HIPAA + Medical Spa Marketing: What you need to know to stay out of the brig.

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What does HIPAA mean for your medical spa’s marketing?

HHS, which implements, enforces, and offers helpful information about HIPAA and related topics, has provided specific information on healthcare marketing to help clear up some confusion. They define marketing as “a communication about a product or service that encourages recipients of the communication to purchase or use the product or service.” 

That’s a pretty broad description.

The key function of marketing is telling a story that compels someone to purchase a product or service. However, healthcare marketers are not able to access these stories to tell without consent from that person since that would mean using their protected health information (PHI). 

Beyond this central definition, marketing can also refer to an arrangement between a covered entity (CE) and another organization where the CE gives PHI to the other organization in exchange for payment, whether direct or indirect, so that the other entity can then make communication about their products or services. This part of the definition doesn’t have any exceptions but the individual must authorize this usage before that exchange can happen. Covered Entities cannot sell these lists under any circumstances without approval from each and every person on the list. 

Within the scope of the definition of healthcare marketing by the HHS, organizations are still required to receive clear and direct consent from the patient before their protected health information is used in any of these ways. 

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What is NOT considered Healthcare Marketing 

Just as the HHS has clearly defined what marketing is in the context of healthcare & PHI, they have also laid out the exceptions to this definition. There are three exceptions to the marketing definition laid out above which allows these communications to occur without approval from the patient, assuming that they comply with HIPAA in any other ways as necessary. 

The first exception is that communication is not considered marketing if it describes a health-related service or product that is provided by or included in a plan of benefits of the CE making the communication. This means that an email or posting from a covered entity can include a product and service that they offer without being considered marketing. CEs are allowed to let their client lists know about a new piece of equipment they have or a new facility that is being built. 

Another exception to the HHS definition of marketing is that if a form of communication is created for the treatment of the individual that it is sent to, then it is not considered marketing and does not need their approval. This often looks like a healthcare provider sending the patient a prescription refill reminder or a referral for a discussed follow-up testing. Since these types of correspondence are regular parts of the treatment of that individual, they are not marketing. 

The last exception from marketing is a communication that occurs during the care coordination case management process of working with a patient. This is typically where a recommendation for an alternate provider or treatment is suggested and presented. As long as that is part of their treatment and is their genuine recommendation for their patient, then it is not considered marketing but merely a part of caring for the patient. 

HIPAA Compliant Healthcare Marketing

If you are having trouble distinguishing between marketing activities and typical treatment activities, there are a few things to keep in mind. Sometimes in the course of recommending a treatment, a doctor or healthcare provider recommends the purchase of a medicine or product of some sort. This is not considered marketing by the HHS, as the benefit of this product is being portrayed and it is within the regular operations of the healthcare industry. 

Specifically for marketing, the main thing to keep in mind is getting written authorization for any uses of PHI in a campaign or communication that you may be sending out. 

There are many do’s and don’ts to healthcare marketing and complying with HIPAA as a whole that it may seem complicated at times. That is why Accountable exists to simplify the process and steps of achieving HIPAA compliance. Getting written authorization for use of PHI in marketing is important, but there are many other steps that need to be taken for complete compliance.  

#MeToo - Stories Of Sexual Harassment In Cosmetic Medicine

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#MeToo - Is sexual harassment more common in cosmetic medical clinics than other areas? Do you have a story?

In speaking out about sexual harassment, clinicians and estheticians are growing a social movement outing those in power who have engaged in what amounts to criminal sexual behaviors.

In reading a story from the Washington Post on sexual harassment in medicine I began thinking of a number of incidents that I witnessed that, depending upon your point of view, could have been seen as sexual harassment.

From the article:

"A Kaiser Health News review of dozens of legal cases involving health-care workers across the United States shows patterns similar to those found in harassment cases that have cropped up in other fields: The alleged harassers are typically male, and they typically supervise or outrank the workers lodging the complaints. There are slaps on the butt, lewd comments and requests for sex. When superiors are confronted with reports of bad behavior, the complainants, mostly women, are disbelieved, demoted or fired."

Medical spas and cosmetic clinics are almost linear in their conformity to sexual harassment cliches. They are often owned an operated by males, often physicians, and staffed by (generally) younger women who have almost zero power inside of the clinic. Where a nurse in a hospital may have outside resources like a union or an HR department that may at least provide an option to make a complaint or provide a curb on behaviors, most staff in a medspa or cosmetic practice have no recourse other than to quit or file a lawsuit.

