On November 16, 2021, 12 states—Montana, Alabama, Arizona, Georgia, Idaho, Indiana, Louisiana, Mississippi, Oklahoma, South Carolina, Utah and West Virginia—filed a complaint in the US District Court for the Western District of Louisiana requesting that the Interim Final Rule with comment period (IFR) that put in place the vaccination mandate applicable to certain covered healthcare facilities and staff be declared arbitrary and capricious, contrary to law and in excess of the Centers for Medicare and Medicaid Services’ (CMS) statutory authority. CMS published an IFR on November 5, 2021, that implements the Biden administration’s previously announced vaccine mandate for healthcare facilities. The expansive IFR applies to more than a dozen types of healthcare providers and suppliers (facilities), affects more than 10 million healthcare staff and carries an anticipated potential price tag in excess of $1.3 billion dollars for the first year of implementation.
Businesses Left in Limbo on COVID-19 Mandate
Following a US Court of Appeals for the Fifth Circuit decision to temporarily block the Occupational Safety and Health Administration’s (OSHA) new vaccine requirement rule, many employers have found themselves in a state of confusion. According to this article published in The Hill, businesses could face steep penalties if they willfully violate the rule, such as fines of more than $130,000. But even though the rule is temporarily blocked, McDermott Partner Michelle Strowhiro said businesses should continue preparing for important OSHA deadlines.
“I think it’s prudent for employers to proceed with planning assuming that the OSHA rule, at least in some form or fashion, will be implemented pending final resolution of the various court cases,” Strowhiro said.
Federal Appeals Court Temporarily Blocks New OSHA Rule
On November 6, 2021, the US Court of Appeals for the Fifth Circuit temporarily blocked the Emergency Temporary Standard (ETS) issued on November 4, 2021, by the Occupational Safety and Health Administration (OSHA) requiring employers with 100 or more employees to implement COVID-19 vaccination policies. The ETS is stayed until further notice, halting its implementation temporarily. While the future of the ETS remains uncertain, employers may want to continue preparing for the ETS as if it is going to take effect while litigation continues.
OSHA and CMS Vaccination Rules Released: Here Are the Details
On November 4, 2021, the US Occupational Safety and Health Administration (OSHA) unveiled its Emergency Temporary Standard (ETS) to protect employees of large employers in all industries from COVID-19. The Centers for Medicare and Medicaid Services (CMS) simultaneously released its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule, applicable to most Medicare- and Medicaid-certified providers and suppliers, which must be met to continue participation in Medicare and Medicaid programs. Finally, the White House announced that its previously published federal contractor vaccination mandate would be updated to move the compliance deadline from December 8, 2021, to January 4, 2022.
Integration of Technology Into Health Care Delivery
The integration of technology into health care delivery is exploding throughout the health industry landscape. Commentators speculating on the implications of the information revolution’s penetration of the health care industry envision delivery models rivaling those imagined by celebrated science fiction authors, and claim that the integration of information technology into even the most basic health care delivery functions can reduce cost, increase access, improve quality and, in some instances, fundamentally change the way health care is delivered.
These visions are difficult to refute in the abstract; the technology exists or is being developed to achieve what just a few years ago seemed the idle speculation of futurists. But delivering this vision in an industry as regulated as health care is significantly harder than it may seem. While digital health models have existed for many years, the regulatory and reimbursement environment have stifled their evolution into fully integrated components of the health care delivery system.