42 U.S.C. § 1395x : US Code - Section 1395X: Definitions

Search 42 U.S.C. § 1395x : US Code - Section 1395X: Definitions

For purposes of this subchapter -
(a) Spell of illness
The term "spell of illness" with respect to any individual means
a period of consecutive days -
(1) beginning with the first day (not included in a previous
spell of illness) (A) on which such individual is furnished
inpatient hospital services, inpatient critical access hospital
services or extended care services, and (B) which occurs in a
month for which he is entitled to benefits under part A of this
subchapter, and
(2) ending with the close of the first period of 60 consecutive
days thereafter on each of which he is neither an inpatient of a
hospital or critical access hospital nor an inpatient of a
facility described in section 1396r(a)(2) of this title or
subsection (y)(1) of this section.
(b) Inpatient hospital services
The term "inpatient hospital services" means the following items
and services furnished to an inpatient of a hospital and (except as
provided in paragraph (3)) by the hospital -
(1) bed and board;
(2) such nursing services and other related services, such use
of hospital facilities, and such medical social services as are
ordinarily furnished by the hospital for the care and treatment
of inpatients, and such drugs, biologicals, supplies, appliances,
and equipment, for use in the hospital, as are ordinarily
furnished by such hospital for the care and treatment of
inpatients; and
(3) such other diagnostic or therapeutic items or services,
furnished by the hospital or by others under arrangements with
them made by the hospital, as are ordinarily furnished to
inpatients either by such hospital or by others under such
arrangements;
excluding, however -
(4) medical or surgical services provided by a physician,
resident, or intern, services described by subsection (s)(2)(K)
of this section, certified nurse-midwife services, qualified
psychologist services, and services of a certified registered
nurse anesthetist; and
(5) the services of a private-duty nurse or other private-duty
attendant.
Paragraph (4) shall not apply to services provided in a hospital by
-
(6) an intern or a resident-in-training under a teaching
program approved by the Council on Medical Education of the
American Medical Association or, in the case of an osteopathic
hospital, approved by the Committee on Hospitals of the Bureau of
Professional Education of the American Osteopathic Association,
or, in the case of services in a hospital or osteopathic hospital
by an intern or resident-in-training in the field of dentistry,
approved by the Council on Dental Education of the American
Dental Association, or in the case of services in a hospital or
osteopathic hospital by an intern or resident-in-training in the
field of podiatry, approved by the Council on Podiatric Medical
Education of the American Podiatric Medical Association; or
(7) a physician where the hospital has a teaching program
approved as specified in paragraph (6), if (A) the hospital
elects to receive any payment due under this subchapter for
reasonable costs of such services, and (B) all physicians in such
hospital agree not to bill charges for professional services
rendered in such hospital to individuals covered under the
insurance program established by this subchapter.
(c) Inpatient psychiatric hospital services
The term "inpatient psychiatric hospital services" means
inpatient hospital services furnished to an inpatient of a
psychiatric hospital.
(d) Supplier
The term "supplier" means, unless the context otherwise requires,
a physician or other practitioner, a facility, or other entity
(other than a provider of services) that furnishes items or
services under this subchapter.
(e) Hospital
The term "hospital" (except for purposes of sections 1395f(d),
1395f(f), and 1395n(b) of this title, subsection (a)(2) of this
section, paragraph (7) of this subsection, and subsection (i) of
this section) means an institution which -
(1) is primarily engaged in providing, by or under the
supervision of physicians, to inpatients (A) diagnostic services
and therapeutic services for medical diagnosis, treatment, and
care of injured, disabled, or sick persons, or (B) rehabilitation
services for the rehabilitation of injured, disabled, or sick
persons;
(2) maintains clinical records on all patients;
(3) has bylaws in effect with respect to its staff of
physicians;
(4) has a requirement that every patient with respect to whom
payment may be made under this subchapter must be under the care
of a physician, except that a patient receiving qualified
psychologist services (as defined in subsection (ii) of this
section) may be under the care of a clinical psychologist with
respect to such services to the extent permitted under State law;
(5) provides 24-hour nursing service rendered or supervised by
a registered professional nurse, and has a licensed practical
nurse or registered professional nurse on duty at all times;
except that until January 1, 1979, the Secretary is authorized to
waive the requirement of this paragraph for any one-year period
with respect to any institution, insofar as such requirement
relates to the provision of twenty-four-hour nursing service
rendered or supervised by a registered professional nurse (except
that in any event a registered professional nurse must be present
on the premises to render or supervise the nursing service
provided, during at least the regular daytime shift), where
immediately preceding such one-year period he finds that -
(A) such institution is located in a rural area and the
supply of hospital services in such area is not sufficient to
meet the needs of individuals residing therein,
(B) the failure of such institution to qualify as a hospital
would seriously reduce the availability of such services to
such individuals, and
(C) such institution has made and continues to make a good
faith effort to comply with this paragraph, but such compliance
is impeded by the lack of qualified nursing personnel in such
area;
(6)(A) has in effect a hospital utilization review plan which
meets the requirements of subsection (k) of this section and (B)
has in place a discharge planning process that meets the
requirements of subsection (ee) of this section;
(7) in the case of an institution in any State in which State
or applicable local law provides for the licensing of hospitals,
(A) is licensed pursuant to such law or (B) is approved, by the
agency of such State or locality responsible for licensing
hospitals, as meeting the standards established for such
licensing;
(8) has in effect an overall plan and budget that meets the
requirements of subsection (z) of this section; and
(9) meets such other requirements as the Secretary finds
necessary in the interest of the health and safety of individuals
who are furnished services in the institution.
For purposes of subsection (a)(2) of this section, such term
includes any institution which meets the requirements of paragraph
(1) of this subsection. For purposes of sections 1395f(d) and
1395n(b) of this title (including determination of whether an
individual received inpatient hospital services or diagnostic
services for purposes of such sections), section 1395f(f)(2) of
this title, and subsection (i) of this section, such term includes
any institution which (i) meets the requirements of paragraphs (5)
and (7) of this subsection, (ii) is not primarily engaged in
providing the services described in subsection (j)(1)(A) of this
section and (iii) is primarily engaged in providing, by or under
the supervision of individuals referred to in paragraph (1) of
subsection (r) of this section, to inpatients diagnostic services
and therapeutic services for medical diagnosis, treatment, and care
of injured, disabled, or sick persons, or rehabilitation services
for the rehabilitation of injured, disabled, or sick persons. For
purposes of section 1395f(f)(1) of this title, such term includes
an institution which (i) is a hospital for purposes of sections
1395f(d), 1395f(f)(2), and 1395n(b) of this title and (ii) is
accredited by the Joint Commission on Accreditation of Hospitals,
or is accredited by or approved by a program of the country in
which such institution is located if the Secretary finds the
accreditation or comparable approval standards of such program to
be essentially equivalent to those of the Joint Commission on
Accreditation of Hospitals. Notwithstanding the preceding
provisions of this subsection, such term shall not, except for
purposes of subsection (a)(2) of this section, include any
institution which is primarily for the care and treatment of mental
diseases unless it is a psychiatric hospital (as defined in
subsection (f) of this section). The term "hospital" also includes
a religious nonmedical health care institution (as defined in
subsection (ss)(1) of this section), but only with respect to items
and services ordinarily furnished by such institution to
inpatients, and payment may be made with respect to services
provided by or in such an institution only to such extent and under
such conditions, limitations, and requirements (in addition to or
in lieu of the conditions, limitations, and requirements otherwise
applicable) as may be provided in regulations consistent with
section 1395i-5 of this title. For provisions deeming certain
requirements of this subsection to be met in the case of accredited
institutions, see section 1395bb of this title. The term "hospital"
also includes a facility of fifty beds or less which is located in
an area determined by the Secretary to meet the definition relating
to a rural area described in subparagraph (A) of paragraph (5) of
this subsection and which meets the other requirements of this
subsection, except that -
(A) with respect to the requirements for nursing services
applicable after December 31, 1978, such requirements shall
provide for temporary waiver of the requirements, for such period
as the Secretary deems appropriate, where (i) the facility's
failure to fully comply with the requirements is attributable to
a temporary shortage of qualified nursing personnel in the area
in which the facility is located, (ii) a registered professional
nurse is present on the premises to render or supervise the
nursing service provided during at least the regular daytime
shift, and (iii) the Secretary determines that the employment of
such nursing personnel as are available to the facility during
such temporary period will not adversely affect the health and
safety of patients;
(B) with respect to the health and safety requirements
promulgated under paragraph (9), such requirements shall be
applied by the Secretary to a facility herein defined in such
manner as to assure that personnel requirements take into account
the availability of technical personnel and the educational
opportunities for technical personnel in the area in which such
facility is located, and the scope of services rendered by such
facility; and the Secretary, by regulations, shall provide for
the continued participation of such a facility where such
personnel requirements are not fully met, for such period as the
Secretary determines that (i) the facility is making good faith
efforts to fully comply with the personnel requirements, (ii) the
employment by the facility of such personnel as are available to
the facility will not adversely affect the health and safety of
patients, and (iii) if the Secretary has determined that because
of the facility's waiver under this subparagraph the facility
should limit its scope of services in order not to adversely
affect the health and safety of the facility's patients, the
facility is so limiting the scope of services it provides; and
(C) with respect to the fire and safety requirements
promulgated under paragraph (9), the Secretary (i) may waive, for
such period as he deems appropriate, specific provisions of such
requirements which if rigidly applied would result in
unreasonable hardship for such a facility and which, if not
applied, would not jeopardize the health and safety of patients,
and (ii) may accept a facility's compliance with all applicable
State codes relating to fire and safety in lieu of compliance
with the fire and safety requirements promulgated under paragraph
(9), if he determines that such State has in effect fire and
safety codes, imposed by State law, which adequately protect
patients.
The term "hospital" does not include, unless the context otherwise
requires, a critical access hospital (as defined in subsection
(mm)(1) of this section).
(f) Psychiatric hospital
The term "psychiatric hospital" means an institution which -
(1) is primarily engaged in providing, by or under the
supervision of a physician, psychiatric services for the
diagnosis and treatment of mentally ill persons;
(2) satisfies the requirements of paragraphs (3) through (9) of
subsection (e) of this section;
(3) maintains clinical records on all patients and maintains
such records as the Secretary finds to be necessary to determine
the degree and intensity of the treatment provided to individuals
entitled to hospital insurance benefits under part A of this
subchapter; and
(4) meets such staffing requirements as the Secretary finds
necessary for the institution to carry out an active program of
treatment for individuals who are furnished services in the
institution.
In the case of an institution which satisfies paragraphs (1) and
(2) of the preceding sentence and which contains a distinct part
which also satisfies paragraphs (3) and (4) of such sentence, such
distinct part shall be considered to be a "psychiatric hospital".
(g) Outpatient occupational therapy services
The term "outpatient occupational therapy services" has the
meaning given the term "outpatient physical therapy services" in
subsection (p) of this section, except that "occupational" shall be
substituted for "physical" each place it appears therein.
(h) Extended care services
The term "extended care services" means the following items and
services furnished to an inpatient of a skilled nursing facility
and (except as provided in paragraphs (3), (6), and (7)) by such
skilled nursing facility -
(1) nursing care provided by or under the supervision of a
registered professional nurse;
(2) bed and board in connection with the furnishing of such
nursing care;
(3) physical or occupational therapy or speech-language
pathology services furnished by the skilled nursing facility or
by others under arrangements with them made by the facility;
(4) medical social services;
(5) such drugs, biologicals, supplies, appliances, and
equipment, furnished for use in the skilled nursing facility, as
are ordinarily furnished by such facility for the care and
treatment of inpatients;
(6) medical services provided by an intern or resident-in-
training of a hospital with which the facility has in effect a
transfer agreement (meeting the requirements of subsection (l) of
this section), under a teaching program of such hospital approved
as provided in the last sentence of subsection (b) of this
section, and other diagnostic or therapeutic services provided by
a hospital with which the facility has such an agreement in
effect; and
(7) such other services necessary to the health of the patients
as are generally provided by skilled nursing facilities, or by
others under arrangements with them made by the facility;
excluding, however, any item or service if it would not be included
under subsection (b) of this section if furnished to an inpatient
of a hospital.
(i) Post-hospital extended care services
The term "post-hospital extended care services" means extended
care services furnished an individual after transfer from a
hospital in which he was an inpatient for not less than 3
consecutive days before his discharge from the hospital in
connection with such transfer. For purposes of the preceding
sentence, items and services shall be deemed to have been furnished
to an individual after transfer from a hospital, and he shall be
deemed to have been an inpatient in the hospital immediately before
transfer therefrom, if he is admitted to the skilled nursing
facility (A) within 30 days after discharge from such hospital, or
(B) within such time as it would be medically appropriate to begin
an active course of treatment, in the case of an individual whose
condition is such that skilled nursing facility care would not be
medically appropriate within 30 days after discharge from a
hospital; and an individual shall be deemed not to have been
discharged from a skilled nursing facility if, within 30 days after
discharge therefrom, he is admitted to such facility or any other
skilled nursing facility.
(j) Skilled nursing facility
The term "skilled nursing facility" has the meaning given such
term in section 1395i-3(a) of this title.
(k) Utilization review
A utilization review plan of a hospital or skilled nursing
facility shall be considered sufficient if it is applicable to
services furnished by the institution to individuals entitled to
insurance benefits under this subchapter and if it provides -
(1) for the review, on a sample or other basis, of admissions
to the institution, the duration of stays therein, and the
professional services (including drugs and biologicals)
furnished, (A) with respect to the medical necessity of the
services, and (B) for the purpose of promoting the most efficient
use of available health facilities and services;
(2) for such review to be made by either (A) a staff committee
of the institution composed of two or more physicians (of which
at least two must be physicians described in subsection (r)(1) of
this section), with or without participation of other
professional personnel, or (B) a group outside the institution
which is similarly composed and (i) which is established by the
local medical society and some or all of the hospitals and
skilled nursing facilities in the locality, or (ii) if (and for
as long as) there has not been established such a group which
serves such institution, which is established in such other
manner as may be approved by the Secretary;
(3) for such review, in each case of inpatient hospital
services or extended care services furnished to such an
individual during a continuous period of extended duration, as of
such days of such period (which may differ for different classes
of cases) as may be specified in regulations, with such review to
be made as promptly as possible, after each day so specified, and
in no event later than one week following such day; and
(4) for prompt notification to the institution, the individual,
and his attending physician of any finding (made after
opportunity for consultation to such attending physician) by the
physician members of such committee or group that any further
stay in the institution is not medically necessary.
