Licensing, Regulations, and Hearings Before the DEA

DR writing RXAlex Fisher was contacted by the Albany Law Review to provide a review of the article published in their 78th volume, “Drug Diversion, Administrative Revocation, and Application hearing for Medical and Pharmacy Practitioners: A Primer for Navigating Murky, Drug-Infested Waters.” This article, written by Drug Enforcement Administration (“DEA”) Chief Administrative Law Judge John Mulrooney and DEA law clerk, Andrew Hull, which can be found here, and provides an excellent summary of the administrative process surrounding DEA licenses.

Basis for DEA Discipline

After receiving discipline at the state level on their medical, nurse practitioner, or physician assistant license, many of my clients are often contacted by the DEA regarding agreed-to restrictions on their DEA license, or even the agreed surrender of that license.

The DEA has the authority to suspend, revoke, or otherwise sanction a healthcare provider’s DEA license on the following five bases:

  • material falsification in registration application
  • conviction relating to a violation of state or federal controlled substance law
  • state action against state controlled substance privilege
  • exclusion from participation in a federal health care program, and
  • the commission of an action that would “render enjoyment of the registration inconsistent with public interest.”

Id. at p. 104-105.

The fifth basis on which the DEA may discipline a healthcare provider’s DEA license, the commission of an action that would “render enjoyment of the registration inconsistent with public interest,” is substantially similar to a common state catchall provision found within the regulations for each profession.

For instance, here in Tennessee, discipline of a licensee by the Board of Medical Examiners is permitted on the grounds of “unprofessional, dishonorable, or unethical conduct.” The DEA’s “inconsistent with public interest” provision also encompasses the discipline of a healthcare provider by their state licensing board, such as the Board of Medical Examiners or Board of Nursing as a legal basis for discipline of a provider’s DEA license. Id. at 111.

In addition to a healthcare provider’s discipline by their professional board, the DEA also considers a criminal conviction relating to manufacturing, distributing, or dispensing of controlled substances as an appropriate basis for the discipline of a provider’s DEA license. Id. at 120.

The DEA also considers “self-abuse of controlled substances and alcohol” and “failure to take steps to prevent against diversion of controlled substances” as potential “public interest” concerns that could lead to the limitation or revocation of a health care provider’s DEA license. Id. at 131. Specifically, the DEA considers “self-abuse of controlled substances and alcohol” and “failure to take steps to prevent against diversion of controlled substances” as potential “public interest” concerns that could lead to the limitation or revocation of a health care provider’s DEA license. Id. at 131.

DEA Administrative Hearing

Within the article, Judge Mulrooney explains in detail the process of an administrative hearing before the DEA. As in most administrative hearings, the burden is on the government to prove that an applicant or licencee has violated a provision of the DEA and that their license should be revoked, disciplined, refused. Id. at 135. Additionally DEA hearings usually take place at one central location—the DEA Hearing Facility in Arlington, Virginia. Id. at 141-42.

As with administrative hearing at the state level, a party appearing before a DEA administrative proceeding may retain an attorney or represent him or herself. Id. at 153. Uniquely, the DEA administrative proceeding also allows a party to be represented by an employee of the party, which contemplates that pharmacies and manufacturers, as the entities themselves, are often the respondent before a DEA administrative proceeding. Id.

At the actual hearing, similar also to state administrative proceedings under the Uniform Administrative Procedures Act in Tennessee, hearsay evidence may be admissible if relevant. Id. at 156.

Conclusion

In concluding, Judge Mulrooney makes an excellent point:

“An unprepared or unschooled counsel can unwittingly choose a tactic or make a concession that can result in the loss of a medical or pharmaceutical practitioner’s livelihood” Id. at 162.

As in any specialized field, but even more so when a practitioner’s ability to prescribe is on the line, it is important for a provider who is facing discipline by the DEA to be represented by counsel who is familiar with and has an intimate knowledge of the process and proceeding before the DEA.

Just as a patient wouldn’t choose a cardiology to perform brain surgery, a healthcare provider should not retain counsel to represent them before the DEA or in any administrative proceeding who is not experienced and specialized in this unique area.

Alex Scarbrough Fisher

Alex Scarbrough Fisher is an associate attorney at Thompson Burton PLLC. Her practice area focuses on litigation and administrative law. Alex’s administrative law practice’s emphasis is in health care related boards, including the Tennessee Board of Medical Examiners and the Tennessee Board of Nursing.

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Tennessee’s New Prescribing Laws and Old Habits: Effectively Caring for Patients Using Controlled Substances

This paper is republished here with the consent of the article’s authors, William Swiggart and Dr. Charlene Dewey of the Vanderbilt Center for Professional Health, and Alex Scarbrough Fisher of Thompson Burton, PLLC. This piece was first written and published in January 2014 in conjunction with the Vanderbilt Center for Professional Health. Although it was initially published several months ago, its contents regarding prescribing laws in Tennessee are still germane for healthcare providers who practice in the state of Tennessee.  