There seems to be something of a societal shift taking place that may recalibrate what is appropriate and clamp down on unwanted sexual behaviors.

I've witnessed a number of encounters that made me uncomfortable; a physician having a foot-rub from an employee, a couple of comments about looks, the occasional double entendre. But these were just observations of how physicians and others behaved in their own clinics.

I've also observed any number of actions that - in any other work situation - would be clearly outside of the bounds of permissible behavior; before and after photos of staff members being used to show vaginal rejuvenation or breast augmentation being just one of many examples.

As with most human interactions there are often two sides to the story.

If you have been subjected to unwanted sexual actions in a practice, or if you've been accused of misconduct that didn't happen, please click on the button below and tell your story. (We will not use your name or any identifiable information if your story is published.)

Dermal Fillers: How Often Will Patients Sue You?

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Everyone is offering fillers. If you're practicing cosmetic medicine for any period of time, you're going to have an occasional unhappy patient or unwanted outcome. Since dermal fillers are so popular, we wanted to take a look at how often fillers are causing problems that result in lawsuits.

Restylane, Juvederm, HylaForm, Belotero... the fillers are all here and deeply ingrained in every practice. The safety and efficacy of fillers is pretty well known and you've probably got a lot of experience already since you're performing lip augmentation and facial wrinkle treatments every day. But it's exactly the fact that fillers are so common and performed so often that can put you at risk. The odds that any individual treatment will have an unwanted outcome is really low, but since the number of patients you're treating are quite high, it's still a possibility you need to take seriously.

Here are some interesting results from studies that have been conducted in the last few years. (Links to all of the studies are at the bottom.) 

A couple of things to note here is that sometimes we're not comparing straight apples to apples. While OB-GYNs are the most common specialty to be sued, surgeons are next. If you're a cosmetic or plastic surgeon there may be a bias that elevates your risk somewhat. (If anyone has a study showing this please link to in in the comments.)

  • Medscape study, surgeons are second to OB-GYNs for being sued by the public.
  • Vila-Nova da Silva et al., 2015, breast surgery was the most common procedure filed for a lawsuit.

You're undoubtedly disclosing the possible side effects and expectations when you're doing your consultations, but there's an interesting study that correlates an expectation of the clinician with an elevated risk of being sued. The study found that disclosing all possible risks and outcomes didn't scare the patients, but that those physicians who thought so were at increased risk of a suit which is interesting. (Boyll et al., 2017) 

One of the last articles JAMA Facial Plastic Surgery published in 2017 were litigation cases filed due to dermal fillers and there is some risk of unwanted outcomes or mid-term issues; Hyaluronic acid fillers typically cause swelling and infection, while CaHA causes infection and pain, and PLLA and PMMA both cause nodules. In the study, most of the swelling were found in the tear troughs, while only infection were found in the nasolabial folds. Additionally, intra-arterial injections especially without sequelae were found in the lip and nasolabial folds (Rayess et al., 2017).

Other than this study, Ezra et al. (2015) also examined litigation earlier, and may have encountered the similar cases as with Rayess et al. (2017) back then, only granulomas were found as an adverse effect that resulted in a filed suit. 

In the Ezra 2015 study,  the real cause of most of the problems becomes clear - non-physicians who are performing the injection and there can be additional disciplinary actions in addition to a patient filing suit.

From the study: (This is about disciplinary actions, not lawsuits)

A total of 24 legal documents were identified: 19 cases and 5 disciplinary actions. Of the 19 cases, physicians were named as defendants in 13. Six of the 7 cases that named a nonphysician as a defendant involved a substance being injected different than the reported filler. Overall, 50% of legal actions from soft-tissue fillers were related to a nonphysician performing the procedure. Of physician subspecialists, dermatologists and plastic surgeons had the highest proportion of litigation (17% each); this is likely due to these specialties performing a higher volume of the relevant procedures. The majority of disciplinary actions were reprimanding physicians for not being present while a nonphysician employee injected patients with soft-tissue fillers. In 3 of the 5 reprimands, physicians were functioning as medical directors of medical spas.

