Senate Bill 195 and Changes to DPS Controlled Substances Registration Requirements


Some notable legislation came out of the 84th Legislative Session, at least as it relates to the practice of medicine in the state, and specifically the state’s efforts to fight prescription abuse. Senate Bill 195, passed in the most recent legislative session, serves up some significant changes to the Department of Public Safety’s (DPS) role in regulating the prescribing of controlled substances. 

Effective September 1, 2016, a physician or practitioner in the state of Texas will no longer need to hold a Controlled Substances Registration (CSR) through the DPS. I see this as a positive change as requiring a state DPS registration alongside the federal registration already mandated by the federal Drug Enforcement Administration is redundant and unnecessary. Practitioner’s will probably be happy to have one less expiration date to track, and one less fee to pay.         

Senate Bill 195 also moves the Prescription Access Texas (PAT) electronic prescription database from one state agency to another, specifically from the DPS to the Texas State Board of Pharmacy (Pharmacy Board). PAT has been available for wide use since 2012. Most practitioners who might have occasion to use PAT, are probably aware of it at this point. It makes prescribing data more easily accessible to physicians, pharmacists, and law enforcement. The primary utility for practitioners is the ability to access a patient’s full prescribing history and verify that patients are not receiving controlled medication from multiple sources. It is also useful to monitor whether the practitioner’s own prescribing authority has been used without their knowledge.

So, what is going to change now that PAT is moving under the Pharmacy Board’s operation and control? It appears improvements that have been considered include allowing access to prescription data from surrounding states or nationwide, creating a more user-friendly interface with increased functionality, and ensuring reliable access to the program. The legislature decided that the Pharmacy Board, as a healthcare agency, and an agency engaged in the regulation of filling prescriptions, is better equipped than DPS to implement those changes. We shall see.


Texas Medical Board Turns Its Attention to Testosterone and Hormone Replacement Therapy


It should go without saying given the Texas Medical Board’s recent aggressive regulatory stance on the treatment of chronic pain, Texas physicians involved in the practice of testosterone and hormone replacement therapy should be made aware of a discussion by the Board at a recent Board meeting regarding a U.S. Food and Drug Association (FDA) safety announcement.

On January 31, 2014, the FDA issued a safety announcement alerting the public the FDA was investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. The FDA stated that although it had been monitoring risks related to testosterone products and decided to reassess this safety issue based on the recent publication of two separate studies suggesting an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.

To be clear, the FDA safety announcement stressed the FDA had not concluded FDA-approved testosterone products increased the risk of stroke, heart attack, or death or that patients should stop taking prescribed testosterone products. The Texas Medical Board’s discussions on these issues focused on relevant Board rules regarding standards for physicians practicing complementary and alternative medicine, including requirements of patient assessment, disclosure of expected outcomes, risks and benefits of treatment, a documented treatment plan with periodic review, adequate medical records, and therapeutic validity. The Board also discussed potential disciplinary issues with testosterone therapy which could arise with the “off-label” use of testosterone if the physician did not provide and obtain proper informed consent for off-label use or if the physician did not discuss the benefits weighed against possible risks of the therapy.

Because of the Board’s interest in this particular topic, Texas physicians in the field of testosterone or hormone replacement need to be hyper-vigilant in keeping proper consents and documentation, and keeping apprised of the relevant Board rules.   The attorneys at the Leichter Law Firm have aided numerous Texas physicians to implement best practices.  If the attention has shifted to you and you have an investigation or legal case pending before the Texas Medical Board, and want a knowledgeable administrative law attorney with experience working with the Board and its members, please call the attorneys at the Leichter Law Firm for a free consultation at 512-495-9995.


Texas Dental Board Offers Proposed Order Without Giving Dentists a Full Opportunity to Respond


The processing of complaints filed with the State Board of Dental Examiners (“Board”) is governed by Chapter 255, Title 3, Occupations Code and Rules 107.00 through 107.103 of the Board’s Rules. After deciding that the complaint involves potential violations, Board Staff has the authority to schedule an informal settlement conference, draw up a proposed board order, or file a formal complaint with the State Office of Administrative Hearings. As the informal settlement conference track gives the licensees an opportunity to present their mitigating or exculpatory evidence to a Board member who has the authority to resolve an investigation, such a setting is many times favorable to flesh out the facts and give the licensees a venue to clarify the issues. 

