposal. Controlled drugs no longer needed by the patient 
are disposed of in compliance with State requirements. In the absence of 
State requirements, the pharmacist and a registered nurse dispose of the 
drugs and prepare a record of the disposal.

[48 FR 56026, Dec. 16, 1983; 48 FR 57282, Dec. 29, 1983; 49 FR 23010, 
June 1, 1984, as amended at 53 FR 11509, Apr. 7, 1988; 55 FR 50835, Dec. 
11, 1990; 68 FR 1386, Jan. 10, 2003; 69 FR 18803, Apr. 9, 2004; 69 FR 
49266, Aug. 11, 2004; 70 FR 15237, Mar. 25, 2005; 71 FR 55339, Sept. 22, 
2006]



                       Subpart F_Covered Services



Sec. 418.200  Requirements for coverage.

    To be covered, hospice services must meet the following 
requirements. They must be reasonable and necessary for the palliation 
or management of the terminal illness as well as related conditions. The 
individual must elect hospice care in accordance with Sec. 418.24 and a 
plan of care must be established as set forth in Sec. 418.58 before 
services are provided. The services must be consistent with the plan of 
care. A certification that the individual is terminally ill must be 
completed as set forth in Sec. 418.22.



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:
    (a) Nursing care provided by or under the supervision of a 
registered nurse.
    (b) Medical social services provided by a social worker under the 
direction of a physician.
    (c) Physicians' services performed by a physician as defined in 
Sec. 410.20 of this chapter except that the services of the hospice 
medical director or the physician member of the interdisciplinary group 
must be performed by a doctor of medicine or osteopathy.
    (d) Counseling services provided to the terminally ill individual 
and the family members or other persons caring for the individual at 
home. Counseling, including dietary counseling, may be provided both for 
the purpose of training the individual's family or other caregiver to 
provide care, and for the purpose of helping the individual and those 
caring for him or her to adjust to the individual's approaching death.
    (e) Short-term inpatient care provided in a participating hospice 
inpatient unit, or a participating hospital or SNF, that additionally 
meets the standards in Sec. 418.202 (a) and (e) regarding staffing and 
patient areas. Services provided in an inpatient setting must conform to 
the written plan of care. Inpatient care may be required for procedures 
necessary for pain control or acute or chronic symptom management.

Inpatient care may also be furnished as a means of providing respite for 
the individual's family or other persons caring for the individual at 
home. Respite care must be furnished as specified in Sec. 418.98(b). 
Payment for inpatient care will be made at the rate appropriate to the 
level of care as specified in Sec. 418.302.
    (f) Medical appliances and supplies, including drugs and 
biologicals. Only drugs as defined in section 1861(t) of the Act and 
which are used primarily for the relief of pain and symptom control 
related to the individual's terminal illness are covered. Appliances may 
include covered durable medical equipment as described in Sec. 410.38 
of this chapter as well as other self-help and personal comfort items 
related to the palliation or management of the patient's terminal 
illness. Equipment is provided by the hospice for use in the patient's 
home while he or she is under hospice care. Medical supplies include 
those that are part of the written plan of care.
    (g) Home health aide services furnished by qualified aides as 
designated in Sec. 418.94 and homemaker services. Home health aides may 
provide personal care services as defined in Sec. 409.45(b) of this 
chapter. Aides may perform household services to maintain a safe and 
sanitary environment in areas of the home used by the patient, such as 
changing

[[Page 208]]

bed linens or light cleaning and laundering essential to the comfort and 
cleanliness of the patient. Aide services must be provided under the 
general supervision of a registered nurse. Homemaker services may 
include assistance in maintenance of a safe and healthy environment and 
services to enable the individual to carry out the treatment plan.
    (h) Physical therapy, occupational therapy and speech-language 
pathology services in addition to the services described in Sec. 409.33 
(b) and (c) of this chapter provided for purposes of symptom control or 
to enable the patient to maintain activities of daily living and basic 
functional skills.
    (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.

[48 FR 56026, Dec. 16, 1983, as amended at 51 FR 41351, Nov. 14, 1986; 
55 FR 50835, Dec. 11, 1990; 59 FR 65498, Dec. 20, 1994; 70 FR 70547, 
Nov. 22, 2005]



Sec. 418.204  Special coverage requirements.

