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Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedural

Coding System (HCPCS) Public Meeting Agenda for


Drugs, Biologicals, and Radiopharmaceuticals
Tuesday, May 15, 2007, 9:00 am – 5:00 pm
CMS Auditorium
7500 Security Boulevard
Baltimore (Woodlawn), Maryland 21244-1850

8:15 a.m. Arrival and sign-in

9:00 a.m. Welcome


Background and purpose of meeting
Meeting Format and Ground Rules

For each agenda item, a written overview of the request and CMS’s preliminary coding
decision is provided. Preliminary decisions are not final or binding upon any payer, and
are subject to change. Meeting participants will hear presentations about the agenda item
from the registered primary speaker and other speakers (if any). Presentations will be
followed by an opportunity for questions regarding that particular agenda item. The public
meetings provide an opportunity for the general public to provide additional input related
to requests to modify the HCPCS code set. Final decisions are not made at the public
meetings. Applicants will be notified of final decisions in November.

The agenda includes a summary of each HCPCS code application on the agenda. The
information provided in each summary reflects claims made by the applicant and should
not be construed as a statement of fact or an endorsement by the federal government.

AGENDA ITEM #1
Attachment #07.29
Request to establish a code to identify Intravenous Immune Globulin (Human) with an IgA
concentration of less than 1mg/ml, Trade Name: GAMMAGARD S/D, IgA less than 1 µg/mL in
5% Solution.

Attachment #07.30
Request to establish a code to identify Immune Globulin Intravenous (human) 10%, Trade Name:
GAMMAGARD LIQUID.

AGENDA ITEM #2
Attachment #07.38
Request to establish a code to identify Intravenous Immune Globulin, Trade Name: Carimune®
NF, Nanofiltered.

AGENDA ITEM #3
Attachment # 07.70
Request to establish a code to identify immune globulin intravenous (Human), trade name:
Octagam® 5%.
AGENDA ITEM #4
Attachment #07.97
Request to add a new J code to identify Immune Globulin Intravenous [Human], 10%
Caprylate/Chromatography Purified, Trade Name: GAMUNEX®.

AGENDA ITEM #5
Attachment # 07.74
Request to establish a code to identify sodium hyaluronate, trade name: Hyalgan®.

AGENDA ITEM #6
Attachment #07.01
Request to establish a code to identify sodium tetradecyl sulfate injection, trade name: Sotradecol.

AGENDA ITEM #7
Attachment #07.12
Request to establish a code to identify Idursulfase, Trade Name: ELAPRASE™.

AGENDA ITEM #8
Attachment #07.31
Request to establish a code to identify Aripiprazole, Trade Name: ABILIFY®.

AGENDA ITEM #9
Attachment #07.37
Request to establish a code to identify Alglucosidase Alfa, Trade Name: Myozyme®.

AGENDA ITEM #10


Attachment #07.45
Request to establish a code to identify panitumumab, trade name: Vectibix.

AGENDA ITEM #11


Attachment #07.59
Request to modify code J0585. Trade Name: BOTOX®.

AGENDA ITEM #12


Attachment # 07.71
Request to establish a code to identify an etonogestrel implant, trade name: Implanon™ 68mg.

AGENDA ITEM #13


Attachment #07.91
Request to modify existing code S1025 “INHALED NITRIC OXIDE FOR THE TREATMENT
OF HYPOXIC RESPIRATORY FAILURE IN THE NEONATE; PER DIEM” for the drug nitric
oxide, Trade Name: INOmax® to instead read: “INHALED NITRIC OXIDE, UP TO ONE
HOUR.”

AGENDA ITEM #14


Attachment #07.101
Request to establish a code to identify arformoterol tartrate, trade name: Brovana™ Inhalation
Solution.
AGENDA ITEM #15
Attachment #07.124
Request to add a new Level II HCPCS J Code to identify Ranibizumab, Trade Name:
LUCENTIS®.

AGENDA ITEM #16


Attachment #07.125
Request to discontinue code Q4079, “Injection, Natalizumab, per 1mg,” for the biologic for
Natalizumab, Trade Name: TYSABRI®, and replace it with a “J” code, using a different dose
descriptor.

AGENDA ITEM #17


Attachment #07.126
Request to establish a code to identify Protein C Concentrate (Human), Trade Name:
CEPROTIN®.

AGENDA ITEM #18


Attachment #07.127
Request to establish a code to identify Soliris™ (Eculizumab), Trade Name: Soliris™.

AGENDA ITEM #19


Attachment # 07.84
Request to establish a code to identify Technetium tc-99m Teboroxime, trade name: CardioTec®.

AGENDA ITEM #20


Attachment #07.55
Request to revise existing code A9524 which currently reads: “Iodine I-131 Iodinated Serum
Albumin, Diagnostic, per 5 microcuries” to instead read “Iodine I-131 Iodinated Serum Albumin,
Diagnostic, per study dose, 25 microcuries”. Trade Name: Volumex.

AGENDA ITEM #21


Attachment #07.93
Request to revise the verbiage of code A9527 which currently reads: A9527 “IODINE I-125
SODIUM IODIDE SOLUTION, THERAPEUTIC, PER MILLICURIE”, to instead read: “Iotrex
I-125, sodium iodide solution, therapeutic, per 1 milliliter up to 200mCi”.

AGENDA ITEM #22


Attachment #07.02
Request to 1) revise code A9516 which currently reads: “Iodine I-123 Sodium Iodide Capsule(s),
Diagnostic, per 100 Microcuries” to read: “Iodine I-123 Sodium Iodide, Diagnostic, per 100
Microcuries, up to 600 Microcuries”; and 2) establish a new code to identify Iodine I-123 sodium
iodide. This request is to omit the word “capsule” from existing A9516, and implement separate
code for above and below 600 microcuries.

AGENDA ITEM #23


Attachment #07.03
Request to establish a code to identify Technetium Tc-99M filtered sulfur colloid.
AGENDA ITEM #24
Attachment #07.04
Request to establish a code to identify Technetium Tc-99M Exametazime autologous labeled
white blood cells.

Attachment #07.05
Request to either revise code A9547 or to delete code A9547 and establish a code to identify
Indium In-111 autologous labeled white blood cells.

Attachment #07.06
Request to establish a code to identify Indium In-111 autologous labeled platelets.

AGENDA ITEM #25


Attachment #07.44
Request to revise existing code A9565 which currently reads: “Indium In-111 Pentetreotide,
diagnostic, per millicurie” to instead read “Indium In-111 Pentetreotide, diagnostic, per dose up
to 6mCi”. Trade Name: OctreoScan®.

AGENDA ITEM #26


Attachment #07.87
Request to establish a code to identify Dexrazoxane, trade name: Totect™.
HCPCS Meeting Agenda Item #1
May 15, 2007

Attachment #07.29

Topic/Issue:
Request to establish a code to identify Intravenous Immune Globulin (Human) with an IgA
concentration of less than 1mg/ml, Trade Name: GAMMAGARD S/D, IgA< 1 µg/mL in 5%
Solution.

