California Registered Nurse Who Ordered Botox From Canadian Company Via Internet for Medical Spa Pleads Guilty to Federal Charge of Receipt and Delivery of a Misbranded Drug

One important issue for all medical providers is to understand where FDA medications and injectables come from. Ordering on the Internet or from unauthorized distributers can create serious legal issues, including criminal charges, license discipline and in cases where insurance or Medicare/Medi-Cal (Medicaid) has been billed there will be demands for overpayment and allegations of fraudulent billing.

A registered nurse who owned and operated a day spa in Laguna Niguel, California has learned this lesson the hard way. This month she agreed to plead guilty to a federal charge related to the illegal distribution of Botox that was not approved for use in the United States.  

Bridget “Gigi” Goddard, who allegedly owned Pure Indulgence Skin Rejuvenation in Laguna Niguel, has agreed to plead guilty to one count of receipt and delivery of a misbranded drug, a crime that carries a statutory maximum penalty of three years in federal prison. It would be highly unlikely she would receive the maximum but it is a felony and will likely have license repurcussions.

Lesson of the Case. The issue is often whether there is criminal intent and there have been thousands of physicians purchasing. How is that shown? One way is whether the individual received a letter from FDA about it and continued to order from other countries.  FDA has been transparent about notifying medical providers about illegal use of Botox and other medications from outside the U.S. On the FDA website there's a list of medical providers who were notified from 2013 to the present and there's a list of "repeat offenders." Ms. Goddard unfortunately was one of those listed as having been notified in 2013 and apparently still used product from outside the U.S. The undercover agent was key in her case. 

Government Has List of Providers Who Bought From SB Medical, Inc., TC Medical and Gallant Pharmaceutical. This case comes out of a larger federal case against SB Medical that was filed in Alexandria, Virginia against SB Medical, Inc. and its principals. In that case, the company plead guilty and was ordered to pay a $45 million fine and to forfeit $30 million for smuggle misbranded pharmaceuticals into the United States. The government sent letters to medical clinics and medical spas who had bought Botox and other injectables from SB Medical, Inc. and other companies under investigation and then followed up with them. Other entities that were also prosecuted include Gallant Pharmaceutical. 

Allegations Against Ms. Goddard. The government alleged that the Botox that Ms. Goddard purchased had been manufactured for distribution in foreign nations such as Turkey and was not approved by the FDA for distribution in the United States. All Botox products approved for distribution in the United States by the United States Food and Drug Administration are manufactured by Allergan and must be administered under the supervision of a licensed physician. 

Ms. Goddard admitted in her plea agreement that, over the course of several years, she ordered Botox over the internet from Canadian companies that sold unapproved drugs to customers in the United States. In April 2016, the government send an undercover FDA agent to Pure Indulgence which compounded Ms. Goddard's legal issues.  The government alleges that at this undercover visit, Ms. Goddard told the undercover agent that the undercover agent did not need to be examined by a physician before the Botox injections were administered, and she knowingly misled the agent as to whether the Botox was approved for use in the United States.

Ms. Goddard is scheduled to make her first appearance in this case in United States District Court in Santa Ana on December 12. The investigation into Goddard was conducted by FDA’s Office of Criminal Investigation. The case is being prosecuted by Assistant United States Attorney Scott D. Tenley of the Santa Ana branch office.

Attorney Commentary. The high price of Botox and other injectibles have caused entrepreneurs to buy overseas and sell in the U.S. in person or through the Internet. The salespersons represent that the product is the "same" but often that is not the case. In addition, even if the product were Allergan from overseas - if the drugs are not distributed by Allergan and sold in the U.S., it is illegal to import the products from outside the U.S. One of the reasons is that there are counterfeiters who repackage, are not using real product, and the chain of custody is not guaranteed. In addition, there is product liability insurance in the U.S. that is not available for products purchased from outside the U.S. 

While the pricing structure of pharmaceuticals and medical devices may not seem fair, it is the law and medical providers must be careful and instruct office managers and nurses to order from the manufacturer or authorized distributors. If there is an investigation or visit by an FDA agent, it is important to not handle this alone and seek experience counsel since mistakes during an interview can have serious repurcussions.

How do you prevent an FDA investigation from turning into a criminal case? The government looks for criminal intent. The FDA had been heavy handed in some cases and was even named the Botox Police. Allergan had its own financial interest in pursuing charges. 

Tips. First, if there is an interview request -- and trust me, the agents do not call for an appointment and simply show up in pairs -- be polite and ask for time to have an attorney present and so you can gather all your records and prepare for an interview (or decide not to be interviewed depending on the facts). 

Second, do not lie. Do not fabricate records. Do not ask anyone else to lie or fabricate an invoice. This is what the government loves - when someone panics and acts like a foolish teenager and lies without thinking - since it shows "criminal intent." 

Third, do not minimize the importance of these investigations and attempt to handle it on your own. When you are stressed, part of your brain shuts down and at the time of the interview, the FDA or other goverment agency knows a lot more facts than you.