You can also access the article in .pdf format at Tennessee’s New Prescribing Laws.

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Introduction

The Robert Wood Johnson Foundation identified substance abuse as this nation’s number one health problem in 2004.1 Substance abuse, particularly abuse of controlled prescription drugs, is closely interwoven with pain management. Physicians have the unique opportunity to identify substance misuse and abuse. Physicians can intervene early for patients at risk. Proper prescribing of controlled prescription drugs (CPD) is essential to patient care and appropriate pain management. Many medications used in pain management have potential for creating dependence and/or abuse and relapse. Physicians’ use of screening and monitoring techniques can be useful in identifying and reducing misuse and abuse. Over the past three years, the state of Tennessee has enacted new laws to tighten regulations of controlled prescription drugs (CPDs) in an effort to reduce the CPD problem in Tennessee. The overall purpose of the new Tennessee laws is to help reduce negative outcomes, diversion and misuse/abuse of CPDs for all patients. This paper reviews new Tennessee state laws around proper prescribing and offers suggestions for proper prescribing practices.

Current Legislation

The current legislation (T.C.A. § 53-11-308) “is part of a statewide effort to reduce problems associated with misuse of these powerful drugs,” according to the Tennessee Department of Health’s Chief Medical Officer, David Reagan, M.D., Ph.D.

Two recent changes include the 2012 Prescription Safety Act (T.C.A. §53-10-300) and the 2011-12 pain clinic regulations (T.C.A. § 63-1-300). Beginning in April 2013, Tennessee law requires health care professionals to check the Controlled Substance Monitoring Database (CSMD) before prescribing a controlled substance to a patient in a majority of cases and as a routine for those on chronic CPD management.2

Effective October 1, 2013, a new Tennessee law (T.C.A. § 53-11-308) sets a limit on the amount of Schedule II and III drugs being prescribed or dispensed to a 30-day supply. This regulation will also require practitioners to assess patients for substance misuse by conducting urine drug testing at least every thirty days if they prescribe Schedule II or III drugs alone or in combination beyond a thirty day period. Within this law, any Tennessee licensed pharmacist, receiving prescriptions written from either in or outside of Tennessee, cannot dispense more than a 30-day supply of any Schedule II or III drug regardless of the amount prescribed by the practitioner.

While the time frame for which a physician may prescribe opioids and benzodiazepines has been limited, the number of pills a physician may prescribe has not been limited, as long as that number falls within the range of a 30-day supply for a patient based on the morphine dose equivalent.

Aetna, Blue Cross Blue Shield of Tennessee, and Cigna insurance providers plan to honor the new law and any prescription written for 90 days will only be filled for 30 days. Separate co-pay will apply for each refill of the prescription.3

Previously Enacted Legislation

Effective April 1, 2013, all practitioners in Tennessee are required to use tamper-resistant paper for all prescriptions written or printed (T.C.A. § 53-10-400). Each prescriber should be aware of the requirements specific to their practice.4

Effective July 1, 2013, physicians supervising physician assistants must follow additional specific guidelines for prescribing Schedule II substances (T.C.A. § 63-19-107).

Also, effective July 1, 2013, dispensing of controlled substances by pain management clinics is prohibited (T.C.A. § 63-1-313). Pharmacists are required to use their professional judgment to make every reasonable effort to prevent abuse of drugs he or she dispenses (T.C.A. § 53-10-112). All of these new laws enacted in 2013 serve the purpose of limiting or preventing the abuse of prescription drugs in Tennessee.

Implications of New Legislation

While the goal of this law is to decrease abuse of opioids and benzodiazepines by patients, it is likely that the law will have secondary effects for physicians and their office practices, patients and pharmacists (T.C.A. § 53-11-308). Such secondary effects include more frequent patient encounters, more time with patients, and changes within the office infrastructure.

Physicians will see patients who are prescribed opioids and benzodiazepines more often. Physicians will have to query the CSMD themselves or delegate the task to other qualified office personnel. The office team must determine the best office plan to implement an efficient and effective monitoring system. According to the CSMD guidelines/rules, each physician can have two designated individuals to query the CSMD. The health care team might consider focus clinic days. For example, set aside days in which patients on chronic CPDs are seen (e.g., Tuesday and Thursday). This type of office plan may support patient compliance and make office practices more efficient. All patients on chronic CPD would return on their assigned day for visits and refills. Training and education may reduce the problem of the on-call physician receiving refill requests on weekends. Checking the CSMD for all patients scheduled for a select day can be completed at the close of the day before or the morning of the appointment. All monitoring (CSMD queries, pill counts and urine drug tests or UDT) can be completed and followed up on selected weekdays.

Patients will certainly be impacted with regards to their lifestyle and finances. Patient return appointments, visits to pick up prescriptions, and lab visits will increase resulting in higher costs for patients, which along with separate co-pays for each refill, may make certain prescriptions prohibitively expensive.

