Industry Requests Three Additional Safe Harbors Under Anti-Kickback Statutes
AdvaMed is asking for three new safe harbors from potential Anti-Kickback Statute (AKS) violations to shelter value-based pricing, warranty, and risk-sharing arrangements formed among hospitals, physicians and device manufacturers.
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Under changes announced on 9 October by the US Health and Human Services Office of Inspector General (HHS OIG) and the Centers for Medicare and Medicaid Services (CMS), new so-called "safe harbors" to the anti-kickback statute and planned changes to the physician self-referral statute (Stark Law) would shelter health-care providers – including device-makers – who enter into value-based care arrangements for services paid for by Medicare. Such changes have been promoted by medtech firms.
Industry trade groups spend millions of dollars and walk thousands of steps in the halls of the US Congress each year to persuade legislators and their staff to support votes on device-tax repeal, Medicare payment reform, and other issues. Using lobbying reports downloaded by a public interest group, Medtech Insight has analyzed what industry spent and paid out to hire legislative experts to lobby Congress in the first half of 2019, and which topics they lobbied for the most.
In setting his agenda for the US Senate Finance Committee in 2019, incoming Chairman Chuck Grassley, R-Iowa, says he will continue to cosponsor bills to end the device tax, focus on lowering prescription drugs and other medical product health-care costs, expand tax breaks for business, and make sure Congress has a strong hand in negotiating trade and tariff talks.