Source: https://www.law.cornell.edu/uscode/text/42/1320c%E2%80%933
Timestamp: 2019-04-22 14:21:31+00:00

Document:
in case such services and items are proposed to be provided in a hospital or other health care facility on an inpatient basis, such services and items could, consistent with the provision of appropriate medical care, be effectively provided more economically on an outpatient basis or in an inpatient health care facility of a different type.
such payment is authorized under section 1395x(v)(1)(G) of this title.
Subject to subparagraphs (B) and (D), whenever the organization makes a determination that any health care services or items furnished or to be furnished to a patient by any practitioner or provider are disapproved, the organization shall promptly notify such patient and the agency or organization responsible for the payment of claims under subchapter XVIII of this chapter of such determination.
provided such practitioner or provider an opportunity for discussion and review of the proposed determination.
The discussion and review conducted under subparagraph (B)(ii) shall not affect the rights of a practitioner or provider to a formal reconsideration of a determination under this part (as provided under section 1320c–4 of this title).
if the provider or practitioner requests such a reconsideration, the organization has made such a reconsideration.
If a provider or practitioner is provided a reconsideration, such reconsideration shall be in lieu of any subsequent reconsideration to which the provider or practitioner may be otherwise entitled under section 1320c–4 of this title, but shall not affect the right of a beneficiary from seeking reconsideration under such section of the organization’s determination (after any reconsideration requested by the provider or physician under clause (ii)).
In the case of services or items provided by an entity or practitioner other than a physician, the Secretary may substitute the entity or practitioner which provided the services or items for the term “physician” in the notice described in clause (i).
The organization shall, after consultation with the Secretary, determine the types and kinds of cases (whether by type of health care or diagnosis involved, or whether in terms of other relevant criteria relating to the provision of health care services) with respect to which such organization will, in order to most effectively carry out the purposes of this part, exercise review authority under the contract. The organization shall notify the Secretary periodically with respect to such determinations. Each quality improvement organization shall provide that a reasonable proportion of its activities are involved with reviewing, under paragraph (1)(B), the quality of services and that a reasonable allocation of such activities is made among the different cases and settings (including post-acute-care settings, ambulatory settings, and health maintenance organizations). In establishing such allocation, the organization shall consider (i) whether there is reason to believe that there is a particular need for reviews of particular cases or settings because of previous problems regarding quality of care, (ii) the cost of such reviews and the likely yield of such reviews in terms of number and seriousness of quality of care problems likely to be discovered as a result of such reviews, and (iii) the availability and adequacy of alternative quality review and assurance mechanisms.
The contract of each organization shall provide for the review of services (including both inpatient and outpatient services) provided by eligible organizations pursuant to a risk-sharing contract under section 1395mm of this title (or that is subject to review under section 1395ss(t)(3) of this title) for the purpose of determining whether the quality of such services meets professionally recognized standards of health care, including whether appropriate health care services have not been provided or have been provided in inappropriate settings and whether individuals enrolled with an eligible organization have adequate access to health care services provided by or through such organization (as determined, in part, by a survey of individuals enrolled with the organization who have not yet used the organization to receive such services). The contract of each organization shall also provide that with respect to health care provided by a health maintenance organization or competitive medical plan under section 1395mm of this title, the organization shall maintain a beneficiary outreach program designed to apprise individuals receiving care under such section of the role of the peer review system, of the rights of the individual under such system, and of the method and purposes for contacting the organization. The previous two sentences shall not apply with respect to a contract year if another entity has been awarded a contract under subparagraph (C). Under the contract the level of effort expended by the organization on reviews under this subparagraph shall be equivalent, on a per enrollee basis, to the level of effort expended by the organization on utilization and quality reviews performed with respect to individuals not enrolled with an eligible organization.
The organization shall consult with nurses and other professional health care practitioners (other than physicians described in section 1395x(r)(1) of this title) and with representatives of institutional and noninstitutional providers of health care services, with respect to the organization’s responsibility for the review under paragraph (1) of the professional activities of such practitioners and providers.
the type of health care facility which is considered, consistent with such standards, to be the type in which health care services which are medically appropriate for such illness or condition can most economically be provided.