    (a) Periods of crisis. Nursing care may be covered on a continuous 
basis for as much as 24 hours a day during periods of crisis as 
necessary to maintain an individual at home. Either homemaker or home 
health aide services or both may be covered on a 24-hour continuous 
basis during periods of crisis but care during these periods must be 
predominantly nursing care. A period of crisis is a period in which the 
individual requires continuous care to achieve palliation or management 
of acute medical symptoms.
    (b) Respite care. (1) Respite care is short-term inpatient care 
provided to the individual only when necessary to relieve the family 
members or other persons caring for the individual.
    (2) Respite care may be provided only on an occasional basis and may 
not be reimbursed for more than five consecutive days at a time.
    (c) Bereavement counseling. Bereavement counseling is a required 
hospice service but it is not reimbursable.

[48 FR 56026, Dec. 16, 1983, as amended at 55 FR 50835, Dec. 11, 1990]



Sec. 418.205  Special requirements for hospice pre-election evaluation and counseling services.

    (a) Definition. As used in this section the following definition 
applies.
    Terminal illness has the same meaning as defined in Sec. 418.3.
    (b) General. Effective January 1, 2005, payment for hospice pre-
election evaluation and counseling services as specified in Sec. 
418.304(d) may be made to a hospice on behalf of a Medicare beneficiary 
if the requirements of this section are met.
    (1) The beneficiary. The beneficiary:
    (i) Has been diagnosed as having a terminal illness as defined in 
Sec. 418.3.
    (ii) Has not made a hospice election.
    (iii) Has not previously received hospice pre-election evaluation 
and consultation services specified under this section.
    (2) Services provided. The hospice pre-election services include an 
evaluation of an individual's need for pain and symptom management and 
counseling regarding hospice and other care options. In addition, the 
services may include advising the individual regarding advanced care 
planning.
    (3) Provision of pre-election hospice services. (i) The services 
must be furnished by a physician.
    (ii) The physician furnishing these services must be an employee or 
medical director of the hospice billing for this service.
    (iii) The services cannot be furnished by hospice personnel other 
than employed physicians, such as but not limited to nurse 
practitioners, nurses, or social workers, physicians under contractual 
arrangements with the hospice or by the beneficiary's physician, if that 
physician is not an employee of the hospice.
    (iv) If the beneficiary's attending physician is also the medical 
director or a physician employee of the hospice, the attending physician 
may not provide nor may the hospice bill for this service because that 
physician already possesses the expertise necessary to

[[Page 209]]

furnish end-of-life evaluation and management, and counseling services.
    (4) Documentation. (i) If the individual's physician initiates the 
request for services of the hospice medical director or physician, 
appropriate documentation is required.
    (ii) The request or referral must be in writing, and the hospice 
medical director or physician employee is expected to provide a written 
note on the patient's medical record.
    (iii) The hospice agency employing the physician providing these 
services is required to maintain a written record of the services 
furnished.
    (iv) If the services are initiated by the beneficiary, the hospice 
agency is required to maintain a record of the services and 
documentation that communication between the hospice medical director or 
physician and the beneficiary's physician occurs, with the beneficiary's 
permission, to the extent necessary to ensure continuity of care.

[69 FR 66425, Nov. 15, 2004]



                   Subpart G_Payment for Hospice Care



Sec. 418.301  Basic rules.

    (a) Medicare payment for covered hospice care is made in accordance 
with the method set forth in Sec. 418.302.
    (b) Medicare reimbursement to a hospice in a cap period is limited 
to a cap amount specified in Sec. 418.309.
    (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.

[48 FR 56026, Dec. 16, 1983, as amended at 56 FR 26919, June 12, 1991; 
70 FR 70547, Nov. 22, 2005]



Sec. 418.302  Payment procedures for hospice care.

