Your Medical Spa Is Going To Be Sued

New England Journal of Medicine: Most doctors (and probably your medical spa) in America will be sued at some point during their career.

A Harvard study released yesterday in the New England Journal of Medicine has found that physicians who perform high-risk procedures, including neurosurgeons, obstetricians, and plastic surgeons, face a near certainty of being named in a malpractice case before they reach age 65.

Yet a relatively small number of claims, about 22 percent, result in payments to patients or their families.

Authors of the study, which examined 15 years of data, said it highlights the need for changes in malpractice law so that doctors and patients can resolve disputes before they resort to litigation, which often costs both parties money and heartache.

“Doctors get sued far more frequently than anyone would have thought, and in some specialties, it’s extremely high,’’ said Amitabh Chandra, an economist and professor of public policy at the Harvard Kennedy School and an author of the study. “In some sense, the payment is the least important part, because you can insure against it, but you can’t insure against the hassle cost.’’

The study looked at malpractice claims data for nearly 41,000 physicians from 1991 to 2005. The researchers found that 7.4% of physicians had a malpractice claim against them each year and that 1.6% had a claim that led to a payment each year.

Chandra and his coauthor, Dr. Anupam B. Jena of Mass. General, said they hope their study will dispel the fear that many doctors have of big payouts. Their study found just 66 claims that resulted in payments exceeding $1 million. Average claims by specialty ranged from $117,832 in dermatology to $520,923 in pediatrics.

So how can you lessen your chances of being sued by an unhappy patient even further?

Previous studies have shown that patients are less likely to sue when they receive an apology and explanation from their doctor.

Brian Rosman, research director of Health Care for All, said everyone will benefit if patient- doctor communication is divorced from legal proceedings and could actually inprove the quality of care. That would allow doctors and hospitals to deal more directly with the root cause of an error.

One medical society has been working with Beth Israel Deaconess Medical Center, using a $273,782 federal grant, to design a plan for a system that would encourage apologies and compensation, when justified, in Massachusetts. The plan is set to be released this fall.

It seems that nearly universal support exists for a system that encourages doctors to apologize and prevent the escalation of an unwanted outcome into a malpractice lawsuit.

Of course, this wall of scilence goes up on both sides. As soon as an unhappy patient contacts a lawyer they're instructed to have no further contact with the doctor to prevent anything that might mitigate damages or obstruct the lawsuit, like an admission to the doctor that they didn't follow instructions or a 'softening' of their stance as the identify with the physician as a person.

When I was running Surface Medical we ran in to this very problem many times. In one case in Park City, Surface Medical Spas and two of our physicians were sued by a patient who had been burned during an IPL treatment.

Have you been in a lawsuit? Have you ever appologized to a patient?

Medical Spa Sublease, Bankruptcy, & Physician Lawsuits

Here's a cautionary tale for physicians: be wary of what the 'medical spa' that you're extending your license to is doing in your absence.

Here's a story about a physician 'medical spa director' and state regulators both being sued by a subtenant that was running a 'medical spa' under the physicians license.

Despite Williams winning this order, Monday’s complaint says: "Williams claims to be a 'creditor' in the instant bankruptcy proceeding. However, the only possible connection which could create a debtor/creditor relationship between the plaintiff and Dr. Williams is one of bogus 'sublease' agreements created through fraud by Dr. Williams, purportedly to 'protect' his medical license by 'separating’ his practice from the business of the Medical Spa.’

Click to read more ...

Free Webinar: How To Protect Your Professional Reputation Online

Free Webinar: How To Control & OWN Your Business & Personal Reputations Online!

While I'll be teaching this for any business or professional who needs to own their own reputation, this is especially important for physicians.

Reputation management has become an incredibly hot and relevant topic with the rise of all of the review sites that are filled with flaming physician reviews. So, I'm going to be teaching a number of techniques and strategies for physicians who need to protect and control there reputations.... By the way, this is you.

Your business or medical reputation can be hijacked in seconds by a one unhappy patient, disgruntled employee or nasty competitor... but in just one hour, you'll discover exactly how to protect and OWN your personal and business reputations online without needing a phD in geek.

Here's some of what you'll learn:

• What you should NEVER do when you're flamed online (but what almost everyone does)!
• How to get negative reviews and comments removed!
• What you should do IMMEDIATELY when your reputation is attacked!
• How to make negative reviews and comments impossible to find!
• What legal options you have!
• The insider tips and tricks that the pros use to protect their own reputations!
• How to get your existing patients to give you RAVING reviews!

This is a must-see webinar for any professional or business owner.

Thanks to Ryan over at Frontdesk for putting these together and getting everyone on board.

