SEC. 1891.
[42 U.S.C. 1395bbb] (a)
The conditions of participation that a home
health agency is required to meet under this subsection are as
follows:
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(1) The agency protects and promotes the rights of each individual
under its care, including each of the following rights:
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(A) The right to be fully informed in advance about the care
and treatment to be provided by the agency, to be fully informed
in advance of any changes in the care or treatment to be provided
by the agency that may affect the individual's well-being, and
(except with respect to an individual adjudged incompetent) to
participate in planning care and treatment or changes in care or
treatment.
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(B) The right to voice grievances with respect to treatment
or care that is (or fails to be) furnished without discrimination
or reprisal for voicing grievances.
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(C) The right to confidentiality of the clinical records described
in section 1861(o)(3).
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(D) The right to have one's property treated with respect.
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(E) The right to be fully informed orally and in writing (in
advance of coming under the care of the agency) of—
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(i) all items and services furnished by (or under arrangements
with) the agency for which payment may be made under this title,
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(ii) the coverage available for such items and services under
this title, title XIX, and any other Federal program of which
the agency is reasonably aware,
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(iii) any charges for items and services not covered under this
title and any charges the individual may have to pay with respect to
items and services furnished by (or under arrangements with) the
agency, and
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(iv) any changes in the charges or items and services described
in clause (i), (ii), or (iii).
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(F) The right to be fully informed in writing (in advance of
coming under the care of the agency) of the individual's rights
and obligations under this title.
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(G) The right to be informed of the availability of the State
home health agency hot-line established under section 1864(a).
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(2) The agency notifies the State entity responsible for the
licensing or certification of the agency of a change in—
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(A) the persons with an ownership or control interest (as defined
in section 1124(a)(3)) in the agency,
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(B) the persons who are officers, directors, agents, or managing
employees (as defined in section 1126(b)) of the agency, and
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(C) the corporation, association, or other company responsible
for the management of the agency.
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Such notice shall be given at the time of the change and shall
include the identity of each new person or company described in
the previous sentence.
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(3)(A) The agency must not use as a home health aide (on a
full-time, temporary, per diem, or other basis), any individual
to provide items or services described in section 1861(m) on or
after January 1, 1990, unless the individual—
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(i) has completed a training and competency evaluation program,
or a competency evaluation program, that meets the minimum standards established
by the Secretary under subparagraph (D), and
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(ii) is competent to provide such items and services.
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For purposes of clause (i), an individual is not considered
to have completed a training and competency evaluation program,
or a competency evaluation program if, since the individual's most
recent completion of such a program, there has been a continuous
period of 24 consecutive months during none of which the individual
provided items and services described in section 1861(m) for compensation.
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(B)(i) The agency must provide, with respect to individuals
used as a home health aide by the agency as of July 1, 1989, for
a competency evaluation program (as described in subparagraph
(A)(i)) and such preparation as may be necessary for the individual
to complete such a program by January 1, 1990.
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(ii) The agency must provide such regular performance review
and regular in-service education as assures that individuals used
to provide items and services described in section 1861(m) are
competent to provide those items and services.
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(C) The agency must not permit an individual, other than in
a training and competency evaluation program that meets the minimum
standards established by the Secretary under subparagraph (D),
to provide items or services of a type for which the individual
has not demonstrated competency.
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(D)(i) The Secretary shall establish minimum standards for the
programs described in subparagraph (A) by not later than October
1, 1988.
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(ii) Such standards shall include the content of the curriculum,
minimum hours of training, qualification of instructors, and procedures
for determination of competency.
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(iii) Such standards may permit approval of programs offered
by or in home health agencies, as well as outside agencies (including
employee organizations), and of programs in effect on the date
of the enactment of this section;[738] except that they may not
provide for the approval of a program offered by or in a home health
agency which, within the previous 2 years—
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(I) has been determined to be out of compliance with subparagraph (A),
(B), or (C);
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(II) has been subject to an extended (or partial extended)
survey under subsection (c)(2)(D);
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(III) has been assessed a civil money penalty described in
subsection (f)(2)(A)(i) of not less than $5,000; or
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(IV) has been subject to the remedies described in subsection
(e)(1) or in clauses (ii) or (iii) of subsection (f)(2)(A).
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(iv) Such standards shall permit a determination that an individual
who has completed (before July 1, 1989) a training and competency
evaluation program or a competency evaluation program shall be
deemed for purposes of subparagraph (A) to have completed a program
that is approved by the Secretary under the standards established
under this subparagraph if the Secretary determines that, at the
time the program was offered, the program met such standards.
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(E) In this paragraph, the term “home health aide”
means any individual who provides the items and services described
in section 1861(m), but does not include an individual—
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(i) who is a licensed health professional (as defined in subparagraph (F)),
or
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(ii) who volunteers to provide such services without monetary
compensation.
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(F) In this paragraph, the term “licensed health professional” means
a physician, physician assistant, nurse practitioner, physical,
speech, or occupational therapist, physical or occupational therapy
assistant, registered professional nurse, licensed practical nurse,
or licensed or certified social worker.
