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Complementary and Alternative Medicine (CAM) Providers are an essential part of a vibrant health and wellness system. CAM provider disciplines include chiropractic, acupuncture, functional medicine, integrative medicine, spiritual healing, mindfulness meditation, reiki, ayurvedic medicine, massage, and coaching to name a few. CAM providers typically operate outside traditional health care provider systems, such as hospitals or physician clinics. Often, CAM providers are entrepreneurs who go into business to serve patients or clients because conventional medicine has failed those patients or clients. In my experience as a health lawyer who focuses on serving as the attorney for alternative medicine providers, as well…
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In the final days of 2020, the nearly 5,600-page Consolidated Appropriations Act, 2021 (the CAA) became law. The pandemic relief and government spending package includes a myriad of provisions that affect group health plans and insurers. With most health coverage provisions taking effect for the 2022 plan year or sooner, and the CAA’s promise of regulations, group health plan sponsors will want to start preparing early. The CAA also included a number of provisions relevant to retirement plans, which are summarized in our prior alert, Appropriations Act Includes Several Provisions Applicable to Qualified Retirement Plans. Below is a brief…
On January 7, 2021, the EEOC finally released the proposed language revising the wellness incentive rules under the Americans with Disabilities Act (ADA) and the Genetic Information and Nondiscrimination Act (GINA). This language was what the wellness industry has been waiting for since the EEOC met on the proposed rules on June 11, 2020. Now that we have the language, it is much easier to evaluate the proposed changes to the rules. Recall these changes are occurring as a result of a court order issued in the AARP v. EEOC case. In that case, the judge agreed with the…
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Although the share of people who are willing to get the COVID19 vaccine has increased since Fall 2020, from about 64% in September 2020 to 71% in December 2020, about nine percent of the holdouts say they will only get the vaccine if required for work, school or other activities. See Kaiser Family Foundation (KFF) Covid-19 Vaccine Monitor:  December 2020. The percentages will continue to shift as the COVID19 vaccine rolls out through 2021. But many employers will likely have employees who will refuse the vaccine unless forced to get it. It is unclear whether governments will mandate the…
When it comes to substances that people ingest, get injected or apply on their body, the key question wellness providers must ask is whether that substance qualifies as a “drug” or something else.  If it is something else, such as a nutritional supplement or cosmetic, the burden of FDA regulation is much lighter. To determine whether a substance qualifies as a drug, the wellness provider should ask the following questions: Is my product intended to diagnose, cure, mitigate, treat or prevent disease? Is my product something other than food and intended to affect the structure or any function of the…
Given the increased stress felt by employees, particularly in the aftermath of COVID-19, many employers and wellness professionals may seek assistance from health and wellness coaches who specialize in mindfulness. According to mindful.org, “mindfulness is the basic human ability to be fully present, aware of where we are and what we’re doing, and not overly reactive or overwhelmed by what’s going on around us.”[1] According to the same source, mindfulness is something everyone has the ability to learn with the proper technique.[2] An important and relevant legal question is whether mindfulness can be taught by unlicensed wellness professionals,…
Late Monday, Congress passed a $900 billion COVID-19 relief bill that includes a provision that allows business owners to claim tax deductions for expenses covered by Paycheck Protection Program (PPP) loan proceeds. The bill goes to President Donald Trump today, who is expected to sign it into law. Among other tax provisions, the bill specifies that business expenses paid with forgiven PPP loans are tax-deductible. This supersedes IRS guidance (as we previously discussed here) that such expenses could not be deducted and brings the policy in line with what the American Institute of Certified Public Accountants (AICPA) and hundreds…
In 1996, the Journal of the American Medical Association published a study on nuns and their unique writing styles. Before joining a nunnery, the School Sisters of Notre Dame, young women were asked to write brief autobiographies. Many decades later, their medical information, autobiographies, and other personal attributes were studied. Researchers noticed that distinctions in the nuns’ writing styles “predicted with uncanny accuracy” which of them would become severely afflicted with Alzheimer’s disease 60 years later.1 Results like these and advancements in computing since 1996 inspire further inquiry: Can we use personal information to predict future health conditions? The…
