Join an experienced health care attorney and medical spa expert as we navigate through the quagmire of state and federal regulations regarding this industry.
Showing posts with label medical spa attorney. Show all posts
Showing posts with label medical spa attorney. Show all posts
Monday, December 31, 2012
Every Medical Spa Professional Needs to Have a Marketing System
Friday, June 17, 2011
An Update on Laser and Who May Operate a Laser
There is one area of aesthetic medicine that seems to be misunderstood and the subject of a lot of misinformation. Lasers and other light sources have been the subject of a lot of debate since the early 1990’s when the aesthetic use of laser began with the introduction of the CO2 laser. There also seems to be waves of misunderstanding regarding these devices and it appears that we are in another such wave. The development of new lasers and light-based devices that are non-ablative seem to have brought this issue to the forefront again.
The questions that we are frequently asked revolve around who can operate a laser. Before we address that issue, it is prudent to address the more global issue: Who can own and operate a laser?
Most (if not virtually all) efficacious aesthetic lasers are federally classified medical devices. They are classified such that they must be owned and operated by a physician since they are classified as medical devices. Yes, there are some devices that are classified as medical but are available to other professionals (some LED). These devices are the exception to this principle. Most of the devices must be acquired by a physician and the physician is then free to delegate the use of the device to some in his or her office. Others should only be utilized by the physician.
One of the confusing issues is the dichotomy of state and federal law. Generally speaking, federal law takes precedence over state law on a particular subject matter if both state and the federal government have regulated such area. An exception to this general principle is whenever the state law is more strict. Again, it is federal law that classifies the devices and state laws have varying additional regulations about who and under what circumstances may utilize such devices.
The question of who can acquire a laser is clearer than who may operate it and under what circumstances. The moment a physician allows someone else to perform the treatments, a whole litany of issues arise. The first issue would be what is the non-physician treating? There may be a difference between light based hair removal and treating a medical condition. It is clear that only a physician or appropriate allied health provider can make a medical diagnosis. This cannot be delegated by a physician. For example, someone operating a laser or light device cannot assess that a patient has acne and then treat them for acne under an established protocol.
Accordingly, it would be prudent to have the physician make a medical diagnosis prior to treatment. In any case, it is better protocol to allow the physician to see that patient prior to treatment.
The second issue would be where the procedure can be performed. Whenever the location of treatment is anywhere other than the physician’s office, there will be scrutiny of the relationship between the physician sand the owner or tenant of the other location. This is a complicated issue and it will vary from state to state. There are medical supervisory issues as well as delegation issues and fee splitting issues of state and federal law.
The third issue would be who is performing the treatment. The ability of someone other than a physician to operate a laser is based upon the concept that physicians are free to delegate the treatment plan to non-physicians to provide better and faster care to patients. Such concepts were developed long before the aesthetic use of light devices and in limited situations; they have not been modified to reflect delegation of light-based treatments.
Historically, physicians began delegating laser to existing office personnel. Some states began enacting legislation that limited a physician’s ability to do this. Again, this varies from state to state so we can only discuss general concepts. It would be prudent for a physician to delegate to medical personnel. The further you get away from medical personnel, the more risk there is to being noncompliant. Estheticians are not medical personnel and although some have “para” medical esthetician training, they are not considered medical personnel and their licensure is governed by a state board of cosmetology. It can be argued that non-medical staff can perform purely aesthetic procedures such as laser hair removal or tattoo removal. In such cases, bear in mind that the devices being utilized are still federally classified as medical devices and the use (and ownership) may be limited by that concept. Consideration should also be given to the location of the treatment and the best case scenario would be in the office of the physician that acquired the device.
The fourth issue would be under what circumstances the procedure is being performed. The safest location would be within the office of the physician that acquired the device. Removing the procedure from that office triggers the issues stated above. The availability of the acquiring physician to be present during treatment is also a significant issue. However, it should be noted that a medical procedure should always be performed in a medical facility. I should not have to state this, but a spa is not a medical facility. A non-physician owned “medical spa” is also not a medical facility.
Another issue that relates to the circumstances surrounding a treatment is where the after care is being administered. This is medical regardless of the procedure since the issues are frequently burning, hypo or hyper pigmentation and general wound healing. Non-medical personnel may make an initial review and listen to the patient’s concerns. The minute that there is any irregularity or subjective complaint from the patient, a physician or appropriate medical provider should be brought in to manage the patient care. There may be other idiosyncratic reactions and these would be classified as medical too.
