The Pledge: An Ethical Commitment

By Daniel L Monahan. MD, Elna Masuda, MD, Robert L. Kistner, MD

This seems to be the year of the conscience in vein care. At the annual American College of Phlebology meeting in November 2015, and the annual American Venous Forum meeting in February 2016, and in other meetings, calls for ethical and appropriate treatment came from the podium, followed by numerous hallway conversations. A number of articles have been published in this issue of VEIN Magazine discussing the same topic.

In his Crawford lecture at the Society for Vascular Surgery Annual Meeting in 2014, Dr. Peter Lawrence brought public attention to the exponentially increasing numbers of venous ablation cases performed across the country. The ongoing problem of overutilization of resources became nationally visible as a result. While there have been occasional physicians practicing unethically for as long as there has been physicians, the ablation revolution in venous disease seems to have set off an epidemic.

Almost as soon as the thermal ablation technologies became available, there emerged opportunistic physicians without adequate training in venous disease that presumed to perform these procedures. In the past, there were debates as to which specialists should perform these venous procedures. The pendulum has swung from that debate to a conversation about identifying inappropriate care and searching for solutions.

Outpatient vs inpatient thermal ablation

The first and foremost factor is that these procedures can be done in the office. Unlike procedures performed in hospitals or surgical centers, there is no quality assurance oversight. Questionable practices can occur, and who is to know? But we do know. We hear about the practices as we see patients who have been to physicians who have recommended inappropriate care. We hear reports of inappropriate care from industry representatives. We hear it from nurses and technologists as they report unconscionable practice patterns.

Furthermore, we even hear it from the guilty parties as they boast of their productivity and income, or publicly share their experience. And, as noted, we know that the numbers of ablations performed have been increasing out of proportion to what goes on in vein centers run by credible physicians.

The motivation behind the inappropriate behavior can be genuine ignorance in some cases, but often reflects a practitioner putting self-interest over patient welfare—exploiting patients for financial gain.

Unfortunately, there is no scientific data proving or identifying the scope of the problem. Ideally, a scientific approach would identify the behaviors of concern, their prevalence, and their economic impact. It would provide a measure that would identify physicians who ignore the current treatment guidelines. This could lead to solutions that would control overtreatment or abuse.

Curbing thermal ablation overutilization

For possible solutions, the first step of creating guidelines has been taken by the Society for Vascular Surgery-American Venous Forum Guidelines Committee, which published clinical practice guidelines on the care of patients with varicose veins and associated chronic venous diseases (CVD) in the Journal of Vascular Surgery in 2011. Using these guidelines as grounds for what is proper to do for CVD, the presence of exploitive behaviors now demands the establishment of a list of behaviors that are considered unacceptable, and should be denied insurance compensation.

In the previous issue of VEIN, a panel recommended a code of conduct be developed by a council or alliance composed of members of various societies involved in vein treatment. This will take time, possibly years, and, in the interim, strategies are needed to curb patently-unacceptable practices. One method may be mandatory accreditation, but there is lack of agreement as to whether this is likely to be effective.

Dr. Lawrence’s lecture was published widely, including reporting in the national media. The media puts articles about inappropriate behavior in headlines, perhaps because physicians are supposed to be trustworthy. It is a presupposition that the physician will reliably place the patients’ interests first and would never exploit or do anything harmful to patients. However, exploitation is what Dr. Lawrence discussed, and it falls in the realm of the Hippocratic Oath. It is an ethical standard that speaks to every violator: shame on you.

If there are enough venous specialists who affirm these principles, which could be termed “The Pledge”, it may lead to more rapid curtailment of “bad” practices in the field of the venous specialist. Consequent to the publication of this affirmation, a referring colleague might recognize those patients subjected to exploitive practices and therefore withhold future referrals.

Patients themselves may recognize exploitive behavior and seek another option. The media could initiate a groundswell over these unacceptable practices, which could lead to insurance payors withholding payment for their practice. To promote this, we offer the following list of “don’t do’s” while we await more formal delineation of the acceptable and non-acceptable day-to-day practices from the societies. This can be called “The Pledge” for adoption by all credible venous practitioners.

