The Ryan Haight Act and the Changing Face of Telemedicine

 

The advent of telemedicine has made it possible to provide high quality medical care for underserved areas of Texas. Patients in rural areas now have the opportunity to receive care from the state’s best physicians when before travel costs would have made it impossible. Because of the new nature of telemedicine, state and federal laws and regulations have remained in flux. It is important for any telemedicine provider to be aware of these changes to ensure they remain compliant. 

One of the most significant changes to telemedicine was the passage of the Ryan Haight Act in 2008. The Act places a number of restrictions on the practice of online pharmacies and the ability of practitioner's to prescribe medications through the internet. It was named after Ryan Haight, a teenager who died of a drug overdose in 2001 from controlled substances he bought from an online pharmacy. Mr. Haight was able to procure a prescription for Vicodin online without ever meeting a doctor.

The Act regulates anyone who delivers, distributes, or dispenses medication by means of the internet. The Drug Enforcement Agency treats a practitioner who prescribes medication following a telemedicine evaluation as covered under the Act. Generally a practitioner is in violation of the act if he or she does not perform at least one in-person assessment of the patient before prescribing medication.

The Act does exempt practitioners from this requirement as long as a practitioner meets the federal definition of practicing telemedicine. A physician practicing telemedicine may prescribe controlled substances without an in-person evaluation if: (1) The patient is treated by, and physically located in a hospital or clinic which has a valid DEA registration; and (2) the telemedicine practitioner is treating the patient in the usual course of professional practice, in accordance with state law, and with a valid DEA registration. 21 USC 802(54)(A). The most important thing to note for a practitioner is that the location where the patient is being treated must be a hospital or clinic that is itself registered with the DEA.

The requirement that the patient be in a hospital or clinic with a DEA registration is more stringent than Texas Medical Board requirements. Under Board rules, a physical, in-person evaluation is not necessarily required to prescribe medication and there is no requirement that the hospital or clinic have a DEA registration. A physician may treat a patient solely through telemedicine as long as the physician creates a physician-patient relationship, the patient is being treated at an “established medical” site, e.g., a clinic or hospital, and all additional requirements are met, including the use of a qualified presenter to examine the patient. Texas law also mandates that a telemedicine provider create and maintain detailed written protocols aimed at preventing fraud and abuse as well as separate policies covering the protection of patient privacy.

There are a number of other special types of telemedicine that under federal law allow a practitioner to prescribe medication without an in person visit, such as practicing telemedicine while working for the Veterans Administration, or receiving a special exemption from the Attorney General. The interaction between federal law and state law in this field is complicated and changing, and made all the more complicated by the piecemeal construction of the Controlled Substances Act.

If you are a physician who is thinking of beginning a telemedicine practice, it is important to seek the advice of experienced counsel to ensure your practice meets all federal and state law requirements.  The applicable law can be complex and involve overlapping mandates on both the state and federal level. In Texas the rules regarding telemedicine continue to evolve as the Texas Medical Board frequently revisits this issue, often with an eye towards making more stringent regulation. The attorneys at the Leichter Law Firm have aided numerous physicians and other providers navigate both state and federal telemedicine law and implement best practices to help avoid the most common problems endemic to this field. In our experience, telemedicine is a complaint rich area where seeking the advice of a qualified attorney prior to being subjected to state or federal scrutiny makes all the difference.

 

Texas Medical Board Weighing New Rule Applicable to Non-Surgical Cosmetic Procedures

 

Since the summer of 2011, the Texas Medical Board has been considering adopting a new rule applicable to non-surgical, cosmetic procedures such as Botox or dermal filler injections. The proposal would create new standards and requirements applicable to physicians who perform or delegate the performance of such procedures. Currently, this area is covered by Chapter 157 of the Medical Practice Act which governs a physician's ability to delegate the performance of medical acts to a non-physician. This includes a person who is not licensed, such as a medical assistant, and individuals who are licensed but are not allowed to diagnose illness or create a treatment plan, such as a cosmetologist.

