Wednesday, June 29, 2011

Ya Wanna Know What is Wrong with Health Care in America??

A friend is having surgery so i asked if there is anything that I can do! The response was that a prescription needed to be picked up for post surgical protocol. OK, no problem, I will pick it up. Well it seems that there was a problem with the insurance card. Pharmacist claimed that a new card was issued for the patient.

OK, that was the FIRST problem. The prescription was renewed online 12 hours earlier yet no one from the pharmacy bothered to call and see if the plan member had received a new card.

I get to the 24 hour CVS and the pharmacist tells me that he cannot get an approval because a new insurance card had been issued. Great! It is 1 AM and I dare not call the patient who is getting up in 3 hours.

Well, I thought that I would ask..."how much is the prescription". Pharmacist replies, $11.99! Great, I will just pay for it! WELL, that started a 20 minute debacle. Changing something int eh computer...RE-FILLING the prescription (WHY??). Pharmacist returns with the prescription and I HAD to ask..."how much would the co-pay have been?? He replied, "$15". THAT is what is wrong with health care in this country. Exhibit A. Not to mention that the pharmacist stated that this happens all of the time!!! Great!

Monday, June 20, 2011

Stem Cells, DNA and Smoking in the Sauna

Those that know me are aware that I also have a PhD and work in DNA and stem cell research. I am helping us to live a longer, healthier life. In fact, the human genome has a genetic lifespan of at least 150 - 200 years and we have enough stem cells for us to live to be 1,000 years old. Biblical accounts of humans living that long may not be fodder after all (Methuselah for example). Many cultures have stories about a super/warrior race that was 8-10 feet tall and lived very long lives. In my opinion, these warrior races were humans with overly active stem cells. I have already worked on a project that has taken hundreds off of the knee replacement list via stem cell treatments. I have also helped to develop a stem cell mask which has had an amazing impact on those that have used it...younger skin..disappearance of age spots etc.

Anyway, I digress a bit. Tonight I went to the swimming pool and hot tub and then I went to the fitness center. I am in Las Vegas this week and smoking is tolerated in most areas here. However, while minding my own business and listening to some tunes in the sauna...a gentleman came in SMOKING A CIGARETTE! I politely and slowly removed my headset and asked him to extinguish the cancer stick. HE REFUSED mumbling something about being able to do whatever he wants because this is Vegas!! This is where being 6'4", 275 lbs. and from NEW JERSEY comes in handy.

I stood up... took the cigarette from his hand and extinguished it on his forehead!!! Then I mumbled something about being able to do whatever I want because this is Vegas! Poor bastard still doesn't know what happened! LOL. Smoking a cigarette in a sauna....a new high in lows!

Sunday, June 19, 2011

Chart Issues in a Medical Spa...Who Owns the Chart??

The traditional “rules” of medical practice medical charts are not adequate in the modern age of aesthetic medicine.
There are two issues that have been misinterpreted and misunderstood. The first issue is who “owns” the patient chart. The second issue is under what circumstances should a practice maintain two sets of charts or records. There is no question that the “cosmetic” patient is more challenging in terms of results, satisfaction and “hand holding”. Consequently, more cosmetic patients leave a practice and request their medical records. There are also more medical professionals leaving a practice to work in another facility and battles over the charts have become common and emotional.
The discussion must begin with a common misconception. The practice or the doctor does NOT own the medical chart. The patient “owns” his or her medical chart. The doctor or practice is merely the custodian of the chart or record. Accordingly, when a patient requests a chart, you MUST provide it to them. It is prudent to give the patient the original chart if they request it and keep a copy in the practice to coordinate care and maintain records as required by state and federal law. It is appropriate to charge a fee for the chart, but the fee should rarely exceed twenty-five dollars.
It is also acceptable and advisable to have the patient sign a release for the chart. The release should direct where the chart is going (even if it is to the patient) and it should be plain language The release should only reference the chart and a release of liability for the transfer of the chart to the patient or other facility.
Many patients receive services from several different aesthetic and medical providers within the same practice. Accordingly, there is substantial confusion over the entire chart documentation process and there are more issues than it initially appears.
The question of whether to have two sets of charts is itself complicated. Some additional considerations further complicate the issue. Some practices have one chart for all services while others have separate charts for medical and non-medical services. Practices have valid justification for their policies in both instances.
The answer of which protocol is more acceptable is difficult to answer and clarification comes in the form of a middle ground that can keep all practices safe and compliant. It is prudent to maintain two sets of patient records; one for the medical procedures and the other for esthetic or non medical services performed within the facility. However, it is also prudent to keep the two sets of records together and color coded. For example, the medical charts may be the traditional manila charts. However, the non-medical chart should be a different color and all of the non medical services kept in the colored chart. This will enable easy removal by an esthetic provider (to provide a service) without disruption of the chart. It is also important to do keep charts in this manner because patients do not “own” the esthetic chart and if they request their medical records, you may not want to copy and provide the esthetic chart for non medical services (such as laser hair removal and superficial peels).
This is a significant distinction because when an esthetic provider (non-medical services) leaves the practice, they will frequently take the “charts” or the records so your employment agreement with them must address this occurrence. If they do not take the actual chart, he or she may take the information and contact the “clients” and you may not desire this so the employment agreement must address this too.
Keeping two sets of records but in one file will also coordinate care. Many “esthetic” procedures are at the direction of the medical provider. A good example would be acne patients that are receiving glycolic peels for oil control. The medical provider may want to review the peel history during medical treatment evaluation so access to the record is important. Laser hair removal may also be another good example since many patients are treated medically for burns, hyper and hypo pigmentation.
This issue is complicated when the non-medical services are performed in a separate facility that may have common ownership with the medical practice. I will discuss this in the next blog.
There have been many recent questions regarding medical and non-medical providers leaving a practice and trying to take medical records with them. In the event that a non-medical provider (such as an esthetician) desires to leave and take the charts, a policy should be in place in the practice for such occurrences and it should be anticipated and addressed in the employment agreement as well. A practice does not have the argument that the chart must remain in the practice because they are the custodian of it since the patient does not “own” the chart and the practice is not the custodian of the esthetic records.