  Contact legal counsel immediately; at times, you will be functioning under specific time frames in which you must act, and report. Responding without assistance from legal counsel may lead to your response revealing too much or too little information. Lawyers with expertise in responding to license complaints can guide you in crafting an optional response that will not lead to further questioning by the government. Failure to no respond at all could lead to other legal actions. Also, not being informed about the law or missing deadlines is not an   Communications from the State Licensing Board may take…
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Because of the COVID 19 pandemic, federal and state governments have relaxed some regulatory requirements that may permit health and wellness practitioners to implement their business plans in ways that would not have been possible prior to the pandemic.  We discuss some of these changes, below.  Please note that regulatory changes are evolving quickly.  Thus, more relevant changes may occur after the writing of this blog. Relaxation of Virtual Platforms under HIPAA The federal Department of Health and Human Services (HHS) Office of Civil Rights (OCR) has relaxed the standards relating to use of remote communications technologies.  OCR will exercise…
The 2014 Farm Bill opened the floodgates for the widespread distribution of CBD products by distinguishing hemp from marijuana in the Controlled Substances Act. As a result, the CBD market is expected to grow at a staggering rate of 706% in coming years. Given the ravenous demand, many health practitioners seek a share of this lucrative market. Practitioners who choose to develop, distribute or promote CBD products should proceed with extreme caution. At some point, the FTC, FDA, state medical boards, and possibly a group of unhappy consumers will make an example of an unlucky few. Prudent legal advice at…
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Late last week, the United States Department of Health and Human Services, Office for Civil Rights (HHS) issued a Notice of Proposed Rulemaking (NPR) to make significant revisions to the Health Insurance Portability and Accountability Act of 1996, commonly known as HIPAA.  HIPAA was first enacted in the late 1990s and the health care system has seen significant changes since that time.  Many of these changes, such as the emergence of the opioid problem and the increase in availability of digital health information, have resulted with many in the health care system advocating for revisions  to the regulations that balance…
In Being Mortal: Medicine and What Matters in the End, Dr. Atul Gawande writes about how often medicine fails the elderly and those with terminal illness. His first example is a man who chose a surgery that didn’t stand a chance of giving him what he really wanted (“his continence, his strength, the life he had previously known”). Despite seeing his wife die in intensive care and resolving to avoid the same fate, the man chose a risky surgery that led, 14 days later, to exactly that. To Gawande, the remarkable thing was not the poor choice; it was…
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With the news that COVID-19 vaccines will soon be available in Wisconsin, employers are beginning to question whether they can—or should—require employees to be vaccinated against COVID-19. Although employers can mandate the COVID-19 vaccination as a condition of employment, as discussed below, this may not be the best choice for most employers. When determining whether to implement a mandatory vaccination, employers should assess the exposure risk inherent in the workplace. For example, is it a high risk workplace, such as a hospital or nursing home? Second, employers should consider the effect of a mandatory vaccination program on workplace morale. Recent…
Many health and wellness professionals and companies see the advantage of providing direct care to employees at the worksite.  However, before jumping into this exciting and growing area of health and wellness service delivery, it is imperative that you have a solid understanding of the legal landscape of offering services directly at or near the worksite. The legal considerations generally fall into two buckets:  1) Health Plan Issues; and 2) Provider Licensing Issues. We will tackle both of these buckets in this blog post. Health Plan Issues Onsite or near-site clinics present a number of legal issues in relation to…
As each day of COVID19 passes, anticipation for a vaccine to remove all the social barriers grows.  According to the New York Times, researchers are testing 44 vaccines on humans, but a vaccine available for mass use probably won’t be available until spring or summer 2021.[1]  And this assumes that there will be sufficient production capacity, vaccination supplies and staffing to reach everyone.[2] Once a vaccine becomes available, to be effective, studies indicate that at least 75% of the population would need to be vaccinated, assuming that the vaccine itself is at least 70% effective in preventing…