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EX-99.1 - EXHIBIT 99.1 - SECOND SIGHT MEDICAL PRODUCTS INCs106754_ex99-1.htm

 

FORM 8-K

 

CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934

 

Date of report (Date of earliest event reported): June 30, 2017

 

SECOND SIGHT MEDICAL PRODUCTS, INC.
(Exact Name of Registrant as Specified in Its Charter)
 
California
(State or Other Jurisdiction of Incorporation)
 
  333-198073     02-0692322  
  (Commission File Number)     (IRS Employer Identification No.)  
   

12744 San Fernando Road, Suite 400
Sylmar, California 91342

(Address of Principal Executive Offices)
 
(818) 833-5000
(Registrant’s Telephone Number, Including Area Code)
 
 
(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

 

Item 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

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: July 6, 2017

 

SECOND SIGHT MEDICAL PRODUCTS, INC.

 

/s/ Thomas B. Miller  
By: Thomas B. Miller  
Chief Financial Officer