On November 8, 2021, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued an update to the Health Care Fraud Self-Disclosure Protocol (SDP). This update revises and renames the Provider Self-Disclosure Protocol last updated by OIG in 2013. The changes are mostly procedural in nature and update the SDP based on legislative adjustments to penalty amounts.
The courts continue to move the vaccine mandate goalposts on employers as dozens of legal challenges work their way through the courts. The latest developments are major game changers for employers. As of today, the US Occupational Safety and Health Administration (OSHA) Emergency Temporary Standard (ETS) vaccine-or-test rule is enforceable nationwide, and the US Centers for Medicare & Medicaid Services (CMS) Interim Final Rule (IFR) mandating vaccination, subject to exemptions, is enforceable in 25 states.
A flurry of litigation in federal district and appellate courts has led to an even split between states in which the COVID-19 vaccine mandate issued by the US Centers for Medicare and Medicaid Services (CMS) may be implemented and states in which such implementation has been prevented. Additional appeals are expected shortly; however, the practical effect of these decisions on enforcement of the CMS mandate remains uncertain.
On December 13, 2021, the Commissioner of the New York City Department of Health and Mental Hygiene (DOHMH), Dr. Dave A. Chokshi, published an order (the Order) requiring private employers to impose COVID-19 vaccine mandates upon all in-person employees within New York City, with limited exceptions, as of December 27, 2021. DOHMH provided a series of FAQs and additional guidance on December 15, 2021. The Order follows Mayor Bill de Blasio’s December 6, 2021, announcement of this impending mandate.
While the fate of the Centers for Medicare & Medicaid Services’ (CMS) November 5 vaccination mandate rests in the hands of the federal courts, experts say the potential loss of healthcare employees outweighs any of the mandate’s benefits. In this Health Care Compliance Association article, McDermott Partner Sandra M. DiVarco called the situation “bonkers.”
“Almost every hospital has so many unfilled positions, and they are concerned even a small amount of forced terminations will impact their ability to staff and risk burnout in the staff they have,” DiVarco said.
On December 7, 2021, the US District Court for the Southern District of Georgia issued a nationwide injunction that blocks the federal government from enforcing the federal contractor and subcontractor vaccine mandate. The preliminary injunction issued is for the pendency of the litigation challenging the enforceability of the mandate filed by the states of Georgia, Alabama, Idaho, Kansas, South Carolina, Utah and West Virginia. This injunction order may be challenged on appeal.
On December 6, 2021, New York City Mayor Bill de Blasio announced that all New York City employers, regardless of size, will be required to impose COVID-19 vaccination mandates on all employees (subject to legally protected exemptions) by December 27, 2021.
This new vaccine requirement is in addition to the City’s existing COVID-19 vaccination mandate for establishments providing indoor dining, gyms, theaters and other entertainment services. Mayor de Blasio cited the combination of the new Omicron COVID-19 variant and holiday gatherings as the motivation for this mandate.
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.
On November 2, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that it will implement increased penalties for hospitals that do not comply with the Hospital Price Transparency Rule, effective January 1, 2022. CMS will also finalize several additional requirements for hospitals, including a requirement that hospitals ensure standard charge information is accessible to automated searches and direct downloads.
CMS will implement a sliding penalty scale based on the hospital’s number of beds. Hospitals with 30 or fewer beds will face a maximum daily penalty of $300, while hospitals with between 31 and 550 beds will face a maximum daily penalty of $10 per bed. Hospitals with more than 550 beds will face a maximum daily penalty of $5,500.
A coalition launched by several major health systems and a hospital-at-home company aims to continue delivering hospital-level-at-home care in the wake of the COVID-19 pandemic. McDermott+Consulting Vice President Mara McDermott said providers have demonstrated that the model is “of high value to patients.”
“At the end of the pandemic, without some sort of extension, the new model is at risk of going away or dramatically shrinking,” McDermott said. “Action by the federal government will ensure that this important and innovative source of care can continue.”
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