According to a recent study (Study) published in Nature Reviews Drug Discovery on May 10, 2020 regarding the impact that the COVID-19 pandemic has had on the conduct of oncology clinical trials,[i]  the COVID-19 pandemic has materially disrupted the conduct of clinical research and trials in much of the world.  The observed disruptors include an observed decrease in patient enrollment in clinical trials and the operational challenges arising from the need to protect patient safety and comply with the social distancing, shelter-in-place and other rules and regulations that have become key elements of the public health response to the pandemic.  As a result of these and other disrupters, investigators who participated in the Study reported that they are, “adopting or planning to adopt technology-based interventions aimed at reducing on-site monitoring visits and in-person patient visits to minimize potential viral exposure and spread, including telemedicine, remote electronic medical record access for monitors and virtual monitoring of data and study documentation.”
Continue Reading Going Virtual: Clinical Trials, Telemedicine, Electronic Medical Records, And All That.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act provided trillions in economic relief in response to the COVID-19 pandemic, including hundreds of billions of dollars in aid for the healthcare industry.  Regulators in the healthcare industry have also adjusted regulations and procedures in response to the changing landscape caused by the pandemic.  While the CARES Act and regulatory changes provide much-needed help, accepting funds and navigating the regulatory changes can add many legal pitfalls to an already cluttered regulatory scheme.  As the government prepares to prosecute fraud and abuse by recipients of CARES Act funds, healthcare entities—the top payors of government enforcement and qui tam dollars—should take care to avoid claims of misconduct under the CARES Act.
Continue Reading Tips for the Unwary: Precautions Against Liability for Healthcare Businesses Receiving CARES Act Funds

In 2012, the U.S. Supreme Court in NFIB v. Sebelius struck down a provision in the Patient Protection and Affordable Care Act (the “ACA”) which, for all intents and purposes, made the expansion of the Medicaid program voluntary for individual states.  As a consequence, the Medicaid expansion provided for in the ACA has been rolled out in piecemeal fashion, with various states opting to expand Medicaid in the years since the ACA’s passage, and other so-called “holdout” states choosing to preserve their respective pre-ACA structured Medicaid programs.  These holdout states tend to be more conservative and Republican-controlled, with governors and state legislatures opposed to the ACA’s Medicaid expansion for various political and economic reasons.  The COVID-19 pandemic, however, seems to have prompted some of these “holdout” states, even considerably conservative states, to reconsider their decision not to expand Medicaid.
Continue Reading Will COVID-19 Prompt “Holdout States” to Reconsider Medicaid Expansion?

As discussed in a prior blog post, in order to manage the unprecedented medical need due to the COVID-19 pandemic, some states have loosened scope of practice restrictions imposed on healthcare professionals. The relaxing of these restrictions has enabled registered nurses, nurse practitioners, physician assistants, pharmacists and other health care professionals to provide certain medical services that are outside the scope of practice permitted under the practitioner’s license during the COVID-19 crisis.
Continue Reading COVID-19: Medical Liability for Expanded Scope of Services

As we discussed in our April 27, 2020 blog post, nursing homes have become the focus of significant attention during the COVID-19 crisis.  In many respects, the attention is well deserved:

  1. Nursing homes traditionally serve seniors who often struggle with chronic health conditions. As a result, nursing home residents are particularly vulnerable to coronavirus infection due to both their age and health status;
  2. Nursing homes residents are highly interactive with each other. The close proximity of nursing home rooms/beds and the personal relationships often formed among nursing home residents make social distancing hard to maintain;
  3. In order to relieve pressure on hospitals that need to reserve their beds for the most acute COVID-19 patients, nursing homes are under significant pressure to accept COVID-19 patients who have been discharged from hospitals because they no longer require an acute level of care but still may be symptomatic and require isolation and treatment; and
  4. Most importantly, the above three factors and others have turned many nursing homes across the country into hot spots for coronavirus infection and, in some cases, COVID-19 fatalities. Overwhelming data as to the dangers found in nursing homes is highlighted in the blog article referenced above.


