Health Care

As of April 5, 2021, health care providers, health information exchanges, health information networks, and certified health IT developers are subject to the 21st Century Cures Act Information Blocking Rule. The changes necessitated by the Information Blocking Rule are daunting. A diverse team of stakeholders within the health care space spent the better part of last summer and fall working to develop policies, plans, educational materials, workflows, software adjustments, and patient materials as part of a comprehensive Information Blocking Rule compliance plan. The Nov. 2, 2020, effective date for the 21st Century Cures Act Information Blocking Rule was coming like…
An algorithm is a set of steps that leads to a conclusive result. Both humans and computers can process algorithms – even simple arithmetic is an algorithm. Computers use complex algorithmic formulas that reference large quantities of data in order to make automated decisions. Governments, employers, insurance companies, and health care providers are dramatically increasing their reliance on automatic decision-making software. Decisions as diverse as evaluating risk during criminal sentencing, deciding where to prioritize police resources, sorting resumes, ranking patients by greatest medical need, and determining eligibility and quantity of public benefits may all rely on computer automation. Julia Veenendaal,…
One question that frequently arises in my wellness law practice is whether and how employers can tie incentives to Health Savings Account (HSA) contributions. Given that tax season is upon us, and HSA’s are tax-favored accounts, I thought it would be appropriate to offer some background and legal considerations on this topic. The Role of High Deductible Health Plans (HDHPs) Many employers tackle the rising costs of health benefits by offering high deductible health plans (HDHPs). By offering HDHPs, employees can then enroll in an HSA. According to the Bureau of Labor Statistics: HDHPs allow workers to establish Health Savings…
Today the Employee Benefits Security Administration (EBSA), the section of the Department of Labor that handles all things employee benefit plans, posted a dedicated webpage with much anticipated (and much needed) employer tools on the “COBRA subsidy” provision of the American Rescue Plan Act of 2021 (“ARPA”), which was enacted on March 11, 2021.  The webpage can be found here COBRA Premium Subsidy | U.S. Department of Labor (dol.gov).   The new webpage provides FAQs for both workers and employers, model general COBRA notices (for new qualified beneficiaries) and model extended election period notices (for those who became qualified beneficiaries…
On March 11, 2021, President Biden signed the American Rescue Plan into law. Among a wide variety of other aims, the $1.9 trillion bill extended tax incentives for certain employers that chose to provide their employees with qualifying paid leave related to the COVID-19 pandemic. In March 2020, the Families First Coronavirus Response Act (“FFCRA”) was signed into law. The FFCRA contained two leave components: the Emergency Paid Sick Leave Act (“EPSLA”) and the Emergency and Family and Medical Leave Act (“EFMLA”). Under the EPSLA, employers with fewer than 500 employees were required to provide employees with up two weeks…
On Saturday, President Biden signed into law the COVID-19 Bankruptcy Relief Extension Act of 2021. This act extends the $7.5 million debt limitation under the Small Business Reorganization Act of 2019 (SBRA) for another year, until March 27, 2022. Last year, Congress passed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to provide emergency assistance for individuals and businesses affected by the COVID-19 pandemic. The CARES Act temporarily increased the debt limitation under the SBRA from $2,725,625 to $7.5 million. The SBRA, which took effect on February 19, 2020, created Subchapter V of the Bankruptcy Code to provide…
Under the Coronavirus Response and Relief Supplemental Appropriations Act of 2021 and the American Rescue Plan Act of 2021, the Federal Emergency Management Agency (FEMA) will provide financial assistance for COVID-19-related funeral expenses incurred after January 20, 2020. FEMA estimates that qualifying families can expect reimbursements of $3,000 to $7,000 out of the program’s total budget of $2 billion. To be eligible for funeral assistance, you must meet the following conditions: The death must have occurred in the United States; The death certificate must indicate the death was attributed to COVID-19; and The applicant must be a U.S. citizen, non-citizen…
The physician self-referral law, or “Stark Law,” prohibits physicians from referring patients to receive “designated health services” — payable by Medicare or Medicaid — from entities in which the physician holds a direct or indirect financial interest. For instance, a physician cannot refer a patient to an entity that provides magnetic resonance imaging (MRI) scans if the physician has a direct or indirect financial interest in the MRI entity. Why? Because physicians should make referrals based on the patient’s best interest, and the allure of compensation may detract from that goal. Enacted in 1989 and expanded in 1993 with many…
