NOVITAS DRAFT POLICY

Our friends in Novitas have again come out with a policy that makes little clinical sense. This policy DL37796 – Sclerotherapy and Endovenous Non-Thermal Treatment of Varicose Veins tries to accomplish two goals. The first is to detail the covered indications and who may provide sclerotherapy. The second is to disallow use of the three primary non-thermal ablation tools available.

See it here.

 

Sclerotherapy:

There is some very interesting language in this proposed policy. Under Covered Indications, section 2, it states that patient must have already undergone EVLA or RFA treatment. It further states in another section that a recent Doppler US has to show absence of continued, recurrent or clinically significant reflux at the saph/fem junction or the pop/saph junction.

 

In short, if I read this as written, you will not be able to perform medically necessary sclerotherapy at the same time you perform an ablation (a pretty normal process for most practices). You will need to bring the patient back, perform a diagnostic US to determine if there is reflux, and then begin sclerotherapy treatment(s).

 

The policy also notes that the ‘distinct nature’ of the risk must be clearly documented in the medical records. When we review charts there is usually a minimal amount of information on the need for medically necessary sclerotherapy. Novitas is significantly increasing the documentation requirements. Here is their list:

Clear and definitive history and description of patient symptoms.

  • Physical characteristics including location, number, size, level of incompetence of the vein and the┬ásymptomatic┬ávaricose veins being treated.
  • Photographs of pre-treatment targeted symptomatic varicose veins.
  • Process/steps used to exclude other causes of symptoms in the legs.
  • Performance of and results of appropriate tests, including required venous Doppler ultrasound as applicable to confirm the presence, and of persistent symptomatic veins within six months of endovenous or surgical treatment.

Another change is they clearly outline who can perform US guidance. In brief it must be someone with RVT, RPVI, RPhS or RVS credentials. We have always advocated for physicians providing phlebology services should be RPVI or RPhS certified but it is now becoming legislated by some payers.

 

Finally, if you have a mid-level practitioner, they will no longer be allowed to perform sclerotherapy unless a qualified physician is physically in the office. As this is federal, it does not matter what your state may allow or disallow a mid-level to perform.

 

Non-Thermal Ablation:

Under Limitations, section 5, is the information regarding non-thermal ablation techniques. The opening sentence is perhaps the most jarring example of their lack of knowledge about the treatment of venous disease. In regards to Varithena, ClariVein and VenaSeal it states: “The following methods for treating varicose veins have not been shown to actively affect the vein integrity directly, but solicit thrombosis at the site of the injection.” I read a lot of the medical literature and I, as a non-physician, feel pretty confident that the above technologies do more than create a thrombosis at the site of the injection.

 

Oddly enough, the sentence written to exclude Vairthena appears to suggest it is perfectly fine to use ‘other methods of foam or compounded liquid sclerotherapy’. Given the concerns some physicians have expressed in using compounded sclerosants it is puzzling to see it recommended in this fashion.

 

Next Steps:

Whether or not you use a non-thermal technique in your practice and whether or not you are in the Novitas administrative area, the last thing we as an industry need is poorly written policies being used as an example to further write bad policy. We strongly ecommend sending a letter regarding your concerns about this draft policy. They are accepting commentary until July 5th. The address is:

 

Novitas Solutions Medical Policy Department
Union Trust Building Suite 600
501 Grant Street
Pittsburgh, PA 15219-4407
DraftLCDComments@novitas-solutions.com

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