Section 1135 Waivers Provide Some Regulatory Flexibility for Healthcare Providers During COVID-19


On March 13, 2020, the Secretary of the U.S. Department of Health & Human Services (“Secretary”) authorized waivers and modifications under Section 1135 of the Social Security Act, retroactive to March 1, 2020. This authorization followed the Secretary’s declaration of a public health emergency in the entire United States on January 31, 2020. The Section 1135 waivers waive certain statutory requirements of the Social Security Act for healthcare providers during the COVID-19 public health emergency.

Several 1135 waivers have been issued so far. As discussed in our Client Alert, HHS has issued a limited waiver of sanctions and penalties for certain HIPAA non-compliance. In addition, as discussed more in our Client Alert, the Centers for Medicare & Medicaid Services (CMS) waived certain limitations on Medicare coverage for telehealth visits. Finally, CMS issued several nationwide blanket waivers. In addition to the blanket waivers, CMS can issue waivers for EMTALA, HIPAA, Stark Law, Medicaid or other Medicare requirements for healthcare providers on a case-by-case basis. For more information regarding the blanket waivers and requests for other Section 1135 waivers, please see the Fact Sheet and MLN Article.

If you have questions regarding COVID-19 and compliance and enforcement, please contact a member of our Healthcare and Life Sciences Practice Group below. You can also check out our COVID-19 Resources page for more information.

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