Underlying the Texas Medical Board's initiative is a concern that physicians have not been exercising sufficient control and supervision over the unlicensed persons performing delegated non-surgical, cosmetic medical acts. This includes allowing an unlicensed person to determine the need for the cosmetic procedure as well as deciding how this procedure was to be performed- i.e. how many Botox units to use and the selection of injection sites. In the reports submitted to the Board Committee drafting the new rule, Medical Board Staff have argued that this constitutes the unlicensed practice medicine.

Prior to the initial stakeholder's meeting weighing in on a proposed rule, the attorneys at my firm had represented a physician who had delegated filler injections to a medical assistant. The Board invited our client to an informal conference to address allegations that this constituted improper supervision and delegation. Based on our argument that the physician's actions were proper under Chapter 157's delegation provisions, the Texas Medical Board closed the case and convened the stakeholder's meeting.

The current version of the proposed rule would supplement the present requirements for physician delegation found in Chapter 157. The main change is a mandate that any patient receiving a non-surgical, cosmetic procedure must first be assessed and examined by the physician or, in the alternative, a midlevel practitioner acting under the delegation of the physician. The physician or midlevel practitioner is then responsible for establishing a diagnosis, obtaining the patient's informed consent, and preparing a treatment plan. Under the present law, a non-physician can arguably perform many of these functions as long as it is closely delineated by standing delegation orders and protocols developed by the physician.

The Texas Medical Board's proposed new rule also requires that either the physician or a midlevel practitioner be on-site during the performance of any delegated procedures. Additionally, the supervising physician is required to develop and maintain detailed protocols governing their delegates and must also create a quality assurance program satisfying various criteria. Importantly, the proposed rule makes clear the physician retains ultimate responsibility for the safety of the patient and the proper performance of the procedure.  

Several exemptions are located in the rule: These include laser hair removal performed in accordance with the Texas Health and Safety Code, the use of nonprescription devices, surgery as defined in the Medical Practice Act, and procedures performed by midlevel practitioners at their supervising physician's primary practice site.

Although the rule has not yet been accepted by the Medical Board, I anticipate it will eventually be adopted. This has been a hot topic lately and it is clear the existing law is not satisfactory to both the Board's Members and Staff. Physicians and unlicensed individuals performing these types of procedures need to be aware of the new rule and poised to ensure they are in compliance when and if it is enacted.

The Texas Medical Board aggressively pursues perceived violations in this area and I would only expect this to increase should the rule be adopted. My firm recently represented a licensed cosmetologist who was issued a Cease and Desist Order by the Board based on their belief my client was practicing medicine in the course of providing Botox injections due to inadequate oversight by her supervising physician. Attorneys at the Leichter Law Firm filed an appeal against the Order and the Texas Medical Board agreed to rescind it based on inadequate notice to our client. Currently, the matter is expected to proceed to a new cease and desist hearing.

Physicians and their delegates concerned about remaining in compliance with both the current law and proposed new rule should feel free to contact the Leichter Law Firm at 512-495-9995. We have assisted several other clients in this area some of which faced active cases with the Texas Medical Board and others who only wanted to ensure their protocols and procedures passed muster.

New TMB Law on Pain Management Clinic Certfiication Goes Into Effect on September 1st, 2010

 

In its last session the Texas Legislature passed a new law concerning Pain Management Clinics. The law, which becomes effective on September 1, 2010, makes it illegal to own / operate a Pain Management Clinic in Texas without first obtaining a certificate from the Texas Medical Board. Although it appears benign enough at first blush, upon closer review of its certification requirements the law’s fairly draconian nature comes into focus.

