As noted in our March 31, 2020 blog article, “Strategies in Responding to COVID-19: Expanding Scope of Practice to Increase Patient Access to Healthcare” and in our May 8, 2020 blog article, “COVID-19: Medical Liability for Expanded Scope of Services,” the COVID-19 pandemic has revealed limitations in the healthcare system that have impeded access to medical care, often for rural, low-income, and minority communities. In order to increase healthcare access, many states and the federal government have worked to (i) expand the scope of practice for different types of non-physician practitioners (“NPPs”) to provide a wider range of healthcare services; (ii) eliminate or relax physician supervision requirements so that NPPs can practice independently without having to rely on physicians who are, themselves, scarce healthcare resources; and (iii) insulate NPPs from liability for the provision of those healthcare services that fall outside of their traditional scopes of practice.

Continue Reading The Scope-of-Practice Debate Takes Center Stage: The 2021 Medicare Inpatient Rehabilitation Facility Prospective Payment System Final Rule

Many areas of the country are experiencing resurgences of COVID-19, and it is foreseeable that second and perhaps third waves of the virus will hit pockets of the country throughout the remainder of 2020. As healthcare organizations struggle to balance their continued response efforts to the pandemic, with preparations for future waves, we have received many questions from provider organizations regarding how best to prepare their organizations.
Continue Reading Reopening Challenges: FAQs On Preparing For Additional Waves Of COVID-19

On July 17, 2020, the Department of Health and Human Services (“HHS”) announced it will begin distributing $10 billion in a second round of funding to hospitals operating in high impact COVID-19 areas. The distribution is anticipated to begin as early as today, Monday, July 20, 2020. Hospitals with over 161 COVID-19 admissions between January 1 and June 10, 2020, or one admission per day, or that experienced a disproportionate intensity of COVID-19 admissions (exceeding the average ratio of COVID-19 admissions/bed) will receive funding in this distribution in the amount of $50,000 per eligible admission.
Continue Reading More Money On the Way in COVID-19 Fight: HHS Announces Additional $10B for Hospitals in High Impact COVID-19 Areas

According to an April 13, 2020 Press Release issued by the National Association of ACOs (“NAACOS”),  a recent NAACOS survey shows that 56% of the survey-participating at-risk accountable care organizations (“ACOs”) – i.e., ACOs participating in a Center for Medicare and Medicaid Innovation (“CMMI”) alternative payment model (“APM”) and assuming financial risk thereunder – said that they were likely to drop out of their APM because of their fear of having to cover massive losses resulting from the COVID-19 pandemic.  In addition, the survey revealed that, as a result of swings in unpredictability and spikes in expensive hospitalizations, 21% of at-risk ACOs were “very likely” to leave the Medicare ACO program, 14% said they were “likely,” and another 21% said they were “somewhat likely” to leave.  Almost 80% of responding at-risk ACOs said they were “very concerned” about their 2020 financial performance in general and how their financial performance compared to their applicable annual APM benchmarks.
Continue Reading More Help Is On The Way For Accountable Care Organizations: CMS Announces New Relief For ACOs Struggling With The COVID-19 Crisis

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