As a component of the norms described in clause (i) or (ii), the organization shall take into account the special problems associated with delivering care in remote rural areas, the availability of service alternatives to inpatient hospitalization, and other appropriate factors (such as the distance from a patient’s residence to the site of care, family support, availability of proximate alternative sites of care, and the patient’s ability to carry out necessary or prescribed self-care regimens) that could adversely affect the safety or effectiveness of treatment provided on an outpatient basis.
publish (not less often than annually) and distribute to providers and practitioners whose services are subject to review a report that describes the organization’s findings with respect to the types of cases in which the organization has frequently determined that (I) inappropriate or unnecessary care has been provided, (II) services were rendered in an inappropriate setting, or (III) services did not meet professionally recognized standards of health care.
in the case of psychiatric and physical rehabilitation services, make arrangements to ensure that (to the extent possible) initial review of such services be made by a physician who is trained in psychiatry or physical rehabilitation (as appropriate).
inspect the facilities in which care is rendered or services are provided (which are located in such area) of any practitioner or provider of health care services providing services with respect to which such organization has a responsibility for review under paragraph (1).
The organization shall perform such duties and functions and assume such responsibilities and comply with such other requirements as may be required by this part or under regulations of the Secretary promulgated to carry out the provisions of this part or as may be required to carry out section 1395y(a)(15) of this title.
The organization shall collect such information relevant to its functions, and keep and maintain such records, in such form as the Secretary may require to carry out the purposes of this part, and shall permit access to and use of any such information and records as the Secretary may require for such purposes, subject to the provisions of section 1320c–9 of this title.
If the organization finds, after reasonable notice to and opportunity for discussion with the physician or practitioner concerned, that the physician or practitioner has furnished services in violation of section 1320c–5(a) of this title and the organization determines that the physician or practitioner should enter into a corrective action plan under section 1320c–5(b)(1) of this title, the organization shall notify the State board or boards responsible for the licensing or disciplining of the physician or practitioner of its finding and of any action taken as a result of the finding.
other public or private review organizations as may be appropriate.
The organization shall make available its facilities and resources for contracting with private and public entities paying for health care in its area for review, as feasible and appropriate, of services reimbursed by such entities.
As part of the organization’s review responsibility under paragraph (1), the organization shall review all ambulatory surgical procedures specified pursuant to section 1395l(i)(1)(A) of this title which are performed in the area, or, at the discretion of the Secretary, a sample of such procedures.
Notwithstanding paragraph (4), the organization shall perform the review described in paragraph (1) with respect to early readmission cases to determine if the previous inpatient hospital services and the post-hospital services met professionally recognized standards of health care. Such reviews may be performed on a sample basis if the organization and the Secretary determine it to be appropriate. In this paragraph, an “early readmission case” is a case in which an individual, after discharge from a hospital, is readmitted to a hospital less than 31 days after the date of the most recent previous discharge.
The organization shall conduct an appropriate review of all written complaints about the quality of services (for which payment may otherwise be made under subchapter XVIII) not meeting professionally recognized standards of health care, if the complaint is filed with the organization by an individual entitled to benefits for such services under such subchapter (or a person acting on the individual’s behalf). The organization shall inform the individual (or representative) of the organization’s final disposition of the complaint. Before the organization concludes that the quality of services does not meet professionally recognized standards of health care, the organization must provide the practitioner or person concerned with reasonable notice and opportunity for discussion.
During each year of the contract entered into under section 1320c–2(b) of this title, the organization shall perform on-site review activities as the Secretary determines appropriate.
The organization shall provide for a review and report to the Secretary when requested by the Secretary under section 1395dd(d)(3) of this title. The organization shall provide reasonable notice of the review to the physician and hospital involved. Within the time period permitted by the Secretary, the organization shall provide a reasonable opportunity for discussion with the physician and hospital involved, and an opportunity for the physician and hospital to submit additional information, before issuing its report to the Secretary under such section.