The new law bars individuals and entities from certification in any of a long list of circumstances. To summarize, if the owner/operator of a pain management clinic, their employee, or any person or entity who contracts with such a clinic have any of the following in their record, they are not eligible for certification by the Medical Board:

1)      Any individual who has had restrictions placed on or been denied a certificate or license by any federal or state agency authorizing them to prescribe, administer, supply, or sell a controlled substance;

2)      Any person who has been subject to a disciplinary action by a licensing entity (such as the Texas Medical Board) for conduct relating to the inappropriate prescribing, dispensing, administering, supplying, or selling of a controlled substance.

3)      Any individual who has been convicted of, pled no contest to, or received deferred adjudication for any felony;

4)       Any individual who has been convicted of, pled no contest to, or received deferred adjudication for a misdemeanor when the underlying conduct relates to the distribution of illegal prescription drugs or a controlled substance as defined in the Medical Practice Act.

In a single stroke this new regulation threatens to close numerous independent pain clinics in Texas. In my experience it seems overly burdensome, strict, and unreasonable to issue such blanket restrictions on those involved in pain management. This is especially true as those physicians whose primary practice involves the treatment of chronic pain are typically subject to some of the greatest scrutiny by the Medical Board. The TMB has a decidedly conservative view on pain medicine and this is reflected in the number of Board Orders and other disciplinary actions which focus on this area.  The new law has a “one strike and you’re out” mentality that does not provide for second chances, the opportunity to redeem oneself, or provide for the possibility that a previous disciplinary action may have been unwarranted or even plain wrong. All a physician needs is a single mark on their record where the Board disagreed with their treatment or prescription plan for a single patient and they will be barred from receiving a certification. Owner’s face a particularly onerous burden as the slightest infraction by one of their workers or contractors in or outside the workplace could mean the loss of the clinic’s certificate and, thus, their business.

I find it regrettable that nothing in the law permits a Pain Management Clinic currently in operation to be “grandfathered in” and given a certificate. Even if clinic has years of demonstrated compliance with all previous rules and regulations its owner could still be denied a certificate and immediately shut down if any of the stipulations above apply. Meaning, that on September 1, 2010, many owners with past infractions may lose their business outright, and those owners who have never faced disciplinary actions will now be faced with firing valuable and loyal employees or contractors who regrettably made mistakes in their past. This is especially troubling as physicians who signed Agreed Orders or accepted plea deals years in the past now face a serious consequence which was completely unforeseen at the time. If these individuals had know the future effect of such settlements, they may been chosen to more strenuously contest past allegations.

The only recourse for a Pain Management Clinic who will not be able to meet the criteria for certification is to attempt to restructure their business so they can meet one of the specified exemptions. In addition to state and federal facilities, the new law exempts hospitals, including outpatient facilities and clinics, as well as hospices. Realistically, the only real option available is sell or rearrange the clinic so that it is a subdivision of a local hospital. This pain management laws also raises potential federal preemptions issues depending on how it is enforced by the Medical Board.

It is unclear what will be the final impact of the new credentialing requirements. What can be said with confidence, however, is that pain management clinics have become a highly regulated sphere in Texas.

Recent Rule Changes at the Texas Medical Board

Recent rule changes by the Texas Medical Board will be taking effect on June 19th. Licensed doctors and licensed physicians in the state of Texas ought to be aware of these changes. The attorneys of the Leichter Law Office has the experience and expertise necessary to assist medical licensees or medical license applicants in these and other issues relating to your medical license.

 

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22 Tex. Admin. Code § 173.1(b)(1) (2009) (Tex. Med. Board, Profile Contents)

 

(a) The Texas Medical Board (the “board”) shall develop and make available to the public a comprehensive profile of each licensed physician electronically via the Internet or in paper format upon request.

 

(b) The profile of each licensed physician shall contain the following information listed in paragraphs (1) – (27) of thus subsection:

(1)   full name as the physician is licensed;

(2) – (27) (No change.)

 

Subsection (b)(1) previously read “full name as the physician requests that it be published;” with this rule change in effect the physician’s name will be published as it reads on the license, not when the physician requests it be published.