    (a) CMS establishes payment amounts for specific categories of 
covered hospice care.
    (b) Payment amounts are determined within each of the following 
categories:
    (1) Routine home care day. A routine home care day is a day on which 
an individual who has elected to receive hospice care is at home and is 
not receiving continuous care as defined in paragraph (b)(2) of this 
section.
    (2) Continuous home care day. A continuous home care day is a day on 
which an individual who has elected to receive hospice care is not in an 
inpatient facility and receives hospice care consisting predominantly of 
nursing care on a continuous basis at home. Home health aide or 
homemaker services or both may also be provided on a continuous basis. 
Continuous home care is only furnished during brief periods of crisis as 
described in Sec. 418.204(a) and only as necessary to maintain the 
terminally ill patient at home.
    (3) Inpatient respite care day. An inpatient respite care day is a 
day on which the individual who has elected hospice care receives care 
in an approved facility on a short-term basis for respite.
    (4) General inpatient care day. A general inpatient care day is a 
day on which an individual who has elected hospice care receives general 
inpatient care in an inpatient facility for pain control or acute or 
chronic symptom management which cannot be managed in other settings.
    (c) The payment amounts for the categories of hospice care are fixed 
payment rates that are established by CMS in accordance with the 
procedures described in Sec. 418.306. Payment rates are determined for 
the following categories:
    (1) Routine home care.
    (2) Continuous home care.
    (3) Inpatient respite care.
    (4) General inpatient care.
    (d)(1) The intermediary reimburses the hospice its appropriate 
payment amount for each day for which an eligible Medicare beneficiary 
is under the hospice's care.
    (2) Effective December 8, 2003, if a hospice makes arrangements with 
another hospice to provide services under the circumstances specified in 
section 1861(dd)(5)(D) of the Act, the intermediary reimburses the 
hospice for which the beneficiary has made an election as described in 
paragraph (d)(1) of this section.
    (e) The intermediary makes payment according to the following 
procedures:

[[Page 210]]

    (1) Payment is made to the hospice for each day during which the 
beneficiary is eligible and under the care of the hospice, regardless of 
the amount of services furnished on any given day.
    (2) Payment is made for only one of the categories of hospice care 
described in Sec. 418.302(b) for any particular day.
    (3) On any day on which the beneficiary is not an inpatient, the 
hospice is paid the routine home care rate, unless the patient receives 
continuous care as defined in paragraph (b)(2) of this section for a 
period of at least 8 hours. In that case, a portion of the continuous 
care day rate is paid in accordance with paragraph (e)(4) of this 
section.
    (4) The hospice payment on a continuous care day varies depending on 
the number of hours of continuous services provided. The continuous home 
care rate is divided by 24 to yield an hourly rate. The number of hours 
of continuous care provided during a continuous home care day is then 
multiplied by the hourly rate to yield the continuous home care payment 
for that day. A minimum of 8 hours of care must be furnished on a 
particular day to qualify for the continuous home care rate.
    (5) Subject to the limitations described in paragraph (f) of this 
section, on any day on which the beneficiary is an inpatient in an 
approved facility for inpatient care, the appropriate inpatient rate 
(general or respite) is paid depending on the category of care 
furnished. The inpatient rate (general or respite) is paid for the date 
of admission and all subsequent inpatient days, except the day on which 
the patient is discharged. For the day of discharge, the appropriate 
home care rate is paid unless the patient dies as an inpatient. In the 
case where the beneficiary is discharged deceased, the inpatient rate 
(general or respite) is paid for the discharge day. Payment for 
inpatient respite care is subject to the requirement that it may not be 
provided consecutively for more than 5 days at a time. Payment for the 
sixth and any subsequent day of respite care is made at the routine home 
care rate.
    (f) Payment for inpatient care is limited as follows: (1) The total 
payment to the hospice for inpatient care (general or respite) is 
subject to a limitation that total inpatient care days for Medicare 
patients not exceed 20 percent of the total days for which these 
patients had elected hospice care.
    (2) At the end of a cap period, the intermediary calculates a 
limitation on payment for inpatient care to ensure that Medicare payment 
is not made for days of inpatient care in excess of 20 percent of the 
total number of days of hospice care furnished to Medicare patients.
    (3) If the number of days of inpatient care furnished to Medicare 
patients is equal to or less than 20 percent of the total days of 
hospice care to Medicare patients, no adjustment is necessary. Overall 
payments to a hospice are subject to the cap amount specified in Sec. 
418.309.
    (4) If the number of days of inpatient care furnished to Medicare 
patients exceeds 20 percent of the total days of hospice care to 
Medicare patients, the total payment for inpatient care is determined in 
accordance with the procedures specified in paragraph (f)(5) of this 
section. That amount is compared to actual payments for inpatient care, 
and any excess reimbursement must be refunded by the hospice. Overall 
payments to the hospice are subject to the cap amount specified in Sec. 
418.309.
    (5) If a hospice exceeds the number of inpatient care days described 
in paragraph (f)(4), the total payment for inpatient care is determined 
as follows:
    (i) Calculate the ratio of the maximum number of allowable inpatient 
days to the actual number of inpatient care days furnished by the 
hospice to Medicare patients.
    (ii) Multiply this ratio by the total reimbursement for inpatient 
care made by the intermediary.
    (iii) Multiply the number of actual inpatient days in excess of the 
limitation by the routine home care rate.
    (iv) Add the amounts calculated in paragraphs (f)(5)(ii) and (iii) 
of this section.
    (g) Payment for routine home care, continuous home care, general 
inpatient care and inpatient respite care is

