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HHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) Emergency

Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (full text available here) that waives or modifies certain health care laws and regulations in connection with the COVID-19 pandemic.  This “1135 Waiver” applies nationwide and took effect on March 15 at 6:00 p.m., but its applicability is retroactive to March 1, 2020.  The 1135 Waiver applies for a period of 60 days (subject to extension by the Secretary for successive 60-day periods) or for the duration of the COVID-19 national emergency (if earlier), except the waiver of the HIPAA Privacy Rule described below applies for only 72 hours following a hospital’s implementation of its disaster protocol.

The 1135 Waiver:

  • Waives EMTALA sanctions for the direction or relocation of an individual to another location to receive medical screening pursuant to an appropriate state emergency preparedness plan or 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 for the COVID-19 pandemic.

  • Waives the following HIPAA Privacy Rule regulations for 72 hours following the implementation by a hospital of its disaster protocol:

    • the requirements to obtain a patient’s agreement to speak with family members or friends or to honor a patient’s request to opt out of the facility directory (as set forth in 45 C.F.R. § 164.510);

    • the requirement to distribute a notice of privacy practices (as set forth in 45 C.F.R. § 164.520); and

    • the patient’s right to request privacy restrictions or confidential communications (as set forth in 45 C.F.R. § 164.522).

  • Waives requirements that physicians and other health care professionals hold licenses in the State in which they provide services, if they have an equivalent license from another State (and are not affirmatively barred from practice in that State or any State a part of which is included in the emergency area).

  • Waives or modifies certain conditions of participation, certification requirements, program participation or similar requirements for health care providers (including hospitals), as deemed necessary by the Centers for Medicare and Medicaid Services (CMS) to ensure the availability of health care items and services in connection with the COVID-19 pandemic.

  • Waives Stark Law sanctions as determined appropriate by CMS.

  • Waives payment limitations under the Medicare Advantage Program related to direct payments to providers for services provided to enrollees.

  • Modifies certain deadlines and timetables for the performance of required federal health care program activities, as determined by CMS.

In connection with this 1135 Waiver issued by HHS, CMS also issued blanket waivers of certain laws, rules and regulations, including without limitation:

  • Waiver of the skilled nursing facility (SNF) 3-day hospital inpatient stay requirement for those patients who need to be transferred to a SNF as a result of the effect of a disaster or emergency.

  • Waives requirements that, for purposes of Medicare and Medicaid, out-of-state providers be licensed in the state where they are providing services when they are licensed in another state.

  • Allows acute care hospitals with distinct psychiatric units or inpatient rehabilitation units, to move patients from those units to acute care beds/units, and also allows acute care hospitals to move acute care patients to “excluded distinct part units” (e.g., to the psychiatric or IRF units), if appropriate for the care to be provided.

  • Waives enrollment screening requirements addressing application fees, criminal background checks, and site visits.

  • Establishes a toll-free hotline for non-certified Part B suppliers, physicians and nonphysician practitioners to enroll and receive temporary Medicare billing privileges, and expediting any pending or new applications for providers.

  • Allows all licensed providers to render services outside of their state of enrollment.

  • Postpones revalidation actions.

The CMS guidance also provides information on how states can request an 1135 Waiver of additional specific provisions under Medicare, Medicaid and CHIP.

The COVID-19 pandemic represents a dynamic challenge to the health care system, and as a result new guidance is being provided continuously. We will endeavor to provide updates as necessary to support our clients and their communities.

Copyright © 2020 Robinson & Cole LLP. All rights reserved.National Law Review, Volume X, Number 76

TRENDING LEGAL ANALYSIS


About this Author

Conor Duffy Cybersecurity Attorney
Associate

Conor Duffy is a member of the firm's Health Law Group and its Data Privacy + Cybersecurity Team. He advises hospitals, physician groups, community providers, and other health care entities on general corporate matters and health law issues. He also counsels clients on what measures are needed to safeguard data and patient information.

Regulatory

Conor provides legal counsel to health care clients on various regulatory matters, such as Medicare and Medicaid program compliance, federal fraud and abuse laws, and the Emergency Medical Treatment & Labor Act...

860.275.8342
Lisa Boyle Health Lawyer Robinson Cole Law Firm
Partner

Lisa Boyle chairs the firm's Health Law Group. She has spent more than 25 years representing a wide range of health care providers, including health systems, hospitals, physicians, physician groups, and ambulatory surgery centers. In addition, she represents clinically integrated networks, accountable care organizations, home health agencies, continuing care retirement communities, and federally qualified health centers.

Transactional

Lisa has substantial experience representing health care providers in all types of complex transactions, including mergers and acquisitions, joint ventures, private placements, and reorganizations. She regularly serves as counsel to health systems, hospitals, and physician groups in developing strategies and structuring and documenting sophisticated joint ventures.

Regulatory

Lisa regularly advises health care providers on the myriad regulatory issues they face, such as compliance with the Stark law, the anti-kickback statute, and the Emergency Medical Treatment and Labor Act (EMTALA); gainsharing; medical staff and peer review; clinical integration, physician recruitment, and compensation; medical staff bylaws; management arrangements; and electronic medical records. She also focuses on corporate governance, corporate compliance, risk management, and patient care issues. 

Community Involvement

Lisa is an advocate of community work. Each holiday season, she coordinates Robinson+Cole's drive to collect gifts for more than 130 children in need from the Northwest Boys & Girls Clubs of Hartford. She served on the Board of Trustees and as an officer of the organization for more than 15 years. 

Lisa frequently lectures on a variety of health care topics, including the Stark law, clinical integration, physician recruitment, physician compensation, peer review, HIPAA, and informed consent. She is the author of the book entitled HIPAAa Guide to Health Care Privacy and Security Law, published by Aspen Publishers. She is also a contributor to Robinson+Cole's health care blog, Health Law Diagnosis.

860.275.8350
Brian Nichols Health Lawyer Robinson Cole Law Firm
Partner

Brian Nichols is a member of the firm's Health Law Group. He represents and advises hospitals, physician groups, nursing homes, community providers, and other health care entities on a range of transactional and regulatory health care law issues. Brian has broad experience in health law and business. Prior to joining the firm, he worked in several industries, including health insurance, aerospace/defense and electric utilities. Brian understands clients’ businesses, and crafts solutions which are legally compliant and allow clients to achieve their business objectives. He is also a...

860.275.8354