The organization shall execute its responsibilities under subparagraphs (A) and (B) of paragraph (1) by offering to providers, practitioners, Medicare Advantage organizations offering Medicare Advantage plans under part C, and prescription drug sponsors offering prescription drug plans under part D quality improvement assistance pertaining to prescription drug therapy. For purposes of this part and subchapter XVIII, the functions described in this paragraph shall be treated as a review function.
The organization shall perform, subject to the terms of the contract, such other activities as the Secretary determines may be necessary for the purposes of improving the quality of care furnished to individuals with respect to items and services for which payment may be made under subchapter XVIII.
health care services provided in or by an institution, organization, or agency, if he or any member of his family has, directly or indirectly, a significant financial interest in such institution, organization, or agency.
For purposes of this subsection, a physician’s family includes only his spouse (other than a spouse who is legally separated from him under a decree of divorce or separate maintenance), children (including legally adopted children), grandchildren, parents, and grandparents.
the hospital may provide the patient (or the patient’s representative) with a notice (meeting conditions prescribed by the Secretary under section 1395pp of this title) of the determination.
to (4) Repealed. Pub. L. 106–554, § 1(a)(6) [title V, § 521(c)], Dec. 21, 2000, 114 Stat. 2763, 2763A–543.
A prior section 1320c–3, act Aug. 14, 1935, ch. 531, title XI, § 1154, as added Oct. 30, 1972, Pub. L. 92–603, title II, § 249F(b), 86 Stat. 1432; amended Oct. 25, 1977, Pub. L. 95–142, § 5(b), (d)(2)(C), 91 Stat. 1184, 1186; Dec. 5, 1980, Pub. L. 96–499, title IX, § 924(a), 94 Stat. 2628; Aug. 13, 1981, Pub. L. 97–35, title XXI, §§ 2112(a)(1), (2)(B), (b), 2113(c), 2121(e), 95 Stat. 793, 794, 796, related to trial period for Professional Standards Review Organizations, prior to the general revision of this part by Pub. L. 97–248.
2011—Pub. L. 112–40, § 261(a)(2)(B), substituted “quality improvement” for “peer review” in section catchline.
Subsec. (a). Pub. L. 112–40, § 261(a)(2)(C), (c)(2)(A)(i), in introductory provisions, substituted “Subject to subsection (b), any quality improvement” for “Any utilization and quality control peer review” and inserted “one or more of” before “the following functions”.
Subsec. (a)(2)(B), (3)(E)(i), (4)(A). Pub. L. 112–40, § 261(a)(2)(C), substituted “quality improvement” for “peer review”.
Subsec. (a)(4)(C). Pub. L. 112–40, § 261(c)(2)(A)(ii), struck out subpar. (C) which related to State-by-State competitive procurement procedures for review of quality of health care services and required certain contractual terms.
Subsec. (a)(10)(B). Pub. L. 112–40, § 261(a)(2)(C), substituted “quality improvement” for “peer review”.
Subsec. (a)(12). Pub. L. 112–40, § 261(c)(2)(A)(iii), added par. (12).
Subsec. (a)(15). Pub. L. 112–40, § 261(c)(2)(A)(iv), substituted “on-site review activities as the Secretary determines appropriate” for “significant on-site review activities, including on-site review in at least 20 percent of the rural hospitals in the organization’s area”.
Subsec. (a)(18). Pub. L. 112–40, § 261(d), added par. (18).
Subsec. (b). Pub. L. 112–40, § 261(c)(2)(C), added subsec. (b). Former subsec. (b) redesignated (c).
Subsec. (c). Pub. L. 112–40, § 261(c)(2)(B), redesignated subsec. (b) as (c). Former subsec. (c) redesignated (d).
Pub. L. 112–40, § 261(a)(2)(C), substituted “quality improvement” for “utilization and quality control peer review”.
Subsec. (f). Pub. L. 112–40, § 261(a)(2)(C), substituted “quality improvement” for “peer review”.
2003—Subsec. (a)(1). Pub. L. 108–173, § 109(a), inserted “, to Medicare Advantage organizations pursuant to contracts under part C, and to prescription drug sponsors pursuant to contracts under part D” after “under section 1395mm of this title”.
Subsec. (a)(17). Pub. L. 108–173, § 109(b), added par. (17).
