COVID-19 Viewpoints

The government’s continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 Fraud Enforcement Task Force’s (CFETF) report released on April 9, 2024. The CFETF, which represents a concerted effort across numerous federal agencies to investigate pandemic-related fraud, has, according to its 2024 report, succeeded in prosecuting over 3,500 defendants in criminal enforcement matters, in bringing civil enforcement actions resulting in more than 400 civil settlements and judgments, and in securing more than $1.4 billion in seizures and forfeitures. The report itself is a showcase of the CFETF’s COVID-19 fraud enforcement efforts to date.

In April, 2020, in an effort to facilitate a national pivot to telehealth in light of the COVID-19 Public Health Emergency (PHE), the U.S. Department of Health & Human Services Office for Civil Rights (OCR) announced a policy of Health Insurance Portability and Accountability Act of 1996 (HIPAA) enforcement discretion for regulated health care providers (Covered Entities) implementing communications technologies that weren’t fully compliant with HIPAA or using those technologies in a manner that didn’t comply with HIPAA. Examples of flexibilities included allowing technology providers access to protected health information (PHI) without a HIPAA Business Associate Agreement (BAA). OCR’s enforcement discretion enabled Covered Entities to minimize the need for in-person visits for all kinds of health care services, not just COVID-19 related care. OCR also implemented flexibilities to promote public health during the COVID-19 pandemic; for example, it allowed for Business Associates to share COVID-19 data with government agencies for such purposes without specific authority to do so under BAAs.  

The COVID-19 Public Health Emergency (PHE), which was originally declared nearly three years ago, has been renewed through April 2023. As we’ve previously covered, the PHE allowed federal and state regulators to relax certain telehealth requirements, which has led to a rapid expansion in the availability of telehealth services. The Biden Administration has committed to provide at least 60 days’ notice prior to terminating the PHE or allowing it to expire, but several news outlets are reporting that this could be the final extension. 

Various COVID relief programs pumped $5 trillion into the economy, incredibly quickly, and with relatively minimal vetting. Within that enormous and necessary set of economic stimulus packages was likely the greatest amount of fraud committed on the government in the shortest amount of time in history. This article takes a look at the various issues facing government agencies as they attempt to investigate allegations of PPP fraud related to pandemic-era applications and the role of the Pandemic Response Accountability Committee in coordinating and overseeing these investigations.

Many of the flexibilities upon which telehealth providers have come to rely in recent years are tied to the federal Public Health Emergency related to the COVID-19 pandemic (PHE). As we move into Fall 2022, we review the current state of the PHE flexibilities around Medicare reimbursement and prescription of controlled substances, examine pending legislation that, if passed, would bring greater certainty to patients and providers, and discuss what we know about the status of a possible PHE extension.

Jen Rubin, chair of Mintz’s ESG practice group, looks at the recent California court decision striking down the state’s law mandating corporate board seats for underrepresented communities. She says boards still need to dedicate themselves to a meaningful process for seating the right board and offers suggestions for ways to ensure community representation.

Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services (HHS) is authorized to distribute funds from its Provider Relief Fund (PRF) to certain providers. These providers can then use the funds to support COVID-19 prevention, preparedness, and response, or to alleviate loss of patient care revenue.  However, HRSA requires that providers receiving PRF funds comply with certain requirements, including post-payment reporting requirements.  HRSA is now notifying providers that failed to comply with the reporting requirements that they must return the PRF funds they received. 

Last week saw a lot of great news in the world of telehealth. On March 15, President Biden signed into law H.R. 2471, the “Consolidated Appropriations Act, 2022”, which extends many of the Medicare telehealth flexibilities put in place during the COVID-19 pandemic for a period following the end of the Public Health Emergency (“PHE”). The same day, the OIG issued a report highlighting the positive impact telehealth had on increasing access for beneficiaries during the first year of the pandemic. Then, during a press conference on March 18, HHS Secretary Xavier Becerra said that HHS will seek to sustain and expand access to telehealth services after the public health emergency ends. While these developments signal the continued expansion of telehealth, there is still some uncertainty surrounding coverage, reimbursement and licensure flexibilities that have allowed telehealth to flourish for the past two years.