The Pledge

Pledge #1: Ablation procedures will be performed only on truncal veins associated with established symptoms and signs of venous disease.

Comment: There is no evidence to support ablation of saphenous veins in the absence of symptoms and signs. There is no scientific ground to the idea that ablating a vein that is unassociated with signs or symptoms prevents later problems. The SVS-AVF Guidelines specifically identify appropriate symptoms and signs, and exclude—as medical indications and from insurance coverage—treatment for cosmetic purposes alone.

The systematic ablation of the GSV, SSV, and AAGSV, and perforator veins in the same limb, and even both limbs, of a patient may be rarely justified, but should never be a frequent practice of a given practitioner.

Pledge #2: Ablation procedures will only be performed when imaging-confirmed reflux is documented in truncal veins associated with appropriate symptoms and signs.

Comment: We are aware that there are physicians who seek to perform as many ablation procedures as possible in a given patient for their own financial gain. There are physicians who recommend ablation for truncal veins that do not show reflux on examination.

Significant reflux on ultrasound examination is reported in some centers even in cases where actual reflux is absent or negligible. This is falsification of data and is completely unethical. In addition, reflux identified in an isolated segment of a saphenous vein does not by itself justify an ablation procedure.

Pledge #3: Truncal vein reflux will be treated with a single procedure for each named vein (GSV, AAGSV, and SSV).

Comment: We are aware that there are physicians who perform, and bill for, multiple ablation procedures on a single truncal vein at the same setting or at different settings, treating different levels of the same vein with separate procedures. They might recommend three or four ablation procedures at different levels on a single great saphenous vein. This practice should be thoroughly investigated in every case, and rarely justified, in the absence of previously failed procedures.

Pledge #4: Ultrasound technicians should not be financially, or otherwise, rewarded for finding and reporting reflux in truncal veins, which intentionally creates a monetary incentive for sonographers to find cases for ablations.

Comment: We are aware that there are some physicians who monetarily provide bonuses for their ultrasound technicians to “find reflux.” Ancillary providers should be paid for the job done, not for the results. Also, physicians should not intentionally falsify or alter the duplex ultrasound findings to justify ablations. This practice has led to ablation of veins that are actually normal.

Pledge #5: Sclerotherapy or phlebectomy of varicose veins should be performed by the treating physician at the time of the truncal ablation procedure (e.g., concomitantly), or at a planned future time (e.g., staged).

Comment: We are aware that some physicians who treat varicose veins only perform truncal ablations and omit addressing varicosities with either phlebectomy or sclerotherapy. Frequently these patients have to seek out another physician who can complete their treatment. This is a case of exploitation not only of patients, but also of colleagues. The vein specialist, by training and intent, will take responsibility for the treatment of underlying reflux sources as well as visible varicosities.

There may be situations in which different physicians complete the treatment based on prior arrangement. In that case, the patient is informed and aware of the treatment plan. Ablation procedures as a sole treatment should be relatively uncommon, and it is the responsibility of the treating physician to take responsibility for future treatment of surface varicosities.

It may be that exceptions can be found to some of these statements. So, let’s be clear: these statements are made in reference to treating patients with varicose veins and spider veins, and not specifically with regard to patients with more advanced venous stasis. Much of the exploitive behavior is overtreatment in patients who actually need minimal or no treatment. However, issues of incomplete treatment can affect those patients with advanced disease as well.

Summary

Vein specialists should be held to an ethical standard that condemns practices of exploitation of patients and colleagues, which have no basis in scientific study and contradict established guidelines. A code of acceptable principles needs to be developed and promulgated. This is especially important with regard to those who have falsified records for insurance authorizations.

The individual who exploits the system for financial gain is not only taking advantage of his patients, but also siphoning health care funds intended for legitimate treatment. The exploiter is a thief within the system, and is robbing everyone with his/her selfish actions. While we await means by which these behaviors can be eliminated, prevented or punished, we need to do something, and one effort is to submit “The Pledge” as an instrument of peer pressure.

Our effort is to participate in a community affirmation, and, hopefully, see this or a similar approach adopted by venous specialists who are concerned about the quality of service provided for our venous patients. Medicare has announced that it is up to the specialty practitioners to police their ranks, or someone else will do it for them. Our time has come.