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No Longer Elective: States Lay Down the Law

Posted By Administration, Thursday, March 26, 2020

injection

By Patrick O’Brien, JD, legal coordinator, American Med Spa Association

Multiple authorities, from the surgeon general to the White House and the CDC, all recommend that elective surgical procedures be postponed or rescheduled in the face of the COVID-19 outbreak. Likewise, AmSpa recommends that aesthetic practices halt elective treatments and close during this crisis. These, of course, are recommendations and do not carry any legal penalties with them. However, many state and city leaders are adopting executive orders and emergency measures that do carry punishments for failing to follow them. Let’s examine a few of these orders and how they apply to aesthetic practices.

The recommendations, executive orders and emergency rules base their elective procedure stance on two main goals. The first is to limit the spread of coronavirus infections, both to patients who may be susceptible to serious complications following surgery and to medical professionals who may be called on to support more urgent medical needs; the second is to reduce the expenditure of personal protective equipment (PPE) and medical resources. Each order is worded slightly differently, so they vary somewhat in their effect, but all are trying to further these two goals.

Ohio was one of the earliest states to take action on this. Its Department of Health released an order on March 17 (available here). In it, the department requires that all non-essential or elective surgeries and procedures that use PPE not be performed. It provides a list of elements to help determine which procedures are essential versus those that can be delayed. In short, if not performing the procedure carries a risk of death or irrevocable worsening of a condition, then it is considered essential; others that can be delayed without risk to the patient must be. Much more directly the Alabama Governor Kay Ivey has ordered that all elective medical or dental procedures be delayed.

In these examples, it is clear how these edicts would apply in a medical spa setting. Practitioners should be using some form of PPE in all aesthetic medical procedures under normal circumstances. Moreover, with very few exceptions a patient is not at risk of death or harm if a medical spa treatment is delayed.

Many cities and counties also are instituting “shelter-in-place” orders, which close non-essential businesses, but typically categorize health care services as “essential” and allow them to remain open. Therefore, for a medical spa or aesthetic practice, the question is, “Am I an ‘essential business?’” Again, the answer depends on the language of the order, but they usually will prevent a medical spa from providing in-person services. If we look at Dallas County, Texas’ Stay Home Stay Safe order, we notice that it allows “essential health care operations” to continue and the delivery of those services to be uninterrupted, but elsewhere prohibits “elective medical procedures” as well. A medical spa would not be forced to close under this rule, but it would effectively be prohibited from providing any aesthetic procedures. Practitioners could still see patients—ideally using telemedicine—prescribe medications and make recommendations, but any aesthetic treatments or procedures would need to wait until this crisis has passed and these restrictions are lifted.

While many locations are now under “shelter in place” orders or prohibit non-critical medical procedures, many are not yet subject to these restrictions. Should practices in these locations voluntarily follow the recommendations and close? Our opinion is yes, but here is another aspect to consider: the standard of care. Aesthetic medical practices are held to the duty to provide safe, quality care and to inform their patients of risks, as are all other medical practices. In the case of a widespread disease that can be contiguous well before the onset of symptoms and little testing except in serious cases, many people may not even realize they are sick. Of course, it is possible to take precautions to limit the chance of infection, but there is no way to entirely remove that risk. An adverse incident or failing to appropriately address these risks may lead to professional repercussions from licensing board investigations or damage to public reputation. As such, we feel medical spas should temporarily halt in-person services.

During this time, the situation is evolving rapidly, so check frequently with our Coronavirus Resource Center and your local authorities to stay up to date. 

Tags:  Business and Financials  COVID-19  Med Spa Law 

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Doctors Without Clinics: The Overnight Rise of Telemedicine to Combat COVID-19

Posted By Administration, Wednesday, March 25, 2020

telemedicine

By Bradford E. Adatto, Partner, ByrdAdatto

Many of you are familiar with the organization Doctors Without Borders, but very few would have ever thought of a day when doctors could no longer work in their office clinics. How do you continue to treat patients when the federal, state and local government is banning elective medicine? Many of our clients are shifting overnight to doing medical consults exclusively via telemedicine as a means to continue to treat their patients without direct contact. Countless clinics, however, have not implemented guidelines on how to implement this strategy. A good policy needs to protect the patient’s privacy, abide by the state’s telemedicine rules on the proper standard of care and comply with the prescription laws with regard to controlled substances.

