
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC1320c-5]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                       CHAPTER 7--SOCIAL SECURITY
 
   SUBCHAPTER XI--GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE 
                             SIMPLIFICATION
 
 Part B--Peer Review of Utilization and Quality of Health Care Services
 
Sec. 1320c-5. Obligations of health care practitioners and 
        providers of health care services; sanctions and penalties; 
        hearings and review
        

(a) Assurances regarding services and items ordered or provided by 
        practitioner or provider

    It shall be the obligation of any health care practitioner and any 
other person (including a hospital or other health care facility, 
organization, or agency) who provides health care services for which 
payment may be made (in whole or in part) under this chapter, to assure, 
to the extent of his authority that services or items ordered or 
provided by such practitioner or person to beneficiaries and recipients 
under this chapter--
        (1) will be provided economically and only when, and to the 
    extent, medically necessary;
        (2) will be of a quality which meets professionally recognized 
    standards of health care; and
        (3) will be supported by evidence of medical necessity and 
    quality in such form and fashion and at such time as may reasonably 
    be required by a reviewing peer review organization in the exercise 
    of its duties and responsibilities.

(b) Sanctions and penalties; hearings and review

    (1) If after reasonable notice and opportunity for discussion with 
the practitioner or person concerned, and, if appropriate, after the 
practitioner or person has been given a reasonable opportunity to enter 
into and complete a corrective action plan (which may include remedial 
education) agreed to by the organization, and has failed successfully to 
complete such plan, any organization having a contract with the 
Secretary under this part determines that such practitioner or person 
has--
        (A) failed in a substantial number of cases substantially to 
    comply with any obligation imposed on him under subsection (a) of 
    this section, or
        (B) grossly and flagrantly violated any such obligation in one 
    or more instances,

such organization shall submit a report and recommendations to the 
Secretary. If the Secretary agrees with such determination, the 
Secretary (in addition to any other sanction provided under law) may 
exclude (permanently or for such period as the Secretary may prescribe, 
except that such period may not be less than 1 year) such practitioner 
or person from eligibility to provide services under this chapter on a 
reimbursable basis. If the Secretary fails to act upon the 
recommendations submitted to him by such organization within 120 days 
after such submission, such practitioner or person shall be excluded 
from eligibility to provide services on a reimbursable basis until such 
time as the Secretary determines otherwise.
    (2) A determination made by the Secretary under this subsection to 
exclude a practitioner or person shall be effective on the same date and 
in the same manner as an exclusion from participation under the programs 
under this chapter becomes effective under section 1320a-7(c) of this 
title, and shall (subject to the minimum period specified in the second 
sentence of paragraph (1)) remain in effect until the Secretary finds 
and gives reasonable notice to the public that the basis for such 
determination has been removed and that there is reasonable assurance 
that it will not recur.
    (3) In lieu of the sanction authorized by paragraph (1), the 
Secretary may require that (as a condition to the continued eligibility 
of such practitioner or person to provide such health care services on a 
reimbursable basis) such practitioner or person pays \1\ to the United 
States, in case such acts or conduct involved the provision or ordering 
by such practitioner or person of health care services which were 
medically improper or unnecessary, an amount not in excess of up to 
$10,000 for each instance of the medically improper or unnecessary 
services so provided. Such amount may be deducted from any sums owing by 
the United States (or any instrumentality thereof) to the practitioner 
or person from whom such amount is claimed.
---------------------------------------------------------------------------
    \1\ So in original. Probably should be ``pay''.
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    (4) Any practitioner or person furnishing services described in 
paragraph (1) who is dissatisfied with a determination made by the 
Secretary under this subsection shall be entitled to reasonable notice 
and opportunity for a hearing thereon by the Secretary to the same 
extent as is provided in section 405(b) of this title, and to judicial 
review of the Secretary's final decision after such hearing as is 
provided in section 405(g) of this title.
    (5) Before the Secretary may effect an exclusion under paragraph (2) 
in the case of a provider or practitioner located in a rural health 
professional shortage area or in a county with a population of less than 
70,000, the provider or practitioner adversely affected by the 
determination is entitled to a hearing before an administrative law 
judge (described in section 405(b) of this title) respecting whether the 
provider or practitioner should be able to continue furnishing services 
to individuals entitled to benefits under this chapter, pending 
completion of the administrative review procedure under paragraph (4). 
If the judge does not determine, by a preponderance of the evidence, 
that the provider or practitioner will pose a serious risk to such 
individuals if permitted to continue furnishing such services, the 
Secretary shall not effect the exclusion under paragraph (2) until the 
provider or practitioner has been provided reasonable notice and 
opportunity for an administrative hearing thereon under paragraph (4).
    (6) When the Secretary effects an exclusion of a physician under 
paragraph (2), the Secretary shall notify the State board responsible 
for the licensing of the physician of the exclusion.