Finally, each case is different and there could be an additional 10 tips but it will be case specific. Even chain pharmacies have counterfeit and fake drugs and over the counter medications. Counterfeiting is a huge business. Be smart and breathe, take your time to get experienced representation and prepare for an interview like you would anything else.

Posted by Tracy Green, Esq.

Green and Associates, Attorneys at Law
Email:  tgreen@greenassoc.com
Office: 213-233-2261

California Medical Board Can Subpoena Medical Records From Physicians Even If Patients Object to Production

A recent opinion by the Court of Appeals is an administrative subpoena case that gives additional guidance to doctors and other professionals who have their records subpoened even when the patients or clients object to the production of records. The case is David Fett, MD v. Medical Board of California, No. B262469.

We often see cases where the Medical Board approaches patients and asks them to sign consent forms for records release while telling them at the same time that if they refuse to sign, they will simply subpoena the records. We have also had cases where the "patients" were undercover officers and the records release was simply a way to build a case against the physician.

Our experience has been that the Superior Courts will enforce the subpoenas even against the objection of the patient or where there is a criminal investigation.  This Court of Appeal case confirms that at this time, the courts will not allow patients to prevent the production of their personal medical records where the Medical Board can show good cause.

Pain Management Physicians' Treatment Plans And Records Are Being Reviewed With Great Scrutiny - How To Respond To Request For Records and Interview

Board certified pain management physicians are beginning to have records requested from the California Medical Board with greater frequency. In many cases, the Medical Board has requested them due to complaints from family members or pharmacists. 

It is critical to be prepared and handle any requests for records or interviews with great care and seek expert attorney and expert witness review at the earliest time. 

It is also important to review your office's systems and documentation standards now before any records are requested. Remember, if any complaint is made it is highly likely that records will be requested and patient charts are not usually perfectly documented and the standards 

What You Can Learn From One Pain Management Physician's Medical Board Case. 

Here is a sample case of a pain management physician that ended up in a Medical Board Accusation being filed against him for unprofessional conduct, gross negligence, repeated negligence, and excessively prescribing to a patient without a proper medical indication in violation of California Business and Profession Code Section 725, 2234(b)(c) or (d), and 2242(a) relating to several patients.  This was a highly trained and regarded physician in the field of pain management.

How did this case end up as an Accusation and what can you do to avoid a similar situation? 

1.  Documentation Issues - Especially With Long Term Patients. The pain management physician had treated each of the patients for over ten (10) years and as trust and time goes on, the documentation is not always as thorough as it is for short-term patients. Document the rationale for decreasing or increasing dosages or changing medications even if it is brief. Document the treatment plan with the objective for caring for the patient, treating the underlying condition causing the pain, and addressing the pain.

JOHN HOPKINS' RESEARCH SHOWS MANY PRIMARY CARE PHYSICIANS DO NOT UNDERSTAND BASIC FACTS ABOUT HOW PEOPLE MAY ABUSE DRUGS OR HOW ADDICTIVE MEDICATIONS MAY BE

Many primary care physicians – the top prescribers of prescription pain pills in the United States – don’t understand basic facts about how people may abuse the drugs or how addictive different formulations of the medications can be, new Johns Hopkins Bloomberg School of Public Health research suggests.

This lack of understanding may be contributing to the ongoing epidemic of prescription opioid abuse and addiction in the U.S.

Since Vicodin was the largest prescribed drug in the United States last year, primary care physicians need to rethink their views on these issues. All it takes is one patient who may suffer from undiagnosed depression or have a hidden addiction issue to change that physicians' professional and personaL life. That includes civil lawsuit, Medical Board problems, and even potential criminal exposure.

Reporting online June 23 in the Clinical Journal of Pain, the researchers found that nearly half of the internists, family physicians and general practitioners surveyed incorrectly thought that abuse-deterrent pills – such as those formulated with physical barriers to prevent their being crushed and snorted or injected – were actually less addictive than their standard counterparts. In fact, the pills are equally addictive.

“Physicians and patients may mistakenly view these medicines as safe in one form and dangerous in another, but these products are addictive no matter how you take them,” says study leader G. Caleb Alexander, MD, MS, an associate professor in the Bloomberg School’s Department of Epidemiology and co-director of the school’s Center for Drug Safety and Effectiveness. “If doctors and patients fail to understand this, they may believe opioids are safer than is actually the case and prescribe them more readily than they should.”

He adds: “Opioids serve an important role in the treatment of some patients. However, our findings highlight the importance of patient and provider education regarding what abuse-deterrent products can and cannot do. When it comes to the opioid epidemic, we must be cautious about overreliance on technological fixes for what is first and foremost a problem of overprescribing.”

Another finding from the new research: One-third of the doctors erroneously said they believed that most prescription drug abuse is by means other than swallowing the pills as intended. Numerous studies have shown that the most common route by which drugs of abuse are administered is ingestion, followed by snorting and injection, with the percentage of those ingesting the drugs ranging from 64 percent to 97 percent, depending on the population studied. Certain medications are more likely than others to be snorted or injected.