The chances that you'll be sued by a patient for a filler injection treatment is extremely small unless you're doing something stupid like allowing someone who is unqualified, unskilled, or unlicensed. Be sure that you're using clinic best practices and procedures and that your staff is trained. Almost all of these problems can be avoided if you avoid the trap of thinking that any procedure is routine.

References:

  • https://jamanetwork.com/journals/jamafacialplasticsurgery/article-abstract/2665429?redirect=true
  • http://www.jaad.org/article/S0190-9622(15)01857-5/fulltext
  • https://academic.oup.com/asj/advance-article-abstract/doi/10.1093/asj/sjx182/4461847?redirectedFrom=fulltext

Can A Dentist Own A Medical Spa?

Can a dentist own a medical spa?

There's been a fair amount of angst around dentists performing Botox treatments and whether it's legal or not.

This is from a press release that was emailed to me from a thread on a LinkedIn forum:

In Illinois, for instance, only a licensed physician may own a medical spa. Under the Illinois Medical Corporation Act, a medical spa, or any entity that provides medical treatment, must be owned and operated only by persons licensed under the Medical Practice Act of 1987 (the Medical Practice Act governs the medical licensing of physicians).

In Florida, for example, anyone, including a dentist, can own a medical spa. And in Washington and Oregon, non-physicians are not completely precluded from med spa ownership if they structure the business in a particular way.

Similarly, the laws vary widely from state to state as to whether dentists can even perform medical procedures like Botox and laser hair removal, which are commonly offered in med spas. In most states, dentists are limited to injecting Botox or other injectables in certain areas around the mouth. In Kentucky and Illinois, the use of Botox and other injectables falls within the scope of dentistry as long as it involves conditions surrounding the mouth but in other states like Missouri, the law does not provide express guidance on whether dentists may administer Botox or other injectables."

Does anyone know any cases where a state has come down on a dentist who owns a laser clinic or medical spa?

Avoid Medspa Litigation Claims = Provide Comprehensive Information

Exceptional patient services will do more than just keep your patients happy, they'll also keep you out of court (or may your stay much shorter).

In a recently decided case of James v. Decorato, the defendant medical practitioner was absolved of liability after showing to the court the the patient has been adequately informed about the procedure that she will be undergoing.

Their case stemmed when the patient and plaintiff Rebecca B. James sued the defendants John W. Decorato, M.D. and Aesthetic Pavilion, LLC for alleged negligence and malpractice by the latter. In her complaint, Rebecca claimed there was negligence in the performance of various cosmetic surgeries which included liposuction, blepharoplasty, lipoplasty, autologous gluteal augmentation with fat grafting, submental and neck smartlipo, bilateral transconjunctival lower blepharoplasty with CO2 laser resurfacing, and autologous upper and lower lip augmentation with fat grafting.

She alleged that there the malpractice resulted in the formation of excessive and severe scarring, non-uniform appearance of her abdomen, concave left inner thigh with pain, hypo-pigmented skin under eyes leaving non-uniform skin color on the face, among others.

Further, she said that Dr. Decorato violated the Public Health Law when he allegedly failed to disclose alternatives, risks and benefits that may arise after the treatment. She said that had she known of them, she would not have undergone with the treatments altogether.

In an answer, Dr. Decorato said that the plaintiff was able to sign multiple consent forms which outlined the risks and effects that may happen after the treatment. The defendant doctor also argued that the plaintiff's argument must be summarily dismissed because they only stemmed out of her dissatisfaction with the results of the procedures.

In support, Dr. Decorato submitted to the court the examination done by Dr. Theodore Diktaban, a certified Plastic, Reconstructive as well as Head and Neck Surgeon. Dr. Diktaban indicated that he was able to review the consent forms signed by the plaintiff and found them all clear and complete.

According to Dr. Diktaban's affidavit,

The forms adequately provided for the proposed procedures, alternatives thereto, and the reasonably foreseeable risks and benefits associated therewith, including the need for revisionary surgery. The lack of an informed consent could not be a proximate cause of any of plaintiff's subjective dissatisfaction, which she classifies as injuries. Regarding the issue on malpractice and negligence, the pre-and post-operative care rendered to plaintiff comports with good and accepted medical practice.

He further opined that the results of plaintiff's surgery were devoid of any functional deficits, except for the purported and subjective paresthesias of the left medial thigh.

