Department of Health & Human Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard, Mail Stop S2-26-12
Baltimore, Maryland 21244-1850
March 18, 2021
Howard A. Zucker, M.D., J.D.
Commissioner
New York State Department of Health
Empire Plaza
Corning Tower (OCP-1211)
Albany, New York 12237
Re: Section 1135 Flexibilities Requested in August 25, 2020 Disaster Relief State Plan Amendment Transmittal Number 20-0048
Dear Commissioner Zucker:
The Centers for Medicare & Medicaid Services (CMS) granted an initial approval to the State of New York for multiple section 1135 flexibilities on March 26, 2020. Your Disaster Relief SPA submission, Transmittal Number 20-0048, submitted on August 25, 2020, and follow-up communication on October 7, 2020, detailed an additional federal requirement that also poses issues or challenges for the health care delivery system in New York and requested a modification of an additional requirement. Attached, please find a response to this additional request for modifications, pursuant to section 1135 of the Social Security Act (Act), to address the challenges posed by COVID-19. This approval addresses the requests related to Medicaid. To the extent the requirement the state requested to waive or modify apply to CHIP, the state may apply the approved flexibilities to CHIP. This applies to the waivers included below, as well as the 1135 waivers granted to the state on March 26, 2020, May 6, 2020, June 15, 2020, June 22, 2020, August 4, 2020, August 19, 2020 and October 6, 2020.
On March 13, 2020, the President of the United States issued a proclamation that the COVID-19 outbreak in the United States constitutes a national emergency by the authorities vested in him by the Constitution and the laws of the United States, including sections 201 and 301 of the National Emergencies Act (50 U.S.C. 1601 et seq.), and consistent with section 1135 of the Act. On March 13, 2020, pursuant to section 1135(b) of the Act, the Secretary of the United States Department of Health and Human Services invoked his authority to waive or modify certain requirements of titles XVIII, XIX, and XXI of the Act as a result of the consequences of the COVID-19 pandemic, to the extent necessary, as determined by CMS, to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in the respective programs and to ensure that health care providers that furnish such items and services in good faith, but are unable to comply with one or more of such requirements as a result of the COVID-19 pandemic, may be reimbursed for such items and services and exempted from sanctions for such noncompliance, absent any determination of fraud or abuse. This authority took effect as of 6PM Eastern Standard Time on March 15, 2020, with a retroactive effective date of March 1, 2020. The emergency period will terminate, and section 1135 waivers will no longer be available, upon termination of the public health emergency, including any extensions.
To streamline the section 1135 waiver request and approval process, CMS has issued a number of blanket waivers for many Medicare provisions, which primarily affect requirements for individual facilities, such as hospitals, long term care facilities, home health agencies, and so on. Waiver or modification of these provisions does not require individualized approval, and, therefore, these authorities are not addressed in this letter. Please refer to the current blanket waiver issued by CMS.
CMS continues to work on the additional waiver or modification requests that are not currently reflected in the attached approval. For those waiver or modification requests that require approval under authority other than section 1135, such as under applicable regulations, through an amendment to the state plan, or through a section 1115 demonstration, my staff will continue to work with your team to review and make determinations regarding approval as quickly as possible.
Please contact Jackie Glaze, Deputy Director, Medicaid and CHIP Operations Group, at (404) 387-0121 or by email at Jackie.Glaze@cms.hhs.gov if you have any questions or need additional information. We appreciate the efforts of you and your staff in responding to the needs of the residents of the State of New York and the health care community.
Sincerely,
Anne Marie Costello
Acting Deputy Administrator and Director
STATE OF NEW YORK
APPROVAL OF FEDERAL SECTION 1135 WAIVER REQUESTS
CMS Response: March 18, 2021
To the extent applicable, the following waivers and modifications also apply to CHIP.
Clinic Facility Requirement
Pursuant to section 1135(b)(1)(B) of the Act, CMS approves a waiver modifying the requirement in 42 C.F.R. § 440.90 that services provided under that regulation be provided “by a facility that is not part of a hospital but is organized and operated to provide medical care to outpatients.” This waiver is provided only to the extent necessary to provide the state’s patients with access to health services that would otherwise be unavailable during the COVID-19 PHE, by permitting the state and clinic to temporarily designate a clinic practitioner’s location as part of the clinic facility so that clinic services may be provided when neither the patient nor practitioner is physically onsite at the clinic. The waiver permits services provided at beneficiaries’ residences; outdoor locations; school-based health centers (SBHCs) or other school-affiliated clinics using “isolation rooms” located outside the designated clinic space; community based locations, such as libraries; Women, Infants and Children (WIC) Centers; and supermarkets to be considered to be provided at the clinic for purposes of 42 C.F.R. § 440.90(a).
Duration of Approved Waivers
Unless otherwise specified above, the section 1135 waivers described herein are effective March 1, 2020 and will terminate upon termination of the public health emergency, including any extensions. In no case will any of these waivers extend past the last day of the public health emergency (or any extension thereof).