CMS grants statuses to VisionCare, Omeros products

Seattle and Seratoga, CA-The Center for Medicare and Medicaid Services (CMS) has granted billing and reimbursement statuses to products from Omeros Corp. and VisionCare Ophthalmic Technologies, respectively.

Omeros received transitional pass-through status for its lead product, phyenlephrine and kerotorolac injection (Omidria 1%/0.3%) from CMS.

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Approved earlier this year by the FDA for use during cataract surgery or IOL replacement, the drug treatment is the only FDA-approved product for intraocular administration that prevents intraoperative miosis and reduces postoperative pain, according to the company.

Transitional pass-through status will allow ambulatory surgery centers and other outpatient facilities to bill Medicare and other insurance providers for the drug treatment using a temporary Healthcare Common Procedure Coding System code unique to the product.

Pass-through status for the drug treatment will become effective on Jan. 1 and reimbursement will be based on the product’s wholesale acquisition cost of between $400 and $500 per single-use vial.

“We are pleased with CMS’s decision to grant pass-through for (the product),” said Gregory A. Demopulos, MD, chairman and chief executive officer of Omeros. “Pass-through status should streamline the billing and reimbursement process for facilities that use (the treatment) and could accelerate adoption of the product across cataract and other IOL procedures.

Coincident with this new clarity on reimbursement, our commercial team is in the process of adding the second wave of sales representatives, and we plan to launch (the injection) no later than early 2015,” he continued.

In addition, the CMS will reimburse the Implantable Miniature Telescope, by Dr. Isaac Lipshitz, under a revised Ambulatory Payment Classification designation, A{C 0351, Level V Intraocular Procedures.

According to VisionCare, the outpatient surgical procedure for telescope implantation has been restricted to hospitals until now due to current reimbursement rules.

The CMS ruling provides the mechanisms needed for broad ambulatory surgery center (ASC) adoption of the therapy, which will “significantly improve patient access and bolster ophthalmologist and healthcare provider efficiency,” VisionCare said.

When the new designation takes effect on Jan. 1, reimbursement payment levels will increase overall and ASC payment levels will be comparable to those paid to hospital outpatient departments.  

According to the company, the telescope implant is the “integral component” of VisionCare's comprehensive treatment program called CentraSight, which helps patients follow the steps necessary for proper diagnosis, surgical evaluation, implantation, and postoperative care.

"We envisioned and designed the CentraSight program to function within the Medicare system to better assure the telescope implant will be broadly assessable and within financial reach of most Medicare eligible individuals," said Allen W. Hill, president and chief executive officer, VisionCare Ophthalmic Technologies. "It is vitally important to both patients and their healthcare providers that our telescope implant procedure be available and economically viable in local ASCs where ophthalmologists conduct the vast majority of their surgical procedures.

“This CMS ruling will go a long way in helping make this a reality," he added.

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