The federal and state governments are passing laws and issuing exceptions to many of these rules faster than we can write about it.  Those medical clinics wishing to stay open using telemedicine need to understand the new normal.

Last week, the U.S. Office for Civil Rights (OCR), a part of the Department of Health and Human Services, issued new Notification of Enforcement Discretion for telehealth during the COVID-19. The statement basically allows providers to use less-than-perfect solutions under the security standards, including “any non-public facing remote communication product that is available to communicate with patients.” Providers who want to use these platforms can use them as long as the provider advises patient of the risks and the patient agrees to them, and the provider has taken reasonable steps to protect the patient’s privacy; this can include finding a secure location and setting the security level in the “telemedicine” software to the highest encryption and security level. As such, medical providers can work from home or another remote location via Zoom, Skype, FaceTime and other apps approved by this OCR notice and still render medical decisions for patients in less-than-perfect encryption standards. To be clear, the OCR only wants you to use apps that provide HIPAA-compliant video communication products, provided the vendor will enter into a business associate agreement. Facebook Live, Twitch, TikTok and similar video communication applications are public-facing, and as such would not be compliant.

Finally, the restrictions on rendering telemedicine across state lines also have been temporarily waived by the federal government and many state authorities. Please check with your local medical boards on what restrictions still apply.

AmSpa members receive a complimentary 20-minute Introductory Compliance Assessment with a ByrdAdatto attorney. Click here to learn how to join AmSpa today!

Bradford E. Adatto is a partner at ByrdAdatto, a national business and health care boutique law firm with offices in Dallas and Chicago. His background is in regulatory, transactional and securities law. Having worked in health care law his entire career, he has an in-depth knowledge of the “dos and don’ts” of this heavily regulated industry. Brad has worked with physicians, physician groups, and other medical service providers in developing ambulatory surgical centers, in-office and freestanding ancillary service facilities, and other medical joint ventures. He regularly counsels clients with respect to federal and state health care regulations that impact investments, transactions and contract terms, including Medicare fraud and abuse, antitrust, anti-kickback, anti-referral, and private securities laws. Adatto has been recognized as Top Rated Lawyer by the Dallas Morning News (2016) and a Best Lawyer in Dallas in health care by D Magazine (2016 & 2018-2019), selected as a Best Lawyer in America in health care (2017-2019), and was recently named a Best Lawyer in Texas (2019) and Texas Super Lawyer, published by Thompson Reuters (2019).

Tags:  ByrdAdatto  COVID-19  Med Spa Law 

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States Adjust Unemployment Requirements in Face of COVID-19

Posted By Administration, Friday, March 20, 2020

state legislature

By Patrick O’Brien, JD, legal coordinator, American Med Spa Association

In light of the ongoing COVID-19 pandemic and the resulting economic disruption, multiple states have adopted emergency rules relaxing many of the requirements needed to apply for unemployment, allowing more flexibility for employers and jobseekers. Here are several states that have made changes. Not all states are listed so if you do not see your state below, reach out to your workforce commission for details. New aid packages and rules are coming in daily, so if you have been affected by this pandemic, check back frequently with your state and watch the news for additional information.

