Flexibilities for DMEPOS, Laboratories and Ambulances During COVID-19 - McDermott Will & Emery

Flexibilities for DMEPOS, Laboratories and Ambulances During COVID-19



The Centers for Medicare and Medicaid Services (CMS) released fact sheets and subsequent guidance detailing regulatory flexibilities for suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS), Laboratories and Ambulances during the Coronavirus (COVID-19) pandemic. The additional flexibilities help to expand and expedite access to COVID-19 testing and allow certain healthcare providers to provide necessary services more quickly and efficiently during the national emergency.

In Depth

CMS recently released guidance for multiple provider types as part of its broad package of blanket Section 1135 waivers, providing additional regulatory flexibility during the Coronavirus (COVID-19) pandemic national emergency. A summary of the scope of additional flexibility afforded to DMEPOS suppliers, laboratories and ambulances follows.

Blanket Waiver Package

CMS’ broad package of Section 1135 waivers issued on March 30, 2020 (summarized here) builds upon a more limited set of waivers issued on March 13, 2020 (analyzed here). Additional guidance was issued on April 9, 2020, in the form of further updates to a provider fact sheet and provider FAQs that reflect information in the Interim Final Rule and Comment issued on March 30, 2020 (as expanded, FAQs). The updated waivers and guidance address common concerns among providers and suppliers nationwide, including waivers to allow expansion of availability of needed healthcare services and increased COVID-19 testing capabilities. CMS also clarified that in order to operate under COVID-19-related blanket waivers, Medicare-enrolled providers and suppliers need not provide written notice of intent to do so.

Durable Medical Equipment, Prosthetics, Orthotics, and Supplies

Generally, when DMEPOS is lost, destroyed, irreparably damaged or otherwise unusable, CMS, through the Medicare Administrative Contractors (MACs), requires suppliers to meet specific requirements in order to obtain replacement DMEPOS. For the duration of the COVID-19 pandemic, CMS is allowing MACs to offer suppliers seeking replacement DMEPOS temporary flexibility to refrain from adhering to the “face-to-face” requirement and the requirements to obtain a new physician’s order and new medical necessity documentation. Suppliers must still include a narrative description on the claim explaining the reason for replacement and noting that documentation is unavailable as the result of the emergency.

CMS is also pausing the national Medicare Prior Authorization program for certain DMEPOS items and is not requiring accreditation for newly enrolling DMEPOS suppliers. Expiring supplier accreditation is extended for a 90-day time period. In addition, DMEPOS suppliers will not have to adhere to signature and proof of delivery requirements when the supplier is unable to obtain a signature. Suppliers should document the date of delivery and inability to obtain a signature due to COVID-19 in the medical record.

See the DMEPOS Flexibility Fact Sheet here.


The new flexibilities offered to laboratories by CMS include measures to expand access to and payment for COVID-19 testing, and clarifies the locations where testing can occur. CMS has also provided that during the COVID-19 pandemic emergency, Medicare will pay a specimen collection fee for travel associated with a laboratory technician’s collection of a sample for COVID-19 testing at a beneficiary’s home, including a nursing home. The FAQs identify new Healthcare Common Procedure Coding System codes for specimen collection for COVID-19, effective February 4, 2020. The fees are $23.46 for homebound individuals and $25.46 for individuals in a skilled nursing facility or who are part of a home health agency. A home health nurse or visiting nurse already treating the beneficiary pursuant to a Medicare-covered visit can obtain a sample to send to the laboratory for COVID-19 diagnostic testing.

CMS clarified in the FAQs that “homebound” patients for purposes of Medicare payment include those patients where a physician has determined that it is medically contraindicated for a beneficiary to leave the home because (1) the patient has a confirmed or suspected diagnosis of COVID-19; or (2) because the patient has a condition that may make the patient more susceptible to contracting COVID-19. A patient who is exercising “self-quarantine” for one’s own safety would not be considered “confined to the home” unless a physician certifies that it is medically contraindicated for the patient to leave the home.

To help facilitate the expansion of COVID-19 testing capabilities, CMS also clarified that it will exercise enforcement discretion to facilitate pathologists’ ability to review pathology slides remotely; expedite review of CLIA certificates and applications to ensure laboratories wishing to perform COVID-19 testing can begin to do so as quickly as possible; allow laboratories within a hospital/university hospital campus to hold a single certificate for the laboratory sites within the same physical location or street address; and allow alternate specimen collection devices and media to be used to collect and transport COVID-19 samples.

See the Laboratories Flexibility Fact Sheet here. CMS released additional FAQs on Laboratory COVID-19 testing services as part of the FAQs, here.


CMS is temporarily expanding the list of allowable destinations for ambulance transports to include any destination that is able to provide treatment to the patient in a manner consistent with state and local emergency medical services (EMS) protocols in use where the services are being furnished. Locations may include alternative sites determined to be part of a hospital, SNFs, community mental health centers, federally qualified health centers (FQHCs), physician’s offices, urgent care facilities, ambulatory surgery centers (ASCs), the beneficiary’s home and any other location furnishing dialysis services. CMS clarified in the FAQs that Medicare will pay for ambulance transportation to approved locations according to the usual payment guidelines.

CMS is also offering states involved in the Repetitive Scheduled Non-Emergent Ambulance Transports demonstration the option of pausing participation for the duration of the COVID-19 emergency.

See the Ambulances Flexibilities Fact Sheet here. The FAQs include those related to Ambulance services.

Common Waivers to all Provider Types

In addition to the above-listed waivers, like other Medicare providers, DMEPOS, laboratories and ambulances are also eligible for accelerated/advanced payments from Medicare. The Accelerated and Advance Payment Program provides immediate cash payments to eligible providers of amounts up to the amount of payments received from Medicare during the last quarter of 2019. For more information on the program, see our prior article “CMS Expands Accelerated and Advance Payment Program to All Medicare Providers, Suppliers.”

CMS also clarifies several Medicare appeals procedures for providers and suppliers enrolled in Medicare Fee for Service (FFS), Medicare Advantage (MA) and Part D plans, including the opportunity to obtain extensions to file appeals. Separate requirements apply depending on the Medicare programs.

Key Takeaways

For the period of the COVID-19 national emergency, CMS has afforded DMEPOS, laboratories and ambulances the ability to expand and provide related services more quickly and efficiently. CMS is waiving several requirements previously applicable to replacement of DMEPOS, offering laboratories greater flexibility to expand access to COVID-19 testing services and expanding the allowable list for ambulance transports.