Prescription drug abuse is the nation’s fastest growing drug problem, according to a report released by the White House in 2011. According to the U.S. Centers for Disease Control and Prevention, prescription drug overdose death rates in the United States have more than tripled since 1990 and have never been higher. The clinical use of prescription opioids nearly doubled between 2000 and 2010. By 2009, prescription drugs surpassed motor vehicle crashes as a leading cause of unintentional death, with more people dying from prescription opioids than cocaine and heroin combined.

“Doctors continue to overestimate the effectiveness of prescription pain medications and underestimate their risks, and that’s why we are facing such a public health crisis,” Alexander says.

For the study, Alexander and his colleagues conducted a nationally representative survey of 1,000 primary care physicians between February and May 2014 examining their knowledge, attitudes and beliefs regarding prescription drug abuse. 

They focused not only on opioid abuse and diversion (the use of prescription drugs for recreational purposes), but also their support for clinical and regulatory interventions that may reduce opioid-related injuries and deaths.

The researchers found that all respondents believed that prescription drug abuse was at least a small problem in their communities, with more than half reporting it was a “big problem.” While there was disconnect in physicians’ understanding of some elements of abuse and addiction, the researchers found large support for a variety of measures that could reduce prescription opioid abuse.

Nearly nine out of 10 physicians said they “strongly supported” requiring patients to get opioids from a single prescriber and/or pharmacy, something that would cut down on the number of patients who go from doctor to doctor to get more pain pills than one doctor would prescribe.

Two-thirds of doctors strongly supported the use of patient contracts, where patients agree to properly use their pain medication and not give or sell it to others. 

More than one-half strongly supported the use of urine testing for chronic opioid users to make sure patients are taking their medication and not diverting it and are not taking drugs they are not prescribed.

Alexander says he is heartened by the numbers, but believes some physicians may be overstating their support for such measures, as they would be time-consuming to implement and, in the case of urine testing, are already recommended by some guidelines yet typically underused.

“Despite the high levels of support, there are many barriers to implementation and there may be reluctance to translate these changes into real-world practice,” he says. “But for the sake of making a dent in an epidemic of injuries and deaths, we have to find ways to make changes. Too many lives are at stake to stick with the status quo."

Attorney Commentary: Compliance, training and new procedures are key. The world of prescribing has changed. Have someone outside your practice evaluate your prescribing, documentation and efforts to confirm prior diagnoses, prior prescriptions to patients, screen for drug abuse and minimize risk. It is good for patients and for your own professional practice. This is healthy risk management. Have patient contracts and create new procedures for anyone receiving pain medications - even if just for a short term problem.

Posted by Tracy Green, Esq.

Green and Associates, Attorneys at Law

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Telemedicine (Telehealth) Rules Are Changing Slowly and Medical Boards and Payors Are Slowly Adapting. Be Careful to Follow State, Federal and Payor Rules

Today's New York Times has an article about telemedicine (we call it telehealth in California) entitled "Modern Doctors' House Calls: Skype Calls and Fast Diagnosis." It is a worthwhile read.

In my practice, I get calls from physicians and health care providers telling me that "telemedicine is now legal." This is especially common in aesthetic medicine (medical spas) in compliance with a physician or advanced practitioner visit before services are performed. While it is under certain circumstances, the efforts to make medicine like Uber or Lyft will face some challenges from medical boards, malpractice lawsuits, HIPAA compliance, prescribing issues, and insurance companies.

I have seen many physicians, health care providers and psychologists use Skype and FaceTime without researching their compliance and state rules. Remember, telemedicine (telehealth) is simply a valuable tool for providing health care services. 

It is as good as the policies and procedures followed. It is a valuable tool and can be very helpful to patients and practices. 

Here are things to think about if you are providing or plan to provide health care services via telemedicine (telehealth):

1.  If it is a new patient, you will be held to the standard of care for a physician having an in office visit. 

Physicians are held to the same standards and duties associated with practicing medicine regardless of whether they are practicing via telehealth or face-to-face, in-person visits. Your specialty will also come into play. Thus, if you are an internist or family practice physician, that is the standard. 

What if the patient has not had a physican in a certain number of years? How do you rule out other medical conditions?

How will you run labs (urine or blood) or perform other diagnostic studies? If the standard of care is that you take vital signs, how would that be accomplished?

2.  Prescribing is an issue. How will you prescribe for a new patient without a face to face visit? 

The prescribing laws in California for example are different than the telehealth laws and you must comply with them. For example, California requires that physicians perform a “physical exam” before prescribing drugs, and explicitly outlaws prescribing on “the internet” without a prior examination. Will your documentation meet this standard?

3.  Licensing. Most states require that you be licensed in their state. For example, physicians using telehealth technologies to provide care to patients located in California MUST be licensed in California. There are exceptions for consults but that requires that a physician request the consult and the other physician is simply using your review of the patient or medical records as a consultation.