Written protocols are another circumstances issue. Any physician should have clear and written protocols for each type of procedure being performed within his or her office or outside of it if the physician is allowing such treatments to be performed under his or her license. The absence of written protocols will be very damaging in any lawsuit brought by a patient or governmental compliance audit.
Such protocols should be thorough and clear. Procedures should be implemented to regulate adherence to the protocols as well. The fact is that many of the issues discussed in this article and others that relate to the topic are subjective and within a “gray” area of the law. This is done purposely by legislatures as the technology always leads the law. The law reacts to technology and tries to anticipate future changes. Since much of the regulatory and liability claims are subjective, the written protocols are critical as I have seen that the mere existence of them has terminated investigations.
It should also be noted that I have seen abuses of these concepts in the devices being utilized to treat fat or cellulite. There is misconception that these are not medical devices and I have seen them in far too many spas. The original device FDA cleared in the United States was Endermolgie in 1996. It is acceptable as a non medical device as long as the claims being made regarding the results are in FDA compliance. However, the newer generation products also contain a light-based component and most of these devices are federally classified as medical devices.
A final note that should also go without stating is that many laser companies will sell anyone a laser. I have been known to say that they would sell a laser to my dog Stoli if he ponied up the money! I have also heard too many times that the laser company has a letter from an attorney or the FDA allowing the sale to a non-physician. After 17 years of doing this, I am still waiting to see this mystery letter.
The questions that we are frequently asked revolve around who can operate a laser. Before we address that issue, it is prudent to address the more global issue: Who can own and operate a laser?
Most (if not virtually all) efficacious aesthetic lasers are federally classified medical devices. They are classified such that they must be owned and operated by a physician since they are classified as medical devices. Yes, there are some devices that are classified as medical but are available to other professionals (some LED). These devices are the exception to this principle. Most of the devices must be acquired by a physician and the physician is then free to delegate the use of the device to some in his or her office. Others should only be utilized by the physician.
One of the confusing issues is the dichotomy of state and federal law. Generally speaking, federal law takes precedence over state law on a particular subject matter if both state and the federal government have regulated such area. An exception to this general principle is whenever the state law is more strict. Again, it is federal law that classifies the devices and state laws have varying additional regulations about who and under what circumstances may utilize such devices.
The question of who can acquire a laser is clearer than who may operate it and under what circumstances. The moment a physician allows someone else to perform the treatments, a whole litany of issues arise. The first issue would be what is the non-physician treating? There may be a difference between light based hair removal and treating a medical condition. It is clear that only a physician or appropriate allied health provider can make a medical diagnosis. This cannot be delegated by a physician. For example, someone operating a laser or light device cannot assess that a patient has acne and then treat them for acne under an established protocol.
Accordingly, it would be prudent to have the physician make a medical diagnosis prior to treatment. In any case, it is better protocol to allow the physician to see that patient prior to treatment.
The second issue would be where the procedure can be performed. Whenever the location of treatment is anywhere other than the physician’s office, there will be scrutiny of the relationship between the physician sand the owner or tenant of the other location. This is a complicated issue and it will vary from state to state. There are medical supervisory issues as well as delegation issues and fee splitting issues of state and federal law.
The third issue would be who is performing the treatment. The ability of someone other than a physician to operate a laser is based upon the concept that physicians are free to delegate the treatment plan to non-physicians to provide better and faster care to patients. Such concepts were developed long before the aesthetic use of light devices and in limited situations; they have not been modified to reflect delegation of light-based treatments.
Historically, physicians began delegating laser to existing office personnel. Some states began enacting legislation that limited a physician’s ability to do this. Again, this varies from state to state so we can only discuss general concepts. It would be prudent for a physician to delegate to medical personnel. The further you get away from medical personnel, the more risk there is to being noncompliant. Estheticians are not medical personnel and although some have “para” medical esthetician training, they are not considered medical personnel and their licensure is governed by a state board of cosmetology. It can be argued that non-medical staff can perform purely aesthetic procedures such as laser hair removal or tattoo removal. In such cases, bear in mind that the devices being utilized are still federally classified as medical devices and the use (and ownership) may be limited by that concept. Consideration should also be given to the location of the treatment and the best case scenario would be in the office of the physician that acquired the device.