Cyber Discrimination: A New Frontier of Liability for Healthcare Providers

By Dr. Jeffrey Segal, MD, JD of Medical Justice

Pause for a second, stop reading this article and close your eyes. Imagine living life as one of the 1.3 million blind people in the United States. Think about how you would access information exchanged over the Internet. For 60-year old New York resident Mindy Jacobsen, this is her reality. She has been blind since birth.

Thanks to the American for Disabilities Act (“ADA”) it is easier for Mindy to navigate around New York City. She can walk sidewalk to sidewalk, hop on a train and live a fully functional life, except when it comes to navigating through the internet.

“You go to a hospital’s website and want to get the pre-op information there, but it isn’t available and if it is, it is in a format we can’t read. Then we have to ask people to read it to us and it becomes such a big deal,” Jacobsen said.

Mindy uses a screen reader to read web pages to herself. It is a helpful tool that allows her to navigate the World Wide Web.

"We have computers that take advantage of the speech kit that is built into all computers. Instead of using that speech kit to show a movie, which it certainly can do, we have a program that uses that speech kit to read the screen. So every time the screen refreshes, the software sends the information to the speech kit and it is read aloud to us,“ Jacobsen said.

Section 508, added to the Rehabilitation Act in 1986 and amended in 1992 and 1998, requires Federal agencies to make their websites accessible to people with disabilities. Outside of Federal agency websites, the United States government policy is to encourage self-regulation of the Internet wherever possible. Only if self-regulation is insufficient does government involvement become necessary.

Self-regulation hasn’t fared well for a handful of public companies nationwide. The most famous and commonly cited case was litigated several years ago, when the National Federation of the Blind filed a suit against the retail giant, Target.  The plaintiffs alleged Target's website was not compliant within the outlines of the ADA.   National Federation of the Blind v. Target Corp., 452 F. Supp. 2d 946 (N.D. Cal. 2006) asserted the requirements that Title III of the ADA imposes on places of public accommodation also applies to e-commerce websites.  The plaintiffs were blind individuals who claimed the Target website discriminated against them since the website did not work well with screen reading software.  The case was the first lawsuit applying the ADA to a website that survived a motion to dismiss.  The Target case was recently settled out of court for reportedly six million dollars. Quite a sum. 

Target is not the only organization whose website triggered a claim under the ADA. Southwest Airlines has been named as a defendant, as well as Twentieth Century Fox and Schering-Plough. It seems reasonable to anticipate a wave of litigation against healthcare providers that, in whole or in part, provide services to disabled individuals.

Title III of the ADA provides, “No individual shall be discriminated against on the basis of disability in the full and equal enjoyment of the goods, services, facilities, privileges, advantages, or accommodations of any place of public accommodation….” 42 U.S.C. § 12182(a).  Is a website a public place?  There seems to be so strong arguments that a judge could say, "Yes." 

"I hope that legislation will come about requiring anyone on the internet to make his or her site accessible.  I am dreaming but it is a hope,” Jacobsen said.

Mindy’s hopes are not far off. In July of 2010 the Department of Justice (DOJ) published documents saying they are considering updating the ADA regulations so that it would explicitly state that both state and local government and places of public accommodations must make websites usable to people with disabilities. Public comments were accepted by the DOJ for an advanced notice through January, 2011. Many take this as a clear sign that rules applying ADA regulations to commercial websites are coming in the near future.

To help physicians get a jump start before legislation may take effect, there are a handful of easy changes to their websites to make them more accessible. First, physicians who already have a website should get it tested for accessibility.

Accessibility Partners is a company that helps organizations implement electronic and information technology accessibility solutions for people with disabilities. Their company hires people with and without disabilities to scan websites to make sure there are no kinks during operation.

“If somebody doesn’t have use of their hands and arms and they have some type of mobile disability, they might use some type of speech recognition to navigate the web. If they are trying to research a medical practice in their city and they Google it and doctors office comes up and they get to the website and the website is not accessible for them; it might be like getting to the door and having the door locked and having the doorbell be out of reach. So it kind of cuts off, unintentionally a whole population of potential clients,” Dana Marlowe with Accessibility Partners said.

A screen reader can read almost anything - eliminating barriers for the blind like Mindy; until it comes across a graphic with no behind the scenes description attached to it for the screen reader to read.

“When my screen reader encounters graphics, it can’t read them. So it just quiets down and doesn’t do anything,” Jacobsen said.

This encounter has been described more graphically by Premium Websites web designer Dotty Scott.

“It is like somebody reading off a Uniform Resource Locator (URL) that has a bunch of question marks and numbers, stuff that is not relevant to what they are looking for. Unfortunately, most websites are built that way, so the person is actually forced to sit and listen to all of that before they actually get to the information they are looking to find,” Scott said.