These claims were opposed by the plaintiff Rebecca and presented the statement of a cosmetic surgeon, Dr. Richard Marfuggi. He claimed that after examining Rebecca, he can say that "with a reasonable degree of medical probability, the complications experienced by plaintiff were the result of Dr. Decorato's failure to follow good and accepted practice".

According to the Supreme Court, the basis for establishing the liability of the physician is the departure of the physician from accepted community standards of practice and this was the proximate or direct cause of the plaintiff's injuries.

The Supreme Court sided with Dr. Decorato and summarily dismissed the case. Dr. Decorato, with the affirmation of the statement of Dr. Diktaban, was able to show that indeed he did not deviate from accepted medical procedures. The Supreme Court noted that the plaintiff's claim of "lack of informed consent" has not been proven. Instead, Dr. Decorato was able to produce in evidence the fact that Rebecca was able to sign the consent forms.

On the other hand, the plaintiff Rebecca and Dr. Marfuggi's affidavits did not show any medical evidence establishing that Dr. Decorato was indeed negligent. According to the Supreme Court, Dr. Marfuggi's recitation of facts failed to address the concern of whether or not this was a departure from accepted practices.

Note to self: make sure that all forms are clear and complete.

Getting Naked on the Internet: What does the law say?

Medical 

Telemedicine and Cyber Security

The Health Information Portability and Accountability Act (HIPAA) is a federal law that protects the privacy of your personal health information (PHI). HIPAA includes several rules and provisions that set guidelines and requirements for the administration and enforcement of HIPAA. The relevant ones for the exchange of PHI in the digital cyberspace are the Privacy Rule1, the Security Rule2, and the aptly named Health Information Technology for Economic and Clinical Health (HITECH) Act3.

Telemedicine is a burgeoning field of medicine that incorporates digital technology such as electronic health records (EHR), information sharing, and videoconferencing to enhance the interaction between physicians and their patients, and ultimately, improve the delivery of healthcare. Having been a plastic surgeon for several years now, I’m all too familiar with meeting people at social events, and immediately getting bombarded with intrusive and unusual questions and requests as soon as my chosen profession is ousted. Sure, it’s unlikely that a woman will disrobe and expose herself in front of me and my wife at a friend’s dinner party, but get us into an online “private” videoconference call, and who knows what body parts will make an abrupt entrance into the conversation. Physicians must approach with caution, says American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) President Stephen S. Park, M.D. in a recent article4. But, for me and most physicians I know, I feel like the cat is already out of the bag. Considering the amount of texts, emails, online chats, phone conversations over internet and satellite lines, and selfies of both pre- and post-op patients I’ve been privy to, I’m sure I’ve already broken too many laws, and completely disregarded the good doctor’s advice. The truth is, though, that we’ve only begun to scratch the surface.

Telemedicine may involve the electronic exchange of PHI which is protected under HIPAA law. Security considerations with telemedicine involve making sure unauthorized third parties cannot eavesdrop on or record a videoconferencing session where sensitive PHI is transmitted seamlessly, and unfortunately, innocently. Recently, a monumental data breach at one of the nation’s largest insurance providers has spurred a bipartisan political effort to reexamine HIPAA as it relates to telemedicine, possibly adding costly and cumbersome requirements to encrypt EHR data5. Additionally, a recent report done by BitSight Technologies, a cyber security risk analysis and management firm, found that healthcare and pharmaceutical companies ranked the lowest among the four industry categories studied6. Suffice it to say, people are taking heed of this emerging new threat.

The aforementioned laws, rules, and regulations guide the generation, maintenance, and implementation of telemedicine HIPAA compliance. We must be cautioned, though, that HIPAA compliance does not necessarily equate to actual cyber security, and that simply meeting standards set forth in these regulations may not be enough. As more public attention and scrutiny rise to the forefront of media exposure, look for the healthcare industry to take the cyber security threat much more seriously.

Daniel Kaufman, MD
Discreet Plastic Surgery

Bibliography
1. http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/
2. http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/
3. http://www.healthit.gov/policy-researchers-implementers/health-it-legislation-and-regulations
4. http://cosmeticsurgerytimes.modernmedicine.com/cosmetic-surgery-times/news/cosmetic-virtual-consult
5. http://medicaleconomics.modernmedicine.com/medical-economics/news/senate-review-hipaa-security-medical-records-light-anthem-breach
6. http://info.bitsighttech.com/bitsight-insights-industry-security-ratings-vol-4-rc

Connecticut Passes New Medical Spa Bill Requiring More Medical Oversight

Conneticut has passed new laws for medicals spas that requires all medical spas to employ on staff or by contract a physicain, PA or APRN and that those oversight providers make an assessment before any medical proceedure.