Unfortunately, the more recent trend has pointed to Board Staff presenting proposed board orders to licensees in lieu of scheduling informal settlement conferences to resolve cases. These board orders are prepared and reviewed by Board Staff, including the dental director who is employed by the Board.  In the proposed order Board Staff will make findings of fact and conclusion of law, and list sanctions without any input from the licensee. The proposed orders are sent to the licensees accompanied by a form letter stating the failure to sign the order would result in a formal complaint and a contested case hearing at the State Office of Administrative Hearings. Many times, licensees, without an understanding of the disciplinary process will be coerced to sign the order as the prospects of a formal hearing are daunting. What the dentist often does not know is they still have the right to request an informal conference and obtain a copy of all non-confidential information in Staff’s investigative file. For these reasons, among others, licensees investigated by the Board should seriously consider hiring an attorney.

The attorneys at the Leichter Law Firm have extensive experience in professional licensing and administrative law and will generally help to secure better outcomes than a practitioner facing the Board alone. In the scenario explained above, we would request an informal settlement conference so that we would be better able to marshal evidence and present your case to Board Staff and a representative Board member.  If you have received a proposed board order without having been afforded the opportunity for a face-to-face informal meeting, please call the attorneys at the Leichter Law Firm for a free consultation at 512-495-9995.


Recent Changes to the Texas Peer Assistance Program for Nurses

In the past year-and-a-half there have been several changes to the Texas Peer Assistance Program for Nurses (TPAPN). First, the length of participation has been increased from two years to three years for RNs and LVNs and three to five years for nurse practitioners and CRNAs. This change brings TPAPN more in line with the other official peer assistance programs for health care professionals in Texas such as the Texas Physician Health Program and Professional Recovery Network.

Another important change has been the Board’s move towards offering confidential TPAPN orders in certain cases. Previously, the Board had the option to either refer a nurse to TPAPN directly or enter a public order requiring the nurse to enroll. For cases raising moderate to severe public safety concerns or where the nurse had previously participated in TPAPN, the Board was highly unlikely to agree to a TPAPN referral without a public order. Now such cases can be settled through a non-public order accomplishing the same result. This is a good option in many cases as it allows the nurse to avoid a public order which would follow them for the rest of their careers.

More recently, TPAPN has initiated a new program for nurses with marginal mental health issues comparable to the Extended Evaluation Program (EEP) available to nurses who may have misused a mind-altering substance but lack a DSM-V substance abuse or chemical dependency diagnosis. Like EEP, the new mental health track is a one year commitment, confidential, and not considered to be disciplinary. Typically the participant is only required to regularly meet with their mental health provider who is expected to supply periodic status reports to TPAPN. My experience thus far has been that clients with minor mental health issues or diagnoses in long-term remission are most likely to be accepted.

Given these new developments it is more important than ever for a nurse to contact an experienced attorney to discuss their options if they have been asked or are considering participation in TPAPN. The changes outlined above offer new possibilities for resolution which were not previously available. It takes a lawyer familiar with the Board and TPAPN to know what might be available to a nurse and how to navigate the system to achieve the best result. The increased length of the standard TPAPN contract makes it all the more important for a nurse to seek knowledgeable counsel rather than proceed on their own.

Inappropriate Referrals to the Texas Physician Health Program


Since its inception several years ago, the Texas Physician Health Program has provided a valuable option for physicians suffering from chemical dependency, serious mental illness, or physical impairment. For appropriate Texas physicians, the Physician Health Program (also known by its acronym “PHP”) can help a practitioner set up a structured recovery or monitoring program based on recommendations by qualified medical and mental health professionals. Additionally, in most instances participation in PHP is confidential and will not be reportable to the National Practitioner Databank, hospitals, insurance networks, or other credentialing entities.

Unfortunately, my firm has observed an increasing number of Texas physicians referred to PHP by the Texas Medical Board for marginal issues. This includes physicians with a single DWI conviction, long stable mental health conditions, and physical conditions unlikely to affect their practice. Such a physician can quickly find themselves asked to sign a long-term participation agreement with PHP that imposes restrictions on their practice and onerous monitoring conditions. This situation is tragic as in many instances it is possible to obtain a dismissal if the physician hires an attorney and allows the Board to review their case.