Scott encourages all web designers to experience a screen reader. Then it becomes obvious what they need to do.

“It was shocking and eye opening. It is amazing to me, the patience blind people have to find anything on the internet. It really is an eye opener,” Scott said.

Here are a few changes physicians can make to their website to make them more user friendly immediately.

• Provide text alternatives ("alt") for images and other non-text content.
• Make it easier for users to read text by using high contrast colors between the text and        background, and making text resizable.
• Provide captions and other alternatives for multimedia.
• Use headings to group information and mark up the heading in the code.
• Make all functionality available from a keyboard, since some people cannot use a mouse.

W3C is the international organization that defines the standards for the web. Within the W3C is the Web Accessibility Initiative (WAI). The WAI's core mission is to make sure the web is accessible to those with disabilities.

 WAI has developed web accessibility standards that organizations can follow, although WAI itself is not an enforcement body. The DOJ is considering using those standards in revising regulations for the Americans with Disabilities Act. Shawn Henry has been working to help organizations understand WAI's standards with the hope that many will make the changes on their own.

"Organizations would be wise to think about accessibility when they are updating their website, instead of waiting until they get a complaint," Henry said.

About: Dr. Jeffrey Segal, MD, JD, is Chief Executive Officer and Founder of Medical Justice and is also a board-certified neurosurgeon.

Michael J. Sacopulos is a Partner with Sacopulos, Johnson & Sacopulos, in Terre Haute, Indiana. His core expertise is in medical malpractice defense and third party payment disputes. Sacopulos may be reached at mike_sacopulos@sacopulos.com

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Understanding The HITECH Act: HIPAA On Steroids

By Jeffrey Segal MD JD and Michael J. Sacopulos JD

Understanding the law before you send your patients any e-mail.

Snail mail is becoming less popular as the calendar pages turn. E-mail and social media networks have changed how we communicate. Before clicking the send button in an e-mail template, healthcare professionals should better understand that HIPAA violations have also entered a new era. More cases are prosecuted with assessment of both statutory civil fines and criminal penalties.

A little background: Even though HIPAA passed in 1996, little prosecution followed when patient privacy was violated. Since the law took effect in 2003, nearly 45,000 complaints were filed with the Health and Human Services (HHS) Office for Civil Rights. Of these complaints, only 775 cases were referred to the Department of Justice or the Centers for Medicare and Medicaid Services for investigation. None resulted in direct civil monetary penalties.

Then, in 2009 the HITECH Act (“HIPAA on steroids”) was enacted. This act intended to increase HIPAA confidentiality protections of Electronic Protected Heath Information(ePHI), instill tough civil and criminal penalties for violations, mandate notification of breaches of HIPAA protected heath information, and extend the definition of covered entities to include business associates. A tall order indeed.

For example under the tougher HITECH Act, in April 2010 a former employee of a hospital was sentenced to four months in prison for accessing the medical records of his coworkers and various celebrities. He had no “valid” reason for accessing these records.

According to the Health and Human Services (HHS), penalties have increased. Prior to the HITECH Act, the HHS Secretary could not impose a penalty of more than $100 for each violation or $25,000 for all identical violations of the same provision. Section 13410(d) of the HITECH Act strengthened the civil money penalty scheme by establishing tiered ranges of increasing penalty amounts, with a maximum penalty of $1.5 million for all violations of an identical provision.

Just how "high tech" are physicians when it comes to communicating with patients?

A survey by the health information firm Manhattan Research in 2009 found that 42 percent of physicians had some online communication with patients.

The American Academy of Family Physicians reported in a 2009 survey that just 6 percent of responding members had performed a Web-based consultation - that number was more than double the 2.6 percent who had done so in 2008.

But is all of this electronic communication legal?

The HITECH Act requires that all communications involving ePHI be encrypted.  HHS recently adopted National Institute of Standards and Technology guidelines for encryption.  This means that if a physician wants to consult, refer, or prescribe for a patient by e-mail, the e-mail had better be encrypted.  Of course most patients do not have software to decrypt.  So what alternatives do healthcare providers have? And, more importantly, how can this be made easy and pragmatic. Email was designed to simplify, not complicate.

Healthcare providers may seek their patient's consent to communicating via unencrypted e-mail.  While HHS does not provide a standard form for securing patient consent, basic "informed consent" strategies should apply.  First, get the patient's consent in writing.  The patient should not be given just a binary choice – but a menu of choices.  For example, a patient may wish to electronically receive information on appointment dates but not test results.  The consent document – as is standard with most routine HIPAA forms -should also note that the patient may withdraw his or her consent at a later time. This can be part of an expanded HIPAA form the patient signs when first seeing you in the office.