The review committee must be composed as provided in clause (B) of
paragraph (2) rather than as provided in clause (A) of such
paragraph in the case of any hospital or skilled nursing facility
where, because of the small size of the institution, or (in the
case of a skilled nursing facility) because of lack of an organized
medical staff, or for such other reason or reasons as may be
included in regulations, it is impracticable for the institution to
have a properly functioning staff committee for the purposes of
this subsection. If the Secretary determines that the utilization
review procedures established pursuant to subchapter XIX of this
chapter are superior in their effectiveness to the procedures
required under this section, he may, to the extent that he deems it
appropriate, require for purposes of this subchapter that the
procedures established pursuant to subchapter XIX of this chapter
be utilized instead of the procedures required by this section.
(l) Agreements for transfer between skilled nursing facilities and
hospitals
A hospital and a skilled nursing facility shall be considered to
have a transfer agreement in effect if, by reason of a written
agreement between them or (in case the two institutions are under
common control) by reason of a written undertaking by the person or
body which controls them, there is reasonable assurance that -
(1) transfer of patients will be effected between the hospital
and the skilled nursing facility whenever such transfer is
medically appropriate as determined by the attending physician;
and
(2) there will be interchange of medical and other information
necessary or useful in the care and treatment of individuals
transferred between the institutions, or in determining whether
such individuals can be adequately cared for otherwise than in
either of such institutions.
Any skilled nursing facility which does not have such an agreement
in effect, but which is found by a State agency (of the State in
which such facility is situated) with which an agreement under
section 1395aa of this title is in effect (or, in the case of a
State in which no such agency has an agreement under section 1395aa
of this title, by the Secretary) to have attempted in good faith to
enter into such an agreement with a hospital sufficiently close to
the facility to make feasible the transfer between them of patients
and the information referred to in paragraph (2), shall be
considered to have such an agreement in effect if and for so long
as such agency (or the Secretary, as the case may be) finds that to
do so is in the public interest and essential to assuring extended
care services for persons in the community who are eligible for
payments with respect to such services under this subchapter.
(m) Home health services
The term "home health services" means the following items and
services furnished to an individual, who is under the care of a
physician, by a home health agency or by others under arrangements
with them made by such agency, under a plan (for furnishing such
items and services to such individual) established and periodically
reviewed by a physician, which items and services are, except as
provided in paragraph (7), provided on a visiting basis in a place
of residence used as such individual's home -
(1) part-time or intermittent nursing care provided by or under
the supervision of a registered professional nurse;
(2) physical or occupational therapy or speech-language
pathology services;
(3) medical social services under the direction of a physician;
(4) to the extent permitted in regulations, part-time or
intermittent services of a home health aide who has successfully
completed a training program approved by the Secretary;
(5) medical supplies (including catheters, catheter supplies,
ostomy bags, and supplies related to ostomy care, and a covered
osteoporosis drug (as defined in subsection (kk) of this
section), but excluding other drugs and biologicals) and durable
medical equipment while under such a plan;
(6) in the case of a home health agency which is affiliated or
under common control with a hospital, medical services provided
by an intern or resident-in-training of such hospital, under a
teaching program of such hospital approved as provided in the
last sentence of subsection (b) of this section; and
(7) any of the foregoing items and services which are provided
on an outpatient basis, under arrangements made by the home
health agency, at a hospital or skilled nursing facility, or at a
rehabilitation center which meets such standards as may be
prescribed in regulations, and -
(A) the furnishing of which involves the use of equipment of
such a nature that the items and services cannot readily be
made available to the individual in such place of residence, or
(B) which are furnished at such facility while he is there to
receive any such item or service described in clause (A),
but not including transportation of the individual in connection
with any such item or service;
excluding, however, any item or service if it would not be included
under subsection (b) of this section if furnished to an inpatient
of a hospital. For purposes of paragraphs (1) and (4), the term
"part-time or intermittent services" means skilled nursing and home
health aide services furnished any number of days per week as long
as they are furnished (combined) less than 8 hours each day and 28
or fewer hours each week (or, subject to review on a case-by-case
basis as to the need for care, less than 8 hours each day and 35 or
fewer hours per week). For purposes of sections 1395f(a)(2)(C) and
1395n(a)(2)(A) of this title, "intermittent" means skilled nursing
care that is either provided or needed on fewer than 7 days each
week, or less than 8 hours of each day for periods of 21 days or
less (with extensions in exceptional circumstances when the need
for additional care is finite and predictable).
(n) Durable medical equipment
The term "durable medical equipment" includes iron lungs, oxygen
tents, hospital beds, and wheelchairs (which may include a power-
operated vehicle that may be appropriately used as a wheelchair,
but only where the use of such a vehicle is determined to be
necessary on the basis of the individual's medical and physical
condition and the vehicle meets such safety requirements as the
Secretary may prescribe) used in the patient's home (including an
institution used as his home other than an institution that meets
the requirements of subsection (e)(1) of this section or section
1395i-3(a)(1) of this title), whether furnished on a rental basis
or purchased, and includes blood-testing strips and blood glucose
monitors for individuals with diabetes without regard to whether
the individual has Type I or Type II diabetes or to the
individual's use of insulin (as determined under standards
established by the Secretary in consultation with the appropriate
organizations); except that such term does not include such
equipment furnished by a supplier who has used, for the
demonstration and use of specific equipment, an individual who has
not met such minimum training standards as the Secretary may
establish with respect to the demonstration and use of such
specific equipment. With respect to a seat-lift chair, such term
includes only the seat-lift mechanism and does not include the
chair.
(o) Home health agency
The term "home health agency" means a public agency or private
organization, or a subdivision of such an agency or organization,
which -
(1) is primarily engaged in providing skilled nursing services
and other therapeutic services;
(2) has policies, established by a group of professional
personnel (associated with the agency or organization), including
one or more physicians and one or more registered professional
nurses, to govern the services (referred to in paragraph (1))
which it provides, and provides for supervision of such services
by a physician or registered professional nurse;
(3) maintains clinical records on all patients;
(4) in the case of an agency or organization in any State in
which State or applicable local law provides for the licensing of
agencies or organizations of this nature, (A) is licensed
pursuant to such law, or (B) is approved, by the agency of such
State or locality responsible for licensing agencies or
organizations of this nature, as meeting the standards
established for such licensing;
(5) has in effect an overall plan and budget that meets the
requirements of subsection (z) of this section;
(6) meets the conditions of participation specified in section
1395bbb(a) of this title and such other conditions of
participation as the Secretary may find necessary in the interest
of the health and safety of individuals who are furnished
services by such agency or organization;
(7) provides the Secretary with a surety bond -
(A) effective for a period of 4 years (as specified by the
Secretary) or in the case of a change in the ownership or
control of the agency (as determined by the Secretary) during
or after such 4-year period, an additional period of time that
the Secretary determines appropriate, such additional period
not to exceed 4 years from the date of such change in ownership
or control;
(B) in a form specified by the Secretary; and
(C) for a year in the period described in subparagraph (A) in
an amount that is equal to the lesser of $50,000 or 10 percent
of the aggregate amount of payments to the agency under this
subchapter and subchapter XIX of this chapter for that year, as
estimated by the Secretary; and
(8) meets such additional requirements (including conditions
relating to bonding or establishing of escrow accounts as the
Secretary finds necessary for the financial security of the
program) as the Secretary finds necessary for the effective and
efficient operation of the program;
except that for purposes of part A of this subchapter such term
shall not include any agency or organization which is primarily for
the care and treatment of mental diseases. The Secretary may waive
the requirement of a surety bond under paragraph (7) in the case of
an agency or organization that provides a comparable surety bond
under State law.
(p) Outpatient physical therapy services
The term "outpatient physical therapy services" means physical
therapy services furnished by a provider of services, a clinic,
rehabilitation agency, or a public health agency, or by others
under an arrangement with, and under the supervision of, such
provider, clinic, rehabilitation agency, or public health agency to
an individual as an outpatient -
(1) who is under the care of a physician (as defined in
paragraph (1), (3), or (4) of subsection (r) of this section),
and
(2) with respect to whom a plan prescribing the type, amount,
and duration of physical therapy services that are to be
furnished such individual has been established by a physician (as
so defined) or by a qualified physical therapist and is
periodically reviewed by a physician (as so defined);
excluding, however -
(3) any item or service if it would not be included under
subsection (b) of this section if furnished to an inpatient of a
hospital; and
(4) any such service -
(A) if furnished by a clinic or rehabilitation agency, or by
others under arrangements with such clinic or agency, unless
such clinic or rehabilitation agency -
(i) provides an adequate program of physical therapy
services for outpatients and has the facilities and personnel
required for such program or required for the supervision of
such a program, in accordance with such requirements as the
Secretary may specify,
(ii) has policies, established by a group of professional
personnel, including one or more physicians (associated with
the clinic or rehabilitation agency) and one or more
qualified physical therapists, to govern the services
(referred to in clause (i)) it provides,
(iii) maintains clinical records on all patients,
(iv) if such clinic or agency is situated in a State in
which State or applicable local law provides for the
licensing of institutions of this nature, (I) is licensed
pursuant to such law, or (II) is approved by the agency of
such State or locality responsible for licensing institutions
of this nature, as meeting the standards established for such
licensing; and
(v) meets such other conditions relating to the health and
safety of individuals who are furnished services by such
clinic or agency on an outpatient basis, as the Secretary may
find necessary, and provides the Secretary on a continuing
basis with a surety bond in a form specified by the Secretary
and in an amount that is not less than $50,000, or
(B) if furnished by a public health agency, unless such
agency meets such other conditions relating to health and
safety of individuals who are furnished services by such agency
on an outpatient basis, as the Secretary may find necessary.
The term "outpatient physical therapy services" also includes
physical therapy services furnished an individual by a physical
therapist (in his office or in such individual's home) who meets
licensing and other standards prescribed by the Secretary in
regulations, otherwise than under an arrangement with and under the
supervision of a provider of services, clinic, rehabilitation
agency, or public health agency, if the furnishing of such services
meets such conditions relating to health and safety as the
Secretary may find necessary. In addition, such term includes
physical therapy services which meet the requirements of the first
sentence of this subsection except that they are furnished to an
individual as an inpatient of a hospital or extended care facility.
The term "outpatient physical therapy services" also includes
speech-language pathology services furnished by a provider of
services, a clinic, rehabilitation agency, or by a public health
agency, or by others under an arrangement with, and under the
supervision of, such provider, clinic, rehabilitation agency, or
public health agency to an individual as an outpatient, subject to
the conditions prescribed in this subsection. Nothing in this
subsection shall be construed as requiring, with respect to
outpatients who are not entitled to benefits under this subchapter,
a physical therapist to provide outpatient physical therapy
services only to outpatients who are under the care of a physician
or pursuant to a plan of care established by a physician. The
Secretary may waive the requirement of a surety bond under
paragraph (4)(A)(v) in the case of a clinic or agency that provides
a comparable surety bond under State law.
(q) Physicians' services
The term "physicians' services" means professional services
performed by physicians, including surgery, consultation, and home,
office, and institutional calls (but not including services
described in subsection (b)(6) of this section).
(r) Physician
The term "physician", when used in connection with the
performance of any function or action, means (1) a doctor of
medicine or osteopathy legally authorized to practice medicine and
surgery by the State in which he performs such function or action
(including a physician within the meaning of section 1301(a)(7) of
this title), (2) a doctor of dental surgery or of dental medicine
who is legally authorized to practice dentistry by the State in
which he performs such function and who is acting within the scope
of his license when he performs such functions, (3) a doctor of
podiatric medicine for the purposes of subsections (k), (m),
(p)(1), and (s) of this section and sections 1395f(a),
1395k(a)(2)(F)(ii), and 1395n of this title but only with respect
to functions which he is legally authorized to perform as such by
the State in which he performs them, (4) a doctor of optometry, but
only for purposes of subsection (p)(1) of this section and with
respect to the provision of items or services described in
subsection (s) of this section which he is legally authorized to
perform as a doctor of optometry by the State in which he performs
them, or (5) a chiropractor who is licensed as such by the State
(or in a State which does not license chiropractors as such, is
legally authorized to perform the services of a chiropractor in the
jurisdiction in which he performs such services), and who meets
uniform minimum standards promulgated by the Secretary, but only
for the purpose of subsections (s)(1) and (s)(2)(A) of this section
and only with respect to treatment by means of manual manipulation
of the spine (to correct a subluxation) which he is legally
authorized to perform by the State or jurisdiction in which such
treatment is provided. For the purposes of section 1395y(a)(4) of
this title and subject to the limitations and conditions provided
in the previous sentence, such term includes a doctor of one of the
arts, specified in such previous sentence, legally authorized to
practice such art in the country in which the inpatient hospital
services (referred to in such section 1395y(a)(4) of this title)
are furnished.