A common scenario begins with a physician fulfilling their duty to self-report a first-time DWI or Public Intoxication conviction to the Texas Medical Board. As a follow-up, the physician will often receive a letter from the TMB stating the Board is referring their case to the Physician Health Program for evaluation in lieu of an investigation or possible disciplinary action. The physician is then typically contacted by PHP and asked to set up a meeting with the program director, also a physician, at their office in Austin, Texas. Out of an abundance of caution, PHP will then usually ask the physician to sign a participation agreement with or without further evaluation or treatment. At this juncture, many physicians will enter into the agreement out of a fear of Board action even though their case would likely be dismissed by the Board at an informal conference.

My firm has represented many physicians in the same and similar situations and, through skillful representation before the Medical Board, obtained a dismissal at or before an informal conference. If the issue is marginal, not supported by a diagnosis, or is an existing diagnosis in long-term remission, it is often possible to put together appropriate evidence and expert opinion, present this to the TMB, and convince the Board to dismiss the case without taking any action.

The Board’s decision to refer a case to the Physician Health Program is usually reflexive and done prior to any real review of the physician’s case and circumstances. Effective advocacy by an attorney familiar with the Board’s process can allow a physician with a marginal issue to avoid both discipline by the Board or participation in PHP. Any physician finding themselves in this type of situation should contact an attorney to discuss their options. Evaluation and participation in the Texas Physician Health Program may be inappropriate and unnecessary.


An Overview of the Physician Peer Review Process and the Importance of Legal Counsel


A hospital peer review has the potential to seriously disrupt a physician’s medical practice, often bringing with it a cascade of legal consequences that can devastate a health professional's practice and reputation. If you are a physician facing the prospect of a peer review due to allegations of unprofessional behavior or a standard of care complaint, the earlier you seek help from an experienced healthcare law attorney familiar with the peer review process, the better positioned you will be to protect yourself against these consequences.

An understanding of the process and its possible sequela is important for any physician faced with the prospect of a peer review. There is much more at stake for the physician than whether he or she will retain their ability to work at a particular hospital and many pitfalls which can catch the doctor unawares.

For example, if a physician resigns his privileges during the course of a hospital investigation, the resignation will likely result in a report to the National Practitioner Databank ("Databank" or "NPDB") , a national clearinghouse of information regarding physician misconduct. A report will also be forwarded to the Texas Medical Board which will then open an investigation leading to potential disciplinary action. The NPDB report, and possible Board order, will be visible to other hospitals where the physician holds privileges, and may result in yet further investigations. Any attempt to move on and gain new privileges will require an explanation of the report. Finally, the NPDB report will raise questions with insurance carriers, whom may attempt to remove the physician from their provider network.

The Investigation Stage:

Broadly speaking, the peer review process takes place in two stages: an investigation followed by a fair hearing.  The specifics of this process will be governed by the hospital's medical staff bylaws which outline any right of the physician to participate in the investigation and the procedural details of the subsequent fair hearing.

Investigations are typically initiated by the hospital's Medical Executive Committee ("MEC") following a poor patient outcome or complaints about a physician's behavior or professional conduct. In some instances the hospital administration will also have the authority to open an investigation which will then be passed on to the MEC.

In cases where there is a perceived threat the physician's continued practice would pose an imminent threat to the hospital's patients or staff, the MEC may decide to immediately suspend the physician’s privileges pending further investigation. In addition to the severe damage such a temporary suspension inflicts on a physician's practice and reputation, should such a suspension continue for more than thirty days, the hospital is required to file a report with the NPDB and Medical Board.   

If the MEC proceeds without temporarily suspending the physician's privileges, the formal investigation process will begin and the physician will receive official written notice of the allegations. If the investigation is related to medical care, the MEC will likely send the relevant medical records out for external peer review by medical professionals in the same field as the physician. After these reviews are complete, the MEC or an investigative panel, made up of other physicians, will then interview the physician.

During the hospital’s investigation, the physician’s ability to actively defend against the allegations is usually limited. For example, the physician may be given little to no access to the relevant medical records. Likewise, the physician may not be allowed to speak with staff members who are potential witnesses to the issue under review. Additionally, the hospital will often restrict the participation of the physician's lawyer during the MEC's investigative meeting(s) even though the physician is typically asked to attend and answer questions.