4.  Informed consent. Physicians are held to the same responsibilities of providing informed consent. How will you obtain the written informed consent? How will that be in your file?

There are ways to handle this. The informed consent could be extremely useful to address some of the other issues raised here (the scope of the visit for example and a requirement that the patient go get a full physical and that you are not the primary care physician) but this needs to be thought out.

5.  HIPAA and State Privacy Laws. Physicians are held to the same responsibilities of ensuring the privacy of medical information. Skype and Facetime may not meet those requirements. They are not fully encrypted. There are services that are HIPAA compliant but Skype is not.

6.  Record keeping. Physicians are held to the same responsibilities of medical recordkeeping. 

7.  Malpractice and informed consent lawsuits and Board Complaints. I can imagine that in a couple of years we will see a lot of horror story lawsuits and Board complaints - probably many of them nuisance - simply because physicians and health care providers did not obtain written informed consents, did not follow HIPAA, did not keep good records and/or did not perform physicals or refer the patient for follow up.

8.  Medicare, Medi-Cal (Medicaid) and Private Insurance. Check with your biller on these issues. Medicare is not allowing billing for telemedicine and make sure your biller does not bill for phone or Skype visits or follow-up.

At present, the state laws are often limiting coverage to urgent care telemedicine.

For example, Washington is the 24th state to ensure reimbursement for some telemedicine services, does NOT cover virtual urgent care outside a medical facility.

It is the future but it will be carrier by carrier. UnitedHealthcare announced that by next year it would cover virtual urgent care visits for most of its 26 million commercial members by next year, citing the shortage of primary care doctors and the cost of less than $50 per virtual visit. Anthem will cover virtual urgent care visits for 16 million members in 11 states by the end of this year, and it expects the number to reach 20 million next year. 

Both insurers are relying on third-party telemedicine companies to provide the doctors and the technology platform for the service, just as most health systems do for now. Remember that these patients are already in the system where physicians have access to their records and they have a primary care physician. And the limit currently is for "urgent care." 

I believe that technology will vastly improve patients' lives and reduce the cost of health care. It will take time for us to adapt face-to-face to virtual examinations and get patients, providers, insurers, licensing boards, and malpractice standard of care all on the same page. If you are doing this, take the time to create policies and procedurers and run your plan by a health care lawyer. This is preventive medicine for your own practice.

For information or advice for your own practice, feel free to contact attorney Tracy Green at tgreen@greensasoc.com or 213-233-2260. Be careful out there.

How We Prepare For Your Administrative Hearing & 3 Basic Tips We Give Our Clients to Help Prepare for Hearings

Administrative and Board hearings are similar to trials, but some differences exist in procedure and practice. There is no jury and the administrative law judges (ALJ) must follow statutes, regulations, administrative procedure act (APA), constitutional requirements of due process and consider guidelines from the regulating agency. 

We encourage our clients to understand the administrative rules and procedures that will govern the conduct of the hearing since this is not simply making your "case" to the judge as if it were a jury that decides "guilty" or "not guilty." There are very different standards.

This is one of the reasons that individuals and businesses that represent themselves in pro per have a very difficult time and usually do not do well. Although the paperwork sent out by the agencies indicates that they can represent themselves it is almost universally a bad idea. At a minimum, if a client has financial restrictions and limitations, they should try to work out a payment plan with an attorney or at least pay for a consultation and find out what they need to do to prepare for their case at hearing or settlement.  

What else do you need to know if you are preparing for a State of California administrative hearing? Here are 3 things you need to know. There are many more levels but here are three basic things to know and consider:

First, you must know that if the ALJ reaches a decision that the board or bureau will not approve, that bureau or board does not have to adopt it. It is therefore important as an advocate to suggest a result and create a strong record that the board or bureau at issue will adopt. Otherwise, our client will have to start over again. 

Thus, if you have a recent felony conviction for fraud, the likelihood of going to a hearing and persuading an ALJ to dismiss the Accusation and impose no discipline would be difficult to achieve. But if it were achieved, it would be very unlikely that the board or bureau will adopt it unless the circumstances are so unusual and the record is well-established. Then you have to go through another hearing. In other words, trying a "Hail Mary" pass.

Second, we are creating a "record" with admissible evidence including administrative hearsay. We want a strong record for a couple of reasons: to have the ALJ adopt the findings we want and to have a record that will allow the board or bureau to adopt it. We push our clients to obtain evidence and expert testimony that they sometimes do not think is important but they do not understand that we want something other than their own testimony just in case the ALJ says our client is "not credible." Preparation is key. In most cases, witness testimony, without more, is not sufficient to prove your case. Exhibits, including documents and other forms of evidence such as expert witness reports, are often necessary.

This is where we seek to be creative when there are challenging facts or why we will seek to introduce a great deal of evidence in the record that can support our suggested level of discipline or findings of no discipline. This is also important for creating a record on appeal.  

