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.”
Hospitals are pushing back after the US Department of Health and Human Services (HHS) cut Medicaid reimbursement rates to participating hospitals under the 340B drug discount program.
According to this article published in The Well News, 340B program supporters have filed a petition with the Supreme Court, arguing that HHS failed to collect sufficient data and that the department overstepped its authority with the cuts. McDermott Partner Emily Jane Cook said that the cuts will mean rural hospitals are “deprived of an important source of support for the services that they provide to their communities.”
Even though the US Court of Appeals for the Fifth Circuit temporarily blocked the Occupational Safety and Health Administration’s (OSHA) COVID-19 vaccination rule for employers (though not for the healthcare sector), businesses should continue preparing for important OSHA deadlines.
According to this Reuters article, workplace whistleblowers and fears of disappearing federal funds will likely help with vaccination mandates within businesses, hospitals and nursing homes. However, OSHA is unlikely to demand proof from every healthcare provider of vaccination and testing protocols. The Centers for Medicare & Medicaid Services (CMS) also typically does not survey accredited healthcare providers unless there is a complaint or a need for recertification, McDermott Partner Sandra DiVarco noted.
“On a stakeholder call, CMS reiterated their desire to work with providers to come into compliance and not to sort of send SWAT teams to go out and look for problems,” DiVarco said.
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.
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.
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.
On July 19, 2021, US President Joe Biden’s administration released a proposed rule that would increase penalties for hospitals that do not comply with the Hospital Price Transparency Rule, effective January 1, 2022. According to McDermott’s Emily Jane Cook and Steven J. Schnelle, the proposed rule also provides certain potentially burdensome clarifications and requests comment on further rulemaking activity relating to the Hospital Price Transparency Rule.
The Centers for Medicare & Medicaid Services recently published its annual proposed changes to the Medicare Physician Fee Schedule, which include several key telehealth and other virtual care-related proposals. The proposals address long-standing restrictions that have historically limited the use of telehealth and virtual care, including geographic and originating site restrictions, and limitations on audio-only care, as well as coverage extensions for some services added during the COVID-19 public health emergency.
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