Emergency Temporary Standard Issued for the Healthcare Industry by OSHA

On June 10, 2021, the U.S. Department of Labor’s Occupational Safety and Health Administration submitted for publication in the Federal Register its COVID-19 Emergency Temporary Standard (ETS), setting forth new mandatory safety requirements designed to protect workers from COVID-19. The much-anticipated ETS is generally applicable only to certain healthcare workplaces and imposes differing obligations with respect to vaccinated and unvaccinated employees in various contexts.

To read the full text of this Duane Morris Alert, please visit the firm website.

New National Standard for Barrier Face Coverings Approved by ASTM International

On February 15, 2021, ASTM International, a voluntary standards-setting organization, approved a new national standard for barrier face coverings that establishes minimum design, performance, labeling and care requirements for disposable and reusable face masks. Manufacturers should take full advantage of this new guidance as it implements a universal standard for the evaluation of barrier face coverings utilized by a majority of Americans every day.

To read the full text of this Duane Morris Alert, please visit the firm website.

H.B. 3360 and S.B. 72: Assessing Prejudgment Interest to Personal Injury and Wrongful Death Verdicts in Illinois

By Nicholas J. Lynn

On March 25, 2021, Illinois Governor J. B. Pritzker vetoed a bill that would assess prejudgment interest to personal injury and wrongful death verdicts. The bill originally was reported as House Bill 3360 (“H.B. 3360”) and more recently passed the Legislature as a compromised plan, S.B. 72, which reduced the prejudgment rate from 9% to 6 %, allowing plaintiffs with personal injury or wrongful death verdicts to recover the interest on all damages except punitive damages, sanctions, statutory attorneys’ fees, and statutory costs. On January 13, 2021, H.B. 3360 passed the Democrat-controlled chambers of the General Assembly. H.B. 3360 provided 9% prejudgment interest to personal injury and wrongful death verdicts to be calculated annually from the time the defendant was placed on notice of the injury to the date of judgement. Illinois remains one of just four States not to have some form of prejudgment interest available for trial-winning plaintiffs.

HHS Issues Proposed Changes to the HIPAA Privacy Rule

On December 10, 2020, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“NPRM”) to modify the HIPAA Privacy Rule. HHS stated that the proposed modifications, which are being issued as part of HHS’s “Regulatory Sprint to Coordinated Care,” are aimed at removing barriers to coordinated care, strengthening individuals’ access to their own medical information, and reducing unnecessary administrative burdens. Proposed changes to the HIPAA Privacy Rule in the NPRM include: Continue reading “HHS Issues Proposed Changes to the HIPAA Privacy Rule”

Considerations for Seniors Housing Communities and COVID-19 Vaccines

More than nine months after start of the coronavirus pandemic, the beginning of the end finally appears to be within sight. Novel vaccines have shown tremendous promise in clinical trials, and the United States Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) to the first two COVID-19 vaccines—one developed by a collaboration between Pfizer and BioNTech SE and the other developed by Moderna. The first Americans received initial doses of the Pfizer-BioNTech vaccine on Monday, December 14, 2020—a remarkably quick turnaround from the initial identification of the SARS-CoV-2 virus at the end of 2019 to the delivery of the first doses of a vaccine one year later.

While the efforts to bring vaccines to long-term care communities will not begin in earnest until December 21 or December 28, residents of long-term care communities in a handful of states have begun to receive COVID-19 vaccines. To that end, although companies in the seniors housing industry are likely well on their way to preparing for the upcoming vaccinations in their communities, this Special Issue Brief provides some background on the COVID-19 vaccine approvals and an overview of some of the key issues operators should make sure to consider.

To read the full text of this article by Duane Morris attorney Alison T. Rosenblum, please visit the American Seniors Housing Association website.

Office of Inspector General Issues Special Fraud Alert on Speaker Programs

On November 16, 2020, the Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert addressing speaker programs presented by pharmaceutical and medical device companies. Such programs, at which companies may pay physicians or other health care professionals (HCPs) for speeches or presentations about drugs and devices in addition to providing remuneration to attendees, are frequently sponsored by pharmaceutical and device companies seeking to provide education regarding their products. Highlighting what it called “inherent fraud and abuse risks,” OIG’s Special Fraud Alert expressed concerns surrounding the offer or payment of remuneration from pharmaceutical and device companies to physicians or other HCPs associated with such programs.