The law also ends some practices like "Botox parties" where there's often a party atmosphere (sometimes including alchol) that can affect consent practices. 

Most medspas already operate according to these types of standards and these measures are actually targeting the king of treatments that are offered in hair salons and day spas.

Here's the law. Link

Connecticut Seal - Medical Spa Bill

Substitute Senate Bill No. 418 | Public Act No. 14-119

AN ACT CONCERNING THE DEPARTMENT OF PUBLIC HEALTH'S RECOMMENDATIONS CONCERNING MEDICAL SPAS.

Be it enacted by the Senate and House of Representatives in General Assembly convened:

Section 1. (NEW) (Effective October 1, 2014) (a) For purposes of this section:

(1) "Medical spa" means an establishment in which cosmetic medical procedures are performed; and

(2) "Cosmetic medical procedure" means any procedure performed on a person that is directed at improving the person's appearance and that does not meaningfully promote the proper function of the body or prevent or treat illness or disease and may include, but is not limited to, cosmetic surgery, hair transplants, cosmetic injections, cosmetic soft tissue fillers, dermaplaning, dermastamping, dermarolling, dermabrasion that removes cells beyond the stratum corneum, chemical peels using modification solutions that exceed thirty per cent concentration with a pH value of lower than 3. 0, laser hair removal, laser skin resurfacing, laser treatment of leg veins, sclerotherapy and other laser procedures, intense pulsed light, injection of cosmetic filling agents and neurotoxins and the use of class II medical devices designed to induce deep skin tissue alteration.

(b) Each medical spa shall employ or contract for the services of: (1) A physician licensed pursuant to chapter 370 of the general statutes; (2) a physician assistant licensed pursuant to chapter 370 of the general statutes; or (3) an advanced practice registered nurse licensed pursuant to chapter 378 of the general statutes. Each such physician, physician assistant or advanced practice registered nurse shall: (A) Be actively practicing in the state; and (B) have received education or training from an institution of higher education or professional organization to perform cosmetic medical procedures and have experience performing such procedures. Any cosmetic medical procedure performed at a medical spa shall be performed in accordance with the provisions of titles 19a and 20 of the general statutes, and shall only be performed by such physician, physician assistant or advanced practice registered nurse, or a registered nurse licensed pursuant to chapter 378 of the general statutes.

(c) A physician, physician assistant or advanced practice registered nurse who is employed by, or under contract with, the medical spa shall perform an initial physical assessment of each person undergoing a cosmetic medical procedure at the medical spa prior to such procedure being performed.

(d) Each medical spa shall post information, including the names and any specialty areas of any physician, physician assistant, advanced practice registered nurse or registered nurse performing cosmetic medical procedures, in a conspicuous place that is accessible to customers at the medical spa and on any Internet web site maintained by the medical spa. Such information shall also be: (1) Contained in any advertisement by the medical spa or state that such information may be found on the medical spa's Internet web site and list the address for such Internet web site; and (2) contained in a written notice that is provided to each person before undergoing any cosmetic medical procedure at the medical spa.

Laser & IPL Hair Removal Regulations In Dubai

As in other places in the world where regulatory bodies aren't keeping up with advancing technology, the Dubai Health Authority saw that cosmetic lasers and IPLs were being purchased by hair salons and spas and being used to treat patients.

It's interesting to see how different countries deal with regulation and just how much they use the regulatory bodies of the US, Canada and Europe as base lines to implement their own regulation.

Here's a link to the Dubai Health Authorities regulations for Laser and IPL hair removal wich is interesting both for what it includes, and what it doesn't:

The number of facilities offering to remove unwanted hair through the use of lasers or similar medical devices is growing in the Emirates of Dubai.

By adding non-invasive and minimally invasive therapies to the beauty saloons services, beauty saloons start to treat patients instead of treating clients. This regulation is intended to be the fundamental regulation that will govern patient safety in any facility providing laser or similar medical devices hair removal services in the Emirate of Dubai.

The persons, establishment, public or private facility shall cease laser hair removal services with effect from August 31st, 2011 if the facility did not meet the laser hair removal regulation requirements.