(s) Medical and other health services
The term "medical and other health services" means any of the
following items or services:
(1) physicians' services;
(2)(A) services and supplies (including drugs and biologicals
which are not usually self-administered by the patient) furnished
as an incident to a physician's professional service, of kinds
which are commonly furnished in physicians' offices and are
commonly either rendered without charge or included in the
physicians' bills (or would have been so included but for the
application of section 1395w-3b of this title);
(B) hospital services (including drugs and biologicals which
are not usually self-administered by the patient) incident to
physicians' services rendered to outpatients and partial
hospitalization services incident to such services;
(C) diagnostic services which are -
(i) furnished to an individual as an outpatient by a hospital
or by others under arrangements with them made by a hospital,
and
(ii) ordinarily furnished by such hospital (or by others
under such arrangements) to its outpatients for the purpose of
diagnostic study;
(D) outpatient physical therapy services and outpatient
occupational therapy services;
(E) rural health clinic services and Federally qualified health
center services;
(F) home dialysis supplies and equipment, self-care home
dialysis support services, and institutional dialysis services
and supplies;
(G) antigens (subject to quantity limitations prescribed in
regulations by the Secretary) prepared by a physician, as defined
in subsection (r)(1) of this section, for a particular patient,
including antigens so prepared which are forwarded to another
qualified person (including a rural health clinic) for
administration to such patient, from time to time, by or under
the supervision of another such physician;
(H)(i) services furnished pursuant to a contract under section
1395mm of this title to a member of an eligible organization by a
physician assistant or by a nurse practitioner (as defined in
subsection (aa)(5) of this section) and such services and
supplies furnished as an incident to his service to such a member
as would otherwise be covered under this part if furnished by a
physician or as an incident to a physician's service; and
(ii) services furnished pursuant to a risk-sharing contract
under section 1395mm(g) of this title to a member of an eligible
organization by a clinical psychologist (as defined by the
Secretary) or by a clinical social worker (as defined in
subsection (hh)(2) of this section), and such services and
supplies furnished as an incident to such clinical psychologist's
services or clinical social worker's services to such a member as
would otherwise be covered under this part if furnished by a
physician or as an incident to a physician's service;
(I) blood clotting factors, for hemophilia patients competent
to use such factors to control bleeding without medical or other
supervision, and items related to the administration of such
factors, subject to utilization controls deemed necessary by the
Secretary for the efficient use of such factors;
(J) prescription drugs used in immunosuppressive therapy
furnished, to an individual who receives an organ transplant for
which payment is made under this subchapter;
(K)(i) services which would be physicians' services and
services described in subsection (ww)(1) of this section if
furnished by a physician (as defined in subsection (r)(1) of this
section) and which are performed by a physician assistant (as
defined in subsection (aa)(5) of this section) under the
supervision of a physician (as so defined) and which the
physician assistant is legally authorized to perform by the State
in which the services are performed, and such services and
supplies furnished as incident to such services as would be
covered under subparagraph (A) if furnished incident to a
physician's professional service, but only if no facility or
other provider charges or is paid any amounts with respect to the
furnishing of such services,(!1)
(ii) services which would be physicians' services and services
described in subsection (ww)(1) of this section if furnished by a
physician (as defined in subsection (r)(1) of this section) and
which are performed by a nurse practitioner or clinical nurse
specialist (as defined in subsection (aa)(5) of this section)
working in collaboration (as defined in subsection (aa)(6) of
this section) with a physician (as defined in subsection (r)(1)
of this section) which the nurse practitioner or clinical nurse
specialist is legally authorized to perform by the State in which
the services are performed, and such services and supplies
furnished as an incident to such services as would be covered
under subparagraph (A) if furnished incident to a physician's
professional service, but only if no facility or other provider
charges or is paid any amounts with respect to the furnishing of
such services;
(L) certified nurse-midwife services;
(M) qualified psychologist services;
(N) clinical social worker services (as defined in subsection
(hh)(2) of this section);
(O) erythropoietin for dialysis patients competent to use such
drug without medical or other supervision with respect to the
administration of such drug, subject to methods and standards
established by the Secretary by regulation for the safe and
effective use of such drug, and items related to the
administration of such drug;
(P) prostate cancer screening tests (as defined in subsection
(oo) of this section);
(Q) an oral drug (which is approved by the Federal Food and
Drug Administration) prescribed for use as an anticancer
chemotherapeutic agent for a given indication, and containing an
active ingredient (or ingredients), which is the same indication
and active ingredient (or ingredients) as a drug which the
carrier determines would be covered pursuant to subparagraph (A)
or (B) if the drug could not be self-administered;
(R) colorectal cancer screening tests (as defined in subsection
(pp) of this section); and (!2)
(S) diabetes outpatient self-management training services (as
defined in subsection (qq) of this section);
(T) an oral drug (which is approved by the Federal Food and
Drug Administration) prescribed for use as an acute anti-emetic
used as part of an anticancer chemotherapeutic regimen if the
drug is administered by a physician (or as prescribed by a
physician) -
(i) for use immediately before, at, or within 48 hours after
the time of the administration of the anticancer
chemotherapeutic agent; and
(ii) as a full replacement for the anti-emetic therapy which
would otherwise be administered intravenously;
(U) screening for glaucoma (as defined in subsection (uu) of
this section) for individuals determined to be at high risk for
glaucoma, individuals with a family history of glaucoma and
individuals with diabetes;
(V) medical nutrition therapy services (as defined in
subsection (vv)(1) of this section) in the case of a beneficiary
with diabetes or a renal disease who -
(i) has not received diabetes outpatient self-management
training services within a time period determined by the
Secretary;
(ii) is not receiving maintenance dialysis for which payment
is made under section 1395rr of this title; and
(iii) meets such other criteria determined by the Secretary
after consideration of protocols established by dietitian or
nutrition professional organizations;
(W) an initial preventive physical examination (as defined in
subsection (ww) of this section);
(X) cardiovascular screening blood tests (as defined in
subsection (xx)(1) of this section);
(Y) diabetes screening tests (as defined in subsection (yy) of
this section); and
(Z) intravenous immune globulin for the treatment of primary
immune deficiency diseases in the home (as defined in subsection
(zz) of this section);
(3) diagnostic X-ray tests (including tests under the
supervision of a physician, furnished in a place of residence
used as the patient's home, if the performance of such tests
meets such conditions relating to health and safety as the
Secretary may find necessary and including diagnostic mammography
if conducted by a facility that has a certificate (or provisional
certificate) issued under section 354 of the Public Health
Service Act [42 U.S.C. 263b]), diagnostic laboratory tests, and
other diagnostic tests;
(4) X-ray, radium, and radioactive isotope therapy, including
materials and services of technicians;
(5) surgical dressings, and splints, casts, and other devices
used for reduction of fractures and dislocations;
(6) durable medical equipment;
(7) ambulance service where the use of other methods of
transportation is contraindicated by the individual's condition,
but, subject to section 1395m(l)(14) of this title, only to the
extent provided in regulations;
(8) prosthetic devices (other than dental) which replace all or
part of an internal body organ (including colostomy bags and
supplies directly related to colostomy care), including
replacement of such devices, and including one pair of
conventional eyeglasses or contact lenses furnished subsequent to
each cataract surgery with insertion of an intraocular lens;
(9) leg, arm, back, and neck braces, and artificial legs, arms,
and eyes, including replacements if required because of a change
in the patient's physical condition;
(10)(A) pneumococcal vaccine and its administration and,
subject to section 4071(b) of the Omnibus Budget Reconciliation
Act of 1987, influenza vaccine and its administration; and
(B) hepatitis B vaccine and its administration, furnished to an
individual who is at high or intermediate risk of contracting
hepatitis B (as determined by the Secretary under regulations);
(11) services of a certified registered nurse anesthetist (as
defined in subsection (bb) of this section);
(12) subject to section 4072(e) of the Omnibus Budget
Reconciliation Act of 1987, extra-depth shoes with inserts or
custom molded shoes with inserts for an individual with diabetes,
if -
(A) the physician who is managing the individual's diabetic
condition (i) documents that the individual has peripheral
neuropathy with evidence of callus formation, a history of pre-
ulcerative calluses, a history of previous ulceration, foot
deformity, or previous amputation, or poor circulation, and
(ii) certifies that the individual needs such shoes under a
comprehensive plan of care related to the individual's diabetic
condition;
(B) the particular type of shoes are prescribed by a
podiatrist or other qualified physician (as established by the
Secretary); and
(C) the shoes are fitted and furnished by a podiatrist or
other qualified individual (such as a pedorthist or orthotist,
as established by the Secretary) who is not the physician
described in subparagraph (A) (unless the Secretary finds that
the physician is the only such qualified individual in the
area);
(13) screening mammography (as defined in subsection (jj) of
this section);
(14) screening pap smear and screening pelvic exam; and
(15) bone mass measurement (as defined in subsection (rr) of
this section).
No diagnostic tests performed in any laboratory, including a
laboratory that is part of a rural health clinic, or a hospital
(which, for purposes of this sentence, means an institution
considered a hospital for purposes of section 1395f(d) of this
title) shall be included within paragraph (3) unless such
laboratory -
(16) if situated in any State in which State or applicable
local law provides for licensing of establishments of this
nature, (A) is licensed pursuant to such law, or (B) is approved,
by the agency of such State or locality responsible for licensing
establishments of this nature, as meeting the standards
established for such licensing; and
(17)(A) meets the certification requirements under section 353
of the Public Health Service Act [42 U.S.C. 263a]; and
(B) meets such other conditions relating to the health and
safety of individuals with respect to whom such tests are
performed as the Secretary may find necessary.
There shall be excluded from the diagnostic services specified in
paragraph (2)(C) any item or service (except services referred to
in paragraph (1)) which would not be included under subsection (b)
of this section if it were furnished to an inpatient of a hospital.
None of the items and services referred to in the preceding
paragraphs (other than paragraphs (1) and (2)(A)) of this
subsection which are furnished to a patient of an institution which
meets the definition of a hospital for purposes of section 1395f(d)
of this title shall be included unless such other conditions are
met as the Secretary may find necessary relating to health and
safety of individuals with respect to whom such items and services
are furnished.
(t) Drugs and biologicals
(1) The term "drugs" and the term "biologicals", except for
purposes of subsection (m)(5) of this section and paragraph (2),
include only such drugs (including contrast agents) and
biologicals, respectively, as are included (or approved for
inclusion) in the United States Pharmacopoeia, the National
Formulary, or the United States Homeopathic Pharmacopoeia, or in
New Drugs or Accepted Dental Remedies (except for any drugs and
biologicals unfavorably evaluated therein), or as are approved by
the pharmacy and drug therapeutics committee (or equivalent
committee) of the medical staff of the hospital furnishing such
drugs and biologicals for use in such hospital.
(2)(A) For purposes of paragraph (1), the term "drugs" also
includes any drugs or biologicals used in an anticancer
chemotherapeutic regimen for a medically accepted indication (as
described in subparagraph (B)).
(B) In subparagraph (A), the term "medically accepted
indication", with respect to the use of a drug, includes any use
which has been approved by the Food and Drug Administration for the
drug, and includes another use of the drug if -
(i) the drug has been approved by the Food and Drug
Administration; and
(ii)(I) such use is supported by one or more citations which
are included (or approved for inclusion) in one or more of the
following compendia: the American Hospital Formulary Service-Drug
Information, the American Medical Association Drug Evaluations,
the United States Pharmacopoeia-Drug Information, and other
authoritative compendia as identified by the Secretary, unless
the Secretary has determined that the use is not medically
appropriate or the use is identified as not indicated in one or
more such compendia, or
(II) the carrier involved determines, based upon guidance
provided by the Secretary to carriers for determining accepted
uses of drugs, that such use is medically accepted based on
supportive clinical evidence in peer reviewed medical literature
appearing in publications which have been identified for purposes
of this subclause by the Secretary.
The Secretary may revise the list of compendia in clause (ii)(I) as
is appropriate for identifying medically accepted indications for
drugs.
(u) Provider of services
The term "provider of services" means a hospital, critical access
hospital, skilled nursing facility, comprehensive outpatient
rehabilitation facility, home health agency, hospice program, or,
for purposes of section 1395f(g) and section 1395n(e) of this
title, a fund.
(v) Reasonable costs
(1)(A) The reasonable cost of any services shall be the cost
actually incurred, excluding therefrom any part of incurred cost
found to be unnecessary in the efficient delivery of needed health
services, and shall be determined in accordance with regulations
establishing the method or methods to be used, and the items to be
included, in determining such costs for various types or classes of
institutions, agencies, and services; except that in any case to
which paragraph (2) or (3) applies, the amount of the payment
determined under such paragraph with respect to the services
involved shall be considered the reasonable cost of such services.
In prescribing the regulations referred to in the preceding
sentence, the Secretary shall consider, among other things, the
principles generally applied by national organizations or
established prepayment organizations (which have developed such
principles) in computing the amount of payment, to be made by
persons other than the recipients of services, to providers of
services on account of services furnished to such recipients by
such providers. Such regulations may provide for determination of
the costs of services on a per diem, per unit, per capita, or other
basis, may provide for using different methods in different
circumstances, may provide for the use of estimates of costs of
particular items or services, may provide for the establishment of
limits on the direct or indirect overall incurred costs or incurred
costs of specific items or services or groups of items or services
to be recognized as reasonable based on estimates of the costs
necessary in the efficient delivery of needed health services to
individuals covered by the insurance programs established under
this subchapter, and may provide for the use of charges or a
percentage of charges where this method reasonably reflects the
costs. Such regulations shall (i) take into account both direct and
indirect costs of providers of services (excluding therefrom any
such costs, including standby costs, which are determined in
accordance with regulations to be unnecessary in the efficient
delivery of services covered by the insurance programs established
under this subchapter) in order that, under the methods of
determining costs, the necessary costs of efficiently delivering
covered services to individuals covered by the insurance programs
established by this subchapter will not be borne by individuals not
so covered, and the costs with respect to individuals not so
covered will not be borne by such insurance programs, and (ii)
provide for the making of suitable retroactive corrective
adjustments where, for a provider of services for any fiscal
period, the aggregate reimbursement produced by the methods of
determining costs proves to be either inadequate or excessive.
(B) In the case of extended care services, the regulations under
subparagraph (A) shall not include provision for specific
recognition of a return on equity capital.
(C) Where a hospital has an arrangement with a medical school
under which the faculty of such school provides services at such
hospital, an amount not in excess of the reasonable cost of such
services to the medical school shall be included in determining the
reasonable cost to the hospital of furnishing services -
(i) for which payment may be made under part A of this
subchapter, but only if -
(I) payment for such services as furnished under such
arrangement would be made under part A of this subchapter to
the hospital had such services been furnished by the hospital,
and
(II) such hospital pays to the medical school at least the
reasonable cost of such services to the medical school, or
(ii) for which payment may be made under part B of this
subchapter, but only if such hospital pays to the medical school
at least the reasonable cost of such services to the medical
school.
(D) Where (i) physicians furnish services which are either
inpatient hospital services (including services in conjunction with
the teaching programs of such hospital) by reason of paragraph (7)
of subsection (b) of this section or for which entitlement exists
by reason of clause (II) of section 1395k(a)(2)(B)(i) of this
title, and (ii) such hospital (or medical school under arrangement
with such hospital) incurs no actual cost in the furnishing of such
services, the reasonable cost of such services shall (under
regulations of the Secretary) be deemed to be the cost such
hospital or medical school would have incurred had it paid a salary
to such physicians rendering such services approximately equivalent
to the average salary paid to all physicians employed by such
hospital (or if such employment does not exist, or is minimal in
such hospital, by similar hospitals in a geographic area of
sufficient size to assure reasonable inclusion of sufficient
physicians in development of such average salary).
(E) Such regulations may, in the case of skilled nursing
facilities in any State, provide for the use of rates, developed by
the State in which such facilities are located, for the payment of
the cost of skilled nursing facility services furnished under the
State's plan approved under subchapter XIX of this chapter (and
such rates may be increased by the Secretary on a class or size of
institution or on a geographical basis by a percentage factor not
in excess of 10 percent to take into account determinable items or
services or other requirements under this subchapter not otherwise
included in the computation of such State rates), if the Secretary
finds that such rates are reasonably related to (but not
necessarily limited to) analyses undertaken by such State of costs
of care in comparable facilities in such State. Notwithstanding the
previous sentence, such regulations with respect to skilled nursing
facilities shall take into account (in a manner consistent with
subparagraph (A) and based on patient-days of services furnished)
the costs (including the costs of services required to attain or
maintain the highest practicable physical, mental, and psychosocial
well-being of each resident eligible for benefits under this
subchapter) of such facilities complying with the requirements of
subsections (b), (c), and (d) of section 1395i-3 of this title
(including the costs of conducting nurse aide training and
competency evaluation programs and competency evaluation programs).