When the investigation is concluded, the MEC will consider the evidence and make a recommendation. If the recommendation is to drop the allegations, the peer review ends. If, however, the MEC decides to modify, suspend, or revoke a physician's privileges, the physician must be timely notified in writing of the proposed action, the reasons for this recommendation, and informed their right to a fair hearing. In Texas, physicians also have the right to attempt to mediate the dispute with the MEC and hospital.

The Fair Hearing Stage:

If the physician does not agree to the MEC’s recommendation, they may request a fair hearing. A fair hearing is usually conducted at the hospital before a panel of physicians who are also on the medical staff. Ideally, the panel should include one or more physicians in the same specialty. The panel should not include any doctor in direct economic competition with the physician being peer reviewed.  

A hearing officer, normally a lawyer, will be appointed to oversee the hearing. The hearing officer's role is to resolve disputes between the physician and the hospital regarding the admissibility of evidence and hearing procedure and advise the hearing panel on other legal issues.  A hearing officer should also ensure that the hearing is conducted in compliance with provisions of the Federal Health Care Quality Improvement Act ("HCQIA"). The HCQIA requires the hospital to provide a physician certain due process rights, and a failure on the hospital’s part to provide these rights could result in the hospital and MEC losing its statutorily granted immunity from certain types of lawsuits.


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Texas Department of Insurance-Division of Worker's Compensation Increases Oversight and Enforcement Actions Against Designated Doctors


For the past several years the Texas Department of Insurance-Division of Worker's Compensation (TDI-DWC) has steadily increased the number of enforcement actions initiated against Designated Doctors serving the Texas worker's compensation system. The results of such enforcement actions can range widely— from a requirement that the Designated Doctor (DD) complete additional training, the payment of a sizable administrative penalty, to removal of the physician's Designated Doctor (DD) status. Most DD's are likely aware of this trend as it corresponds with broader efforts by DWC to more tightly regulate the worker's compensation process.

To accommodate this augmented activity the Division of Worker's Compensation's enforcement division has expanded its staff through recruitment from other state healthcare agencies, such as the Texas Medical Board. As a by-product of this hiring policy the DWC has adopted and modified many of the procedures commonly used by these other administrative bodies. This includes implementing an informal conference procedure which largely models that used by the Medical Board. Similarly, DWC Staff also frequently forward a proposed settlement agreement to a Designated Doctor prior to an informal conference or other adequate opportunity to respond to alleged deficiencies. This procedure mirrors that used by the Texas Board of Dental Examiners and Texas Board of Nursing.

A DD will often first become aware of a pending enforcement action through a records request from DWC's enforcement division asking for all documentation still in the DD's possession related to one or more specified patients. Alternatively, DWC will send the Designated Doctor official correspondence expressly notifying them an enforcement action has been opened, listing the matters being investigated, and ask for a response. Prior to providing a response, a Designated Doctor in receipt of such a letter from the Division of Worker's Compensation should promptly contact an experienced attorney to discuss their case and determine whether it is advisable to retain legal representation. We have seen many clients unknowingly do irreparable harm to their case by submitting a response first and only seeking legal counsel after they receive a proposed resolution from the enforcement division.

The DWC can initiate an enforcement action against a Designated Doctor for a broad array of different reasons, including submitting Designated Doctor's Evaluations (DDE) late, establishing a date of Maximum Medical Improvement (MMI) or Impairment Rating (IR) with which the Division's Office of the Medical Advisor disagrees, or having an Administrative Law Judge subsequently overturn the DD's findings in a hearing involving an injured worker. In fact, the kind of conduct, issues, errors, and omissions that can be considered a violation of the DWC's Rules is vast and many may seem picayune to the physician or outside observer. Regardless, the enforcement division pursues each issue zealously and makes full use of DWC's broad discretion to regulate its DD's in seeking enforcement action.

Any Designated Doctor who has been targeted for a possible enforcement action by DWC should immediately contact an attorney experienced in representing clients before the agency. The risks of going it alone are substantial and the DWC does not shy from removing physicians as Designated Doctors, particularly not in the overactive regulatory climate which currently prevails. My firm has been very successful in achieving successful outcomes for DD's before DWC and this includes physicians whom the enforcement division sought to have removed from the program. A vigorous rebuttal and/or remedial presentation by a lawyer experienced in advocating before the DWC can make all the difference in the final outcome.