New California Law Protects Patients From "Disparagement Clauses" That Some Medical Spas Are Using

A new California state law just signed by Gov. Jerry Brown makes reviews a lot safer for patients, and prevents medical spas or cosmetic practices from pursuing any legal action against patients who post negative reviews online.

This legislation is the first of it's kind and addresses so-called "disparagement clauses" that are sometimes used in a clinics patient forms that prohibit patients from posting negative comments about the services, staff, clinic or physician.

This new law effectively bans such clauses and any clinic that tries to enforce one could pay $2,500 for the first offense and $5,000 each additional time, with an extra $10k tacked on if the action is considered "willful, intentional, or reckless".

The First Amendment is only in the US of course, France is a different story. In July a French blogger was fined because her negative review of a restaurant was appearing too high in Google's search.

If you're in California, not only is any non-disparagement clause uninforcable, it's now illegal.

Here's the copy from the bill:

Read More

Louisiana Cosmetic Laser & IPL Law Questions & Answers

Legal issues around who can own or use a cosmetic laser or IPL are among the most common questions asked by both physicians and non-physicians who are investigating the medical spa market.

Here's a question posted inside the Medical Spa MD LinkedIn Group

What is the best way to find out what the Louisiana Laws are for operating lasers at your spa? From what I have read, it seems as though you have to have a physician present, however, most of the medi spas around run lasers but do not have physicians present so I am very confused. Does anyone know a way to find out more information?

Texas Law & Medical Spas

The first of July (2014), a Texas judge in the 126th State District Court in Austin ruled that the Texas Medical Board Rule 193.17 which sought to impose restrictions on who could practice cosmetic medicine was without "reasoned justification" and should be remanded for further consideration.

Mark one up for the Texas Association of Aesthetic Nurses.

The association had sued asking for the rule to be invalidated and it seems that the judge agreed.

Under Rule 193.17, among a laundry list of requirements, medical spas could not perform nonsurgical medical procedures without having a physician, a nurse practitioner or physician assistant on staff to complete a 10-step process before beginning the procedure. The rule did not, however, require a physician actually be on the premises during the procedure, but rather necessitated only that a doctor be available for an emergency consultation. Judge Yelenosky’s order noted that: The rule allows qualified unlicensed personnel to perform a procedure without a physician or midlevel practitioner onsite during the procedure and without requiring the physician to go onsite in the event of an adverse outcome. Yet the reason given for the rule is that the presence of a physician or midlevel provider during procedures to personally treat or supervise treatment of any complications arising from the procedure insures patient safety. The rule and the justification contradict one another.

According to the ruling it seems that if the Rule were to require a physician or midlevel practitioner to be present during a procedure, it would probably pass muster with the judge.

Although I don't think that Texas has passed specific legislation or adopted particular rules governing medical spa operations (check with your lawer if you're in TX), there has been a number of administrative actions taken related to unauthorized services being performed or the failure of such licensed professionals to adequately supervise the performance of such services. Additionally, the Texas Medical Board has established a rule that requires physicians who perform procedures for which anesthesia services, including the use of analgesics and anxiolytics, are provided in an outpatient setting to register with the TMB. While this TMB registration requirement primarily affects outpatient surgeries performed at licensed Ambulatory Surgery Centers in Texas, the language of the rule would also cover any outpatient surgeries performed in a medical spa that require anesthesia services. A new TMB rule related to nonsurgical medical cosmetic procedures (22 Tex. Admin. Code § 193.17) became effective on November 7, 2013.

Texas often likes to chart it's own course so we'll watch and see where this goes.

My opinion is that a physician should be on site if a NP or PA is not the one administering the treatments. It seems somewhat rediculous to allow the term "medical spa" to be used as it is in Canada and parts of SA and the EU when there's no medical personnel involved. It seems that the medical board in Texas stretched just a little too far in trying to restrict cosmeitic medicine to physicians but not making them be on site.

New European Aesthetics Standards To Be Split Between "Surgical" and "Non-surgical".

For the past three years a new pan European services standard for the aesthetics sector has been in development.

This work has been coordinated at the European level by CEN, the European Committee for Standardization. Member states, including the UK, have been making considerable input into this work, and it had been hoped to publish the standard (as EN 16372) by Q2 / Q3 2014. 

