
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: 42USC1395hh]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                       CHAPTER 7--SOCIAL SECURITY
 
        SUBCHAPTER XVIII--HEALTH INSURANCE FOR AGED AND DISABLED
 
                    Part D--Miscellaneous Provisions
 
Sec. 1395hh. Regulations


(a) Authority to prescribe regulations; ineffectiveness of substantive 
        rules not promulgated by regulation

    (1) The Secretary shall prescribe such regulations as may be 
necessary to carry out the administration of the insurance programs 
under this subchapter. When used in this subchapter, the term 
``regulations'' means, unless the context otherwise requires, 
regulations prescribed by the Secretary.
    (2) No rule, requirement, or other statement of policy (other than a 
national coverage determination) that establishes or changes a 
substantive legal standard governing the scope of benefits, the payment 
for services, or the eligibility of individuals, entities, or 
organizations to furnish or receive services or benefits under this 
subchapter shall take effect unless it is promulgated by the Secretary 
by regulation under paragraph (1).

(b) Notice of proposed regulations; public comment

    (1) Except as provided in paragraph (2), before issuing in final 
form any regulation under subsection (a) of this section, the Secretary 
shall provide for notice of the proposed regulation in the Federal 
Register and a period of not less than 60 days for public comment 
thereon.
    (2) Paragraph (1) shall not apply where--
        (A) a statute specifically permits a regulation to be issued in 
    interim final form or otherwise with a shorter period for public 
    comment,
        (B) a statute establishes a specific deadline for the 
    implementation of a provision and the deadline is less than 150 days 
    after the date of the enactment of the statute in which the deadline 
    is contained, or
        (C) subsection (b) of section 553 of title 5 does not apply 
    pursuant to subparagraph (B) of such subsection.

(c) Publication of certain rules; public inspection; changes in data 
        collection and retrieval

    (1) The Secretary shall publish in the Federal Register, not less 
frequently than every 3 months, a list of all manual instructions, 
interpretative rules, statements of policy, and guidelines of general 
applicability which--
        (A) are promulgated to carry out this subchapter, but
        (B) are not published pursuant to subsection (a)(1) of this 
    section and have not been previously published in a list under this 
    subsection.

    (2) Effective June 1, 1988, each fiscal intermediary and carrier 
administering claims for extended care, post-hospital extended care, 
home health care, and durable medical equipment benefits under this 
subchapter shall make available to the public all interpretative 
materials, guidelines, and clarifications of policies which relate to 
payments for such benefits.
    (3) The Secretary shall to the extent feasible make such changes in 
automated data collection and retrieval by the Secretary and fiscal 
intermediaries with agreements under section 1395h of this title as are 
necessary to make easily accessible for the Secretary and other 
appropriate parties a data base which fairly and accurately reflects the 
provision of extended care, post-hospital extended care and home health 
care benefits pursuant to this subchapter, including such categories as 
benefit denials, results of appeals, and other relevant factors, and 
selectable by such categories and by fiscal intermediary, service 
provider, and region.

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1871, as added Pub. L. 89-97, 
title I, Sec. 102(a) July 30, 1965, 79 Stat. 331; amended Pub. L. 99-
509, title IX, Sec. 9321(e)(1), Oct. 21, 1986, 100 Stat. 2017; Pub. L. 
100-203, title IV, Sec. 4035(b), (c), Dec. 22, 1987, 101 Stat. 1330-78.)


                               Amendments

    1987--Subsec. (a). Pub. L. 100-203, Sec. 4035(b), designated 
existing provisions as par. (1) and added par. (2).
    Subsec. (c). Pub. L. 100-203, Sec. 4035(c), added subsec. (c).
    1986--Pub. L. 99-509 designated existing provisions as subsec. (a) 
and added subsec. (b).


                    Effective Date of 1987 Amendment

    Amendment by Pub. L. 100-203 effective Dec. 22, 1987, and applicable 
to budgets for fiscal years beginning with fiscal year 1989, see section 
4035(a)(3) of Pub. L. 100-203, set out as a note under section 1395h of 
this title.


                    Effective Date of 1986 Amendment

    Section 9321(e)(3)(A) of Pub. L. 99-509 provided that: ``The 
amendments made by paragraph (1) [amending this section] shall apply to 
notices of proposed rulemaking issued after the date of the enactment of 
this Act [Oct. 21, 1986].''


                               Regulations

    Pub. L. 101-508, title IV, Sec. 4207(j), formerly Sec. 4027(j), Nov. 
5, 1990, 104 Stat. 1388-124, as renumbered and amended by Pub. L. 103-
432, title I, Sec. 160(d)(4), (12), Oct. 31, 1994, 108 Stat. 4444, 
provided that: ``The Secretary of Health and Human Services shall issue 
such regulations (on an interim or other basis) as may be necessary to 
implement this subtitle [subtitle A (Secs. 4000-4361) of title IV of 
Pub. L. 101-508, see Tables for classification] and the amendments made 
by this subtitle.''
    Section 4039(g) of title IV of Pub. L. 100-203 provided that: ``The 
Secretary of Health and Human Services shall issue such regulations (on 
an interim or other basis) as may be necessary to implement this 
subtitle and the amendments made by this subtitle [subtitle A 
(Secs. 4001-4097) of title IV of Pub. L. 100-203, see Tables for 
classification].''

                  Section Referred to in Other Sections

    This section is referred to in sections 1395h, 1395u, 1395ff of this 
title.