(c) Enlistment of support of other organizations to assure 
        practitioner's or provider's compliance with obligations

    It shall be the duty of each utilization and quality control peer 
review organization to use such authority or influence it may possess as 
a professional organization, and to enlist the support of any other 
professional or governmental organization having influence or authority 
over health care practitioners and any other person (including a 
hospital or other health care facility, organization, or agency) 
providing health care services in the area served by such review 
organization, in assuring that each practitioner or person (referred to 
in subsection (a) of this section) providing health care services in 
such area shall comply with all obligations imposed on him under 
subsection (a) of this section.

(Aug. 14, 1935, ch. 531, title XI, Sec. 1156, as added Pub. L. 97-248, 
title I, Sec. 143, Sept. 3, 1982, 96 Stat. 388; amended Pub. L. 100-93, 
Sec. 6, Aug. 18, 1987, 101 Stat. 691; Pub. L. 100-203, title IV, 
Sec. 4095(a), Dec. 22, 1987, 101 Stat. 1330-138; Pub. L. 100-203, title 
IV, Sec. 4039(h)(5), Dec. 22, 1987, as added Pub. L. 100-360, title IV, 
Sec. 411(e)(3), July 1, 1988, 102 Stat. 775; Pub. L. 101-508, title IV, 
Sec. 4205(a)(1), (d)(2)(A), Nov. 5, 1990, 104 Stat. 1388-112, 1388-114; 
Pub. L. 101-597, title IV, Sec. 401(c)(1), Nov. 16, 1990, 104 Stat. 
3035; Pub. L. 103-432, title I, Sec. 156(b)(1), Oct. 31, 1994, 108 Stat. 
4441; Pub. L. 104-191, title II, Secs. 214, 231(f), Aug. 21, 1996, 110 
Stat. 2005, 2014.)


                            Prior Provisions

    A prior section 1320c-5, act Aug. 14, 1935, ch. 531, title XI, 
Sec. 1156, as added Oct. 30, 1972, Pub. L. 92-603, title II, 
Sec. 249F(b), 86 Stat. 1435, provided for development of norms of health 
care services by Professional Standards Review Organizations, prior to 
the general revision of this part by Pub. L. 97-248.