The fourth issue would be under what circumstances the procedure is being performed. The safest location would be within the office of the physician that acquired the device. Removing the procedure from that office triggers the issues stated above. The availability of the acquiring physician to be present during treatment is also a significant issue. However, it should be noted that a medical procedure should always be performed in a medical facility. I should not have to state this, but a spa is not a medical facility. A non-physician owned “medical spa” is also not a medical facility.
Another issue that relates to the circumstances surrounding a treatment is where the after care is being administered. This is medical regardless of the procedure since the issues are frequently burning, hypo or hyper pigmentation and general wound healing. Non-medical personnel may make an initial review and listen to the patient’s concerns. The minute that there is any irregularity or subjective complaint from the patient, a physician or appropriate medical provider should be brought in to manage the patient care. There may be other idiosyncratic reactions and these would be classified as medical too.
Written protocols are another circumstances issue. Any physician should have clear and written protocols for each type of procedure being performed within his or her office or outside of it if the physician is allowing such treatments to be performed under his or her license. The absence of written protocols will be very damaging in any lawsuit brought by a patient or governmental compliance audit.
Such protocols should be thorough and clear. Procedures should be implemented to regulate adherence to the protocols as well. The fact is that many of the issues discussed in this article and others that relate to the topic are subjective and within a “gray” area of the law. This is done purposely by legislatures as the technology always leads the law. The law reacts to technology and tries to anticipate future changes. Since much of the regulatory and liability claims are subjective, the written protocols are critical as I have seen that the mere existence of them has terminated investigations.
It should also be noted that I have seen abuses of these concepts in the devices being utilized to treat fat or cellulite. There is misconception that these are not medical devices and I have seen them in far too many spas. The original device FDA cleared in the United States was Endermolgie in 1996. It is acceptable as a non medical device as long as the claims being made regarding the results are in FDA compliance. However, the newer generation products also contain a light-based component and most of these devices are federally classified as medical devices.
A final note that should also go without stating is that many laser companies will sell anyone a laser. I have been known to say that they would sell a laser to my dog Stoli if he ponied up the money! I have also heard too many times that the laser company has a letter from an attorney or the FDA allowing the sale to a non-physician. After 17 years of doing this, I am still waiting to see this mystery letter.
Wednesday, May 25, 2011
An Emerging and Disturbing Trend in Medical Spas....
For those that follow the medical spa industry, there is always a new product or service that is being touted as the latest and greatest in the industry. Many are little more than marketing hype.
One emerging trend is the hCG diet. Supporters argue that it has allowed many to lose weight. Others maintain that there is no scientific evidence that indicates that it is effective. They further opine that any weight loss is a result of near starvation diet levels of calorie intake (less than 500 calories per day).
hCG is human chorionic gonadotrophin and it is a pregnancy hormone. It is non existent in the male anatomy except for a brief period after birth. It only exists on women during pregnancy. It use is linked to near starvation diets in the weight loss use.
It is important to note that its use is not FDA cleared. By itself, this is not a concern because physicians routinely utilize medical and prescriptive materials "off label" if they believe that it is warranted in a given situation.
However, it is appearing in many non-physician owned medical spas. The HCG dispensed in such settings cannot be medical grade hCG and popular belief is that the non medical grade hCG is non efficacious for weight loss. In fact, in January of 2011, the FDA determined that homeopathic hCG is "fraudulent and illegal" when sold for weight loss. Even in a medical setting, with physicians utilizing medical grade hCG, the product must carry a warning which indicates that there's no proof they accelerate weight loss, redistribute fat, or numb the hunger and discomfort typical of a low-calorie diet.
The bottom line is that there is no scientific evidence to suggest that hCG works.
The disturbing thing is that I have noticed many medical spas that are touting outrageous results from the use of hCG. It appears that many spas are promoting hCG without differentiating between homeopathic grade and medical grade.
In any event, the use of such a product must be carefully watched. Practitioners need to exercise extreme care in providing this service. Extreme caution must be made in marketing the service. From what I have observed, there are a lot of fraudulent claims that may result in severe damage to patients and client...
One emerging trend is the hCG diet. Supporters argue that it has allowed many to lose weight. Others maintain that there is no scientific evidence that indicates that it is effective. They further opine that any weight loss is a result of near starvation diet levels of calorie intake (less than 500 calories per day).
hCG is human chorionic gonadotrophin and it is a pregnancy hormone. It is non existent in the male anatomy except for a brief period after birth. It only exists on women during pregnancy. It use is linked to near starvation diets in the weight loss use.
