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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…
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…
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,…
  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…
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…
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…
A lot of health and wellness professionals invent devices to help their patients and clients live better lives.  These devices often supplement the services health and wellness professionals provide.  A looming question for these professionals, however, is whether their invention needs approval by the Food and Drug Administration (FDA), or is subject to FDA regulation. This blog post provides an overview of FDA regulatory compliance issues for medical and wellness devices. FDA Medical Device Historical Background In 1976, Congress amended the FDCA with the Medical Device Amendments (MDA).  These amendments broadly defined a medical device as follows: An instrument, apparatus,…
We will be studying the fallout from COVID19 for years to come, but one change is already apparent: the increased use and popularity of telehealth. According to the CDC, there was a 154% increase in telehealth use from March 2019 to March 2020. According to McKinsey, in 2019, only 11% of consumers used telehealth. In 2020, 46% of consumers use it, and 76% are interested in using it going forward. Because of this radical change in telehealth use and interest, wellness programs and practitioners are also jumping on the telehealth bandwagon, particularly as it relates to employers
We will be studying the fallout from COVID19 for years to come, but one change is already apparent: the increased use and popularity of telehealth. According to the CDC, there was a 154% increase in telehealth use from March 2019 to March 2020. According to McKinsey, in 2019, only 11% of consumers used telehealth. In 2020, 46% of consumers use it, and 76% are interested in using it going forward. Because of this radical change in telehealth use,telemedicine legal issues and interest, wellness programs and practitioners are also jumping on the telehealth bandwagon, particularly as it relates…