Background/Discussion
According to the requester, GAMMAGARD S/D with a content of less than 1 µg/mL of IgA in a
5% Solution (GAMMAGARD S/D, IgA < 1 µg/mL) is a solvent/detergent-treated, sterile, freeze
dried preparation of highly purified immunoglobulin G (IgG) for intravenous use derived from
large pools of human plasma. [Note: It is currently marketed under the trade name
GAMMAGARD S/D]. It is used for patients who have a primary immune deficiency disease to
reduce the frequency and severity of infection and reduces the risk for people with an IgA
deficiency that may have allergic reaction (anaphylactic or anaphylactoid) to other IVIG brands
and require antibody replacement therapy. GAMMAGARD S/D, IgA< 1 µg/mL is the only IVIG
product to guarantee such a small amount of IgA content in every lot. It contains a broad
spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and
neutralization of microbes and toxins. According to the requester, “code J1566 does not
adequately recognize the “significantly therapeutic differences between the IgA content among
IVIG products”… and “a unique code is necessary in order to track patients for whom
GAMMAGARD S/D… is medically indicated”.

Preliminary Decision:
1) Revise code J1566 which currently reads: “INJECTION, IMMUNE GLOBULIN,
INTRAVENOUS, LYOPHILIZED (E.G. POWDER), 500 MG” to instead read: "INJECTION,
IMMUNE GLOBULIN, INTRAVENOUS, LYOPHILIZED (E.G., POWDER), NOS, 500 MG"

2) Revised code J1566 adequately describes the product that is the subject of this request and is
available for assignment by insurers as they deem appropriate.
HCPCS Meeting Agenda Item #1
May 15, 2007

Attachment #07.30

Topic/Issue:
Request to establish a code to identify Immune Globulin Intravenous (human) 10%, Trade Name:
GAMMAGARD LIQUID. Requester’s suggested language: “Injection, Immune Globulin,
intravenous, non-lyophilized (e.g. liquid), 10% sugar/sodium free, triple virally inactivated, 500
mg”

Background/Discussion:
According to the requester, GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)]
10% is an IVIG formulation for people with primary immunodeficiency (PI) disorders associated
with humoral immunity. These disorders have a wide range of symptoms and are caused by
errors in the genes of cells that make up the immune system. GAMMAGARD LIQUID is a
ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G
(IgG) antibodies that can help people with PI by replacing their IgG antibodies, helping the
immune system function properly. Immunoglobulins, or antibodies, are an important part of the
body’s defense system – the immune system. The major class of immunoglobulins, IgG, is made
up of antibodies that protect the body against bacterial and some viral infections. People with PI
often cannot produce enough of these protective antibodies. Currently, GAMMAGARD LIQUID
is the only 10% liquid IVIG solution drug product to contain no sugar, no sodium, no
preservatives, and provide latex-free packaging. According to the requester, this is an important
distinction because it has been reported that a disproportionate share of renal dysfunction and
acute renal failure has been associated with IGIV products containing sucrose as a stabilizer. The
current code J1567 INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, NON-
LYOPHILIZED (E.G. LIQUID), 500 MG does not adequately describe GAMMAGARD
LIQUID because it does not recognize the pharmaceutical differences in marketed IGIV products,
which vary considerably among manufacturers.

Preliminary Decision:
Establish Q4088 "INJECTION, IMMUNE GLOBULIN, (GAMMAGARD LIQUID),
INTRAVENOUS, NON-LYOPHILIZED, (E.G. LIQUID), 500 MG", effective 7/1/2007.
HCPCS Meeting Agenda Item #2
May 15, 2007

Attachment #07.38

Topic/Discussion:
Request to establish a code to identify Intravenous Immune Globulin, Trade Name: Carimune®
NF, Nanofiltered. Requester’s suggested language: “Injection, Immune Globulin, Nanofiltration,
500 mg”.

Background/Discussion:
According to the requester, Carimune® NF, Nanofiltered, Immune Globulin Intravenous
(Human) (IGIV) is a sterile, highly purified polyvalent antibody product containing in lyophilized
form all the IgG antibodies which regularly occur in the donor population. This broad spectrum
antibody content is particularly important in replacement therapy for primary immune deficient
patients.

Carimune® NF is indicated for the maintenance treatment of patients with primary


immunodeficiencies. Carimune® NF is also indicated for the treatment of acute and chronic
Immune Thromobocytopenia (ITP) through Immunoglobulin G well recognized anti-
inflammatory mechanism mediated through the Fc domains.

Carimune® NF offers flexibility in concentration and diluents to individualize care specifically in


patients with risk factors or co-morbidities. It contains no preservative, reconstituted diluents
include sterile water, 5% dextrose or 0.9% saline with protein concentration from 3% to 12%.
Vial sizes are 3g, 6g and 12g. According to the requester, existing code J1566 “Immune globulin
lyophilized, 500mg” does not include the nanofiltration viral inactivation process.

Preliminary Decision:
1) Revise code J1566 “INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, LYOPHILIZED
(E.G. POWDER), 500 MG” to instead read: "INJECTION, IMMUNE GLOBULIN,
INTRAVENOUS, LYOPHILIZED (E.G., POWDER), NOS, 500 MG"

2) Revised code J1566 adequately describes the product that is the subject of this request and is
available for assignment by insurers as they deem appropriate.
HCPCS Meeting Agenda Item #3
May 15, 2007

Attachment #07.70

Topic/Issue:
Request to establish a code to identify immune globulin intravenous (Human), trade name:
Octagam® 5%.

Background/Discussion:
Octagam® 5% is a liquid, room temperature stable, intravenous immunoglobulin solution. It is
prepared from the plasma of health US donors. Viral safety is assured through a combination of
cold ethanol fractionation, solvent-detergent treatment-a process that rapidly and irreversibly
destroys lipid enveloped viruses and a 24 hour incubation at pH4- a process that will inactivate
both enveloped and non-enveloped viruses. Octagam® 5% is used to replace immunoglobulins
(antibodies) in patients with primary immune deficiency diseases, who are unable to produce
antibodies. Treatment with Octagam® 5% can prevent infections and their long-term sequelae in
this vulnerable patient group. It is indicated for the treatment of primary immune deficiency
diseases. The usual dose in primary immunodeficiency disease is 300 to 600 mg/kg body weight
administered every 3 to 4 weeks. Doses may be adjusted over time to achieve the desired trough
levels and clinical responses. It is administered intravenously. It is supplied in 10g, 2.5g, 5g, or
10g single use glass bottles. The applicant requests that a HCPCS level II code be established for
Octagam® 5% based on observations that clinically significant differences in the product
formulation of Octagam® 5%, which make the product more or less suitable for different
patients, are not considered within the current HCPCS code (J1567). Differences among
intravenous immunoglobulin (IVIG) products in terms of manufacturer, virus inactivation,
composition, concentration, biochemical properties and stabilization can impact clinical safety,
tolerability, and efficacy. These differences, although subtle, result in markedly different
tolerability profiles, especially for patients with risk factors. Octagam® 5% is distinguished from
other IVIG products by a number of clinical usage characteristics including its absence of a
stabilizer, its extended shelf-life at room temperature, and its very low incidence of adverse
events, making the product particularly suitable for the non-acute and homecare setting. In
addition, Octagam® 5% differs from other liquid IVIG products in the J1567 code in terms of its
manufacturing process, virus inactivation methods, biochemical profile (pH, osmolality, IgA
content) and its isotonic agent – maltose. These differences are thought to account for the unique
stability and clinical tolerability of Octagam 5%.

