Source: http://www.law.cornell.edu/uscode/text/42/1395hh?quicktabs_8=2
Timestamp: 2014-12-25 10:28:35
Document Index: 535431063

Matched Legal Cases: ['§ 1871', '§ 102', '§ 9321', '§ 4035', '§ 902', '§ 902', '§ 902', '§ 903', '§ 903', '§ 903', '§ 904', '§ 4035', '§ 4035', '§ 902', '§ 902', '§ 903', '§ 903', '§ 903', '§ 9321', '§ 4207', '§ 4027', '§ 160', '§ 4000', '§ 4001', '§ 904', 'art 484', 'art 121', 'art 400', 'art 401', 'art 402', 'art 403', 'art 405', 'art 406', 'art 407', 'art 408', 'art 409', 'art 410', 'art 411', 'art 412', 'art 413', 'art 414', 'art 417', 'art 418', 'art 419', 'art 420', 'art 421', 'art 422', 'art 424', 'art 425', 'art 46642', 'art 47342', 'art 482', 'art 483', 'art 486', 'art 488', 'art 489', 'art 495', 'art 498', 'art 505', 'art 1000', 'art 1001']

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.
Paragraph (1) shall not apply where—
a statute specifically permits a regulation to be issued in interim final form or otherwise with a shorter period for public comment,
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
subsection (b) ofsection 553 of title 5 does not apply pursuant to subparagraph (B) of such subsection.
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—
are promulgated to carry out this subchapter, but
are not published pursuant to subsection (a)(1) of this section and have not been previously published in a list under this subsection.
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.
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.
1 Retroactivity of substantive changes; reliance upon written guidance (1)
A substantive change in regulations, manual instructions, interpretative rules, statements of policy, or guidelines of general applicability under this subchapter shall not be applied (by extrapolation or otherwise) retroactively to items and services furnished before the effective date of the change, unless the Secretary determines that—
such retroactive application is necessary to comply with statutory requirements; or
failure to apply the change retroactively would be contrary to the public interest.
Except as provided in clause (ii), a substantive change referred to in subparagraph (A) shall not become effective before the end of the 30-day period that begins on the date that the Secretary has issued or published, as the case may be, the substantive change.
The Secretary may provide for such a substantive change to take effect on a date that precedes the end of the 30-day period under clause (i) if the Secretary finds that waiver of such 30-day period is necessary to comply with statutory requirements or that the application of such 30-day period is contrary to the public interest. If the Secretary provides for an earlier effective date pursuant to this clause, the Secretary shall include in the issuance or publication of the substantive change a finding described in the first sentence, and a brief statement of the reasons for such finding.
No action shall be taken against a provider of services or supplier with respect to noncompliance with such a substantive change for items and services furnished before the effective date of such a change.
a provider of services or supplier follows the written guidance (which may be transmitted electronically) provided by the Secretary or by a medicare contractor (as defined in section 1395zz
(g) of this title) acting within the scope of the contractor’s contract authority, with respect to the furnishing of items or services and submission of a claim for benefits for such items or services with respect to such provider or supplier;
the Secretary determines that the provider of services or supplier has accurately presented the circumstances relating to such items, services, and claim to the contractor in writing; and
the guidance was in error;
the provider of services or supplier shall not be subject to any penalty or interest under this subchapter or the provisions of subchapter XI of this chapter insofar as they relate to this subchapter (including interest under a repayment plan under section 1395ddd of this title or otherwise) relating to the provision of such items or service or such claim if the provider of services or supplier reasonably relied on such guidance.
Subparagraph (A) shall not be construed as preventing the recoupment or repayment (without any additional penalty) relating to an overpayment insofar as the overpayment was solely the result of a clerical or technical operational error.
Report on areas of inconsistency or conflict (1)
Not later than 2 years after December 8, 2003, and every 3 years thereafter, the Secretary shall submit to Congress a report with respect to the administration of this subchapter and areas of inconsistency or conflict among the various provisions under law and regulation.
