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42 U.S.C. § 1395gg — Agreements with States

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395gg — Agreements with States

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Source location: Title 42, Chapter 7, § 1395gg; chapter-007-social-security.md

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**(a) Use of State agencies to determine compliance by providers of services with conditions of participation** The Secretary shall make an agreement with any State which is able and willing to do so under which the services of the State health agency or other appropriate State agency (or the appropriate local agencies) will be utilized by him for the purpose of determining whether an institution therein is a hospital or skilled nursing facility, or whether an agency therein is a home health agency, or whether an agency is a hospice program or whether a facility therein is a rural health clinic as defined in [section 1395x(aa)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395x/aa/2&num=0&edition=prelim), a critical access hospital, as defined in [section 1395x(mm)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395x/mm/1&num=0&edition=prelim), or a comprehensive outpatient rehabilitation facility as defined in [section 1395x(cc)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395x/cc/2&num=0&edition=prelim), or whether a laboratory meets the requirements of paragraphs (16) and (17) of [section 1395x(s) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395x/s&num=0&edition=prelim), or whether a clinic, rehabilitation agency or public health agency meets the requirements of subparagraph (A) or (B), as the case may be, of [section 1395x(p)(4) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395x/p/4&num=0&edition=prelim), or whether an ambulatory surgical center meets the standards specified under [section 1395k(a)(2)(F)(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395k/a/2/F/i&num=0&edition=prelim), or whether a facility is a rural emergency hospital as defined in [section 1395x(kkk)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395x/kkk/2&num=0&edition=prelim). To the extent that the Secretary finds it appropriate, an institution or agency which such a State (or local) agency certifies is a hospital, skilled nursing facility, rural health clinic, comprehensive outpatient rehabilitation facility, home health agency, or hospice program (as those terms are defined in [section 1395x of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395x&num=0&edition=prelim)) may be treated as such by the Secretary. Any State agency which has such an agreement may (subject to approval of the Secretary) furnish to a skilled nursing facility, after proper request by such facility, such specialized consultative services (which such agency is able and willing to furnish in a manner satisfactory to the Secretary) as such facility may need to meet one or more of the conditions specified in [section 1395i–3(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395i–3/a&num=0&edition=prelim). Any such services furnished by a State agency shall be deemed to have been furnished pursuant to such agreement. Within 90 days following the completion of each survey of any health care facility, ambulatory surgical center, rural health clinic, comprehensive outpatient rehabilitation facility, laboratory, clinic, agency, or organization by the appropriate State or local agency described in the first sentence of this subsection, the Secretary shall make public in readily available form and place, and require (in the case of skilled nursing facilities) the posting in a place readily accessible to patients (and patients’ representatives), the pertinent findings of each such survey relating to the compliance of each such health care facility, ambulatory surgical center, rural health clinic, comprehensive outpatient rehabilitation facility, laboratory, clinic, agency, or organization with (1) the statutory conditions of participation imposed under this subchapter and (2) the major additional conditions which the Secretary finds necessary in the interest of health and safety of individuals who are furnished care or services by any such health care facility, ambulatory surgical center, rural health clinic, comprehensive outpatient rehabilitation facility, laboratory, clinic, agency, or organization. Any agreement under this subsection shall provide for the appropriate State or local agency to maintain a toll-free hotline (1) to collect, maintain, and continually update information on home health agencies and hospice programs located in the State or locality that are certified to participate in the program established under this subchapter (which information shall include any significant deficiencies found with respect to patient care in the most recent certification survey conducted by a State agency or accreditation survey conducted by a private accreditation agency under [section 1395bb of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395bb&num=0&edition=prelim) with respect to the home health agency or the hospice program, when that survey was completed, whether corrective actions have been taken or are planned, and the sanctions, if any, imposed under this subchapter with respect to the agency or the hospice program) and (2) to receive complaints (and answer questions) with respect to home health agencies and hospice programs in the State or locality. Any such agreement shall provide for such State or local agency to maintain a unit for investigating such complaints that possesses enforcement authority and has access to survey and certification reports, information gathered by any private accreditation agency utilized by the Secretary under [section 1395bb of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395bb&num=0&edition=prelim), and consumer medical records (but only with the consent of the consumer or his or her legal representative). **(b) Payment in advance or by way of reimbursement to State for performance of functions of subsection (a)** The Secretary shall pay any such State, in advance or by way of reimbursement, as may be provided in the agreement with it (and may make adjustments in such payments on account of overpayments or underpayments previously made), for the reasonable cost of performing the functions specified in subsection (a), and for the Federal Hospital Insurance Trust Fund’s fair share of the costs attributable to the planning and other efforts directed toward coordination of activities in carrying out its agreement and other activities related to the provision of services similar to those for which payment may be made under part A, or related to the facilities and personnel required for the provision of such services, or related to improving the quality of such services. **(c) Use of State or local agencies to survey hospitals** The Secretary is authorized to enter into an agreement with any State under which the appropriate State or local agency which performs the certification function described in subsection (a) will survey, on a selective sample basis (or where the Secretary finds that a survey is appropriate because of substantial allegations of the existence of a significant deficiency or deficiencies which would, if found to be present, adversely affect health and safety of patients), provider entities that, pursuant to [section 1395bb(a)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395bb/a/1&num=0&edition=prelim), are treated as meeting the conditions or requirements of this subchapter. The Secretary shall pay for such services in the manner prescribed in subsection (b). **(d) Fulfillment of requirements by States** The Secretary may not enter an agreement under this section with a State with respect to determining whether an institution therein is a skilled nursing facility unless the State meets the requirements specified in [section 1395i–3(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395i–3/e&num=0&edition=prelim) and [section 1395i–3(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395i–3/g&num=0&edition=prelim) and the establishment of remedies under sections 1395i–3(h)(2)(B) and 1395i–3(h)(2)(C) of this title (relating to establishment and application of remedies). **(e) Prohibition of user fees for survey and certification** Notwithstanding any other provision of law, the Secretary may not impose, or require a State to impose, any fee on any facility or entity subject to a determination under subsection (a), or any renal dialysis facility subject to the requirements of [section 1395rr(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395rr/b/1&num=0&edition=prelim), for any such determination or any survey relating to determining the compliance of such facility or entity with any requirement of this subchapter (other than any fee relating to [section 263a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section263a&num=0&edition=prelim)).