(F) Such regulations shall require each provider of services
(other than a fund) to make reports to the Secretary of information
described in section 1320a(a) of this title in accordance with the
uniform reporting system (established under such section) for that
type of provider.
(G)(i) In any case in which a hospital provides inpatient
services to an individual that would constitute post-hospital
extended care services if provided by a skilled nursing facility
and a quality control and peer review organization (or, in the
absence of such a qualified organization, the Secretary or such
agent as the Secretary may designate) determines that inpatient
hospital services for the individual are not medically necessary
but post-hospital extended care services for the individual are
medically necessary and such extended care services are not
otherwise available to the individual (as determined in accordance
with criteria established by the Secretary) at the time of such
determination, payment for such services provided to the individual
shall continue to be made under this subchapter at the payment rate
described in clause (ii) during the period in which -
(I) such post-hospital extended care services for the
individual are medically necessary and not otherwise available to
the individual (as so determined),
(II) inpatient hospital services for the individual are not
medically necessary, and
(III) the individual is entitled to have payment made for post-
hospital extended care services under this subchapter,
except that if the Secretary determines that there is not an excess
of hospital beds in such hospital and (subject to clause (iv))
there is not an excess of hospital beds in the area of such
hospital, such payment shall be made (during such period) on the
basis of the amount otherwise payable under part A with respect to
inpatient hospital services.
(ii)(I) Except as provided in subclause (II), the payment rate
referred to in clause (i) is a rate equal to the estimated adjusted
State-wide average rate per patient-day paid for services provided
in skilled nursing facilities under the State plan approved under
subchapter XIX of this chapter for the State in which such hospital
is located, or, if the State in which the hospital is located does
not have a State plan approved under subchapter XIX of this
chapter, the estimated adjusted State-wide average allowable costs
per patient-day for extended care services under this subchapter in
that State.
(II) If a hospital has a unit which is a skilled nursing
facility, the payment rate referred to in clause (i) for the
hospital is a rate equal to the lesser of the rate described in
subclause (I) or the allowable costs in effect under this
subchapter for extended care services provided to patients of such
unit.
(iii) Any day on which an individual receives inpatient services
for which payment is made under this subparagraph shall, for
purposes of this chapter (other than this subparagraph), be deemed
to be a day on which the individual received inpatient hospital
services.
(iv) In determining under clause (i), in the case of a public
hospital, whether or not there is an excess of hospital beds in the
area of such hospital, such determination shall be made on the
basis of only the public hospitals (including the hospital) which
are in the area of the hospital and which are under common
ownership with that hospital.
(H) In determining such reasonable cost with respect to home
health agencies, the Secretary may not include -
(i) any costs incurred in connection with bonding or
establishing an escrow account by any such agency as a result of
the surety bond requirement described in subsection (o)(7) of
this section and the financial security requirement described in
subsection (o)(8) of this section;
(ii) in the case of home health agencies to which the surety
bond requirement described in subsection (o)(7) of this section
and the financial security requirement described in subsection
(o)(8) of this section apply, any costs attributed to interest
charged such an agency in connection with amounts borrowed by the
agency to repay overpayments made under this subchapter to the
agency, except that such costs may be included in reasonable cost
if the Secretary determines that the agency was acting in good
faith in borrowing the amounts;
(iii) in the case of contracts entered into by a home health
agency after December 5, 1980, for the purpose of having services
furnished for or on behalf of such agency, any cost incurred by
such agency pursuant to any such contract which is entered into
for a period exceeding five years; and
(iv) in the case of contracts entered into by a home health
agency before December 5, 1980, for the purpose of having
services furnished for or on behalf of such agency, any cost
incurred by such agency pursuant to any such contract, which
determines the amount payable by the home health agency on the
basis of a percentage of the agency's reimbursement or claim for
reimbursement for services furnished by the agency, to the extent
that such cost exceeds the reasonable value of the services
furnished on behalf of such agency.
(I) In determining such reasonable cost, the Secretary may not
include any costs incurred by a provider with respect to any
services furnished in connection with matters for which payment may
be made under this subchapter and furnished pursuant to a contract
between the provider and any of its subcontractors which is entered
into after December 5, 1980, and the value or cost of which is
$10,000 or more over a twelve-month period unless the contract
contains a clause to the effect that -
(i) until the expiration of four years after the furnishing of
such services pursuant to such contract, the subcontractor shall
make available, upon written request by the Secretary, or upon
request by the Comptroller General, or any of their duly
authorized representatives, the contract, and books, documents
and records of such subcontractor that are necessary to certify
the nature and extent of such costs, and
(ii) if the subcontractor carries out any of the duties of the
contract through a subcontract, with a value or cost of $10,000
or more over a twelve-month period, with a related organization,
such subcontract shall contain a clause to the effect that until
the expiration of four years after the furnishing of such
services pursuant to such subcontract, the related organization
shall make available, upon written request by the Secretary, or
upon request by the Comptroller General, or any of their duly
authorized representatives, the subcontract, and books, documents
and records of such organization that are necessary to verify the
nature and extent of such costs.
The Secretary shall prescribe in regulation (!3) criteria and
procedures which the Secretary shall use in obtaining access to
books, documents, and records under clauses required in contracts
and subcontracts under this subparagraph.
(J) Such regulations may not provide for any inpatient routine
salary cost differential as a reimbursable cost for hospitals and
skilled nursing facilities.
(K)(i) The Secretary shall issue regulations that provide, to the
extent feasible, for the establishment of limitations on the amount
of any costs or charges that shall be considered reasonable with
respect to services provided on an outpatient basis by hospitals
(other than bona fide emergency services as defined in clause (ii))
or clinics (other than rural health clinics), which are reimbursed
on a cost basis or on the basis of cost related charges, and by
physicians utilizing such outpatient facilities. Such limitations
shall be reasonably related to the charges in the same area for
similar services provided in physicians' offices. Such regulations
shall provide for exceptions to such limitations in cases where
similar services are not generally available in physicians' offices
in the area to individuals entitled to benefits under this
subchapter.
(ii) For purposes of clause (i), the term "bona fide emergency
services" means services provided in a hospital emergency room
after the sudden onset of a medical condition manifesting itself by
acute symptoms of sufficient severity (including severe pain) such
that the absence of immediate medical attention could reasonably be
expected to result in -
(I) placing the patient's health in serious jeopardy;
(II) serious impairment to bodily functions; or
(III) serious dysfunction of any bodily organ or part.
(L)(i) The Secretary, in determining the amount of the payments
that may be made under this subchapter with respect to services
furnished by home health agencies, may not recognize as reasonable
(in the efficient delivery of such services) costs for the
provision of such services by an agency to the extent these costs
exceed (on the aggregate for the agency) for cost reporting periods
beginning on or after -
(I) July 1, 1985, and before July 1, 1986, 120 percent of the
mean of the labor-related and nonlabor per visit costs for
freestanding home health agencies,
(II) July 1, 1986, and before July 1, 1987, 115 percent of such
mean,
(III) July 1, 1987, and before October 1, 1997, 112 percent of
such mean,
(IV) October 1, 1997, and before October 1, 1998, 105 percent
of the median of the labor-related and nonlabor per visit costs
for freestanding home health agencies, or
(V) October 1, 1998, 106 percent of such median.
(ii) Effective for cost reporting periods beginning on or after
July 1, 1986, such limitations shall be applied on an aggregate
basis for the agency, rather than on a discipline specific basis.
The Secretary may provide for such exemptions and exceptions to
such limitation as he deems appropriate.
(iii) Not later than July 1, 1991, and annually thereafter (but
not for cost reporting periods beginning on or after July 1, 1994,
and before July 1, 1996, or on or after July 1, 1997, and before
October 1, 1997), the Secretary shall establish limits under this
subparagraph for cost reporting periods beginning on or after such
date by utilizing the area wage index applicable under section
1395ww(d)(3)(E) of this title and determined using the survey of
the most recent available wages and wage-related costs of hospitals
located in the geographic area in which the home health service is
furnished (determined without regard to whether such hospitals have
been reclassified to a new geographic area pursuant to section
1395ww(d)(8)(B) of this title, a decision of the Medicare
Geographic Classification Review Board under section 1395ww(d)(10)
of this title, or a decision of the Secretary).
(iv) In establishing limits under this subparagraph for cost
reporting periods beginning after September 30, 1997, the Secretary
shall not take into account any changes in the home health market
basket, as determined by the Secretary, with respect to cost
reporting periods which began on or after July 1, 1994, and before
July 1, 1996.
(v) For services furnished by home health agencies for cost
reporting periods beginning on or after October 1, 1997, subject to
clause (viii)(I), the Secretary shall provide for an interim system
of limits. Payment shall not exceed the costs determined under the
preceding provisions of this subparagraph or, if lower, the product
of -
(I) an agency-specific per beneficiary annual limitation
calculated based 75 percent on 98 percent of the reasonable costs
(including nonroutine medical supplies) for the agency's 12-month
cost reporting period ending during fiscal year 1994, and based
25 percent on 98 percent of the standardized regional average of
such costs for the agency's census division, as applied to such
agency, for cost reporting periods ending during fiscal year
1994, such costs updated by the home health market basket index;
and
(II) the agency's unduplicated census count of patients
(entitled to benefits under this subchapter) for the cost
reporting period subject to the limitation.
(vi) For services furnished by home health agencies for cost
reporting periods beginning on or after October 1, 1997, the
following rules apply:
(I) For new providers and those providers without a 12-month
cost reporting period ending in fiscal year 1994 subject to
clauses (viii)(II) and (viii)(III), the per beneficiary
limitation shall be equal to the median of these limits (or the
Secretary's best estimates thereof) applied to other home health
agencies as determined by the Secretary. A home health agency
that has altered its corporate structure or name shall not be
considered a new provider for this purpose.
(II) For beneficiaries who use services furnished by more than
one home health agency, the per beneficiary limitations shall be
prorated among the agencies.
(vii)(I) Not later than January 1, 1998, the Secretary shall
establish per visit limits applicable for fiscal year 1998, and not
later than April 1, 1998, the Secretary shall establish per
beneficiary limits under clause (v)(I) for fiscal year 1998.
(II) Not later than August 1 of each year (beginning in 1998) the
Secretary shall establish the limits applicable under this
subparagraph for services furnished during the fiscal year
beginning October 1 of the year.
(viii)(I) In the case of a provider with a 12-month cost
reporting period ending in fiscal year 1994, if the limit imposed
under clause (v) (determined without regard to this subclause) for
a cost reporting period beginning during or after fiscal year 1999
is less than the median described in clause (vi)(I) (but determined
as if any reference in clause (v) to "98 percent" were a reference
to "100 percent"), the limit otherwise imposed under clause (v) for
such provider and period shall be increased by 1/3 of such
difference.
(II) Subject to subclause (IV), for new providers and those
providers without a 12-month cost reporting period ending in fiscal
year 1994, but for which the first cost reporting period begins
before fiscal year 1999, for cost reporting periods beginning
during or after fiscal year 1999, the per beneficiary limitation
described in clause (vi)(I) shall be equal to the median described
in such clause (determined as if any reference in clause (v) to "98
percent" were a reference to "100 percent").
(III) Subject to subclause (IV), in the case of a new provider
for which the first cost reporting period begins during or after
fiscal year 1999, the limitation applied under clause (vi)(I) (but
only with respect to such provider) shall be equal to 75 percent of
the median described in clause (vi)(I).
(IV) In the case of a new provider or a provider without a 12-
month cost reporting period ending in fiscal year 1994, subclause
(II) shall apply, instead of subclause (III), to a home health
agency which filed an application for home health agency provider
status under this subchapter before September 15, 1998, or which
was approved as a branch of its parent agency before such date and
becomes a subunit of the parent agency or a separate agency on or
after such date.
(V) Each of the amounts specified in subclauses (I) through (III)
are such amounts as adjusted under clause (iii) to reflect
variations in wages among different areas.
(ix) Notwithstanding the per beneficiary limit under clause
(viii), if the limit imposed under clause (v) (determined without
regard to this clause) for a cost reporting period beginning during
or after fiscal year 2000 is less than the median described in
clause (vi)(I) (but determined as if any reference in clause (v) to
"98 percent" were a reference to "100 percent"), the limit
otherwise imposed under clause (v) for such provider and period
shall be increased by 2 percent.
(x) Notwithstanding any other provision of this subparagraph, in
updating any limit under this subparagraph by a home health market
basket index for cost reporting periods beginning during each of
fiscal years 2000, 2002, and 2003, the update otherwise provided
shall be reduced by 1.1 percentage points. With respect to cost
reporting periods beginning during fiscal year 2001, the update to
any limit under this subparagraph shall be the home health market
basket index.
(M) Such regulations shall provide that costs respecting care
provided by a provider of services, pursuant to an assurance under
title VI or XVI of the Public Health Service Act [42 U.S.C. 291 et
seq., 300q et seq.] that the provider will make available a
reasonable volume of services to persons unable to pay therefor,
shall not be allowable as reasonable costs.
(N) In determining such reasonable costs, costs incurred for
activities directly related to influencing employees respecting
unionization may not be included.
(O)(i) In establishing an appropriate allowance for depreciation
and for interest on capital indebtedness with respect to an asset
of a provider of services which has undergone a change of
ownership, such regulations shall provide, except as provided in
clause (iii), that the valuation of the asset after such change of
ownership shall be the historical cost of the asset, as recognized
under this subchapter, less depreciation allowed, to the owner of
record as of August 5, 1997 (or, in the case of an asset not in
existence as of August 5, 1997, the first owner of record of the
asset after August 5, 1997).
(ii) Such regulations shall not recognize, as reasonable in the
provision of health care services, costs (including legal fees,
accounting and administrative costs, travel costs, and the costs of
feasibility studies) attributable to the negotiation or settlement
of the sale or purchase of any capital asset (by acquisition or
merger) for which any payment has previously been made under this
subchapter.
(iii) In the case of the transfer of a hospital from ownership by
a State to ownership by a nonprofit corporation without monetary
consideration, the basis for capital allowances to the new owner
shall be the book value of the hospital to the State at the time of
the transfer.
(P) If such regulations provide for the payment for a return on
equity capital (other than with respect to costs of inpatient
hospital services), the rate of return to be recognized, for
determining the reasonable cost of services furnished in a cost
reporting period, shall be equal to the average of the rates of
interest, for each of the months any part of which is included in
the period, on obligations issued for purchase by the Federal
Hospital Insurance Trust Fund.
(Q) Except as otherwise explicitly authorized, the Secretary is
not authorized to limit the rate of increase on allowable costs of
approved medical educational activities.
(R) In determining such reasonable cost, costs incurred by a
provider of services representing a beneficiary in an unsuccessful
appeal of a determination described in section 1395ff(b) of this
title shall not be allowable as reasonable costs.