  • Washington: Washington state has adopted emergency rules that allow workers who are mildly ill with COVID-19, are quarantined due to exposure or are immunocompromised, or are caring for a family member to be eligible for unemployment insurance. Under the normal rules, these people would not be able to apply. The Employment Security Department has a helpful chart here and provides an information page here.
  • New Hampshire: New Hampshire has expanded eligibility to persons under quarantine, those caring for quarantined family members and those whose employment has been disrupted by school closures. You can find more information here.
  • Ohio: By executive order, Ohio has opened unemployment benefits to people who have been requested to self-isolate, and the normal waiting period for eligibility is waived. To help employers, any unemployment claim during this declared emergency is mutualized among contributory employers. Information on Ohio unemployment coverage is available here.
  • Texas: So far, Texas has not made any large changes, but it has waived its work search requirement and one-week waiting period; you can learn more here. However, Governor Greg Abbott has ordered bars and restaurants closed across the state beginning midnight Friday, so additional changes may be forthcoming.
  • California: California has not made major changes to its benefit programs in light of COVID-19, but its programs were fairly comprehensive prior to the crisis. Workers who fall ill or are quarantined and are unable to work can file a disability insurance claim. By executive order, the one-week unpaid waiting period has been waived. Workers can file a Paid Family Leave claim if they miss work due to caring for a family member. Also, missed work due to a child’s school being closed is treated as an unemployment insurance claim on a case-by-case basis. Here is a helpful resource put together by the state.
  • New York: New York state has waived its seven-day unpaid waiting period to apply for unemployment benefits. The Department of Labor requires that businesses provide notice prior to closing or layoffs and offers some alternatives to layoffs. Here is a helpful information resource put together by the state’s Office of Emergency Management.
  • Pennsylvania: Pennsylvania has suspended its waiting week and work search requirements for unemployment insurance. You also can apply if you employer tells you to stay home for fear of spreading or contracting the disease, in addition to reduced hours or job loss because of the ongoing crisis. Here is a useful information page.
  • Massachusetts: Massachusetts has excused and extended deadlines for both employers and jobseekers concerning unemployment claims. Additionally, work search requirements have been altered to favor paying benefits, and seminars are suspended. More information is available here.

Tags:  Business and Financials  COVID-19  Med Spa Law 

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Letter from the CEO: It’s Time for All Medical Spas to Close

Posted By Administration, Thursday, March 19, 2020

business closing

By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)

Like all of you, the American Med Spa Association (AmSpa) team has been closely monitoring the developments surrounding the spread of COVID-19.

Although the lack of testing and complete information has made it difficult for governmental leaders to come to any sort of consensus, the scientific community has been very consistent in its position that drastic and immediate action is needed.

In order to contain this outbreak – and, more importantly, to shorten the timeline of economic hardship to all – nearly every epidemiologist, infection specialist, and researcher has made the same recommendation: all elective surgeries and non-essential medical procedures that can be delayed, should be delayed. It is the recommendation of the U.S. Surgeon General, the American College of Surgeons, and the White House Coronavirus Task Force that all non-essential medical procedures be postponed. Many cities and states are taking this stance, as well.

Accordingly, it is AmSpa’s strong recommendation that all medical spas close their doors and refrain from offering any elective procedures for at least the next 30 days, or until further notice. Although this will be a difficult time for us all, AmSpa strongly encourages its members and the industry at large to heed this advice.

These are difficult times for all of us, and unfortunately, difficult times result in leaders having to make difficult decisions. This is one of those times. Closing your business can have devastating consequences, even for a week, let alone 30 days. We at AmSpa understand that, and, as a small business, we’re living it, too. Our livelihoods are at stake here, and the decision to recommend that members shut down – let alone having to actually do it – is a painful one. We understand what this means for all of you, and the gravity of this recommendation for the entire industry is not lost on us.

I strongly believe, however, that the medical aesthetics industry will all pull through this, but not without help, both from others in the industry and from outside agencies. AmSpa is committed to providing as much support, influence, and information as we can to help each of you through this difficult time. To ensure our industry’s continuing viability, AmSpa has already begun doing the following:

  • I have personally reached out to the heads of the largest industry suppliers (Allergan, Galderma, Merz, etc.) and requested that they work with our members on outstanding invoices and expired product, including postponing current invoices by at least 30 days (with more extensions if needed). As many of you know, their response has been encouraging and I have no doubt all industry vendors will be flexible with their accounts receivable.
  • AmSpa is providing as much content, information, and guidance as possible to its members.
  • AmSpa is providing guidance on obtaining emergency capital and funding. (We have already reached out to the U.S. Small Business Administration (SBA) to learn the process for accessing their disaster relief fund, and we hope to have more information within a day or two).
  • AmSpa is encouraging our leaders at the federal level to allocate relief funds for aesthetic businesses impacted by the COVID-19 pandemic.

We understand how difficult and stressful this time is for you, and we want all professionals in the medical aesthetics industry to know that AmSpa is dedicated to ensuring the prosperity of this industry. Please let us know if you have any questions or ideas for how we can help. We are in this together, and we’ll get through it together.

