Authority to waive requirements during national emergencies

that sufficient health care items and services are available to meet the needs of individuals in such area enrolled in the programs under subchapters XVIII, XIX, and XXI; and that health care providers (as defined in subsection (g)(2)) that furnish such items and services in good faith, but that are unable to comply with one or more requirements described in subsection (b), may be reimbursed for such items and services and exempted from sanctions for such noncompliance, absent any determination of fraud or abuse. conditions of participation or other certification requirements for an individual health care provider or types of providers, program participation and similar requirements for an individual health care provider or types of providers, and pre-approval requirements; requirements that physicians and other health care professionals be licensed in the State in which they provide such services, if they have equivalent licensing in another State and are not affirmatively excluded from practice in that State or in any State a part of which is included in the emergency area; a transfer of an individual who has not been stabilized in violation of subsection (c) of such section if the transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period; or pursuant to an appropriate State emergency preparedness plan; or in the case of a public health emergency described in subsection (g)(1)(B) that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan or a plan referred to in clause (i), whichever is applicable in the State; sanctions under section 1395nn(g) of this title (relating to limitations on physician referral); deadlines and timetables for performance of required activities, except that such deadlines and timetables may only be modified, not waived; limitations on payments under section 1395w–21(i) of this title for health care items and services furnished to individuals enrolled in a Medicare+Choice plan by health care professionals or facilities not included under such plan; requirements to obtain a patient’s agreement to speak with family members or friends; and the requirement to honor a request to opt out of the facility directory; section 164.520 of such title, relating to the requirement to distribute a notice; or the patient’s right to request privacy restrictions; and the patient’s right to request confidential communications; in the case of a telehealth service (as defined in paragraph (4)(F) of section 1395m(m) of this title) furnished in any emergency area (or portion of such an area) during any portion of any emergency period, the requirements of section 1395m(m) of this title; and any requirement under section 1395x(s)(7) of this title or section 1395m(l) of this title that an ambulance service include the transport of an individual to the extent necessary to allow payment for ground ambulance services furnished in response to a 911 call (or the equivalent in areas without a 911 call system) in cases in which an individual would have been transported to a destination permitted under Medicare regulations (as described in section 410.40 to title 42, Code of Federal Regulations (or successor regulations)) but such transport did not occur as a result of community-wide emergency medical service (EMS) protocols due to the public health emergency described in subsection (g)(1)(B). A waiver or modification of requirements pursuant to this section may, at the Secretary’s discretion, be made retroactive to the beginning of the emergency period or any subsequent date in such period specified by the Secretary. the specific provisions that will be waived or modified; the health care providers to whom the waiver or modification will apply; the geographic area in which the waiver or modification will apply; and the period of time for which the waiver or modification will be in effect; and a certification that the waiver or modification is necessary to carry out the purpose specified in subsection (a). the termination of the applicable declaration of emergency or disaster described in subsection (g)(1)(A); the termination of the applicable declaration of public health emergency described in subsection (g)(1)(B); or subject to paragraph (2), the termination of a period of 60 days from the date the waiver or modification is first published (or, if applicable, the date of extension of the waiver or modification under paragraph (2)). The Secretary may, by notice, provide for an extension of a 60-day period described in paragraph (1)(C) (or an additional period provided under this paragraph) for additional period or periods (not to exceed, except as subsequently provided under this paragraph, 60 days each), but any such extension shall not affect or prevent the termination of a waiver or modification under subparagraph (A) or (B) of paragraph (1). Within one year after the end of the emergency period in an emergency area in which the Secretary exercised the authority provided under this section, the Secretary shall report to the Congress regarding the approaches used to accomplish the purposes described in subsection (a), including an evaluation of such approaches and recommendations for improved approaches should the need for such emergency authority arise in the future. an emergency or disaster declared by the President pursuant to the National Emergencies Act [50 U.S.C. 1601 et seq.] or the Robert T. Stafford Disaster Relief and Emergency Assistance Act [42 U.S.C. 5121 et seq.]; and a public health emergency declared by the Secretary pursuant to section 247d of this title. the public health emergency declared by the Secretary pursuant to section 247d of this title on January 31, 2020, entitled “Determination that a Public Health Emergency Exists Nationwide as the Result of the 2019 Novel Coronavirus”; and any renewal of such declaration pursuant to such section 247d of this title. The term “health care provider” means any entity that furnishes health care items or services, and includes a hospital or other provider of services, a physician or other health care practitioner or professional, a