Under the 2012 Prescription Safety Act, dispensers (pharmacists, clinics, etc.) will have an increased work load as the number of monthly prescriptions multiplies. The increased work load includes more patient visits to fill prescriptions, meaning more prescriptions to fill, and more time to upload data into the CSMD (currently set at every seven days).

Under our new laws, collaboration between the physician and pharmacist is valuable and beneficial to both parties. The greatest benefit of a collaborative working relationship between practitioner and pharmacist, however, is better patient care through early identification of patients exhibiting behaviors consistent with misuse, abuse and/or diversion. This takes a true interprofessional team effort between health care providers, patients and family members.

Action for Physicians

There are additional measures that can reduce the number of scheduled drugs being diverted while adequately treating pain at the same time. We suggest a five-pronged approach when prescribing CPDs for chronic, non-cancer pains including: 1) using a systematic four-step approach to patient care, 2) screening for potential substance abuse and at-risk behaviors for patients using CPDs, 3) providing informed consent and a written pain agreement for all patients requiring chronic CPDs, 4) monitoring all patients using both the CSMD and UDT and 5) using the 100 mg morphine milligram dose equivalents and referring to specialists if patient requires more pain control. For a thorough review of guidelines for managing chronic non-cancer pain, see the article by Chou et al.5

1. Using a systematic four-step approach for all patients reduces the chance of missing critical information. The four-step approach is easy and based on the SOAP note format. Step 1 – gather subjective and objective data. Take a thorough history and complete a focused physical exam as you always do, but add an emphasis on asking an appropriate screening question for substance use. Ask the patient about their substance use history and history within their family. Step 2 – implement Screening, Brief Intervention, and Referral to Treatment (SBIRT). If the substance use question in the step above is positive, implement a full SBIRT. (See SBIRT below.) Step 3 – assessment and plan. Complete your assessment and plan focusing on pain, diagnostic studies needed, results, and treatment plans/goals. Step 4 – Document. Use any state specific or Federation of State Medical Boards documentation guidelines. For all patients on chronic CPDs, ask and document the four A’s (analgesia, activities of daily living, adverse events, and aberrance) on each follow up visit.5-6

2. Proper screening for substance abuse and at-risk behaviors is a critical first step in patient care because it identifies a patient at risk and allows for early intervention. There is ample evidence that physicians are not adequately trained in screening and intervening on patients with substance abuse issues.7 Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a well-researched model for reducing harm related to at risk alcohol use. It reduces risks for patients, emergency department visits, and health care costs.8 SBIRT has been used for patients on CPDs.9 To screen patients, physicians can ask, “do you now or have you ever used alcohol, tobacco, controlled prescription drugs, marijuana, cocaine, hallucinogens, street drugs, etc. Ask each question and allow the patient to answer. Determine if their use is normal or misuse, which includes excessive amounts, diversion, and incorrect use due to poor understanding or misinterpretations of the directions. Ask about any at risk behaviors or consequences from substance use such as driving under the influence (DUI), financial problems due to substance use, etc. Ask the same question related to the patient’s family. This identifies a potential genetic risk. For at-risk patients or patients whose behaviors are suspicious of misuse, implement an opioid risk assessment tool. For a patient who screens positive, use motivational interviewing to advise them of their risk, assess if they are able to cut down or stop, assist them with treatment options and make arrangements for follow up and when needed, referral to an appropriate substance use program, addiction medicine, pain medicine and/or mental health specialist.

3. Complete an informed consent regarding the risk and benefits of each specific pain medication for every patient who requires CPDs. A written pain agreement should be implemented setting clear boundaries regarding refills, lost or stolen medication, and the expectation for routine and random drug screens. The screens are useful to both verify that the medication is in fact being consumed by the patient and if other medications and/or street drugs are being used. Women of childbearing ages will need full informed consent regarding pregnancy prevention and risk to the fetus. Read the DEA Practitioner’s Manual for important information on proper prescribing practices. The DEA remains committed to the 2001 balanced policy of promoting pain relief and preventing abuse of pain medications.10

4. Implement monitoring for patients using chronic CPDs for more than thirty days continuously. The Tennessee Prescription Safety Act (TN-PSA) of 2012 requires that physicians check the CSMD on all patients prescribed CPDs for more than seven days and at least annually if patients are maintained on the CPD long term. One trial using a combination of opioid agreements & compliance monitoring (CSMD + UDT) was prospectively associated with a 50% reduction in opioid abuse in a chronic pain population.11 Emergency department physicians should also check the CSMD for patients with suspected overdoses.12 The TN-PSA stipulates that the CSMD need not be checked in the following four circumstances: 1) if the amount prescribed is less than a single, seven day, non-refillable treatment plan; 2) in particular medical specialties with a low potential for abuse by patients in that specialty; 3) if the CPD is prescribed by certain interventionists or proceduralists as a non-refillable prescription as part of treatment for a surgical procedure in a licensed healthcare facility; or 4) if the patient is enrolled in hospice care. The Tennessee physician should document the results of the CSMD query without placing the document in the medical record. Physicians should periodically query the database assessing their own DEA number to assure there is no misuse of their DEA number. Physicians living near a state border should register for that state’s monitoring database and query it when appropriate. It is not uncommon for physicians to discover prescriptions that they did not write. Other methods for monitoring patients on chronic CPDs includes pill counts (know what the pills should look like) and urine drug testing (UDT). When implementing UDT, make sure the urine received is from the patient being tested. With readily available ‘clean urine’ samples for purchase over the internet, patients can easily trick the practitioner. Make sure to observe sampling or implement a double void policy; meaning the patient must void twice during the clinic visit to obtain two appropriate urine samples.