Tags:  Business and Financials  COVID-19  Med Spa Law  Med Spa Trends 

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UPDATED: A Look at the Federal COVID-19 Relief Bills

Posted By Administration, Thursday, March 19, 2020
Updated: Thursday, March 19, 2020

capitol building

By Patrick O’Brien, JD, legal coordinator, American Med Spa Association

UPDATE: HR 6201 has been signed into law. The final version is available to read here. The general paid sick time mandate discussed in the original article has been replaced with an “emergency paid sick leave” requirement that applies only to the current crisis. Not mentioned in the original article, HR 6201 requires reimbursement or insurance coverage for testing for the coronavirus but does not change coverage for treatments. Because this is new law guidance and specific instructions are not yet available, regulatory agencies should provide more information in the coming days.

The major takeaways for medical spa owners and operators are:

Employees who have been on the job for at least 30 days are eligible to take a job-protected leave to quarantine, care for quarantined family or recover. The leave is unpaid and can be up to 12 weeks. the Department of Labor hasn’t yet updated its webpage, but you can find more information here when it does.

Employers must provide all employees with emergency paid sick leave, available for immediate use. Full-time employees are entitled to 80 hours of paid time, and part-time employees are entitled to the number of hours they work in a two-week period. The paid sick time may be used if the employee is unable to work or telework, because they are:

  • Subject to federal, state or local quarantine orders;
  • Advised by a health care provider to self-quarantine;
  • Experiencing symptoms of or seeking diagnosis for COVID-19;
  • Caring for an individual subject to quarantine;
  • Caring for a son or daughter due to school closure; or
  • Another similar circumstance.

Employers and self-employed individuals get a tax credit to offset the costs of the emergency paid sick leave. It is a quarterly credit against employment taxes for 100% of the wages paid up to $200 per day, or $511 per day if the reason is due to quarantine, ordered self-quarantine or the person experiencing COVID-19 symptoms. However, the credit can only account for 10 days per quarter.

ORIGINAL POST: The federal bills aimed at providing relief for COVID-19 would require employers provide paid sick time for employees and create a federal additional sick time for public health emergencies. The Senate version, known as S 3415, is currently with the Committee on Health, Education, Labor and Pensions for deliberation. The House’s bill, known as HR 6201, has passed the House vote; however, recent reports indicate there are some issues with adopting amendments on the specific terms and funding for some of these new benefits and to whom they apply that must be addressed before passage. We’ll briefly review some of the tenets of HR 6201, since it is the more expansive bill; however, bear in mind that they may change substantially once these measures are finally passed.

Paid Sick Time

Under HR 6201, all employers with one or more employees would need to provide a paid sick leave benefit. The sick leave may be used for a number of health related absences, such as when the employee is ill or caring for a parent, child or spouse, as well as when a place of employment is closed by a state or federal official, or by the employer’s discretion due to a public health emergency. The sick time must accrue at the rate of at least one hour for every 30 hours worked, up to 56 hours in a year; however, the employer has the option of choosing higher limits. Exempt employees also earn this time. The sick time would begin accruing following the 60th day of employment. However, in the event of a public health emergency—such as the one we’re currently experiencing—the employee may use a special emergency paid sick time (discussed below). This sick time benefit will carry over from year to year, but employers are not required to provide more than 56 hours at any one time. Terminated or resigned employees are not entitled to be paid for unused time.

Employees also are entitled to additional paid sick time in the event of a declared public health emergency in addition to any regular sick time they have accrued. Full-time salaried employees would receive the equivalent of 14 days of leave; part-time and hourly employees would receive the number of hours they would normally have worked in a 14-day period. In a public health emergency, this sick time is used up first, followed by the normally accrued time. Employers with 50 or fewer employees are able to request a reimbursement of these emergency leave wages from the Secretary of Labor by submitting an affidavit showing the periods and wages associated with this additional paid sick time. Funds will be paid by the Secretary of the Treasury after approval.