(S)(i) Such regulations shall not include provision for specific
recognition of any return on equity capital with respect to
hospital outpatient departments.
(ii)(I) Such regulations shall provide that, in determining the
amount of the payments that may be made under this subchapter with
respect to all the capital-related costs of outpatient hospital
services, the Secretary shall reduce the amounts of such payments
otherwise established under this subchapter by 15 percent for
payments attributable to portions of cost reporting periods
occurring during fiscal year 1990, by 15 percent for payments
attributable to portions of cost reporting periods occurring during
fiscal year 1991, and by 10 percent for payments attributable to
portions of cost reporting periods occurring during fiscal years
1992 through 1999 and until the first date that the prospective
payment system under section 1395l(t) of this title is implemented.
(II) The Secretary shall reduce the reasonable cost of outpatient
hospital services (other than the capital-related costs of such
services) otherwise determined pursuant to section
1395l(a)(2)(B)(i)(I) of this title by 5.8 percent for payments
attributable to portions of cost reporting periods occurring during
fiscal years 1991 through 1999 and until the first date that the
prospective payment system under section 1395l(t) of this title is
implemented.
(III) Subclauses (I) and (II) shall not apply to payments with
respect to the costs of hospital outpatient services provided by
any hospital that is a sole community hospital (as defined in
section 1395ww(d)(5)(D)(iii) of this title) or a critical access
hospital (as defined in subsection (mm)(1) of this section).
(IV) In applying subclauses (I) and (II) to services for which
payment is made on the basis of a blend amount under section
1395l(i)(3)(A)(ii) or 1395l(n)(1)(A)(ii) of this title, the costs
reflected in the amounts described in sections 1395l(i)(3)(B)(i)(I)
and 1395l(n)(1)(B)(i)(I) of this title, respectively, shall be
reduced in accordance with such subclause.(!4)
(T) In determining such reasonable costs for hospitals, no
reduction in copayments under section 1395l(t)(5)(B) (!5) of this
title shall be treated as a bad debt and the amount of bad debts
otherwise treated as allowable costs which are attributable to the
deductibles and coinsurance amounts under this subchapter shall be
reduced -
(i) for cost reporting periods beginning during fiscal year
1998, by 25 percent of such amount otherwise allowable,
(ii) for cost reporting periods beginning during fiscal year
1999, by 40 percent of such amount otherwise allowable,
(iii) for cost reporting periods beginning during fiscal year
2000, by 45 percent of such amount otherwise allowable, and
(iv) for cost reporting periods beginning during a subsequent
fiscal year, by 30 percent of such amount otherwise allowable.
(U) In determining the reasonable cost of ambulance services (as
described in subsection (s)(7) of this section) provided during
fiscal year 1998, during fiscal year 1999, and during so much of
fiscal year 2000 as precedes January 1, 2000, the Secretary shall
not recognize the costs per trip in excess of costs recognized as
reasonable for ambulance services provided on a per trip basis
during the previous fiscal year (after application of this
subparagraph), increased by the percentage increase in the consumer
price index for all urban consumers (U.S. city average) as
estimated by the Secretary for the 12-month period ending with the
midpoint of the fiscal year involved reduced by 1.0 percentage
point. For ambulance services provided after June 30, 1998, the
Secretary may provide that claims for such services must include a
code (or codes) under a uniform coding system specified by the
Secretary that identifies the services furnished.
(2)(A) If the bed and board furnished as part of inpatient
hospital services (including inpatient tuberculosis hospital
services and inpatient psychiatric hospital services) or post-
hospital extended care services is in accommodations more
expensive than semi-private accommodations, the amount taken into
account for purposes of payment under this subchapter with respect
to such services may not exceed the amount that would be taken into
account with respect to such services if furnished in such semi-
private accommodations unless the more expensive accommodations
were required for medical reasons.
(B) Where a provider of services which has an agreement in effect
under this subchapter furnishes to an individual items or services
which are in excess of or more expensive than the items or services
with respect to which payment may be made under part A or part B of
this subchapter, as the case may be, the Secretary shall take into
account for purposes of payment to such provider of services only
the items or services with respect to which such payment may be
made.
(3) If the bed and board furnished as part of inpatient hospital
services (including inpatient tuberculosis hospital services and
inpatient psychiatric hospital services) or post-hospital extended
care services is in accommodations other than, but not more
expensive than, semi-private accommodations and the use of such
other accommodations rather than semi-private accommodations was
neither at the request of the patient nor for a reason which the
Secretary determines is consistent with the purposes of this
subchapter, the amount of the payment with respect to such bed and
board under part A of this subchapter shall be the amount otherwise
payable under this subchapter for such bed and board furnished in
semi-private accommodations minus the difference between the charge
customarily made by the hospital or skilled nursing facility for
bed and board in semi-private accommodations and the charge
customarily made by it for bed and board in the accommodations
furnished.
(4) If a provider of services furnishes items or services to an
individual which are in excess of or more expensive than the items
or services determined to be necessary in the efficient delivery of
needed health services and charges are imposed for such more
expensive items or services under the authority granted in section
1395cc(a)(2)(B)(ii),(!6) of this title, the amount of payment with
respect to such items or services otherwise due such provider in
any fiscal period shall be reduced to the extent that such payment
plus such charges exceed the cost actually incurred for such items
or services in the fiscal period in which such charges are imposed.
(5)(A) Where physical therapy services, occupational therapy
services, speech therapy services, or other therapy services or
services of other health-related personnel (other than physicians)
are furnished under an arrangement with a provider of services or
other organization, specified in the first sentence of subsection
(p) of this section (including through the operation of subsection
(g) of this section) the amount included in any payment to such
provider or other organization under this subchapter as the
reasonable cost of such services (as furnished under such
arrangements) shall not exceed an amount equal to the salary which
would reasonably have been paid for such services (together with
any additional costs that would have been incurred by the provider
or other organization) to the person performing them if they had
been performed in an employment relationship with such provider or
other organization (rather than under such arrangement) plus the
cost of such other expenses (including a reasonable allowance for
traveltime and other reasonable types of expense related to any
differences in acceptable methods of organization for the provision
of such therapy) incurred by such person, as the Secretary may in
regulations determine to be appropriate.
(B) Notwithstanding the provisions of subparagraph (A), if a
provider of services or other organization specified in the first
sentence of subsection (p) of this section requires the services of
a therapist on a limited part-time basis, or only to perform
intermittent services, the Secretary may make payment on the basis
of a reasonable rate per unit of service, even though such rate is
greater per unit of time than salary related amounts, where he
finds that such greater payment is, in the aggregate, less than the
amount that would have been paid if such organization had employed
a therapist on a full- or part-time salary basis.
(6) For purposes of this subsection, the term, "semi-private
accommodations" means two-bed, three-bed, or four-bed
accommodations.
(7)(A) For limitation on Federal participation for capital
expenditures which are out of conformity with a comprehensive plan
of a State or areawide planning agency, see section 1320a-1 of this
title.
(B) For further limitations on reasonable cost and determination
of payment amounts for operating costs of inpatient hospital
services and waivers for certain States, see section 1395ww of this
title.
(C) For provisions restricting payment for provider-based
physicians' services and for payments under certain percentage
arrangements, see section 1395xx of this title.
(D) For further limitations on reasonable cost and determination
of payment amounts for routine service costs of skilled nursing
facilities, see subsections (a) through (c) of section 1395yy of
this title.
(8) Items unrelated to patient care. - Reasonable costs do not
include costs for the following -
(i) entertainment, including tickets to sporting and other
entertainment events;
(ii) gifts or donations;
(iii) personal use of motor vehicles;
(iv) costs for fines and penalties resulting from violations of
Federal, State, or local laws; and
(v) education expenses for spouses or other dependents of
providers of services, their employees or contractors.
(w) Arrangements for certain services; payments pursuant to
arrangements for utilization review activities
(1) The term "arrangements" is limited to arrangements under
which receipt of payment by the hospital, critical access hospital,
skilled nursing facility, home health agency, or hospice program
(whether in its own right or as agent), with respect to services
for which an individual is entitled to have payment made under this
subchapter, discharges the liability of such individual or any
other person to pay for the services.
(2) Utilization review activities conducted, in accordance with
the requirements of the program established under part B of
subchapter XI of this chapter with respect to services furnished by
a hospital or critical access hospital to patients insured under
part A of this subchapter or entitled to have payment made for such
services under part B of this subchapter or under a State plan
approved under subchapter XIX of this chapter, by a quality control
and peer review organization designated for the area in which such
hospital or critical access hospital is located shall be deemed to
have been conducted pursuant to arrangements between such hospital
or critical access hospital and such organization under which such
hospital or critical access hospital is obligated to pay to such
organization, as a condition of receiving payment for hospital or
critical access hospital services so furnished under this part or
under such a State plan, such amount as is reasonably incurred and
requested (as determined under regulations of the Secretary) by
such organization in conducting such review activities with respect
to services furnished by such hospital or critical access hospital
to such patients.
(x) State and United States
The terms "State" and "United States" have the meaning given to
them by subsections (h) and (i), respectively, of section 410 of
this title.
(y) Extended care in religious nonmedical health care institutions
(1) The term "skilled nursing facility" also includes a religious
nonmedical health care institution (as defined in subsection
(ss)(1) of this section), but only (except for purposes of
subsection (a)(2) of this section) with respect to items and
services ordinarily furnished by such an institution to inpatients,
and payment may be made with respect to services provided by or in
such an institution only to such extent and under such conditions,
limitations, and requirements (in addition to or in lieu of the
conditions, limitations, and requirements otherwise applicable) as
may be provided in regulations consistent with section 1395i-5 of
this title.
(2) Notwithstanding any other provision of this subchapter,
payment under part A of this subchapter may not be made for
services furnished an individual in a skilled nursing facility to
which paragraph (1) applies unless such individual elects, in
accordance with regulations, for a spell of illness to have such
services treated as post-hospital extended care services for
purposes of such part; and payment under part A of this subchapter
may not be made for post-hospital extended care services -
(A) furnished an individual during such spell of illness in a
skilled nursing facility to which paragraph (1) applies after -
(i) such services have been furnished to him in such a
facility for 30 days during such spell, or
(ii) such services have been furnished to him during such
spell in a skilled nursing facility to which such paragraph
does not apply; or
(B) furnished an individual during such spell of illness in a
skilled nursing facility to which paragraph (1) does not apply
after such services have been furnished to him during such spell
in a skilled nursing facility to which such paragraph applies.
(3) The amount payable under part A of this subchapter for post-
hospital extended care services furnished an individual during any
spell of illness in a skilled nursing facility to which paragraph
(1) applies shall be reduced by a coinsurance amount equal to one-
eighth of the inpatient hospital deductible for each day before
the 31st day on which he is furnished such services in such a
facility during such spell (and the reduction under this paragraph
shall be in lieu of any reduction under section 1395e(a)(3) of this
title).
(4) For purposes of subsection (i) of this section, the
determination of whether services furnished by or in an institution
described in paragraph (1) constitute post-hospital extended care
services shall be made in accordance with and subject to such
conditions, limitations, and requirements as may be provided in
regulations.
(z) Institutional planning
An overall plan and budget of a hospital, skilled nursing
facility, comprehensive outpatient rehabilitation facility, or home
health agency shall be considered sufficient if it -
(1) provides for an annual operating budget which includes all
anticipated income and expenses related to items which would,
under generally accepted accounting principles, be considered
income and expense items (except that nothing in this paragraph
shall require that there be prepared, in connection with any
budget, an item-by-item identification of the components of each
type of anticipated expenditure or income);
(2)(A) provides for a capital expenditures plan for at least a
3-year period (including the year to which the operating budget
described in paragraph (1) is applicable) which includes and
identifies in detail the anticipated sources of financing for,
and the objectives of, each anticipated expenditure in excess of
$600,000 (or such lesser amount as may be established by the
State under section 1320a-1(g)(1) of this title in which the
hospital is located) related to the acquisition of land, the
improvement of land, buildings, and equipment, and the
replacement, modernization, and expansion of the buildings and
equipment which would, under generally accepted accounting
principles, be considered capital items;
(B) provides that such plan is submitted to the agency
designated under section 1320a-1(b) of this title, or if no such
agency is designated, to the appropriate health planning agency
in the State (but this subparagraph shall not apply in the case
of a facility exempt from review under section 1320a-1 of this
title by reason of section 1320a-1(j) of this title);
(3) provides for review and updating at least annually; and
(4) is prepared, under the direction of the governing body of
the institution or agency, by a committee consisting of
representatives of the governing body, the administrative staff,
and the medical staff (if any) of the institution or agency.
(aa) Rural health clinic services and Federally qualified health
center services
(1) The term "rural health clinic services" means -
(A) physicians' services and such services and supplies as are
covered under subsection (s)(2)(A) of this section if furnished
as an incident to a physician's professional service and items
and services described in subsection (s)(10) of this section,
(B) such services furnished by a physician assistant or a nurse
practitioner (as defined in paragraph (5)), by a clinical
psychologist (as defined by the Secretary) or by a clinical
social worker (as defined in subsection (hh)(1) of this section),
and such services and supplies furnished as an incident to his
service as would otherwise be covered if furnished by a physician
or as an incident to a physician's service, and
(C) in the case of a rural health clinic located in an area in
which there exists a shortage of home health agencies, part-time
or intermittent nursing care and related medical supplies (other
than drugs and biologicals) furnished by a registered
professional nurse or licensed practical nurse to a homebound
individual under a written plan of treatment (i) established and
periodically reviewed by a physician described in paragraph
(2)(B), or (ii) established by a nurse practitioner or physician
assistant and periodically reviewed and approved by a physician
described in paragraph (2)(B),
when furnished to an individual as an outpatient of a rural health
clinic.