5. Side effects and accidental overdoses due to CPDs increase over the 100 mg morphine dose equivalent level. In Tennessee, the CSMD calculates the morphine dose equivalent for you. You may also use on-line or printed tables estimating the 100 mg morphine milligram dose equivalent. When appropriate, reduce the dose for those who exceed this level. If patients require more pain control, refer them to a pain medicine specialist. Several available on-line tools exist to help the practitioner with calculations or adjustments.

Summary

There are major important changes for Tennessee prescribers. Each physician is responsible for understanding and abiding by the rules and laws that govern prescribing practices. The state medical board expects physicians to be aware of and follow these new practice and prescribing guidelines. Our hope is that you practice smart, treat pain appropriately, consult and refer as needed, and document appropriately so that patient care is improved. Patients greatly benefit from a health care team that works together to help reduce misuse, abuse and diversion of CPDs. Below is a list of our recommendations to help improve your comfort and knowledge around proper prescribing of controlled prescription drugs.

Recommendations:

1. Familiarize yourself with the new TN prescribing laws and identify office practices that need to be adjusted.

2. Read the DEA Practitioner’s Manual and comply with their prescribing guidelines. (http://www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html)

3. Follow a systematic four-step approach and implement office changes as needed.

4. Screen all patients to assess risk using SBIRT.

5. Take a course on SBIRT, either online or in person.

6. Query the CSMD for all patients requiring CPDs for more than seven days and at least annually if on chronic treatment.

7. Implement random urine drug testing for patients on chronic CPD treatment.

8. Query your own name in the CSMD.

9. Identify treatment resources in your area by going to the SAMSHA website and looking at their treatment finder. (http://findtreatment.samhsa.gov/)

10. Work collaboratively with other health care professionals including pharmacists, nurses, psychiatry, pain, and addition medicine specialists.

References:

1. Substance Abuse: The Nation’s Number One Health Problem; Key Indicators for Policy Update. The Robert Wood Johnson Foundation. February, 2001.

2. “New Prescription Drug Laws in Tennessee This Month in Effect,” October 13, 2013, WGSN Radio, http://wgnsradio.com/new-prescription-drug-laws-in-tennessee-this-month-in-effect–cms-15536.

3. Williams, Brenda, “New Law Limits dispensing of Opioids, Benzodiazepines.” Tennessee Medical Association, September 18, 2013; http://www.tnmed.org/2013/09/new-law-limits-dispensing-opioids-benzodiazepines.

4. T.C.A. § 63-8-126 applies to optometrists, T.C.A. § 63-3-127 applies to podiatrists, T.C.A. § 63-5-122 applies to dentists, T.C.A. § 63-6-236 applies to physicians and surgeons, T.C.A. § 63-9-116 applies to osteopathic physicians, T.C.A. § 63-7-123 applies to nurse practitioners.

5. Chou R, et al. Opioid Treatment Guidelines Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. The Journal of Pain, Vol. 10, No 2 (February); pp 113-130; 2009.

6. Prescribing Controlled Drugs Program Manual. The Center for Professional Health. Vanderbilt University Medical Center, Nashville, TN www.mc.vanderbilt.edu/cph.

7. Bollinger LC. Under the Counter: The Diversion and Abuse of Controlled Prescription Drugs in the U.S. The National Center on Addiction and Substance Abuse (CASA). 2005.

8.Babor TF, McRee BG, Kassebaum PA, Grimaldi PL, Ahmed K, Bray J. Screening, Brief Intervention, and Referral to Treatment (SBIRT): toward a public health approach to the management of substance abuse. Substance Abuse. 28(3):7-30; 2007.

9. Madras BK, Compton WM, Avula D, Stegbauer T, Stein JB, Clark HW. Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: comparison at intake and 6 months later. Drug Alcohol Depend. 99(1-3):280-295; Jan 1 2009.

10. Rannazzisi J, Caverly M. United States Department of Justice Drug Enforcement Administration Office of Diversion Control “Practitioner’s Manual: An Informational Outline of the Controlled Substances Act” 2006 Edition. http://www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html. Last accessed 1/20/14.

11. Manchikanti L. Prescription drug abuse: what is being done to address this new drug epidemic? Testimony before the Subcommittee on Criminal Justice, Drug Policy and Human Resources. Pain Physician. Oct; 9(4):287-321;2006.