Preliminary Decision:
Establish Q4087 "INJECTION, IMMUNE GLOBULIN, (OCTAGAM), INTRAVENOUS, NON-
LYOPHILIZED, (E.G. LIQUID), 500 MG", effective 7/1/2007.
HCPCS Meeting Agenda Item #4
May 15, 2007

Attachment #07.97

Topic/Issue:
Request to add a new J code to identify Immune Globulin Intravenous [Human], 10%
Caprylate/Chromatography Purified, Trade Name: GAMUNEX®. Requester’s suggested
language: JXXXX Injection, immune globulin, intravenous, non-lyophilized,
caprylate/chromatography purified (IVIG-C).

Background/Discussion:
According to the requester, GAMUNEX® is a drug used as a replacement therapy for primary
immunodeficiency (PI) states in which severe impairment of antibody forming capacity has been
shown, such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked
immunodeficiency with hyper IgM, Wiskott-Aldrich syndrome, and severe combined
immunodeficiences. In addition, it is also for use in idiopathic thrombocytopenic purpura to
rapidly raise platelet counts to prevent bleeding or allow a patient with ITP to undergo surgery.
GAMUNEX® (Immune Globulin Intravenous, Non-lyophilized, Caprylate/Chromatography
Purified (IVIG-C) solution is administered by intravenous infusion only. According to the
requester, existing code J1567 INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, NON-
LYOPHILIZED (E.G. LIQUID) 500 MG is currently being billed for this product. Other
products include: Flebogamma® 5% (Grifols), GAMMAGARD® Liquid 10% (Baxter), and
Octagam® (Octapharma). All IGIVs vary in terms of formulation, concentration, and osmolality
as well as the final pH. Products contain varying amounts of sodium and sugars and are
manufactured using varying methods of viral inactivation. The applicant supports differential
coding based on “clinically relevant” differences other than lyophilized vs. non-lyophilized, to
enable tracking.

Preliminary Decision:
1) Discontinue code J1567 “INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, NON-
LYOPHILIZED, (E.G., LIQUID), 500 MG”, effective 12/31/2007.

2) Establish Q4092 “INJECTION, IMMUNE GLOBULIN, (GAMUNEX), INTRAVENOUS,


NON-LYOPHILIZED, (E.G. LIQUID), 500 MG”, effective 7/1/2007.
HCPCS Meeting Agenda Item #5
May 15, 2007

Attachment #07.74

Topic/Issue:
Request to establish a code to identify sodium hyaluronate, trade name: Hyalgan®.
Requester’s suggested language: JXXXX “Hyaluronate sodium/hyaluronate sodium derivative of
midpoint molecular weight 500-699 kDa, for intra-articular injection, per 20 mg dose”

Background/Discussion:
According to the requester, Hyalgan is indicated for the treatment of pain in osteoarthritis (OA) of
the knee in patients who have failed to respond adequately to conservative nonpharmacologic
therapy, and to simple analgesics, e.g., acetaminophen. It relieves pain associated with OA of the
knee. Intra-articular administration of Hyalgan into arthritic knees leads to an increase in the
viscoelasticity of the synovial fluid. The requester also stated that other proposed actions, such as
activation of endogenous hyaluronate production, decreased hyaluronate degradation, increased
extracellular matrix production in cartilage, extended maintenance of chondrocyte viability,
modulation of inflammatory responses, and coating of pain receptors thereby dampening their
activation, have also been investigated and reported in the medical literature. Hyalgan is
administered by intra-articular injection in a 20mg dose. A treatment cycle consists of five
injections given at weekly intervals. Some patients may experience benefit with three injections
given at weekly intervals. Hyalgan is supplied as a sterile, non-pyrogenic solution in 2ml vials or
2 mL pre-filled syringes, both of which contain 20mg of Hyalgan. The requester recommends
specific code to identify each single-source product differentiated by midpoint molecular weight
ranges (or some other appropriate descriptor). This will provide equitable coding across the class
and will allow clinical factors alone to guide product selection in patient treatment

Preliminary Decision:
Existing code Q4083 “HYALURONAN OR DERIVATIVE, HYALGAN OR SUPARTZ, FOR
INTRA-ARTICULAR INJECTION” adequately describes the product that is the subject of this
request.
HCPCS Meeting Agenda Item #6
May 15, 2007

Attachment #07.01

Topic/Issue:
Request to establish a code to identify sodium tetradecyl sulfate injection, trade name: Sotradecol.

Background/Discussion:
According to the requester, Sotradecol is a sclerosing agent used in the treatment of varicose
veins. It is a sterile nonpyrogenic solution that causes intima inflammation and thrombus
formation. This usually occurs occludes the injected vein. Subsequent formation of fibrous
tissue results in partial or complete vein obliteration that may or may not be permanent.
Sotradecol is indicated in the treatment of small uncomplicated varicose veins of the lower
extremities that show simple dilation with competent valves. It can help alleviate the
inflammation, ulceration, edema, pain and swelling that can accompany this condition.
Sotradecol is given intravenously and the strength of solution required depends on the size and
degree of varicosity. Generally, the 1% solution is found most useful and the 3% solution is
preferred for larger varicosities. The dosage should be kept small, using 0.5 to 2ml for each
injection, and the maximum single treatment should not exceed 10ml. Sotradecol is supplied in
1% 2ml vials (packages of 5) and 3% 2ml vials (packages of 5).

Preliminary Decision:
No insurer (i.e., Medicare, Medicaid, Private Insurance Sector) identified a national program
operating need to establish a code to identify this product. CMS recommends that the applicant
separately submit an inquiry to the American Medical Association (AMA) practice expense
advisory committee regarding inclusion of Sotradecol when it is used in the procedure. Use of
J3490 or any other miscellaneous code is inappropriate.
HCPCS Meeting Agenda Item #7
May 15, 2007

Attachment #07.12

Topic/Issue:
Request to establish a code to identify Idursulfase, Trade Name: ELAPRASE™.
Requester’s suggested language: JXXXX “Idursulfase, intravenous, per 3mL”.

Background/Discussion:
According to the requester, ELAPRASE is an enzyme replacement therapy (ERT) indicated for
patients with mucopolysaccharidosis II (MPSII), also known as Hunter syndrome. Hunter
syndrome is a rare lysosomal storage disorder that interferes with the body’s ability to break
down mucopolysaccarides (MPS). ELAPRASE™ is an enzyme providing exogenous enzyme for
uptake into cellular lysosomes. Therapy involves replacing the deficient enzyme by IV infusion.
It has been shown to help keep patients ambulatory, reduce organ size and urinary GAG
excretion, and improve pulmonary function. ELAPRASE™ is a solution for intravenous
infusion. It is supplied as a sterile, aqueous, clear to slightly opalescent, colorless solution. From
a single use vial, the recommended dosage regimen of ELAPRASE is 0.5 mg/kg of body weight
administered every week. The ELAPRASE™ concentrated solution must be diluted in 100mL of
0.9% sodium chloride injection, USP. The total volume of infusion may be administered over a
period of 1 to 3 hours. According to the requester, there is not an existing code that represents this
single-source orphan drug. At this time, J3590 UNCLASSIFIED BIOLOGICS is the only code
available to report Idursulfase.

CMS HCPCS Workgroup Preliminary Decision:


Establish JXXXX “INJECTION, IDURSULFASE, 1 MG”
HCPCS Meeting Agenda Item #8
May 15, 2007

Attachment #07.31

Topic/Issue:
Request to establish a code to identify aripiprazole, Trade Name: ABILIFY®.
Requester’s suggested language: “Injection, aripiprazole for intramuscular injection, 9.75mg”

Background/Discussion:
According to the requester, ABILIFY® Injection is the first and only available dopamine partial
agonist indicated for the treatment of bipolar I disorder, manic or mixed and schizophrenia. The
exact mechanism of action of ABILIFY®, as with other drugs having efficacy in bipolar I
disorder and schizophrenia, is unknown.