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(4) The agency includes an individual's plan of care required
under section 1861(m) as part of the clinical records described
in section 1861(o)(3).
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(5) The agency operates and provides services in compliance
with all applicable Federal, State, and local laws and regulations
(including the requirements of section 1124) and with accepted
professional standards and principles which apply to professionals
providing items and services in such an agency.
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(6) The agency complies with the requirement of section 1866(f)
(relating to maintaining written policies and procedures respecting
advance directives).
(b)
It is the duty and responsibility of the
Secretary to assure that the conditions of participation and requirements
specified in or pursuant to section 1861(o) and subsection (a)
of this section and the enforcement of such conditions and requirements
are adequate to protect the health and safety of individuals under
the care of a home health agency and to promote the effective and efficient
use of public moneys.
(c)(1)
Any agreement entered into or renewed
by the Secretary pursuant to section 1864 relating to home health
agencies shall provide that the appropriate State or local agency
shall conduct, without any prior notice, a standard survey of each
home health agency. Any individual who notifies (or causes to be
notified) a home health agency of the time or date on which such
a survey is scheduled to be conducted is subject to a civil money
penalty of not to exceed $2,000. The provisions of section 1128A
(other than subsections (a) and (b)) shall apply to a civil money
penalty under this paragraph in the same manner as such provisions
apply to a penalty or proceeding under section 1128A. The Secretary
shall review each State's or local agency's procedures for scheduling and
conduct of standard surveys to assure that the State or agency
has taken all reasonable steps to avoid giving notice of such a
survey through the scheduling procedures and the conduct of the
surveys themselves.
(2)(A) Except as provided in subparagraph (B), each home health
agency shall be subject to a standard survey not later than 36
months after the date of the previous standard survey conducted
under this paragraph. The Secretary shall establish a frequency
for surveys of home health agencies within this 36-month
interval commensurate with the need to assure the delivery of
quality home health services.
(B) If not otherwise conducted under subparagraph (A), a standard
survey (or an abbreviated standard survey) of an agency—
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(i) may be conducted within 2 months of any change of ownership,
administration, or management of the agency to determine whether
the change has resulted in any decline in the quality of care
furnished by the agency, and
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(ii) shall be conducted within 2 months of when a significant
number of complaints have been reported with respect to the agency
to the Secretary, the State, the entity responsible for the licensing
of the agency, the State or local agency responsible for maintaining
a toll-free hotline and investigative unit (under section 1864(a)),
or any other appropriate Federal, State, or local agency.
(C) A standard survey conducted under this paragraph with respect
to a home health agency—
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(i) shall include (to the extent practicable), for a case-mix
stratified sample of individuals furnished items or services by
the agency—
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(I) visits to the homes of such individuals, but only with the
consent of such individuals, for the purpose of evaluating (in
accordance with a standardized reproducible assessment instrument
(or instruments) approved by the Secretary under subsection (d))
the extent to which the quality and scope of items and services
furnished by the agency attained and maintained the highest practicable
functional capacity of each such individual as reflected in such
individual's written plan of care required under section 1861(m)
and clinical records required under section 1861(o)(3); and
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(II) a survey of the quality of care and services furnished
by the agency as measured by indicators of medical, nursing, and
rehabilitative care;
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(ii) shall be based upon a protocol that is developed, tested,
and validated by the Secretary not later than January 1, 1989;
and
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(iii) shall be conducted by an individual—
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(I) who meets minimum qualifications established by the Secretary not
later than July 1, 1989,
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(II) who is not serving (or has not served within the previous
2 years) as a member of the staff of, or as a consultant to, the
home health agency surveyed respecting compliance with the conditions
of participation specified in or pursuant to section 1861(o) or
subsection (a) of this section, and
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(III) who has no personal or familial financial interest in
the home health agency surveyed.
(D) Each home health agency that is found, under a standard
survey, to have provided substandard care shall be subject to an
extended survey to review and identify the policies and procedures
which produced such substandard care and to determine whether the
agency has complied with the conditions of participation specified
in or pursuant to section 1861(o) or subsection (a) of this section.
Any other agency may, at the Secretary's or State's discretion,
be subject to such an extended survey (or a partial extended survey).
The extended survey shall be conducted immediately after the standard
survey (or, if not practical, not later than 2 weeks after the
date of completion of the standard survey).
(E) Nothing in this paragraph shall be construed as requiring
an extended (or partial extended) survey as a prerequisite to
imposing a sanction against an agency under subsection (e) on the
basis of the findings of a standard survey.
(d)(1)
Not later than January 1, 1989, the Secretary
shall designate an assessment instrument (or instruments) for use
by an agency in complying with subsection (c)(2)(C)(i)(I).[739]
(2)(A) Not later than January 1, 1992, the Secretary shall—
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(i) evaluate the assessment process,
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(ii) report to Congress on the results of such evaluation, and
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(iii) based on such evaluation, make such modifications in the
assessment process as the Secretary determines are appropriate.
(B) The Secretary shall periodically update the evaluation conducted
under subparagraph (A), report the results of such update to Congress,
and, based on such update, make such modifications in the assessment
process as the Secretary determines are appropriate.