Here are some more recommendations when communicating with patients electronically:

1) A physician may be held responsible for a delay when responding to a patient's e-mail. Solution: A physician that wishes to accept e-mail from patients should use an auto response feature that informs the patient that a) the physician typically responds to e-mail within XXX number of hours/days; b) if the patient requires immediate attention, the patient should telephone the physician's office or contact an emergency healthcare provider.  

2) If a patient initiates an e-mail with a physician, Rachel Seeger of HHS Office for Civil Rights says that it is assumed that the patient consents to unencrypted communication.  "If this situation occurs, the healthcare provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual”.

3) If a physician does end up sending a patient an e-mail, double check the recipients’ e-mail address before clicking the send button. This is to prevent the e-mail from being sent to the wrong person, therefore sharing private information to an unintended party. Good advice also in the non-healthcare world.

4) Add any e-mail a patient sends (and any response) to the patient's chart.

5) In the HITECH Act code 170.210 section B states that the date, time, patient identification and user identification must be recorded when electronic health information is created, modified, deleted, or printed; and an indication of which actions occurred must also be recorded. This means if you send an email to a patient with protected health information – and delete it – you will need a record of what was deleted and when. This is not dissimilar to crossing out a line in a paper medical record- updating the record – with a date of the update.

6) Since communicating with patients via e-mail is becoming stricter, more physician offices and hospitals are using portals as a means of communication. This allows the patient to sign in with a secure username and password to view their records and communicate with their physicians. The security rule allows for Electronic Protected Heath Information (e-PHI) to be sent over an electronics open network, as long as it is adequately protected.  Of course, this is more complicated than using Outlook or gmail.

The HITECH Act has ushered in a new era of technology requirements and standards that must be met by physicians.  Given HHS's recent enforcement efforts, physicians should use caution when electronically communicating with patients.  By working within the boundaries of the six points above, physicians should comply with the HITECH Act. 

Jeffrey Segal MD JD and Michael J. Sacopulos JD are with Medical Justice, a Medical Spa MD Select Partner that protects physicians from frivilous lawsuits.

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Treating Non-English Speaking Medical Spa Patients

By Jeffrey Segal MD JD and Mike Sacopulos, JD

According to the 2000 U.S. Census 18% of people living in the U.S. spoke a language other than English in their home.

Jump ahead 11 years and that number continues to grow. We are asked to press one for English and have the option of reading everything from a manual to a menu in Spanish. 

Of the more than 18% who don’t speak English as their first language, most, if not all, will see a physician here in the U.S. at some point. The physician they choose may not speak their native tongue.

 Title VI of the Civil Rights Act prohibits discrimination based on race, color, or national origin. The Act goes even further in protecting against discrimination of those with limited English proficiency -also known as “LEP”.

 Health care providers receiving Federal financial funds are mandated by law to take adequate steps ensuring those who can’t speak English are provided with the necessary tools to clearly communicate with their physician. Physicians who are unsure whether they receive financial assistance from the government should think twice. Physicians who receive reimbursement from Medicaid or Medicare are recipients of Federal financial assistance, and, thus must comply with Title VI requirements for language assistance.

The challenge goes beyond compliance with government rules.  Failure to comply can also result in civil liability claims.  The type of language assistance that must be provided to LEP patients depends on a variety of factors including:

•        The size of the medical practice
•        The size of the LEP population
•        The nature of the service
•        The total resources available to the medical practice
•        The frequency with which particular languages are encountered 

If the Office Civil Rights (“OCR”) gets a complaint about a noncompliant physician’s office, they will inform the practice in writing of its findings and identify the steps that must be taken to become compliant. If the practice chooses to ignore the OCR’s helpful hints,  the OCR is empowered to terminate any Federal funding (after an administrative hearing).

A practice’s responsibility

• Contact the Department of Justice (“DOJ”) to get the information they provide to health care providers on compliance with the American with Disabilities Act

• Decide what foreign language assistance is most needed in the area

• Find out what LEP services are already available in your area examples: hospital, community center, schools and the library.

• Develop a written policy for your practice to ensure effective communication with the LEP population. The policy must be in compliance with federal laws and regulations. The plan should also include a list of qualified individuals who have the medical terminology to satisfy your requirements. A physician’s position in a lawsuit will be enhanced if they have relied on the interpretation of a qualified individual.

• Educate the staff on LEP requirements and practice policies.

• Schedule extra time with an LEP patient to ensure translation was as complete and accurate as possible

How should physician offices handle telephone calls to and from LEP patients? 

