DRUG AGENDA - May 2015

Cortiva 

Request to establish a new Level II HCPCS code to identify Cortiva™, 1 mm allograft dermis. 
Applicant's suggested language: QXXXX -Cortiva, 1 mm, per square.

Background/Discussion:
    RTI Surgical, dba RTI Biologic, Inc., submitted a request for a new HCPCS code to identify
Cortiva 1mm (allograft dermis).  Cortiva, 1mm is a sterile, dehydrated dermis from donated
human tissue. It is preserved by the Tutoplast process, whereby low-dose gamma irradiation is
applied terminally to the product to achieve a sterility assurance level of 10-6, while preserving
structural integrity. Cortiva, 1mm is an implant regulated as a 361 human cell and tissue product
(HCT/P) and restricted to homologous use for the repair, replacement, reconstruction or
augmentation of soft tissue, including supplemental support and reinforcement of soft tissue in
hernia repair.The requester claims that there are no existing codes that describe Cortiva, 1mm. 
A code is needed in order to process claims and track costs.  Currently, miscellaneous skin substitute code Q4100 is being used to identify this product on claims.

Preliminary Decision:
  A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify Cortiva, 1mm, which is
included as part of the surgical procedure.

HPTM

Request to establish a new Level II HCPCS code to identify a porcine-derived, non-cross linked,
cellular dermal matrix surgical mesh, Trade Name HPTM.  Applicant's suggested language: Q41XX -
HPTM, per square centimeter.


Background/Discussion:
      LifeCell Corporation requests the creation of a new HCPCS code to identify HPTM, a sterile,
porcine derived, non-cross linked biologic, acellular tissue matrix surgical mesh. HPTM is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require the use of reinforcing or bridging material to obtain the desired surgical outcome.  The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery.  Once applied by a surgeon, HPTM supports revascularization, cell repopulation and white cell migration while providing mechanical support. 

The surgeon determines the most appropriate size and shape of HPTM to use on the patient.
Each package contains one piece of HPTM, an outer carton, an outer foil package containing a
sterile inner foil pouch with HPTM. The requester comments that a new code is necessary in order
to provide for greater coding accuracy and utilization documentation for providers and insurers
when billing for the use of this product.


Preliminary Decision:
      A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify HPTM, which is included as
part of the surgical procedure.

Ologen

Repeat request to establish a unique Level II HCPCS Q-code to identify a porcine-derived
collagen matrix, Trade Name:  Ologen®Applicant's suggested language: QXXXX-Ologen®
Collagen Matrix, per unit.

Background/Discussion:
        A request was submitted on behalf of Aeon Astron Europe BV, for a HCPCS code to identify
Ologen Collagen Matrix. According to the requester, Ologen Collagen Matrix is a medical device made of atellocollagen which is derived from porcine skin. This atelocollagen is cross-linked and lyophilized with glycosaminoglycan to obtain Ologen collaten Matrix.  It is configured to support and mudultate wound healing in connective and epithelial ocular tissue, and is used exclusively in ophthalmic surgery procedures such as glaucoma filtering surgery, primarily in the trabeculectomy surgical procedure.

The requester claims that there is a “significant therapeutic distinction” between Ologen and other collagen matrices, in that none of the other matrices are indicated by the FDA for ophthalmic surgery.


Preliminary Decision:
       A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify Ologen Collagen Matrix,
which is included as part of the surgical procedure.

DRUG AGENDA - May 2015

Tutopatch

       Request to establish a new Level II HCPCS code to identify Tutopatch™ bovine pericardium.
Applicant's suggested language: QXXXX -  Tutopatch, per square centimeter


Background/Discussion:
   RTI Surgical dba RTI Biologics, Inc., submitted a request for a new code to identify Tutopatch
(Bovine Pericardium). Tutopatch is indicated for use in general and plastic surgery applications.
It is intended for repair of pericardial structures and for use in surgical repair of soft tissue
deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle
flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias
(including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical hernias). 

