Utilization Review Guidelines apply clinical practice guidelines to determine whether the health care services provided or planned for an individual member are the most appropriate and cost-effective services under the specific circumstances.īenefit coverage for health services is determined by the member specific benefit plan document, such as a Certificate of Coverage, Schedule of Benefits, or Summary Plan Description, and applicable laws that may require coverage for a specific service. Coverage Determination Guidelines may address such matters as whether services are skilled versus custodial, or reconstructive versus cosmetic. Services determined to be experimental, investigational, unproven, or not medically necessary by the clinical evidence are typically not coveredĬoverage Determination Guidelines are used to determine whether a service falls within a benefit category or is excluded from coverage.
They are also used to decide whether a given health service is medically necessary. Our Medical Policies and Medical Benefit Drug Policies express our determination of whether a health service (e.g., test, drug, device or procedure) is proven to be effective based on the published clinical evidence. Members should always consult their physician before making any decisions about medical care. Treating physicians and health care providers are solely responsible for determining what care to provide to their patients. These policies and guidelines are provided for informational purposes, and do not constitute medical advice. UnitedHealthcare has developed Medical Policies, Medical Benefit Drug Policies, Coverage Determination Guidelines, and Utilization Review Guidelines to assist us in administering health benefits. Marx, Ph.D., President and COO, Cerapedics.Please read the terms and conditions below carefully. “The next generation product we’re developing with DSM is showing tremendous potential, and will allow us to bring the bone forming potential of the P-15 technology into the lumbar spine,” said Jeffrey G. following the FDA Premarket Approval (PMA) of i-FACTOR Bone Graft, and we are excited to be partnered with DSM in delivering our next generation product to market,” said Glen Kashuba, CEO, Cerapedics. “Over the past year we have been focused on accelerating our commercialization efforts in the U.S. Cerapedics is partnering with DSM to collaboratively develop and commercialize the next generation of this technology. for anterior cervical discectomy and fusion (ACDF) procedures since late 2015. The company’s first-generation product, i-FACTOR™ Peptide Enhanced Bone Graft, has been commercially available outside of the U.S. “Together, from concept to commercialization, we are at the leading edge of advanced healing solutions.”Ĭerapedics developed P-15 technology to support bone growth through cell attraction, attachment, and activation. “The partnership combines the industry leading expertise and capabilities in bioceramic materials of DSM with Cerapedics’ innovative growth factor, delivering a new product solution to improve people’s lives,” said David Yonce, Vice President and Global Head of Innovation at DSM Biomedical.
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Under the partnership agreement with Cerapedics, DSM will also provide a collagen carrier, final packaging, and full support from concept through commercialization. The strategic partnership aligns DSM’s regenerative materials capabilities with proprietary synthetic small peptide (P-15) technology developed by Cerapedics.ĭSM’s newest bioceramic platform is a carbonated apatite matrix designed for fast, predictable remodeling in bone graft substitute applications. DSM Biomedical, a global solutions provider in biomedical science and regenerative medicine, today announced that it is partnering with Cerapedics, a privately-held orthobiologics company, to develop and manufacture the next generation peptide enhanced bone graft.
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