2000—Subsec. (e)(2) to (4). Pub. L. 106–554 struck out pars. (2) to (4), which had: in par. (2), authorized peer review organization review of validity of hospital’s determination that a patient no longer required inpatient hospital care but attending physician had not agreed with the hospital’s determination; in par. (3), authorized review of the determination where patient or patient’s representative had received a notice under par. (1) and requested the review; and in par. (4), directed that hospital could not charge patient for inpatient services furnished before noon of the day after the date the patient or representative received notice of the decision where request for review had been made not later than noon of the first working day after notice under par. (1) had been received and section 1395pp(a)(2) conditions had been met.
1994—Subsec. (a)(4)(B). Pub. L. 103–432, § 171(h)(2), substituted “(or that is subject to review under section 1395ss(t)(3) of this title)” for “(or subject to review under section 1395ss(t) of this title)”.
Subsec. (d). Pub. L. 103–432, § 156(a)(2)(A)(ii), struck out “(and except as provided in section 1320c–13 of this title)” after “discretion of the Secretary”.
Subsec. (a)(3)(E). Pub. L. 101–508, § 4205(g)(1)(A), designated existing provisions as cl. (i), inserted “provided by a physician that were” after “items”, substituted “physician.” for “physician and hospital.”, and added cl. (ii).
Subsec. (a)(4)(B). Pub. L. 101–508, § 4358(b)(3), inserted “(or subject to review under section 1395ss(t) of this title)” after “section 1395mm of this title” in first sentence.
Subsec. (a)(7)(A)(i). Pub. L. 101–508, § 4205(b)(1)(A), inserted “, optometry, and podiatry” after “dentistry”.
Subsec. (a)(9). Pub. L. 101–508, § 4205(d)(1)(A), designated existing provisions as subpar. (A) and added subpar. (B).
Subsec. (a)(16). Pub. L. 101–508, § 4207(a)(1)(B), formerly § 4027(a)(1)(B), as renumbered by Pub. L. 103–432, § 160(d)(4), added par. (16).
Subsec. (c). Pub. L. 101–508, § 4205(b)(1)(B), substituted “dentistry, optometry, or podiatry” for “or dentistry” in three places.
Subsec. (a)(3)(A). Pub. L. 101–239, § 6224(b)(1)(A), substituted “subparagraphs (B) and (D)” for “subparagraph (B)”.
Subsec. (a)(3)(B). Pub. L. 101–239, § 6224(b)(1)(B), inserted “with respect to services or items disapproved by reason of subparagraph (A) or (C) of paragraph (1)” after “under subparagraph (A)”.
Subsec. (a)(3)(D), (E). Pub. L. 101–239, § 6224(b)(1)(C), added subpars. (D) and (E).
Subsec. (a)(16). Pub. L. 101–234, repealed Pub. L. 100–360, § 203(d)(2), and provided that the provisions of law amended or repealed by such section are restored or revived as if such section had not been enacted, see 1988 Amendment note below.
1988—Subsec. (a)(3)(C). Pub. L. 100–360, § 411(j)(2), designated last sentence of par. (3) as subpar. (C).
Subsec. (a)(4). Pub. L. 100–360, § 411(e)(3), added Pub. L. 100–203, § 4039(h)(3), see 1987 Amendment note below.
Subsec. (a)(6). Pub. L. 100–360, § 411(j)(3)(A), made technical amendment to directory language of Pub. L. 100–203, § 4094(a), see 1987 Amendment note below.
Subsec. (a)(15). Pub. L. 100–360, § 411(j)(3)(B), substituted “review in at least” for “review at at least”.
Subsec. (a)(16). Pub. L. 100–360, § 203(d)(2), added par. (16) which related to review of home intravenous drug therapy services.
Subsec. (d). Pub. L. 100–360, § 411(e)(3), added Pub. L. 100–203, § 4039(h)(4), see 1987 Amendment note below.
Subsec. (e)(3)(A)(i). Pub. L. 100–360, § 411(j)(4)(C), as amended by Pub. L. 100–485, § 608(d)(25)(B), substituted “paragraph (1)” for “paragraph (1) or (2)”.