ABILIFY® Injection is administered by intramuscular injection and is indicated for the treatment
of agitation associated with schizophrenia and bipolar I disorder, manic or mixed. Patients
typically present in the Emergency Department, where they receive ABILIFY® Injection to calm
the agitation associated with schizophrenia and bipolar I disorder. The efficacy of aripiprazole
injection in controlling agitation in these disorders was demonstrated in a range of 5.25mg to
15mg. The recommended dose in these patients is 9.75mg. If agitation warranting a second dose
persists following the initial dose, cumulative doses of up to 30mg/day may be given. However,
the efficacy of repeated doses of aripiprazole injection in agitated patients has not been
systematically evaluated in controlled trials. According to the applicant, ABILIFY® Injection is
a unique molecular entity, and there is no HCPCS code to describe this product.

Preliminary Decision:
Establish JXXXX "INJECTION, ARIPIPRAZOLE, INTRAMUSCULAR, 0.25 MG"
HCPCS Meeting Agenda Item #9
May 15, 2007

Attachment #07.37

Topic/Issue:
Request to establish a code to identify alglucosidase alfa, Trade Name: Myozyme®.

Background/Discussion:
According to the requester, Myozyme® is a purified form of the human enzyme acid alpha-
glucosidase and provides an exogenous source of GAA that increases the enzymatic activity in
cleaving glycogen. It is the first and only approved treatment for all patients with a confirmed
diagnosis of Pompe disease (GAA deficiency). Myozyme® has been shown to improve
ventilator-free survival in patients with infantile-onsite Pompe disease as compared to an
untreated historical control, whereas use of Myozyme® in patients with other forms of Pompe
disease has not been adequately studied to assure safety and efficacy.

The recommended dosage regimen of Myozyme® is 20mg/kg body weight administered every 2
weeks as an intravenous infusion. The total volume of infusion is determined by the patient’s
body weight and should be administered over approximately 4 hours. Myozyme® is supplied in
50 mg vials.

Preliminary Decision:
Establish JXXXX “INJECTION, AGLUCOSIDASE ALFA, 10 MG."
HCPCS Meeting Agenda Item #10
May 15, 2007

Attachment #07.45

Topic/Discussion:
Request to establish a code to identify panitumumab, Trade name: Vectibix.
Requester’s suggested language: JXXXX “Injection, Panitumumab, 10 mg”

Background/Discussion:
According to the requester, Vectibix is a recombinant, human IgG2 kappa monoclonal antibody
used for the treatment of Epidermal Growth Factor (EGF)-expressing, metastic colorectal
carcinoma with disease progression on or following fluoropyrimidine, oxalipatin, and/or
irinotecan-containing chemotherapy regimens. It is a targeted therapy, which acts on the specific
cellular signaling pathway, EGF. Additionally, Vectibix is a fully human monoclonal antibody
treatment designed to directly target tumors by inhibiting their growth. Vectibix binds
specifically to EGFR on both normal and tumor cells, and competitively inhibits the binding of
ligands for EGFR. According to the requester, nonclinical studies the binding of Vectibix to the
EGFR prevents ligand-induced receptor autophosphorylation and activation or receptor-
associated kinases, resulting in inhibition of cell growth, induction of apoptosis, decreased pro-
inflammatory cytokine and vascular growth factor production, and internalization of the EGFR.
In vitro assays and in vivo animal studies demonstrate that Vectibix inhibits the growth and
survival of selected human tumor cell lines expressing EGFR. The recommended dosage of
Vectibix is 6mg/kg administered over 60 minutes as an intravenous infusion every 14 days.
Doses higher than 1000mg should be administered over 90 minutes. It is supplied as a sterile,
colorless, preservative-free, solution containing 20 mg/ml panitumumab in a single-use vial.
Vectibix is provided as one vial per carton. Each 5 ml single-use vial contains 100 mg of
panitumomab in 5mL. Each 10 mL single-use vial contains 200mg of panitumomab in 10mL.
Each 20 ml single-use vial contains 400 mg of panitumumab in 20 ml.

Preliminary Decision:
Establish JXXXX "INJECTION, PANITUMUMAB, 10 MG"
HCPCS Meeting Agenda Item #11
May 15, 2007

Attachment #07.59

Topic/Issue:
Request to modify code J0585 to identify BOTOX®. Requester suggested language: If United
States Adopted Names (USAN) adopts the new non-proprietary name “onbotulinatoxin”, we
would recommend the code descriptor to be changed to: “Onbotulinatoxin, per unit”. If the
USAN does not complete its determination in 2007, we would request alternative new
nomenclature for J0585: “Botulinum toxin type A, per [Allergan] unit”.

Background/Discussion:
According to the requester, BOTOX® is a physician-injected, orphan biologic, approved for the
treatment of strabismus, blepharospasm, cervical dystonia, and severe primary axillary
hyperhidrosis. BOTOX® is currently being billed using J0585 “Botulinum toxin type A, per
unit”. No two botulinum toxin biologics are interchangeable. Units of one type A serotype
biologic are not interchangeable with units of any other type A serotype e.g., the mean BOTOX®
dose in cervical dystonia is 236 [Allergan] units whereas the initial recommended dose of
Dysport® (a different serotype A botulinum toxin) for cervical dystonia is 500 [Ipsen] units.
With the anticipated introduction of other “botulinum toxin type A” biologics beginning in 2008,
Allergan recognized the risk of confusion and recently requested the unique nonproprietary
USAN name “onbotulinatoxin” for BOTOX®. Other serotype A botulinum toxins would be
assigned different non-proprietary names. A determination on this application is expected in
2007.

Whether or not USAN finalizes its determination in 2007, distinct HCPCS codes are necessary to
describe the unique units of each botulinum toxin type A product in order to avoid medical errors
and to facilitate claims processing and tracking (botulinum toxin type A is a bioterrorism select
agent). Failure to distinguish among botulinum toxin biologics may result in under or over
dosage and under or overpayment based on incorrect units.

Preliminary Decision:
Existing code J0585 “BOTULINUM TOXIN TYPE A, PER UNIT” adequately describes the
product that is the subject of this request.
HCPCS Meeting Agenda Item #12
May 15, 2007

Attachment #07.71

Topic/Issue:
Request to establish a code to identify an etonogestrel implant, trade name: Implanon™ 68mg.
Requester’s suggested language: JXXXX “Etonogestrel contraceptive implant, 68 mg”

Background/Discussion:
According to the requester, Implanon is a single-rod contraceptive implant that is inserted just
under the skin of the inner side of the upper arm. It is used for the prevention of pregnancy in
women of reproductive age, and consists of a non-biodegradable rod measuring 40mm in length
and 2mm in diameter. Implanon is inserted just under the skin in the medial aspect of the upper
arm 6-8 cm above the elbow crease in the overlying groove between the biceps and triceps
muscles. Insertion and removal is to be performed by a medical professional trained on the
procedure. Each rod consists of an ethylene vinylacetate (EVA) copolymer core, containing
68mg of the synthetic progestin etonogestrel (ENG), surrounded by an EVA copolymer skin. The
average hormone release rate is approximately 30 micrograms per day, enough to ensure effective
contraceptive protection. After insertion, the rod slowly releases a progestogenic hormone,
etonogestrel. Implanon must be removed no later than three years after the insertion date. One
Implanon package consists of a single rod implant contained in the needle of a disposable
applicator. The sterile applicator is packed in a blister pack.

