Interpace Biosciences Terminates Rights Offering Announces Change in CMS Medicare Reimbursement of its Thyroid Tests
Interpace Biosciences (OTCQX: IDXG) has terminated its rights offering and standby purchase agreement with 3K Limited Partnership due to a new billing policy by the Centers for Medicare & Medicaid Services (CMS). This policy disallows reimbursements for the ThyGeNEXT® and ThyraMIR® tests when billed together by the same provider on the same date. The company is assessing the policy's financial impact and preparing an appeal. CEO Tom Burnell expressed disappointment but emphasized efforts to secure alternative financing.
- The company has five commercialized molecular tests and is actively involved in personalized medicine.
- Interpace is pursuing alternative financing options to support its business despite the recent challenges.
- Termination of rights offering and standby purchase agreement due to CMS policy change.
- Potential negative financial impact from the new CMS billing policy that affects reimbursement for key diagnostic tests.
PARSIPPANY, NJ, Jan. 28, 2022 (GLOBE NEWSWIRE) -- Interpace Biosciences, Inc. (OTCQX: IDXG) (“Interpace” or the “Company”) a leader in enabling personalized medicine, announced today that it was terminating its previously announced rights offering and the mutual termination of the standby purchase agreement with 3K Limited Partnership.
Interpace also announced that it just became aware that the Centers for Medicare & Medicaid Services (CMS) issued a new billing policy whereby CMS will no longer reimburse for the use of the Company’s ThyGeNEXT® and ThyraMIR® tests when billed together by the same provider/supplier for the same beneficiary on the same date of service. The Company is currently evaluating the new policy’s potential impact on the Company while simultaneously preparing an appeal. The CMS change does not in any way impact the efficacy of the diagnostic information provided to clinicians.
Tom Burnell, Interpace’s President and CEO stated, “We are disappointed to terminate the rights offering due to the likely adverse impact of the change in CMS’s policy but we are determined to seek alternative sources of financing to support the Company’s business. We will continue to evaluate the impact of the change in the CMS policy and potential changes on the Company’s operations and will keep our stockholders informed.”
Peter Kamin, an affiliate of 3K Limited Partnership, added “In light of the change in CMS’s policy, we are disappointed that we are unable to proceed with the rights offering and the standby purchase agreement. Nevertheless, we look forward to working together with Interpace to assess the change in CMS’s policy and to develop a new plan to satisfy the Company’s financial and operational goals.”
About Interpace Biosciences
Interpace Biosciences is an emerging leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.
Clinical services, through Interpace Diagnostics, provides clinically useful molecular diagnostic tests, bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Interpace has five commercialized molecular tests and one test in a clinical evaluation program (CEP): PancraGEN® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; PanDNA, a “molecular only” version of PancraGEN® that provides physicians a snapshot of a limited number of factors; ThyGeNEXT® for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay; ThyraMIR® for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay; and RespriDX® that differentiates lung cancer of primary versus metastatic origin. In addition, BarreGEN®, a molecular based assay that helps resolve the risk of progression of Barrett’s Esophagus to esophageal cancer, is currently in a clinical evaluation program (CEP) whereby we gather information from physicians using BarreGEN® to assist us in gathering clinical evidence relative to the safety and performance of the test and also providing data that will potentially support payer reimbursement.
Pharma services, through Interpace Pharma Solutions, provides pharmacogenomics testing, genotyping, biorepository and other customized services to the pharmaceutical and biotech industries. Pharma services also advances personalized medicine by partnering with pharmaceutical, academic, and technology leaders to effectively integrate pharmacogenomics into their drug development and clinical trial programs with the goals of delivering safer, more effective drugs to market more quickly, while also improving patient care.
For more information, please visit Interpace Biosciences’ website at www.interpace.com.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company's future financial and operating performance. The Company has attempted to identify forward looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from those expressed or implied by any forward-looking statements, including, but not limited to, the adverse impact on the Company of the change in CMS’s reimbursement policy regarding the use of ThyGeNEXT® and ThyraMIR® tests when used together, the adverse impact of the COVID-19 pandemic on the Company’s operations and revenues, the substantial doubt about the Company’s ability to continue as a going concern, the possibility that the Company’s estimates of future revenue, cash flows and adjusted EBITDA may prove to be materially inaccurate, the Company’s history of operating losses, the Company’s ability to adequately finance its business and seek alternative sources of financing, the Company’s ability to repay borrowings with Comerica Bank and BroadOak, the Company’s dependence on sales and reimbursements from its clinical services, the Company’s ability to retain or secure reimbursement including its reliance on third parties to process and transmit claims to payers and the adverse impact of any delay, data loss, or other disruption in processing or transmitting such claims, and the Company’s revenue recognition being based in part on estimates for future collections which estimates may prove to be incorrect. Additionally, all forward-looking statements are subject to the “Risk Factors” detailed from time to time in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as amended, Current Reports on Form 8-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
Contacts:
Investor Relations
Interpace Biosciences, Inc.
(855) 776-6419
Info@Interpace.com
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