Tutopatch is preserved by the Tutoplast process, whereby low - dose gamma irradiation is
applied terminally to the product to achieve a sterility assurance level of 10-6, while
preserving structural integrity. This process retains the original three-dimensional collagen
structure responsible for the multidirectional, mechanical properties of tissue. The typical patient
population is persons over the age of 18 who present with soft tissue repair needs.

The requester claims that there are no existing codes that describe Tutopatch. 
A code is needed in order to process claims and track costs.  Currently, miscellaneous
skin substitute code Q4100 is being used to identify this product on claims.

Preliminary Decision:

    A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify Tutopatch, which is included
as part of the surgical procedure.

Tutomesh

Request to establish a new Level II HCPCS code to identify Tutomesh™ bovine pericardium.
Applicant's suggested language: QXXXX - Tutomesh, per square centimeter


Background/Discussion:
   RTI Surgical, dba RTI Biologics,Inc.,requests a new code to identify Tutomesh, a fenestrated version of bovine pericardium tissue.  According to the requester, Tutomesh is preserved by the Tutoplast process, whereby low-dose gamma irradiation is applied terminally to the product to achieve a sterility assurance level of 10 -6, while preserving structural integrity. Tutomesh is used in general and plastic surgery applications.

It is a biological scaffold intended to be replaced by newly formed connective tissue through remodeling. 

Tutomesh bovine pericardium is intended for use to reinforce soft tissue where weakness exists
in general and plastic surgery applications and is indicated f or repair of pericardial structures
and for use for surgical repair of soft tissue deficiencies including gastric banding muscle
flap reinforcement, repair of rectal prolapse using an abdominal approach, reconstruction of the
pelvic floor using an abdominal approach, and hernias. The typical patient population is adults
over the age of 18 who present with soft tissue repair needs.

The requester claims that there are no existing codes that describe Tutomesh.  A code is needed
in order to process claims and track costs.  Currently, miscellaneous skin substitute code Q4100
is being used to identify this product on claims.

Preliminary Decision:
     A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify Tutomesh, which is included
as part of the surgical procedure.

Cortiva

Request to establish a new Level II HCPCS code to identify Cortiva™, allograft dermis. 
Applicant's suggested language: QXXXX - Cortiva, per square centimeter

Background/Discussion:
       RTI Surgical, dba RTI Biologic, Inc., submitted a request for a new HCPCS code to identify
Cortiva (allograft dermis). Cortiva is a sterile, dehydrated dermis from donated human tissue.
It is preserved by the Tutoplast process, whereby low-dose gamma irradiation is applied terminally
to the product to achieve a sterility assurance level of 10-6, while preserving structural integrity.
Cortiva is an implant regulated as a 361 human cell and tissue product (HCT/P) and restricted to
homologous use for the repair, replacement, reconstruction or augmentation of soft tissue, including
supplemental support and reinforcement of soft tissue in hernia repair.

The requester claims that there are no existing codes that describe Cortiva.  A code is needed in order to process claims and track costs.  Currently, miscellaneous skin substitute code Q4100 is being used to identify this product on claims.


Preliminary Decision:
   A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify Cortiva, which is included as
part of the surgical procedure

DRUG AGENDA - May 2015

OMIDRIA (Phenylephrine and ketorolac)

       Request to establish a unique Level II HCPCS code to identify phenylephrine and ketorolac injection 1%/0.3%., Trade Name: Omidria.  Applicant's suggested language: “JXXXX -injection, phenylephrine and ketorolac 1% / 0.3%, 4 mL vial”

Background/Discussion:
   Omeros Corporation submitted a request for a code to identify Omidria.  According to the requester, Omidria is a preservative-free, bisulfite-free, sodium citrate-buffered, sterile drug solution that is added to standard irrigation solution and is used during cataract surgery or other IOL replacement procedures.