On March 17, 2022, the designation of COVID-19 as an airborne infectious disease that presents a serious risk of harm to the public health under the HERO Act ended.  The New York State Department of Labor (“NYSDOL”) declined to extend this designation.  The most immediate effect of this designation ending is that the activation of workplace exposure prevention plans mandated under the HERO Act is over.

The EEOC has once again updated its guidance and answers regarding the ongoing COVID-19 pandemic’s interaction with anti-discrimination laws. We previously discussed this guidance here. This guidance, updated on March 1, 2022, provides additional detail to Section L (Vaccinations – Title VII and Religious Objections to COVID-19 Vaccine Mandates). We discuss the key details below.

The U.S. Department of Justice (DOJ) has continued to investigate and prosecute alleged COVID-19 related fraud over the past two years since the pandemic began. On Thursday, DOJ announced the appointment of a Director for COVID-19 Fraud Enforcement, who will lead DOJ’s enforcement efforts in this area. Associate Deputy Attorney General Kevin Chambers will fill this position.

On Monday, February 7, 2022, U.S. Senators Catherine Cortez Masto, D-Nevada, and Todd Young, R-Indiana, introduced the Telehealth Extension and Evaluation Act, which if passed, would extend several of the telehealth waivers for two years after the end of the federal public health emergency (PHE). See our previous coverage of telehealth during the COVID-19 pandemic. The PHE was most recently renewed for an additional 90 days on January 16, 2022. Since January 2020, providers who pivoted to telehealth in order to deliver care to their patients during the pandemic have had to closely monitor the status of the PHE, which the Secretary of HHS is only authorized to extend for 90 days at a time. Passage of the proposed legislation would provide some much-needed certainty and would give providers time to transition back to in-person care where necessary. It would also further the growth and expansion of telehealth services and continued integration into our health care delivery system.

On December 15, 2021, USCIS and ICE announced they again extended flexibility relating to in-person Form I-9 compliance. This flexibility allows employers whose entire workforce is working remotely to defer the physical presence requirements associated with the Employment Eligibility Verification (Form I-9) and section 274A of the Immigration and Nationality Act. In addition, it applies to employees hired on or after April 1, 2021, who work exclusively in a remote setting due to COVID-19-related precautions.

On January 4, 2022, and faced with record numbers of COVID-19 cases in New York State, the New York State Department of Health (“NYSDOH”) issued Interim Updated Isolation & Quarantine Guidance. The Interim Guidance aligns NYSDOH’s isolation and quarantine recommendations for the general population with the guidance issued by the CDC on December 27, 2021, which the CDC has updated repeatedly since then, and about which we previously reported on here. This Interim Guidance also supersedes the essential worker portion of NYSDOH’s December 24, 2021 shortened isolation guidance, although the portion pertaining to healthcare workers remains in effect. We will continue to provide updates on NYSDOH’s recommendations, as well as those issued by other public health agencies, as events continue to unfold.

UPDATE: Following its original announcement, the CDC further updated its guidance to apply the 5 day quarantine rule to those who are asymptomatic but now also to those whose symptoms are resolving (without fever for 24 hours). The guidance now also includes a reminder that applicable local laws continue to apply and that the recommendations do not apply to healthcare workers (for whom the CDC has issued separate guidance). The CDC separately updated its definitions of “isolation” and “quarantine” and outlined additional recommendations regarding testing and masking procedures for individuals who test positive and those who are exposed to COVID-19. This post has been updated to reflect these changes.

It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12 months and consider what the agency is likely to focus on going forward. This year, however, we’re taking a different approach and will be providing more of a birds-eye view of our favorite federal agency as it stands as of the end of 2021. Because there is just too much going on at the administrative, enforcement, and legislative levels to get into the details of everything in one fell swoop. So make sure you’re signed up for Mintz Health Law Viewpoints to receive updates throughout the year on issues as they develop.