In preparing a report under paragraph (1), the Secretary shall collect—
information from individuals entitled to benefits under part A of this subchapter or enrolled under part B of this subchapter, or both, providers of services, and suppliers and from the Medicare Beneficiary Ombudsman with respect to such areas of inconsistency and conflict; and
information from medicare contractors that tracks the nature of written and telephone inquiries.
A report under paragraph (1) shall include a description of efforts by the Secretary to reduce such inconsistency or conflicts, and recommendations for legislation or administrative action that the Secretary determines appropriate to further reduce such inconsistency or conflicts.
(Aug. 14, 1935, ch. 531, title XVIII, § 1871, as added Pub. L. 89–97, title I, § 102(a)July 30, 1965, 79 Stat. 331; amended Pub. L. 99–509, title IX, § 9321(e)(1),Oct. 21, 1986, 100 Stat. 2017; Pub. L. 100–203, title IV, § 4035(b), (c),Dec. 22, 1987, 101 Stat. 1330–78; Pub. L. 108–173, title IX, §§ 902(a)(1), (b)(1), 903
(a)(1), (b)(1), (c)(1), 904
(b),Dec. 8, 2003, 117 Stat. 2375–2377.)
2003—Subsec. (a)(3). Pub. L. 108–173, § 902(a)(1), added par. (3).
Subsec. (a)(4). Pub. L. 108–173, § 902(b)(1), added par. (4).
Subsec. (e). Pub. L. 108–173, § 903(a)(1), added subsec. (e).
Subsec. (e)(1)(B), (C). Pub. L. 108–173, § 903(b)(1), added subpars. (B) and (C).
Subsec. (e)(2). Pub. L. 108–173, § 903(c)(1), added par. (2).
Subsec. (f). Pub. L. 108–173, § 904(b), added subsec. (f).
1987—Subsec. (a). Pub. L. 100–203, § 4035(b), designated existing provisions as par. (1) and added par. (2).
Subsec. (c). Pub. L. 100–203, § 4035(c), added subsec. (c).
1986—Pub. L. 99–509designated existing provisions as subsec. (a) and added subsec. (b).
Pub. L. 108–173, title IX, § 902(a)(2),Dec. 8, 2003, 117 Stat. 2375, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect on the date of the enactment of this Act [Dec. 8, 2003]. The Secretary [of Health and Human Services] shall provide for an appropriate transition to take into account the backlog of previously published interim final regulations.”
Pub. L. 108–173, title IX, § 902(b)(2),Dec. 8, 2003, 117 Stat. 2376, provided that: “The amendment made by paragraph (1) [amending this section] shall apply to final regulations published on or after the date of the enactment of this Act [Dec. 8, 2003].”
Pub. L. 108–173, title IX, § 903(a)(2),Dec. 8, 2003, 117 Stat. 2376, provided that: “The amendment made by paragraph (1) [amending this section] shall apply to substantive changes issued on or after the date of the enactment of this Act [Dec. 8, 2003].”
Pub. L. 108–173, title IX, § 903(b)(2),Dec. 8, 2003, 117 Stat. 2376, provided that: “The amendment made by paragraph (1) [amending this section] shall apply to compliance actions undertaken on or after the date of the enactment of this Act [Dec. 8, 2003].”
Pub. L. 108–173, title IX, § 903(c)(2),Dec. 8, 2003, 117 Stat. 2377, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect on the date of the enactment of this Act [Dec. 8, 2003] and shall only apply to a penalty or interest imposed with respect to guidance provided on or after July 24, 2003.”
Amendment by Pub. L. 100–203effective Dec. 22, 1987, and applicable to budgets for fiscal years beginning with fiscal year 1989, see section 4035(a)(3) ofPub. L. 100–203, set out as a note under section 1395h of this title.
Pub. L. 99–509, title IX, § 9321(e)(3)(A),Oct. 21, 1986, 100 Stat. 2018, 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].”