It contains 10.16 mg/mL (1%w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac in a single-patient-use vial. Omidria is indicated for maintaining pupil size by preventing intraoperative miosis and for reducing postoperative ocular pain.Omidria is currently indicated for use in adults during refractive lens exchange (RLE).

Omidria must be diluted prior to intraocular use.  For administration to patients undergoing cataract surgery or intraocular lens replacement, 4 mL of Omidria is diluted in 500 mL of ophthalmic irrigation solution, to be used as needed for the surgical procedure.  Safety and efficacy of Omidria in pediatric patients has not been established.

Omidria is supplied as a sterile solution concentrate in a clear, 5-mL single-patient-use vial containing 4 mL of sterile solution.Omidria is supplied in a multi-pack containing four single-patient-use vials:NDC 62225-600-04 or ten single-patient-use vials:NDC 62225-6001.According to the applicant, there are no existing HCPCS codes that accurately describe Omidria.


Preliminary Decision:
   A national program operating need was not identified by Medicare, Medicaid or the Private Insurance sector to establish a new HCPCS code to identify Omidria, which is included in surgical the procedure.  Existing code C9447 "

 Injection, Phenylephrine and Ketorolac, 4 ml vial", is available for assignment by insurers if they deem appropriate

AmnioClear

  Request to establish a unique Level II HCPCS code to identify an injectable flowable allograft,
Trade Name:  AmnioClear® LTC.  Applicant's suggested language: J73XX - AmnioClear LTC, per ml.


Background/Discussion:
       Liventa Bioscience requests a new code for AmnioClear.  According to the requester, AmnioClear LTC (loose connective tissue) is minimally processed amniotic tissue.  It is an injectable flowable allograft reduces knee pain and inflammation while also increasing the knee range of motion, lubrication and shock absorption by supplementing the existing knee synovial fluid with human allograft.  

It is intended for use in supplementing synovial fluid in articulating joints. 
The typical dose for viscosupplementation of the knee is 4 mL.  The typical patient-candidate
presents with musculoskeletal joint pain often caused by osteoarthritis.The requester claims that
AmnioClear LTC“is very similar to the viscosupplement products for which HCPCS codes have been established (J7321 to J7327) and therefore should be treated as a drug or biological.

The typical dose for injection into the knee as a viscosupplement is 4ml. A 2ml injection may be
appropriate for smaller patients.AmnioClear LCT comes in 1ml, 2ml, and 4ml vial sizes. 
The requester comments that a new code in the J73XX seectin is warranted because there is
currently no code that describes the human tissue-based viscosupplement product by the brand - name AmnioClear LCT, while there are numerous brand-specific codes for viscosupplement products.

Preliminary Decision:
      A national program operating need was not identified by Medicare, Medicaid or Private
Insurance sector to establish a HCPCS code to identify AmnioClear®LCT.  This product is not
FDA cleared for the indication specified in the code application

Fortiva

Request to establish a unique Level II HCPCS code to identify an extracellular collagen matrix
surgical mesh derived from porcine dermis, Trade Name:  Fortiva.  Applicant's suggested
language: QXXXX - Fortiva, per square centimeter

Background/Discussion:
    RTI Surgical dba RTI Biologics, Inc., submitted a request to establish a new HCPCS code to
identify Fortiva, a porcine-derived extracellular collagen matrix.  Fortiva is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. 

Indications for use include the repair of hernias and/or body wall defects which require the use
of reinforcing or bridging material to obtain he desired surgical outcome.  According to the requester,
Fortiva performs as a scaffold that allows for neovascularization and permits the replacement
of the porcine dermis with the patient's tissue. The matrix is derived from porcine dermis and
preserved using a multi-step sterilization process which includes terminal sterilization by
gamma irradiation. Fortiva is provided hydrated and is ready for immediate use without additional
preparation. As a surgical mesh, Fortiva is hydrated and stored at 10-30 degrees Celsius.