Preliminary Decision:
Establish JXXXX “ETONOGESTREL (CONTRACEPTIVE) IMPLANT SYSTEM,
INCLUDING IMPLANT AND SUPPLIES”
HCPCS Meeting Agenda Item #13
May 15, 2007

Attachment #07.91

Topic/Issue:
Request to modify existing code S1025 “INHALED NITRIC OXIDE FOR THE TREATMENT
OF HYPOXIC RESPIRATORY FAILURE IN THE NEONATE; PER DIEM” for the drug nitric
oxide, Trade Name: INOmax® to instead read: “INHALED NITRIC OXIDE, UP TO ONE
HOUR”.

Background/Discussion:
According to the requester, INOmax® is a drug for use in the treatment of hypoxic respiratory
failure in term and near-term infants with evidence of pulmonary hypertension. When inhaled,
nitric oxide produces pulmonary vasodilation. INOmax is being studied for indications in
addition to hypoxic respiratory failure in neonates. INOmax® (nitric oxide gas) is a drug
administered by inhalation. INOmax® is a gaseous blend of nitric oxide and nitrogen (0.08% and
99.92%, respectively for 800 ppm; 0.01% and 99.99%, respectively for 100 ppm). INOmax is
supplied in aluminum cylinders as a compressed gas under high pressure (2000 pounds per square
inch gauge [psig]). According to the requester, existing code S1025 is restrictive in that its
description includes the product’s indication. The narrow description of the current “S” code
would prevent the code’s use when new indications are available. The billing unit for HCPCS
code S1025 is “per diem”. The INOmeter™ Time-Metric Device records the amount of time the
INOmax (nitric oxide) cylinder valve is open. The institution is charged for the time indicated by
the INOmeter™ Time-Metric Device. Hospitals pay only for time the INOmax® (nitric oxide)
cylinder valve is open, billed on an hourly (not daily) basis. “Per diem”, therefore, does not
represent the smallest billing unit.

Preliminary Decision:
Code S1025 was discontinued effective 3/30/07 based on action published in 2006, following
consideration of similar information provided to CMS last year. The request is not within the
jurisdiction of HCPCS Level II. The ICD-9 coding system is used to identify disease states.
Diseases are typically not included in HCPCS code language.
HCPCS Meeting Agenda Item #14
May 15, 2007

Attachment #07.101

Topic/Issue:
Request to establish a code to identify arformoterol tartrate, trade name: Brovana™ Inhalation
Solution. Requester’s suggested language: JXXXX “Brovana, inhalation solution, FDA-
approved final product, non-compounded, administered through DME, unit dose form, 15mcg”

Background/Discussion:
According to the requester, Brovana is a long-acting beta-2 agonist (LABA) used for the long
term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients
with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and
emphysema. Brovana works by relaxing the airways, thereby exerting bronchodilatory effects
and relieving/preventing symptoms typically seen in patients with COPD, such as wheezing,
cough, chest tightness and shortness of breath, (i.e., dyspnea). The requester also states that
because the elderly have unique challenges that may make administration of treatment more
difficult, such as arthritis and other infirmities that impair coordination of hand actuation with
deep inhalation or difficulty manipulating a device that requires loading each dose, a nebulized
LABA provides an important treatment option in the management of these patients’ COPD.
Studies of Brovana have demonstrated rapid bronchodilation that was sustained over the 12-hour
dosing interval. The recommended dosage for COPD patients is 15mcg twice a day. Brovana is
supplied in 2-ml unit dose vials that are individually over wrapped in foil and housed within a
self-carton container. Each 2-ml unit-dose vial contains 15 mcg of Brovana.

Preliminary Decision:
Establish JXXXX "ARFORMOTEROL TARTRATE, INHALATION SOLUTION, FDA
APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH
DME, UNIT DOSE FORM, PER 5 MICROGRAMS"
HCPCS Meeting Agenda Item #15
May 15, 2007

Attachment #07.124

Topic/Issue:
Request to add a new Level II HCPCS J Code to identify ranibizumab, Trade Name:
LUCENTIS®. Requester’s suggested language: “Ranibizumab, 0.1 mg for intravitreal injection”

Background/Discussion:
According to the requester, LUCENTIS® is a biologic for use in the treatment of an age-related
macular degeneration (AMD) called “wet AMD”, which is responsible for 90% of the severe
central vision loss associated with the disease. AMD is a chronic, progressive disease that affects
the macula, and is the leading cause of central visual loss and legal blindness in persons over 50
years of age in industrialized courtiers. The most common symptoms of AMD are a central blur
or “blank spot” in one’s vision, distortion of objects, or blurred central vision with peripheral
vision usually remaining intact. There are two clinical types of AMD-“dry” and “wet”. “Dry” is
the most common form, representing approximately 90% of all case and “wet” represents the
remaining 10%.
LUCENTIS® is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment
designed specifically for intraocular use. It is designed to block abnormal growth of blood
vessels in the retina and choroid. It is also designed to inhibit leakage of fluid from these
abnormal vessels. It is designed to stop the progression of wet AMD and improve visual acuity,
restore retinal anatomy, and improve patient reported outcomes. It is intended only for use in
patients with wet AMD. The recommended dose of LUCENTIS® is 0.5 mg (0.05 mL)
administered by intravitreal injection once a month. It differs from Pegaptinib (J2503) in that it
binds to all six isoforms or sub-types of vascular endothelial growth factor VEGF-A while others
only bind to one isoform, VEGF-A. According to the applicant, Lucentis is a new biologic and a
unique molecular entity for which a specific HCPCS J code does not currently exist.

Preliminary Decision:
Establish JXXXX "INJECTION, RANIBIZUMAB, PER 0.1 MG."
HCPCS Meeting Agenda Item #16
May 15, 2007

Attachment #07.125

Topic/Issue:
Request to discontinue code Q4079, “Injection, natalizumab, per 1mg,” for the biologic for
natalizumab, Trade Name: TYSABRI®, and replace it with a “J” code, using a different dose
descriptor. Requester’s suggested language: JXXXX “Injection, natalizumab for intravenous
infusion, 10mg”.

Background/Discussion:
According to the Requester, TYSABRI® is a biologic for use in the treatment of patients with
relapsing forms of multiple sclerosis (MS) to delay the accumulation of physical disability and
reduce the frequency of clinical exacerbations. It is a single a unique molecular entity and is the
only monoclonal antibody approved for use in relapsing forms of MS. Adhesion molecules allow
cells to bind to each other, and in the case of MS, allow activated lymphocytes to bind to
endothelial cells (lining the blood vessels), a key step in the process that allows these cells to
enter the central nervous system and cause the immune damage to the brain. It is administered by
intravenous (IV) infusion over a period of approximately one hour. Tysabri concentrate is
supplied in sterile, single-use 300mg vials. The recommended dose in MS is 300 mg every four
weeks. The requested change in dose descriptor from 1 mg to 10 mg is to “facilitate provider
billing and reduce errors”.

Preliminary Decision:
Establish JXXXX “INJECTION, NATALIZUMAB, 1 MG"
Discontinue Q4079 “INJECTION, NATALIZUMAB, 1 MG”
HCPCS Meeting Agenda Item #17
May 15, 2007

Attachment #07.126

Topic/Issue:
Request to establish a code to identify Protein C Concentrate (Human), Trade Name:
CEPROTIN®. Requester’s suggested language: “Human Protein C lyophilized powder for
solution for injection, 1 I.U.”

