DRUG AGENDA - May 2015

ZARXIO 

       Request to establish a new Level II HCPCS code to identify Zarxio, a biosimilar to the reference
drug Filgrastim.  Applicant’s suggested language:  “JXXXX Injection, Filgrastim, Zarxio 1 mcg”

Background/Discussion:

       The applicant states that a new code is warranted and makes the following claims:  no existing
HCPCS codes describe Zarxio; biosimilar products “must be separated”, via HCPCS coding; and
biosimilar products should be considered single source drugs and as such, receive unique codes. 

Preliminary Decision:

        Establish new code Q5101 Injection, Filgrastim (G-CSF), Biosimilar, 1 microgram.  Effective
7/1/15.

VARITHENA

       Second request to establish a new Level II HCPCS code to identify Low-nitrogen 1%
Polidocanol injectable foam, Trade Name:  Varithena.  Applicant’s suggested language: 
“JXXXX Low Nitrogen 1% Polidocanol Injectable foam: Sterile canister, 1 ml.”   

Background/Discussion:

       Provensis Ltd., submitted a request for a new HCPCS code to identify Varithena. 
According to the requester, Varithena is a drug-device combination low
-nitroben 1% Polidocanol sclerosant, used for the treatment of incompetent great saphenous veins,
accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system
above and below the knee. The foam is generated from a proprietary canister system
and is composed of a gas and liquid phase. The foam displaces blood from the target vein
and the polidocanol within the foam scleroses the endothelium. 
Varithena is intended for intravenous injection using ultrasound guidance,
administered via a single cannula into the lumen of the target incompetent trunk vein or by direct
injection into varicosities.The hydrophobic pole of the polidocanol molecule attaches to the
lipid cell membrane of the venous enfothelium and vasospasm.    

Following exposure to polidocanol, the interior surface of the vein becomes thrombogenic,
which leads to thrombus formationand venous occlusion. The occluded vein is eventually
replaced by fibrous connective tissue. Polidocanol is deactivated upon contact with blood,
thus limiting the sclerosant action to the endothelium near the site of injection.

Varithena is supplied in a Tyvek pouch containing two sterile, connected 303 mL aluminum
alloy canisters, one containing polidocanol solution and one containing pressurized oxygen at
approximately 5.4 bar absolute. The connector joins the two canisters and allows activation of
the product.  Upon activation, the multi-use canister generates 45 ml of usable foam.  Up to 5mL
can be used per injection and no more than 15 mL should be used per session.

The applicant claims that a new code is warranted for the following reasons:
 1) no existing code describes Varithena;
 2) due to “poor J coding”, claims cannot be timely processed and physicians
or patients are not paid in a timely manner, (patients have to sign an ABN due to “inadequate J-
coding”; 3) neither CPT codes nor miscellaneous J codes allow “optimal dosing”, or tracking of
clinical outcomes.   

Preliminary Decision:

     Level II HCPCS is not the appropriate coding jurisdiction for this product.  The miscellaneous
CPT code used to report the physician’s office procedure includes all items used, including the
Varithena. Separate coding and billing for Varithena using a “J” code or any other Level II
HCPCS code is duplicative and inappropriate.  Having patients sign an ABN for a product that is
included in the CPT is also inappropriate

ALBUTEROL SULFATE INHALATION SOLUTION

       Request to establish a new Level II HCPCS code to identify Albuterol Sulfate Inhalation
Solution, 0.5% concentrate.   Applicant’s suggested language:  “Albuterol, Inhalation Solution,
fda- approved final product, non - compounded, administered through DME, concentrated form,
unit dose, 0.5 mg (Albuterol non - comp unit).”

Background/Discussion:

       Nephron Pharmaceuticals Corporation requested a new HCPCS code to identify for Albuterol
Sulfate Inhalation Solution, .5% concentrate. According to the requester, the drug is indicated
for the relief of bronchospasm in patients 12 years of age and older with reversible obstructive
airway disease and acute attacks of bronchospasm. Albuterol stimulates adenyl clyclas, the
enzyme that catalyzes the formation of cyclic -3’, 5’- adenosine monophosphate (cyclic AMP)
from adenosine triphosphate (ATP) in beta - adrenergic cells. The cyclic AMP thus formed
mediates the cellular responses. Increased cyclic AMP levels are associated with relaxation of
bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity
from cells, especially from mast cells

The typical dosage for adults and pediatric patients 12 years of age and older is 2.5 mg (one unit
- of - use vial) administered 3 to 4 times daily by nebulization. Albuterol Sulfate Inhalation Solution
is supplied in  sterile, “unit - of - use” vials of 0.5 mL each, supplied in individual foil pouches; 30
pouches in one package.

The applicant claims that there is no existing code to identify a concentrated form
in unit dose packaging, as such, a new code is warranted.
 

Preliminary Decision:

       Existing code J7611 “Albuterol, Inhalation Solution, FDA - approved final product
, non - compounded, administered through DME, concentrated form, 1 mg”, adequately describes the
product that is the subject of this request


Ref:
http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/May-7-2015-DrugAgenda.pdf