The typical patient population is persons over age 18 who present with soft tissue repair needs.
The requester claims that there are no existing codes that describe Fortiva.  A code is needed in
order to process claims and track costs .  Miscellaneous skin substitute code Q4100 is currently
being used to identify this product on claims.

Preliminary Decision:
       A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify Fortiva, which is included as part of the surgical procedure.



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

DRUG AGENDA - May 2015

ADASUVE  (Loxapine)

      Request to establish a new Level II HCPCS code to identify loxapine, Trade Name: 
Adasuve.  Applicant’s suggested language:  “JXXXX Loxapine, inhalation powder, 10 mg.

Background/Discussion:
     Teva Pharmaceuticals requests a new Level II HCPCS code to identify for loxapine.  According
to the requester, loxapine is an atypical antipsychotic drug supplied as a powder for oral
inhalation, indicated for the acute treatment of agitation associated with schizophrenia or bipolar
I disorder in adults.  “Psychomotor agitation” is defined in DSM - IV as “excessive motor activity
associated with a feeling of inner tension.”  Patients experiencing agitation often manifest
behaviors that interfere with their care (e.g., threatening behaviors; escalation or urgently
distressing behavior; self - exhausting behavior), leading clinicians to use a rapidly absorbed
antipsychotic medication to achieve immediate control of the agitation.  To limit the risk of
serious side effects such as bronchospasm, use of Adasuve must only be used in healthcare
facilities enrolled in the Adasuve Risk Evaluation and Mitigation Strategy (REMS) Program
that have immediate (on-site) access to equipment and personnel trained to manage acute
bronchospasm, including advanced airway management (intubation and mechanical ventilation). 
Adasuve is administered in a single breath inhalation via a single - use, disposable, handheld
inhaler that contains the drug.  Patients are instructed to hold the inhaler away from their mouth
and exhale fully, then put the mouthpiece of the inhaler between their lips, close their lips and
inhale with a single steady, deep breath, remove the mouthpiece and hold their breath for up to
10 seconds.

The applicant comments that a new code is warranted because there are no existing “J”
codes to describe this formulation and delivery method of loxapine. 

Preliminary Decision:
     A national program operating need was not identified by Medicare, Medicaid or Private Insurers
to establish another Level II HCPCS code to identify Adasuve.  Existing code C9497 “Loxapine,
inhalation powder, 10 mg” is available for assignment by insurers if they deem appropriate.  

VIZAMYL (Flutemetamol)

         Request to establish a unique Level II HCPCS code to identify Flutemetamol F18 Injection,
Trade Name:  Vizamyl. 

Background/Discussion:
GE Healthcare submitted a request to establish a new Level II HCPCS code to identify
Flutemetamol F18 Injection (Vizamyl).  According to the requester, Vizamyl is
a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging
of the brain to estimate Beta Amyloid neuritic plaque density in adult patients with
cognitive impairment who are being evaluated for Alzheimer’s disease (AD), or other causes
of cognitive decline.  A negative Viazmyl scan indicates sparse to no neurotic plaques,
and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition.
 A negative scan reduces the likelihood that a patient’s cognitive impairment is a result of AD. 
A positive Vizamyl scan indicates moderate to frequent amyloid neuritic plaques;
neuropathological examination has shown this amount of neuritic plaque is present in patients with A
D, but may also be present in patients with other types of neurologic conditions,
as well as older people with normal cognition.  Vizamyl is an adjunct to other diagnostic evaluations. 
There are, however; some limitations of use. 
A positive Vizamyl scan does not establish a diagnosis of AD or other cognitive disorder. 

Recommended dose is 185 megabecquerels (MBq) [5 millicuries (mCi)]; maximum mass dose
20 micrograms] in a maximum dose volume of 10 mL, administered as a single intravenous
bolus within 40 seconds, followed by an intravenous flush of 0.9% sterile sodium chloride
injection.  It is supplied in a 10 mL or a 30 mL multi-dose vial with 1 -10 mL and 1-30 mL fill
volume respectively.  Each vial is enclosed in a radiation shield.  The total concentration is 150
MBq/mL (4.05 mCi/mL) of flutemetamol F 18 at reference date and time.The applicant comments that a new code
is warranted because no existing HCPCS code accurately describes this product. 


