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