BioStem Technologies Commends OIG’s Recommendation for CMS to Address ASP Reporting Requirements for Skin Substitute Products
POMPANO BEACH, FLORIDA., March 23, 2023 (GLOBE NEWSWIRE) — BioStem Technologies (“BioStem” or the “Company”) (OTCQB: BSEM), a leading provider of innovative regenerative medicine solutions, is commending the U.S. Department of Health and Human Services Office of Inspector General’s (HHS OIG) recent recommendation for the Centers for Medicare and Medicaid Services (CMS) to quickly address issues associated with Average Sales Price (ASP) reporting requirements for skin substitute products.
According to a recent report by the HHS OIG, “Some Skin Substitute Manufacturers Did Not Comply with New ASP Reporting Requirements”, CMS has failed to guarantee that manufacturers are accurately reporting the ASP for skin substitute products, leading to potential errors in payment amounts. This issue has been a concern for BioStem Technologies and others in the industry who are committed to ensuring patient access to high-quality, innovative placental tissue allografts. The report highlights the importance of regulatory compliance and oversight in the field of skin substitutes.
“We welcome the findings of the U.S. Department of Health and Human Services Office of Inspector General report and fully support its recommendations” said Jason Matuszewski, CEO of BioStem Technologies. “In alignment to our mission of Manufacturing Products that Change Lives and putting Medicare beneficiaries’ outcomes first, accurate ASP reporting is critical to ensuring that this patient population has access to the most effective treatments and that providers are fairly reimbursed for their services.”
BioStem Technologies is pleased to endorse the HHS OIG’s endeavor to enhance the precision of ASP reporting for skin substitute products and anticipates continuing its partnership with CMS and other stakeholders to ensure that patients have access to the best possible care. Our company has taken a proactive approach to ensure compliance with the regulations and has implemented robust measures to track and report data related to its skin substitute products. By complying with these reporting requirements, BioStem Technologies has positioned itself for long-term success, as it not only maintains a strong commitment to regulatory compliance but also enhances transparency and builds trust with customers and stakeholders.
About BioStem Technologies, Inc. (OTCQB: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioRetain®processing method. BioRetain® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established per current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes VENDAJETM, VENDAJETM AC, and VENDAJETM OPTIC. Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida.
Forward-Looking Statements: Except for statements of historical fact, this release also contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified using words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate”, “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the reimbursement levels for the Company’s products; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete;(4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred significant losses since inception and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production of its products in sufficient quantities to meet demand; and (10) the COVID-19 pandemic and its impact, if any, on the Company’s fiscal condition and results of operations; You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
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