Preliminary Decision:
   Existing code A9599 “Radiopharmaceutical, diagnostic, for beta - amyloid positron emission
tomography (PET) imaging, per study dose” adequately describes the product that is the subject
of this request.

NEURACEQ (Florbetaben)

   Request to establish a unique Level II HCPCS code to identify florbetaben F 18, Trade
Name:  Neuraceq.  Applicant’s suggested language:  “AXXXX Injection, florbetapen F 18,
diagnostic, per study dose, up to 8.1 millicuries”.

Background/Discussion:
   Piramal Pharma, Inc., submitted a request for a new code to identify Neuraceq (florbetaben F 18).
According to the applicant, Neuraceq is a radioactive diagnostic agent indicated for Positron
Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density
in adult patients with cognitive impairment who are being evaluated for AD and other causes of
cognitive decline. Florbetaben binds to β-amyloid plaques in the brain. This produces a position
signal that is detected by a PET scanner. Neuraceq is administered by intravenous injection.
Recommended dosage is a single IV bolus of 300 MBq of Neuraceq followed 45-130 minutes afterwards
by brain PET imaging for 15 - 20 minutes in duration. Neuraceq is supplied in 30 mL multi-dose vial
s containing 50 to 5000 MBq/mL (1.4 to 135 mCi/mL) florbetaben F 18 at EOS. 
At time of administration, 300 MBq (8.1 mCi_ are contained in up to 10 mL of solution for injection.  

The applicant claims that there is a significant therapeutic distinction between Amyvid and Vizamil
–and Neuraceq.  All three of these products have different dosages; there is also a difference between
the mean effective radiation dose of Neuraceq and Vizamyl and the mean effective radiation dose of Amyvid.  
The applicant claims that, as per prior CMS HCPCS coding determination, existing code A9599,
Radiopharmaceutical, diagnostic, for beta-amyloid positron emission tomography (pet) imaging , per study dose
does not accurately describe Neuraceq, because the descriptor is not specific to the active ingredient, florbetaben F 18.


Preliminary Decision:
Existing code A9599 “Radiopharmaceutical, diagnostic, for beta-amyloid positron emission
tomography (PET) imaging, per study dose” 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

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

CRITICAL CARE SERVICES

CRITICAL CARE SERVICES

           Critical care is the direct delivery by a physician(s) or other qualified health care professional of medical care for a critically ill or critically injured patient.

           A critical illness or injury acutely impairs one or more vital organ systems such that there is a high probability of  life threatening deterioration in the patient's condition.

           Critical care involves high complexity decision making to assess, manipulate, and support vital system function to treat single or multiple vital organ system failure and/or to prevent further life threatening deterioration of the patient's condition.

Examples of vital organ system failure include, but are not limited to, central nervous system failure, circulatory failure, shock, renal, hepatic, metabolic, and/or respiratory failure.

Although critical care typically requires interpretation of multiple physiologic parameters and/or application of advanced technology(s), critical care may be provided in life threatening situations when these elements are not present.

Critical care may be provided on multiple days, even if no changes are made in the treatment rendered to the patient, provided that the patient's condition continues to require the level of attention described above.

Providing medical care to a critically ill, injured, or post-operative patient qualifies as a critical care service only if both the illness or injury and the treatment being provided meet the above requirements.

Time spent with the individual patient should be recorded in the patient's record.

CPT 99291- Critical care, evaluation and management of the critically ill or critically injured patient; first 30-74 minutes

CPT 99292- Critical care, evaluation and management of the critically ill or critically injured patient; each additional 30 minutes (List separately in addition to code for primary service)

Inpatient critical care services provided to infants 29 days through 71 months of age are reported with pediatric critical care codes 99471- 99476

The pediatric critical care codes are reported as long as the infant/young child qualifies for critical care services during the hospital stay through 71 months of age.