Background/Discussion:
According to the requester, CEPROTIN® is expected to be the first protein C concentrate that
will be indicated as replacement therapy for the prevention and treatment of severe congenital
protein C deficiency in pediatric and adult patients. Protein C is an anticoagulant protein that
regulates the coagulation system and prevents thrombosis. By increasing plasma levels of protein
C, CEPROTIN® helps to control or prevent thrombotic complications. An initial dose of 60 to
80 IU/kg is recommended for determination of recovery and half-life, administered via
intravenous injection. A target protein C activity of 100% is recommended for initial treatment of
acute episodes, then maintaining trough protein C activity level above 25% for the duration of
treatment. CEPROTIN® will be available in single-dose vials that contain nominally 500 or
1000 IU human protein C.

Preliminary Decision:
Establish JXXXX “INJECTION, PROTEIN C CONCENTRATE, INTRAVENOUS, HUMAN,
10 I.U.”
HCPCS Meeting Agenda Item #18
May 15, 2007

Attachment #07.127

Topic/Issue:
Request to establish a code to identify Soliris™ (eculizumab), Trade Name: Soliris™.

Background/Discussion:
According to the requester, Soliris™ is intended to treat patients with Paroxysmal Nocturnal
Hemoglobinuria (PNH). PNH is a rare acquired genetic disease. Patients with PNH lack surface
expression of the complement inhibitor CD59 on red blood cells rendering these blood cells more
sensitive to complement-mediated intravascular hemolysis. Persistent intravascular hemolysis
leads to a reduction of the endogenous RBC mass anemia, fatigue, diminished patient functioning
and thromboembolism (TE).

Soliris™ is a humanized monoclonal antibody that is designed to inhibit intravascular hemolysis


by specifically binding to and inhibiting the cleavage of human C5 complement protein, a key
regulatory step in complement-mediated intravascular hemolysis. By inhibiting C5 cleavage,
Soliris™ reduces intravascular hemolysis and may alleviate clinical morbidities associated with
this life-threatening disease.

Soliris is supplied as 300mg single-use vials containing 30 mL of 10mg/mL sterile, preservative-


free solution. Soliris™ is diluted to a final concentration of 5mg/ml. The recommended dosage
regimen will consist of induction and maintenance phases. During the induction phase, 600mg of
Soliris™ is IV infused every week for the first 4 weeks followed by 900mg IV infused in week 5.
The maintenance phase consists of a 900mg dose IV infused every 14 ± 2 days thereafter.

Preliminary Decision:
Establish JXXXX "INJECTION, ECULIZUMAB, 10 MG"
HCPCS Meeting Agenda Item #19
May 15, 2007

Attachment #07.84

Topic/Issue:
Request to establish a code to identify technetium tc-99m teboroxime, trade name: CardioTec®.
Requester’s suggested language: “Technetium Tc-99m Teboroxime diagnostic, per study dose, up
to 30 mCi”.

Background/Discussion:
According to the requester, Technetium Tc99m Teboroxime (trade name CardioTec®) is a
radiopharmaceutical product that is administered to patients intravenously during rest and/or
stress Single Photon Emission Tomographic (SPECT) or planar imaging to detect diseases in the
myocardium. It is manufactured as a kit containing (10) 5mL reaction vials. The product is
supplied to providers who administer this product during Myocardial Perfusion Imaging (MPI)
procedures as a vial or syringe ordered from a nuclear pharmacy. A prepared single dose syringe
of Technetium Tc99m Teboroxime is typically 15-30 millicuries (mCi). A prepared multi-dose
vial typically allows providers to obtain approximately 4 individual doses from the vial. The
amount administered to patients varies based on patient specific factors such as weight and
height.

This product was previously marketed and sold in the U.S. by another manufacturer as a
diagnostic agent indicated for and used during MPI to detect coronary disease, however, a unique
HCPCS code was never established to describe it. Therefore, the applicant is requesting a code to
identify this product.

Preliminary Decision:
No insurer (Medicare, Medicaid or Private Insurance Sector) identified a national program
operating need to establish a code to identify this product. This item is not available in the U.S.
HCPCS Meeting Agenda Item #20
May 15, 2007

Attachment #07.55

Topic/Issue:
Request to revise existing code A9524 which currently reads: “Iodine I-131 Iodinated Serum
Albumin, Diagnostic, per 5 microcuries” to instead read “Iodine I-131 Iodinated Serum Albumin,
Diagnostic, per study dose, 25 microcuries”. Trade Name: Volumex.

Background/Discussion:
According to the requester, Volumex is a diagnostic radiopharmaceutical and is indicated for use
in determinations of total blood and plasma volumes and in protein turnover studies. Volumex is
manufactured, supplied and administered only as a single-use, single-unit, per study dose of
Albumin I-131 containing 25 microcuries. The current descriptor of “per 5 microcuries” is
inaccurate as it requires a customer to indicate five (5) units of Volumex to equal the “per study
dose” of 25 microcuries. The current descriptor causes usage, billing and unit cost data reporting
and analysis inconsistencies as customers administer a single-use, single-unit, per study dose, but
are required to report five (5) units of A9524 to properly reflect the single-use, single-unit, per
study dose of 25 microcuries and to receive appropriate reimbursement. Volumex is used solely
in conjunction with a blood volume analyzer, for the determination of total blood and plasma
volumes, and for protein turnover studies.

Preliminary Decision:
Existing code A9524 “IODINE I-131 IODINATED SERUM ALBUMIN, DIAGNOSTIC, PER 5
MICROCURIES” adequately describes the product that is the subject of this request. Use the
“units” column on the claim to report appropriate multiples.
HCPCS Meeting Agenda Item #21
May 15, 2007

Attachment #07.93

Topic/Issue:
Request to revise the verbiage of code A9527 which currently reads: A9527 IODINE I-125
SODIUM IODIDE SOLUTION, THERAPEUTIC, PER MILLICURIE, to instead read: “Iotrex I-
125, sodium iodide solution, therapeutic, per 1 milliliter up to 200mCi”.

Background/Discussion:
According to the requester, there is concern about the current code descriptor because it refers to
1 millicurie unit of measurement while Iotrex is supplied in a 1 milliliter vial or pre-filled syringe
which contains 150-200 millicuries. The requester states that “as a result of the inconsistent units
of measurement, hospitals are mistakenly billing for 1 millicurie when in fact they intend to bill
for a 1 mL vial (containing 150-200 millicuries) because it is routine hospital practice to bill for a
single vial of substance as a single unit for billing purposes.” In addition, the requester claims
that hospitals are failing to recognize that a 1mL vial of Iotrex contains 150-200 millicuries and
that it is necessary to bill in millicurie units rather than milliliter units. Consequently, the claim
data is inaccurate and cannot be used as a reliable measure to calculate appropriate payment
levels. Without appropriate payment, hospitals may not be able to continue offering this vital
brain cancer radiotherapy treatment to patients. Modifying the descriptor to a consistent unit of
measure will eliminate the hospital confusion regarding the correct unit of billing for Iotrex.
Typical dosage of Iotrex is 1-3 vials depending on the size of the tumor.