Health Emergency Leave

In addition to the paid sick leave mentioned above, HR 6201 includes a separate emergency paid leave for those affected by COVID-19 who are either diagnosed ill, under quarantine or caregiving due to illness or facility closure. This leave is paid by the Social Security Commissioner in 30-day increments, up to three increments (i.e. 90 days total). The leave is at the rate of two-thirds of the average monthly earnings, up to $4,000. However, there is a dollar-for-dollar reduction in this benefit for any state or private paid leave the individual receives during this period. In order to use this benefit, individuals would need to first use up their paid leave, wages paid that period or unemployment compensation for the week. These funds would not be subject to income tax for federal tax purposes.

Employers also would need to provide protected unpaid leave up to 12 weeks in public health emergencies. This would be under the Family and Medical Leave Act, which typically only applies to employers with 50 or more employees, but for “public health emergencies” applies to any employer with one or more employee. This unpaid leave may be taken intermittently or on a reduced schedule. The employee can choose to substitute accrued paid leave or vacation for the unpaid time. However, the employer cannot force them to do so.

Other Provisions

HR 6201 contains additional provisions not found in S 3415. HR 6201 would require the adoption of emergency standards for health care workers to protect them from COVID-19; these standards would be developed jointly by the Centers for Disease Control and the Occupational Health and Safety Administration. It also would make additional funds available for SNAP assistance, student lunches and child nutrition, and provide waivers on state certification periods and reporting requirements to facilitate rapid implementation. HR 6201 also would require the adoption of emergency standards to protect health care and elevated-risk workers.

These bills, HR 6201 in particular, are moving and changing rapidly, so any specific provisions may be changed by the time they are finally passed. As this is a rapidly evolving crisis, it is likely that one of these measures will be adopted in the coming days. AmSpa will endeavor to stay on top of developments in these bills and keep you informed.

Tags:  Business and Financials  COVID-19  Med Spa Law  Med Spa Trends 

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The Pandemic, Elective Surgical Care and Informed Consent

Posted By Administration, Thursday, March 19, 2020

empty hospital beds

By Jeff Segal, MD, JD, ByrdAdatto and Medical Justice

As I write this, we are reading in the news about potential quarantines and lockdowns. In addition, there’s talk about canceling all elective surgical cases, leaving hospital operating rooms empty so beds will be available to take care of those affected by COVID-19.

Have all elective cases been canceled across the US? No. Weirdly enough, while most people are hunkered down, there is a sizeable cohort who are capitalizing on their time off. Business is slowing, and they’ve been told to work remotely from home. Now they have a window of time to undergo that procedure they have been putting off.

Does the fact that there is a background pandemic change anything? Yes. Any surgery is an insult to the body. It is stressful. It affects the immune response. You know that. Most of the time, the body heals as expected.

What if the patient gets COVID-19 while convalescing? Perhaps nothing would change, and it would be no different than if they got the flu. But if the patient gets extremely sick, do not be shocked if a plaintiff’s attorney argues that the patient was not reasonably informed about the increased risk of COVID-19 while the body was in a weakened state. I’m not suggesting a patient’s post-surgical state may cause exacerbation of COVID-19—I’m just prognosticating the legal argument.

So, what to do? If your practice stays open and you are performing elective surgical cases, make sure the patient understands that any surgery increases their susceptibility to an infection, including the coronavirus. It’s unlikely to move the needle much. It will depend upon the patient’s underlying health, the body’s reaction and the viral load, and these variables are not entirely predictable. As long as the patient is reasonably informed and the procedure is not unnecessarily risky relative to the background viral activity, the legal argument should be neutralized.

Use good judgment and stay healthy!

Jeffrey J. Segal, MD, JD, is a neurosurgeon turned serial entrepreneur turned attorney at ByrdAdatto who has literally been in both business and medicine. Segal was a neurosurgeon in private practice before beginning the second phase of his career as a serial entrepreneur in the health care field. He then founded or co-founded four separate health care startups. Segal lives and breathes health care and understands it viscerally.

Tags:  ByrdAdatto  COVID-19  Med Spa Law 

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How the SBA Can Help Your Medical Spa During the COVID-19 Outbreak

Posted By Administration, Wednesday, March 18, 2020

upset doctor

By Patrick O’Brien, JD, legal coordinator, American Med Spa Association

The Small Business Administration (SBA) is charged with providing support and financing to small businesses in America. It has set up a COVID-19 information page to provide guidance to small business owners during the coronavirus pandemic. This page offers a number of resources that may prove helpful for businesses affected by quarantine, loss of business or interruption of services during this time.