Inpatient critical care services provided to neonates (28 days of age or younger) are reported with the neonatal critical care codes 99468 and 99469.

The neonatal critical care codes are reported as long as the neonate qualifies for critical care services during the hospital stay through the 28th postnatal day.

The reporting of the pediatric and neonatal critical care services is not based on time or the type of unit (eg, pediatric or neonatal critical care unit) and it is not dependent upon the type of physician or other qualified health care professional delivering the care.

To report critical care services provided in the outpatient setting (eg, emergency department or office), for neonates and pediatric patients up through 71 months of age, see the critical care codes 99291, 99292.

 If the same individual provides critical care services for a neonatal or pediatric patient in both the outpatient and inpatient settings on the same day, report only the appropriate neonatal or pediatric critical care code 99468-99472 for all critical care services provided on that day.

Also report 99291-99292 for neonatal or pediatric critical care services provided by the individual providing critical care at one facility but transferring the patient to another facility.

Critical care services provided by a second individual of a different specialty not reporting a per day neonatal or pediatric critical care code can be reported with codes 99291, 99292.

For additional instructions on reporting these services, see the Neonatal and Pediatric Critical Care section and codes 99468-99476. Services for a patient who is not critically ill but happens to be in a critical care unit are reported using other appropriate E/M codes.

            Critical care services include the treatment of vital organ failure or prevention of further life–threatening conditions. Delivering medical care in a moment of crisis and in time of emergency is not the only requirement for providing CC services. Presence of a patient in an ICU or use of ventilation is not sufficient to bill a CC service.

The following three criteria must be met for reporting CC service:

            1.       The severity of illness

            2.       The intensity of services required treating the illness, and

            3.       The time spent in providing the care.

Proper documentation showing the medical necessity for providing CC services is an absolute requirement.

Usually a critical care service is provided to a patient in a "critical care area" such as the

        1.       Coronary care unit (CCU),

        2.       Intensive care unit (ICU),

        3.       Respiratory care unit, or

        4.       Emergency room.

This code is applicable for a critical care service provided for first 30 – 74 minutes. Any CC service provided for less than 30 minutes should be billed with the appropriate level of E/M code.

Critical care services require a cumulative time of at least 30 minutes on a given date of service

– Time can be continuous or intermittent on the date of service and must be clearly documented in the medical record.

     The total time can be calculated by the time spent evaluating, managing, and providing critical care services to a critically ill or injured person.

     The time to be billed for CC must be spent at the immediate bedside or elsewhere on the floor as long as the physician is available to the patient. Full attention of a physician must be paid towards the CC service

This code is applicable for patients 25 months of age and older.

Inclusive Services:

The following services are included in "critical care service" time when performed during the critical period by the same physician(s) providing critical care and should not be reported separately:

          1.       The interpretation of cardiac output measurements (93561,93562)

          2.       Pulse oximetry (94760, 94761, 94762)

          3.       Chest x–rays, professional component (71010, 71015, 71020)

          4.       Blood gases, and information data stored in computers (e.g., ECGs, blood pressures, hematologic data–CPT 99090)

          5.       Gastric intubation (43752, 91105)

          6.       Transcutaneous pacing (92953)

          7.       Ventilator management (94002–94004, 94660, 94662)

          8.       Vascular access procedures (36000, 36410, 36415, 36591, 36600)

Code 99291 is used to report the first 30-74 minutes of critical care on a given date. It should be used only once per date even if the time spent by the individual is not continuous on that date. 

Critical care of less than 30 minutes total duration on a given date should be reported with the appropriate E/M code. 

Code 99292 is used to report additional block(s) of time, of up to 30 minutes each beyond the first 74 minutes. 