[[Page 211]]

made on the basis of the geographic location where the services are 
provided.

[48 FR 56026, Dec. 16, 1983, as amended at 56 FR 26919, June 12, 1991; 
70 FR 45145, Aug. 4, 2005; 70 FR 70547, Nov. 22, 2005; 72 FR 50228, Aug. 
31, 2007]



Sec. 418.304  Payment for physician and nurse practitioner services.

    (a) The following services performed by hospice physicians and nurse 
practitioners are included in the rates described in Sec. 418.302:
    (1) General supervisory services of the medical director.
    (2) Participation in the establishment of plans of care, supervision 
of care and services, periodic review and updating of plans of care, and 
establishment of governing policies by the physician member of the 
interdisciplinary group.
    (b) For services not described in paragraph (a) of this section, a 
specified Medicare contractor pays the hospice an amount equivalent to 
100 percent of the physician fee schedule for those physician services 
furnished by hospice employees or under arrangements with the hospice. 
Reimbursement for these physician services is included in the amount 
subject to the hospice payment limit described in Sec. 418.309. 
Services furnished voluntarily by physicians are not reimbursable.
    (c) 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 not considered hospice services and are not 
included in the amount subject to the hospice payment limit described in 
Sec. 418.309. These services are paid by the carrier under the 
procedures in subpart B, part 414 of this chapter.
    (d) Payment for hospice pre-election evaluation and counseling 
services. The intermediary makes payment to the hospice for the services 
established in Sec. 418.205. Payment for this service is set at an 
amount established under the physician fee schedule, for an office or 
other outpatient visit for evaluation and management associated with 
presenting problems of moderate severity and requiring medical decision-
making of low complexity other than the portion of the amount 
attributable to the practice expense component. Payment for this pre-
election service does not count towards the hospice cap amount.
    (e)(1) Effective December 8, 2003, Medicare pays for attending 
physician services provided by nurse practitioners to Medicare 
beneficiaries who have elected the hospice benefit and who have selected 
a nurse practitioner as their attending physician. This applies to nurse 
practitioners without regard to whether they are hospice employees.
    (2) Nurse practitioners may bill and receive payment for services 
only if the--
    (i) Nurse practitioner is the beneficiary's attending physician as 
defined in Sec. 418.3;
    (ii) Services are medically reasonable and necessary;
    (iii) Services are performed by a physician in the absence of the 
nurse practitioner; and
    (iv) Services are not related to the certification of terminal 
illness specified in Sec. 418.22.
    (3) Payment for nurse practitioner services are made at 85 percent 
of the physician fee schedule amount.

[48 FR 56026, Dec. 16, 1983, as amended at 69 FR 66426, Nov. 15, 2004; 
70 FR 45145, Aug. 4, 2005; 70 FR 70547, Nov. 22, 2005]



Sec. 418.306  Determination of payment rates.