To read the full text of this Duane Morris Alert, please visit the firm website.

Could Medical Device Manufacturers Accelerate the FDA Approval Process by Using COVID-19 Data?

Medical device shortages and shortcomings during the COVID-19 pandemic have led the Food and Drug Administration (FDA) to grant Emergency Use Authorization (EUA) to many medical devices manufacturers. Were it not for these EUAs, these manufacturers would be unable to market their devices, as their FDA applications would still be pending. Once the present “emergency” ends, these EUAs will expire, and manufacturers will again be unable to market their devices for the indications cleared under the EUA.

Still, the real-world evidence (RWE) gained about these devices while marketed under the EUA need not be lost with the passing of the pandemic. Once the pandemic ends, manufacturers should be able to use the data collected to support their pending applications for market clearance and for new indications for already-cleared devices.

To read the full text of this article by Duane Morris partners Frederick R. Ball and Erin M. Duffy, please visit the Wharton Health Care Management Alumni Association website.

Nursing Homes Under Siege from More than COVID-19

U.S. nursing homes would benefit from a less punitive approach to performance improvement, according to Doctors Without Borders, the international medical humanitarian organization that has been assisting U.S. nursing homes with their response to COVID-19. The organization recently conducted in-person infection prevention and control trainings and provided technical support and wellness sessions to staff and residents in over 50 Michigan nursing homes and adult care facilities, and now is doing the same in Texas. Continue reading “Nursing Homes Under Siege from More than COVID-19”

Healthcare Employers Who Have Excluded Employees from COVID-related Leave Benefits under FFCRA Must Reconsider after USDOL Amends Temporary Regulations

By Jennifer Long and Nicholas J. Lynn

The United States Department of Labor’s (DOL) initial temporary regulations that interpreted and implemented the Families First Coronavirus Response Act (FFCRA) permitted employers to elect to exclude healthcare provider employees from eligibility for the COVID-related leave benefits made available under FFCRA. The initial DOL regulations provided a broad definition of healthcare provider, allowing most employees working for a healthcare provider employer to be excluded from FFCRA leave benefits, including Paid Sick Leave (PSL) and Extended Family and Medical Leave (EFMLA). After a federal district court decision struck down parts of the DOL’s prior final rule, the DOL now has issued revised regulations, which became effective on September 16, 2020, and expire along with the FFCRA on December 31, 2020. For a detailed discussion of the FFCRA requirements and the DOL’s revised temporary regulations, see our April 3, 2020 Alert and our September 17, 2020 Alert. Continue reading “Healthcare Employers Who Have Excluded Employees from COVID-related Leave Benefits under FFCRA Must Reconsider after USDOL Amends Temporary Regulations”

An Executive Order’s Potential for Setting a Precedent With Regard to the Reimbursement Rate for Out-of-Network Emergency Services

Emergency Order Issued by Governor Baker of Massachusetts

On April 9, 2020, Governor Baker issued an emergency order (the “Order”), mandating that insurers cover all medically necessary emergency department and inpatient services costs of COVID-19 treatment at both out-of-network (“OON”) and in-network hospitals and other medical facilities, without any cost to the patient, setting the OON reimbursement rate at 135% of Medicare, and prohibiting providers from balance billing.  The Governor appears to have relied on § 7 of the Massachusetts emergency preparedness and response law in issuing the Order.  Section 7 gives the Governor broad powers during a state of emergency, including “[r]egulation of the business of insurance and protection of the interests of the holders of insurance policies and contracts and of beneficiaries thereunder and of the interest of the public in connection therewith.”

Provider Concerns with the Emergency Order

From a provider perspective, the Order raises at least three concerns.  First, the OON payment is based on the Medicare rate, a rate set by the government, not intended to reflect market rates.  Second, the Order does not include the right to resolve payment disputes between an insurer and a provider.  Third, the excessively low reimbursement rate is problematic because emergency departments, and the physicians staffing them, face unprecedented financial strain because of the ongoing COVID-19 pandemic.  To address and allay these concerns, physician groups generally advocate a commercially reasonable payment, based on local charges as determined through a known independent, transparent, and verifiable database (such as FAIR Health), using baseball-style binding arbitration to resolve payment disputes between the insurer and the provider.

Continue reading “An Executive Order’s Potential for Setting a Precedent With Regard to the Reimbursement Rate for Out-of-Network Emergency Services”