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 704 — Use of allotment funds

**(a) Covered services** Except as otherwise provided under this section, a State may use amounts paid to it under [section 703 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section703&num=0&edition=prelim) for the provision of health services and related activities (including planning, administration, education, and evaluation and including payment of salaries and other related expenses of National Health Service Corps personnel) consistent with its application transmitted under [section 705(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section705/a&num=0&edition=prelim). **(b) Restrictions** Amounts described in subsection (a) may not be used for— (1) inpatient services, other than inpatient services provided to children with special health care needs or to high-risk pregnant women and infants and such other inpatient services as the Secretary may approve; (2) cash payments to intended recipients of health services; (3) the purchase or improvement of land, the purchase, construction, or permanent improvement (other than minor remodeling) of any building or other facility, or the purchase of major medical equipment; (4) satisfying any requirement for the expenditure of non-Federal funds as a condition for the receipt of Federal funds; (5) providing funds for research or training to any entity other than a public or nonprofit private entity; or (6) payment for any item or service (other than an emergency item or service) furnished— (A) by an individual or entity during the period when such individual or entity is excluded under this subchapter or subchapter XVIII, XIX, or XX pursuant to section 1320a–7, 1320a–7a, 1320c–5, or 1395u(j)(2) of this title, or (B) at the medical direct

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395aa — Medicare Prescription Drug Account in the Federal Supplementary Medical Insurance Trust Fund

**(a) Establishment and operation of Account** (1) **Establishment** — There is created within the Federal Supplementary Medical Insurance Trust Fund established by [section 1395t of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395t&num=0&edition=prelim) an account to be known as the “Medicare Prescription Drug Account” (in this section referred to as the “Account”). (2) **Funding** — The Account shall consist of such gifts and bequests as may be made as provided in [section 401(i)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section401/i/1&num=0&edition=prelim), accrued interest on balances in the Account, and such amounts as may be deposited in, or appropriated to, such Account as provided in this part. (3) **Separate from rest of Trust Fund** — Funds provided under this part to the Account shall be kept separate from all other funds within the Federal Supplementary Medical Insurance Trust Fund, but shall be invested, and such investments redeemed, in the same manner as all other funds and investments within such Trust Fund. **(b) Payments from Account** (1) **In general** — The Managing Trustee shall pay from time to time from the Account such amounts as the Secretary certifies are necessary to make payments to operate the program under this part, including— (A) payments under [section 1395w–114 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w-114&num=0&edition=prelim) (relating to low-income subsidy payments); (B) payments under [section 1395w–115 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w-115&num=0&edition=prelim) (relating to subsidy payments and payments for fallback