The American Rescue Plan Act of 2021, or ARPA, will allow some current and past employees and their dependents to receive fully subsidized COBRA continuation coverage for periods from April 1, 2021 through September 30, 2021 – even if they never elected COBRA or dropped coverage. Here is what employers with group health plans subject to federal COBRA need to know about the new law. The Relief Overview ARPA provides three main areas of relief for affected individuals: (1) free COBRA coverage for “assistance eligible individuals” (AEIs) for periods of coverage from April 1, 2021 through September 30, 2021, with…
Many new health and wellness coaches and other start-ups wrestle with the decision of whether to create a legal entity.  With the advent of virtual platforms or telehealth technology, starting a wellness coaching or virtual health business is gaining traction. I have had many clients seeking health coaching lawyers ask me should I even bother?  The basis for this question is that when you venture out on your own, you become a “sole proprietor” unless you actively register your business with a State, such as your own state or another state like Delaware.  So, the default legal status of any…
Now that the COVID19 vaccine is rolling out, many employers are wondering whether and how they might incentivize employees to receive the vaccine. As noted in a previous blog post, the Equal Employment Opportunity Commission (EEOC) has issued guidance on mandating the COVID19 vaccine. One would think that if the EEOC has laid a pathway for mandating the vaccine, then merely incentivizing the vaccine should be permissible by default. But employers are wary of making that assumption, and in early February, forty-two of them wrote the EEOC asking for clarification on whether incentivizing the vaccine is permissible. This desire…
Although passed into law 15 years ago, the Public Readiness and Emergency Preparedness Act (PREP Act) resulted in fairly limited litigation – that is, until this past year. The PREP Act was enacted to shield drug makers from liability when bringing vaccines to market during a public health emergency. With the recent focus on the rapid development of COVID-19 testing, mitigation, and vaccine strategies, the PREP Act has taken on new relevance since the onset of the COVID-19 pandemic, and as such, given rise to a slew of class-action lawsuits, many targeting long-term care facilities and nursing homes. PREP Act…
The rise in COVID-19 vaccinations and the slowing of new cases in the U.S. offer hope that a sense of pre-pandemic normalcy may be on the horizon, but the way we live our lives will never be quite the same. While one’s personal wellbeing and productivity may be best-served by embracing the “new normal” as it emerges, health care providers can ill afford to operate under a wait-and-see strategy given the complex and ever-changing health care regulatory environment. Despite the uncertainty that looms, there are many actions providers can take now to strengthen compliance and position themselves for a smooth…
It is in an employer’s best interest to have employees be healthy and happy, because such traits lead to more productivity and job satisfaction. But employees are not always healthy or happy. Life happens to employees, and sometimes those life changes are short-lived, and other times those changes can have long-lasting consequences. Enter the employee wellness program. Having worked with many workplace wellness professionals over the years, I can attest that the community sincerely wants all employees to lead better lives and thereby achieve greater wellbeing. But not every employee may be on board with the idea. Some are skeptical…
The Center for Health and Wellness Law, LLC helps a lot of start-ups. The founders of these newly formed businesses often have methods or devices that they have invented, or logos, slogans or business names that are unique. Should they protect those inventions, logos, slogans or names? The short answer is yes. But the long answer requires diving into whether the wellness professional is willing to invest their resources in obtaining such protection. It can be a long, expensive, and grueling process, particularly for patents, and particularly if you go it alone. Here are some examples of intellectual property wellness…
Starting in 2022, patients will know in advance what most health care services will cost. Enacted at the end of 2020 as part of the Consolidated Appropriations Act, 2021 (the CAA), the No Surprises Act requires that group health plans and insurers provide advance cost estimates, called advanced explanations of benefits (advanced EOBs), for scheduled services. The No Surprises Act also requires plans and insurers to provide price comparison guidance online and by phone, similar to what non-grandfathered plans and insurers already were required to do starting in 2023 under the Transparency in Coverage regulations. This article, part of our…