It is important to note that its use is not FDA cleared. By itself, this is not a concern because physicians routinely utilize medical and prescriptive materials "off label" if they believe that it is warranted in a given situation.
However, it is appearing in many non-physician owned medical spas. The HCG dispensed in such settings cannot be medical grade hCG and popular belief is that the non medical grade hCG is non efficacious for weight loss. In fact, in January of 2011, the FDA determined that homeopathic hCG is "fraudulent and illegal" when sold for weight loss. Even in a medical setting, with physicians utilizing medical grade hCG, the product must carry a warning which indicates that there's no proof they accelerate weight loss, redistribute fat, or numb the hunger and discomfort typical of a low-calorie diet.
The bottom line is that there is no scientific evidence to suggest that hCG works.
The disturbing thing is that I have noticed many medical spas that are touting outrageous results from the use of hCG. It appears that many spas are promoting hCG without differentiating between homeopathic grade and medical grade.
In any event, the use of such a product must be carefully watched. Practitioners need to exercise extreme care in providing this service. Extreme caution must be made in marketing the service. From what I have observed, there are a lot of fraudulent claims that may result in severe damage to patients and client...
Friday, May 13, 2011
The Importance of Reviewing Leases for Medical Spas
Leases are rarely considered an important aspect of medical spa issues. However, I have had numerous instances where a lease became a major problem; and others in which it helped alleviate a problem. Many lease related issues arise but the most important is the "intended use" provision of the lease.
A medical spa should be considered a medical facility even if it is non-physician owned. Accordingly, the use and zoning should be appropriate for a medical practice. This is not a minor issue. Medical zoning is typically such that there are certain areas of a municipality that are zoned for medical use. There are parking issues, handicap parking issues and electric and plumbing issues.
There are also "exclusive" use issues that pertain to most medical spas. Skin care is a frequent issue. Occasionally, there will be an existing tenant that has an exclusive right to retail skin care. This would prohibit you from retailing skin care in your space. Therefore, it is essential to identify to the landlord the totality of your business and ask whether there are any "exclusive use" issues with existing tenants.
I was contacted this week by a spa that has an exclusive use issue with a SHOE STORE!! The shoe store had the exclusive use for MASSAGE! The spa may have to locate to a new facility!!
A medical spa should be considered a medical facility even if it is non-physician owned. Accordingly, the use and zoning should be appropriate for a medical practice. This is not a minor issue. Medical zoning is typically such that there are certain areas of a municipality that are zoned for medical use. There are parking issues, handicap parking issues and electric and plumbing issues.
There are also "exclusive" use issues that pertain to most medical spas. Skin care is a frequent issue. Occasionally, there will be an existing tenant that has an exclusive right to retail skin care. This would prohibit you from retailing skin care in your space. Therefore, it is essential to identify to the landlord the totality of your business and ask whether there are any "exclusive use" issues with existing tenants.
I was contacted this week by a spa that has an exclusive use issue with a SHOE STORE!! The shoe store had the exclusive use for MASSAGE! The spa may have to locate to a new facility!!
Friday, April 8, 2011
Update from the 19th Annual World Congress on Anti-Aging and Aesthetic Medicine
Here is an update from the 19th Annual World Conference on Anti Aging and Aesthetic Medicine in Orlando. There is deservedly a lot of talk about two emerging trends..stem cell applications and hormone therapy and conditions. There is no question that stem cells are the future of medicine and will provide tremendous benefit in out lifetimes. Stem cells currently have over 220 applications in the human genome and additional applications in the veterinary world. Science is evolving rapidly and new treatments are already being offered and many more in the not to distant future.
We are also learning more and more about the endocrine system and the inter-relationship of hormones. We are also learning more about the problems that hormonal imbalance can cause. This is a complicated field and there is a lot more to learn.
The challenge for medical providers will be to separate false claims from reality in these two fields. I have heard some supportable claims at the conference as well as other claims that are....for lack of a better term....NOT supportable by the science!!!
We are also learning more and more about the endocrine system and the inter-relationship of hormones. We are also learning more about the problems that hormonal imbalance can cause. This is a complicated field and there is a lot more to learn.
The challenge for medical providers will be to separate false claims from reality in these two fields. I have heard some supportable claims at the conference as well as other claims that are....for lack of a better term....NOT supportable by the science!!!