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1 U.S.C. § 106 — Printing bills and joint resolutions

Every bill or joint resolution in each House of Congress shall, when such bill or resolution passes either House, be printed, and such printed copy shall be called the engrossed bill or resolution as the case may be. Said engrossed bill or resolution shall be signed by the Clerk of the House or the Secretary of the Senate, and shall be sent to the other House, and in that form shall be dealt with by that House and its officers, and, if passed, returned signed by said Clerk or Secretary. When such bill, or joint resolution shall have passed both Houses, it shall be printed and shall then be called the enrolled bill, or joint resolution, as the case may be, and shall be signed by the presiding officers of both Houses and sent to the President of the United States. During the last six days of a session such engrossing and enrolling of bills and joint resolutions may be done otherwise than as above prescribed, upon the order of Congress by concurrent resolution.

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42 U.S.C. § 1395k — Payments to providers of services

**(a) Determination of amount** The Secretary shall periodically determine the amount which should be paid under this part to each provider of services with respect to the services furnished by it, and the provider of services shall be paid, at such time or times as the Secretary believes appropriate (but not less often than monthly) and prior to audit or settlement by the Government Accountability Office, from the Federal Hospital Insurance Trust Fund, the amounts so determined, with necessary adjustments on account of previously made overpayments or underpayments; except that no such payments shall be made to any provider unless it has furnished such information as the Secretary may request in order to determine the amounts due such provider under this part for the period with respect to which the amounts are being paid or any prior period. **(b) Conditions** No payment shall be made to a provider of services which is a hospital for or with respect to services furnished by it for any period with respect to which it is deemed, under [section 1395x(w)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395x/w/2&num=0&edition=prelim), to have in effect an arrangement with a quality improvement organization for the conduct of utilization review activities by such organization unless such hospital has paid to such organization the amount due (as determined pursuant to such section) to such organization for the review activities conducted by it pursuant to such arrangements or such hospital has provided assurances satisfactory to the Secretary that such organization will promptly be paid the amount so due to it from the proceeds of the payment claimed by the hospital. Payment under this subchapter for utilization review activities

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42 U.S.C. § 1395x — Manufacturer discount program

**(a) Establishment** The Secretary shall establish a manufacturer discount program (in this section referred to as the “program”). Under the program, the Secretary shall enter into agreements described in subsection (b) with manufacturers and provide for the performance of the duties described in subsection (c). **(b) Terms of agreement** (1) **In general** (A) *Agreement* — An agreement under this section shall require the manufacturer to provide, in accordance with this section, discounted prices for applicable drugs of the manufacturer that are dispensed to applicable beneficiaries on or after January 1, 2025. (B) *Clarification* — Nothing in this section shall be construed as affecting— (i) the application of a coinsurance of 25 percent of the negotiated price, as applied under paragraph (2)(A) of [section 1395w–102(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–102/b&num=0&edition=prelim), for costs described in such paragraph; or (ii) the application of the copayment amount described in paragraph (4)(A) of such section, with respect to costs described in such paragraph. (C) *Timing of agreement* (i) *Special rule for 2025* — In order for an agreement with a manufacturer to be in effect under this section with respect to the period beginning on January 1, 2025, and ending on December 31, 2025, the manufacturer shall enter into such agreement not later than March 1, 2024. (ii) *2026 and subsequent years* — In order for an agreement with a manufacturer to be in effect under this section with respect to plan year 2026 or a subsequent plan year, the manufacturer shall enter into such agreement not later than a calendar quarter or semi-annual deadline established by the Secretary. (2)

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42 U.S.C. § 1395m — Federal Hospital Insurance Trust Fund

