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42 U.S.C. § 1320b–5 — Authority to waive requirements during national emergencies

submitted 91 years ago by Pub. L. 107-188 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 1,743 words · no verdicts yet

in plain englishAI-generated · not legal advice

During specified emergencies, the Secretary may temporarily waive or modify listed Medicare, Medicaid, and CHIP requirements to preserve health-care access and protect good-faith providers from sanctions absent fraud or abuse. The section limits the authority by subject, notice, duration, nondiscrimination, and reporting rules.

(a) Purpose. In an emergency area and emergency period as defined in subsection (g)(1), the Secretary must, as far as feasible, ensure—
(1) enough health-care items and services for people in the area enrolled in subchapters XVIII, XIX, and XXI; and
(2) reimbursement and freedom from sanctions for providers that furnish those items and services in good faith but cannot meet a requirement in subsection (b), unless fraud or abuse is found.

(b) Secretarial authority. To the extent needed for subsection (a), the Secretary may temporarily waive or modify, for providers or classes of providers in an emergency area during part of an emergency period, requirements of subchapters XVIII, XIX, or XXI and related regulations, and related requirements of this subchapter, concerning—
(1) provider participation or certification, program participation, similar requirements, and preapproval;
(2) State licensing of doctors and other professionals when they hold equivalent licenses in another State and are not affirmatively excluded from practice there or in any State partly within the emergency area;
(3) section 1395dd emergency examination and treatment requirements for—
(A) transferring an unstabilized person when the declared emergency requires it; or
(B) directing or moving a person for screening at an alternative location under an appropriate State emergency-preparedness plan, or, for a pandemic infectious-disease public-health emergency, under a State pandemic plan or that other plan;
(4) physician-referral sanctions under section 1395nn(g);
(5) deadlines and timetables for required activities, which may be modified but not waived;
(6) Medicare+Choice payment limits for out-of-network providers;
(7) HIPAA sanctions for specified requirements about family or friend communications, opting out of a facility directory, notices, privacy restrictions, and confidential communications under the cited regulations;
(8) for telehealth services, requirements of section 1395m(m); and
(9) ambulance requirements to include transport when community-wide EMS protocols during the specified public-health emergency prevented a 911 or equivalent call transport to a Medicare-permitted destination.
For paragraph (6), the Secretary must, as far as circumstances allow, reconcile payments so enrollees do not pay more than in-network amounts and may reconcile payments to the plan organization. A waiver under paragraph (3) or (7) may not discriminate based on payment source or ability to pay and generally lasts only 72 hours after a hospital disaster protocol begins. A paragraph (7) waiver must then be withdrawn for a patient still in the provider’s care. For a pandemic, paragraph (3)’s duration follows subsection (e). Paragraph (9) ground ambulance payment is the applicable base fee-schedule rate without mileage, with the specified critical-access-hospital rule.

(c) Authority for retroactive waiver. The Secretary may make a waiver or modification retroactive to the emergency period’s beginning or another date in that period.

(d) Certification to Congress. At least 2 days before using this authority for an emergency area, the Secretary must give Congress certification and advance written notice stating—
(1) the provisions waived or modified, providers covered, geographic area, and effective period; and
(2) that the action is necessary for subsection (a)’s purpose.

(e) Duration of waiver
(1) A waiver or modification ends when the applicable presidential emergency or disaster declaration ends, when the applicable public-health emergency declaration ends, or, subject to paragraph (2), 60 days after it is first published (or after an extension).
(2) The Secretary may extend each 60-day period by notice for additional periods generally no longer than 60 days. An extension does not prevent ending the waiver when either declaration ends.

(f) Report to Congress. Within 1 year after the emergency period ends in an area where the authority was used, the Secretary must report to Congress on the approaches used, evaluate them, and recommend improvements for future emergencies.

(g) Definitions
(1) Emergency area; emergency period.
(A) Subject to (B), an emergency area is a geographic area where, and an emergency period is a time when, both a presidential emergency or disaster under the National Emergencies Act or Stafford Act and a Secretary-declared public-health emergency under section 247d exist.
(B) For subsection (b)(8) and (9), the area and period instead mean those covered by the Secretary’s January 31, 2020 COVID-19 public-health emergency declaration and its renewals under section 247d.
(2) Health-care provider means any entity furnishing health-care items or services, including a hospital or other provider of services, doctor or other practitioner, health-care facility, or supplier.

the actual law source: uscode.house.gov ↗public domain
(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.

Source credit: (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.)

history & why it existsrecord from the source credit
  • 1935Enacted · Pub. L. 107-188 · 116 Stat. 627
  • 2004Amended · Pub. L. 108-276 · 118 Stat. 863
  • 2006Amended · Pub. L. 109-417 · 120 Stat. 2855
  • 2020Amended · Pub. L. 116-123 · 134 Stat. 156
  • 2020Amended · Pub. L. 116-127 · 134 Stat. 210
  • 2020Amended · Pub. L. 116-136 · 134 Stat. 416
  • 2021Amended · Pub. L. 117-2 · 135 Stat. 222

A history note hasn’t been published yet. The record shows enactment by Pub. L. 107-188 on 1935-08-14.

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