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42 U.S.C. § 18001 — Immediate access to insurance for uninsured individuals with a preexisting condition

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

42 U.S.C. § 18001 — Immediate access to insurance for uninsured individuals with a preexisting condition

**(a) In general** Not later than 90 days after March 23, 2010, the Secretary shall establish a temporary high risk health insurance pool program to provide health insurance coverage for eligible individuals during the period beginning on the date on which such program is established and ending on January 1, 2014. **(b) Administration** (1) **In general** — The Secretary may carry out the program under this section directly or through contracts to eligible entities. (2) **Eligible entities** — To be eligible for a contract under paragraph (1), an entity shall— (A) be a State or nonprofit private entity; (B) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require; and (C) agree to utilize contract funding to establish and administer a qualified high risk pool for eligible individuals. (3) **Maintenance of effort** — To be eligible to enter into a contract with the Secretary under this subsection, a State shall agree not to reduce the annual amount the State expended for the operation of one or more State high risk pools during the year preceding the year in which such contract is entered into. **(c) Qualified high risk pool** (1) **In general** — Amounts made available under this section shall be used to establish a qualified high risk pool that meets the requirements of paragraph (2). (2) **Requirements** — A qualified high risk pool meets the requirements of this paragraph if such pool— (A) provides to all eligible individuals health insurance coverage that does not impose any preexisting condition exclusion with respect to such coverage; (B) provides health insurance coverage— (i) in which the issuer’s share of the total allowed costs of benefits provided under such co

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Stable record: federal_law:legal_authorities:record_usc_1b1e13acaef68c3522cd5329
Source file: Laws/federal/codes/united-states-code/title-42/section-18001-immediate-access-to-insurance-for-uninsured-individuals-with-a-preexisti--6a5e0b3ec4.md
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Source location: Title 42, Chapter 157, § 18001; chapter-157-quality-affordable-health-care-for-all-americans.md

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**(a) In general** Not later than 90 days after March 23, 2010, the Secretary shall establish a temporary high risk health insurance pool program to provide health insurance coverage for eligible individuals during the period beginning on the date on which such program is established and ending on January 1, 2014. **(b) Administration** (1) **In general** — The Secretary may carry out the program under this section directly or through contracts to eligible entities. (2) **Eligible entities** — To be eligible for a contract under paragraph (1), an entity shall— (A) be a State or nonprofit private entity; (B) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require; and (C) agree to utilize contract funding to establish and administer a qualified high risk pool for eligible individuals. (3) **Maintenance of effort** — To be eligible to enter into a contract with the Secretary under this subsection, a State shall agree not to reduce the annual amount the State expended for the operation of one or more State high risk pools during the year preceding the year in which such contract is entered into. **(c) Qualified high risk pool** (1) **In general** — Amounts made available under this section shall be used to establish a qualified high risk pool that meets the requirements of paragraph (2). (2) **Requirements** — A qualified high risk pool meets the requirements of this paragraph if such pool— (A) provides to all eligible individuals health insurance coverage that does not impose any preexisting condition exclusion with respect to such coverage; (B) provides health insurance coverage— (i) in which the issuer’s share of the total allowed costs of benefits provided under such coverage is not less than 65 percent of such costs; and (ii) that has an out of pocket limit not greater than the applicable amount described in [section 223(c)(2) of title 26](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title26-section223/c/2&num=0&edition=prelim) for the year involved, except that the Secretary may modify such limit if necessary to ensure the pool meets the actuarial value limit under clause (i); (C) ensures that with respect to the premium rate charged for health insurance coverage offered to eligible individuals through the high risk pool, such rate shall— (i) except as provided in clause (ii), vary only as provided for under [section 300gg of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300gg&num=0&edition=prelim) (as amended by this Act and notwithstanding the date on which such amendments take effect); (ii) vary on the basis of age by a factor of not greater than 4 to 1; and (iii) be established at a standard rate for a standard population; and (D) meets any other requirements determined appropriate by the Secretary. **(d) Eligible individual** An individual shall be deemed to be an eligible individual for purposes of this section if such individual— (1) is a citizen or national of the United States or is lawfully present in the United States (as determined in accordance with [section 18081 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section18081&num=0&edition=prelim)); (2) has not been covered under creditable coverage (as defined in [section 300gg(c)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300gg/c/1&num=0&edition=prelim) as in effect on March 23, 2010) during the 6-month period prior to the date on which such individual is applying for coverage through the high risk pool; and (3) has a pre-existing condition, as determined in a manner consistent with guidance issued by the Secretary. **(e) Protection against dumping risk by insurers** (1) **In general** — The Secretary shall establish criteria for determining whether health insurance issuers and employment-based health plans have discouraged an individual from remaining enrolled in prior coverage based on that individual’s health status. (2) **Sanctions** — An issuer or employment-based health plan shall be responsible for reimbursing the program under this section for the medical expenses incurred by the program for an individual who, based on criteria established by the Secretary, the Secretary finds was encouraged by the issuer to disenroll from health benefits coverage prior to enrolling in coverage through the program. The criteria shall include at least the following circumstances: (A) In the case of prior coverage obtained through an employer, the provision by the employer, group health plan, or the issuer of money or other financial consideration for disenrolling from the coverage. (B) In the case of prior coverage obtained directly from an issuer or under an employment-based health plan— (i) the provision by the issuer or plan of money or other financial consideration for disenrolling from the coverage; or (ii) in the case of an individual whose premium for the prior coverage exceeded the premium required by the program (adjusted based on the age factors applied to the prior coverage)— (I) the prior coverage is a policy that is no longer being actively marketed (as defined by the Secretary) by the issuer; or (II) the prior coverage is a policy for which duration of coverage form 11 So in original. Probably should be “from”. issue or health status are factors that can be considered in determining premiums at renewal. (3) **Construction** — Nothing in this subsection shall be construed as constituting exclusive remedies for violations of criteria established under paragraph (1) or as preventing States from applying or enforcing such paragraph or other provisions under law with respect to health insurance issuers. **(f) Oversight** The Secretary shall establish— (1) an appeals process to enable individuals to appeal a determination under this section; and (2) procedures to protect against waste, fraud, and abuse. **(g) Funding; termination of authority** (1) **In general** — There is appropriated to the Secretary, out of any moneys in the Treasury not otherwise appropriated, $5,000,000,000 to pay claims against (and the administrative costs of) the high risk pool under this section that are in excess of the amount of premiums collected from eligible individuals enrolled in the high risk pool. Such funds shall be available without fiscal year limitation. (2) **Insufficient funds** — If the Secretary estimates for any fiscal year that the aggregate amounts available for the payment of the expenses of the high risk pool will be less than the actual amount of such expenses, the Secretary shall make such adjustments as are necessary to eliminate such deficit. (3) **Termination of authority** (A) *In general* — Except as provided in subparagraph (B), coverage of eligible individuals under a high risk pool in a State shall terminate on January 1, 2014. (B) *Transition to Exchange* — The Secretary shall develop procedures to provide for the transition of eligible individuals enrolled in health insurance coverage offered through a high risk pool established under this section into qualified health plans offered through an Exchange. Such procedures shall ensure that there is no lapse in coverage with respect to the individual and may extend coverage after the termination of the risk pool involved, if the Secretary determines necessary to avoid such a lapse. (4) **Limitations** — The Secretary has the authority to stop taking applications for participation in the program under this section to comply with the funding limitation provided for in paragraph (1). (5) **Relation to State laws** — The standards established under this section shall supersede any State law or regulation (other than State licensing laws or State laws relating to plan solvency) with respect to qualified high risk pools which are established in accordance with this section.