12. HOUSE BILL 482. By Williams R. http://www.capitol.tn.gov/Bills/108/Bill/HB0482.pdf. Last accessed 1/20/14.

Alex Scarbrough Fisher

Alex Scarbrough Fisher is an associate attorney at Thompson Burton PLLC. Her practice area focuses on litigation and administrative law. Alex’s administrative law practice’s emphasis is in health care related boards, including the Tennessee Board of Medical Examiners and the Tennessee Board of Nursing.

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What Doctors Wish Their Attorneys Knew

What Doctors Wish their Attorneys Knew from Thompson Burton on Vimeo.

When doctors find themselves on the wrong side of a complaint against their professional license, they usually hire a lawyer who doesn’t understand their practice or predicament. In this interview, administrative lawyer Alex Fisher interviews Dr. Wayne Henderson about what doctors wish their attorneys knew about the practice of medicine.

In this interview, Alex and Dr. Henderson discuss:

1. The nervousness physicians experience when interacting with the legal world–particularly when a physician practices pain management.

2. How physicians can properly care for patients and not worry about the Board of Medical Examiners always looking over their shoulder to see if they have done something wrong.

3. The benefit of electronic record keeping over paper record keeping.

4. The potential for a physician to change his or her practice style when nervous about being criticized of doing something wrong.

5. The fact that physicians want an attorney to represent them who (1) they feel comfortable with, (2) who is specialized in the administrative law field, and (3) who has a basic knowledge of the practice of medicine.

6. The importance of documentation interventions and conversations with patients so that a physician knows exactly what happen and what he was thinking in each patient encounter.

 I hope you find the video informative.  If you learned anything, feel free to share or contact me here.

Alex Scarbrough Fisher

Alex Scarbrough Fisher is an associate attorney at Thompson Burton PLLC. Her practice area focuses on litigation and administrative law. Alex’s administrative law practice’s emphasis is in health care related boards, including the Tennessee Board of Medical Examiners and the Tennessee Board of Nursing.

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Nursing Discipline Article Published in Tennessee Nursing Extra

tn nursing extra 2Tennessee Nursing Extra’s Summer 2014 edition features an article titled “What Should You Do If You Receive a 4-5-320(c) Notification Letter From the Tennessee Department of Health?” written by Alex Scarbrough Fisher. The article begins on page ten, and can be accessed here.

The article is a republication of this blog’s September 18, 2013 post of the same title. However, the article in Tennessee Nursing Extra contains specific references to a nursing rather than a medical license.

Tennessee Nursing Extra is a widely read and respected publication that coveys information regarding licensing, regulatory updates, scope of practice, and disciplinary actions. The professionals professionals is published four times a year, and is distributed to over 150,000 nurses, students, educators, and other healthcare professionals.

Alex Scarbrough Fisher

Alex Scarbrough Fisher is an associate attorney at Thompson Burton PLLC. Her practice area focuses on litigation and administrative law. Alex’s administrative law practice’s emphasis is in health care related boards, including the Tennessee Board of Medical Examiners and the Tennessee Board of Nursing.

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Spotlight on the Vanderbilt Center for Professional Health

Vandy&SkylineThe Vanderbilt Center for Professional Health (“CPH”) was established in 1998 to provide education and training to physicians and other healthcare professionals. Last week the co-directors of CPH, Dr. Charlene Dewey and Mr. William Swiggart, took a few moments out of their day to explain the purpose and process behind the work they do at the Center for Professional Health.

What the Center for Professional Health Offers for Health Care Providers

One of the main educational offerings of CPH is its three-day Continuing Medical Education courses on Maintaining Proper Boundaries, Prescribing Controlled Drugs, and a Program for Distressed Physicians. Each course is offered at least four times a year with the most highly attended course, Prescribing Controlled Drugs, offered seven times throughout the year.

Physicians, physician assistants, and nurse practitioners from around the country attend all three courses. Some of these individuals attend on their own initiative, while others attend as part of a Consent Order or Final Order issued by their state’s Board of Medical Examiners. Attendees of the Distressed Physicians course are often referred by their hospital board or employer.

“We wanted to give the Board[s] of Medical Examiners an option between revoking someone’s license and letting them continue to practice,” stated Mr. Swiggart, who has been involved in the practice of psychotherapy for forty years. “Becoming a physician is an enormous investment,” added Dr. Dewey, who is also a faculty member at the Vanderbilt University School of Medicine. “We want to allow physicians to continue in their profession for as long as possible.”

How CPH Accomplishes Teaching and Healing for Physicians

In order to accomplish this goal, the Center for Professional Health begins by putting their course attendees at ease in a comfortable group-learning environment. Mr. Swiggart stated that when CPH began its Prescribing Controlled Substances course, the theory was that physicians who overprescribed were likely addicts as well. However, as it turns out, the majority of physicians who were disciplined for overprescribing were usually conflict avoidance individuals, often in isolated communities, rather than addicts.

