1135 Waivers
Issuing Waivers/Modifications
The Secretary is authorized to take certain actions (in addition to his regular authorities) under section 1135 of the Social Security Act:
- When the President declares a major disaster or an emergency under the Stafford Act or an emergency under the National Emergencies Act, and
- The HHS Secretary declares a
public health emergency.
Waivers or modifications may be issued to ensure that in an emergency area, during an emergency period, sufficient health care items and services are available to the maximum possible extent to meet the needs of individuals enrolled in Social Security Act (SSA) programs and that providers of such services in good faith who are unable to comply with certain statutory requirements are reimbursed and exempted from sanctions for noncompliance other than fraud or abuse.
Waivers or Modifications of Requirements
The Secretary may waive or modify certain Medicare, Medicaid, Children’s Health Insurance Program (CHIP), Health Insurance Portability and Accountability Act (HIPAA), and Emergency Medical Treatment and Labor Act (EMTALA) requirements as necessary.
|
Requirements |
Description |
|
Conditions of Participation
|
certain conditions of participation, certification requirements, program participation or similar requirements for individual health care providers or types of health care providers
|
|
Pre-approval
|
pre-approval requirements
|
|
Licensure
|
requirements that physicians and other health care professionals hold licenses in the State in which they provide services if they have a license from another State (and are not affirmatively barred from practice in that State or any State in the emergency area) for purposes of Medicare, Medicaid, and CHIP reimbursement only
|
|
Sanctions
|
- sanctions under the Emergency Medical Treatment and Active Labor Act (EMTALA) for redirection or reallocation of an individual to another location to receive a medical screening pursuant to an appropriate state emergency preparedness plan or a state preparedness plan for the transfer of an individual who has not been stabilized if the transfer is necessitated by the circumstances of the declared Federal public health emergency. A waiver of EMTALA sanctions is effective only if actions under the waiver do not discriminate on the basis of a patient’s source of payment or ability to pay;
- sanctions under section 1877(g) (Stark) relating to limitations on physician referral under such conditions and in such circumstances as the Centers for Medicare & Medicaid determines appropriate
- sanctions and penalties arising from noncompliance with HIPAA privacy regulations relating to: a) obtaining a patient’s agreement to speak with family members or friends or honoring a patient’s request to opt out of the facility directory, b) distributing a notice of privacy practices, or c) the patient’s right to request privacy restrictions or confidential communications. The waiver of HIPAA requirements is effective only if actions under the waiver do not discriminate on the basis of a patient’s source of payment or ability to pay.
|
|
Deadlines/Timetables
|
deadlines and time tables for performance of required activities to allow timing of such deadlines to be modified;
|
|
Payment limitations
|
limitations on payments for healthcare items and services to permit Medicare Advantage Plan enrollees to use out-of-network providers in an emergency situation. To the extent possible, the Secretary must reconcile payments so that enrollees do not pay additional charges and so that the plan pays for services included in the capitation payment;
|
Notice and Reporting
At least two days before formally exercising the waiver authority, the Secretary must provide a certification and notice to Congress that describes the specific provision to be waived or modified, the health care providers to whom the waiver will apply, the geographic area in which the waiver or modification will apply, the period of time the modification will be in effect, and a statement that the waiver or modification is necessary to achieve the purposes of the SSA. The Secretary must report to Congress within one year after the end of the emergency period evaluating the approaches used and making recommendations for improvements.
Duration of Waivers and Modifications
|
Waivers or Modifications |
Duration |
|
Waivers or modifications
|
- may be retroactive to the beginning of the emergency period (or any subsequent date)
- terminate either upon termination of the emergency period or 60 days after the waiver or modification is first published (subject to 60-day renewal periods until termination of the emergency)
|
|
EMTALA Waivers (for other than a pandemic disease) or HIPAA requirements
|
- are effective only for 72 hours beginning on implementation of a hospital disaster protocol
- EMTALA sanction waivers in connection with an emergency involving a pandemic disease (ie. pandemic influenza) is effective until the termination of the pandemic-related public health emergency
|
Note, however, that a particular waiver or modification will terminate prior to the ultimate termination date described above if the Secretary determines that as of an earlier date, the waiver or modification is no longer necessary to accomplish the purposes set forth in Section 1135(a).
View all existing and past waivers or modifications of requirements under section 1135 of the Social Security Act
