Aspira Women’s Health Secures Reimbursement for Ova1Plus(R) from California Medicaid (Medi-Cal)

Rhea-AI Summary

Aspira Women’s Health Inc. (AWH) announced that California Medicaid (Medi-Cal) added Ova1Plus® to its fee schedule at $897 per test. Aspira will be reimbursed at a rate of $897 for all Ova1Plus® tests processed for Medi-Cal patients meeting applicable coverage requirements, effective from October 15, 2023. The addition of Ova1Plus® to the fee schedule provides expanded access to this groundbreaking technology for women in California facing an ovarian cancer diagnosis.

California Medicaid (Medi-Cal) added Ova1Plus(R) to its fee schedule at $897 per test

AUSTIN, Texas, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira” or “the Company”) (Nasdaq: AWH), a bio-analytical company focused on the development and commercialization of women’s health diagnostic tools for gynecologic diseases, today announced that California Medicaid (Medi-Cal) added Ova1Plus^® to its fee schedule. Aspira will be reimbursed at a rate of $897 for all Ova1Plus^® tests processed for Medi-Cal patients meeting applicable coverage requirements beginning immediately and going back to date of service back to October 15, 2023.

The California Department of Health Care Services who is responsible for establishing policy and covered health care services for the California Medicaid (Medi-Cal) program, inclusive of both the fee-for-service and managed care delivery systems has added the Ova1Plus^® CPT 81503 to its Provider Manual and fee schedule at the Medicare rate of $897.

“We are pleased to announce Medi-Cal’s decision to add Ova1Plus® to its fee schedule,” said Nicole Sandford, President and CEO of Aspira. “This means that women in California facing an ovarian cancer diagnosis, regardless of economic status, will have expanded access to this ground-breaking technology.”

About Aspira Women’s Health Inc. 
Aspira Women’s Health Inc. is transforming women’s gynecological health with the discovery, development, and commercialization of innovative testing options for women of all races and ethnicities, starting with ovarian cancer.

Our ovarian cancer risk assessment portfolio is marketed to healthcare providers as OvaSuite^SM, which includes OvaWatch, a non-invasive, blood-based test intended for use in the initial clinical assessment of ovarian cancer risk in women with benign or indeterminate adnexal masses for which surgical intervention may be either premature or unnecessary. With a negative predictive value (NPV) of 99%, OvaWatch allows physicians to confidently rule out ovarian cancer malignancy and choose the appropriate clinical management for the right patient at the right time. Ova1Plus^® combines our FDA-cleared products, Ova1 and Overa^®, to detect risk of ovarian malignancy in women with adnexal masses planned for surgery.

EndoCheck^SM, Aspira’s first-of-its-kind non-invasive diagnostic test for endometriosis, is currently in development. Visit our website for more information at www.aspirawh.com.

Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the potential effects of widespread use of OvaWatch and the availability of OvaWatch in New York. Forward-looking statements involve a number of risks and uncertainties. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties, and assumptions, including those described in the section entitled “Risk Factors” in Aspira’s Annual Report on Form 10-K for the year ended December 31, 2022, as amended by Form 10-K/A filed on October 26, 2023, and as supplemented in Aspira’s 10-Q filings for the quarter ended March 31, 2023, June 30, 2023, and September 30, 2023. These risks include, but are not limited to: our ability to continue as a going concern; our ability to comply with Nasdaq’s continued listing requirements; impacts resulting from potential changes to coverage of Ova1 through our Medicare Administrative Carrier for Ova1; impacts resulting from or relating to the COVID-19 pandemic and actions taken to contain it; anticipated use of capital and its effects; our ability to increase the volume of our product sales; failures by third-party payers to reimburse for our products and services or changes to reimbursement rates; our ability to continue developing existing technologies and to develop, protect and promote our proprietary technologies; plans to develop and perform laboratory developed tests; our ability to comply with Food and Drug Administration (“FDA”) regulations that relate to our products and to obtain any FDA clearance or approval required to develop and commercialize medical devices; our ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; or our suppliers’ ability to comply with FDA requirements for production, marketing and post-market monitoring of our products; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; in the event that we succeed in commercializing our products outside the United States, the political, economic and other conditions affecting other countries; changes in healthcare policy; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of Aspira Labs; our ability to use our net operating loss carryforwards; our ability to use intellectual property; our ability to successfully defend our proprietary technology against third parties; our ability to obtain licenses in the event a third party successfully asserts proprietary rights; the liquidity and trading volume of our common stock; the concentration of ownership of our common stock; our ability to retain key employees; our ability to secure additional capital on acceptable terms to execute our business plan; business interruptions; the effectiveness and availability of our information systems; our ability to integrate and achieve anticipated results from any acquisitions or strategic alliances; future litigation against us, including infringement of intellectual property and product liability exposure; and additional costs that may be required to make further improvements to our laboratory operations. The events and circumstances reflected in Aspira’s forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Aspira expressly disclaims any obligation to update, amend or clarify any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

Investor Relations Contact:
Jamie Sullivan
Director of Corporate Communications
Aspira Women’s Health
Jsullivan@aspirawh.com 

FAQ

What is the latest announcement from Aspira Women’s Health Inc. (AWH)?

Aspira Women’s Health Inc. (AWH) announced that California Medicaid (Medi-Cal) added Ova1Plus® to its fee schedule at $897 per test.

What is the reimbursement rate for Ova1Plus® tests processed for Medi-Cal patients?

Aspira will be reimbursed at a rate of $897 for all Ova1Plus® tests processed for Medi-Cal patients meeting applicable coverage requirements.

When does the reimbursement for Ova1Plus® tests for Medi-Cal patients begin?

The reimbursement for Ova1Plus® tests for Medi-Cal patients begins immediately and goes back to the date of service back to October 15, 2023.

What is the significance of adding Ova1Plus® to the fee schedule for California Medicaid (Medi-Cal)?

The addition of Ova1Plus® to the fee schedule provides expanded access to this groundbreaking technology for women in California facing an ovarian cancer diagnosis.