Sunday, March 27, 2011
An Important Update on HIPAA
Over a year ago, an important update to HIPAA occurred and few medical practices and vendors have made adjustments to there operations as a result. For the first time, HIPAA now is also enforced against the vendors of a medical practice. HIPAA addresses protection of certain Protected Health Information (PHI) of patients.
Historically the duty of protecting the information and the fines and penalties for a violation were the sole duty of the medical practice. However, new legislation signed into law in 2009 and made effective February of 2010 now places a duty on the business vendors of a medical practice too.
It is now important (if not required) that a medical practice have a Business Associate Agreement in place with business vendors who have access to the PHI. Examples of this would be computer software vendors, outside marketing firms, staff that is not directly employed by the physician practice (such as in many medical spas in which spa personnel schedule appointments or handle check in an check out), even janitorial if there is a possibility of them accessing PHI, pharmaceutical reps..and many more.
In my experience, practices are not adopting new Business Associate Agreements and this is vital. Business vendors are not doing it either - however they are likely to be unaware of the need for them. In my opinion, changes in patient intake forms should be adopted as well as a result of this new law.
Historically the duty of protecting the information and the fines and penalties for a violation were the sole duty of the medical practice. However, new legislation signed into law in 2009 and made effective February of 2010 now places a duty on the business vendors of a medical practice too.
It is now important (if not required) that a medical practice have a Business Associate Agreement in place with business vendors who have access to the PHI. Examples of this would be computer software vendors, outside marketing firms, staff that is not directly employed by the physician practice (such as in many medical spas in which spa personnel schedule appointments or handle check in an check out), even janitorial if there is a possibility of them accessing PHI, pharmaceutical reps..and many more.
In my experience, practices are not adopting new Business Associate Agreements and this is vital. Business vendors are not doing it either - however they are likely to be unaware of the need for them. In my opinion, changes in patient intake forms should be adopted as well as a result of this new law.
Saturday, March 26, 2011
Is a Medical Spa REALLY a Medical Practice??
Many people perceive that a medical spa is a spa that offers medical treatments. It is a fair assumption, but the reality is that a "medical" spa is medical practice that is offering medical treatments in a spa setting or one that offers salon and/or spa treatments in addition to the medical services. The distinction is significant.
For this reason, I advocate that a medical spa be owned by a physician. I specifically indicated "physician" and not a nurse, mid-level provider such as Nurse Practitioner, Physician Assistant or other non-physician. It is possible for a on-physician to own a "medical" spa, but there are many issues and it is a complex business/legal/medical arrangement. In my experience of 20 years in the medical spa industry, I have rarely seen a properly structured medical spa that is owned by a non-physician.
There are two central reasons that a medical spa should be owned by a physician: Medical procedures and/or medical devices and equipment is being utilized in the delivery of services and in 45/50 states there are statutes prohibiting the "corporate practice of medicine".
Today, I received a "groupon" email for discounted laser services in Las Vegas. "Paddy Deighan, you can receive 56% laser facial services at (redacted) laser spa". Really?? I investigated the facility and it is owned and operated by an esthetician that is clearly practicing medicine. This is typical of many, many similar infractions.
There is a lot to lose...monetary fines, loss of professional license, and in some cases, prison time! Why people risk sooo much for a perceived value of owning a "medical spa" has been a mystery to me....
For this reason, I advocate that a medical spa be owned by a physician. I specifically indicated "physician" and not a nurse, mid-level provider such as Nurse Practitioner, Physician Assistant or other non-physician. It is possible for a on-physician to own a "medical" spa, but there are many issues and it is a complex business/legal/medical arrangement. In my experience of 20 years in the medical spa industry, I have rarely seen a properly structured medical spa that is owned by a non-physician.
There are two central reasons that a medical spa should be owned by a physician: Medical procedures and/or medical devices and equipment is being utilized in the delivery of services and in 45/50 states there are statutes prohibiting the "corporate practice of medicine".
Today, I received a "groupon" email for discounted laser services in Las Vegas. "Paddy Deighan, you can receive 56% laser facial services at (redacted) laser spa". Really?? I investigated the facility and it is owned and operated by an esthetician that is clearly practicing medicine. This is typical of many, many similar infractions.
There is a lot to lose...monetary fines, loss of professional license, and in some cases, prison time! Why people risk sooo much for a perceived value of owning a "medical spa" has been a mystery to me....
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