Foreign Medical Graduates and the H-1B Visa: A Better Choice


A foreign physician coming to this country to pursue his residency is often faced with two visa options. He is typically required to choose either a J-1 visa or an H1-B visa. Both of these visas are "non-immigrant" visas, which do not entitle the visa holder to any permanent status in the US. For most foreign medical graduates, however, the H-1B visa is a better choice for physicians wishing to remain in the US after the completion of their residencies. 

From 1976 through 1990 physicians coming to the United States to provide direct patient care, including those coming to the US to do their residencies, could only come on J visas. While easy to obtain, J visas were particularly hard on physicians because of the 2-year foreign residence requirement - After finishing their residencies, doctors were required to return to their country of nationality or last residence for 2 years. In 1990, Congress changed the law and allowed foreign physicians, including those coming to do their residencies, to petition for H-1B visas.

Many residency programs prefer doctors to come on a J-1 visa because of their familiarity with this process and the fewer formalities associated with it. For instance, programs offering J-1 visas do not have to file a Labor Condition Application (LCA) with the Secretary of Labor. The LCA requires programs offering H-1B visas to make certain attestations, such as guaranteeing equal pay with similarly qualified US doctors; a violation of the LCA can leave the program exposed to fines and restrictions on employing foreign workers. 

Many foreign medical graduates (FMGs) also prefer coming on a J-1 visa because of the easier United States Medical Licensing Examination (USMLE) requirements.  J-1 foreign medical graduates need only pass USMLE I & II whereas H-1B visa seekers must pass all three steps. Additionally, a J-1 visa typically lasts the duration of the training program, whereas H-1B visas only last three years with a one-time extension of another three years, though in certain circumstances multiple extensions may be allowed.   

Requirements for Foreign Medical Graduates (i.e. foreign citizens who went to medical school outside the United States) to obtain an H-1B visa include:

  1. Completing Steps 1, 2 and 3 of the USMLE;
  2. Holding a license or other authorization to practice in the state of employment;
  3. Demonstrating English proficiency;
  4. Having an unrestricted license in a foreign state or documentation showing graduation from a  foreign medical school. 

Though seemingly less attractive than the J-1, the H-1B offers the huge benefit of allowing the foreign medical graduate the ability to apply for an immigrant visa (green card) and remain working in the country pending the determination of the application— once an employment-based immigrant visa petition has been filed, the H-1B can be renewed until such time the petition is decided on. The terms of the J-1 visa on the other hand requires the FMG to return to his country of residence for at least two years before returning to the US. 

In some cases, the J-1 two-year residence abroad requirement can be waived, but only by accepting employment in healthcare professional shortage areas or medically underserved areas. The number of waivers are very limited if granted by a state agency - 30 per state per year, making the waiver a risky proposition. Additionally, such a J-1 waiver only allows the FMG to transition to the H-1B visa - not directly to a green card. As a result, the FMG's immigration process is further delayed.  Even if the foreign medical graduate on a J-1 marries a US citizen, the physician must still fulfill the two-year residence abroad requirement or obtain a waiver.  

Though some states, such as Texas and New York, enacted laws that neuter the H-1B's benefits, see here, the severe shortage of doctors has required those states to rethink their laws. In 2012 a federal appellate court struck down the New York law discriminating against foreign doctors. Moreover, in June 2013, Texas repealed its law requiring H1-B physicians to work in medically underserved areas such as their J-1 waiver counterparts. As a result of these new developments, the H-1B remains the best option for a physician to pursue residency and eventually obtain permanent status in the US.   


The National Resident Matching Program and Common Problems to Avoid

The National Resident Matching Program (NRMP) is the non-profit, non-governmental organization that facilitates the annual “match” between medical students and residency programs. Created in 1952, it was implemented to make the process more streamlined, and initially to ease the competition between programs in filling available positions. While it has changed over the years, the NRMP employs a matching algorithm to match qualified students and programs together. Taking part in the match process requires both the program and the student to enter into a Match Participation Agreement with the NRMP that makes the NRMP’s match a binding commitment. Neither the program, nor the student, can unilaterally break the match, though either party can apply for a waiver of the binding commitment if either side can demonstrate serious or extreme hardship as a result of the match.   