The current working title for the EN 16372 standard, reflecting its wide scope, is: 'Aesthetic surgery and aesthetic non-surgical medical services'. However CEN have announced that, for procedural reasons, the decision has now been made to split EN 16372 into two separate standards. One will deal solely with 'aesthetic surgery services', and the other with 'aesthetic non-surgical medical services'. It is anticipated that the content of the two separate standards will be similar to the recent public consultation draft - but simply split into two documents. The target publication dates for the two standards are by Q2 and Q4 2014 respectively.

Mike Regan 
Chair, BSI Committee CH/403
Aesthetic Surgery Services

via the Medical Spa MD LinkedIn Group

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Connecticut Governor Vetoes New Regulations For Medical Spas

New Regulations For Medical SpasConnecticut Governor Dannel P. Malloy vetoed a bill that would have imposed new standards on “medical spas” providing cosmetic medical procedures.

The medical spas bill would have required a physician to act as a spa’s medical director, perform every initial assessment and perform or supervise all cosmetic medical procedures. The bills passed with the support of trial lawyers and labor lawyers and associations representing dermatologists and plastic surgeons who claimed that physician only oversight would improve patient safety.

Governer Malloy said that could unnecessarily limit the scope of practice of Advanced Practice Registered Nurses and other licensed medical professionals and that a professional board or the Department of Public Health should make such recommendations and that both bills were "deficient".

“Protecting public health is an essential role of government, and I strongly support the objectives of this bill,” Malloy wrote. “Many of the procedures covered in this bill should only be performed by a licensed medical professional.”

But the governor said the bill may unnecessarily limit the scope of practice of other medical professionals like Advanced Practice Registered Nurses writing, “Requiring physicians employed or on contract with a medical spa to perform all initial assessments may also unduly burden small businesses if such assessments could be done by another medical professional or an individual’s own physician”.

Thoughtful comments welcome.

Medical Spas + Legal Changes

Laws that define and emcompass medical spas and cosmetic clinics are changing all of the time, usually driven by a desire to protect someone's turf under the guise of 'safety'.

Pretty much all medicine comes with some risks. In fact, according to a 1999 report by the Institute of Medicine, as many as 98,000 Americans were dying every year because of medical mistakes. Here's a story about that from the New York Times.

Not a nice statistic at all. 

So of course there are going to be mistakes made in cosmetic medicine and there are clinics that are operating unsafely, with insufficient oversight, and with people performing treatments who should not be.

As will all things, these new moves are pushed by complaints, both from injured patients, and also by people, generally physicians, who have an interest in protecting a market space.

Here's part of a Wall Street Journal article: Medical Spas Get A Checkup. Link

A few months ago, Maryland Gov. Martin O'Malley signed a new law directing the state health department to oversee cosmetic-surgery facilities after one woman died and two others became seriously ill with Group A streptococcus infections traced to liposuction at a Baltimore clinic

Florida now requires that liposuctions removing more than two pounds of fat be performed in a state-licensed surgical center with emergency equipment on hand, after two women died from overdoses of lidocaine, a local anesthetic. In California, it is now a felony, punishable by up to five years in prison and a $50,000 fine, for a corporate entity to own a medical spa; the majority owners must be M.D.s.

Pennsylvania is weighing tighter rules on who can provide laser treatments. Fourteen states are considering "truth in advertising" laws, many of which would require medical spas to list personnel's training and credentials in all marketing. Some proposals, like New York's, would require anyone who wears a white coat and treats patients to list credentials on a nametag.

The push for more regulation is being driven in part by dermatologists who say allowing nonphysicians to perform cosmetic procedures puts patients at risk.

"It's the difference between four years of medical school and four to five years of residency versus beauty school," says Timothy Flynn, president of the American Society for Dermatologic Surgery Association, which has lobbied for stricter rules in several states. The ASDSA considers any use of lasers, lights, electrical impulses, chemical peels, injections, insertions or tissue augmentation to be the practice of medicine, which it says should be performed by a physician or midlevel health professional, such as a physician assistant, under a doctor's supervision.

Supporters of medical spas say they get a bad rap when it comes to injuries. "In 2009, there were over 9,000 deaths in hospitals related to errors, but one death occurs in a medical spa and it's on the national news...

"I've treated patients who were burned at the hands of a doctor," says Paula Young, a nurse who owns three medical spas with her physician husband in Pennsylvania. She says she would have to lay off seven experienced laser technicians and close her tattoo- and hair-removal clinic under the state's proposal allowing only physicians or physician-supervised nurses and PAs to perform laser treatments.