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

42 U.S.C. § 254c — Rural health care services outreach, rural health network development, and small health care provider quality improvement grant programs

**(a) Purpose** The purpose of this section is to provide grants for expanded delivery of health care services in rural areas, for the planning and implementation of integrated health care networks in rural areas, and for the planning and implementation of small health care provider quality improvement activities. **(b) Definitions** (1) **Director** — The term “Director” means the Director specified in subsection (d). (2) **Federally qualified health center; rural health clinic** — The terms “Federally qualified health center” and “rural health clinic” have the meanings given the terms in [section 1395x(aa) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395x/aa&num=0&edition=prelim). (3) **Health professional shortage area** — The term “health professional shortage area” means a health professional shortage area designated under [section 254e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section254e&num=0&edition=prelim). (4) **Medically underserved community** — The term “medically underserved community” has the meaning given the term in [section 295p(6) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section295p/6&num=0&edition=prelim). (5) **Medically underserved population** — The term “medically underserved population” has the meaning given the term in [section 254b(b)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section254b/b/3&num=0&edition=prelim). **(c) Program** The Secretary shall establish, under [section 241 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section241&num=0&edition=prelim), a small health care provider quality improvement grant program. **(

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 254c

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

42 U.S.C. § 254b — Health centers

**(a) “Health center” defined** (1) **In general** — For purposes of this section, the term “health center” means an entity that serves a population that is medically underserved, or a special medically underserved population comprised of migratory and seasonal agricultural workers, the homeless, and residents of public housing, by providing, either through the staff and supporting resources of the center or through contracts or cooperative arrangements— (A) required primary health services (as defined in subsection (b)(1)); and (B) as may be appropriate for particular centers, additional health services (as defined in subsection (b)(2)) necessary for the adequate support of the primary health services required under subparagraph (A); for all residents of the area served by the center (hereafter referred to in this section as the “catchment area”). (2) **Limitation** — The requirement in paragraph (1) to provide services for all residents within a catchment area shall not apply in the case of a health center receiving a grant only under subsection (g), (h), or (i). **(b) Definitions** For purposes of this section: (1) **Required primary health services** (A) *In general* — The term “required primary health services” means— (i) basic health services which, for purposes of this section, shall consist of— (I) health services related to family medicine, internal medicine, pediatrics, obstetrics, or gynecology that are furnished by physicians and where appropriate, physician assistants, nurse practitioners, and nurse midwives; (II) diagnostic laboratory and radiologic services; (III) preventive health services, including— (aa) prenatal and perinatal services; (bb) appropriate cancer screening; (cc) well-chil

