CMS Issues Broad Package of Blanket Waivers Under Section 1135

Late on March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a broad package of blanket regulatory waivers, as permitted under Section 1135 and other provisions of the Social Security Act, applicable to certain providers and suppliers (updated waivers). The updated waivers build upon a more limited set of Section 1135 waivers issued on March 13, 2020 (analyzed here), and include waivers applicable to many Medicare provider and suppliers. The waivers are effective retroactive to March 1, 2020.

General Themes

The updated waivers address common concerns among providers and suppliers across the country, including waivers in cases where a provider is part of a “surge” or acting as a “surge facility” or “surge site.” Providers should review both the specific fact sheet guidance for their provider or supplier type(s) (discussed below), along with the consolidated summary of the updated waivers to review the scope of the waivers provided by CMS.

Important Process Changes

CMS clarified that providers and suppliers need not provide written notice of intent to operate under blanket waivers, including the updated waivers. Providers and suppliers that have identified the need for additional waiver relief under Section 1135 based on their specific facts and circumstances in relation to the Coronavirus (COVID-19) pandemic may still apply for “case-by-case” waivers over and above those provided in the updated waivers. However, requests for case-by-case waivers outside the scope of the updated waivers or previously granted waivers should be requested by emailing 1135waiver@cms.hhs.gov rather than emailing the provider’s CMS Regional Office as indicated by prior guidance.

While CMS has issued blanket Stark Law waivers, requests for additional Stark Law waivers should be sent to 1877CallCenter@cms.hhs.gov.

Examples of Provider Types and Features of the Updated Waivers

Hospitals (defined for these purposes as general acute care, psychiatric and critical access hospitals) may, among other actions permitted by the prior waivers and the updated waivers:

• Screen patients at locations offsite from the hospital’s campus to prevent spread of COVID-19, so long as consistent with the state emergency preparedness or pandemic plans (collectively, state plans)
• Use non-hospital buildings/space for patient care and quarantine sites, so long as approved by the provider’s state and not inconsistent with the state plans
• Waive certain requirements under the Medicare conditions of participation (CoPs) and the provider-based department requirements to allow hospitals to establish and operate as part of the hospital any location meeting those CoPs that continue to apply during the emergency
• More liberally utilize verbal orders
• Not report all deaths of patients in restraints
• Disregard certain provisions of the patient rights COP in circumstances where the hospital is located in a state “impacted by a widespread outbreak of COVID-19,” which currently means 51 or more confirmed cases (which is already the case in many states)
• Re-use face masks in sterile compounding areas, so long as certain requirements are met
• Adapt discharge planning processes to reduce the burden on caregivers
• Continue medical staff privileges where the privileges expire or provide new privileges prior to a full medical staff and governing body review, to assist with workforce concerns
• Relax requirements for medical records department staffing, the form and content of the record and record retention requirements, so long as in compliance with state plans
• Function under relaxed telemedicine requirements
• Rely upon non-physician providers to provide and oversee care to patients, so long as permitted by state plans
• Relax requirements for QAPI programs
• Relieve the requirement for preparing and updating nursing care plans and maintaining certain outpatient policies and procedures regarding nursing coverage.

For critical access hospitals, the waivers also include relief related to personnel qualifications, staff licensure, critical access hospital status and location, and length of stay.

Long term care and skilled nursing facilities (SNFs) may, among other actions permitted by the updated waivers:

• Postpone Minimum Data Set reporting and submission of staffing data
• Suspend pre-admission screening and annual resident review assessments for a limited time
• Use non-SNF buildings as temporarily certified facilities available for use by a SNF should isolation be necessary for COVID-19-positive residents that cannot be provided in the current physical space
• Coordinate with the state to open a new nursing facility if the state determines such a temporary isolation and treatment location is necessary
• Modify nurses’ aide training and certification requirements for a limited time period
• Permit telehealth visits in lieu of in-person physician visits
• Disregard resident roommate choice provisions in favor of grouping or cohorting residents with respiratory symptoms or confirmed COVID-19 separate from asymptomatic or COVID-19-negative residents
•  Facilitate certain resident transfers based on COVID-19 status to help isolate infectious residents and temporarily observe potentially infected residents for the identified incubation period, provided certain requirements are met.

Home health agencies may, among other actions permitted by the updated waivers:

• Extend timeframes for certain OASIS transmissions
• Undertake initial assessments and determination of homebound status remotely or by record review
• Temporarily disregard the requirement for certain onsite nursing visits for HHA supervision.

Hospice providers may, among other actions permitted by the updated waivers:

• Extend the timeframe for completion of certain comprehensive assessments
• Disregard the requirement to provide non-core services such as PT, OT and speech/language pathology services
• Temporarily disregard the requirement for certain onsite nursing visits for hospice aide supervision.

Relevant to other provider types, CMS simultaneously issued additional fact sheets specific to:

• Durable medical equipment, prosthetics, orthotics and supplies (DMEPOS)
• Physicians and other practitioners
• Ambulances
• End stage renal dialysis (ESRD) facilities
• Teaching hospitals and medical residency programs
• Inpatient rehabilitation facilities
• LTACHs and cancer hospitals
• Rural health clinics and FQHCs
• Laboratories covid-long-term-care-hospitals.pdf
• Diabetes prevention programs
• Medicare Advantage and Part D plans.

Additional Medicare Enrollment Flexibilities

The updated waivers build upon prior enrollment waivers and flexibilities (analyzed here) and include:

• Permitting Part A certified providers and suppliers establishing isolation facilities to call the Medicare Administrative Contractor hotlines to enroll and receive temporary Medicare billing privileges
• Allowing physicians and other practitioners to render telehealth services from their home without reporting their home address on their Medicare enrollment while continuing to bill from their currently enrolled location.
• Allowing opted-out physicians and non-physician practitioners to terminate their opt-out status early and enroll in Medicare to provide care to more patients.

Open Issues

To date, CMS has primarily provided guidance on COVID-19 flexibility through sub-regulatory guidance documents with limited operational details, and has frequently updated its guidance as circumstances evolve. While it appears that CMS is committed to being responsive to the needs of providers and the public, the specific legal authority supporting many of the flexibilities that are being provided outside of the scope of the Section 1135 waiver authority remains unclear.

Providers should consult with counsel before operating under the waiver provisions to ensure that the services being provided fall within the scope of the waiver. Further, providers operating under the waivers are advised to regularly monitor CMS websites for changes to the scope of waived provisions and information regarding operational and documentation requirements that may be imposed at a later date

Key Takeaways: The updated waivers provide additional regulatory relief as providers and suppliers continue to address the operational challenges presented by the COVID-19 pandemic. Tracking the current scope of the waivers, understanding what is not waived, and clearly communicating that information to internal stakeholders—including clinical and operational staff and management—is important to ensure a consistent understanding of the boundaries of the regulatory relief. Contemporaneous documentation, where possible, of a provider’s election to operate under waivers, or to take steps that may be at the outer reaches of what waivers permit, may be of assistance after the pandemic subsides, should an outside agency retrospectively review the provider’s operations. Providers and suppliers must also continue to ensure regulatory compliance with state law requirements.