So where's the line?

Lest you think that we're for less or looser oversight, let me say that we're not. In my opinion, a physician should be on site and see every single patient before treatment. However, if you're doing an axillia hair removal treatment, I don't think that that physician needs to be a board certified plastic surgeon or dermatologist. Rational opinions welcome.

Client Referral Rewards

Legitimate Marketing Or Unacceptable Practice?

Your client tells you they will send lots of friends your way, if only you will give them a discount for their goodwill. Or you decide that because your neighboring practice offers a $200 incentive for every referral, perhaps you should do this too in order to compete. You want to show your appreciation for the new business that might have otherwise incurred advertising costs, so why shouldn't you offer financial acknowledgement of the referral?

Hair salons and massage practices rely heavily on referral rewards programs. So why not Medical Spas or Cosmetic Centers? Well, if you are a physician and you offer consideration of any kind for referrals, you are in direct conflict with AMA Code of Ethics Opinion 6.021. You may also be violating your state Board of Medicine regulations, many of which simply defer to the AMA Code for ethical compliance. The opinion argues that the reward may incent the referring client to alter the information and expectations to others in an untruthful or unrealistic way. 

Early in my practice, prior to the AMA opinion, I succumbed for a short time to clients requesting rewards. The referred clients never seemed to have the same level of motivation to have a procedure as someone who came on their own accord. Now when a client asks me for a discount or a free service because they will send lots of friends, I simply tell them the following:

"A referral is the greatest compliment you could ever give me. And I appreciate the kind mention of your pleasant experience. I promise to always give you and those you send to me my very best work."

Plastic Surgery & Malpractice Lawsuits In The US & Canada

If you're a plastic surgeon in the US and you've been practicing for a while, the odds are good that you've been sued by a patient.

In the US there are about 95 medical liability claims filed for every 100 physicians—or almost one per doctor—and nearly 61% of physicians age 55 and older have been sued, according to a report released by the American Medical Association and based on a survey of 5,825 “non-federal patient care physicians” conducted in 2007 and 2008.  The survey, which included doctors practicing across 42 specialties, found that 42.2% of the respondents had a claim filed against them at some point, with more than 20% of physicians sued at least twice.

The most-sued specialties were obstetricians/gynecologists and general surgeons, with 69.2% of them being sued. (Psychiatrists were the least sued at 22.2%...  probably because they can use the Jedi mind tricks to mitigate their risk by keeping their patients happy.)

The study also found that 47.5% of male physicians had been sued, with 26.3% having been sued twice; and that 23.9% of female doctors had been sued and only 9.4% had been sued twice... andticdotal evidence that female physicians may be able to manage patient interactions better post treatment.

This brings up some of the interesting differences between practicing in the US and other countries. Certainly the US is letigious, perhaps the most country in the world. (If that's not the case, please comment.) I've posted before about how our Members outside the US can end up handling unhappy patients.

Read Learning From Physicians World Wide: Unhappy Patient? If You're In Mexico Just Call The Cops

In Canada under the single payer system, the numbers are dramatically different for a number of reasons, all of them economic. Between 2002 and 2006 the C.M.P.A. reports only 5246 lawsuits were filed against doctors in Canada: only about a 1000 claims per year.

Why?

First, In Canada, court awards are much lower than awards for similar injuries from courts in the United States. Cases that might be successful in the U.S. are simply not economically feasible to pursue in Canada.

Second, In Canada, most doctors are defended by a single organization, the Canadian Medical Protection Association (the C.M.P.A.) with a couple of billion of dollars in the bank that can be used to defend physicians. The C.M.P.A. reports it's success rate in defending claims brought against doctors. More than 3800 of the 5000 claims were dismissed or abandoned because the victim or their family quit or ran out of money, or died before trial.

The result? A couple of online articles on this subject express these stats: more than 5000 lawsuits filed against Canadian doctors, only two percent (2%) resulted in trial verdicts for the plantiff and for the few plantiffs who won at trial, the median damage award was only $95,500. Just try and get a US lawyer to go for that. (If you're a physician in Canada and you can clarify this, please leave a comment.)

There are advantages to being a physician in the US for sure, but there are also risks. The numbers are bigger on both ends.