**(a) Creation; deposits; transfers from Treasury** There is hereby created on the books of the Treasury of the United States a trust fund to be known as the “Federal Hospital Insurance Trust Fund” (hereinafter in this section referred to as the “Trust Fund”). The Trust Fund shall consist of such gifts and bequests as may be made as provided in [section 401(i)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section401/i/1&num=0&edition=prelim), and such amounts as may be deposited in, or appropriated to, such fund as provided in this part. There are hereby appropriated to the Trust Fund for the fiscal year ending June 30, 1966, and for each fiscal year thereafter, out of any moneys in the Treasury not otherwise appropriated, amounts equivalent to 100 per centum of— (1) the taxes imposed by sections 3101(b) and 3111(b) of the Internal Revenue Code of 1986 with respect to wages reported to the Secretary of the Treasury or his delegate pursuant to subtitle F of such Code after December 31, 1965, as determined by the Secretary of the Treasury by applying the applicable rates of tax under such sections to such wages, which wages shall be certified by the Commissioner of Social Security on the basis of records of wages established and maintained by the Commissioner of Social Security in accordance with such reports; and (2) the taxes imposed by section 1401(b) of the Internal Revenue Code of 1986 with respect to self-employment income reported to the Secretary of the Treasury or his delegate on tax returns under subtitle F of such Code, as determined by the Secretary of the Treasury by applying the applicable rate of tax under such section to such self-employment income, which self-employment income shall be certified by the Commission

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42 U.S.C. § 1395cc — Special rules for employer-sponsored programs

**(a) Subsidy payment** (1) **In general** — The Secretary shall provide in accordance with this subsection for payment to the sponsor of a qualified retiree prescription drug plan (as defined in paragraph (2)) of a special subsidy payment equal to the amount specified in paragraph (3) for each qualified covered retiree under the plan (as defined in paragraph (4)). This subsection constitutes budget authority in advance of appropriations Acts and represents the obligation of the Secretary to provide for the payment of amounts provided under this section. (2) **Qualified retiree prescription drug plan defined** — For purposes of this subsection, the term “qualified retiree prescription drug plan” means employment-based retiree health coverage (as defined in subsection (c)(1)) if, with respect to a part D eligible individual who is a participant or beneficiary under such coverage, the following requirements are met: (A) *Attestation of actuarial equivalence to standard coverage* — The sponsor of the plan provides the Secretary, annually or at such other time as the Secretary may require, with an attestation that the actuarial value of prescription drug coverage under the plan (as determined using the processes and methods described in [section 1395w–111(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–111/c&num=0&edition=prelim)) is at least equal to the actuarial value of standard prescription drug coverage, not taking into account the value of— (i) for years prior to 2025, any discount or coverage provided during the gap in prescription drug coverage that occurs between the initial coverage limit under [section 1395w–102(b)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-

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42 U.S.C. § 1395c — Prohibition against any Federal interference

Nothing in this subchapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

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42 U.S.C. § 1396r — Requirements for nursing facilities

**(a) “Nursing facility” defined** In this subchapter, the term “nursing facility” means an institution (or a distinct part of an institution) which— (1) is primarily engaged in providing to residents— (A) skilled nursing care and related services for residents who require medical or nursing care, (B) rehabilitation services for the rehabilitation of injured, disabled, or sick persons, or (C) on a regular basis, health-related care and services to individuals who because of their mental or physical condition require care and services (above the level of room and board) which can be made available to them only through institutional facilities, and is not primarily for the care and treatment of mental diseases; (2) has in effect a transfer agreement (meeting the requirements of section 1395x(l) of this title) with one or more hospitals having agreements in effect under [section 1395cc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395cc&num=0&edition=prelim); and (3) meets the requirements for a nursing facility described in subsections (b), (c), and (d) of this section. Such term also includes any facility which is located in a State on an Indian reservation and is certified by the Secretary as meeting the requirements of paragraph (1) and subsections (b), (c), and (d). **(b) Requirements relating to provision of services** (1) **Quality of life** (A) *In general* — A nursing facility must care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident. (B) *Quality assessment and assurance* — A nursing facility must maintain a quality assessment and assurance committee, consisting of the director of nursing services, a

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42 U.S.C. § 263a — Certification of laboratories

**(a) “Laboratory” or “clinical laboratory” defined** As used in this section, the term “laboratory” or “clinical laboratory” means a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. **(b) Certificate requirement** No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary under this section applicable to the category of examinations or procedures which includes such examination or procedure. **(c) Issuance and renewal of certificates** (1) **In general** — The Secretary may issue or renew a certificate for a laboratory only if the laboratory meets the requirements of subsection (d). (2) **Term** — A certificate issued under this section shall be valid for a period of 2 years or such shorter period as the Secretary may establish. **(d) Requirements for certificates** (1) **In general** — A laboratory may be issued a certificate or have its certificate renewed if— (A) the laboratory submits (or if the laboratory is accredited under subsection (e), the accreditation body which accredited the laboratory submits), an application— (i) in such form and manner as the Secretary shall prescribe, (ii) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory including— (I) the number and types of laboratory examinations and other procedures

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