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 254b

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

21 U.S.C. § 360bbb–0a — Investigational drugs for use by eligible patients

**(a) Definitions** For purposes of this section— (1) the term “eligible patient” means a patient— (A) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations)); (B) who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who— (i) is in good standing with the physician’s licensing organization or board; and (ii) will not be compensated directly by the manufacturer for so certifying; and (C) who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent; (2) the term “eligible investigational drug” means an investigational drug (as such term is used in [section 360bbb of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb&num=0&edition=prelim))— (A) for which a Phase 1 clinical trial has been completed; (B) that has not been approved or licensed for any use under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)]; (C) (i) for which an application has been filed under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) or section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](htt

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360bbb–0a

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

42 U.S.C. § 18014 — Treatment of expatriate health plans under ACA

**(a) In general** Subject to subsection (b), the provisions of (including any amendment made by) the Patient Protection and Affordable Care Act (Public Law 111–148) and of title I and subtitle B of title II of the Health Care and Education Reconciliation Act of 2010 (Public Law 111–152) shall not apply with respect to— (1) expatriate health plans; (2) employers with respect to such plans, solely in their capacity as plan sponsors for such plans; or (3) expatriate health insurance issuers with respect to coverage offered by such issuers under such plans. **(b) Minimum essential coverage and reporting requirements** (1) **In general** — For the purpose of [section 5000A(f) of title 26](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title26-section5000A/f&num=0&edition=prelim), and any other section of title 26 that incorporates the definition of minimum essential coverage under such section 5000A(f) by reference: (A) An expatriate health plan offered to primary enrollees who are described in subsections (d)(3)(A) and (d)(3)(B) of this section shall be treated as an eligible employer sponsored plan under 5000A(f)(2) of such title. (B) An expatriate health plan offered to primary enrollees who are described in subsection (d)(3)(C) of this section shall be treated as a plan in the individual market under section 5000A(f)(1)(C) of such title. This subparagraph shall apply solely for the purposes of sections 36B, 5000A, and 6055 of such title. (2) **Exception** — Subsection (a) shall not apply with respect to [section 6055 of title 26](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title26-section6055&num=0&edition=prelim), or sections 4980H and 6056 of such title in the case of an applicable large employer (as defined in section 4980H

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 18014

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

42 U.S.C. § 1395u — Establishment of supplementary medical insurance program for aged and disabled

There is hereby established a voluntary insurance program to provide medical insurance benefits in accordance with the provisions of this part for aged and disabled individuals who elect to enroll under such program, to be financed from premium payments by enrollees together with contributions from funds appropriated by the Federal Government.

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 1395u

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

42 U.S.C. § 300gg — Fair health insurance premiums

**(a) 11 So in original. No subsec. (b) has been enacted. Prohibiting discriminatory premium rates** (1) **In general** — With respect to the premium rate charged by a health insurance issuer for health insurance coverage offered in the individual or small group market— (A) such rate shall vary with respect to the particular plan or coverage involved only by— (i) whether such plan or coverage covers an individual or family; (ii) rating area, as established in accordance with paragraph (2); (iii) age, except that such rate shall not vary by more than 3 to 1 for adults (consistent with [section 300gg–6(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300gg–6/c&num=0&edition=prelim)); and (iv) tobacco use, except that such rate shall not vary by more than 1.5 to 1; and (B) such rate shall not vary with respect to the particular plan or coverage involved by any other factor not described in subparagraph (A). (2) **Rating area** (A) *In general* — Each State shall establish 1 or more rating areas within that State for purposes of applying the requirements of this subchapter. (B) *Secretarial review* — The Secretary shall review the rating areas established by each State under subparagraph (A) to ensure the adequacy of such areas for purposes of carrying out the requirements of this subchapter. If the Secretary determines a State’s rating areas are not adequate, or that a State does not establish such areas, the Secretary may establish rating areas for that State. (3) **Permissible age bands** — The Secretary, in consultation with the National Association of Insurance Commissioners, shall define the permissible age bands for rating purposes under paragraph (1)(A)(iii). (4) **Application of variat