    (a) Applicability. CMS establishes payment rates for each of the 
categories of hospice care described in Sec. 418.302(b). The rates are 
established using the methodology described in section 1814(i)(1)(C) of 
the Act.
    (b) Payment rates. The payment rates for routine home care and other 
services included in hospice care are as follows:
    (1) The following rates, which are 120 percent of the rates in 
effect on September 30, 1989, are effective January 1, 1990 through 
September 30, 1990 and October 21, 1990 through December 31, 1990:

Routine home care.............................................    $75.80
Continuous home care:
  Full rate for 24 hours......................................    442.40
  Hourly rate.................................................     18.43
Inpatient respite care........................................     78.40
General inpatient care........................................    337.20
 


[[Page 212]]

    (2) Except for the period beginning October 21, 1990, through 
December 31, 1990, the payment rates for routine home care and other 
services included in hospice care for Federal fiscal years 1991, 1992, 
and 1993 and those that begin on or after October 1, 1997, are the 
payment rates in effect under this paragraph during the previous fiscal 
year increased by the market basket percentage increase as defined in 
section 1886(b)(3)(B)(iii) of the Act, otherwise applicable to 
discharges occurring in the fiscal year. The payment rates for the 
period beginning October 21, 1990, through December 31, 1990, are the 
same as those shown in paragraph (b)(1) of this section.
    (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.
    (c) Adjustment for wage differences. CMS will issue annually, in the 
Federal Register, a hospice wage index based on the most current 
available CMS hospital wage data, including any changes to the 
definitions of Metropolitan Statistical Areas. The payment rates 
established by CMS are adjusted by the intermediary to reflect local 
differences in wages according to the revised wage index.
    (d) Federal Register notices. CMS publishes as a notice in the 
Federal Register any proposal to change the methodology for determining 
the payment rates.

[56 FR 26919, June 12, 1991, as amended at 59 FR 26960, May 25, 1994; 62 
FR 42882, Aug. 8, 1997; 70 FR 70548, Nov. 22, 2005]



Sec. 418.307  Periodic interim payments.

    Subject to the provisions of Sec. 413.64(h) of this chapter, a 
hospice may elect to receive periodic interim payments (PIP) effective 
with claims received on or after July 1, 1987. Payment is made biweekly 
under the PIP method unless the hospice requests a longer fixed interval 
(not to exceed one month) between payments. The biweekly interim payment 
amount is based on the total estimated Medicare payments for the 
reporting period (as described in Sec. Sec. 418.302-418.306). Each 
payment is made 2 weeks after the end of a biweekly period of service as 
described in Sec. 413.64(h)(5) of this chapter. Under certain 
circumstances that are described in Sec. 413.64(g) of this chapter, a 
hospice that is not receiving PIP may request an accelerated payment.

[59 FR 36713, July 19, 1994]



Sec. 418.308  Limitation on the amount of hospice payments.

    (a) Except as specified in paragraph (b) of this section, the total 
Medicare payment to a hospice for care furnished during a cap period is 
limited by the hospice cap amount specified in Sec. 418.309.
    (b) Until October 1, 1986, payment to a hospice that began operation 
before January 1, 1975 is not limited by the amount of the hospice cap 
specified in Sec. 418.309.
    (c) The intermediary notifies the hospice of the determination of 
program reimbursement at the end of the cap year in accordance with 
procedures similar to those described in Sec. 405.1803 of this chapter.

[[Page 213]]

    (d) Payments made to a hospice during a cap period that exceed the 
cap amount are overpayments and must be refunded.

[48 FR 56026, Dec. 16, 1983; 48 FR 57282, Dec. 29, 1983]



Sec. 418.309  Hospice cap amount.

