Legal Insights and Perspectives for the Healthcare Industry

CMS posted an expanded set, dated April 29, of Medicare regulatory flexibility measures for hospice organizations related to the coronavirus (COVID-19) pandemic, supplementing the previous COVID hospice flexibilities guidance from March 29.

As we all settle into our new sense of normalcy, Health Law Scan continues to monitor developments surrounding the coronavirus (COVID-19) pandemic. We have lawyers across the firm providing updates on a wide variety of topics to keep our clients apprised of all the developments.

Morgan Lewis is staying informed on all of the developments surrounding the coronavirus (COVID-19) pandemic. Our healthcare team continues to follow developments, producing a number of publications and webinars to help keep our healthcare industry readers informed.

COVID-19 Healthcare Provider Updates: We have hosted a number of brief webinars addressing questions of interest to healthcare providers during this time:

Our telecommunications, media, and technology group prepared a LawFlash discussing two programs that the Federal Communications Commission established on March 31 to help eligible healthcare providers purchase and deploy telehealth technology. The programs provide immediate relief for telehealth and healthcare providers during the coronavirus (COVID-19) pandemic and aim to improve telehealth outcomes over the longer term.

Read the LawFlash

CORONAVIRUS COVID-19 TASK FORCE

For our clients, we have formed a multidisciplinary Coronavirus COVID-19 Task Force to help guide you through the broad scope of legal issues brought on by this public health challenge. We also have launched a resource page to help keep you on top of developments as they unfold. If you would like to receive a daily digest of all new updates to the page, please subscribe now to receive our COVID-19 alerts.

The Center for Medicare and Medicaid Services (CMS) released a far-reaching interim final rule (IFR) to address the coronavirus (COVID-19) pandemic on March 30. The IFR represents a comprehensive set of policy changes designed to shift the provision of Medicare services from face-to-face care to remote care through telehealth, in order to mitigate the risks of exposure to COVID-19 for patients and healthcare providers. Above all else, the IFR prioritizes physically distancing patients from their care teams and other patients.

The IFR, with a display copy totaling 220 pages, is a massive rule issued at perhaps historic speed. Although it was published just three weeks after the passage of initial legislation (the CPRSAA), and only days after the passage of the CARES Act, the IFR touches on nearly every aspect of the Medicare program, including home health and hospice, intensive care services, radiation therapy management, physicians’ services, and inpatient rehabilitation.

The Morgan Lewis healthcare team continues to monitor the developments surrounding the coronavirus (COVID-19) pandemic. We are acutely aware of what the healthcare service provider community is currently facing and are here to help. We are hosting two webinars a week to address the evolving unprecedented legal issues that arise from pandemic. The webinars will be held on Tuesdays and Thursdays. Below we provide the webinars we have previously hosted, and we will keep our COVID-19 Healthcare Provider Update Webinars page updated with the latest webinars.

UPCOMING SESSIONS

PREP Act and Other Considerations for Hospitals Experimenting with COVID Treatments – 4.7.20

COVID-19 Healthcare Provider Update Webinars – 4.9.20

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.