Legal Insights and Perspectives for the Healthcare Industry

The Centers for Medicare and Medicaid Services (CMS) issued an Open Payments COVID-19 Announcement on March 25 saying that it planned in some cases to exercise enforcement discretion with respect to late or incomplete data reporting. CMS stated that, although it is sensitive to the challenges caused by the coronavirus (COVID-19) pandemic, it does not have the authority to waive the statutory requirement that Program Year 2019 Open Payments data be submitted by the March 31, 2020, deadline or to postpone the publication deadline of June 30, 2020. CMS will, however, “exercise enforcement discretion with respect to submissions completed after the statutory deadline due to circumstances beyond the reporting entity’s control associated with the pandemic,” and will consider the impact that these circumstances have on reporting entities’ ability to report in a timely, accurate, and complete manner in deciding whether to impose civil monetary penalties.

In managing the quickly evolving healthcare landscape during this current crisis, healthcare companies should be wary of fraudsters who attempt to divert critical resources. The US Department of Justice (DOJ) and the US Department of Health and Human Services Office of Inspector General (OIG) are alerting the public about fraud schemes related to the coronavirus (COVID-19).

As we noted in our previous Health Law Scan blog CMS Issues Program Instructions for Medicare Telehealth Waiver, CMS issued program instructions on March 17 to implement the Medicare telehealth waiver in response to the coronavirus (COVID-19) crisis. We noted that the Office of Inspector General (OIG) and the Office for Civil Rights (OCR) at HHS simultaneously issued policy statements with respect to their exercise of enforcement discretion regarding, respectively, telehealth-related copay waivers and HIPAA violations. These coordinated policy announcements represent a concerted effort by federal government agencies to broaden telehealth flexibility to immediately promote and expand the use of technology to help Medicare beneficiaries follow guidance from the CDC, including practicing social distancing, thereby enabling vulnerable beneficiaries and beneficiaries with mild symptoms to access the care they need from their homes. Not only will this help protect Medicare beneficiaries who are particularly vulnerable to COVID-19 infection, it presumably will help deter the spread of the virus and ease the burden on already over-stressed emergency departments, doctor’s offices, and other healthcare facilities.

In the face of the coronavirus (COVID-19) pandemic, the US president’s National Emergency Declaration, issued on March 13, set in motion several actions required of other agencies to provide the regulatory relief needed to ensure that healthcare providers have flexibility in responding quickly to the growing need in the United States.

First, the secretary of the US Department of Health and Human Services (HHS) issued a Waiver or Modification of Requirements under Section 1135 of the Social Security Act on March 13, with a retroactive effective date of March 1, 2020 (1135 Waiver). The 1135 Waiver suspends certain Medicare, Medicaid, and Children’s Health Insurance Program requirements “only to the extent necessary, as determined by the Centers for Medicare & Medicaid Services” to meet the needs of those programs’ participants and to assure that providers furnishing care to such participants in good faith are reimbursed.

Healthcare industry lawyers Eric Knickrehm and Jake Harper recently authored a LawFlash analyzing medical licensure waivers issued in connection with the coronavirus (COVID-19) emergency that permit healthcare professionals to receive federal healthcare program reimbursement for telehealth services in states where they do not hold a license.

Noting that such waivers are limited in scope to conditions of participation and payment for federal healthcare programs such as Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP), Knickrehm cautions that “these waivers alone do not waive the requirement for physicians and other healthcare providers to maintain licensure in states where they are practicing a licensed profession, including via telehealth.” Waivers by state medical boards to implement emergency changes to licensure requirements are also addressed.

Read the full LawFLash.

CMS issued program instructions on March 17 (through a Fact Sheet and FAQ) to implement the Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSAA), which was enacted on March 6 in response to the coronavirus (COVID-19) crisis. Telehealth and other healthcare stakeholders have been waiting for these program instructions to be released to determine how CMS will fully implement the Medicare telehealth waiver.

Traditionally, under the Medicare program, professional telehealth services are restricted by statute to originating site locations (defined generally as healthcare facilities and physician offices) that are located in rural areas or outside of Metropolitan Statistical Areas (MSAs). Medicare beneficiaries generally would not be allowed to receive telehealth services in their home. CPRSAA waived both of these requirements, enabling Medicare beneficiaries across the country (regardless of urban or rural location) to receive telehealth services, including in their home, from a doctor in a remote location directly through their smart phone or computer.

In this LawFlash, Morgan Lewis healthcare industry partner Susan Feigin Harris analyzes recent CMS guidance on Emergency Medical Treatment and Labor Act (EMTALA) requirements and implications related to the coronavirus (COVID-19). The guidance, which provides advice concerning EMTALA screening, stabilization, transfer, and recipient hospital obligations, “reminds the industry of the rare circumstance in which EMTALA obligations may be waived.” Flexibility in managing EMTALA requirements regarding individuals with suspected or confirmed COVID-19 are also addressed.

Read the LawFlash

Morgan Lewis lawyers are here to help guide healthcare organizations through this fluid public health crisis. Please see our dedicated webpage on Responding to the Coronavirus for updates and developments as they unfold.

The Centers for Medicare & Medicaid Services (CMS) issued a statement on March 9 related to actions the agency is taking to protect the health and safety of patients and providers. CMS urges providers to stay abreast of CDC guidance on the 2019 Novel Coronavirus (COVID-19). As of March 9, CMS has issued COVID-19-specific guidance for hospice providers and nursing homes. Both guidance documents are linked in the CMS press release. Morgan Lewis will continue to monitor CMS statements related to COVID-19, including any regulatory relief for providers, as those statements are made available.