(2) The term "rural health clinic" means a facility which -
(A) is primarily engaged in furnishing to outpatients services
described in subparagraphs (A) and (B) of paragraph (1);
(B) in the case of a facility which is not a physician-directed
clinic, has an arrangement (consistent with the provisions of
State and local law relative to the practice, performance, and
delivery of health services) with one or more physicians (as
defined in subsection (r)(1)) of this section under which
provision is made for the periodic review by such physicians of
covered services furnished by physician assistants and nurse
practitioners, the supervision and guidance by such physicians of
physician assistants and nurse practitioners, the preparation by
such physicians of such medical orders for care and treatment of
clinic patients as may be necessary, and the availability of such
physicians for such referral of and consultation for patients as
is necessary and for advice and assistance in the management of
medical emergencies; and, in the case of a physician-directed
clinic, has one or more of its staff physicians perform the
activities accomplished through such an arrangement;
(C) maintains clinical records on all patients;
(D) has arrangements with one or more hospitals, having
agreements in effect under section 1395cc of this title, for the
referral and admission of patients requiring inpatient services
or such diagnostic or other specialized services as are not
available at the clinic;
(E) has written policies, which are developed with the advice
of (and with provision for review of such policies from time to
time by) a group of professional personnel, including one or more
physicians and one or more physician assistants or nurse
practitioners, to govern those services described in paragraph
(1) which it furnishes;
(F) has a physician, physician assistant, or nurse practitioner
responsible for the execution of policies described in
subparagraph (E) and relating to the provision of the clinic's
services;
(G) directly provides routine diagnostic services, including
clinical laboratory services, as prescribed in regulations by the
Secretary, and has prompt access to additional diagnostic
services from facilities meeting requirements under this
subchapter;
(H) in compliance with State and Federal law, has available for
administering to patients of the clinic at least such drugs and
biologicals as are determined by the Secretary to be necessary
for the treatment of emergency cases (as defined in regulations)
and has appropriate procedures or arrangements for storing,
administering, and dispensing any drugs and biologicals;
(I) has a quality assessment and performance improvement
program, and appropriate procedures for review of utilization of
clinic services, as the Secretary may specify;
(J) has a nurse practitioner, a physician assistant, or a
certified nurse-midwife (as defined in subsection (gg) of this
section) available to furnish patient care services not less than
50 percent of the time the clinic operates; and
(K) meets such other requirements as the Secretary may find
necessary in the interest of the health and safety of the
individuals who are furnished services by the clinic.
For the purposes of this subchapter, such term includes only a
facility which (i) is located in an area that is not an urbanized
area (as defined by the Bureau of the Census) and in which there
are insufficient numbers of needed health care practitioners (as
determined by the Secretary), and that, within the previous 3-year
period, has been designated by the chief executive officer of the
State and certified by the Secretary as an area with a shortage of
personal health services or designated by the Secretary either (I)
as an area with a shortage of personal health services under
section 330(b)(3) (!7) or 1302(7) [42 U.S.C. 300e-1(7)] of the
Public Health Service Act, (II) as a health professional shortage
area described in section 332(a)(1)(A) of that Act [42 U.S.C.
254e(a)(1)(A)] because of its shortage of primary medical care
manpower, (III) as a high impact area described in section
329(a)(5) (!7) of that Act, or (IV) as an area which includes a
population group which the Secretary determines has a health
manpower shortage under section 332(a)(1)(B) of that Act [42 U.S.C.
254e(a)(1)(B)], (ii) has filed an agreement with the Secretary by
which it agrees not to charge any individual or other person for
items or services for which such individual is entitled to have
payment made under this subchapter, except for the amount of any
deductible or coinsurance amount imposed with respect to such items
or services (not in excess of the amount customarily charged for
such items and services by such clinic), pursuant to subsections
(a) and (b) of section 1395l of this title, (iii) employs a
physician assistant or nurse practitioner, and (iv) is not a
rehabilitation agency or a facility which is primarily for the care
and treatment of mental diseases. A facility that is in operation
and qualifies as a rural health clinic under this subchapter or
subchapter XIX of this chapter and that subsequently fails to
satisfy the requirement of clause (i) shall be considered, for
purposes of this subchapter and subchapter XIX of this chapter, as
still satisfying the requirement of such clause if it is
determined, in accordance with criteria established by the
Secretary in regulations, to be essential to the delivery of
primary care services that would otherwise be unavailable in the
geographic area served by the clinic. If a State agency has
determined under section 1395aa(a) of this title that a facility is
a rural health clinic and the facility has applied to the Secretary
for approval as such a clinic, the Secretary shall notify the
facility of the Secretary's approval or disapproval not later than
60 days after the date of the State agency determination or the
application (whichever is later).
(3) The term "Federally qualified health center services" means -

(A) services of the type described in subparagraphs (A) through
(C) of paragraph (1), and
(B) preventive primary health services that a center is
required to provide under sections 329, 330, and 340 (!7) of the
Public Health Service Act,
when furnished to an individual as an outpatient of a Federally
qualified health center and, for this purpose, any reference to a
rural health clinic or a physician described in paragraph (2)(B) is
deemed a reference to a Federally qualified health center or a
physician at the center, respectively.
(4) The term "Federally qualified health center" means an entity
which -
(A)(i) is receiving a grant under section 330 (other than
subsection (h)) of the Public Health Service Act [42 U.S.C.
254b], or
(ii)(I) is receiving funding from such a grant under a contract
with the recipient of such a grant, and (II) meets the
requirements to receive a grant under section 330 (other than
subsection (h)) of such Act [42 U.S.C. 254b];
(B) based on the recommendation of the Health Resources and
Services Administration within the Public Health Service, is
determined by the Secretary to meet the requirements for
receiving such a grant;
(C) was treated by the Secretary, for purposes of part B of
this subchapter, as a comprehensive Federally funded health
center as of January 1, 1990; or
(D) is an outpatient health program or facility operated by a
tribe or tribal organization under the Indian Self-Determination
Act [25 U.S.C. 450f et seq.] or by an urban Indian organization
receiving funds under title V of the Indian Health Care
Improvement Act [25 U.S.C. 1651 et seq.].
(5)(A) The term "physician assistant" and the term "nurse
practitioner" mean, for purposes of this subchapter, a physician
assistant or nurse practitioner who performs such services as such
individual is legally authorized to perform (in the State in which
the individual performs such services) in accordance with State law
(or the State regulatory mechanism provided by State law), and who
meets such training, education, and experience requirements (or any
combination thereof) as the Secretary may prescribe in regulations.
(B) The term "clinical nurse specialist" means, for purposes of
this subchapter, an individual who -
(i) is a registered nurse and is licensed to practice nursing
in the State in which the clinical nurse specialist services are
performed; and
(ii) holds a master's degree in a defined clinical area of
nursing from an accredited educational institution.
(6) The term "collaboration" means a process in which a nurse
practitioner works with a physician to deliver health care services
within the scope of the practitioner's professional expertise, with
medical direction and appropriate supervision as provided for in
jointly developed guidelines or other mechanisms as defined by the
law of the State in which the services are performed.
(7)(A) The Secretary shall waive for a 1-year period the
requirements of paragraph (2) that a rural health clinic employ a
physician assistant, nurse practitioner or certified nurse midwife
or that such clinic require such providers to furnish services at
least 50 percent of the time that the clinic operates for any
facility that requests such waiver if the facility demonstrates
that the facility has been unable, despite reasonable efforts, to
hire a physician assistant, nurse practitioner, or certified nurse-
midwife in the previous 90-day period.
(B) The Secretary may not grant such a waiver under subparagraph
(A) to a facility if the request for the waiver is made less than 6
months after the date of the expiration of any previous such waiver
for the facility, or if the facility has not yet been determined to
meet the requirements (including subparagraph (J) of the first
sentence of paragraph (2)) of a rural health clinic.
(C) A waiver which is requested under this paragraph shall be
deemed granted unless such request is denied by the Secretary
within 60 days after the date such request is received.
(bb) Services of a certified registered nurse anesthetist
(1) The term "services of a certified registered nurse
anesthetist" means anesthesia services and related care furnished
by a certified registered nurse anesthetist (as defined in
paragraph (2)) which the nurse anesthetist is legally authorized to
perform as such by the State in which the services are furnished.
(2) The term "certified registered nurse anesthetist" means a
certified registered nurse anesthetist licensed by the State who
meets such education, training, and other requirements relating to
anesthesia services and related care as the Secretary may
prescribe. In prescribing such requirements the Secretary may use
the same requirements as those established by a national
organization for the certification of nurse anesthetists. Such term
also includes, as prescribed by the Secretary, an anesthesiologist
assistant.
(cc) Comprehensive outpatient rehabilitation facility services
(1) The term "comprehensive outpatient rehabilitation facility
services" means the following items and services furnished by a
physician or other qualified professional personnel (as defined in
regulations by the Secretary) to an individual who is an outpatient
of a comprehensive outpatient rehabilitation facility under a plan
(for furnishing such items and services to such individual)
established and periodically reviewed by a physician -
(A) physicians' services;
(B) physical therapy, occupational therapy, speech-language
pathology services, and respiratory therapy;
(C) prosthetic and orthotic devices, including testing,
fitting, or training in the use of prosthetic and orthotic
devices;
(D) social and psychological services;
(E) nursing care provided by or under the supervision of a
registered professional nurse;
(F) drugs and biologicals which cannot, as determined in
accordance with regulations, be self-administered;
(G) supplies and durable medical equipment; and
(H) such other items and services as are medically necessary
for the rehabilitation of the patient and are ordinarily
furnished by comprehensive outpatient rehabilitation facilities,
excluding, however, any item or service if it would not be included
under subsection (b) of this section if furnished to an inpatient
of a hospital. In the case of physical therapy, occupational
therapy, and speech pathology services, there shall be no
requirement that the item or service be furnished at any single
fixed location if the item or service is furnished pursuant to such
plan and payments are not otherwise made for the item or service
under this subchapter.
(2) The term "comprehensive outpatient rehabilitation facility"
means a facility which -
(A) is primarily engaged in providing (by or under the
supervision of physicians) diagnostic, therapeutic, and
restorative services to outpatients for the rehabilitation of
injured, disabled, or sick persons;
(B) provides at least the following comprehensive outpatient
rehabilitation services: (i) physicians' services (rendered by
physicians, as defined in subsection (r)(1) of this section, who
are available at the facility on a full- or part-time basis);
(ii) physical therapy; and (iii) social or psychological
services;
(C) maintains clinical records on all patients;
(D) has policies established by a group of professional
personnel (associated with the facility), including one or more
physicians defined in subsection (r)(1) of this section to govern
the comprehensive outpatient rehabilitation services it
furnishes, and provides for the carrying out of such policies by
a full- or part-time physician referred to in subparagraph
(B)(i);
(E) has a requirement that every patient must be under the care
of a physician;
(F) in the case of a facility in any State in which State or
applicable local law provides for the licensing of facilities of
this nature (i) is licensed pursuant to such law, or (ii) is
approved by the agency of such State or locality, responsible for
licensing facilities of this nature, as meeting the standards
established for such licensing;
(G) has in effect a utilization review plan in accordance with
regulations prescribed by the Secretary;
(H) has in effect an overall plan and budget that meets the
requirements of subsection (z) of this section;
(I) provides the Secretary on a continuing basis with a surety
bond in a form specified by the Secretary and in an amount that
is not less than $50,000; and
(J) meets such other conditions of participation as the
Secretary may find necessary in the interest of the health and
safety of individuals who are furnished services by such
facility, including conditions concerning qualifications of
personnel in these facilities.
The Secretary may waive the requirement of a surety bond under
subparagraph (I) in the case of a facility that provides a
comparable surety bond under State law.
(dd) Hospice care; hospice program; definitions; certification;
waiver by Secretary
(1) The term "hospice care" means the following items and
services provided to a terminally ill individual by, or by others
under arrangements made by, a hospice program under a written plan
(for providing such care to such individual) established and
periodically reviewed by the individual's attending physician and
by the medical director (and by the interdisciplinary group
described in paragraph (2)(B)) of the program -
(A) nursing care provided by or under the supervision of a
registered professional nurse,
(B) physical or occupational therapy, or speech-language
pathology services,
(C) medical social services under the direction of a physician,
(D)(i) services of a home health aide who has successfully
completed a training program approved by the Secretary and (ii)
homemaker services,
(E) medical supplies (including drugs and biologicals) and the
use of medical appliances, while under such a plan,
(F) physicians' services,
(G) short-term inpatient care (including both respite care and
procedures necessary for pain control and acute and chronic
symptom management) in an inpatient facility meeting such
conditions as the Secretary determines to be appropriate to
provide such care, but such respite care may be provided only on
an intermittent, nonroutine, and occasional basis and may not be
provided consecutively over longer than five days,
(H) counseling (including dietary counseling) with respect to
care of the terminally ill individual and adjustment to his
death, and
(I) any other item or service which is specified in the plan
and for which payment may otherwise be made under this
subchapter.
The care and services described in subparagraphs (A) and (D) may be
provided on a 24-hour, continuous basis only during periods of
crisis (meeting criteria established by the Secretary) and only as
necessary to maintain the terminally ill individual at home.
(2) The term "hospice program" means a public agency or private
organization (or a subdivision thereof) which -
(A)(i) is primarily engaged in providing the care and services
described in paragraph (1) and makes such services available (as
needed) on a 24-hour basis and which also provides bereavement
counseling for the immediate family of terminally ill individuals
and services described in section 1395d(a)(5) of this title,
(ii) provides for such care and services in individuals' homes,
on an outpatient basis, and on a short-term inpatient basis,
directly or under arrangements made by the agency or
organization, except that -
(I) the agency or organization must routinely provide
directly substantially all of each of the services described in
subparagraphs (A), (C), and (H) of paragraph (1), except as
otherwise provided in paragraph (5), and
(II) in the case of other services described in paragraph (1)
which are not provided directly by the agency or organization,
the agency or organization must maintain professional
management responsibility for all such services furnished to an
individual, regardless of the location or facility in which
such services are furnished; and
(iii) provides assurances satisfactory to the Secretary that
the aggregate number of days of inpatient care described in
paragraph (1)(G) provided in any 12-month period to individuals
who have an election in effect under section 1395d(d) of this
title with respect to that agency or organization does not exceed
20 percent of the aggregate number of days during that period on
which such elections for such individuals are in effect;
(B) has an interdisciplinary group of personnel which -
(i) includes at least -
(I) one physician (as defined in subsection (r)(1) of this
section),
(II) one registered professional nurse, and
(III) one social worker,
employed by or, in the case of a physician described in
subclause (I), under contract with the agency or organization,
and also includes at least one pastoral or other counselor,
(ii) provides (or supervises the provision of) the care and
services described in paragraph (1), and
(iii) establishes the policies governing the provision of
such care and services;
(C) maintains central clinical records on all patients;
(D) does not discontinue the hospice care it provides with
respect to a patient because of the inability of the patient to
pay for such care;
(E)(i) utilizes volunteers in its provision of care and
services in accordance with standards set by the Secretary, which
standards shall ensure a continuing level of effort to utilize
such volunteers, and (ii) maintains records on the use of these
volunteers and the cost savings and expansion of care and
services achieved through the use of these volunteers;
(F) in the case of an agency or organization in any State in
which State or applicable local law provides for the licensing of
agencies or organizations of this nature, is licensed pursuant to
such law; and
(G) meets such other requirements as the Secretary may find
necessary in the interest of the health and safety of the
individuals who are provided care and services by such agency or
organization.
(3)(A) An individual is considered to be "terminally ill" if the
individual has a medical prognosis that the individual's life
expectancy is 6 months or less.
