SECOND SIGHT MEDICAL PRODUCTS, INC. (NASDAQ:EYES) Files An 8-K Other EventsItem 8.01 Other Events
Novitas Solutions, Inc. (Novitas), the Medicare Administrative Contractor (MAC) for Jurisdiction H (covering Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas) and Jurisdiction L (covering Delaware, District of Columbia, Maryland, New Jersey, and Pennsylvania), removed code CPT 0100T (Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intra-ocular retinal electrode array, with vitrectomy) from the listing of codes in the Services That Are Not Reasonable and Necessary Local Coverage Determination (LCD) that are considered not reasonable and necessary and therefore not covered. This development enables coverage of the Argus II implantation procedure for Medicare patients in both Novitas jurisdictions covering the above listed 11 states and the District of Columbia. The Argus II implantation procedure must meet all regulatory requirements, including the reasonable and necessary threshold, to qualify for coverage.
The Centers for Medicare & Medical Services (CMS), a federal agency that runs the Medicare program, relies on a network of Medicare Administrative Contractors, or MACs, to administer and process most Medicare Fee-for-Service Part A and Part B claims across 12 regions or jurisdictions within the United States. CMS also delegates the authority to MACs to make the coverage determinations for a given service, procedure or device in the absence of a national coverage policy.
Currently, seven Medicare jurisdictions, including CGS (J15 — Ohio and Kentucky), Palmetto GBA (JM — Virginia, (excluding Part B for Arlington and Fairfax counties), West Virginia, North Carolina and South Carolina), NGS (J6 — Minnesota, Illinois and Wisconsin), NGS (JK — Connecticut, New York, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont), FCSO (JN — Florida, Puerto Rico and the U.S. Virgin Islands), and Novitas (JH and JL — Arkansas, Colorado, Delaware, District of Columbia, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania, and Texas) provide coverage of the Argus II in 28 states, two territories and the District of Columbia when medically necessary.
The Company continues to work with other MACs and payers to secure additional positive coverage policies for the Argus II.
On July 3, 2017, the Company issued a press release announcing that Novitas on June 30, 2017 published a local coverage determination which extends coverage of Argus II, when medically necessary, to Medicare beneficiaries in 11 states and the District of Columbia as of April 26, 2017. A copy of our press release entitled “Second Sight Announces Expansion of Medicare Coverage for Argus II Retinal Prosthesis System to 11 Additional States and the District of Columbia” is attached as Exhibit 99.1 to this Current Report on Form 8-K, and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
| 99.1 | Press Release issued July 3, 2017 |
SECOND SIGHT MEDICAL PRODUCTS INC ExhibitEX-99.1 2 s106754_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Second Sight Announces Expansion of Medicare Coverage for Argus II Retinal Prosthesis System to 11 Additional States and the District of Columbia — Argus II Can Now Be Covered in Seven of 12 Medicare Administrative Contractor Jurisdictions,…To view the full exhibit click here
About SECOND SIGHT MEDICAL PRODUCTS, INC. (NASDAQ:EYES)
Second Sight Medical Products, Inc. is engaged in developing, manufacturing and marketing prosthetic devices that restore vision to blind individuals. The Company’s product, the Argus II System, treats outer retinal degenerations, such as retinitis pigmentosa (RP). The Argus II System provides an artificial form of vision that differs from the vision of people with normal sight. It does not restore normal vision and it does not slow or reverse the progression of the disease. The Company’s Argus II System employs electrical stimulation to bypass degenerated photoreceptor cells and to stimulate remaining viable retinal cells thereby inducing visual perception in blind individuals. The Argus II System works by converting video images captured by a miniature camera housed in a patient’s glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes that are implanted on the surface of the retina.
