§1320b–5. Authority to waive requirements during national emergencies
(a) Purpose
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))-
(1) 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
(2) 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.
(b) Secretarial authority
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-
(1)(A) conditions of participation or other certification requirements for an individual health care provider or types of providers,
(B) program participation and similar requirements for an individual health care provider or types of providers, and
(C) pre-approval requirements;
(2) 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;
(3) actions under section 1395dd of this title (relating to examination and treatment for emergency medical conditions and women in labor) for-
(A) 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
(B) the direction or relocation of an individual to receive medical screening in an alternative location-
(i) pursuant to an appropriate State emergency preparedness plan; or
(ii) 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;
(4) sanctions under section 1395nn(g) of this title (relating to limitations on physician referral);
(5) deadlines and timetables for performance of required activities, except that such deadlines and timetables may only be modified, not waived;
(6) 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;
(7) 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)- 1
(A) section 164.510 of title 45, Code of Federal Regulations, relating to-
(i) requirements to obtain a patient's agreement to speak with family members or friends; and
(ii) the requirement to honor a request to opt out of the facility directory;
(B) section 164.520 of such title, relating to the requirement to distribute a notice; or
(C) section 164.522 of such title, relating to-
(i) the patient's right to request privacy restrictions; and
(ii) the patient's right to request confidential communications;
(8) 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
(9) 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).
Insofar as the Secretary exercises authority under paragraph (6) with respect to individuals enrolled in a Medicare+Choice plan, to the extent possible given the circumstances, the Secretary shall reconcile payments made on behalf of such enrollees to ensure that the enrollees do not pay more than would be required had they received services from providers within the network of the plan and may reconcile payments to the organization offering the plan to ensure that such organization pays for services for which payment is included in the capitation payment it receives under part C of subchapter XVIII. A waiver or modification provided for under paragraph (3) or (7) shall only be in effect if such actions are taken in a manner that does not discriminate among individuals on the basis of their source of payment or of their ability to pay, and, except in the case of a waiver or modification to which the fifth sentence of this subsection applies, shall be limited to a 72-hour period beginning upon implementation of a hospital disaster protocol. A waiver or modification under such paragraph (7) shall be withdrawn after such period and the provider shall comply with the requirements under such paragraph for any patient still under the care of the provider. If a public health emergency described in subsection (g)(1)(B) involves a pandemic infectious disease (such as pandemic influenza), the duration of a waiver or modification under paragraph (3) shall be determined in accordance with subsection (e) as such subsection applies to public health emergencies. Ground ambulance services for which payment is made pursuant to paragraph (9) shall be paid at the base rate that would have been paid under the fee schedule established under 2 1395m(l) of this title (excluding any mileage payment) if the individual had been so transported and, with respect to ambulance services furnished by a critical access hospital or an entity described in paragraph (8) of such section, at the amount that otherwise would be paid under such paragraph.
(c) Authority for retroactive waiver
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.
(d) Certification to Congress
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-
(1) a description of-
(A) the specific provisions that will be waived or modified;
(B) the health care providers to whom the waiver or modification will apply;
(C) the geographic area in which the waiver or modification will apply; and
(D) the period of time for which the waiver or modification will be in effect; and
(2) a certification that the waiver or modification is necessary to carry out the purpose specified in subsection (a).
(e) Duration of waiver
(1) In general
A waiver or modification of requirements pursuant to this section terminates upon-
(A) the termination of the applicable declaration of emergency or disaster described in subsection (g)(1)(A);
(B) the termination of the applicable declaration of public health emergency described in subsection (g)(1)(B); or
(C) 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)).
(2) Extension of 60-day periods
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).
(f) Report to Congress
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.
(g) Definitions
For purposes of this section:
(1) Emergency area; emergency period
(A) In general
Subject to subparagraph (B), an "emergency area" is a geographical area in which, and an "emergency period" is the period during which, there exists-
(i) 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
(ii) a public health emergency declared by the Secretary pursuant to section 247d of this title.
(B) Exception
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-
(i) 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
(ii) any renewal of such declaration pursuant to such section 247d of this title.
(2) Health care provider
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.
(Aug. 14, 1935, ch. 531, title XI, §1135, as added
Editorial Notes
References in Text
Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (b)(7), is section 264(c) of
The National Emergencies Act, referred to in subsec. (g)(1)(A)(i), is
The Robert T. Stafford Disaster Relief and Emergency Assistance Act, referred to in subsec. (g)(1)(A)(i), is
Prior Provisions
A prior section 1320b–5, act Aug. 14, 1935, ch. 531, title XI, §1135, as added
Amendments
2021-Subsec. (b).
Subsec. (b)(9).
Subsec. (g)(1)(B).
2020-Subsec. (b)(8).
"(A) the requirements of paragraph (4)(C) of such section, except that a facility fee under paragraph (2)(B)(i) of such section may only be paid to an originating site that is a site described in any of subclauses (I) through (IX) of paragraph (4)(C)(ii) of such section; and
"(B) the restriction on use of a telephone described in the second sentence of section 410.78(a)(3) of title 42, Code of Federal Regulations (or a successor regulation), but only if such telephone has audio and video capabilities that are used for two-way, real-time interactive communication."
Subsec. (g)(1).
"(A) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Robert T. Stafford Disaster Relief and Emergency Assistance Act; and
"(B) a public health emergency declared by the Secretary pursuant to section 247d of this title."
Subsec. (g)(3).
Subsec. (g)(3)(A).
2006-Subsec. (b).
Subsec. (b)(3)(B).
2004-Subsec. (b).
Subsec. (b)(3).
Subsec. (b)(7).
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
Effective Date of 2006 Amendment
Effective Date
Coverage of Testing for COVID–19
"(a)
"(1) 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-
"(A) 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);
"(B) 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;
"(C) 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
"(D) other test that the Secretary determines appropriate in guidance.
"(2) 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.
"(b)
"(c)
"(d)
Implementation of 2020 Amendment
1 So in original. A second closing parenthesis probably should precede the dash.
2 So in original. The word "section" probably should appear.