42 U.S.C. § 1395hh : US Code - Section 1395HH: Regulations

Search 42 U.S.C. § 1395hh : US Code - Section 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).
(3)(A) The Secretary, in consultation with the Director of the
Office of Management and Budget, shall establish and publish a
regular timeline for the publication of final regulations based on
the previous publication of a proposed regulation or an interim
final regulation.
(B) Such timeline may vary among different regulations based on
differences in the complexity of the regulation, the number and
scope of comments received, and other relevant factors, but shall
not be longer than 3 years except under exceptional circumstances.
If the Secretary intends to vary such timeline with respect to the
publication of a final regulation, the Secretary shall cause to
have published in the Federal Register notice of the different
timeline by not later than the timeline previously established with
respect to such regulation. Such notice shall include a brief
explanation of the justification for such variation.
(C) In the case of interim final regulations, upon the expiration
of the regular timeline established under this paragraph for the
publication of a final regulation after opportunity for public
comment, the interim final regulation shall not continue in effect
unless the Secretary publishes (at the end of the regular timeline
and, if applicable, at the end of each succeeding 1-year period) a
notice of continuation of the regulation that includes an
explanation of why the regular timeline (and any subsequent 1-year
extension) was not complied with. If such a notice is published,
the regular timeline (or such timeline as previously extended under
this paragraph) for publication of the final regulation shall be
treated as having been extended for 1 additional year.
(D) The Secretary shall annually submit to Congress a report that
describes the instances in which the Secretary failed to publish a
final regulation within the applicable regular timeline under this
paragraph and that provides an explanation for such failures.
(4) If the Secretary publishes a final regulation that includes a
provision that is not a logical outgrowth of a previously published
notice of proposed rulemaking or interim final rule, such provision
shall be treated as a proposed regulation and shall not take effect
until there is the further opportunity for public comment and a
publication of the provision again as a final regulation.
(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.
(e) (!1) Retroactivity of substantive changes; reliance upon
written guidance
(1)(A) 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 -
(i) such retroactive application is necessary to comply with
statutory requirements; or
(ii) failure to apply the change retroactively would be
contrary to the public interest.
(B)(i) 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.
(ii) 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.
(C) 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.
(2)(A) If -
(i) 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;
(ii) 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
(iii) 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.
(B) 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.
(f) 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.
(2) In preparing a report under paragraph (1), the Secretary
shall collect -
(A) 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
(B) information from medicare contractors that tracks the
nature of written and telephone inquiries.
(3) 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.