Saturday, June 18, 2011

A Real Estate Career Alternative: Real Estate Appraiser

Probably one of the most well-known but seldom talked about careers in real estate is that of a real estate appraiser. Appraisers provide professional, objective opinions about the market value of a piece of real estate. There are many reasons to get an appraisal, including if a property owner wants to obtain a loan, change their property taxes, insure a property, settle an estate, establish value or, of course, sell their property. In order for an appraisal to be useful, it must, ultimately, “reflect a credible estimate of value”. Appraisers are responsible for identifying the end-users of the appraisal, including who requested the appraisal, as well as the intended use and the purpose of the report. They also must include a full description of the property including location attributes, physical attributes, legal attributes and economic attributes as well as easements, restrictions, encumbrances, leases, reservations, covenants, contracts, declarations, special assessments, ordinances and division of interest in the property. All of these items and many other small details are used to create as comprehensive a picture of the value of the property as possible.

By now, being an appraiser probably sounds like a pretty interesting job, but it is also probably clear that you need an attention to detail. Appraisers must be certified in the state in which they wish to work and may work for corporations or individuals. Presently, there are many new restrictions on appraisers thanks to the real estate market crash, so make sure that if you decide to become involved in this business you understand exactly how, for whom and in what capacity you can legally work. Real estate appraisers can be salaried or work on contract or commission. They can make more than $100,000 a year and often work flexible but long hours. There is a higher demand for real estate appraisers than ever and there will be a lot more work in the future. Most appraisers are pretty busy today so be patient with them!

The Use of Titles and Certifications in Aesthetic Medicine

There is an increasing tendency for individuals in aesthetic medicine to utilize titles, designations or certifications in their marketing and daily practice. There has been a corresponding increase in complaints to medical boards, boards of cosmetology and FTC regarding this issue so it is a good time to review the issues.

Many providers receive a license from a state governing board. This governing board provides “scope of license” parameters and these should always be strictly followed. You should never advertise, in any manner, proficiency beyond the scope of license granted top you. You should never indicate or advertise additional proficiency beyond the license that the state granted you. The reason is simple: it is deceitful to the public and advertising proficiency in something beyond the scope of license can result in loss of license and momentary fine. In some situations, it can also be criminally actionable against you.

There are many examples that I notice on a daily basis: a physician advertising that he or she is “board certified” and neglecting to mention in what specialization board. For example, an aesthetic medical provider that is providing laser and dermal fillers should not indicate that they are “board certified” without also mentioning by which board. The reason is that this practice may be deceiving the public and the Federal Trade Commission (FTC) and state board of medicine will take action against such physicians. It is deceitful (arguably) because the physician may be board certified in something that has nothing to do with dermal fillers or laser (which are under the specialty of dermatology).

Another example relevant to physicians is the use of ancillary organizations which are not part of the American Board¬¬¬¬ of Medical Specialties. Membership in the American Academy of Cosmetic Surgery for example does not make you board certified in cosmetic surgery and many advertisements convey this message. Not only will state medical boards and the FTC have a problem with this, but an astute lawyer in a professional negligence action will as well.

In a similar manner, aestheticians, nurses, technicians, etc. should not advertise credentials beyond the scope of their license or training. There is no such thing as a “medical esthetician” or “para medical esthetician” for example. True, you may have received additional training but this does not enable you to perform additional services beyond the scope of your license and it does not mean that you can refer to yourself as such. The issue again is deception of the public. There is seldom a designation for “Certified Laser Technician” either and in many instances, such designation refers to individuals that REPAIR lasers not operate them. Again, the additional training is commendable, but it does not enable a provider to advertise or describe themselves in any manner that expands or alters the scope of their license or the use of medical devices as a designee of a physician.

Compliance in these areas is on the rise. Complaints by peers and clients and patients are on the rise as is professional negligence claim so be prudent when marketing your skills and training!!

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.

Saturday, June 4, 2011

An Explanation of the FDA Process....

I had a call from a client last evening. He is from the raw food/vegan world and a believer in holistic cures whenever possible. He inquired about a product utilized to promote reduction in mercury levels in humans. He indicated the he could no longer get the product because the FDA will not allow its sale. The predictable rant about the FDA and how they are ruining can imagine.

Many do not seem to understand that the FDA does not "approve" products for medical uses. They "clear" them for marketing after the manufacturer has proven that the claims that will be made can be substantiated and medically/scientifically proven.

I did some research into this product and it was not the product itself that proved to be a problem for the FDA, it was the claims that the manufacturer was making. The claims may well have been legitimate but there was no independent validation.

The FDA is not a governmental agency hell bent on destroying holistic medicine. It is here to protect us from unsubstantiated claims. Do we want the days of snake oil salesman to return?? Ohhh, wait, there are a ton of snake oil salesman today!! LOL

I am not defending or promoting the FDA. There are plenty of times that I disagree with them either as a scientist or an attorney. Recently in fact, I strongly disagreed with a position of an examiner and we talked about it and he saw that my points were valid.

If you are going to make claims about efficacy of a product that is utilized to cure, prevent or maintain and illness, you better seek FDA clearance...