(3) The Secretary shall provide for the comprehensive training
of State and Federal surveyors in matters relating to the performance
of standard and extended surveys under this section, including
the use of any assessment instrument (or instruments) designated
under paragraph (1).
(e)(1)
If the Secretary determines on the basis
of a standard, extended, or partial extended survey or otherwise,
that a home health agency that is certified for participation under
this title is no longer in compliance with the requirements specified
in or pursuant to section 1861(o) or subsection (a) and determines
that the deficiencies involved immediately jeopardize the health
and safety of the individuals to whom the agency furnishes items
and services, the Secretary shall take immediate action to remove
the jeopardy and correct the deficiencies through the remedy specified
in subsection (f)(2)(A)(iii) or terminate the certification of
the agency, and may provide, in addition, for 1 or more of the
other remedies described in subsection (f)(2)(A).
(2) If the Secretary determines on the basis of a standard,
extended, or partial extended survey or otherwise, that a home
health agency that is certified for participation under this title
is no longer in compliance with the requirements specified in or
pursuant to section 1861(o) or subsection (a) and determines that
the deficiencies involved do not immediately jeopardize the health and
safety of the individuals to whom the agency furnishes items and
services, the Secretary may (for a period not to exceed 6 months)
impose intermediate sanctions developed pursuant to subsection
(f), in lieu of terminating the certification of the agency. If,
after such a period of intermediate sanctions, the agency is still
no longer in compliance with the requirements specified in or pursuant
to section 1861(o) or subsection (a), the Secretary shall terminate
the certification of the agency.
(3) If the Secretary determines that a home health agency that
is certified for participation under this title is in compliance
with the requirements specified in or pursuant to section 1861(o)
or subsection (a) but, as of a previous period, did not meet such
requirements, the Secretary may provide for a civil money penalty
under subsection (f)(2)(A)(i) for the days in which it finds that
the agency was not in compliance with such requirements.
(4) The Secretary may continue payments under this title with
respect to a home health agency not in compliance with the requirements
specified in or pursuant to section 1861(o) or subsection (a) over
a period of not longer than 6 months, if—
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(A) the State or local survey agency finds that it is more
appropriate to take alternative action to assure compliance of
the agency with the requirements than to terminate the certification
of the agency,
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(B) the agency has submitted a plan and timetable for corrective
action to the Secretary for approval and the Secretary approves
the plan of corrective action, and
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(C) the agency agrees to repay to the Federal Government payments received
under this subparagraph if the corrective action is not taken in accordance
with the approved plan and timetable.
The Secretary shall establish guidelines for approval of corrective
actions requested by home health agencies under this subparagraph.
(f)(1)
The Secretary shall develop and implement,
by not later than April 1, 1989—
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(A) a range of intermediate sanctions to apply to home health
agencies under the conditions described in subsection (e), and
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(B) appropriate procedures for appealing determinations relating
to the imposition of such sanctions.
(2)(A) The intermediate sanctions developed under paragraph (1)
shall include—
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(i) civil money penalties in an amount not to exceed $10,000
for each day of noncompliance,
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(ii) suspension of all or part of the payments to which a home
health agency would otherwise be entitled under this title with
respect to items and services furnished by a home health agency
on or after the date on which the Secretary determines that intermediate
sanctions should be imposed pursuant to subsection (e)(2), and
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(iii) the appointment of temporary management to oversee the
operation of the home health agency and to protect and assure
the health and safety of the individuals under the care of the
agency while improvements are made in order to bring the agency
into compliance with all the requirements specified in or pursuant
to section 1861(o) or subsection (a).
The provisions of section 1128A (other than subsections (a)
and (b)) shall apply to a civil money penalty under clause (i)
in the same manner as such provisions apply to a penalty or proceeding
under section 1128A(a). The temporary management under clause (iii)
shall not be terminated until the Secretary has determined that
the agency has the management capability to ensure continued compliance
with all the requirements referred to in that clause.
(B) The sanctions specified in subparagraph (A) are in addition
to sanctions otherwise available under State or Federal law and
shall not be construed as limiting other remedies, including any
remedy available to an individual at common law.
(C) A finding to suspend payment under subparagraph (A)(ii)
shall terminate when the Secretary finds that the home health agency
is in substantial compliance with all the requirements specified
in or pursuant to section 1861(o) and subsection (a).
(3) The Secretary shall develop and implement, by not later than
April 1, 1989, specific procedures with respect to the conditions
under which each of the intermediate sanctions developed under
paragraph (1) is to be applied, including the amount of any fines
and the severity of each of these sanctions. Such procedures shall
be designed so as to minimize the time between identification of
deficiencies and imposition of these sanctions and shall provide
for the imposition of incrementally more severe fines for repeated
or uncorrected deficiencies.
(g)
PAYMENT ON BASIS OF LOCATION
OF SERVICE.—A home health agency shall submit claims
for payment for home health services under this title only on the
basis of the geographic location at which the service is furnished,
as determined by the Secretary.