In addition to the commonly known loan programs, the SBA has local offices and partnerships that can help provide counseling, mentorship and training to help small business owners adapt to current market circumstances. During times like these, it recommends business owners assess what, if any, insurance coverage they may have, and review potential issues you may have in workforce capacity, acquiring supplies for your business, planning for changing circumstances, and marketing to your customers your efforts and business situation.

Economic Injury Disaster Loan

The SBA’s Economic Injury Disaster Loan program is the main type of capital access it provides during disasters. It now offers special loans available to businesses affected in declared disaster areas during this epidemic. These loans are intended to be used to make up for lost revenue or operating capital. Up to $2 million dollars in assistance is available to qualifying applicants. Interest rates on these loans are 3.75% (2.75% for non-profits), with variable repayment terms up to 30 years. Currently, the catch is that only those in declared disaster areas are eligible to apply for this type of loan. You can find out more information on the program and view a current list of locations here—it currently includes certain counties in California, Connecticut, Maine and Washington.

Other Programs

In addition to the Economic Injury Disaster Loan Program, the SBA has a number of different products and programs that provide capital through their lending partners. Of note, these programs are generally available and are not contingent on being located in a declared disaster area, as is needed for the Economic Injury Disaster Loan. These programs range in size from microloans (up to $50k) up to the 7(a) program (up to $5 million). There also is an “express” 7 (a) loan option that allows loans up to $350k for up to seven years with a 36-hour approval process. Not all businesses will be eligible for every loan program, but at least one of the offerings should work for most situations.

Whether or not you intend to apply for any of the SBA’s loan products or to utilize any of its resources, you still should review the information it provides. While something it offers may not be helpful to you now, it may become so in the future, or a colleague may be able to make use of it. It also is likely that as the COVID-19 outbreak spreads, additional disaster areas will be declared, opening up the Economic Injury Disaster Loan program to more businesses.

Tags:  Business and Financials  COVID-19  Med Spa Law 

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AmSpa Launches AmSpa Live Series to Address Current Medical Spa Issues

Posted By Administration, Tuesday, March 17, 2020

webinars

The world of medical aesthetics—and life in general in the United States—has changed a great deal in the past week. The COVID-19 pandemic has affected every person’s life and livelihood. Maintaining social distance and remaining at home are prudent decisions aimed at preventing a mass outbreak of a deadly disease, but they are also causing enormous problems for small businesses in all sectors, including medical aesthetics.

At AmSpa, we realize that this is a crucial time for your business, and we’re here to help you weather the storm. To that end, we’re launching AmSpa Live, a series of interactive online presentations designed to bring you the timely information you need to keep your medical aesthetic business running in these trying times.

AmSpa Live will be programmed from week to week, in order to provide viewers with the most useful, up-to-date information available. This week’s presentations are:

  • Tuesday, March 17, 11am Central—Coronavirus and Your Medical Spa: Medical and Business Perspectives: Recording coming soon!
    Dr. Robin Patel, the director of the Infectious Diseases Research Laboratory at the Mayo Clinic and the president of the American Society for Microbiology, and Kim Chambers, HR Generalist from Cognos HR, will help answer the questions you have regarding the virus itself, its spread and how it will affect your business.
  • Wednesday, March 18, 1pm Central—Paying for Productivity: Compensation Programs That Don’t Violate Fee-splitting Laws: In order to get the most out of their workforce and incentivize employees to give their all, employers often structure compensation programs that reward employees for productivity by giving them a piece of the pie. This standard concept can become complicated in the medical field, as many states have anti-kickback and fee-splitting laws that can restrict or prevent employers from providing certain personnel with a piece of the medical procedure fee. In this regularly scheduled webinar, Robert Fisher from ByrdAdatto, PLLC, will discuss these fee-splitting laws and how an employer can legally structure compensation programs to incentivize employees in a compliant way.
  • Thursday, March 19—How Do Small Businesses Handle Employment Issues During the COVID-19 Outbreak? In this webinar, Renee Coover, partner with ByrdAdatto, will address concerns that small businesses are facing across the country as the COVID-19 outbreak fundamentally changes the way we work and the economic landscape. Renee will provide guidance on wage and hour considerations; how to handle sick or potentially sick employees; employee travel restrictions; telecommuting and alternative means of providing services to clients; vacation, PTO and sick leave policies for small employers; employee leaves and the intersect of the ADA, FMLA and NLRA; and changes in working conditions in response to this global outbreak.
  • Friday March 20—COVID-19 and Your Medical Spa: Not Business as Usual: Learn how some of the industry’s leaders are handling the situation surrounding COVID-19 at their own businesses. Nicole Chiaramonte, owner of Synergy MedAesthetics, Kennewick, Washington; Marria Pooya, managing partner of Greenwich Medical Spa; and Ben Chew, owner/administrator of Illume Aesthetics, Ashland, Oregon, join us to discuss what they’re doing to address the issues that are emerging.