Subsec. (e)(3)(B). Pub. L. 100–360, § 411(j)(4)(C), as amended by Pub. L. 100–485, § 608(d)(25)(B), substituted “paragraph (1)” for “paragraph (1) or (2)” in introductory provisions.
Subsec. (a)(4). Pub. L. 100–203, § 4039(h)(3), as added by Pub. L. 100–360, § 411(e)(3), realigned margins for subpars. (B) and (C) and cls. (i) to (iii) of subpar. (C), in subpar. (B), substituted “risk sharing contract under section 1395mm” for “contract under section 1395mm”, and in subpar. (C), inserted “(other than the ability to perform review functions under this section that are not described in subparagraph (B))”.
Subsec. (a)(4)(B). Pub. L. 100–203, § 4094(c)(2)(A), inserted before period at end of first sentence “and whether individuals enrolled with an eligible organization have adequate access to health care services provided by or through such organization (as determined, in part, by a survey of individuals enrolled with the organization who have not yet used the organization to receive such services). The contract of each organization shall also provide that with respect to health care provided by a health maintenance organization or competitive medical plan under section 1395mm of this title, the organization shall maintain a beneficiary outreach program designed to apprise individuals receiving care under such section of the role of the peer review system, of the rights of the individual under such system, and of the method and purposes for contacting the organization” and substituted “previous two sentences” for “previous sentence” in penultimate sentence.
Subsec. (a)(6). Pub. L. 100–203, § 4094(c)(1)(A), designated existing provisions as subpar. (A), redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, and added subpar. (B).
Subsec. (a)(7)(A). Pub. L. 100–203, § 4094(c)(2)(B), designated existing provisions as cl. (i) and added cl. (ii).
Subsec. (a)(15). Pub. L. 100–203, § 4094(b), added par. (15).
Subsec. (d). Pub. L. 100–203, § 4039(h)(4), as added by Pub. L. 100–360, § 411(e)(3), substituted “1320c–13 of this title” for “1320c–13(b)(4) of this title”.
Subsec. (e)(2). Pub. L. 100–203, § 4096(c)(1), inserted provision at end requiring hospital to notify patient if it has requested a review.
Subsec. (e)(3)(A)(i), (B). Pub. L. 100–203, § 4096(c)(2), inserted “or (2)” after “paragraph (1)”.
1986—Subsec. (a)(1). Pub. L. 99–509, § 9343(d)(1), inserted “and subject to the requirements of subsection (d)” after “subject to the terms of the contract” in introductory provisions.
Pub. L. 99–272, § 9405(a), inserted “(including where payment is made for such services to eligible organizations pursuant to contracts under section 1395mm of this title)” after “subchapter XVIII” in introductory provisions.
Subsec. (a)(2). Pub. L. 99–272, § 9403(a), in introductory provisions substituted “subparagraphs (A), (B), and (C)” for “subparagraphs (A) and (C)”, and following subpar. (D) inserted provision that determinations that payment should not be made by reason of subpar. (B) of par. (1) shall be made only on the basis of criteria which are consistent with guidelines established by the Secretary.
Pub. L. 99–509, § 9353(a)(2)(A), inserted “(A)” after “(4)”.
Pub. L. 99–509, § 9353(a)(2)(B), added subpar. (B).
Subsec. (a)(4)(C). Pub. L. 99–509, § 9353(a)(2)(D), added subpar. (C).
Subsec. (a)(8). Pub. L. 99–272, § 9307(b), inserted “or as may be required to carry out section 1395y(a)(15) of this title” before the period at end.
Subsec. (a)(12). Pub. L. 99–272, § 9401(a), added par. (12).
Subsec. (a)(13). Pub. L. 99–509, § 9352(b), added par. (13).
Subsec. (a)(14). Pub. L. 99–509, § 9353(c)(1), added par. (14).
Subsec. (d). Pub. L. 99–509, § 9343(d)(2), added subsec. (d).
Subsec. (e). Pub. L. 99–509, § 9351(a), added subsec. (e).