Pub. L. 101–508, title IV, § 4207(j), formerly § 4027(j),Nov. 5, 1990, 104 Stat. 1388–124, as renumbered and amended by Pub. L. 103–432, title I, § 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 (§§ 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. 100–203provided 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 (§§ 4001–4097) of title IV of Pub. L. 100–203, see Tables for classification].”
GAO Study on Advisory Opinion Authority
Pub. L. 108–173, title IX, § 904(a),Dec. 8, 2003, 117 Stat. 2377, provided that:
“(1) Study.—The Comptroller General of the United States shall conduct a study to determine the feasibility and appropriateness of establishing in the Secretary [of Health and Human Services] authority to provide legally binding advisory opinions on appropriate interpretation and application of regulations to carry out the medicare program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.]. Such study shall examine the appropriate timeframe for issuing such advisory opinions, as well as the need for additional staff and funding to provide such opinions.
“(2) Report.—The Comptroller General shall submit to Congress a report on the study conducted under paragraph (1) by not later than 1 year after the date of the enactment of this Act [Dec. 8, 2003].”
This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.40 CFR - Protection of Environment40 CFR Part 484
42 CFR - Public Health42 CFR Part 121 - ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK42 CFR Part 400 - INTRODUCTION; DEFINITIONS42 CFR Part 401 - GENERAL ADMINISTRATIVE REQUIREMENTS42 CFR Part 402 - CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS42 CFR Part 403 - SPECIAL PROGRAMS AND PROJECTS42 CFR Part 405 - FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED42 CFR Part 406 - HOSPITAL INSURANCE ELIGIBILITY AND ENTITLEMENT42 CFR Part 407 - SUPPLEMENTARY MEDICAL INSURANCE (SMI) ENROLLMENT AND ENTITLEMENT42 CFR Part 408 - PREMIUMS FOR SUPPLEMENTARY MEDICAL INSURANCE42 CFR Part 409 - HOSPITAL INSURANCE BENEFITS42 CFR Part 410 - SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS42 CFR Part 411 - EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT42 CFR Part 412 - PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES42 CFR Part 413 - PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR END-STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY DETERMINED PAYMENT RATES FOR SKILLED NURSING FACILITIES42 CFR Part 414 - PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES42 CFR Part 417 - HEALTH MAINTENANCE ORGANIZATIONS, COMPETITIVE MEDICAL PLANS, AND HEALTH CARE PREPAYMENT PLANS42 CFR Part 418 - HOSPICE CARE42 CFR Part 419 - PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT DEPARTMENT SERVICES42 CFR Part 420 - PROGRAM INTEGRITY: MEDICARE42 CFR Part 421 - MEDICARE CONTRACTING42 CFR Part 422 - MEDICARE ADVANTAGE PROGRAM42 CFR Part 424 - CONDITIONS FOR MEDICARE PAYMENT42 CFR Part 425 - MEDICARE SHARED SAVINGS PROGRAM42 CFR Part 46642 CFR Part 47342 CFR Part 482 - CONDITIONS OF PARTICIPATION FOR HOSPITALS42 CFR Part 483 - REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES42 CFR Part 486 - CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY SUPPLIERS42 CFR Part 488 - SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES42 CFR Part 489 - PROVIDER AGREEMENTS AND SUPPLIER APPROVAL42 CFR Part 495 - STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY INCENTIVE PROGRAM42 CFR Part 498 - APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT AFFECT THE PARTICIPATION OF ICFs/IID AND CERTAIN NFs IN THE MEDICAID PROGRAM42 CFR Part 505 - ESTABLISHMENT OF THE HEALTH CARE INFRASTRUCTURE IMPROVEMENT PROGRAM42 CFR Part 1000 - INTRODUCTION; GENERAL DEFINITIONS42 CFR Part 1001 - PROGRAM INTEGRITY—MEDICARE AND STATE HEALTH CARE PROGRAMS