On Monday, March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued wide ranging blanket waivers and published an interim final rule intended to “equip the American healthcare system with maximum flexibility” to respond to COVID-19. The waivers will remain in effect until the end of the emergency declaration.

CMS issued a summary of the blanket waivers here.

Blanket Waivers for the Stark Law may be found here.

The pre-publication version of the Interim Final Rule with Comment may be found here.

The wide ranging waivers and authorities include the following:

Stark Blanket Waivers

The blanket waivers of the Physician Self-Referral Law (“Stark Law”) have a retroactive effect to March 1, 2020, nationwide. The blanket waiver approach is much less burdensome to providers than the provider-specific waiver process. Under the blanket waivers, a provider is not required to submit an application or other notice to CMS. Records made in connection with the use of the waivers must be made available to the HHS Secretary upon request, but CMS does not provide prescriptive guidance regarding the form of such records. Critically, the government seems to interpose an intent standard, as the waiver seems to be made available “absent the government’s determination of fraud or abuse.” Thus, providers should document the legitimate factors upon which a waiver program was designed, even if such documentation need not be routed through the governing body as in the case of MSSP ACO waivers. While a program must “be solely limited to COVID-19 Purposes” to qualify for the blanket waivers, that is defined very broadly, including without limitation “[a]ddressing medical practice or business interruption due to the COVID-19 outbreak in the United States in order to maintain the availability of medical care and related services for patients and the community.” The blanket waivers are limited to direct financial relationships, such that special consideration should be given both to how they can be structured (and/or whether they are needed) when, for example, it is a real estate subsidiary rather than a designated-health-services entity, that desires to offer rent abatement to physicians.

In addition, CMS stated that waiver of sanctions under the Stark law related to COVID-19 may be issued by CMS on a case-by-case basis. Individual waivers will require “specific details concerning the actual or proposed financial relationship between the referring physician(s) and the referred-to entity.”

EMTALA

CMS issued a blanket waiver permitting the screening of patients at offsite locations owned or operated by the hospital “to prevent the spread of COVID-19.” The screening of patients at such an offsite location must be consistent with the state’s emergency preparedness or pandemic plan. “Waivers to provide Medical Screening Examinations at an offsite alternate screening location not owned or operated by the hospital will be reviewed on a case by case basis.”

Telehealth Services

Earlier this month, CMS announced that it would temporarily allow providers to bill Medicare for a wide range of telehealth services and reimburse these providers the same amount as they would for in-person visits (previously covered by the HL pulse here). However, CMS still required that these telehealth services include both an audio and visual element. CMS will further expand telehealth services under the Medicare program to include audio-only telephone calls.

CMS’s Hospitals Without Walls

Administrator Seema Verma also announced CMS’s Hospitals Without Walls to “allow hospital systems to create new treatment sites outside of their facility to expand capacity.”

The blanket waivers issued by CMS will enable communities to use alternate locations approved by the facility’s state in order to permit hospitals to separate COVID-19 positive patients from other non-COVID-19 patients. CMS will also waive certain requirements in order to permit used face masks to be “removed and retained in the compounding area to be re-donned and reused during the same work shift in the compounding area only.” CMS is also eliminating its requirement that hospitals document which personnel are qualified to perform certain respiratory procedures so long as this is consistent with its state’s emergency preparedness or pandemic plan.

In addition, CMS is permitting ambulatory surgery centers currently not performing elective surgeries to provide hospital services and allow physician-owned hospitals to “increase the number of their licensed beds, operating rooms, and procedure rooms.” Hospitals will also be allowed to bill for services that do not take place inside their hospitals. For instance, CMS explains that “emergency departments of hospitals can use telehealth services to quickly assess patients to determine the most appropriate site of care, freeing emergency space for those that need it most.” Hospitals, laboratories, and other entities that are performing COVID-19 tests are also permitted to complete these tests at a patient’s home and hospital emergency departments can open drive-through and off-campus test centers to screen patients for COVID-19.

Workforce Flexibilities

In an effort to ensure that there are enough healthcare professionals, Stark Law blanket waivers will allow hospitals to provide their healthcare professionals with additional incidental benefits that may not ordinarily be permissible, such as “multiple daily meals, laundry service for personal clothing, or child care services.” Healthcare professionals can also temporarily enroll in Medicare during the COVID-19 outbreak and CMS will allow healthcare professionals to work to the “fullest extent possible” by the state’s emergency preparedness or pandemic plan.

Norton Rose Fulbright attorneys will continue to provide relevant updates for healthcare providers on the Health Law Pulse during this public health crisis.