                               Amendments

    1996--Subsec. (b)(1). Pub. L. 104-191, Sec. 214(b)(2), struck out in 
concluding provisions ``In determining whether a practitioner or person 
has demonstrated an unwillingness or lack of ability substantially to 
comply with such obligations, the Secretary shall consider the 
practitioner's or person's willingness or lack of ability, during the 
period before the organization submits its report and recommendations, 
to enter into and successfully complete a corrective action plan.'' 
after ``chapter on a reimbursable basis.''
    Pub. L. 104-191, Sec. 214(b)(1), struck out in concluding provisions 
``and determines that such practitioner or person, in providing health 
care services over which such organization has review responsibility and 
for which payment (in whole or in part) may be made under this chapter, 
has demonstrated an unwillingness or a lack of ability substantially to 
comply with such obligations,'' after ``agrees with such 
determination,''.
    Pub. L. 104-191, Sec. 214(a)(1), substituted ``may prescribe, except 
that such period may not be less than 1 year)'' for ``may prescribe)'' 
in concluding provisions.
    Subsec. (b)(2). Pub. L. 104-191, Sec. 214(a)(2), substituted ``shall 
(subject to the minimum period specified in the second sentence of 
paragraph (1)) remain'' for ``shall remain''.
    Subsec. (b)(3). Pub. L. 104-191, Sec. 231(f), substituted ``up to 
$10,000 for each instance'' for ``the actual or estimated cost''.
    1994--Subsec. (b)(1). Pub. L. 103-432 substituted ``whether'' for 
``whehter'' in third sentence.
    1990--Subsec. (b)(1). Pub. L. 101-508, Sec. 4205(a)(1), inserted 
``and, if appropriate, after the practitioner or person has been given a 
reasonable opportunity to enter into and complete a corrective action 
plan (which may include remedial education) agreed to by the 
organization, and has failed successfully to complete such plan,'' after 
``concerned,'' in introductory provisions and inserted after second 
sentence ``In determining whehter [sic] a practitioner or person has 
demonstrated an unwillingness or lack of ability substantially to comply 
with such obligations, the Secretary shall consider the practitioner's 
or person's willingness or lack of ability, during the period before the 
organization submits its report and recommendations, to enter into and 
successfully complete a corrective action plan.''
    Subsec. (b)(5). Pub. L. 101-597 substituted ``health professional 
shortage area'' for ``health manpower shortage area (HMSA)''.
    Subsec. (b)(6). Pub. L. 101-508, Sec. 4205(d)(2)(A), added par. (6).
    1988--Subsec. (b). Pub. L. 100-360 added Pub. L. 100-203, 
Sec. 4039(h)(5), see 1987 Amendment notes below.
    1987--Subsec. (a). Pub. L. 100-93, Sec. 6(1), substituted ``this 
chapter'' for ``subchapter XVIII of this chapter'' and ``this 
subchapter''.
    Subsec. (b)(1). Pub. L. 100-203, Sec. 4039(h)(5)(A), as added by 
Pub. L. 100-360, substituted ``services under this chapter'' for ``such 
services''.
    Pub. L. 100-93, Sec. 6(2), substituted ``this chapter'' for 
``subchapter XVIII of this chapter''.
    Subsec. (b)(2). Pub. L. 100-203, Sec. 4039(h)(5)(B), as added by 
Pub. L. 100-360, substituted ``on the same date and in the same manner 
as an exclusion from participation under the programs under this chapter 
becomes effective under section 1320a-7(c) of this title'' for ``at such 
time and upon such reasonable notice to the public and to the 
practitioner or person furnishing the services involved as may be 
specified in regulations. Such determination shall be effective with 
respect to services furnished to an individual on or after the effective 
date of such determination (except that in the case of institutional 
health care services such determination shall be effective in the manner 
provided in this chapter with respect to terminations of provider 
agreements)''.
    Pub. L. 100-93, Sec. 6(2), substituted ``this chapter'' for 
``subchapter XVIII of this chapter''.
    Subsec. (b)(5). Pub. L. 100-203 added par. (5).


                    Effective Date of 1996 Amendment

    Amendment by section 214 of Pub. L. 104-191 effective Jan. 1, 1997, 
except as otherwise provided, see section 218 of Pub. L. 104-191, set 
out as a note under section 1320a-7 of this title.
    Amendment by section 231(f) of Pub. L. 104-191 applicable to acts or 
omissions occurring on or after Jan. 1, 1997, see section 231(i) of Pub. 
L. 104-191, set out as a note under section 1320a-7a of this title.


                    Effective Date of 1994 Amendment

    Amendment by Pub. L. 103-432 effective as if included in the 
enactment of Pub. L. 101-508, see section 156(b)(6)(A) of Pub. L. 103-
432, set out as a note under section 1320c-9 of this title.


                    Effective Date of 1990 Amendment

    Section 4205(a)(2) of Pub. L. 101-508 provided that: ``The 
amendments made by paragraph (1) [amending this section] shall apply to 
initial determinations made by organizations on or after the date of the 
enactment of this Act [Nov. 5, 1990].''
    Section 4205(d)(2)(B) of Pub. L. 101-508, as amended by Pub. L. 103-
432, title I, Sec. 156(b)(3), Oct. 31, 1994, 108 Stat. 4441, provided 
that: ``The amendment made by this paragraph [amending this section] 
shall apply to sanctions effected more than 60 days after the date of 
the enactment of this Act [Nov. 5, 1990].''