By bringing these individuals together with others who have had similar difficulties, CPH is able to first impress upon these doctors that they are not alone. “The relief in the room is palpable,” states Mr. Swiggart. Next, the courses use the Socratic method to deal with the shame and guilt that the physicians are experiencing as a result of their licensure discipline or other legal action. The courses then move into a skills based approach whereby physicians are taught various tools and techniques to help them avoid their prior behavior.

“After a course, we usually follow up with the class one to two times throughout the next year,” stated Dr. Dewey. “The groups almost become like families—they will email the rest of the class about job updates, weddings, whatever else big is going on in their life.” “I’m not sure if the doctors who come to our courses are any different than the doctors who don’t have complaints against them,” mused Mr. Swiggart.

Physicians who go through a disciplinary proceeding have to realize that they must go through a process to heal and change, stated Dr. Dewey. “The most important part to me is that we can keep people in their careers.”

Programs like those offered by the Center for Professional Health can make a difference in a physician’s ability to continue practicing medicine, as well as their ability to effectively treat and care for their patients. For physicians facing licensure discipline, educational options such as those at CPH can provide a welcome alternative to revocation and other harsh discipline against his or her medical license.

Alex Scarbrough Fisher

Alex Scarbrough Fisher is an associate attorney at Thompson Burton PLLC. Her practice area focuses on litigation and administrative law. Alex’s administrative law practice’s emphasis is in health care related boards, including the Tennessee Board of Medical Examiners and the Tennessee Board of Nursing.

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What You Should Know Before You Sign a Consent Order: Is It Reportable to the National Practitioner Data Bank?

CT  MET-AJ-UNDISCLIPINED-DOCTORSThe National Practitioner Data Bank, or NPDB, is a repository of information created by the federal government to provide a comprehensive review of the professional credentials of health care practitioners, including, but not limited to, any discipline a health care practitioner receives from a state medical board.

Federal regulations govern what state medical boards must report to the National Practitioner Data Bank, and the National Practitioner Data Bank Guidebook helps summarize and interpret these regulations.

What Discipline is Reportable to the National Practitioner Data Bank?

Federal regulation requires that “any adverse action taken by the licensing or certification authority of that state [i.e., the State Board of Medical Examiners] including revocation or suspension of a license…reprimand, censure, or probation….any negative actions or findings by such authority, organization or entity regarding the health care practitioner” be reported to the NPDB. 45 C.F.R. § 60.9(a)(1) and (4).

What does this mean, exactly?

Well, federal regulations define a negative action as anything placing a “limitation on the scope of practice,” for example, a restriction on a physician’s ability to prescribe certain schedules of drugs.

What is NOT Reportable to the National Practitioner Data Bank?

The definition of what is reportable specifically excludes “administrative fines or citations and corrective action plans and other personnel actions.” 45 C.F.R. § 60.3.

The National Practitioner Data Bank Guidebook goes on to confirm that fines and other monetary sanctions should not be reported to the Data Bank, along with settlement agreements that impose monitoring, unless such monitoring restricts the individual’s license.

Why Does it Matter if an Action is Reported to the NPDB?

Almost every employer will query an individual in the NPDB before hiring him or her to work at a hospital, clinic, or pharmacy. If you have reported discipline on your profile, this will adversely affect your desirability as an employee as well as your ability to obtain and maintain employment.

If you are offered a consent order in lieu of a formal disciplinary proceeding, carefully consider negotiating your consent order to reflect actions that are NOT reportable to the NPDB such as corrective action plans, civil penalties, and monitoring agreements that do not restrict your license.

Additionally, it is crucial to be aware of your state medical board’s policies on reporting—even though the NPDB specifically excludes civil penalties from reportable action, some boards report such action to the NPDB anyway. Such policies are worth fighting, because they directly contradict the intent and purpose of the NPDB.

Alex Scarbrough Fisher

Alex Scarbrough Fisher is an associate attorney at Thompson Burton PLLC. Her practice area focuses on litigation and administrative law. Alex’s administrative law practice’s emphasis is in health care related boards, including the Tennessee Board of Medical Examiners and the Tennessee Board of Nursing.

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Use Only As Directed: Medical Renegades Push the Envelope for Unconventional Rx Uses

Film Review Dallas Buyers ClubOne problem body builders encounter when increasing their testosterone levels is that estrogen increases as a natural byproduct. A solution that body builders have found? Using breast cancer drugs such as Arimidex, which acts to inhibit the synthesis of estrogen. Today, anti-estrogens are only marketed for use in the treatment of breast cancer.

However, despite a concern that physicians are prescribing anti-estrogens for unintended purposes, or that body builders are purchasing them online through unregulated means, it seems that such drugs do, in fact, do a pretty good job of blocking estrogen, which allows for the increase of testosterone in proportion to estrogen, and thus, allow a body builder to gain more muscle. The point is, even if anti-estrogens are marketed for breast cancer treatment, they are also effective at helping body builders grow muscle. Through the free market system, those willing to take a risk on experimentation have found a solution to a problem, however trivial this problem may seem to the general public.