•  Determine how your staff is handling calls from LEP patients and develop procedures to help them respond to patient communication needs.
•  If possible, telephone calls from LEP patients should be answered by bilingual office staff or onsite interpreters. 
•  If possible alternatives include enabling staff members to activate three-way calling with a telephonic interpreter or to transfer calls to someone at the office who speaks the relevant language. 
• Answering machine messages should be provided in more than one language (with prompts) if there are a significant number of LEP patients in the practice who speak one or more non-English languages.
•  In the case of a high volume of diverse LEP patients, telephones can be programmed to rollover directly to a phone line with telephonic interpretation services. 
•  If using an answering service, consider contracting with one whose language capacity mirrors that of your practice.

While coming into compliance may seem like a daunting task, it pales in comparison to what will happen if your case is tried in a court of law.  Language does not seem to be a barrier when non-English speaking individuals hires an attorney – to go after you.  A thoughtful compliance plan can save much grief for both physician and patient.

About: Jeffrey Segal, MD, JD, is founder and CEO of Medical Justice Services, A Medical Spa MD Select Partner.  Mike Sacopulos, JD, is general counsel for the organization.

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As A Physician, You Need to Understand Your Online Reputation

By Jeffrey Segal, MD, JD & Michael J. Sacopulos, JD

The observation that social media is experiencing explosive growth is hardly novel. Moreover, social media is significantly influencing the medical profession. 

Free Webinar: "How To Control & OWN Your Professional Reputation Online!"

CNN Money.com reported that Facebook passed the milestone of half a billion signed on users half a year into 2010.  The professional and legal ramifications from the rapid growth of social media touch almost every aspect of physicians practicing today.  One of the most challenging of these ramifications is a physician’s online reputation.

Pew Internet and American Life Project recently released numbers that document just how important the source of information regarding medicine and physicians the internet has become.  Sixty-one percent (61%) of American adults look on-line for health information. Forty-nine percent (49%) of Internet users report researching a specific disease or medical problem on the Internet.  Forty-seven percent (47%) report seeking information about their physician or other healthcare professionals from on-line sources. 

Finally, five percent (5%) of “E-Patients” have posted a review online of a doctor. It is these very reviews from a small subset which form the basis of a physician’s reputation on-line.

Most physicians equate a tainted online reputation with a direct loss of business.  The analysis is simple; the worse the online reputation, the fewer the patients.  There are certainly many examples to support this reasoning. 

Dr. Linda Morrison, a physician practicing in Indiana, experienced first hand the harm that arises from an online reputational attack.  In July of 2000, Dr. Morrison noticed that an anonymous individual was posting defamatory statements about her via the internet.  Dr. Morrison received e-mails from this individual under a pseudonym “Surfycity45” that, among other things, made threats against her medical license.  The attacks continued into the fall of 2000.  Dr. Morrison ultimately learned that “Surfycity45” had been circulating defamatory comments about her while simultaneously encouraging others to do the same.  “Surfycity45” worked hard to organize a cyber mob with Dr. Morrison as its target.  

Dr. Morrison, via counsel, attempted to enjoin Defendant American Online, Inc. from the continued posting of the defamatory statements about her by the anonymous subscriber.  For a variety of legal reasons, the United States Northern District Court of Indiana ruled against the injunction.  Although Dr. Morrison alleged that “Surfycity45” statements were false, defamatory, and had resulted in damage to her professional reputation as a physician, she was unable to have these remarks removed from the Internet in a timely fashion.The damage was done.  

The implications of a physician's online reputation now extends beyond patients.  At least twenty seven (27) states have a recognized cause of action for negligently credentialing a physician.  Given this liability, credentialing committees will likely perform detailed background checks using all available search tools, including social network sites.

It is not just patients and credentialing committees which are scrutinizing physicians’ online reputations.  In any  medical malpractice action, physicians should assume that the plaintiff’s attorney will checking the doctor’s online reputation.  Geoffrey Vance, a thirty eight (38) year old partner at McDermott, Will and Emry, makes use of social networking sites to gather facts about the opposing side for trials.  “I make it a practice to use as many sources as I can to come up with and to find information about the other side” Vance said.  “We used to run Lexus Nexus; we still do that.  We always look at cases, and now we use the internet – Google, and social networking sites.”

Mr. Vance is not alone.  Paul Kiesel, a lawyer in Los Angeles County, admits to using social media not only to investigate the opposing side, but also to help select jurors.  “Last month I had fifty (50) jurors, and as the Court Clerk read out the names, I had two (2) people in the courtroom and the third person back at the office, with all three (3) of them doing research.”

Lawyers are not the only actors in a courtroom who are using social media at trial.  Courts across the country are grappling with the serious problem of “Internet-tainted” jurors.  In case after case, judges and lawyers have discovered that jurors are doing independent research via cell phone during trials.  Last year in Arkansas, a state court judge allowed a 12.6 million dollar verdict to stand even though a juror sent eight (8) messages via Twitter from his cell phone.