 

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22 Tex. Admin. Code § 190.8(1)(L)(iii) (2009) (Tex. Med. Board, Violation Guidelines)

Notwithstanding the provisions of this subparagraph, establishing a professional relationship is not required for a physician to prescribe medications for sexually transmitted diseases for partners of the physician's established patient, if the physician determines that the patient may have been infected with a sexually transmitted disease.

 

This new subsection will be amended to the current § 190.8(1)(L). A physician need not establish a professional relationship with the partner of a patient to prescribe medications for STDs if the patient with whom the physician has a professional relationship has the STD. This new subsection seems to allow the physician greater flexibility in controlling the spread of STDs quickly and effectively. 

 

Nevertheless, the Leichter Law Firm recommends being aware of the partner’s medical history and relationship with your patient in order to protect yourself and your license to practice in Texas.

 

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Whether registering your medical license with the Texas Medical Board, defending yourself in an investigation before the Texas Medical Board, or concerned that your medical license or practice might be in danger, you will need a competent and experienced medical license attorney to assist you. Going it alone against the Texas Medical Board risks your medical license and your livelihood. The attorneys at the Leichter Law Firm have the experience and expertise in dealing with the Texas Medical Board and assisting doctors and physicians in all of their medical licensure needs.

Texas Board of Nursing Abuse of Chemical Dependency Guidelines

 

According to the Texas Board of Nursing’s Administrative Rules any nurse who has a diagnosis of chemical dependency or who otherwise has a history of abuse of controlled substances must demonstrate through “objective, verifiable evidence” that they have been sober for the past twelve months before they can be allowed to continue practicing licensed nursing. Title 22 Texas Administrative Code § 213.29 and the Board’s “Eligibility and Disciplinary Sanctions for Nurses with Substance Abuse, Misuse, Substance Dependency, or other Substance Use Disorder.” Normally, a nurse will establish that they have been sober throughout the past year by offering up AA logs, negative drug screens, an expert evaluation by an addiction specialist, and testimony from support group members, coworkers, and other intimate acquaintances. The idea is that with the evidence in hand, the Nursing Board will be able to verify the nurse’s sobriety date and see if this meets the twelve-month threshold.

 

Regrettably, it has been my recent experience serving as an attorney for such nurses that the Texas Board of Nursing is all too eager to brush aside such offers of proof and race to a full administrative hearing where they seek, contrary to their own rules and policy guidelines, a one-year suspension of the nurse’s license. In the cases I have been involved with, Texas Nursing Board Staff have repeatedly argued that a one year “timeout” is the appropriate sanction. Their idea is that during this year long timeout period, the licensee can work on their recovery and accumulate verifiable evidence of their sobriety. The problem is that the Board maintains that this timeout applies whether or not the nurse all ready has twelve months of verifiable sobriety. This is an incorrect statement of the law and is grossly unfair and unnecessary for nurses who have already been sober for a year or longer.

 

Another problem with the Board trial strategy in this area is that in the lead up time to a full SOAH hearing, they typically refuse to accept a chemically dependent nurse’s evidence of their sobriety date. In line with this any Agreed Order offered by the Board to settle the case fails to include a finding of fact setting forth the licensee’s date of sobriety. Inclusion of the sobriety date is absolutely crucial. This is the finding the nurse needs so that they can trace back twelve months of continuous sobriety. Otherwise when they later seek to lift any bar to their ability to actively practice nursing, the whole issue of when is their initial date of sobriety will have to be litigated all over again. The Board of Nursing will once again reject the nurse’s evidence of sobriety as insufficient and force the licensee to once again hire an attorney and take the matter all the way through to the State Office of Administrative Hearings.