Let’s focus on another problem, this time faced by many cancer patients: wasting syndrome, the process by which a debilitating disease causes muscles and fat tissues to “waste” away, resulting in weakness, inability to continue treatment, and ultimately, death. Ghrelin, known as the hunger hormone, has been a potential targeted treatment for wasting in the form of synthetic Ghrelin, known as Ghrelin mimetic, but it’s not available commercially to the public. It can be obtained, of course, by other means, though such covert methods necessitate a lack of quality control

Anti-estrogens and ghrelin mimetics are currently not included in FDA regulations, and they are not on the controlled substances list. Such drugs fall in a gray area of federal regulatory overlay along with other unregulated supplements and substances. Though physicians recommend that medicine only be used for its intended medicinal purposes, many patients and individuals don’t have time to wait until a medicine is commercially available to see if it works.

Many cancer patients are willing to risk buying research grade ghrelin over the internet if it will increase their odds of survival during chemotherapy. Whereas doctors are concerned with a potential lawsuit by prescribing the wrong drug (and rightly so, in the current litigious culture we live in), patients should be allowed the autonomy to take a risk when it involves their own life their own life hanging in the balance.

Take for example the recent film, Dallas Buyers Club, based on the true story of Ron Woodroof, who formed a Buyers Club in the late 1980s to provide non-FDA approved drugs to fellow AIDS patients like himself. Such medications were slow to be approved by the FDA, and Woodroof gave himself and other AIDS patients an option for survival, albeit a risky one, as an alternative to certain death. And Woodroof? He was given six months to live when he was diagnosed with AIDS. Due to his own tenacity and non-FDA approved treatments, he lived another six years.

Innovation and scientific advancement requires a certain element of risk taking, including an acceptance of danger. For those facing serious medical diagnosis, federal regulatory standards shouldn’t stand in the way of hope, despite the dangers involved.

Alex Scarbrough Fisher

Alex Scarbrough Fisher is an associate attorney at Thompson Burton PLLC. Her practice area focuses on litigation and administrative law. Alex’s administrative law practice’s emphasis is in health care related boards, including the Tennessee Board of Medical Examiners and the Tennessee Board of Nursing.

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How Little Does the Government Have to Prove to Revoke Your Medical License?

scales of justiceThis post looks at the legal standard required to prove facts in a contested case hearing in order to impose discipline on a physician or nurse. Even though this delves into more technical legal concepts than normal on this blog, it’s significant to understand how much, or rather, how little, the Department of Health has to prove in a licensure action against a health care practitioner.

Burden of Proof

In a contested case hearing involving a discipline action brought against one’s medical or nursing license, the Department of Health carries the burden of proof. The burden of proof is the legal term used to describe the threshold a party seeking to prove a fact has to reach in order to have the fact legally established. In a criminal court case, the burden of proof the prosecutor has to reach to establish facts is that of beyond a reasonable doubt. In a civil action, generally, as well as in a contested case hearing involving licensure discipline before the Tennessee Department of Health, the burden of proof required is preponderance of the evidence.

Preponderance of the Evidence: What does that mean?

Preponderance of the evidence requires demonstrating that a fact is more likely true than not. In simple terms, this means that the Department of Health has to convince the Board of Medical Examiners or Board of Nursing that the Department has least 51% of the proof in their favor, while you have only 49% of the proof in your favor.

Proof can be established in a contested case hearing through the testimony of witnesses, the introduction of relevant, nonhearsay documents, or the introduction of affidavits, agreed to by both parties. One of the most important roles of a physician’s attorney in preparing for a contested case hearing is to gather evidence to disprove the allegations that the Department has set forth in the formal notice of charges.

Why does the burden of proof matter?

The preponderance of the evidence standard is significant for an individual preparing for a hearing before the Board of Medical Examiners because it conveys what level of proof the Department is required to reach in order to prove that an individual has violated a law or regulation and deserves punishment. Preponderance of the evidence is an important standard to consider when preparing one’s defense for a contested case hearing.

Finally, preponderance of the evidence is simply a low threshold requirement for the Department of Health to meet in order to revoke an individual’s license to practice medicine or nursing. A physician going before the Board of Medical Examiners needs to be aware of this low standard, and prepared to properly rebut it in a contested case hearing.

Alex Scarbrough Fisher

Alex Scarbrough Fisher is an associate attorney at Thompson Burton PLLC. Her practice area focuses on litigation and administrative law. Alex’s administrative law practice’s emphasis is in health care related boards, including the Tennessee Board of Medical Examiners and the Tennessee Board of Nursing.

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Spotlight on the Tennessee Medical Foundation

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Dr. Roland Gray is the medical director of the Tennessee Medical Foundation, which offers professional assistance to physicians suffering from chemical dependence, mental or emotional illness. He took a few minutes to sit down with me last week and explain the mission of the Tennessee Medical Foundation (“TMF”), as well as the services it offers to physicians across the state.