Continue Reading Nursing Home Liability Waivers and Nursing Home Investigations and Enforcement: A Delicate Balance During the COVID-19 Pandemic

As the COVID-19 emergency continues to heavily impact the U.S. and its health care system, CMS has issued additional flexibilities for providers and payors seeking to respond to the pandemic.  These new flexibilities are described both in revisions to CMS’ blanket waivers and in a new Interim Final Rule with comment period, both issued on April 30.  Many of these flexibilities are responsive to questions and requests submitted to CMS over the past few weeks, providers’ experiences with developing and implementing pandemic response plans, and the regulatory obstacles they have encountered.  While these new flexibilities will not eliminate all of the regulatory challenges currently facing providers responding to COVID-19, and providers must be careful to continue to track the scope of CMS’ flexibilities, they will be very helpful to many providers in their ongoing COVID-19 response efforts.  In particular, and among other things, CMS’ new guidance expands flexibility for telehealth services, provides additional support for COVID-19 testing, relaxes additional regulatory requirements applicable to certain payors, provides other key regulatory flexibilities, and offers guidance to MSSP ACOs on payment calculations for periods affected by the public health emergency.
Continue Reading CMS Updates Waivers, Provides More Flexibility for Providers Responding to COVID-19

On Thursday, April 16, 2020, the California Department of Managed Health Care (the “Department”) released an all plan letter (the “Letter”) regarding changes to the Department’s General Licensure Regulation (the “Regulation”) in light of the coronavirus (COVID-19) pandemic.  The Letter updated the Department’s previous guidance concerning the Regulation that was issued on June 13, 2019.  For further information, see our previous post regarding the Regulation here.  
Continue Reading The California Department of Managed Health Care Extends the Phase-In Period for the General Licensure Regulation

On April 23, 2020, the Kaiser Family Foundation (“KFF”) issued a report authored by Priya Chidambaram entitled, “State Reporting of Cases and Deaths Due to COVID-19 in Long-Term Care Facilities.” In the KFF report, Ms. Chidambaram cited to previous KFF studies showing that COVID-19 has had a disproportionate impact on people who reside or work in long-term care facilities – such populations including 1.3 million nursing home residents, 800,000 assisted living facility residents, 75,000 intermediate care facility residents, and 3 million people who work in skilled nursing or residential care facilities.
Continue Reading Data Reporting, Patient Access and Malpractice Liability: Nursing Homes and Long-Term Care Facilities Command Federal and State Attention during the COVID-19 Public Health Emergency

The unprecedented impact of COVID-19 has created a myriad of challenges for healthcare providers to safely meet the evolving needs of their patients solely through a traditional in-person model. Telehealth has quickly shifted from a “nice-to-have” strategy to an essential tool for all healthcare organizations.
Continue Reading Sheppard Mullin and Citrin Cooperman Rollout Telehealth Maturity Model

On April 16, 2020, the Trump Administration issued its “Opening Up America Again Guidelines” (the “OUAA Guidelines”) as a self-styled roadmap to the staged reopening of the American economy.

On Sunday, April 19, 2020, the Centers for Medicare & Medicaid Services (“CMS”) followed suit by issuing new guidance (the “Reopening Guidance”) designed to reintroduce the provision of non-essential surgeries and medical procedures by healthcare providers located in “Phase 1” states and/or regions.  Such non-elective procedures were previously put on hold at the state and local levels in accordance with prior CMS guidance dated March 18, 2020 (the “March Guidance”) in which CMS called for the delay of all elective surgeries, non-essential medical, surgical, and dental procedures during the COVID-19 state of emergency.
Continue Reading Elective and Non-Essential Medical Procedures: States React to Federal Recommendations and the Opening Up America Again Guidelines