    The hospice cap amount is calculated using the following procedures:
    (a) The cap amount is $6,500 per year and is adjusted for inflation 
or deflation for cap years that end after October 1, 1984, by using the 
percentage change in the medical care expenditure category of the 
Consumer Price Index (CPI) for urban consumers that is published by the 
Bureau of Labor Statistics. This adjustment is made using the change in 
the CPI from March 1984 to the fifth month of the cap year. The cap year 
runs from November 1 of each year until October 31 of the following 
year.
    (b) Each hospice's cap amount is calculated by the intermediary by 
multiplying the adjusted cap amount determined in paragraph (a) of this 
section by the number of Medicare beneficiaries who elected to receive 
hospice care from that hospice during the cap period. For purposes of 
this calculation, the number of Medicare beneficiaries includes--
    (1) Those Medicare beneficiaries who have not previously been 
included in the calculation of any hospice cap and who have filed an 
election to receive hospice care, in accordance with Sec. 418.24, from 
the hospice during the period beginning on September 28 (35 days before 
the beginning of the cap period) and ending on September 27 (35 days 
before the end of the cap period).
    (2) In the case in which a beneficiary has elected to receive care 
from more than one hospice, each hospice includes in its number of 
Medicare beneficiaries only that fraction which represents the portion 
of a patient's total stay in all hospices that was spent in that 
hospice. (The hospice can obtain this information by contacting the 
intermediary.)



Sec. 418.310  Reporting and recordkeeping requirements.

    Hospices must provide reports and keep records as the Secretary 
determines necessary to administer the program.



Sec. 418.311  Administrative appeals.

    A hospice that believes its payments have not been properly 
determined in accordance with these regulations may request a review 
from the intermediary or the Provider Reimbursement Review Board (PRRB) 
if the amount in controversy is at least $1,000 or $10,000, 
respectively. In such a case, the procedure in 42 CFR part 405, subpart 
R, will be followed to the extent that it is applicable. The PRRB, 
subject to review by the Secretary under Sec. 405.1874 of this chapter, 
shall have the authority to determine the issues raised. The methods and 
standards for the calculation of the payment rates by CMS are not 
subject to appeal.



                          Subpart H_Coinsurance



Sec. 418.400  Individual liability for coinsurance for hospice care.

    An individual who has filed an election for hospice care in 
accordance with Sec. 418.24 is liable for the following coinsurance 
payments. Hospices may charge individuals the applicable coinsurance 
amounts.
    (a) Drugs and biologicals. An individual is liable for a coinsurance 
payment for each palliative drug and biological prescription furnished 
by the hospice while the individual is not an inpatient. The amount of 
coinsurance for each prescription approximates 5 percent of the cost of 
the drug or biological to the hospice determined in accordance with the 
drug copayment schedule established by the hospice, except that the 
amount of coinsurance for each prescription may not exceed $5. The cost 
of the drug or biological may not exceed what a prudent buyer would pay 
in similar circumstances. The drug copayment schedule must be reviewed 
for reasonableness and approved by the intermediary before it is used.
    (b) Respite care. (1) The amount of coinsurance for each respite 
care day is equal to 5 percent of the payment made by CMS for a respite 
care day.
    (2) The amount of the individual's coinsurance liability for respite 
care during a hospice coinsurance period may

[[Page 214]]

not exceed the inpatient hospital deductible applicable for the year in 
which the hospice coinsurance period began.
    (3) The individual hospice coinsurance period--
    (i) Begins on the first day an election filed in accordance with 
Sec. 418.24 is in effect for the beneficiary; and
    (ii) Ends with the close of the first period of 14 consecutive days 
on each of which an election is not in effect for the beneficiary.



Sec. 418.402  Individual liability for services that are not considered hospice care.

    Medicare payment to the hospice discharges an individual's liability 
for payment for all services, other than the hospice coinsurance amounts 
described in Sec. 418.400, that are considered covered hospice care (as 
described in Sec. 418.202). The individual is liable for the Medicare 
deductibles and coinsurance payments and for the difference between the 
reasonable and actual charge on unassigned claims on other covered 
services that are not considered hospice care. Examples of services not 
considered hospice care include: Services furnished before or after a 
hospice election period; services of the individual's attending 
physician, if the attending physician is not an employee of or working 
under an arrangement with the hospice; or Medicare services received for 
the treatment of an illness or injury not related to the individual's 
terminal condition.



Sec. 418.405  Effect of coinsurance liability on Medicare payment.

    The Medicare payment rates established by CMS in accordance with 
Sec. 418.306 are not reduced when the individual is liable for 
coinsurance payments. Instead, when establishing the payment rates, CMS 
offsets the estimated cost of services by an estimate of average 
coinsurance amounts hospices collect.

[56 FR 26919, June 12, 1991]