Preliminary Decision:
Existing code A9527 "IODINE I-125, SODIUM IODIDE SOLUTION, THERAPEUTIC, PER
MILLICURIE” adequately describes the product that is the subject of this request. Accurate
billing is accomplished by reporting the appropriate number of multiples on a claim, and may be
a matter of provider education.
HCPCS Meeting Agenda Item #22
May 15, 2007

Attachment #07.02

Topic/Issue:
Request to 1) revise code A9516 which currently reads: “Iodine I-123 Sodium Iodide Capsule(s),
Diagnostic, per 100 Microcuries” to instead read: “Iodine I-123 Sodium Iodide, Diagnostic, per
100 Microcuries, up to 600 Microcuries”; and 2) establish a new code for Iodine I-123 sodium
iodide. Requester’s suggested language: “Iodine I-123 sodium iodide, diagnostic, per millicurie”
for use for quantities greater than 600 microcuries (Do not use AXXXX for quantities equal to or
less than 600 microcuries, see A9516). This request is to omit the word “capsule” from existing
A9516, and implement separate codes for doses above and below 600 microcuries.

Background/Discussion:
According to the requester, Iodine I-123 Sodium Iodide is a radiopharmaceutical used for nuclear
medicine diagnostic imaging and functional measurements of the thyroid gland. The Iodine is
used to synthesize thyroid hormone. Iodine I-123 is used in microcuries quantities much less than
600 microcuries. According to the requester, it has been shown that Iodine I-123 sodium iodide
in millicurie dose is an effective and accurate radiopharmaceutical for whole body metastatic
thyroid cancer detection, with imaging results better than with Iodine I-131 sodium iodide, lower
whole body radiation exposure, and reduced thyroid stunning. When used for thyroid carcinoma
metastasis imaging, Iodine I-123 is used to determine the presence and extent of residual
functioning thyroid tissue and the presence and location of functioning metastatic thyroid cancer.
Iodide I-123 is typically sold and prepared for patient use in capsule forms. However, it can be
provided in liquid form for those patients with swallowing conditions. Therefore, it is requested
that “capsule(s)” be deleted from code A9516. Iodine I-123 sodium iodide provides lower
absorbed radiation dose to the thyroid when compared with Iodine I-131 sodium iodide so that
radiation effects to the thyroid are minimized. The typical dosage for the evaluation of thyroid
function ranges from 200 – 400 microcuries and typical dosage for thyroid carcinoma metastasis
imaging ranges from 1000 – 5000 microcuries.

Preliminary Decision:
1) Discontinue A9516 effective 12/31/07;

2) Establish AXXXX "IODINE I-123 SODIUM IODIDE, DIAGNOSTIC, PER MICROCURIE,


UP TO 999 MICROCURIES; and

3) Establish AXXXX "IODIDE I-123 SODIUM IODIDE, DIAGNOSTIC, PER MILLICURIE


HCPCS Meeting Agenda Item #23
May 15, 2007

Attachment #07.03

Topic/Issue:
Request to establish a code to identify Technetium Tc-99M filtered sulfur colloid. Requester’s
suggested language: “Technetium Tc-99M filtered sulfur colloid, diagnostic, per study dose”

Background/Discussion:
According to the requester, Technetium Tc-99M filtered sulfur colloid (fSC) is used to
demonstrate the historeticular tissue of the retroperitoneal, axillary, paraternal and cervical,
inginal and femoral lymph nodes by interstitially administered radiocolloids. The imaging study
is valuable in the preoperative evaluation of the expected lymph node drainage of tumors such as
melanoma and breast cancer, where it is important to document expected or possible metastatic
lymph node regions for sentinel lymph node biopsy. Technetium Tc-99m fSC can be given in
smaller amounts of 0.4 to 0.6 millicuries because a greater fraction of the particles injected are
able to migrate through the lymphatic channels. Each patient dosage of Technetium Tc-99M
filtered sulfur colloid is custom compounded by a local specialty nuclear pharmacy upon receipt
of a valid prescription. The usual prepared patient dosage administered for lymphoscintigraphy
imaging is 100-500 microcuries. The requester suggested that existing code A9541
TECHNETIUM TC-99M SULFUR COLLOID, DIAGNOSTIC, PER STUDY DOSE, UP TO 20
MILLICURIES continue in use for other applications, but that a new code is warranted for
filtered sulfur colloid because: 1) preparation requires additional supplies, (i.e., a filter and sterile
vial); 2) preparation and dispensing requires “more of a specially trained and qualified
professional’s time “; 3) the cost of a vial is not typically shared by more than one patient; and 4)
filtered form is a different and more expensive form than unfiltered.

Preliminary Decision:
No insurer identified a national program operating need to distinguish filtered from unfiltered
sulfur colloid. Existing code A9541 “TECHNETIUM TC-99M SULFUR COLLOID,
DIAGNOSTIC, PER STUDY DOSE, UP TO 20 MILLICURIES” adequately describes filtered
and unfiltered sulfur colloid, and is available for assignment by insurers.
HCPCS Meeting Agenda Item #24
May 15, 2007

Attachment #07.04

Topic/Issue:
Request to establish a code for Technetium Tc-99M exametazime autologous labeled white blood
cells. Requester’s suggested language: “Technetium Tc-99M exametazime labeled autologous
white blood cells, diagnostic, per study dose”

Background/Discussion:
According to the requester, Technetium Tc-99M exametazime autologous white blood cells
(WBCs) are used to detect inflammatory processes to which leukocytes migrate, such as those
associated with abscesses or other infection (i.e. Intra-abdominal infection and inflammatory
bowel disease). If localizing signs of infection are not present, infection is often difficult to locate
and thus treat. Early detection and localization of an infection improves the likelihood of cure,
and delayed diagnosis is associated with poorer patient outcomes. These WBCs are primarily
used in adults over the age of 18, and each dosage is prepared using the patient’s own blood. The
usual patient adult dosage can vary between 5 and 25 millicuries given intravenously. Once
injected, the lipophilic Tc-99m exametazime complex is taken up by white blood cells and
selectively retained in neutrophils when they migrate to the sites of infection. Tc-99m
exametazime is indicated for WBC scintigraphy as an adjunct in the localization of intra-
abdominal infection and for inflammatory bowel disease. The typical dosage for children is
based on patient weight. According to the requester, current code description and the activity
used to prepare the white blood cells versus the administered dose to the patient creates confusion
when converting from microcuries to millicuries and contributes to inconsistencies in reporting
and pricing of this radiopharmaceutical because WBC labeling efficiency is variable.