 The Tennessee Medical Foundation exists to serve physicians across the state of Tennessee. Friends, family members, or business partners refer the majority of the clients to TMF, while a minority of physicians become clients after referral by their attorney or the Board of Medical Examiners.

Who Does the Tennessee Medical Foundation Help?

 Most physicians who seek assistance from the TMF suffer from alcohol or substance abuse. Once a physician is referred to TMA, he or she undergoes assessment, and in the case of a chemical dependency, will be recommended to undergo in-patient or outpatient treatment, depending on the situation. Once treatment is complete, the TMF typically will recommend a period of monitoring, usually around five years, in which the physician will be required to continue any recommended outpatient treatment and regularly check in with the TMF. If the physician is successful as a result of his treatment, the TMF will serve as an advocate for the physician, whether before the Board of Medical Examiners or through letters of advocacy or support before a physician’s employer.

 The TMF also provides support for distressed physicians who may have difficulties with disruptive behavior. The goal in addressing this behavior is to work in collaborate with the physician, his or her supervisor, and supportively identify the behavior in question in order to alter it. Many physicians are under a great deal of pressure in their professional environments, so it can be helpful to have a third party such as the TMF to serve as a referee in tense personnel situations.

Why Seek Assistance?

 “The goal of the Tennessee Medical Foundation is to be there to support, and turn whatever they are going through into a rehabilitative rather than disciplinary situation,” states Dr. Gray. This goal is best accomplished through early intervention, he adds.

If you or a physician you know is experiencing chemical dependency, mental or emotional illness, consider seeking assistance through the Tennessee Medical Foundation. In addition to potential harm to patients and oneself, a failure to seek early assistance can lead to professional discipline from the Board of Medical Examiners, resulting in probation, suspension, or even revocation of a practitioner’s license.

Alex Scarbrough Fisher

Alex Scarbrough Fisher is an associate attorney at Thompson Burton PLLC. Her practice area focuses on litigation and administrative law. Alex’s administrative law practice’s emphasis is in health care related boards, including the Tennessee Board of Medical Examiners and the Tennessee Board of Nursing.

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What Doctors Need to Know About Prescribing Controlled Substances

Prescriptions- DrugsMost physicians are aware of the increased regulations surrounding the prescribing of controlled substances. Just this year in the state of Tennessee, the Tennessee Department of Health began requiring providers to register with the Tennessee Controlled Substance Monitoring Database, new state legislation dictated that opioids and benzodiazepines cannot be dispensed in quantities greater than 30-day supplies, and physicians are required to report prescription drug overdose deaths beginning later this month. Tennessee is not alone in the strong position the government has taken against the abuse of prescription drugs. What do you as a physician need to know to avoid legal pitfalls surrounding the prescribing of controlled substances?

Is it Fair to Regulate Healthcare Providers Rather than Prescription Drug Abusers?

First, it is important to note that the majority of the legislation regarding the prescribing of controlled substances is targeted at healthcare providers rather than at the abusers of these substances. Despite the lack of fairness in this targeting of healthcare providers, it is simply more efficient for lawmakers and regulatory bodies to do so. One, there are substantially less healthcare providers than drug abusers, making healthcare providers easier to regulate. Two, healthcare providers have more to lose by declining to follow prescribing laws. Physicians and nurse practitioners depend on their ability to practice medicine for their livelihood and the livelihood of others such as their families and staff members. Thus, healthcare providers have a greater incentive to comply with the law than those seeking to abuse prescription drugs.

How can Healthcare Providers Safely Prescribe Controlled Substances?

Physicians and nurse practitioners with the power to prescribe should be meticulous in their record keeping. Every visit by a patient should be properly noted in that patient’s medical record, along with notes of the physician explaining the patient’s condition requiring the prescribing of a controlled substance. Electronic health records are a valuable way to ensure that patient records are time stamped, properly stored, and cannot be removed from the office, lost, or misplaced.

Physicians should consider requiring random drug testing for patients who are prescribed controlled substances to ensure that only the drug prescribed, in the amount prescribed, is in the patient’s system at any given time. Additionally, physicians should consider addiction screening as part of new patient intake in an effort to avoid the intake of patients who are at a high risk of prescription drug abuse.

Ultimately, however, physicians are not expected to behave like DEA agents and investigate any possible doctor shopping by patients. As a healthcare provider, your primary job is to do just that: provide for the health of your patients. Physicians should have policies in place to ensure compliance with state and federal laws regulating the prescribing of controlled substances to avoid legal issues that could affect a physician’s ability to provide care for patients.

Alex Scarbrough Fisher

Alex Scarbrough Fisher is an associate attorney at Thompson Burton PLLC. Her practice area focuses on litigation and administrative law. Alex’s administrative law practice’s emphasis is in health care related boards, including the Tennessee Board of Medical Examiners and the Tennessee Board of Nursing.

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