 

Given the Texas Board of Nursing’s intransigence on this point, a nurse’s only real option is to pursue their case all the way to SOAH the first time around. This is the only way to have a finding of fact issued, in this case by an Administrative Law Judge, establishing their date of sobriety so that they will have a concrete point from which to trace their one-year of sobriety. This is a waste of taxpayer money and needlessly creates stress and drains the finances of the nurse. Simply put, the Board needs to follow their own administrative rules and policies.

 

As an attorney I usually advise my clients in this situation not to accept an Agreed Order that does not contain a sobriety date. Fighting the Board all the way through SOAH may be more expensive in the short run than simply signing the agreement, however, in the long run they will probably need to hire an attorney when they later attempt to reactive their license or lift any bar preventing them from practicing as a nurse. This is because they still need to establish their sobriety date so that they can demonstrate twelve months free from any chemical substances. Furthermore, if they decide to challenge the Board now, their current license will remain active and they will be able to continue working as a nurse while the disciplinary process runs its course. Because of the Board’s refusal to accept a sobriety date, by the time this process has run its course, the nurse may have already accumulated a full year of sobriety and therefore not suffer any down time.

 

I strongly recommend that any nurse’s facing this scenario contact an attorney with experience in administrative law and representing clients before the Texas Board of Nursing. They will be able to help you accumulate the evidence needed to demonstrate twelve months of continuous sobriety and be able to discuss with you the best options for protecting your license.

Texas Board of Nursing and Standard of Care Violations

 

Mirroring general trends, the number of standard of care complaints against Texas nurses have risen dramatically in the past few years. All too often, the Board has chosen to punish nurses as individuals for what are actually institutional defects in the larger medical entities where they practice. This is particularly true for nurses serving marginalized patients such as those found in the prison system. Further, just as in cases of chemical dependency, unprofessional conduct, and criminal convictions, the danger to a nurse’s license is very real.

 

These cases can be especially frustrating for clients because the basic challenge is to their competency as a nurse. All too often the Board is willing to pin the blame on a nurse for situations in which there was no clear breach of the standard of care and in fact no evidence that the stated medical intervention would have made a difference. Modern nursing practice can be a hectic experience and unfortunately the Texas Nursing Board is often reluctant to accept that people do in fact die or get sicker in hospitals without a breach in the standard of care by a nurse. Additionally, the dynamic of these matters is such that the Board may investigate one nurse who then tries to shift blame, whether real or nonexistent, onto another. 

 

The need for legal representation in such cases cannot be stressed enough. Effective advocacy in standard of care cases generally requires the parsing of voluminous medical records and the development of expert testimony on the applicable standard of care and whether or not it was met in that case. A nurse without an attorney will be placed in a decided disadvantage by the lack of their own expert who can independently challenge or verify the opinion of the Board of Nursing’s expert who, not too surprisingly, seems to always side with BON. Add to this the development of any applicable mitigation evidence, and most nurses will be left with a complex situation where an attorney on your side will be an immeasurable help. It’s not worth going it alone, as the Board generally feels they can do what they want to a nurse who doesn’t have a lawyer. Remember, your license and ability to provide for yourself and your family is at stake.

Professional Licensing Lawyers Outside Texas

I continually get phone calls from licensed professionals in other states or need to refer a client to an attorney in another state due to reciprocal discipline / multiple state licenses.  After many successes and a few failures I have come to the conclusion that the following lawyers are who I would send my family members to if they needed help with their occupational / medical license.

California

Frederick M Ray, PC

Attorney at Law

www.calicenselaw.com

800-474-6911

Georgia

Frances Cullen, PC

Attorney at Law

www.franseville.com

523-2044

New York

Fred Friedman

Friedman & Mahdavian, PC

212-302-0100

www.law4docs.com

I have had excellent success with all of these lawyers when they have handled matters for our firm's clients in their jurisdiction.  Fred Ray and Fran Cullen are especially helpful when a criminal matter is involved as they both have extensive criminal trial experience and are capable of efficiently and effectively handling both the criminal case and the administrative proceeding.