42 U.S.C. § 1395hh — Regulations

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

(1) The Secretary^* must issue regulations needed to administer the insurance programs under this subchapter. Unless the context requires otherwise, "regulations" means regulations issued by the Secretary.

(2) A rule, requirement, or policy statement that creates or changes a substantive legal standard about the scope of benefits, payment for services, or eligibility to provide or receive services or benefits under this subchapter cannot take effect unless the Secretary issues it as a regulation under paragraph (1). This does not apply to a national coverage determination. This section does not define "substantive legal standard" or "national coverage determination."

(3)(A) In consultation with the Director^* of the Office of Management and Budget, the Secretary must establish and publish a regular schedule for issuing final regulations that follow a proposed or interim final regulation.

(B) The schedule may differ because regulations differ in complexity, number and scope of comments, or other relevant factors. Except in exceptional circumstances, it may not be longer than 3 years. If the Secretary plans to change a schedule for a final regulation, the Secretary must publish notice of the different schedule in the Federal Register no later than the previously established deadline. The notice must briefly explain why the schedule is changing.

(C) An interim final regulation stops being effective when its regular schedule for a final regulation after public comment expires unless the Secretary publishes a continuation notice at the end of that schedule and, when applicable, at the end of each later 1-year period. The notice must explain why the schedule, including any later 1-year extension, was not met. Publishing the notice extends the schedule for the final regulation by 1 additional year.

(D) Every year the Secretary must report to Congress which final regulations were not published within the applicable schedule and explain each failure.

(4) If a final regulation includes a provision that was not a logical outgrowth of a previously published proposed or interim final rule, that provision is treated as a proposed regulation. It cannot take effect until the public has another opportunity to comment and the provision is published again as a final regulation.

(b) Notice of proposed regulations; public comment.

(1) Before issuing a final regulation under subsection (a), the Secretary must publish notice of the proposed regulation in the Federal Register and allow at least 60 days for public comment, unless paragraph (2) applies.

(2) The 60-day rule does not apply when: (A) a statute specifically permits an interim final regulation or a shorter comment period; (B) a statute sets an implementation deadline less than 150 days after the statute's enactment; or (C) 5 U.S.C. 553(b) does not apply under subparagraph (B) of that subsection.

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

(1) At least every 3 months, the Secretary must publish in the Federal Register a list of all generally applicable manual instructions, interpretive rules, policy statements, and guidelines that: (A) were issued to carry out this subchapter; and (B) were not published under subsection (a)(1) and were not previously listed under this subsection.

(2) Beginning June 1, 1988, each fiscal intermediary and carrier that administers claims for extended care, post-hospital extended care, home health care, or durable medical equipment^* benefits under this subchapter must make public all interpretive materials, guidelines, and policy clarifications about payment for those benefits.

(3) To the extent feasible, the Secretary must change the Secretary's and the fiscal intermediaries' automated data collection and retrieval systems so an accessible database fairly and accurately shows the provision of extended care, post-hospital extended care, and home health care benefits under this subchapter. The database must include categories such as benefit denials, appeal results, and other relevant factors, and users must be able to select information by those categories, fiscal intermediary, service provider, and region.

(d) No text supplied in the section body.

(e) Retroactivity of substantive changes; reliance upon written guidance.

(1)(A) A substantive change in regulations, manual instructions, interpretive rules, policy statements, or generally applicable guidelines under this subchapter may not be applied retroactively, including by extrapolation, to items or services provided before the change's effective date. The exception is when the Secretary determines that retroactive application is necessary to meet statutory requirements or that not applying it would be contrary to the public interest.

(B)(i) A substantive change described in subparagraph (A) generally cannot take effect until 30 days after the Secretary issues or publishes it. (ii) The Secretary may choose an earlier date if the Secretary finds that doing so is necessary to meet statutory requirements or that applying the 30-day period would be contrary to the public interest. The Secretary must include that finding and a brief explanation in the issuance or publication.

(C) No action may be taken against a provider or supplier^* for failing to follow the substantive change for items or services provided before the change's effective date.

(2)(A) A provider or supplier is not subject to a penalty or interest under this subchapter, or under the parts of subchapter XI related to this subchapter, for providing an item or service or submitting a claim if: (i) the provider or supplier followed written guidance, including electronic guidance, from the Secretary or a Medicare contractor acting within its contract authority; (ii) the Secretary determines that the provider or supplier accurately described the relevant items, services, and claim to the contractor in writing; and (iii) the guidance was wrong. This protection applies only if the provider or supplier reasonably relied on the guidance. It includes interest under a repayment plan under section 1395ddd or otherwise.

(B) This rule does not prevent recovering or repaying an overpayment without an additional penalty when the overpayment was caused only by a clerical or technical operational error.

(f) Report on areas of inconsistency or conflict.

(1) Within 2 years after December 8, 2003, and every 3 years afterward, the Secretary must report to Congress on administering this subchapter and on inconsistencies or conflicts among its legal and regulatory provisions.

(2) To prepare the report, the Secretary must collect: (A) information from people entitled to Part A benefits or enrolled in Part B, or both, providers, suppliers, and the Medicare Beneficiary Ombudsman about those inconsistencies and conflicts; and (B) information from Medicare contractors tracking the nature of written and telephone inquiries.

(3) The report must describe the Secretary's efforts to reduce the inconsistencies or conflicts and recommend legislation or administrative action that the Secretary considers appropriate for reducing them further.