Third, we help our clients know the ALJ. We gather information from other advocates about the particular practices of the hearing officer or administrative law judge if we have not previously appeared before him or her. We want to know the following:

How active a role does the ALJ or hearing officer play in taking testimony from witnesses? Some will ask questions or clean up weaknesses in the government's case. Some let you try your case.

How does the ALJ handle exhibits and administrative hearsay introduced by declaration? 

Does the ALJ or hearing officer apply any evidentiary rules? 

Is the hearing officer knowledgeable about the substantive law? 

What is the hearing officer’s attitude toward clients, witnesses, and advocates? 

Should you be prepared for anything unusual about the hearing officer’s conduct during hearings?

Make sure you practice good "Hearing Etiquette." Always arrive at the hearing on time or early. Be polite to the hearing officer and all of the parties. Comport yourself in a professional manner. No eye rolling, head shaking or displays of emotion when the judge or hearing officer is speaking or a witness is testifying. You want to show your professionalism and never compromise your credibility or that of your client by lowering your standards of professionalism or courtesy. And when we are acting professionally, understand that it will help you in the long run. Banging on the table or shouting is just for TV lawyers - an ALJ will stop listening. 

We make good records with witnesses, exhibits and persuasive testimony. We let the facts speak for themselves and that also creates good records on appeal.

For your case, you can call or schedule a complimentary 15 minute consultation. Call 213-233-2260 or email tgreen@greenassoc.com.

Posted by Tracy Green, Esq. 

San Diego Doctor Who Took Photos of Patients On Cell Phone Agrees to Interim Suspension Order Pending Accusation or Criminal Filing

A San Diego physician agreed to an interim suspension order by the California Medical Board as reported by the San Diego Tribune in its article that was effective October 31, 2014. The physician admitted that he took photos and videos of female patients using the camera on his smart phone. The patients were unclothed in some of the photos. In addition, the patients alleged inappropriate touching or photographing. This interim suspension order will require the Medical Board to file an Accusation within 30 days but it appears there is also a criminal investigation as well.

Any physician who takes photos of patients whether clothed or not should be careful to obtain proper consent forms, use a camera for office use only where the photos will be HIPAA compliant and that there is a medical reason for the photos or videos.

Posted by Tracy Green, Esq.

DEA and Medical Boards Target Weight Loss Clinics and Phentermine

We have seen more investigations of physicians or advanced practitioners (physician assistants and nurse practitioners) prescribing phentermine to patients.  Phentermine is a Schedule IV drug and we have seen increased scrutiny of weight loss clinics and investigations into the physicians, nurse practitioners, physician assistants and nurses who work at them.

The investigations include the following topics:

1.   The business structure of the weight loss clinics and whether management companies or non-physicians are involved in the business.

2.   Whether the physician established a bona-fide doctor-patient relationship before prescribing phentermine to patients.

3.   Whether the physician obtained a thorough history or complete a thorough physical examination prior to initiating treatment utilizing a Schedule IV controlled substance.

4.   Whether the physician continued prescribing phentermine to a patient who had failed to lose weight after taking the controlled substances over a period of thirty days.

5.   Whether the physician had initiated treatment utilizing a Schedule IV controlled substance without having performed a review of the patient's prior medical and weight-loss program records to determine that the patient had made a substantial good-faith effort to lose weight in a treatment program utilizing a regimen of weight reduction based on caloric restriction, nutritional counseling, behavior modification and exercise, without the utilization of controlled substances, and that said treatment had been ineffective.

6.   Whether physician had dispensed drugs having addiction-forming or addiction-sustaining liability otherwise than in the course of legitimate professional practice.

7.   Whether the physician had violated 21 C.F.R. Section 1306.04(a) which requires that a controlled-substance prescription "be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice."

8.   Whether the phentermine is being properly stored and dispensed under state and federal rules. Are the DEA logs maintained properly? Is the receptionist or a medical assistant improperly handing the phentermine to the patients? Is the phentermine properly labeled with instructions?

9.   Are referral fees given to patients for referring friends in violation of state anti-kickback and referral fee rules?

10.    Is the phentermine being given at a discount if private or government insurance is billed for other services?

We handled one case outside of California where law enforcement sent in a  confidential informant to gather information on the physician’s weight loss practice. The government informant was female, short and weighed over 210 pounds at the time of her initial visit to the practice and it was obvious that law enforcement chose her to participate in the investigation because she was not only obese, but had a number of other medical conditions as well.

In that case, the physician was investigated for prescribing phentermine (controlled substances) to the undercover without performing an adequate physical examination, properly documenting her medical history, recording adiposity measurements such as BMI or waist circumference, conducting any laboratory testing, or verifying that the undercover had made good faith efforts to lose weight without the aid of controlled substances. We helped obtain the dismissal of criminal charges but the DEA and Medical Board still pursued the physician.  