Physicians’ online reputations are being examined with increasing frequency at crucial moments in their professional career.  It is no longer  prudent for a physician to fail to monitor his or her online reputation.  “Physicians should carefully monitor their online reputation.  I have seen examples of ex-spouses, past employees, and competitors all posing as disgruntled patients in an online effort to damage a physician’s reputation.  This is a real threat that is not going away,” says Rivera.

Whether physicians work through organizations such as Medical Justice or Search Engine Optimization companies or go it alone, they need to guard their online reputations.  In the words of Benjamin Franklin “It takes many good deeds to build a good reputation, and only one bad one to lose it.”

About: Jeffrey Segal, MD, JD, a neurosurgeon, is the founder and CEO of Medical Justice Services. 

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When Clients Demand a Refund: Free Webinar

Our friends over at Healthy Aging Magazine are hosting a free medical webinar that should be of great interest to our members.

What happens when a patient is not happy with service or the result and demands a refund? ADVANCE for Healthy Aging, a trade magazine for cosmetic medicine professionals, will be offering a medical webinar, called “Doctor, I want my money back.”

• This free webinar takes place Wednesday, Jan. 19, 2011, 8:00-9:00 p.m. EST, with presenters Jeffrey Segal, MD, board certified neurosurgeon and CEO of Medical Justice; and  Michael J. Sacopulos, partner with Sacopulos, Johnson & Sacupulos of Terre Haute, Ind. The Webinar will address how doctors can level the playing field; and when refunding makes sense and doesn’t. In addition, these presented will also discuss what to do with negative online reviews—that often come as a result of disgruntled patients.

Use the link below to register:

https://www1.gotomeeting.com/register/590756176

Requred Disclosures For Physicians & Medical Spas

By Arlen Meyers MD MBA

When it comes to working with industry, keep your karma clean.

Working with industry comes with strings. The Patient Protection and Affordable Care Act, signed into law on March 23, 2010,  includes a number of provisions including a requirement that all pharmaceutical and medical device manufacturers publicly post on a website all payments or transfers of value from the manufacturer to a health care professional or institute. Some companies, like Allergan, have taken it a step further and entered into a Corporate Integrity Agreement with the feds. (http://www.allergan.com)

The present oversight environment demands that you disclose and make transparent your interactions with industry and any financial interests that result from that interaction. Here are some things to do to be sure you don't get caught with your stock options down.

Keep score

Be sure to keep an updated inventory of your consulting engagments, contracts and activities and  how you were compensated in cash, stock or some other financial instrument

Disclose

If you are an employee of an organization, like a univeristy of hospital chain, it is likely that you will get  a friendly (hopefully) reminder from your compliance officer to submit your conflict of interest statement. They will review it and get back to you if they see problems.

Don't study or use what you own

Big ticket conflicts make headlines. If you are being paid as a consultant to an orthopedic company and use lots of their products, beware. If you give lectures on depression to docs who like to eat expensive steaks and drink top shelf wines for free, and, you are the biggest prescriber of antidressants in your galaxy, that will raise a red flag.

Disclose your activity to peers and others

When you publish something or give a talk, disclose your interests. If you participate in medical legal activities, like expert witness participation, understand that your commercial interests will come under the magnifying glass of opposing counsel. Likewise, if you agree to work with one company, you will usually be asked to sign something saying that you will not work with another company where there might be a conflict.

When working with industry, it's best be safe than sorry. Doctors hate to flunk tests. The worst one to flunk is the New York Times test.

Arlen Meyers MD MBA is the cofounder, and Chief Medical Officer of MedVoy, a medical tourism company. He is also a Professor of Otolaryngology, Dentistry and Engineering at the University of Colorado at Denver and CEO and President of the Society of Physician Entrepreneurs. He blogs at Freelance MD

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Physicians' Need to Understand & Influence Their Online Reputation

Here's some very good advice from one of our Select Partners, Medical Justice.  

The observation that social media is experiencing explosive growth is hardly novel. Moreover, social media is significantly influencing the medical profession.  CNN Money.com reported that Facebook passed the milestone of half a billion signed on users half a year into 2010.  The professional and legal ramifications from the rapid growth of social media touch almost every aspect of physicians practicing today.  One of the most challenging of these ramifications is a physician’s online reputation.

Pew Internet and American Life Project recently released numbers that document just how important of the source of information regarding medicine and physicians the internet has become.  Sixty-one percent (61%) of American adults look on-line for health information. Forty-nine percent (49%) of Internet users report researching a specific disease or medical problem on the Internet.  Forty-seven percent (47%) report seeking information about their physician or other healthcare professionals from on-line sources.

