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Legal Insights and Perspectives for the Healthcare Industry

We are pleased to announce that we are participating in three upcoming digital health events.

Michele Buenafe, FDA partner and leader of our digital health initiative, will speak at two upcoming FDLI conferences focused on the Food and Drug Administration’s (FDA's) regulation of digital health and developments in digital health regulation before and beyond the coronavirus (COVID-19) pandemic, including significant enforcement discretion policies and exemptions FDA has implemented over the last six months.

On our next Fast Break webinar, Jake Harper will discuss updates in telehealth, a topic that has been top of mind for so many healthcare companies amid the COVID-19 pandemic. Register for Fast Break now.

Don’t forget you can check out all of our latest healthcare events and publications on Our Thinking on Healthcare.

US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. The executive order focuses on rural healthcare providers in particular, noting the difficulties patients in rural areas face in obtaining accessible, high-quality healthcare services over the years. The order contains four specific directives:

  1. The US Department of Health and Human Services (HHS) must create a new 1115A model to test payment mechanisms related to rural healthcare providers.
  2. HHS, the Federal Communications Commission, and the US Department of Agriculture must develop a strategy to improve rural health care through developing healthcare-related infrastructure.
  3. HHS must issue a report regarding existing and planned policy initiatives that enhance various rural healthcare quality metrics, including identifying “regulatory burdens that limit the availability of clinical professionals.”
  4. HHS must propose regulation that would extend the measures taken during the PHE beyond its current duration as to both “the additional telehealth services offered to Medicare beneficiaries” and “the services, reporting, staffing, and supervision flexibilities offered to Medicare providers in rural areas.”

The coronavirus (COVID-19) pandemic has brought a dramatic shift from in-person healthcare visits to telehealth services around the world, unveiling a new normal for providing healthcare services. Our global healthcare industry team authored a LawFlash to highlight how regions, including the United States, China, Singapore, and the United Arab Emirates, around the world have quickly adapted to providing telehealth services as a means to prevent exposure to COVID-19 and allow for patients to get in the in-person care they need.

Read the full LawFlash >>

We are celebrating our 10th year of Technology May-rathon, our annual webinar series focusing on current technology issues, trends, and developments. This year, we have a full schedule of webinars with discussions on privacy and big data, global commerce, fintech, the coronavirus (COVID-19) pandemic, and more. Be sure to register for the many healthcare webinars our lawyers will be presenting on:

And don’t forget to visit our 2020 Technology May-rathon page for our full list of programs!

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