[NOTE: THE FOLLOWING IS TEXT FROM THE U.S. CODE OF FEDERAL REGULATIONS]|
THE LAW HAS BEEN UPDATED IN 2008 and can be seen at:
************************************************************************* [The law presented below is as posted at the Government Printing Office Website at: http://www.access.gpo.gov/nara/cfr/waisidx_00/42cfr418_00.html [Revised as of October 1, 2000] ************************************************************************* [Code of Federal Regulations] [Title 42, Volume 2, Parts 400 to 429] [Revised as of October 1, 2000] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR418.1] [Page 693] TITLE 42--PUBLIC HEALTH CHAPTER IV--HEALTH CARE FINANCING ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 418--HOSPICE CARE--Table of Contents 418.1 Statutory basis. 418.2 Scope of part. 418.3 Definitions. 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. 418.28 Revoking the election of hospice care. 418.30 Change of the designated hospice. 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. 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. 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. 418.200 Requirements for coverage. 418.202 Covered services. 418.204 Special coverage requirements. 418.301 Basic rules. 418.302 Payment procedures for hospice care. 418.304 Payment for physician 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. 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. 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. (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] [CITE: 42CFR418.2] [Page 693] Subpart A--General Provision and Definitions 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. [Page 693] Sec. 418.3 Definitions. For purposes of this part-- Attending physician means a physician who-- (a) Is a doctor of medicine or osteopathy; and (b) 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] [Page 693] 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. [Page 693-694] 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 [[Page 694]] or more of the following election periods: (1) An initial 90-day period. (2) A subsequent 90-day period. (3) A subsequent 30-day period. (4) A subsequent extension period of unlimited duration during the individual's lifetime. (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] [Page 694] 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 two, three, or four 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 no later than two calendar days after the period begins. (3) Exception. For the initial 90-day period, if the hospice cannot obtain the written certifications within two calendar days, it must obtain oral certifications within two calendar days, and written certifications no later than eight calendar days after the period begins. (b) Content of certification. 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. (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. (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] [Page 694-695] 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; and (2) Does not revoke the election under the provisions of Sec. 418.28. (d) Waiver of other benefits. For the duration of an election of hospice care, 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 [[Page 695]] 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] [Page 695] 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. [Page 695] 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. [Page 695-696] 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 [[Page 696]] 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] [Page 696] 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 consistent with accepted standards of practice. [Page 696] 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. [Page 696] Sec. 418.56 Condition of participation--Professional management. Subject to the conditions of participation pertaining to services in Secs. 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] [Page 696-697] 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, [[Page 697]] 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 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. [Page 697] 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. [Page 697] 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. [Page 697] Sec. 418.64 Condition of participation--Inservice training. A hospice must provide an ongoing program for the training of its employees. [Page 697] 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. [Page 697] 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. [Page 697-698] 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 [[Page 698]] 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; (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. [Page 698] 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. [Page 698] 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. [Page 698-699] 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 [[Page 699]] 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] [Page 699] Subpart D--Conditions of Participation: Core Services 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 699] Sec. 418.83 Nursing services--Waiver of requirement that substantially all nursing services be routinely provided directly by a hospice. (a) HCFA 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. HCFA 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) HCFA 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 HCFA, 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] [Page 699] 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. [Page 699] 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. [Page 699-700] 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 [[Page 700]] 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 as well as by other qualified professionals as determined by the hospice. [CITE: 42CFR418.90] [Page 700] 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] [Page 700] 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] [Page 700] 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] [Page 700-701] 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 [[Page 701]] laws. The persons, and each drug and biological they are authorized to administer, must be specified in the patient's plan of care. [Page 701] 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. (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] [Page 701-703] 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 provided in paragraphs (d) (2) and (3) of this section, the hospice must meet the provisions of the 1985 edition of the Life Safety Code of the National Fire Protection Association (which is incorporated by reference)1 that are applicable to hospices. --------------------------------------------------------------------------- \1\ See footnote to Sec. 405.1134(a) of this chapter. --------------------------------------------------------------------------- (2) In consideration of a recommendation by the State survey agency, HCFA 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) Any hospice that, on May 9, 1988, complies with the requirements of the 1981 edition of the Life Safety Code, with or without waivers, will be considered to be in compliance with this standard, as long as the hospice continues to remain in compliance with that edition of the Life Safety Code. [[Page 702]] (4) Any facility of two or more stories that is not of fire resistive construction and is participating on the basis of a waiver of construction type or height, may not house blind, nonambulatory, or physically handicapped patients above the street-level floor unless the facility-- (i) Is one of the following construction types (as defined in the Life Safety Code): (A) Type II (1, 1, 1)--protected non-combustible. (B) Fully sprinklered Type II (0, 0, 0)--non-combustible. (C) Fully sprinklered Type III (2, 1, 1)--protected ordinary. (D) Fully sprinklered Type V (1, 1, 1)--protected wood frame; or (ii) Achieves a passing score on the Fire Safety Evaluation System (FSES). (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, HCFA 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. (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 [[Page 703]] (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 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] [CITE: 42CFR418.200] [Page 703-704] 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 [[Page 704]] 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. [Page 704] Subpart F--Covered Services 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 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. [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] [Page 704-705] 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 [[Page 705]] 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] [CITE: 42CFR418.301] [Page 705] 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. [48 FR 56026, Dec. 16, 1983, as amended at 56 FR 26919, June 12, 1991] [Page 705] 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. [48 FR 56026, Dec. 16, 1983, as amended at 56 FR 26919, June 12, 1991] [Page 706-707] Sec. 418.304 Payment for physician services. (a) The following services performed by hospice physicians 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's reasonable charge 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. [[Page 707]] (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 subparts D or E, part 405 of this chapter. [Page 707] Sec. 418.306 Determination of payment rates. (a) Applicability. HCFA 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 (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 1997, 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; and (iii) 0.5 percentage points in FY 1997. (c) Adjustment for wage differences. HCFA will issue annually, in the Federal Register, a hospice wage index based on the most current available HCFA hospital wage data, including any changes to the definitions of Metropolitan Statistical Areas. The payment rates established by HCFA are adjusted by the intermediary to reflect local differences in wages according to the revised wage index. (d) Federal Register notices. HCFA 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] [Page 707] 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 Secs. 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] [Page 707-708] 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. [[Page 708]] (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. (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] [Page 708] 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.) [Page 708] Sec. 418.310 Reporting and recordkeeping requirements. Hospices must provide reports and keep records as the Secretary determines necessary to administer the program. [Page 708] 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 HCFA are not subject to appeal. [Page 708-709] 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. [[Page 709]] 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 HCFA for a respite care day. (2) The amount of the individual's coinsurance liability for respite care during a hospice coinsurance period may 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. [Page 709] 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. [Page 709] Sec. 418.405 Effect of coinsurance liability on Medicare payment. The Medicare payment rates established by HCFA in accordance with Sec. 418.306 are not reduced when the individual is liable for coinsurance payments. Instead, when establishing the payment rates, HCFA offsets the estimated cost of services by an estimate of average coinsurance amounts hospices collect. [56 FR 26919, June 12, 1991] ************************************************************************* [The above law is as posted at the Government Printing Office Website at: http://www.access.gpo.gov/nara/cfr/waisidx_00/42cfr418_00.html [Revised as of October 1, 2000] *************************************************************************
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