The increase in bankruptcy filings that restructuring professionals have been expecting is now arriving. With rising inflation, increased interest rates, tightening credit markets, labor shortages and supply chain disruptions, we are starting to see a dramatic increase in filings. Last week the American Bankruptcy Institute noted that commercial Chapter 11 filings increased 105% in May … Continue Reading
On March 27, 2023, the U.S. Food &Drug Administration (FDA) released two final guidance documents to assist with the transition of medical devices that were legally distributed: (1) subject to certain enforcement policies issued during the COVID-19 public health emergency (PHE) or (2) Emergency Use Authorizations (EUAs). Manufacturers, distributors, and industry stakeholders that have products … Continue Reading
Earlier this year, the U.S. Department of Health and Human Services (“HHS”) announced the expiration of the COVID-19 public health emergency declarations effective May 11, 2023. As a result, many of the regulatory waivers and flexibilities available to health care providers, including the blanket waivers applicable to many Stark Law requirements (the “Stark Waivers”), will … Continue Reading
Pursuant to federal regulations that took effect on January 1, 2023, individuals who lose Medicaid coverage will be granted a special enrollment right to enroll in Medicare Part B coverage.[1] This special enrollment right was created in part because the COVID health emergency order may soon end, resulting in many people losing Medicaid coverage. In … Continue Reading
In the height of the COVID-19 pandemic, hospitals did what they needed to do to control the spread and keep patients alive. That meant purchasing more of certain specialized equipment than they ever would have needed in non-pandemic times. Sometimes that even meant converting a storage shed on a hospital’s parking lot to a drive … Continue Reading
You’ve just been informed that an employee who apparently contracted COVID-19 from an exposure in your workplace brought the virus home, and now their spouse, who is in a high-risk category, has contracted the virus and is in the hospital. Do you as the employer face potential liability for the spouse’s illness? More than two … Continue Reading
A federal court decision has created a new wrinkle for healthcare employers that are preparing to comply with the new vaccine mandate from the Centers for Medicare and Medicare Services (CMS). On November 29, 2021, Judge Matthew Schelp of the Eastern District of Missouri issued an order blocking the implementation of the CMS vaccine mandate … Continue Reading
Now that OSHA has issued its emergency temporary standard and CMS has issued its own emergency rule, the landscape has changed once again for healthcare employers in terms of addressing employees’ vaccination status. Fortunately, they now have much more certainty, which allows for more specific and detailed planning to address the myriad vaccination-related requirements that … Continue Reading
The Occupational Safety and Health Administration, as well as the Centers for Medicare & Medicaid Services, are preparing to issue new requirements that will have a major impact on healthcare employers, as well as other employers across the U.S. On Thursday, the executive branch announced its plans to have OSHA require employers to ensure that … Continue Reading
In March 2020, the State Medical Board of Ohio issued guidance temporarily relaxing Ohio’s telemedicine rules for physicians, permitting physicians to use telemedicine in place of in-person visits in many circumstances for the duration of Ohio’s COVID-19 state of emergency declaration. With Governor DeWine’s termination of the state of emergency in June of 2021, the … Continue Reading
More than a year after issuing Emergency Use Authorizations (“EUAs”) for filtering facepiece respirators (“FFRs”), surgical masks, and related personal protective equipment (“PPE”), the Food and Drug Administration (“FDA”) is walking back these measures. On June 30, 2021 the FDA announced the revocation of the EUAs for all imported, disposable FFRs not approved by the … Continue Reading
Since the outbreak of COVID-19, the Occupational Safety and Health Administration had limited itself to issuing general guidance concerning COVID-19, as opposed to specific rules or standards. On Thursday, however, OSHA announced that it will issue its first standard specific to COVID-19 for healthcare workers. Although the standard is temporary, it creates significant obligations for … Continue Reading
