We know physicians drive innovation in medicine, and we are dedicated to our data-driven, outcomes-focused approach to advance this field of regenerative medicine. Since the end of the FDA discretionary enforcement period in June of last year, the regenerative medicine community has experienced a shifting landscape in available HCT/P options for their patients. In addition to the new regulatory environment, there are new ASP reporting requirements and speculation regarding its effects on trends in the medical market as a whole. This optimistic speculation drives many physicians to keep the status quo until the situation develops further in regards to the implications of ASP reporting requirements leaving them vulnerable to unfortunate circumstances in many cases. CMS has issued clawbacks for a number of amniotic membrane products including Smith & Nephews’ Grafix/Stravix, LifeNet Health’s Matrion, Amnio Technology’s PalinGen, Tides’ Artacent, and MiMedx’s Epifix.
The days of the rebate/discount programs of the past 30 years are coming to an abrupt and unceremonious end. While rebates and discounts are still outlined as acceptable under safe harbor, the practice of billing Medicare, Tricare, or other insurance for the full pre-rebate/discount price is pointedly fraudulent and has resulted in clawbacks of multiple products in 2022 so far.
The Anti-Kickback Statute (AKS) imposes criminal and civil penalties if a doctor knowingly receives any remuneration in return for purchasing or ordering any item for which payment may be made by a federal healthcare program, such as Medicare. In short, the AKS prohibits kickbacks between doctors and vendors. “Remuneration” under the AKS specifically includes rebates. However, the AKS contains an exception for certain “discounts” if the discount is properly disclosed and appropriately reflected in the costs claimed or charges made by the doctor to Medicare. This exception is commonly referred to as a “safe harbor” provision. A doctor cannot “double recover” for the rebate and Medicare reimbursement. The charges to Medicare should be adjusted to reflect said rebate, and doctors are not exempt from potential investigation and liability.
As providers whose primary focus is achieving better patient outcomes, these fundamental changes caught many off guard. It is too easy for a doctor not to question this familiar model because they have been in similar arrangements for 30 years without an issue. Providers cannot afford to keep the status quo and ignore this shift. Change is required to eliminate the exposure for providers who are receiving rebates or discounts on billable products.
At Regenative, we believe in research, not rebates. Our IRB backed study program allows providers to join a collaborative research community and to be rewarded for their contributions to the field. The program enables providers to log in and record their patient outcomes in a retrospective repository on an intuitive online platform.
The Office of the Inspector General of the Department of Health & Human Services (OIG) recently made additions and revisions to the safe harbor regulations that are designed to enable innovative partnerships among health care providers and suppliers, vendors and technology companies, and other health care entities to improve patient outcomes and manage costs under federal healthcare programs, and to facilitate arrangements that seek to improve outcomes and lower health care costs.
To date, our research community has documented 180+ distinct homologous use applications for connective tissue supplementation and contributed corresponding patient outcomes in excess of 10,000 complete data sets across an array of medical specialties in what is to our knowledge the largest retrospective repository in the country. Upon publication, many of the homologous use applications that have been recorded will represent firsts in clinical literature. The outcomes are undeniable.
While we are excited by the progress that our community has made for the advancement of the field, the more we uncover, the more the need for our community to usher in more physician leadership becomes clear. We are ready to celebrate and showcase your patient outcomes and support you to become a champion in your field! Our dedicated clinical research coordinators and customer support staff are poised to empower frontline practitioners to contribute to the medical literature which is shaping the standard of care of the future. Join us to advance the field of Regenerative Medicine!
CEO Regenative Labs