Subsec. (f). Pub. L. 99–509, § 9353(a)(3), added subsec. (f).
1983—Subsec. (a)(1)(A). Pub. L. 97–448, § 309(b)(3), substituted “and whether such services and items are not allowable under subsection (a)(1) or (a)(9) of section 1395y of this title” for “or otherwise allowable under section 1395y(a)(1) of this title”.
Subsec. (a)(2)(B). Pub. L. 97–448, § 309(b)(4), struck out “posthospital” before “extended care services”.
Pub. L. 108–173, title IX, § 948(d), Dec. 8, 2003, 117 Stat. 2426, provided that the amendment made by section 948(d) is effective as if included in the enactment of section 521(c) of BIPA (the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, as enacted by section 1(a)(6) of Pub. L. 106–554).
subject to paragraph (2), during the 6½-yearperiod beginning with 1992.
For purposes of this paragraph, the term ‘State’ has the meaning given such term by section 210(h) of the Social Security Act (42 U.S.C. 410(h)).
The Secretary of Health and Human Services shall conduct a study that compares the health care costs, quality of care, and access to services under medicare select policies with that under other medicare supplemental policies. The study shall be based on surveys of appropriate age-adjusted sample populations. The study shall be completed by June 30, 1997.
The amendments made by this section have not resulted in savings of premium costs to those enrolled in medicare select policies (in comparison to their enrollment in medicare supplemental policies that are not medicare select policies and that provide comparable coverage).
There have been significant additional expenditures under the medicare program as a result of such amendments.
Access to and quality of care has been significantly diminished as a result of such amendments.
The amendments made by this section shall remain in effect beyond the 6½-yearperiod described in paragraph (1)(B) unless the Secretary determines that any of the findings described in clause (i), (ii), or (iii) of subparagraph (B) are true.
Pub. L. 100–360, title II, § 203(g), July 1, 1988, 102 Stat. 725, which had provided that the amendments made by section 203 of Pub. L. 100–360 (amending this section and sections 1395h, 1395k to 1395n, 1395w–2, 1395x, 1395z, and 1395aa of this title) were to apply to items and services furnished on or after January 1, 1990, was repealed by Pub. L. 101–234, title II, § 201(a), Dec. 13, 1989, 103 Stat. 1981.
Except as provided in paragraph (2), the amendment made by subsection (a) [amending this section] shall apply to denial notices furnished by hospitals to individuals on or after the first day of the first month that begins more than 30 days after the date of the enactment of this Act [Oct. 21, 1986].
Except as provided in clause (ii), the amendments made by paragraph (1) [amending this section] shall apply to contracts entered into or renewed on or after January 1, 1987.
The amendment made by paragraph (1) shall not be construed as requiring, before January 1, 1989, the review of physicians’ services, other than physicians’ services furnished in a hospital, other inpatient facility, ambulatory surgical center, or rural health clinic.
The amendments made by paragraphs (2)(B) and (2)(D) [amending this section] shall apply to contracts as of April 1, 1987.
The amendment made by paragraph (2)(C) [amending this section] shall apply to review activities conducted by organizations on or after January 1, 1988.

References: § 1
 § 521
 § 1154
 § 249
 § 5
 § 924
 § 261
 § 261
 § 261
 § 261
 § 261
 § 261
 § 261
 § 261
 § 261
 § 261
 § 261
 § 261
 § 109
 § 109
 § 171
 § 156
 § 4205
 § 4358
 § 4205
 § 4205
 § 4207
 § 4027
 § 160
 § 4205
 § 6224
 § 6224
 § 6224
 § 203
 § 411
 § 411
 § 4039
 § 411
 § 4094
 § 411
 § 203
 § 411
 § 4039
 § 411
 § 608
 § 411
 § 608
 § 4039
 § 411
 § 4094
 § 4094
 § 4094
 § 4094
 § 4039
 § 411
 § 4096
 § 4096
 § 9343
 § 9405
 § 9403
 § 9353
 § 9353
 § 9353
 § 9307
 § 9401
 § 9352
 § 9353
 § 9343
 § 9351
 § 9353
 § 309
 § 309
 § 948
 § 203
 § 201