42 U.S.C. § 1395bbb : US Code - Section 1395BBB: Conditions of participation for home health agencies; home health quality

Search 42 U.S.C. § 1395bbb : US Code - Section 1395BBB: Conditions of participation for home health agencies; home health quality

(a) Conditions of participation; protection of individual rights;
notification of State entities; use of home health aides; medical
equipment; individual's plan of care; compliance with Federal,
State, and local laws and regulations
The conditions of participation that a home health agency is
required to meet under this subsection are as follows:
(1) The agency protects and promotes the rights of each
individual under its care, including each of the following
rights:
(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.
(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.
(C) The right to confidentiality of the clinical records
described in section 1395x(o)(3) of this title.
(D) The right to have one's property treated with respect.
(E) The right to be fully informed orally and in writing (in
advance of coming under the care of the agency) of -
(i) all items and services furnished by (or under
arrangements with) the agency for which payment may be made
under this subchapter,
(ii) the coverage available for such items and services
under this subchapter, subchapter XIX of this chapter, and
any other Federal program of which the agency is reasonably
aware,
(iii) any charges for items and services not covered under
this subchapter and any charges the individual may have to
pay with respect to items and services furnished by (or under
arrangements with) the agency, and
(iv) any changes in the charges or items and services
described in clause (i), (ii), or (iii).
(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 subchapter.
(G) The right to be informed of the availability of the State
home health agency hot-line established under section 1395aa(a)
of this title.
(2) The agency notifies the State entity responsible for the
licensing or certification of the agency of a change in -
(A) the persons with an ownership or control interest (as
defined in section 1320a-3(a)(3) of this title) in the agency,
(B) the persons who are officers, directors, agents, or
managing employees (as defined in section 1320a-5(b) of this
title) of the agency, and
(C) the corporation, association, or other company
responsible for the management of the agency.
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.
(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 1395x(m) of this
title on or after January 1, 1990, unless the individual -
(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
(ii) is competent to provide such items and services.
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
1395x(m) of this title for compensation.
(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.
(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 1395x(m) of
this title are competent to provide those items and services.
(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.
(D)(i) The Secretary shall establish minimum standards for the
programs described in subparagraph (A) by not later than October
1, 1988.
(ii) Such standards shall include the content of the
curriculum, minimum hours of training, qualification of
instructors, and procedures for determination of competency.
(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
December 22, 1987; 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 -
(I) has been determined to be out of compliance with
subparagraph (A), (B), or (C);
(II) has been subject to an extended (or partial extended)
survey under subsection (c)(2)(D) of this section;
(III) has been assessed a civil money penalty described in
subsection (f)(2)(A)(i) of this section of not less than
$5,000; or
(IV) has been subject to the remedies described in subsection
(e)(1) of this section or in clauses (ii) or (iii) of
subsection (f)(2)(A) of this section.
(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.
(E) In this paragraph, the term "home health aide" means any
individual who provides the items and services described in
section 1395x(m) of this title, but does not include an
individual -
(i) who is a licensed health professional (as defined in
subparagraph (F)), or
(ii) who volunteers to provide such services without monetary
compensation.
(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.
(4) The agency includes an individual's plan of care required
under section 1395x(m) of this title as part of the clinical
records described in section 1395x(o)(3) of this title.
(5) The agency operates and provides services in compliance
with all applicable Federal, State, and local laws and
regulations (including the requirements of section 1320a-3 of
this title) and with accepted professional standards and
principles which apply to professionals providing items and
services in such an agency.
(6) The agency complies with the requirement of section
1395cc(f) of this title (relating to maintaining written policies
and procedures respecting advance directives).
(b) Duty of Secretary
It is the duty and responsibility of the Secretary to assure that
the conditions of participation and requirements specified in or
pursuant to section 1395x(o) of this title 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) Surveys of home health agencies
(1) Any agreement entered into or renewed by the Secretary
pursuant to section 1395aa of this title 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 1320a-7a
of this title (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 1320a-7a
of this title. 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 -
(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
(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 1395aa(a) of this title), or any other
appropriate Federal, State, or local agency.
(C) A standard survey conducted under this paragraph with respect
to a home health agency -
(i) shall include (to the extent practicable), for a case-mix
stratified sample of individuals furnished items or services by
the agency -
(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) of this section) 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
1395x(m) of this title and clinical records required under
section 1395x(o)(3) of this title; and
(II) a survey of the quality of care and services furnished
by the agency as measured by indicators of medical, nursing,
and rehabilitative care;
(ii) shall be based upon a protocol that is developed, tested,
and validated by the Secretary not later than January 1, 1989;
and
(iii) shall be conducted by an individual -
(I) who meets minimum qualifications established by the
Secretary not later than July 1, 1989,
(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 1395x(o) of this title or subsection (a) of
this section, and
(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 1395x(o) of this title 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) of this section
on the basis of the findings of a standard survey.
(d) Assessment process; reports to Congress
(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) of this section.
(2)(A) Not later than January 1, 1992, the Secretary shall -
(i) evaluate the assessment process,
(ii) report to Congress on the results of such evaluation, and
(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) Enforcement
(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
subchapter is no longer in compliance with the requirements
specified in or pursuant to section 1395x(o) of this title or
subsection (a) of this section 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) of this section 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) of this section.
(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
subchapter is no longer in compliance with the requirements
specified in or pursuant to section 1395x(o) of this title or
subsection (a) of this section 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) of this
section, 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 1395x(o) of this title or subsection (a) of
this section, 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 subchapter is in compliance
with the requirements specified in or pursuant to section 1395x(o)
of this title or subsection (a) of this section 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) of
this section 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 subchapter
with respect to a home health agency not in compliance with the
requirements specified in or pursuant to section 1395x(o) of this
title or subsection (a) of this section over a period of not longer
than 6 months, if -
(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,
(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
(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) Intermediate sanctions
(1) The Secretary shall develop and implement, by not later than
April 1, 1989 -
(A) a range of intermediate sanctions to apply to home health
agencies under the conditions described in subsection (e) of this
section, and
(B) appropriate procedures for appealing determinations
relating to the imposition of such sanctions.
(2)(A) The intermediate sanctions developed under paragraph (1)
shall include -
(i) civil money penalties in an amount not to exceed $10,000
for each day of noncompliance,
(ii) suspension of all or part of the payments to which a home
health agency would otherwise be entitled under this subchapter
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) of this section, and
(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 1395x(o) of this title or subsection (a) of this section.
The provisions of section 1320a-7a of this title (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 1320a-7a(a) of this title. 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 1395x(o) of this title and subsection (a) of
this section.
(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 subchapter only on the basis of the
geographic location at which the service is furnished, as
determined by the Secretary.