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.

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.... 

Disturbing Trend in the Medical Spa Environment

Many medical spas are turning to various medical, quasi medical and even non-medical personnel in the delivery of medical spa services.  Some of the activities are legally supportable but most are not.

One disturbing trend is the use of non physician injectors.  I categorize this in three ways: Botox Cosmetic; fillers and sclerotherapy.  Botox Cosmetic is a drug and available only by prescription. The manufacturer, Allergan, allows physicians to dispense it in their offices. Contrary to popular belief, it is not directly available to non-physicians, including nurses.  Fillers, are not prescription per se, but they are actually medical devices and as such they are delivered pursuant to the practice of medicine and state and federal guidelines limit the  use and application of these products. These include Hylaform, Restylane and others.

Sclerotherpay is the injection of sclerosing material (saline and others) into a blood vessel to thrombose the vessel and destroy its ability to carry blood and produce unsightly leg veins.  Many states allow Certified medical Assistants to issue injections. Historically, this was for vaccines and such.  Doctors offices could not handle the influx of flu vaccines in the '60's, '70's and '80's so states created this exception to medical practice rules.  recently, many medial assistants wrongfully asserted that they are allowed to inject and have been injecting Botox Cosmetic, fillers and performing vein treatments. This is NOT legally supportable!!

Advice for Establishing a Medical Spa

It seems that a day does not pass before I am asked "Can I do this" or Can I do that" in my medical spa.  Everyone is seeing the answer to various medical/legal/business issues in a medical spa facility.  As you can imagine, it is often not easy to answer a question because it depends upon other variables and issues.  In 2005, I began to quantify the issues surrounding a true "medical spa".  A medical spa, to me, means that either medical services are performed in a spa setting, or a facility is a combination of medical services ans salon or spa services.

In 2005, I counted 126 variables that could determine the viability of a medical spa business plan.  There are more today. I developed a regression analysis as a toll to provide insight into the legal supportability of business plans. I still use this same analysis today.  No one can provide a simplistic answer in this heavily regulated industry.  There are countless "experts" who magically purported to have all of the answers.  It seems that every day, I am "fixing" a solution that such experts provided for a client.

I also caution medical spa owners and managers to beware of equipment suppliers that provide consulting services as part of the sale.  They have a vested interest in the outcome. This seldom leads to objective and thorough guidance.  For years, I heard of a letter from a legal department regarding the use of aesthetic lasers.  I have yet to find "the guy" that wrote "the letter". LOL  I have often stated that a laser company would sell a laser to my dog Stoli if he could pony up the money!!

Seek counsel from someone that has no financial gain if you move forward....you will be happy that you did!!

Paddy Deighan