Finally, five percent (5%) of “E-Patients” have posted a review online of a doctor. It is these very reviews from a small subset which form the basis of a physician’s reputation on-line.

Reputations are forged when people make judgments upon the mosaic of information available about us.”  Viewed in this light, ratings, blog postings, and web pages are the pieces of the reputation mosaic.  Unfortunately, all it takes is one or two bad pieces for the mosaic to be marred.  The implications of a damaged online reputation are extensive."

Most physicians equate a tainted online reputation with a direct loss of business.  The analysis is simple; the worse the online reputation, the fewer the patients.  There are certainly many examples to support this reasoning. 

Dr. Linda Morrison, a physician practicing in Indiana, experienced first hand the harm that arises from an online reputational attack.  In July of 2000, Dr. Morrison noticed that an anonymous individual was posting defamatory statements about her via the internet.  Dr. Morrison received e-mails from this individual under a pseudonym “Surfycity45” that, among other things, made threats against her medical license.  The attacks continued into the fall of 2000.  Dr. Morrison ultimately learned that “Surfycity45” had been circulating defamatory comments about her while simultaneously encouraging others to do the same.  “Surfycity45” worked hard to organize a cyber mob with Dr. Morrison as its target.  

Dr. Morrison, via counsel, attempted to enjoin Defendant American Online, Inc. from the continued posting of the defamatory statements about her by the anonymous subscriber.  For a variety of legal reasons, the United States Northern District Court of Indiana ruled against the injunction.  Although Dr. Morrison alleged that “Surfycity45” statements were false, defamatory, and had resulted in damage to her professional reputation as a physician, she was unable to have these remarks removed from the Internet in a timely fashion.  The damage was done.

The implications of a physician's online reputation now extends beyond patients.  At least twenty seven (27) states have a recognized cause of action for negligently credentialing a physician.  Given this liability, credentialing committees will likely perform detailed background checks using all available search tools, including social network sites.

Health institutions making credentialing or hiring decisions currently face a dilemma when it comes to information about physicians contained in social network profiles.  Although there may be some risks in searching against them (as discussed in the next section), the potential liability for making a panel decision in the absence of such information likely tips the balance."

It is not just patients and credentialing committees which are scrutinizing physicians’ online reputations.  In any  medical malpractice action, physicians should assume that the plaintiff’s attorney will checking the doctor’s online reputation.  Geoffrey Vance, a thirty eight (38) year old partner at McDermott, Will and Emry, makes use of social networking sites to gather facts about the opposing side for trials.  “I make it a practice to use as many sources as I can to come up with and to find information about the other side” Vance said.  “We used to run Lexus Nexus; we still do that.  We always look at cases, and now we use the internet – Google, and social networking sites.”

Mr. Vance is not alone.  Paul Kiesel, a lawyer in Los Angeles County, admits to using social media not only to investigate the opposing side, but also to help select jurors.  “Last month I had fifty (50) jurors, and as the Court Clerk read out the names, I had two (2) people in the courtroom and the third person back at the office, with all three (3) of them doing research.”

Lawyers are not the only actors in a courtroom who are using social media at trial.  Courts across the country are grappling with the serious problem of “Internet-tainted” jurors.  In case after case, judges and lawyers have discovered that jurors are doing independent research via cell phone during trials.  Last year in Arkansas, a state court judge allowed a 12.6 million dollar verdict to stand even though a juror sent eight (8) messages via Twitter from his cell phone.

 In another case, a juror decided to seek the wisdom of the masses by holding a Facebook online poll. “I don’t know which way to go, so I’m holding a poll, wrote the democratic juror.”  Upon learning of this misadventure, the juror was dismissed and the case proceeded.

Physicians’ online reputations are being examined with increasing frequency at crucial moments in their professional career.  It is no longer  prudent for a physician to fail to monitor his or her online reputation.  “Physicians should carefully monitor their online reputation.  I have seen examples of ex-spouses, past employees, and competitors all posing as disgruntled patients in an online effort to damage a physician’s reputation.  This is a real threat that is not going away,” says Rivera.

In the words of Benjamin Franklin “It takes many good deeds to build a good reputation, and only one bad one to lose it.”

Resource: Physicians + Facebook Marketing - How to do it correctly!

Guest post by Joy Tu of Medical Justice.

Submit a guest post and be heard.

Allergan Shifting Headache Sales Reps to Botox

Allergan sales forces previously working on GlaxoSmithKline headache drugs Imitrex and Amerge as part of a co-promotion will be reassigned to Botox, in support of the drug's new headache indication.

