Proposed Changes to Stark and the Anti-Kickback Statute

Home Blog Proposed Changes to Stark and the Anti-Kickback Statute

Health care is evolving from the traditional “fee-for-service” (“FFS”) model to an “integrated care” model. Under the FFS model, health care providers (physicians, hospitals, therapists, pharmacies, DME suppliers, etc.) operate in separate “silos.” Each provider is paid for the services/products it delivers…regardless of whether such services/products result in a positive patient outcome. Plus, in the FFS model, the providers do not coordinate with each other. This approach is expensive and inefficient.

Government health care programs and commercial insurers are pushing providers into the integrated care model. Under this model, providers are expected to coordinate with each other so that they work as a “team” to heal the patient and then keep the patient healthy. Further, reimbursement is tied to patient outcome.

DME suppliers have a unique role to play in the integrated care model. Unlike most other health care providers, DME suppliers (i) visit their patients’ homes, (ii) communicate regularly with their patients and their caregivers, and (iii) communicate with their patient’s treating physicians. In other words, DME suppliers are in the position to help patients become healthy and, more importantly, to remain healthy.

As suppliers engage in this new model, they will want to work with other providers in which there is some sort of sharing compensation, provide products and services, free of charge, intended to "promote access to care." When doing this, suppliers need to be aware of the federal anti-kickback statute ("AKS"), the federal Stark physician self-referral statute ("Stark'), and the beneficiary inducement statute. Suppliers should also be aware of the easing of restrictions against working with other providers (in which there is a sharing of compensation) and providing free products and services designed to promote access to care. Such easing of restrictions can be found in the Affordable Care Act (“ACA”), OIG regulations, two recent OIG Advisory Opinions, Request for Comments by CMS and the OIG in 2018, and the just published proposed changes to Stark and the AKS.

Read the full story from Medtrade.


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