The Match Participation Agreement also designates conduct that constitutes a violation of the agreement, and for those violations, the NRMP can impose some very serious penalties. For example, any incident decided to be a violation by the NRMP will result in a Final Report detailing the participant’s transgressions, which is sent to the applicant’s medical school, the American Board of Medical Specialties, the residency program, the Federation of State Medical Boards, and others. Other possible penalties include being barred from participating in future NRMP Matches for up to three years, or being barred from accepting a position with any residency program that participates in the NRMP Match. For medical students, the Match is just about the only game in town, especially for M.D.’s, and a prohibition from participating in the Match, or from accepting positions in Match-associated programs, has the potential to throw a giant wrench into one’s medical career just as it is getting started. 

The best way to avoid such consequences is to avoid violations of the Match Participation Agreement, which include: failure to provide complete, timely and accurate information during the match process; attempts to subvert the match process; failure to accept an appointment; and any other irregular behavior. The issues that we come across most frequently are an applicant’s alleged failure to provide complete, timely, and accurate information relating to disciplinary action that they faced at some point in their medical education.   If a residency program makes a fuss about the completeness of an applicant’s disclosures, the NRMP can use their broadly worded Agreement to initiate an investigation. As we stated above, the consequences can be great, including banning an applicant from the Match for a term of years (or life), or decreeing that the applicant cannot take a position with a program that participates in the Match.   

If you are a physician Match-applicant who has run afoul of the NRMP, please consider hiring an experienced healthcare law attorney to assist you. The consequences of NRMP sanctions can be great, especially at this formative stage in your career. Contact the healthcare law attorneys at the Leichter Law Firm, PC, at (512) 495-9995.


TPAPN shifts to three-year program for LVN/RN's and five-year program for APN/CRNA's

Starting September 1st, 2013, the Texas Peer Assistance Program for Nurses (TPAPN) will significantly increase the length of their standard monitoring contracts. Previously an RN or LVN participant could expect to sign a two-year participation agreement while an Advanced Practice Nurse or CRNA would be asked to participate for three years. RN/LVN's and APN/CRNA's will now need to participate for three and five years, respectively. The new change applies to both nurses who enter TPAPN with or without an accompanying Board Order.

This policy change is probably meant to bring TPAPN more in line with the monitoring programs used by other Texas healthcare licensing agencies. For example, the Professional Recovery Network, which serves as the official peer assistance program for the Texas Pharmacy, Dental, and Veterinary Boards normally asks its participants to sign a five-year agreement. The Texas Physician Health Program also frequently makes use of a five-year agreement, although this can be much longer depending on the case.

While it is understandable why the Texas Board of Nursing would want to increase the standard timeframe for TPAPN participation, I have concerns as to how effective this change will be without corresponding reform of the TPAPN process. My firm has represented hundreds of nurses who have participated in TPAPN both with and without a corresponding Board Order. Many of these nurses have ended up in TPAPN even though they do not have a qualifying substance abuse, chemical dependency, or mental health issue. Usually this is due to the nurse believing they have no other option to retain their license and/or avoid action by the Board. This is oftentimes incorrect and our firm has helped numerous nurses achieve a better result.

This being said, for many nurses participation in TPAPN is a good option. TPAPN does provide a level of structure and direction which can be helpful to someone who is new to sobriety and just learning the tools necessary to remain abstinent. Ideally, this should be accompanied by a supportive and non-punitive atmosphere designed to assist this process. TPAPN's goal is, and should be, assisting nurses to become and stay sober while monitoring this process through objective indicators such as drug and alcohol screening and regular reports from employers and medical/mental health providers. Unfortunately, it has been my experience that many of TPAPN's rules and policies are counterproductive to these goals, lead to unnecessary referrals to the Board, and discourage potential participants from enrolling in the program.

Flaws with TPAPN include its policy of refusing to allow a participant to work until they have been cleared by an evaluator and passed a drug and alcohol screen. While sometimes this makes sense, oftentimes it does not as the nurse is already sober and may have been so for some time. This requirement frequently results in the nurse losing their job which significantly undermines their ability to successfully participate both from a sobriety, financial, and mental health standpoint.

TPAPN also prohibits its participants from taking any medication that is potentially abusable even if it is medically indicated, validly prescribed, and completely unrelated to the reason for their participation. For example, a nurse who enrolls in TPAPN due to a history of alcohol abuse but who also has a longstanding and well documented chronic pain syndrome will be asked to discontinue all narcotics. A nurse may also be forced to discontinue psychiatric medications even though these are medically indicated and beneficial. This rule automatically disqualifies a whole range of potential participants who would otherwise be good candidates and can make compliance for existing participants extremely difficult.

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