Preliminary Decision:
1) Discontinue code A9560 TECHNETIUM TC-99M LABELED RED BLOOD CELLS,
DIAGNOSTIC, PER STUDY DOSE, UP TO 30 MILLICURIES

2) Establish the following 3 codes:


AXXX1 RADIOISOTOPE LABELED AUTOLOGOUS RED BLOOD CELLS, DIAGNOSTIC,
PER STUDY DOSE
AXXX2 RADIOISOTOPE LABELED AUTOLOGOUS WHITE BLOOD CELLS,
DIAGNOSTIC, PER STUDY DOSE
AXXX3 RADIOISOTOPE LABELED AUTOLOGOUS PLATELETS, DIAGNOSTIC, PER
STUDY DOSE
HCPCS Meeting Agenda Item #24
May 15, 2007
Attachment #07.05

Topic/Issue:
Request to either revise code A9547 or to delete code A9547 and establish a code for Indium In-
111 autologous labeled white blood cells. Requester’s suggested language: “Indium In-111
autologous labeled white blood cells, diagnostic, per study dose”

Background/Discussion:
According to the requester, Indium In-111 autologous white blood cells (WBCs) are used to
detect inflammatory processes to which leukocytes migrate, such as those associated with
abscesses or other infection. If localizing signs of infection are not present, infection is often
difficult to locate and thus treat. Early detection and localization of an infection improves the
likelihood of cure, and delayed diagnosis is associated with poorer patient outcomes. The
radioactive autologous white blood cells concentrate at sites of infection based on the normal
pathophysiological accumulation of leukocytes. Occult infections can then be seen using nuclear
medicine gamma camera imaging. These cells are administered to the patient intravenously at a
usual patient dosage of 200-500 microcuries. Indium In-111 WBCs is custom compounded by a
local specialty nuclear pharmacy upon receipt of a valid prescription. These WBCs are used in
adults over the age of 18, and each dosage is prepared using the patient’s own blood. According
to the requester, current code description and the activity used to prepare the white blood cells
versus the administered dose to the patient creates confusion when converting from microcuries
to millicuries and contributes to inconsistencies in reporting and pricing of this
radiopharmaceutical. In addition, current HCPCS coding resources lists a code for Indium In-111
oxyquinolone, which does not correctly identify the finished product, “Indium In-111 autologous
labeled white blood cells”. Indium In-111 oxyquinolone is primarily used for radiolabeling
autologous leukocytes and is used only for labeling purposes. It is not administered directly to
the patient.

Preliminary Decision:
1) Discontinue code A9560 TECHNETIUM TC-99M LABELED RED BLOOD CELLS,
DIAGNOSTIC, PER STUDY DOSE, UP TO 30 MILLICURIES

2) Establish the following 3 codes:


AXXX1 RADIOISOTOPE LABELED AUTOLOGOUS RED BLOOD CELLS, DIAGNOSTIC,
PER STUDY DOSE
AXXX2 RADIOISOTOPE LABELED AUTOLOGOUS WHITE BLOOD CELLS,
DIAGNOSTIC, PER STUDY DOSE
AXXX3 RADIOISOTOPE LABELED AUTOLOGOUS PLATELETS, DIAGNOSTIC, PER
STUDY DOSE
HCPCS Meeting Agenda Item #24
May 15, 2007

Attachment #07.06

Topic/Issue:
Request to establish a code for Indium In-111 autologous labeled platelets. Requester’s
suggested language: “Indium In-111 autologous labeled platelets, diagnostic, per study dose”

Background/Discussion:
According to the requester Denise Merlino of the Society of Nuclear Medicine, Indium In-111
autologous labeled platelets are used for the study of platelet kinetics and for in vivo
quantification of sites of platelet distribution and deposition. They have also been used
extensively in the investigation of thrombolitic and vascular disorders and in monitoring the
therapeutic effectiveness of platelet-active drugs in these conditions. These tests are ordered for
patients with diseases such as leukemia and aplastic anemia. The platelets concentrate at sites of
thrombi based on the normal pathophysiological accumulation of platelets. Deep vein thrombosis
can then be seen using nuclear medicine gamma camera imaging. These platelets are also used to
evaluate platelet viability in vivo bio-distribution or recovery. Indium platelets are not indicated
for platelet labeling. Indium In-111 platelets are administered intravenously at a usual dosage of
20-500 microcuries. According to the requester, the current code description and the activity
used to prepare the platelets versus the administered dose to the patient creates confusion when
converting microcuries to millicuries and contributes to inconsistencies in reporting and pricing
of this radiopharmaceutical.

Preliminary Decision:
1) Discontinue code A9560 TECHNETIUM TC-99M LABELED RED BLOOD CELLS,
DIAGNOSTIC, PER STUDY DOSE, UP TO 30 MILLICURIES

2) Establish the following 3 codes:


AXXX1 RADIOISOTOPE LABELED AUTOLOGOUS RED BLOOD CELLS, DIAGNOSTIC,
PER STUDY DOSE
AXXX2 RADIOISOTOPE LABELED AUTOLOGOUS WHITE BLOOD CELLS,
DIAGNOSTIC, PER STUDY DOSE
AXXX3 RADIOISOTOPE LABELED AUTOLOGOUS PLATELETS, DIAGNOSTIC, PER
STUDY DOSE
HCPCS Meeting Agenda Item #25
May 15, 2007

Attachment #07.44

Topic/Discussion:
Request to revise existing code A9565 which currently reads: “Indium In-111 Pentetreotide,
diagnostic, per millicurie” to instead read “Indium In-111 Pentetreotide, diagnostic, per dose up
to 6mCi” to identify OctreoScan®

Background/Discussion:
The requester is asking CMS to revise the code description for administration of OctreoScan®
from “per millicurie” to “per dose” consistent with code descriptions for other
radiopharmaceuticals. According to the requester, a per study dose description of up to 6
millicuries (mCi) is consistent with package insert and medical society guidelines and reflects the
quantity or unit that is typically purchased, supplied and administered to the patient.

Preliminary Decision:
Existing code A9565 “INDIUM IN-111 PENTETREOTIDE, DIAGNOSTIC, PER
MILLICURIE” adequately describes the product that is the subject of this request. Use the
"units” column on the claim to report appropriate multiples.
HCPCS Meeting Agenda Item #26
May 15, 2007

Attachment #07.87

Topic/Issue:
Request to establish a code to identify dexrazoxane, trade name: Totect™. Applicant’s
recommended language: JXXXX “Dexrazoxane for continuous infusion, 500mg”.

Background/Discussion:
According to the requester, Totect™ is an antidote for the treatment of extravasation resulting
from IV anthracycline chemotherapy. It is a sterile, pyrogen-free lyophilizate intended for
intravenous (IV) administration, a bisdiozopiperazine that readily enters cells and is subsequently
hydrolyzed to form a chelating agent analogous to EDTA, a catalytic inhibitor of DNA
topoiomerase II, and in its ring-opened form ADR-925, a potent chelator of heavy metals. The
requester claims that since Totect™ is the only product that has clearly demonstrated
effectiveness in the treatment of biopsy verified cases of anthracycline extravasations, and since it
will be the only approved therapy for this indication, a prominent role in the treatment of
anthracycline extravasations is expected. Totect™ also reduces the need for delaying
chemotherapy, thus improving the chance of chemotherapeutical success. Totect™ powder and
solvent for injection is supplied in a specialized per patient emergency treatment kit containing 10
vials of Totect™ powder (500mg dexrazoxane) and 10 vials of Totect™ solvent. The first
infusion should be initiated as soon as possible and within the first six hours after the accidental
extravasation. Totect™ should be given once daily for 3 consecutive days. According to the
applicant, code J1190 “INJECTION, DEXRAZOXANE HYDROCHLORIDE, PER 250 MG,” is
not appropriate for Totect™ because the products are not directly comparable. Although
Totect™ and other formulations of dexrazoxane share the same active ingredient, the indication,
dosing, administration, packaging, cost, orphan drug status and pharmacoeconomic issues for
Totect™ are different from other formulations of dexrazoxane. There are no other commercially
available formulations of dexrazoxane that can be used in the treatment of extravasation resulting
from IV anthracycline chemotherapy.

Preliminary Decision:
Although Totect™ is still pending FDA approval, there is an existing code, J1190 "INJECTION,
DEXRAZOXANE HYDROCHLORIDE, PER 250MG", which adequately describes the product
and is available for assignment by insurers.