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 300gg

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

21 U.S.C. § 355–2 — Actions for delays of generic drugs and biosimilar biological products

**(a) Definitions** In this section— (1) the term “commercially reasonable, market-based terms” means— (A) a nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug, as defined in [section 1395w–3a(c)(6)(B) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–3a/c/6/B&num=0&edition=prelim); (B) a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection (b)(2)(A)(iv); and (C) no additional conditions are imposed on the sale of the covered product; (2) the term “covered product”— (A) means— (i) any drug approved under subsection (c) or (j) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or biological product licensed under subsection (a) or (k) of [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim); (ii) any combination of a drug or biological product described in clause (i); or (iii) when reasonably necessary to support approval of an application under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), as applicable, or otherwise meet the requirements for approval under either such section, any product, including any device, that is marketed or intended for use with such a drug or biological product; and (B) does not include any drug or biologica

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355–2

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

21 U.S.C. § 384 — Importation of prescription drugs

**(a) Definitions** In this section: (1) **Importer** — The term “importer” means a pharmacist or wholesaler. (2) **Pharmacist** — The term “pharmacist” means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs. (3) **Prescription drug** — The term “prescription drug” means a drug subject to [section 353(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b&num=0&edition=prelim), other than— (A) a controlled substance (as defined in [section 802 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section802&num=0&edition=prelim)); (B) a biological product (as defined in [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)); (C) an infused drug (including a peritoneal dialysis solution); (D) an intravenously injected drug; (E) a drug that is inhaled during surgery; or (F) a drug which is a parenteral drug, the importation of which pursuant to subsection (b) is determined by the Secretary to pose a threat to the public health, in which case [section 381(d)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/d/1&num=0&edition=prelim) shall continue to apply. (4) **Qualifying laboratory** — The term “qualifying laboratory” means a laboratory in the United States that has been approved by the Secretary for the purposes of this section. (5) **Wholesaler** (A) *In general* — The term “wholesaler” means a person licensed as a wholesaler or distributor of prescription drugs in the United States under [section 353(e)(2)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-titl

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 384

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

42 U.S.C. § 18081 — Procedures for determining eligibility for Exchange participation, premium tax credits and reduced cost-sharing, and individual responsibility exemptions

**(a) Establishment of program** The Secretary shall establish a program meeting the requirements of this section for determining— (1) whether an individual who is to be covered in the individual market by a qualified health plan offered through an Exchange, or who is claiming a premium tax credit or reduced cost-sharing, meets the requirements of sections 18032(f)(3), 18071(e), and 18082(d) of this title and [section 36B(e) of title 26](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title26-section36B/e&num=0&edition=prelim) that the individual be a citizen or national of the United States or an alien lawfully present in the United States; (2) in the case of an individual claiming a premium tax credit or reduced cost-sharing under [section 36B of title 26](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title26-section36B&num=0&edition=prelim) or [section 18071 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section18071&num=0&edition=prelim)— (A) whether the individual meets the income and coverage requirements of such sections; and (B) the amount of the tax credit or reduced cost-sharing; (3) whether an individual’s coverage under an employer-sponsored health benefits plan is treated as unaffordable under sections 36B(c)(2)(C) and 5000A(e)(2) of title 26; 11 See References in Text note below. and (4) whether to grant a certification under [section 18031(d)(4)(H) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section18031/d/4/H&num=0&edition=prelim) attesting that, for purposes of the individual responsibility requirement under [section 5000A of title 26](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title26-section5000A&num=0&edition=prelim), a

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 18081

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

42 U.S.C. § 1395 — Conditions of participation for home health agencies; home health quality

**(a) Conditions of participation; protection of individual rights; notification of State entities; use of home health aides; medical equipment; individual’s plan of care; compliance with Federal, State, and local laws and regulations** The conditions of participation that a home health agency is required to meet under this subsection are as follows: (1) The agency protects and promotes the rights of each individual under its care, including each of the following rights: (A) The right to be fully informed in advance about the care and treatment to be provided by the agency, to be fully informed in advance of any changes in the care or treatment to be provided by the agency that may affect the individual’s well-being, and (except with respect to an individual adjudged incompetent) to participate in planning care and treatment or changes in care or treatment. (B) The right to voice grievances with respect to treatment or care that is (or fails to be) furnished without discrimination or reprisal for voicing grievances. (C) The right to confidentiality of the clinical records described in section 1395x(o)(3) of this title. (D) The right to have one’s property treated with respect. (E) The right to be fully informed orally and in writing (in advance of coming under the care of the agency) of— (i) all items and services furnished by (or under arrangements with) the agency for which payment may be made under this subchapter, (ii) the coverage available for such items and services under this subchapter, subchapter XIX, and any other Federal program of which the agency is reasonably aware, (iii) any charges for items and services not covered under this subchapter and any charges the individual may have to pay with respect to items and services furn

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 1395

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