If you have medical weight loss as part of your practice, now is the time to get compliant with state and federal rules and regulations -- before there is an an investigation.  Have us or another experienced firm conduct an audit and make sure you comply before the Medical Board or DEA pays your office a visit or requests records from your office.  If there is an investigation, get counsel right away so you do not respond to records requests or interview requests without representation. 

Posted by Tracy Green, Esq.

Green and Associates, Attorneys at Law

213-233-2260

Email: tgreen@greenassoc.com

Investigations Continue Post-Arrest As Shown By Physician Arrested For Second Time While Charges Pending. Lesson: What Not To Do While On Bail

One of the terms and conditions of bail is "to obey all laws." Committing an offense while on bail is a separate offense and can result in loss of bail. We have had cases where a client committed a new offense while out on bail and it can complicate greatly the defense of a case.

Last week, Yahya Hedvat, a Los Angeles doctor awaiting trial for allegedly prescribing and selling narcotics without a legitimate reason, was arrested for selling hydrocodone to undercover agents. He was arraigned in Los Angeles County Superior Court and pleaded not guilty on August 19, 2014 to the charge in the second case of sale of a controlled substance. His bail was set at $1 million bail. It is also likely that a motion was filed to revoke or increase bail in his first case.

According to City News, Dr. Hedvat was scheduled to go on trial this month on a 10-count indictment accusing him of unlawfully prescribing the drugs hydrocodone, clonazepam and suboxone. Dr. Hedvat was free on his own recognizance while awaiting trial and had surrendered his federal license to prescribe controlled substances, according to the District Attorney's Office. 

On August 8, an undercover investigator with the California Medical Board went to Dr. Hedvat's clinic and allegedly negotiated the purchase of narcotics, including Norco and Ativan. Undercover agents allegedly bought the drugs in the clinic's parking lot from Dr. Hedvat's office assistant, Nikravan Hormuz, 70, who was also charged.

Mr. Hormuz pleaded not guilty to the sale of a controlled substance count and posted bail early Saturday. Dr. Hedvat's bail was more complicated and he was not able to post bail at the first appearance.  

Attorney Commentary: It is quite likely that the investigation was continued in order to obtain more evidence on the first case or to create another case -- which is what has occurred here.  Without a DEA registration, the charge is more serious and enhances the punishment that the doctor faces in his case.

Penal Code Section 23 Order Pending Criminal Case
The new case greatly impacted the criminal case in another way in that it prompted the Medical Board to seek an interim suspension order against him under the authority of Penal Code Section 23.  On August 22, 2014, the Judge in issued a PC23 Order that restricted Dr. Hedvat from practicing pending the criminal case.  Under the Order, as a condition of bail or own recognizance (O.R.) release during the pendency of this criminal action until its final conclusion and sentence, Dr. Hedvat shall:

1.    Forthwith cease and desist from practicing as a physician and surgeon;

2.    Be restricted from prescribing, ordering, administering, furnishing, or dispensing any drugs;

3.    Surrender to the clerk of the Court, any prescription forms in his possession;

4.    Be prohibited from obtaining, ordering, or using any additional prescription forms; and inform his patients that he is not currently permitted to prescribe any drugs due to a pending matter. 

The Penal Code Section 23 orders can range from restrictions on practicing to outright prohibition on practicing while the criminal case is pending. This was a complete prohibition and will cause the physician additional economic and professional consequences while the criminal cases are resolved.  

When we have a client charged, it is critical to ensure that they (and their office staff) are not engaged in any acts that could be used to revoke bail or create new charges. While it may be difficult for clients to accept the fact that they will need to give up certain activities that may be legal (prescribing any controlled substances for example where there is a valid DEA registration), even that may be preferable to having to defend one's clinical judgment.  In this case, it was allegedly more serious without the DEA registration and with an office person who was allegedly engaged in activities that could never be legal.  

The lesson: if you are under investigation or charged, be paranoid.  Be careful. Do not assume that an investigation is "over" and that law enforcement or the Medical Board does not continue to send in invetigators.

We have seen cases where the Medical Board has sent undercover investigators to a clinic on the date the physician or other medical staff are scheduled to be in court to see what happens at the clinic without the physician.  In other words: take these investigations seriously.  

Moreover, you can use the time to create good facts and that your office has been cleaned up, is compliant with all laws and regulations. This can help in the defense of the case as well as in any further administrative proceedings. 

Posted by Tracy Green, Esq.

Green and Associates, Attorneys at Law

Phone: 213-233-2260

Email: tgreen@greenassoc.com

Telemedicine - Medical Providers Need To Be Licensed In State Where Patient Is Located But New Proposed MultiState Compact May Ease Licensing Restrictions

Telemedicine or telehealth by medical providers who do not understand its limits is creating more disciplinary investigations and some criminal cases where physicians treat patients who are located in states that the physicians are not licensed. This is different than consultations or educational demonstrations. 

Under current and even proposed law, the practice of medicine occurs where the patient is located at the time of the physician-patient encounter regardless of where the doctor may be. Thus, if the patient is in Texas and the doctor is in California, the doctor must be licensed in California. For example, in one case we handled, even a pathologist in California reading slides and writing reports for Texas patients must be licensed in Texas according to the Texas Medical Board.

