April 1, 2020
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Health Law Alert: HHS Grants Midwest States Waiver Requests; CMS Issues Guidance on Stark Law Waivers
On March 27, 2020, the U.S. Department of Health and Human Services (HHS) approved the waiver request submitted by the Minnesota Department of Human Services (DHS) earlier this month (the “Minnesota Waiver”). In addition to the Minnesota Waiver, on March 25, 2020, HHS approved the waiver request submitted by the Missouri HealthNet Division, Missouri Department of Social Services (DSS) (the “Missouri Waiver”); on March 24, 2020, HHS approved the waiver request submitted by the Kansas Department of Health and Environment, Division of Health Care Finance (KDHE) (the “Kansas Waiver”); and on March 23, 2020, HHS approved the waiver request submitted by the Illinois Department of Healthcare and Family Services (IDHFS) (the “Illinois Waiver”) (collectively the “Waivers”).
Meanwhile, on March 30, 2020, CMS issued guidance on implementation of the “blanket” Stark Law waivers intended to assist providers in addressing the patient care challenges and financial problems they are facing due to the epidemic (“Stark Law Waivers”). Under the Stark Law Waivers, CMS will reimburse providers for designated health services that would otherwise violate the Law so long as the Waivers’ conditions are satisfied. Providers can use the Stark Law Waivers immediately. It is not necessary to request approval. Providers should maintain records documenting their compliance with the conditions of the relevant Stark Law Waivers
Background on Waivers
These Waivers follow on the heels of the nationwide waiver issued by HHS Secretary Azar on March 13, 2020. HHS has authority under Section 1135 of the Social Security Act to waive or modify certain Medicare, Medicaid, Children’s Health Insurance Program (CHIP) and HIPAA Requirements. The national waiver modified a variety of regulatory requirements under these programs. The national waiver was effective retroactively to March 1, 2020.
HHS granted the Waivers shortly after receiving requests from the various state agencies noted above. All of the Waivers build on the national waiver and modify a variety of specific regulatory requirements from each of those states. A summary of some of the key changes and notation as to which state the changes apply to is below:
Allowing Certain Providers to Render Services in Alternate Settings (Minnesota, Missouri, Illinois, & Kansas) – the Minnesota, Missouri, Illinois, and Kansas Waivers allow nursing facilities, intermediate care facilities for individuals with intellectual and developmental disabilities, psychiatric residential treatment facilities and hospital nursing facilities to be fully reimbursed for services provided in an unlicensed location as a result of relocating residents. The relocation must be due to an emergency evacuation or because of relocations as a result of facility efforts to treat COVID-19 patients. The facility that places residents in unlicensed facilities is responsible for determining how to reimburse the unlicensed facility.
Provider Enrollment & Program Integrity (Minnesota, Missouri, Illinois, & Kansas) – Relaxation of numerous provider enrollment requirements under CHIP and Medicaid, including:
Suspension in Prior Authorization Requirements for Fee-for-Service Care (Minnesota, Missouri, Illinois, & Kansas) – DHS, DSS, IDHFS and KDHE are allowed to waive requirements for providers to obtain prior authorization to determine medical necessity for services paid under Medicaid fee-for-service reimbursement.
Extend pre-existing authorizations for which a beneficiary has previously received prior authorization (Missouri, Illinois, & Kansas) – DSS, IDHFS or KDHE may continue to provide services approved on or after March 1, 2020 without requiring a new or renewed prior authorization, including extensions for beneficiaries with a permanent residence in the geographic area of the public health emergency.
Suspend Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 Days (Missouri, Illinois, & Kansas) – All new admissions can be treated like exempted hospital discharges for 30 days, and mental illness (MI) and intellectual disability (ID) admissions should receive a Resident Review as soon as resources are available. Level I and Level II preadmission screens are not required for patients transferred between nursing facilities (NF).
Modification of Fair Hearing Plan Timeline (Minnesota, Missouri, Illinois, & Kansas) –Enrollees in fee-for-service Medicaid are granted an extension of time (up to 120 days) to file a fair hearing request. Medicaid managed care programs also saw changes under the Minnesota, Missouri, Illinois and Kansas Waivers, with beneficiaries of these programs eligible for an accelerated internal health plan appeals process and therefore quicker fair hearings from DHS, DSS, IDHFS or KDHE.
There are other changes as well, including flexibility for DHS to submit Amendments to the State Medicaid Plan related to the COVID-19 response. Missouri also received a waiver of the public notice requirements with respect to SPAs that provide or increase access to items and services related to COVID-19. In its approval letter to DHS, DSS, IDHFS and KDHE, HHS noted that for specific items requested in their respective submissions (and not specifically approved in the Waivers), HHS will “continue to work with your team to review and make determinations regarding approval as quickly as possible.” It appears, therefore, that additional modifications to the respective state Medicaid and CHIP programs will be forthcoming.
The Waivers are effective retroactively to March 1, 2020 and will last throughout the ongoing COVID-19 public health emergency.
The Waivers build on Secretary Azar’s nationwide waiver. The nationwide or “blanket” wavier modified a variety of regulatory requirements:
Secretary Azar also clarified that these waivers are conditioned on the fact that there has not been any determination of fraud or abuse. The nationwide waivers, including the Stark Law Waiver discussed below, will last throughout the duration of the ongoing COVID public health emergency, unless terminated at an earlier date.
Stark Law Waivers
The Stark Law Waivers protect the exchange of certain types of remuneration between an entity and a physician (or immediate family member) and referrals from the physician to the entity so long as the remuneration and referrals are “solely related to COVID-19 purposes.” CMS provides a list of COVID-19 Purposes, which include:
CMS is waiving all Stark Law sanctions for referrals and claims related to the exchange of specific types of remuneration between physicians and the entities to which they refer designated health services. Examples include the following:
The Stark Law Waivers include several other types of relationships that are also protected. The Stark Law Waivers are effective retroactively to March 1, 2020. They apply to all parts of the Country.
Other States Waivers
Including Minnesota, Missouri, Illinois, and Kansas, there are now 34 states with 1135 waivers, including Colorado, California, Wyoming, Delaware, Pennsylvania, Connecticut, Maryland, Hawaii, Idaho, Massachusetts, New York, Iowa, Indiana, Rhode Island, Kentucky, Oregon, North Dakota, South Dakota, Oklahoma, Alabama, New Hampshire, New Mexico, New Jersey, Arizona, Virginia, North Carolina, Mississippi, Louisiana, Washington and Florida.
If you have questions about the Minnesota, Missouri, Illinois or Kansas Waivers, Section 1135 Waivers or CMS’ Stark Law Waivers, please contact Jesse Berg, Denise Bloch, Julia Reiland or any member of the Lathrop GPM Health Law Team.
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