(B) The term "attending physician" means, with respect to an
individual, the physician (as defined in subsection (r)(1) of this
section) or nurse practitioner (as defined in subsection (aa)(5) of
this section), who may be employed by a hospice program, whom the
individual identifies as having the most significant role in the
determination and delivery of medical care to the individual at the
time the individual makes an election to receive hospice care.
(4)(A) An entity which is certified as a provider of services
other than a hospice program shall be considered, for purposes of
certification as a hospice program, to have met any requirements
under paragraph (2) which are also the same requirements for
certification as such other type of provider. The Secretary shall
coordinate surveys for determining certification under this
subchapter so as to provide, to the extent feasible, for
simultaneous surveys of an entity which seeks to be certified as a
hospice program and as a provider of services of another type.
(B) Any entity which is certified as a hospice program and as a
provider of another type shall have separate provider agreements
under section 1395cc of this title and shall file separate cost
reports with respect to costs incurred in providing hospice care
and in providing other services and items under this subchapter.
(5)(A) The Secretary may waive the requirements of paragraph
(2)(A)(ii)(I) for an agency or organization with respect to all or
part of the nursing care described in paragraph (1)(A) if such
agency or organization -
(i) is located in an area which is not an urbanized area (as
defined by the Bureau of the Census);
(ii) was in operation on or before January 1, 1983; and
(iii) has demonstrated a good faith effort (as determined by
the Secretary) to hire a sufficient number of nurses to provide
such nursing care directly.
(B) Any waiver, which is in such form and containing such
information as the Secretary may require and which is requested by
an agency or organization under subparagraph (A) or (C), shall be
deemed to be granted unless such request is denied by the Secretary
within 60 days after the date such request is received by the
Secretary. The granting of a waiver under subparagraph (A) or (C)
shall not preclude the granting of any subsequent waiver request
should such a waiver again become necessary.
(C) The Secretary may waive the requirements of paragraph
(2)(A)(i) and (2)(A)(ii) for an agency or organization with respect
to the services described in paragraph (1)(B) and, with respect to
dietary counseling, paragraph (1)(H), if such agency or
organization -
(i) is located in an area which is not an urbanized area (as
defined by the Bureau of Census), and
(ii) demonstrates to the satisfaction of the Secretary that the
agency or organization has been unable, despite diligent efforts,
to recruit appropriate personnel.
(D) In extraordinary, exigent, or other non-routine
circumstances, such as unanticipated periods of high patient loads,
staffing shortages due to illness or other events, or temporary
travel of a patient outside a hospice program's service area, a
hospice program may enter into arrangements with another hospice
program for the provision by that other program of services
described in paragraph (2)(A)(ii)(I). The provisions of paragraph
(2)(A)(ii)(II) shall apply with respect to the services provided
under such arrangements.
(E) A hospice program may provide services described in paragraph
(1)(A) other than directly by the program if the services are
highly specialized services of a registered professional nurse and
are provided non-routinely and so infrequently so that the
provision of such services directly would be impracticable and
prohibitively expensive.
(ee) Discharge planning process
(1) A discharge planning process of a hospital shall be
considered sufficient if it is applicable to services furnished by
the hospital to individuals entitled to benefits under this
subchapter and if it meets the guidelines and standards established
by the Secretary under paragraph (2).
(2) The Secretary shall develop guidelines and standards for the
discharge planning process in order to ensure a timely and smooth
transition to the most appropriate type of and setting for post-
hospital or rehabilitative care. The guidelines and standards
shall include the following:
(A) The hospital must identify, at an early stage of
hospitalization, those patients who are likely to suffer adverse
health consequences upon discharge in the absence of adequate
discharge planning.
(B) Hospitals must provide a discharge planning evaluation for
patients identified under subparagraph (A) and for other patients
upon the request of the patient, patient's representative, or
patient's physician.
(C) Any discharge planning evaluation must be made on a timely
basis to ensure that appropriate arrangements for post-hospital
care will be made before discharge and to avoid unnecessary
delays in discharge.
(D) A discharge planning evaluation must include an evaluation
of a patient's likely need for appropriate post-hospital
services, including hospice care and post-hospital extended care
services, and the availability of those services, including the
availability of home health services through individuals and
entities that participate in the program under this subchapter
and that serve the area in which the patient resides and that
request to be listed by the hospital as available and, in the
case of individuals who are likely to need post-hospital extended
care services, the availability of such services through
facilities that participate in the program under this subchapter
and that serve the area in which the patient resides.
(E) The discharge planning evaluation must be included in the
patient's medical record for use in establishing an appropriate
discharge plan and the results of the evaluation must be
discussed with the patient (or the patient's representative).
(F) Upon the request of a patient's physician, the hospital
must arrange for the development and initial implementation of a
discharge plan for the patient.
(G) Any discharge planning evaluation or discharge plan
required under this paragraph must be developed by, or under the
supervision of, a registered professional nurse, social worker,
or other appropriately qualified personnel.
(H) Consistent with section 1395a of this title, the discharge
plan shall -
(i) not specify or otherwise limit the qualified provider
which may provide post-hospital home health services, and
(ii) identify (in a form and manner specified by the
Secretary) any entity to whom the individual is referred in
which the hospital has a disclosable financial interest (as
specified by the Secretary consistent with section
1395cc(a)(1)(S) of this title) or which has such an interest in
the hospital.
(3) With respect to a discharge plan for an individual who is
enrolled with a Medicare+Choice organization under a
Medicare+Choice plan and is furnished inpatient hospital services
by a hospital under a contract with the organization -
(A) the discharge planning evaluation under paragraph (2)(D) is
not required to include information on the availability of home
health services through individuals and entities which do not
have a contract with the organization; and
(B) notwithstanding subparagraph (H)(i) (!8), the plan may
specify or limit the provider (or providers) of post-hospital
home health services or other post-hospital services under the
plan.
(ff) Partial hospitalization services
(1) The term "partial hospitalization services" means the items
and services described in paragraph (2) prescribed by a physician
and provided under a program described in paragraph (3) under the
supervision of a physician pursuant to an individualized, written
plan of treatment established and periodically reviewed by a
physician (in consultation with appropriate staff participating in
such program), which plan sets forth the physician's diagnosis, the
type, amount, frequency, and duration of the items and services
provided under the plan, and the goals for treatment under the
plan.
(2) The items and services described in this paragraph are -
(A) individual and group therapy with physicians or
psychologists (or other mental health professionals to the extent
authorized under State law),
(B) occupational therapy requiring the skills of a qualified
occupational therapist,
(C) services of social workers, trained psychiatric nurses, and
other staff trained to work with psychiatric patients,
(D) drugs and biologicals furnished for therapeutic purposes
(which cannot, as determined in accordance with regulations, be
self-administered),
(E) individualized activity therapies that are not primarily
recreational or diversionary,
(F) family counseling (the primary purpose of which is
treatment of the individual's condition),
(G) patient training and education (to the extent that training
and educational activities are closely and clearly related to
individual's care and treatment),
(H) diagnostic services, and
(I) such other items and services as the Secretary may provide
(but in no event to include meals and transportation);
that are reasonable and necessary for the diagnosis or active
treatment of the individual's condition, reasonably expected to
improve or maintain the individual's condition and functional level
and to prevent relapse or hospitalization, and furnished pursuant
to such guidelines relating to frequency and duration of services
as the Secretary shall by regulation establish (taking into account
accepted norms of medical practice and the reasonable expectation
of patient improvement).
(3)(A) A program described in this paragraph is a program which
is furnished by a hospital to its outpatients or by a community
mental health center (as defined in subparagraph (B)), and which is
a distinct and organized intensive ambulatory treatment service
offering less than 24-hour-daily care.
(B) For purposes of subparagraph (A), the term "community mental
health center" means an entity that -
(i)(I) provides the mental health services described in section
1913(c)(1) of the Public Health Service Act [42 U.S.C. 300x-
2(c)(1)]; or
(II) in the case of an entity operating in a State that by law
precludes the entity from providing itself the service described
in subparagraph (E) of such section, provides for such service by
contract with an approved organization or entity (as determined
by the Secretary);
(ii) meets applicable licensing or certification requirements
for community mental health centers in the State in which it is
located; and
(iii) meets such additional conditions as the Secretary shall
specify to ensure (I) the health and safety of individuals being
furnished such services, (II) the effective and efficient
furnishing of such services, and (III) the compliance of such
entity with the criteria described in section 1931(c)(1) of the
Public Health Service Act [42 U.S.C. 300x-31(c)(1)].
(gg) Certified nurse-midwife services
(1) The term "certified nurse-midwife services" means such
services furnished by a certified nurse-midwife (as defined in
paragraph (2)) and such services and supplies furnished as an
incident to the nurse-midwife's service which the certified nurse-
midwife is legally authorized to perform under State law (or the
State regulatory mechanism provided by State law) as would
otherwise be covered if furnished by a physician or as an incident
to a physicians' service.
(2) The term "certified nurse-midwife" means a registered nurse
who has successfully completed a program of study and clinical
experience meeting guidelines prescribed by the Secretary, or has
been certified by an organization recognized by the Secretary.
(hh) Clinical social worker; clinical social worker services
(1) The term "clinical social worker" means an individual who -
(A) possesses a master's or doctor's degree in social work;
(B) after obtaining such degree has performed at least 2 years
of supervised clinical social work; and
(C)(i) is licensed or certified as a clinical social worker by
the State in which the services are performed, or
(ii) in the case of an individual in a State which does not
provide for licensure or certification -
(I) has completed at least 2 years or 3,000 hours of post-
master's degree supervised clinical social work practice under
the supervision of a master's level social worker in an
appropriate setting (as determined by the Secretary), and
(II) meets such other criteria as the Secretary establishes.
(2) The term "clinical social worker services" means services
performed by a clinical social worker (as defined in paragraph (1))
for the diagnosis and treatment of mental illnesses (other than
services furnished to an inpatient of a hospital and other than
services furnished to an inpatient of a skilled nursing facility
which the facility is required to provide as a requirement for
participation) which the clinical social worker is legally
authorized to perform under State law (or the State regulatory
mechanism provided by State law) of the State in which such
services are performed as would otherwise be covered if furnished
by a physician or as an incident to a physician's professional
service.
(ii) Qualified psychologist services
The term "qualified psychologist services" means such services
and such services and supplies furnished as an incident to his
service furnished by a clinical psychologist (as defined by the
Secretary) which the psychologist is legally authorized to perform
under State law (or the State regulatory mechanism provided by
State law) as would otherwise be covered if furnished by a
physician or as an incident to a physician's service.
(jj) Screening mammography
The term "screening mammography" means a radiologic procedure
provided to a woman for the purpose of early detection of breast
cancer and includes a physician's interpretation of the results of
the procedure.
(kk) Covered osteoporosis drug
The term "covered osteoporosis drug" means an injectable drug
approved for the treatment of post-menopausal osteoporosis provided
to an individual by a home health agency if, in accordance with
regulations promulgated by the Secretary -
(1) the individual's attending physician certifies that the
individual has suffered a bone fracture related to post-
menopausal osteoporosis and that the individual is unable to
learn the skills needed to self-administer such drug or is
otherwise physically or mentally incapable of self-administering
such drug; and
(2) the individual is confined to the individual's home (except
when receiving items and services referred to in subsection
(m)(7) of this section).
(ll) Speech-language pathology services; audiology services
(1) The term "speech-language pathology services" means such
speech, language, and related function assessment and
rehabilitation services furnished by a qualified speech-language
pathologist as the speech-language pathologist is legally
authorized to perform under State law (or the State regulatory
mechanism provided by State law) as would otherwise be covered if
furnished by a physician.
(2) The term "audiology services" means such hearing and balance
assessment services furnished by a qualified audiologist as the
audiologist is legally authorized to perform under State law (or
the State regulatory mechanism provided by State law), as would
otherwise be covered if furnished by a physician.
(3) In this subsection:
(A) The term "qualified speech-language pathologist" means an
individual with a master's or doctoral degree in speech-language
pathology who -
(i) is licensed as a speech-language pathologist by the State
in which the individual furnishes such services, or
(ii) in the case of an individual who furnishes services in a
State which does not license speech-language pathologists, has
successfully completed 350 clock hours of supervised clinical
practicum (or is in the process of accumulating such supervised
clinical experience), performed not less than 9 months of
supervised full-time speech-language pathology services after
obtaining a master's or doctoral degree in speech-language
pathology or a related field, and successfully completed a
national examination in speech-language pathology approved by
the Secretary.
(B) The term "qualified audiologist" means an individual with a
master's or doctoral degree in audiology who -
(i) is licensed as an audiologist by the State in which the
individual furnishes such services, or
(ii) in the case of an individual who furnishes services in a
State which does not license audiologists, has successfully
completed 350 clock hours of supervised clinical practicum (or
is in the process of accumulating such supervised clinical
experience), performed not less than 9 months of supervised
full-time audiology services after obtaining a master's or
doctoral degree in audiology or a related field, and
successfully completed a national examination in audiology
approved by the Secretary.
(mm) Critical access hospital; critical access hospital services
(1) The term "critical access hospital" means a facility
certified by the Secretary as a critical access hospital under
section 1395i-4(e) of this title.
(2) The term "inpatient critical access hospital services" means
items and services, furnished to an inpatient of a critical access
hospital by such facility, that would be inpatient hospital
services if furnished to an inpatient of a hospital by a hospital.
(3) The term "outpatient critical access hospital services" means
medical and other health services furnished by a critical access
hospital on an outpatient basis.
(nn) Screening pap smear; screening pelvic exam
(1) The term "screening pap smear" means a diagnostic laboratory
test consisting of a routine exfoliative cytology test
(Papanicolaou test) provided to a woman for the purpose of early
detection of cervical or vaginal cancer and includes a physician's
interpretation of the results of the test, if the individual
involved has not had such a test during the preceding 2 years, or
during the preceding year in the case of a woman described in
paragraph (3).
(2) The term "screening pelvic exam" means a pelvic examination
provided to a woman if the woman involved has not had such an
examination during the preceding 2 years, or during the preceding
year in the case of a woman described in paragraph (3), and
includes a clinical breast examination.
(3) A woman described in this paragraph is a woman who -
(A) is of childbearing age and has had a test described in this
subsection during any of the preceding 3 years that indicated the
presence of cervical or vaginal cancer or other abnormality; or
(B) is at high risk of developing cervical or vaginal cancer
(as determined pursuant to factors identified by the Secretary).
(oo) Prostate cancer screening tests
(1) The term "prostate cancer screening test" means a test that
consists of any (or all) of the procedures described in paragraph
(2) provided for the purpose of early detection of prostate cancer
to a man over 50 years of age who has not had such a test during
the preceding year.
(2) The procedures described in this paragraph are as follows:
(A) A digital rectal examination.
(B) A prostate-specific antigen blood test.
