Title 42, The Public Health and WelfareRelease 119-110

§1395w–26 Establishment of Standards

Title 42 › CHAPTER 7 — SOCIAL SECURITY › SUBCHAPTER XVIII — HEALTH INSURANCE FOR AGED AND DISABLED › Part C — Medicare+Choice Program › § 1395w–26

Last updated Sep 22, 2026|Official source

Summary

The Secretary must quickly write clear financial rules that provider‑sponsored organizations must meet to be allowed to operate. In making those rules, the Secretary must work with groups like the National Association of Insurance Commissioners, the American Academy of Actuaries, beneficiary groups, and others. The rules must look at the organization’s delivery assets and ability to provide care directly, other ways to guard against going broke (for example reinsurance, surplus funds, letters of credit, guarantees, insurance, partnerships, or valuing direct care capacity), and any NAIC standards for risk‑based health care groups. The rules must protect enrollees so they are not responsible for the organization’s debts if the organization becomes insolvent. The Secretary must publish a notice by not later than 45 days after August 5, 1997, and set April 1, 1998 as the target date to publish the rule. The public comment time is shortened to 15 days. A negotiated rulemaking committee must be named within 30 days after that comment period ends, and a facilitator nominated within 10 days after the committee is chosen. The committee must report on progress by January 1, 1998 and, if it stays, submit a proposed rule by one month before the target date. The rule must be published by the target date, take effect immediately on an interim basis, allow at least 60 days for public comment, and be republished with changes within one year. The Secretary must also put other related rules in place by June 1, 1998; federal standards override state laws except for state licensing and state solvency laws, and major new rules can only start at the beginning of a calendar year.

Full Legal Text

Title 42, §1395w–26

The Public Health and Welfare, Source: USLM XML via OLRC

(a)Establishment of solvency standards for provider-sponsored organizations
(1)Establishment
(A)In general
The Secretary shall establish, on an expedited basis and using a negotiated rulemaking process under subchapter III of chapter 5 of title 5, standards described in section 1395w–25(c)(1) of this title (relating to the financial solvency and capital adequacy of the organization) that entities must meet to qualify as provider-sponsored organizations under this part.
(B)Factors to consider for solvency standards
In establishing solvency standards under subparagraph (A) for provider-sponsored organizations, the Secretary shall consult with interested parties and shall take into account—
(i)the delivery system assets of such an organization and ability of such an organization to provide services directly to enrollees through affiliated providers,
(ii)alternative means of protecting against insolvency, including reinsurance, unrestricted surplus, letters of credit, guarantees, organizational insurance coverage, partnerships with other licensed entities, and valuation attributable to the ability of such an organization to meet its service obligations through direct delivery of care, and
(iii)any standards developed by the National Association of Insurance Commissioners specifically for risk-based health care delivery organizations.
(C)Enrollee protection against insolvency
Such standards shall include provisions to prevent enrollees from being held liable to any person or entity for the Medicare+ÐChoice organization’s debts in the event of the organization’s insolvency.
(2)Publication of notice
In carrying out the rulemaking process under this subsection, the Secretary, after consultation with the National Association of Insurance Commissioners, the American Academy of Actuaries, organizations representative of medicare beneficiaries, and other interested parties, shall publish the notice provided for under section 564(a) of title 5 by not later than 45 days after August 5, 1997.
(3)Target date for publication of rule
As part of the notice under paragraph (2), and for purposes of this subsection, the “target date for publication” (referred to in section 564(a)(5) of such title) shall be April 1, 1998.
(4)Abbreviated period for submission of comments
In applying section 564(c) of such title under this subsection, “15 days” shall be substituted for “30 days”.
(5)Appointment of negotiated rulemaking committee and facilitator (6) Preliminary committee report
The Secretary shall provide for— (A)
(B)the nomination of a facilitator under section 566(c) of such title by not later than 10 days after the date of appointment of the committee.
(7)Final committee report
If the committee is not terminated under paragraph (6), the rulemaking committee shall submit a report containing a proposed rule by not later than 1 month before the target date of publication.
(8)Interim, final effect
The Secretary shall publish a rule under this subsection in the Federal Register by not later than the target date of publication. Such rule shall be effective and final immediately on an interim basis, but is subject to change and revision after public notice and opportunity for a period (of not less than 60 days) for public comment. In connection with such rule, the Secretary shall specify the process for the timely review and approval of applications of entities to be certified as provider-sponsored organizations pursuant to such rules and consistent with this subsection.
(9)Publication of rule after public comment
The Secretary shall provide for consideration of such comments and republication of such rule by not later than 1 year after the target date of publication.
(b)Establishment of other standards
(1)In general
The Secretary shall establish by regulation other standards (not described in subsection (a)) for Medicare+Choice organizations and plans consistent with, and to carry out, this part. The Secretary shall publish such regulations by June 1, 1998. In order to carry out this requirement in a timely manner, the Secretary may promulgate regulations that take effect on an interim basis, after notice and pending opportunity for public comment.
(2)Use of current standards
Consistent with the requirements of this part, standards established under this subsection shall be based on standards established under section 1395mm of this title to carry out analogous provisions of such section.
(3)Relation to State laws
The standards established under this part shall supersede any State law or regulation (other than State licensing laws or State laws relating to plan solvency) with respect to MA plans which are offered by MA organizations under this part.
(4)Prohibition of midyear implementation of significant new regulatory requirements
The Secretary may not implement, other than at the beginning of a calendar year, regulations under this section that impose new, significant regulatory requirements on a Medicare+Choice organization or plan.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Amendments

2003—Subsec. (b)(3). Pub. L. 108–173 reenacted heading without change and amended text generally. Prior to amendment, text consisted of subpars. (A) and (B) stating general rule and listing standards specifically superseded. 2000—Subsec. (b)(3)(B)(i). Pub. L. 106–554, § 1(a)(6) [title VI, § 614(a)(1)], inserted “(including cost-sharing requirements)” after “Benefit requirements”. Subsec. (b)(3)(B)(iv). Pub. L. 106–554, § 1(a)(6) [title VI, § 614(a)(2)], added cl. (iv). Subsec. (b)(4). Pub. L. 106–554, § 1(a)(6) [title VI, § 612(a)], added par. (4).

Statutory Notes and Related Subsidiaries

Change of Name

References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of Pub. L. 108–173, set out as a note under section 1395w–21 of this title.

Effective Date

of 2000 Amendment Pub. L. 106–554, § 1(a)(6) [title VI, § 612(b)], Dec. 21, 2000, 114 Stat. 2763, 2763A–560, provided that: “The amendment made by subsection (a) [amending this section] takes effect on the date of the enactment of this Act [Dec. 21, 2000].” Pub. L. 106–554, § 1(a)(6) [title VI, § 614(b)], Dec. 21, 2000, 114 Stat. 2763, 2763A–561, provided that: “The

Amendments

made by subsection (a) [amending this section] take effect on the date of the enactment of this Act [Dec. 21, 2000].”

Reference

Citations & Metadata

Citation

42 U.S.C. § 1395w–26

Title 42, The Public Health and Welfare

Last Updated

Sep 22, 2026

Release point: 119-110