Each presentation is a webinar in function, so attendees will be able to interact with the presenters and have their questions answered in real time.

No one could have foreseen what has happened in the past week, but now that we’re here, AmSpa is dedicated to helping medical spas survive and thrive in the new world in which we’re living. There’s no telling what will happen next, but with AmSpa Live, we’re dedicated to addressing it.

Tags:  Business and Financials  ByrdAdatto  Med Spa Law  Med Spa Trends 

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Can a Doctor Prescribe Controlled Substances Via Telemedicine?

Posted By Administration, Friday, March 6, 2020

prescriptions via telemedicine

By Bradford E. Adatto, Partner, ByrdAdatto

From groceries to workout classes, entrepreneurs in all industries are attempting to duplicate the “Amazon Effect”—the ongoing evolution and disruption of the retail market, both online and in physical outlets, resulting from increased e-commerce. The digital marketplace is not only shifting the way people shop, but also altering the future of medicine. While the ability to write prescriptions via telemedicine offers an attractive opportunity to streamline the patient-doctor experience and reach patients with limited access to health care, prescribers need to be cautious. Filling internet prescriptions is a highly regulated area of law, especially with regard to controlled substances. Businesses dipping into telemed prescriptions need to familiarize themselves with national and state legislation that affect this digital marketplace.

In many states, a telemed prescription cannot legally be filled without an initial in-person exam by the prescriber. Complicating this rule, the federal government passed the Ryan Haight Act in 2008. Many states look to this legislation for guidance in shaping laws surrounding internet prescriptions and the distribution of controlled substances. In short, the act prohibits the distribution of controlled substances by means of the internet unless the ordering physician/prescriber has conducted at least one in-person exam and the prescription is issued for a valid medical reason. The act also describes seven exceptions from the above requirements. The problem is that these ‘exceptions’ provide such a narrow definition of telemedicine that the act actually inhibits legitimate telemedical prescribers trying to reach patients with otherwise limited access to health care.

While the act was written to shut down internet pharmacies that were attempting to circumvent a physician’s exam and reduce the amount of illegal prescriptions for controlled substances, it has failed to account for how legitimate telemedicine businesses operate. Recently, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients and Communities Act was signed into law. This legislation aims to reduce the number of Americans impacted by opioid addictions and develop alternative treatments. Additionally, the SUPPORT Act requires that the U.S. Drug Enforcement Administration (DEA) promulgate final regulations, specifying the limited circumstances where controlled substances may be prescribed via telemedicine, with a special registration for such telemedicine organizations. However, to date, the DEA has not issued any regulations for the special registration for telemedicine. In the interim, many state legislatures have now passed their own laws to address the issue of the remote prescription of controlled substances.

This is a complicated emerging area of law that will impact any entrepreneur attempting to duplicate the Amazon Effect for prescriptions. As such, prescribers need to be cautious and understand the nuances of individual state law before prescribing controlled substances, or they could be in violation of not only state, but also federal law.

AmSpa members receive a complimentary 20-minute Introductory Compliance Assessment with a ByrdAdatto attorney. Click here to learn how to join AmSpa today!