On June 1, an SPB Partner and other industry experts will co-present on the ABA Webinar: Got Data?: How the Health Data Rules are Changing. The program, organized by the American Bar Association (ABA) will address recent and upcoming developments impacting health data including, CMS and ONC final rules on information blocking and interoperability, HIPPA and guidance … Continue Reading
Regulation 2020/561 (Regulation) was passed by the EU in April last year to take account of issues raised by the COVID-19 pandemic and to defer the date of application of certain provisions of Regulation 2017/745 (MDR) by one year. The Regulation was published on 24 April 2020 through an EU accelerated procedure, and although the … Continue Reading
Squire Patton Boggs Of Counsel Will Kishman recently participated with Kristin McGurn, Seyfarth Shaw LLP, in an American Health Law Association’s (AHLA) Speaking of Health Law podcast, “Labor and Employment Issues with COVID-19 Vaccine Distribution.” It has been published on the AHLA’s Speaking of Health Law channel, and is available to the public. You may … Continue Reading
This is a cross post from Law360. Please contact Sarah Rathke, Kristin Bryan or John Wyand with any questions. In response to American health care needs during the COVID-19 pandemic, the U.S. is seeing a rapid acceleration in mobile health care, however, this new age form of health care does present some risk and legal implications. In the recently published Law360 article, we … Continue Reading
At the time of this writing, two companies, Pfizer Inc. and Moderna, Inc., have announced promising early results from Phase 3 of their COVID-19 vaccine trials. Additional promising results are hoped for from Johnson & Johnson, and AstraZeneca soon, and perhaps from others later. This is good news. Developing a vaccine is one thing, however. Distributing it is another. Indeed, managing … Continue Reading
This is a Cross-Post from Law360. Please contact Sarah Rathke with any questions. The COVID-19 pandemic has revealed shortcomings in U.S. supply chains requiring immediate action to continue to provide personal protective equipment (“PPE”) during the ongoing crisis. Here, we’ve been published in Law360, discussing federal solutions for our national PPE shortages. Read the full … Continue Reading
On October 22, the Department of Health and Human Services (HHS) updated its guidance on how hospitals and other providers should report their use of the nearly $135 billion in Provider Relief Fund payments that have been distributed. The Provider Relief Fund, initially established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, is … Continue Reading
On October 14, the Centers for Medicare and Medicaid Services (CMS) announced that it has expanded its list of telehealth services approved for Medicare beneficiaries during the COVID-19 Public Health Emergency (PHE). The eleven telehealth services CMS just added are for cardiac and pulmonary rehabilitation. CMS approved them using an expedited process it unveiled in … Continue Reading
The Department of Justice (“DOJ”) recently announced its largest ever health care fraud and opioid enforcement action. In a coordinated effort, DOJ charged 345 defendants with more than $6 billion in fraud losses for submitting false and fraudulent claims to federal health care programs and private insurers. The nationwide enforcement operation has been in motion since April … Continue Reading
The Families First Coronavirus Response Act (FFCRA) was enacted on March 18, 2020. The sweeping federal legislation provides emergency paid sick leave (EPSL) and expanded paid Family and Medical Leave (EFML) to certain covered workers impacted by the COVID-19 pandemic. On April 1, 2020, the U.S. Department of Labor (DOL) issued regulations implementing the FFCRA … Continue Reading
Since the COVID-19 outbreak began, healthcare providers have faced a slew of new regulatory requirements. As many healthcare providers know, enforcement agencies have taken starkly different approaches in terms of how often, and how vigorously, they enforce these requirements. Recent reports show, however, that agencies are closely enforcing workplace safety requirements relating to COVID-19, especially … Continue Reading
Although nursing homes appreciate the recent release of $4.9 billion in financial assistance, the bullseye on them continues growing. Troubles that preceded the COVID-19 crisis have gotten worse for facilities caring for high risk seniors. They face scrutiny over death rates from COVID-19, as well as how they will use relief money.… Continue Reading