The move,  confirmed by a company spokesperson,  gives Allergan a jump start with headache specialists, since the GSK co-promotion deal was “a very good way for Allergan to learn the headache market,” Allergan CEO David Pyott told the Journal. Crystal Muilenburg, a spokesperson for Allergan, says that sales forces will initially target neurologists, pain, and headache specialists, to train them on Botox's “injection protocol and dosing regimen.” Muilenburg declined to estimate the number of reps that will support the headache indication, which received an FDA green light on October 15. GSK drugs Imitrex and Amerge have lost patent protection.

A key challenge that we started addressing immediately upon FDA approval is reimbursement,” said Muilenburg. “As with many new drugs, reimbursement is not widely established for Botox in this new therapeutic category.”

Physicians or patients looking for information on reimbursement can visit a dedicated website, call 1-800-44-BOTOX (option 4), or locate a Botox reimbursement business manager for “on-site education, training, and support,” according to the website. Physicians can also sign up to receive forthcoming treatment records and case studies on the headache indication, as they become available.

Allergan paid $600 million to settle Justice Department charges of off-label marketing in September, and pled guilty to marketing Botox off-label for conditions including headache. As part of the settlement, Allergan was forced to drop a First Amendment lawsuit challenging FDA policy on the exchange of “truthful scientific and medical information,” a spokesperson reported at the time. The pending approval in September of Botox for an ailment that previously existed as an off-label use sparked rumors about a relationship between Allergan's lawsuit and FDA's approval of the headache indication, rumors which Muilenburg quelled: “The FDA granted approval of Botox for the treatment of chronic migraine patients based on two phase III pivotal trials, and on its own merit,” she said. “The two actions are completely separate matters.”

Botox's headache indication, specifically, is for the prophylaxis of headaches in adult patients with chronic migraines. GCI Health has been awarded the PR account for the indication. Muilenburg declined to reveal other agency partners for the headache indication launch.

Injecting Botox As A 'Medical Esthetician'

It seems that there are medical spas that are having non-medical staff performing medical treatments... In this case, Botox injections.

Here's a comment that someone posted on the comment thread from the post: Medical Assistants Can Not Inject Botox.

As a medical aesthetician I have injected under a physician's supervision for nearly eight years. That is the concept of a med spa? Medical Aesthetic procedures delivered under a physician's supervision. I have more often seen patients injured by laser treatments. In fact, in a decade of working in spas that offered Botox, I've never seen serious side effect. I've seen one temporarily droopy brow, once, injected by a "diamond" injector physician.
AestheticInjector

@Aesthetic Injector
You may have been doing this. Your supervising physician may know that you're doing this... but this is not legal in the US.

First: There is no such licensee as a 'Medical Aesthetician'. If you're an esthetician working in a medical spa, you're an esthetician working in a medical spa. You have no expanded scope of practice or licensure about what medical treatments you can perform. Your esthetican license allows you to perform certain treatments... none of which allow you to break the dermis. You have no licensure that allows you  to perform injections. In this case there is no difference between an esthetician and the front desk staff (or anyone off the street).

Second; you equate what you're doing directly with a physician. In this you're correct. You are indeed performing medicine.

However, your supervising physician can not extend his or her license to allow you to perform Botox injections. It does not matter if the physician knows about it. It does not matter if the physician trained you to do it. It does not matter if the physician tells you to do it. The fact that it's relatively easy and that you've been doing it (even successfully) is irrelevent. Your physician can not 'expand' the treatments that you're licensed to perform. Injecting Botox is not one of them. There is no legal difference between what you're doing inside of this 'medical spa' and what you would be doing if you were injecting Botox in a motel room somewhere, other than the physician that's allowing you to do this is on the chopping block too.

Third; If you have any issue at all, you are not going to be covered by any malpractice carrier. You (and your supervising physician) are performing entirely without any net or recourse. Your supervising physician is probably in deeper water since his or her medical license is also at risk.

You mention that you've seen 'diamond' injectors who's Botox treatments have resulted in drooping around the eye. This is a known potential complication with Botox. So, if a diamond level physician who's squirting Botox day and night can have a complication, what are the odd that you could run into any sort of complication?

If you ever perform a treatment with a negative outcome that results in any investigation, you'll be found to be performing medicine without a license, without malpractice coverage, and without a chance of any good outcome.

So, what's going to happen?

Truthfully, I don't know, but here's a probable outcome based on experience.

Something is going to go wrong; you're going to have a complication, a patient is going to be unhappy, a staff member is going to be fired but has a grudge... something will happen. It always does at some point. It may even be unrelated.

Someone is going to point out that this clinic is operating outside of both legal and ethical guidelines, and then it's going to get ugly. If it involves a patient or civil suit it's going to be even uglier. These things have a way of cascading out of control.

If you disagree, I'd truly love to hear your arguments.

Anyone else want to weigh in on this?