Bradford E. Adatto is a partner at ByrdAdatto, a national business and health care boutique law firm with offices in Dallas and Chicago. His background is in regulatory, transactional and securities law. Having worked in health care law his entire career, he has an in-depth knowledge of the “dos and don’ts” of this heavily regulated industry. Brad has worked with physicians, physician groups, and other medical service providers in developing ambulatory surgical centers, in-office and freestanding ancillary service facilities, and other medical joint ventures. He regularly counsels clients with respect to federal and state health care regulations that impact investments, transactions and contract terms, including Medicare fraud and abuse, antitrust, anti-kickback, anti-referral, and private securities laws. Adatto has been recognized as Top Rated Lawyer by the Dallas Morning News (2016) and a Best Lawyer in Dallas in health care by D Magazine (2016 & 2018-2019), selected as a Best Lawyer in America in health care (2017-2019), and was recently named a Best Lawyer in Texas (2019) and Texas Super Lawyer, published by Thompson Reuters (2019).

Tags:  ByrdAdatto  Med Spa Law 

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What Your Medical Spa Needs to Know About the Coronavirus

Posted By Administration, Wednesday, February 26, 2020

man with mask

By Patrick O’Brien, JD, legal coordinator, American Med Spa Association

It’s flu season again, but this year we have the added specter of the Coronavirus outbreak in China making daily headlines. While the virus has yet to gain a substantial foothold in the U.S., the threat of this highly contagious and long-lasting disease provides us with an opportunity discuss something much less exciting: employer responsibilities during outbreaks. A recent article from WorldatWork discusses responsibilities and concerns international employers face in this and similar outbreaks; many of these issues will apply to domestic businesses as well. Medical spas, in particular, have some heightened risk of these concerns because of the close and personal nature of the services they provide.

From a business perspective, medical spas are vulnerable to diseases or other disruptive events interfering with their ability to do business. A typical medical spa employs a relatively small number of people, so any absences due to prolonged illness can greatly reduce the spa’s ability to provide services. To compound this, the medical director and supervising health professionals represent critical points of failure in the medical spa. If the physician, physician assistant or nurse practitioner are unable to see patients or supervise, the medical spa would be unable to offer medical services.

Given these vulnerabilities, it would be prudent for medical spas to work to manage these risks and develop contingency plans. This can be as simple as having infection control and hygiene procedures, as well as a leave policy in place. For example, requiring frequent handwashing and room disinfections as well as providing a clear sick leave policy for employees so they may stay home when sick can reduce the chances of infection and limit its spread within your business. Additionally, having an agreement with an alternate medical director can reduce lost revenue due to business disruptions if the primary medical director is unable to supervise or see patients.

To add to the risks to the business operation discussed above, employers also may need to provide disability or medical leave benefits to employees if they become infected in the course of their employment. In the same way an employee is entitled to receive benefits if they are physically injured while on the job, they also would be entitled to benefits if they contracted a debilitating illness in the course of their work.

In addition to these practical concerns, some regulatory issues may need to be considered as well. Employers have a general duty under the Occupational Safety and Health Act (OSHA) to provide a workplace that is “free from recognized hazards that are causing or are likely to cause death or serious physical harm.” This general duty applies equally to physical dangers, such as falling objects, as well as health dangers, such as infection. OSHA’s standards on blood-borne pathogens and needle sticks are the most familiar health risk procedures. If there is a risk of exposure to airborne contagions, such as coronavirus, employers may have a duty under OSHA to adopt policies and procedures to protect their employees. In fact, OSHA has created a resource page specifically for coronavirus; other threats can be viewed here.

It is clear that you need some sort of plan, policy and procedure to address these sorts of outbreak or epidemic risks. Ideally, they should work to limit exposure chances, stop the transmission of infections, provide for recovery for affected employees, and allow the operations of the business to continue. Simple, right? Fortunately, the U.S. Centers for Disease Control provides some guidance in this resource to help you form a response plan. Even if the Coronavirus does not become a widespread issue in the U.S., now is a good time to develop and implement a plan. Infectious diseases will always be a concern—they won’t always make major headlines, but even something as simple as a bout of the flu can cause major disruptions in your business.

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Tags:  Business and Financials  Med Spa Law 

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