                    Effective Date of 1988 Amendment

    Except as specifically provided in section 411 of Pub. L. 100-360, 
amendment by Pub. L. 100-360, as it relates to a provision in the 
Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203, effective as 
if included in the enactment of that provision in Pub. L. 100-203, see 
section 411(a) of Pub. L. 100-360, set out as a Reference to OBRA; 
Effective Date note under section 106 of Title 1, General Provisions.


                    Effective Date of 1987 Amendments

    Section 4095(b) of Pub. L. 100-203 provided that: ``The amendment 
made by subsection (a) [amending this section] shall apply to 
determinations made by the Secretary of Health and Human Services under 
section 1156(b) of the Social Security Act [subsec. (b) of this section] 
on or after the date of the enactment of this Act [Dec. 22, 1987].''
    Amendment by Pub. L. 100-93 effective at end of fourteen-day period 
beginning Aug. 18, 1987, and inapplicable to administrative proceedings 
commenced before end of such period, see section 15(a) of Pub. L. 100-
93, set out as a note under section 1320a-7 of this title.


                Telecommunications Demonstration Projects

    Section 4094(e) of Pub. L. 100-203, as amended by Pub. L. 100-360, 
title IV, Sec. 411(j)(3)(C), as added by Pub. L. 100-485, title VI, 
Sec. 608(d)(25)(A), Oct. 13, 1988, 102 Stat. 2421, provided that: ``The 
Secretary of Health and Human Services shall enter into agreements with 
entities submitting applications under this subsection (in such form as 
the Secretary may provide) to establish demonstration projects to 
examine the feasibility of requiring instruction and oversight of rural 
physicians, in lieu of imposing sanctions, through use of video 
communication between rural hospitals and teaching hospitals under this 
title [probably means title XI of the Social Security Act which is 
classified to this subchapter]. Under such demonstration projects, the 
Secretary may provide for payments to physicians consulted via video 
communication systems. No funds may be expended under the demonstration 
projects for the acquisition of capital items including computer 
hardware.''


Preexclusion Hearings; Transition for Current Cases and Redetermination 
                            in Certain Cases

    Section 4095(c), (d) of Pub. L. 100-203 provided that:
    ``(c) Transition for Current Cases.--In the case of a practitioner 
or person--
        ``(1) for whom a notice of determination under section 1156(b) 
    of the Social Security Act [subsec. (b) of this section] has been 
    provided within 365 days before the date of the enactment of this 
    Act [Dec. 22, 1987],
        ``(2) who has not exhausted the administrative remedies 
    available under section 1156(b)(4) of such Act for review of the 
    determination, and
        ``(3) who requests, within 90 days after the date of the 
    enactment of this Act, a hearing established under this subsection,
the Secretary of Health and Human Services shall provide for a hearing 
described in section 1156(b)(5) of the Social Security Act (as amended 
by subsection (a) of this section).
    ``(d) Redeterminations in Certain Cases.--If, in hearing under 
subsection (c), the judge does not determine, by a preponderance of the 
evidence, that the provider or practitioner will pose a serious risk to 
individuals entitled to benefits under title XVIII of the Social 
Security Act [subchapter XVIII of this chapter] if permitted to continue 
or resume furnishing such services, the Secretary shall not effect the 
exclusion (or shall suspend the exclusion, if previously effected) under 
paragraph (2) of section 1156(b) of such Act [subsec. (b) of this 
section] until the provider or practitioner has been provided an 
administrative hearing thereon under paragraph (4) of such section, 
notwithstanding any failure by the provider or practitioner to request 
the hearing on a timely basis.''

                  Section Referred to in Other Sections

    This section is referred to in sections 704, 1320a-7, 1320a-7a, 
1320c-3, 1320c-9, 1395y, 1396b, 1397d of this title.