(C) For years beginning after 2002, such other procedures as
the Secretary finds appropriate for the purpose of early
detection of prostate cancer, taking into account changes in
technology and standards of medical practice, availability,
effectiveness, costs, and such other factors as the Secretary
considers appropriate.
(pp) Colorectal cancer screening tests
(1) The term "colorectal cancer screening test" means any of the
following procedures furnished to an individual for the purpose of
early detection of colorectal cancer:
(A) Screening fecal-occult blood test.
(B) Screening flexible sigmoidoscopy.
(C) Screening colonoscopy.
(D) Such other tests or procedures, and modifications to tests
and procedures under this subsection, with such frequency and
payment limits, as the Secretary determines appropriate, in
consultation with appropriate organizations.
(2) An "individual at high risk for colorectal cancer" is an
individual who, because of family history, prior experience of
cancer or precursor neoplastic polyps, a history of chronic
digestive disease condition (including inflammatory bowel disease,
Crohn's Disease, or ulcerative colitis), the presence of any
appropriate recognized gene markers for colorectal cancer, or other
predisposing factors, faces a high risk for colorectal cancer.
(qq) Diabetes outpatient self-management training services
(1) The term "diabetes outpatient self-management training
services" means educational and training services furnished (at
such times as the Secretary determines appropriate) to an
individual with diabetes by a certified provider (as described in
paragraph (2)(A)) in an outpatient setting by an individual or
entity who meets the quality standards described in paragraph
(2)(B), but only if the physician who is managing the individual's
diabetic condition certifies that such services are needed under a
comprehensive plan of care related to the individual's diabetic
condition to ensure therapy compliance or to provide the individual
with necessary skills and knowledge (including skills related to
the self-administration of injectable drugs) to participate in the
management of the individual's condition.
(2) In paragraph (1) -
(A) a "certified provider" is a physician, or other individual
or entity designated by the Secretary, that, in addition to
providing diabetes outpatient self-management training services,
provides other items or services for which payment may be made
under this subchapter; and
(B) a physician, or such other individual or entity, meets the
quality standards described in this paragraph if the physician,
or individual or entity, meets quality standards established by
the Secretary, except that the physician or other individual or
entity shall be deemed to have met such standards if the
physician or other individual or entity meets applicable
standards originally established by the National Diabetes
Advisory Board and subsequently revised by organizations who
participated in the establishment of standards by such Board, or
is recognized by an organization that represents individuals
(including individuals under this subchapter) with diabetes as
meeting standards for furnishing the services.
(rr) Bone mass measurement
(1) The term "bone mass measurement" means a radiologic or
radioisotopic procedure or other procedure approved by the Food and
Drug Administration performed on a qualified individual (as defined
in paragraph (2)) for the purpose of identifying bone mass or
detecting bone loss or determining bone quality, and includes a
physician's interpretation of the results of the procedure.
(2) For purposes of this subsection, the term "qualified
individual" means an individual who is (in accordance with
regulations prescribed by the Secretary) -
(A) an estrogen-deficient woman at clinical risk for
osteoporosis;
(B) an individual with vertebral abnormalities;
(C) an individual receiving long-term glucocorticoid steroid
therapy;
(D) an individual with primary hyperparathyroidism; or
(E) an individual being monitored to assess the response to or
efficacy of an approved osteoporosis drug therapy.
(3) The Secretary shall establish such standards regarding the
frequency with which a qualified individual shall be eligible to be
provided benefits for bone mass measurement under this subchapter.
(ss) Religious nonmedical health care institution
(1) The term "religious nonmedical health care institution" means
an institution that -
(A) is described in subsection (c)(3) of section 501 of the
Internal Revenue Code of 1986 and is exempt from taxes under
subsection (a) of such section;
(B) is lawfully operated under all applicable Federal, State,
and local laws and regulations;
(C) provides only nonmedical nursing items and services
exclusively to patients who choose to rely solely upon a
religious method of healing and for whom the acceptance of
medical health services would be inconsistent with their
religious beliefs;
(D) provides such nonmedical items and services exclusively
through nonmedical nursing personnel who are experienced in
caring for the physical needs of such patients;
(E) provides such nonmedical items and services to inpatients
on a 24-hour basis;
(F) on the basis of its religious beliefs, does not provide
through its personnel or otherwise medical items and services
(including any medical screening, examination, diagnosis,
prognosis, treatment, or the administration of drugs) for its
patients;
(G)(i) is not owned by, under common ownership with, or has an
ownership interest in, a provider of medical treatment or
services;
(ii) is not affiliated with -
(I) a provider of medical treatment or services, or
(II) an individual who has an ownership interest in a
provider of medical treatment or services;
(H) has in effect a utilization review plan which -
(i) provides for the review of admissions to the institution,
of the duration of stays therein, of cases of continuous
extended duration, and of the items and services furnished by
the institution,
(ii) requires that such reviews be made by an appropriate
committee of the institution that includes the individuals
responsible for overall administration and for supervision of
nursing personnel at the institution,
(iii) provides that records be maintained of the meetings,
decisions, and actions of such committee, and
(iv) meets such other requirements as the Secretary finds
necessary to establish an effective utilization review plan;
(I) provides the Secretary with such information as the
Secretary may require to implement section 1395i-5 of this title,
including information relating to quality of care and coverage
determinations; and
(J) meets such other requirements as the Secretary finds
necessary in the interest of the health and safety of individuals
who are furnished services in the institution.
(2) To the extent that the Secretary finds that the accreditation
of an institution by a State, regional, or national agency or
association provides reasonable assurances that any or all of the
requirements of paragraph (1) are met or exceeded, the Secretary
may treat such institution as meeting the condition or conditions
with respect to which the Secretary made such finding.
(3)(A)(i) In administering this subsection and section 1395i-5 of
this title, the Secretary shall not require any patient of a
religious nonmedical health care institution to undergo medical
screening, examination, diagnosis, prognosis, or treatment or to
accept any other medical health care service, if such patient (or
legal representative of the patient) objects thereto on religious
grounds.
(ii) Clause (i) shall not be construed as preventing the
Secretary from requiring under section 1395i-5(a)(2) of this title
the provision of sufficient information regarding an individual's
condition as a condition for receipt of benefits under part A of
this subchapter for services provided in such an institution.
(B)(i) In administering this subsection and section 1395i-5 of
this title, the Secretary shall not subject a religious nonmedical
health care institution or its personnel to any medical
supervision, regulation, or control, insofar as such supervision,
regulation, or control would be contrary to the religious beliefs
observed by the institution or such personnel.
(ii) Clause (i) shall not be construed as preventing the
Secretary from reviewing items and services billed by the
institution to the extent the Secretary determines such review to
be necessary to determine whether such items and services were not
covered under part A of this subchapter, are excessive, or are
fraudulent.
(4)(A) For purposes of paragraph (1)(G)(i), an ownership interest
of less than 5 percent shall not be taken into account.
(B) For purposes of paragraph (1)(G)(ii), none of the following
shall be considered to create an affiliation:
(i) An individual serving as an uncompensated director,
trustee, officer, or other member of the governing body of a
religious nonmedical health care institution.
(ii) An individual who is a director, trustee, officer,
employee, or staff member of a religious nonmedical health care
institution having a family relationship with an individual who
is affiliated with (or has an ownership interest in) a provider
of medical treatment or services.
(iii) An individual or entity furnishing goods or services as a
vendor to both providers of medical treatment or services and
religious nonmedical health care institutions.
(tt) Post-institutional home health services; home health spell of
illness
(1) The term "post-institutional home health services" means home
health services furnished to an individual -
(A) after discharge from a hospital or critical access hospital
in which the individual was an inpatient for not less than 3
consecutive days before such discharge if such home health
services were initiated within 14 days after the date of such
discharge; or
(B) after discharge from a skilled nursing facility in which
the individual was provided post-hospital extended care services
if such home health services were initiated within 14 days after
the date of such discharge.
(2) The term "home health spell of illness" with respect to any
individual means a period of consecutive days -
(A) beginning with the first day (not included in a previous
home health spell of illness) (i) on which such individual is
furnished post-institutional home health services, and (ii) which
occurs in a month for which the individual is entitled to
benefits under part A of this subchapter, and
(B) ending with the close of the first period of 60 consecutive
days thereafter on each of which the individual is neither an
inpatient of a hospital or critical access hospital nor an
inpatient of a facility described in section 1395i-3(a)(1) of
this title or subsection (y)(1) of this section nor provided home
health services.
(uu)Screening for glaucoma
The term "screening for glaucoma" means a dilated eye examination
with an intraocular pressure measurement, and a direct
ophthalmoscopy or a slit-lamp biomicroscopic examination for the
early detection of glaucoma which is furnished by or under the
direct supervision of an optometrist or ophthalmologist who is
legally authorized to furnish such services under State law (or the
State regulatory mechanism provided by State law) of the State in
which the services are furnished, as would otherwise be covered if
furnished by a physician or as an incident to a physician's
professional service, if the individual involved has not had such
an examination in the preceding year.
(vv)Medical nutrition therapy services; registered dietitian or
nutrition professional
(1) The term "medical nutrition therapy services" means
nutritional diagnostic, therapy, and counseling services for the
purpose of disease management which are furnished by a registered
dietitian or nutrition professional (as defined in paragraph (2))
pursuant to a referral by a physician (as defined in subsection
(r)(1) of this section).
(2) Subject to paragraph (3), the term "registered dietitian or
nutrition professional" means an individual who -
(A) holds a baccalaureate or higher degree granted by a
regionally accredited college or university in the United States
(or an equivalent foreign degree) with completion of the academic
requirements of a program in nutrition or dietetics, as
accredited by an appropriate national accreditation organization
recognized by the Secretary for this purpose;
(B) has completed at least 900 hours of supervised dietetics
practice under the supervision of a registered dietitian or
nutrition professional; and
(C)(i) is licensed or certified as a dietitian or nutrition
professional by the State in which the services are performed; or
(ii) in the case of an individual in a State that does not
provide for such licensure or certification, meets such other
criteria as the Secretary establishes.
(3) Subparagraphs (A) and (B) of paragraph (2) shall not apply in
the case of an individual who, as of December 21, 2000, is licensed
or certified as a dietitian or nutrition professional by the State
in which medical nutrition therapy services are performed.
(ww) Initial preventive physical examination
(1) The term "initial preventive physical examination" means
physicians' services consisting of a physical examination
(including measurement of height, weight, and blood pressure, and
an electrocardiogram) with the goal of health promotion and disease
detection and includes education, counseling, and referral with
respect to screening and other preventive services described in
paragraph (2), but does not include clinical laboratory tests.
(2) The screening and other preventive services described in this
paragraph include the following:
(A) Pneumococcal, influenza, and hepatitis B vaccine and
administration under subsection (s)(10) of this section.
(B) Screening mammography as defined in subsection (jj) of this
section.
(C) Screening pap smear and screening pelvic exam as defined in
subsection (nn) of this section.
(D) Prostate cancer screening tests as defined in subsection
(oo) of this section.
(E) Colorectal cancer screening tests as defined in subsection
(pp) of this section.
(F) Diabetes outpatient self-management training services as
defined in subsection (qq)(1) of this section.
(G) Bone mass measurement as defined in subsection (rr) of this
section.
(H) Screening for glaucoma as defined in subsection (uu) of
this section.
(I) Medical nutrition therapy services as defined in subsection
(vv) of this section.
(J) Cardiovascular screening blood tests as defined in
subsection (xx)(1) of this section.
(K) Diabetes screening tests as defined in subsection (yy) of
this section.
(xx) Cardiovascular screening blood test
(1) The term "cardiovascular screening blood test" means a blood
test for the early detection of cardiovascular disease (or
abnormalities associated with an elevated risk of cardiovascular
disease) that tests for the following:
(A) Cholesterol levels and other lipid or triglyceride levels.
(B) Such other indications associated with the presence of, or
an elevated risk for, cardiovascular disease as the Secretary may
approve for all individuals (or for some individuals determined
by the Secretary to be at risk for cardiovascular disease),
including indications measured by noninvasive testing.
The Secretary may not approve an indication under subparagraph (B)
for any individual unless a blood test for such is recommended by
the United States Preventive Services Task Force.
(2) The Secretary shall establish standards, in consultation with
appropriate organizations, regarding the frequency for each type of
cardiovascular screening blood tests, except that such frequency
may not be more often than once every 2 years.
(yy) Diabetes screening tests
(1) The term "diabetes screening tests" means testing furnished
to an individual at risk for diabetes (as defined in paragraph (2))
for the purpose of early detection of diabetes, including -
(A) a fasting plasma glucose test; and
(B) such other tests, and modifications to tests, as the
Secretary determines appropriate, in consultation with
appropriate organizations.
(2) For purposes of paragraph (1), the term "individual at risk
for diabetes" means an individual who has any of the following risk
factors for diabetes:
(A) Hypertension.
(B) Dyslipidemia.
(C) Obesity, defined as a body mass index greater than or equal
to 30 kg/m2.
(D) Previous identification of an elevated impaired fasting
glucose.
(E) Previous identification of impaired glucose tolerance.
(F) A risk factor consisting of at least 2 of the following
characteristics:
(i) Overweight, defined as a body mass index greater than 25,
but less than 30, kg/m2.
(ii) A family history of diabetes.
(iii) A history of gestational diabetes mellitus or delivery
of a baby weighing greater than 9 pounds.
(iv) 65 years of age or older.
(3) The Secretary shall establish standards, in consultation with
appropriate organizations, regarding the frequency of diabetes
screening tests, except that such frequency may not be more often
than twice within the 12-month period following the date of the
most recent diabetes screening test of that individual.
(zz) Intravenous immune globulin
The term "intravenous immune globulin" means an approved pooled
plasma derivative for the treatment in the patient's home of a
patient with a diagnosed primary immune deficiency disease, but not
including items or services related to the administration of the
derivative, if a physician determines administration of the
derivative in the patient's home is medically appropriate.
(aaa) Extended care in religious nonmedical health care
institutions
(1) The term "home health agency" also includes a religious
nonmedical health care institution (as defined in subsection
(ss)(1) of this section), but only with respect to items and
services ordinarily furnished by such an institution to individuals
in their homes, and that are comparable to items and services
furnished to individuals by a home health agency that is not
religious nonmedical health care institution.
(2)(A) Subject to subparagraphs (B), payment may be made with
respect to services provided by such an institution only to such
extent and under such conditions, limitations, and requirements (in
addition to or in lieu of the conditions, limitations, and
requirements otherwise applicable) as may be provided in
regulations consistent with section 1395i-5 of this title.
(B) Notwithstanding any other provision of this subchapter,
payment may not be made under subparagraph (A) -
(i) in a year insofar as such payments exceed $700,000; and
(ii) after December 31, 2006.