Health Law Scan

Editorial board

Susan Feigin Harris, Scott A. Memmott, Kathleen P. Rubinstein, Robert L. Abramowitz, Michele L. Buenafe, Gregory N. Etzel, Ryan Kantor, Ayman A. Khaleq, Alexander L. Reid, Mark B. Stein

Health Law Scan

Legal Insights and Perspectives for the Healthcare Industry

Join Us: Labor-Management Relations in the Healthcare Industry: Today, Tomorrow, and Beyond

By Douglas R. Hart and Grace Tse

// September 22, 2020

We invite you to join our labor and employment team on October 1 at 12:00 pm ET for a virtual roundtable on labor-management relations as they relate to the healthcare industry. 2020 has brought a myriad of uncertainties, especially for the healthcare industry, and we anticipate that clients may have a number of questions on how to handle these unprecedented times. The Morgan Lewis team, joined by IRI Consultants, will discuss how to address a number of labor-management-related issues today, tomorrow, and beyond.

Topics will include:

How organized labor is leveraging current events to achieve their organizing and policy goals
Collective bargaining challenges during the pandemic
The importance of contract language as exposed by the coronavirus (COVID-19) pandemic
Dealing with the practical and PR challenges of PPE demonstrations
Important NLRB case takeaways
Latest on COVID-19 mail-in ballot versus manual election developments

If you are interested in attending, please contact Margaret Butler. Register soon, as space is limited.

Tags: Coronavirus, COVID-19, Employers, Healthcare, Labor and Employment, NLRB

Don’t ‘Fall’ Behind: Catch Up on August’s Must-Reads and Webinars

By Kathleen P. Rubinstein

// September 17, 2020

As we continue to move away from a stifling summer and further into the busying fall season, be sure to catch up on August’s hot topics and must-reads from Health Law Scan and on-demand replays of recent webinars.

Recent Webinars

LawFlash: HHS Limits FDA Oversight of LDTs Without Formal Rulemaking, Including During COVID-19 Pandemic

By Michele L. Buenafe , Dennis C. Gucciardo , Kathleen M. Sanzo , and Maria Kalousi-Tatum

// September 15, 2020

Our FDA team recently posted a LawFlash about the US Department of Health and Human Services (HHS) August 19 announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the FDA would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. The announcement has implications not only for LDTs intended for SARS-CoV-2 testing, but also for LDTs intended for other purposes, such as pharmacogenetic testing and direct-to-consumer testing.

Read the full LawFlash >>

Tags: COVID-19, FDA, HHS

CMS Ties Reporting of COVID-19 to Medicare, Medicaid Conditions of Participation—and Imposes Civil Monetary Penalties

By Susan Feigin Harris

// September 11, 2020

In a stunning move, the Centers for Medicare and Medicaid Services (CMS) has linked reporting and tracking of the incidence and impact of the coronavirus (COVID-19) disease to satisfaction of the Medicare Conditions of Participation (CoPs) for hospitals and critical access hospitals, in spite of the federal about-face that has caused confusion concerning that same reporting since the inception of the pandemic.

CMS’s Interim Final Rule (IFR) applies to a large variety of healthcare and non-healthcare providers that are currently testing for coronavirus. Hospitals, employers, and other entities are struggling to ensure they comply with an ever-changing landscape of local, state, and federal reporting requirements. However, this recent IRF subjects these entities to fairly stout enforcement consequences for failure to stay current, comply, and perform. CMS released its IFR with comment for public display on August 25 with publication in the Federal Register on September 2, 2020. Comments are due 60 days after publication.

Tags: CARES Act, CMS, Coronavirus, COVID-19, Healthcare, Interim Final Rule, Pandemic

Upcoming Digital Health Events – September 2020

September 04, 2020

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.

“Is My Digital Health Product a Medical Device?” during the Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA program on September 9
“Regulation of Digital Health During and After COVID-19” during the Digital Health Technology and Regulation During COVID-19 and Beyond program on September 10

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.

Tags: Coronavirus, COVID-19, Digital Health, Fast Break, FDA, Healthcare, Telehealth

Morgan Lewis Lawyers Discuss Kazakhstan’s Health PPP Programme

By Ayesha K. Waheed , Asem B. Bakenova , and Daniyar Zhumakhanov

// August 27, 2020

Partners Ayesha Waheed and Asem Bakenova and associate Daniyar Zhumakhanov have contributed to the PFI Global Infrastructure Report 2020 with an article discussing Kazakhstan’s public-private partnership (PPP) law and its application to the healthcare sector.

In the article, they highlight a number of considerations related to private investment in Kazakhstan’s healthcare sector, which has seen a steady annual increase of 31% from 2016 to 2019.

Read the full article >>

Tags: Healthcare, Healthcare Transactions, Investment

Tele-Tuesday: Singapore’s Telehealth Expansion

By Bernard Lui

// August 25, 2020

Our global healthcare industry team continues to highlight how regions around the world have quickly adapted to providing telehealth services following the coronavirus (COVID-19) pandemic. In Singapore, telehealth providers are mainly focused on providing remote telemedicine and/or on-demand house call services.

Tags: Coronavirus, COVID-19, Healthcare, Pandemic

Register Now: Fast Break: Managing COVID-19 Fraud Enforcement

By Jacob J. Harper , Kathleen McDermott , and Tinos Diamantatos

// August 20, 2020

We invite you to join us on Tuesday, August 25 for our next installment of the Fast Break series, this time focused on fraud enforcement following the coronavirus (COVID-19) pandemic.

Tags: Coronavirus, COVID-19, DOJ, False Claims Act, Healthcare Fraud, OIG, Pandemic

LawFlash: Court Expands Employee Eligibility for COVID-19 Emergency Paid Sick and FMLA Leave

By Susan Harthill

// August 19, 2020

Our labor, employment, and benefits team recently posted a LawFlash on the ruling in federal district court in New York that invalidated significant parts of a US Department of Labor rule. The ruling found that more employees are eligible for up to 12 weeks’ coronavirus (COVID-19)-related emergency paid sick leave and emergency paid FMLA leave. In light of the court’s decision, employers should consider whether they need to adjust their leave determinations in light of the court’s decision.

Read the LawFlash >>

Tags: Coronavirus, COVID-19, Labor and Employment, Paid Sick Leave, Pandemic

As Prescribed: Executive Order on 340B Program is Limited, Unlikely to Take Effect but Could Signal Future Changes

By Donna Lee Yesner

// August 13, 2020

As reported in As Prescribed, US President Donald Trump signed four executive orders implementing policies on drug pricing on July 24. One of the orders directs the secretary of the US Department of Health and Human Services (HHS) to condition future grants under Section 330(e) of the Public Health Service Act on Federally Qualified Health Centers establishing practices that ensure the 340B discount they receive on insulin and injectable epinephrine is passed through to low-income patients who lack insurance or have high copays or deductibles. The HHS secretary has discretion to set the standard for eligible patients.

In the blog post, Morgan Lewis senior counsel Donna Yesner reports that this policy is limited in scope to one category of covered entities—it does not extend to hospitals—and two categories of drugs, but is consistent with the legislative intent of the 340B program to make outpatient drugs accessible to poor and uninsured or underinsured patients of federal grantees. But, as with other drug pricing executive orders, there could be problems carrying out the 340B directive.

Read the full blog post>>

Tags: 340B, HHS, Prescription drugs