Health Law Scan

The Biden administration recently announced its much-anticipated proposed rule for implementing a minimum staffing “floor” for nursing homes in the United States and further launched a nursing home accountability initiative. These efforts are seismic for the long-term care nursing home community and will bring new challenges and scrutiny to a health industry sector battered with healthcare personnel shortages, pandemic recovery obstacles, changing reimbursement models, and regulatory scrutiny.

Throughout the COVID-19 pandemic and related public health emergency (PHE), the US Department of Health and Human Services, Office for Civil Rights (OCR) issued four Notifications of Enforcement Discretion (referred to as “waivers”) designed to offer flexibility to healthcare providers battling the virus. On April 11, the OCR announced that these waivers will officially expire on May 11, 2023, in conjunction with the end of the PHE. While it is not unexpected that the OCR is pulling back these waivers, healthcare providers must ensure that their ongoing operations are fully compliant with the OCR’s HIPAA-related requirements. This blog post details the list of waivers issued by the OCR that will expire on May 11.

COVID-19 significantly affected home-based care providers, such as home health agencies (HHAs) and hospices, whose staff had to overcome both physical and mental burdens of going into patients’ homes to deliver care, especially in the days before a COVID-19 vaccine. While these providers benefitted from a number of Medicare program regulatory flexibilities during the public health emergency (PHE), virtually all of those will sunset on May 11, 2023.

Is the COVID-19 pandemic making you feel a bit like Bill Murray in Groundhog Day? Although most parts of life have returned to the "new normal," the federal government remains in a seemingly endless cycle of regulatory uncertainty.

The federal COVID-19 public health emergency’s (PHE) current expiration date is just one week away—July 14, 2022. While no official extension has been issued by the Biden-Harris administration yet, it is increasingly likely that the PHE will be extended for at least another 90 days. Previously, the federal government had pledged to states that it would announce an end to the PHE at least 60 days before its expiration. That 60-day time frame ended on May 16 with no indication from the US Department of Health and Human Services (HHS) that it was anticipating the end of the PHE.

Fraud stemming from the COVID-19 pandemic continues to be a criminal enforcement priority for the US Department of Justice (DOJ). On April 20, DOJ announced a new round of criminal charges against 21 defendants that stem from over $149 million in allegedly fraudulent billing to federal healthcare programs and pandemic assistance programs. The new cases raise DOJ’s total COVID-19-related enforcement stats to 35 defendants and over $290 million in fraudulent billing across 16 federal districts.

Members of our labor and employment group published a LawFlash discussing the US Equal Employment Opportunity Commission (EEOC) updates on its COVID-19 guidance, detailing its view of employer obligations under Title VII when evaluating religious objections to COVID-19 vaccination mandates and requests for accommodation based on pregnancy under the Americans with Disabilities Act and the Pregnancy Discrimination Act. These updates may be of interest to healthcare employers as they continue to navigate through vaccine mandates.

The Centers for Medicare and Medicaid Services (CMS) announced that it had restarted the Targeted Probe and Educate (TPE) audit process, effective September 1, 2021. More recently, the Medicare Administrative Contractors for hospice have targeted “claims with revenue code 0656 [General Inpatient Care] greater than or equal to 7 days submitted with dates of service on or after January 1, 2020” for active, pre-pay medical review.

Members of our labor, employment and benefits team published a LawFlash covering Texas Governor Greg Abbott’s recently issued Executive Order No. GA-40 (EO GA-40), which purports to prohibit vaccine mandates, but in reality expands the scope of mandatory exemptions to such mandates.

As the availability and variety of digital health tools continue to increase, evidence is also being presented that those tools are having a meaningful impact on health outcomes. In a recent blog post, members of our technology, outsourcing, and commercial transactions team dove into the findings of two reports, Digital Health Trends 2021: Innovation, Evidence, Regulation, and Adoption, offered by the IQVIA Institute for Human Data Science; and a report from the University of Michigan’s Institute for Healthcare Policy and Innovation’s Telehealth Research Incubator.