Licensing laws regarding telemedicine may be changing. Officials representing state medical boards across the country have drafted a model law that would make it much easier for doctors licensed in one state to treat patients in other states, whether in person, by video conference or online. This is a big change in medical licensing and is designed to allow greater use of telemedicine and alleviate the issues of doctor shortage. A New York Times article goes into this proposed compact in detail.

The draft legislation — in the form of an interstate compact, a legally binding agreement among states — would provide that doctors who meet certain standards could sidestep a longstanding requirement that they apply for licenses state by state. But it would preserve the authority of each state to regulate the practice of medicine within its borders.

Working through the commission, a doctor licensed in one state could seek an “expedited license” from one or more additional states. To be eligible, a doctor would have to be certified in a medical specialty and have no history of being disciplined, penalized or punished by a court, a medical licensing agency or the Drug Enforcement Administration. Under this compact, a doctor could not obtain an expedited license if the doctor was “under active investigation by a licensing agency or law enforcement authority in any state, federal or foreign jurisdiction.”

As part of the compact, states would agree to share information on doctors who had been disciplined or were under investigation. The commission would serve as a clearinghouse. If a license is revoked or suspended in a doctor’s home state, then all licenses issued to the doctor by other states participating in the compact could be automatically revoked or suspended.

This has not been adopted yet and any doctors, therapist or medical providers who are engaging in telemedicine through Skype or videoconferencing or by phone calls must ensure that they are complying with their own state laws. 

California has rules regarding telemedicine and informed consent forms that the patients must complete. Failure to obtain the informed consent forms for telemedicine is considered unprofessional conduct. Medical providers are held to the same standard of care with telemedicine with respect to face-to-face visits. This is a changing area of law but medical providers need to familiarize themselves with the rules and regulations and not simply assume that telemedicine is now "legal."  California laws allow California licensed doctors to treat California patients  but only if certain procedures are followed and informed consents obtained.

Posted by Tracy Green, Esq.

Phone: 213-233-2260

Email: tgreen@greenassoc.com

Physicians With Substance Abuse, Depression, Burnout Issues - LA Times' Article Criticizes Proposed Assembly Bill 2346

In California, the State Bar has a program for attorneys that allows them to go in and get treatment at an early stage. In California, there is no such program for physicians. The only program for physicians is to wait until they have a problem that becomes so grave that it is noted by the California Medical Board and results in an Accusation. There is no incentive for early treatment or encouraging physicians to join a confidential treatment program. There was a Diversion Program but it was shut down some years ago.

Assembly Bill 2346 the "Physician and surgeon assistance program" provides as follows:

"Existing law, the Attorney Diversion and Assistance Act requires the establishment and administration of an Attorney Diversion and Assistance Program to provide services for the treatment and recovery of attorneys for the abuse of drugs or alcohol or mental illness, and who may be enrolled as inactive members of the State Bar."

"This bill would authorize establishment of a similar assistance program for physicians and surgeons. The bill would authorize the Medical Board of California to make available the means to rehabilitate a physician and surgeon with impairment due to abuse of dangerous drugs or alcohol, or mental or physical illness, that affects his or her competency so that a physician and surgeon may be treated in a manner that will not endanger the public health and safety. The bill would require the board, if the program is established, to contract with another entity for provision of the administrative services for the program. The bill would make participants in the program responsible for all expenses relating to treatment and recovery, and would authorize the board to charge a reasonable administrative fee to participants for the purpose of offsetting the costs of maintaining the program. The bill would require the board, if the program is established, to engage in outreach to make physicians and surgeons and others aware of the existence and availability of the program."

The Los Angeles Times' opinion writer Michael Hiltzik opposed this bill on the ground that it would compromise patient safety. I think his views are short sighted and show a lack of understanding about depression, mental health and addiction issues. The goal of this bill is not to cover up physician misdeeds but to encourage physicians to seek treatment. If a physician commits gross negligence, has a settlement over $20,000 to a patient or is the subject of a patient complaint - the Medical Board would still have jurisdiction to investigate and impose discipline. In fact, this bill would encourage someone to get treatment before there is misconduct.

I have represented many professionals with mental health issues such as depression, OCD, bipolar and other issues that do not mean there was a problem with patient care.  In fact, sometimes the depression is as a result of the physician being so obsessed with their practice that they have neglected their family and friends and have become isolated. In addition, alcohol and drugs can become an issue when the physician used drugs initially to work long non-stop hours or in an effort to sleep after long shifts or working at night.  That is often why physicians are at risk. However, if we expect physicians to be less than human and truly god like and not allow for confidential treatment before cases go to the Medical Board, and simply want a punitive approach after problems happen, then do not adopt AB 2346. 

