
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC1395w-2]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                       CHAPTER 7--SOCIAL SECURITY
 
        SUBCHAPTER XVIII--HEALTH INSURANCE FOR AGED AND DISABLED
 
 Part B--Supplementary Medical Insurance Benefits for Aged and Disabled
 
Sec. 1395w-2. Intermediate sanctions for providers or suppliers 
        of clinical diagnostic laboratory tests
        
    (a) If the Secretary determines that any provider or clinical 
laboratory approved for participation under this subchapter no longer 
substantially meets the conditions of participation or for coverage 
specified under this subchapter with respect to the provision of 
clinical diagnostic laboratory tests under this part, the Secretary may 
(for a period not to exceed one year) impose intermediate sanctions 
developed pursuant to subsection (b) of this section, in lieu of 
terminating immediately the provider agreement or cancelling immediately 
approval of the clinical laboratory.
    (b)(1) The Secretary shall develop and implement--
        (A) a range of intermediate sanctions to apply to providers or 
    clinical laboratories under the conditions described in subsection 
    (a), 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) directed plans of correction,
        (ii) civil money penalties in an amount not to exceed $10,000 
    for each day of substantial noncompliance,
        (iii) payment for the costs of onsite monitoring by an agency 
    responsible for conducting surveys, and
        (iv) suspension of all or part of the payments to which a 
    provider or clinical laboratory would otherwise be entitled under 
    this subchapter with respect to clinical diagnostic laboratory tests 
    furnished on or after the date on which the Secretary determines 
    that intermediate sanctions should be imposed pursuant to 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 (ii) in 
the same manner as such provisions apply to a penalty or proceeding 
under section 1320a-7a(a) of this title.
    (B) The sanctions specified in subparagraph (A) are in addition to 
sanctions otherwise available under State or Federal law.
    (3) The Secretary shall develop and implement specific procedures 
with respect to when and how each of the intermediate sanctions 
developed under paragraph (1) is to be applied, the amounts of any 
penalties, and the severity of each of these penalties. Such procedures 
shall be designed so as to minimize the time between identification of 
violations and imposition of these sanctions and shall provide for the 
imposition of incrementally more severe penalties for repeated or 
uncorrected deficiencies.

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1846, as added Pub. L. 100-
203, title IV, Sec. 4064(d)(1), Dec. 22, 1987, 101 Stat. 1330-111; 
amended Pub. L. 100-360, title II, Sec. 203(e)(4), title IV, 
Sec. 411(g)(3)(G), July 1, 1988, 102 Stat. 725, 784; Pub. L. 100-485, 
title VI, Sec. 608(d)(22)(C), Oct. 13, 1988, 102 Stat. 2421; Pub. L. 
101-234, title II, Sec. 201(a), Dec. 13, 1989, 103 Stat. 1981; Pub. L. 
101-508, title IV, Sec. 4154(e)(2), Nov. 5, 1990, 104 Stat. 1388-86.)


                               Amendments

    1990--Pub. L. 101-508 substituted ``providers or suppliers of'' for 
``providers of'' in section catchline.
    1989--Pub. L. 101-234 repealed Pub. L. 100-360, Sec. 203(e)(4), 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 notes below.
    1988--Pub. L. 100-360, Sec. 203(e)(4)(A), inserted ``and for 
qualified home intravenous drug therapy providers'' at end of section 
catchline.
    Subsec. (a). Pub. L. 100-360, Sec. 411(g)(3)(G)(i)(I), as amended by 
Pub. L. 100-485, substituted ``approved'' for ``certified''.
    Pub. L. 100-360, Sec. 411(g)(3)(G)(i)(II), inserted ``or for 
coverage'' after ``conditions of participation''.
    Pub. L. 100-360, Sec. 411(g)(3)(G)(i)(III), which directed amendment 
of subsec. (a) by substituting ``terminating immediately the provider 
agreement or cancelling immediately approval of the clinical 
laboratory'' for ``cancelling immediately the certification of the 
provider or clinical laboratory'', was executed by making the 
substitution for ``canceling immediately the certification of the 
provider or clinical laboratory'' to reflect the probable intent of 
Congress.
    Pub. L. 100-360, Sec. 203(e)(4)(B), inserted ``or that a qualified 
home intravenous drug therapy provider that is certified for 
participation under this subchapter no longer substantially meets the 
requirements of section 1395x(jj)(3) of this title'' after ``under this 
part''.
    Subsec. (b)(1)(A). Pub. L. 100-360, Sec. 411(g)(3)(G)(ii), struck 
out ``certified'' before ``clinical laboratories''.
    Subsec. (b)(2)(A). Pub. L. 100-360, Sec. 411(g)(3)(G)(iv), inserted 
at end ``The provisions of section 1320a-7a of this title (other than 
subsections (a) and (b)) shall apply to a civil money penalty under 
clause (ii) in the same manner as such provisions apply to a penalty or 
proceeding under section 1320a-7a(a) of this title.''
    Subsec. (b)(2)(A)(ii). Pub. L. 100-360, Sec. 411(g)(3)(G)(iii), 
substituted ``civil money penalties in an amount not to exceed $10,000 
for each day of substantial noncompliance'' for ``civil fines and 
penalties''.
    Subsec. (b)(2)(A)(iii). Pub. L. 100-360, Sec. 411(g)(3)(G)(v), 
struck out ``certification'' before ``surveys''.
    Subsec. (b)(2)(A)(iv). Pub. L. 100-360, Sec. 411(g)(3)(G)(ii), (vi), 
struck out ``certified'' before ``clinical laboratory'' and substituted 
``furnished on or after the date on'' for ``provided on or after the 
date in''.
    Pub. L. 100-360, Sec. 203(e)(4)(C), inserted ``or home intravenous 
drug therapy services'' after ``clinical diagnostic laboratory tests''.
    Subsec. (b)(3). Pub. L. 100-360, Sec. 411(g)(3)(G)(vii), substituted 
``any penalties'' for ``any fines'' and ``severe penalties'' for 
``severe fines''.


                    Effective Date of 1990 Amendment

    Amendment by Pub. L. 101-508 effective as if included in the 
enactment of the Omnibus Budget Reconciliation Act of 1989, Pub. L. 101-
239, see section 4154(e)(5) of Pub. L. 101-508, set out as a note under 
section 1395l of this title.


                    Effective Date of 1989 Amendment

    Amendment by Pub. L. 101-234 effective Jan. 1, 1990, see section 
201(c) of Pub. L. 101-234, set out as a note under section 1320a-7a of 
this title.


                    Effective Date of 1988 Amendments

    Amendment by Pub. L. 100-485 effective as if included in the 
enactment of the Medicare Catastrophic Coverage Act of 1988, Pub. L. 
100-360, see section 608(g)(1) of Pub. L. 100-485, set out as a note 
under section 704 of this title.
    Amendment by section 203(e)(4) of Pub. L. 100-360 applicable to 
items and services furnished on or after Jan. 1, 1990, see section 
203(g) of Pub. L. 100-360, set out as a note under section 1320c-3 of 
this title.
    Except as specifically provided in section 411 of Pub. L. 100-360, 
amendment by section 411(g)(3)(G) of 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

    Section 4064(d)(2) of Pub. L. 100-203 provided that: ``The amendment 
made by paragraph (1) [enacting this section] shall become effective on 
January 1, 1990.''