 

The following examples 

30-74 minutes (30 minutes - 1 hr. 14 min.) 99291 X 1 

75-104 minutes   (1 hr. 15 min. - 1 hr. 44 min.) 99291 & 99292 X 1 

105-134 minutes (1 hr. 45 min. - 2 hr. 14 min.) 99291 & 99292 X 2 

135-164 minutes (2 hr. 15 min. - 2 hr. 44 min.) 99291 & 99292 X 3 

165-194 minutes (2 hr. 45 min. - 3 hr. 14 min.) 99291 & 99292 X 4

GENITOURINARY SYSTEM (GU)

Non Vascular Interventional Coding

Genitourinary System (GU)

      There are various non vascular Interventional procedures are performed for various conditions which are related to GU system are mentioned below, some of the common Terminology are:

Pyelography:  X ray images of the renal pelvis of the kidney with associated structures after administration of a contrast agent.

Nephrostomy tube:  A very small, soft, plastic tube, which is placed into the renal collecting system for temporary drainage of urine, abscess, or calculus removal.

Pyelostomy tube:   A plastic tube which is placed in the renal pelvis of the kidney for drainage of urine. It is placed either percutaneously or during an open surgical procedure.

Nephrostogram:   An X ray of the kidney after injection of a contrast agent.

Pyeloureterogram:  An X ray of the kidneys, renal pelvis, and ureters after injection of a contrast agent.

Percutaneous Antegrade Pyelogram

A Percutaneous Antegrade Pyelogram  is performed by placing a needle into the kidney or kidney cyst with injection of contrast and taking images.

 CPT 50390- Aspiration and/or injection of renal cyst or pelvis by needle, percutaneous
 For radiological S&I, - 74425,74470, 76942, 77002, 77012, 77021. 

Note:
Don't assign antegrade pyelogram if contrast injection was performed for the purpose of
localization of a posterior calyx for subsequent Percutaneous nephrostomy tube placement.

Nephrostomy Tube Placement

Renal collecting system obstruction would be the major reason behind the placement of Percutaneous nephrostomy tube placement. The procedure consist of placement of a drainage tube into the collecting system of an obstructed kidney. The tube is sutured in place and drains to a bag at the patient’s side.

CPT 50392 - Introduction of intracatheter or catheter into renal pelvis for drainage and/or injection, percutaneous

For radiological S&I, - 74475, 76942, 77012

Note:
If both a diagnostic antegrade pyelogram and a nephrostomy tube placement are performed at
the same session, code 50392 and 50390 with 59 modifier along with appropriate S&I codes.

(The diagnostic antegrade pyelogram is via the initial needle puncture of the collecting system, followed by a new separate percutaneous puncture of a posterior calyx for placement of the drainage catheter)

Nephrostogram

Malfunctioning drainage tube or any complication would be the reason for Nephrostogram procedure following prior Percutaneous nephrostomy tube placement. Nephrostogram involves injection of contrast into a newly placed or pre-existing kidney drainage tube and analyze the internal structures of the kidney, renal pelvis, and/or ureter using imaging guidance.

 

CPT 50394 - Injection procedure for pyelography (as nephrostogram, pyelostogram, antegrade pyeloureterograms) through nephrostomy or pyelostomy tube, or indwelling ureteral catheter

 

For radiological S&I, - 74425

 

Note:  If a tube check or change is performed with the patient in the supine position, it is  via an ileal conduit and is coded with 50684 or 50688.

 

           If a tube check or change is performed with the patient in the prone position, the procedure is performed via flank and is coded with 50394. 

 

Nephrostomy Tube change

Non-functioning nephrostomy tube is the reason behind the Nephrostomy Tube change, Nephrostomy tube is evaluated first by administrating contrast through the existing Nephrostomy Tube (NEPHROSTOGRAM) and The exchange portion of the exam occurs when a wire is placed through the existing tube and the tube is removed, followed by placement of a new tube into the kidney over the wire.

 

CPT 50398 - Change of nephrostomy or pyelostomy tube

 

For radiological S&I, - 75984

 

Note: In case contrast was not documented don't assign 75984 instead can code 76000.