I think AB 2346 is necessary and as physicians will see is no cakewalk or place to hide. In the State Bar program, I have seen attorneys who had some alcohol related arrests during college or law school be required to complete the program successfully as a condition of being admitted to the Bar. That committee is tough and has experts on addiction. They spot problems before they happen and can do it at the application process instead of waiting for clients to be harmed. I accompanied one client to an evaluation by that State Bar Committee and they knew every excuse and even though he was not an alcoholic, they required him to quit drinking because they saw that a couple of alcohol related arrests (without convictions) were signs of a potential future problem. I support AB 2346 and think it will help physicians and their patients in the long run.

Posted by Tracy Green, Esq.

Green and Associates, Attorneys at Law

Phone: 213-233-2260

Email: tgreen@greenassoc.com

California Medical Board Increases Request For Patient Records From Pain Management Physicians - Be Proactive Now And Stay Current

Physicians who treat for pain management physicians are clinicians. They did not go to medical school to become DEA agents, police officers or judges -- even though in today's climate it can seem like they feel pressured to take on these roles. In California and other states, physician who prescribe opioids or controlled substances for pain treatment are under greater scrutiny and have a greater chance of having their records requested by the Board or the DEA for review.

The Los Angeles Times ran an article entitled "Oxycontin maker guards its closely guarded list of suspect doctors" about Purdue Pharmacy and how it has sold $27 billion worth of Oxycontin since 1996. It criticizes the company for not alerting law enforcement or medical authorities to the physicians who are suspected of overprescribing or illegal prescribing. This is part of a series of stories ran by the Times regarding prescription drugs and is a reminder that practitioners in this field are currently under a microscope.

We have had a number of clients whose records have been reviewed by the Board to see if their patient care for pain management was within the standard of care. The request for records are often triggered by a single complaint (such as a pharmacy complaining about overprescribing for a single patient). The Board runs the CURES report on the physician and selects for additional review 8 to 10 patients who are younger, middle-aged or on high opioid treatment dosages or where there are some other red flags with these patients.

In these cases, it is important to get legal counsel immediately even for a consultation to ensure that you are well prepared for any interview and that your complete file is submitted (and in many cases with a summary of the patient's care). In some of our cases, we found weaknesses in our client's practices and procedures and while not conceding any problems, we made positive changes immediately and it was helpful in showing that we had responsible professionals who are staying current with the changing landscape. In some cases, early expert retention may be needed or we found that a patient or two was diverting medications and had to make adjustments at that point.

If pain management treatment is part of your practice, it is time to perform an audit of your practice and make sure that your record keeping, consent forms, screening tools, treatment agreements, referrals for depression, referrals to other physicians as needed, patient education forms, and monitoring practices (urine testing, CURES reports, pill counting, etc.) are keeping up with the changing standard of care and changing laws and regulations. Do you modify your treatment plan when the patient reaches in excess of 120 mg morphine equivalent dosage (MED)? Do you document with specifics how the benefits of opioid treatment outweigh the risks? Build this into your staff and practice so it's part of the process.

It is becoming more important to have "universal" precautions in dealing with patients to ensure there is no risk of diversion. We have had clients who run urine tests and CURES reports on some patients but not on others who seem low risk. However, you cannot simply assume that just because someone is elderly (for example) that they do not pose a risk for diversion. This also makes it easier in your practice in that you then can tell the patients -- this is how we manage everyone -- and they do not take it personally. Drug tests are becoming the standard of care since you're ensuring that the patient is taking the medication as prescribed and that there is not diversion. CURES reports are also the standard of care now since you're ensuring that the patient is not doctor shopping.

Keep up with new monitoring methods. For example, one relatively new practice is to have the patients bring their pill bottles in for a "pill count" (sometimes randomly) -- especially for high risk patients -- for additional monitoring. Follow up on any issues raised by family members or the patient (nodding off during the day, sleep issues at night, preoccupation with the prescribed opioid, etc. Use the opioid risk management tools to assess the patient especially since many of these such as SOAPP are available free on the Internet.

For those in California, review the California Medical Board website on pain management periodically for updates on pain guidelines. even though it is behind the times and do not set forth in detail the standard of care and medical necessity -- but it is does set forth the basic law and policies of the Board.  

Chronic pain is complicated and implementing audits for your practice will not only help with any investigation by the Board or DEA but will also help protect yourself against any potential malpractice case and help prevent any potential criminal liability. The law is clear that unless there is legitimate medical purpose for prescribing scheduled narcotics -- the prescription is not legitimate. If the records are not sufficient or if the patients are diverting medications, there can be a criminal or DEA investigation. We have also represented physicians in criminal investigations, search warrants and criminal cases involving pain management medications -- and our goal is to prevent such cases and investigations.

With the issue of prescription overdose deaths featured prominently in the press, physicians need to take these issues seriously even if they are board certified pain management specialists. We help practitioners ensure legitimate patients' access to appropriate pain care and the right of physicians to practice responsible pain medicine.

Posted by Tracy Green, Attorney at Law
Green and Associates,
(213) 233-2260
Email: tgreen@greenassoc.com