health care facility, or a supplier of health care items or services. is approved, cleared, or authorized under section 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c, 360e, 360bbb–3); the developer has requested, or intends to request, emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3), unless and until the emergency use authorization request under such section 564 has been denied or the developer of such test does not submit a request under such section within a reasonable timeframe; is developed in and authorized by a State that has notified the Secretary of Health and Human Services of its intention to review tests intended to diagnose COVID–19; or other test that the Secretary determines appropriate in guidance. Items and services furnished to an individual during health care provider office visits (which term in this paragraph includes in-person visits and telehealth visits), urgent care center visits, and emergency room visits that result in an order for or administration of an in vitro diagnostic product described in paragraph (1), but only to the extent such items and services relate to the furnishing or administration of such product or to the evaluation of such individual for purposes of determining the need of such individual for such product. The provisions of subsection (a) shall be applied by the Secretary of Health and Human Services, Secretary of Labor, and Secretary of the Treasury to group health plans and health insurance issuers offering group or individual health insurance coverage as if included in the provisions of part A of title XXVII of the Public Health Service Act [42 U.S.C. 300gg et seq.], part 7 of the Employee Retirement Income Security Act of 1974 [probably means part 7 of subtitle B of title I of Pub. L. 93–406, 29 U.S.C. 1181 et seq.], and subchapter B of chapter 100 of the Internal Revenue Code of 1986 [26 U.S.C. 9811 et seq.], as applicable. The Secretary of Health and Human Services, Secretary of Labor, and Secretary of the Treasury may implement the provisions of this section through sub-regulatory guidance, program instruction or otherwise. The terms ‘group health plan’; ‘health insurance issuer’; ‘group health insurance coverage’, and ‘individual health insurance coverage’ have the meanings given such terms in section 2791 of the Public Health Service Act (42 U.S.C. 300gg–91), section 733 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1191b), and section 9832 of the Internal Revenue Code of 1986 [26 U.S.C. 9832], as applicable.” The purpose of this section is to enable the Secretary to ensure to the maximum extent feasible, in any emergency area and during an emergency period (as defined in subsection (g)(1))— To the extent necessary to accomplish the purpose specified in subsection (a), the Secretary is authorized, subject to the provisions of this section, to temporarily waive or modify the application of, with respect to health care items and services furnished by a health care provider (or classes of health care providers) in any emergency area (or portion of such an area) during any portion of an emergency period, the requirements of subchapters XVIII, XIX, or XXI, or any regulation thereunder (and the requirements of this subchapter other than this section, and regulations thereunder, insofar as they relate to such subchapters), pertaining to— actions under section 1395dd of this title (relating to examination and treatment for emergency medical conditions and women in labor) for— the direction or relocation of an individual to receive medical screening in an alternative location— sanctions and penalties that arise from noncompliance with the following requirements (as promulgated under the authority of section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note)— 11 So in original. A second closing parenthesis probably should precede the dash. section 164.510 of title 45, Code of Federal Regulations, relating to— section 164.522 of such title, relating to— The Secretary shall provide a certification and advance written notice to the Congress at least two days before exercising the authority under this section with respect to an emergency area. Such a certification and notice shall include— a description of— A waiver or modification of requirements pursuant to this section terminates upon— For purposes of this section: Subject to subparagraph (B), an “emergency area” is a geographical area in which, and an “emergency period” is the period during which, there exists— For purposes of paragraphs (8) and (9) of subsection (b), an “emergency area” is a geographical area in which, and an “emergency period” is the period during which, there exists— A group health plan and a health insurance issuer offering group or individual health insurance coverage (including a grandfathered health plan (as defined in section 1251(e) of the Patient Protection and Affordable Care Act [42 U.S.C. 18011(e)])) shall provide coverage, and shall not impose any cost sharing (including deductibles, copayments, and coinsurance) requirements or prior authorization or other medical management requirements, for the following items and services furnished during any portion of the emergency period defined in paragraph (1)(B) of section 1135(g) of the Social Security Act (42 U.S.C. 1320b–5(g)) beginning on or after the date of the enactment of this Act [Mar. 18, 2020]: An in vitro diagnostic test defined in section 809.3 of title 21, Code of Federal Regulations (or successor regulations) for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19, and the administration of such a test, that— (Source: (Aug. 14, 1935, ch. 531, title XI, § 1135, as added Pub. L. 107–188, title I, § 143(a), June 12, 2002, 116 Stat. 627; amended Pub. L. 108–276, § 9, July 21, 2004, 118 Stat. 863; Pub. L. 109–417, title III, § 302(b)(1), Dec. 19, 2006, 120 Stat. 2855; Pub. L. 116–123, div. B, § 102(a)(1), (2), (b), Mar. 6, 2020, 134 Stat. 156; Pub. L. 116–127, div. F, § 6010, Mar. 18, 2020, 134 Stat. 210; Pub. L. 116–136, div. A, title III, § 3703, Mar. 27, 2020, 134 Stat. 416; Pub. L. 117–2, title IX, § 9832, Mar. 11, 2021, 135 Stat. 222.))