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HHS to target step therapy, Stark Law in 2019


 


“The Stark Law was written with noble purposes in mind, but it was designed for a fee-for-service system, not the kind of system we are moving toward today,” he said. “We’ve heard from many, many stakeholders, including the AMA, about the need to update the enumerated exceptions in the Stark Law to include value-based approaches to care.”

He added that how care coordination interacts with the antikickback statutes and HIPAA are also going to be examined.

He used most of his speech to discuss recent regulatory actions around drug pricing and pushed for support for the Part B drug pricing model that the agency is preparing for a formal proposed rule, despite having received a critical reception from medical societies.

“If you have a small practice that uses infusions, and you don’t want to bear the risk of buy and bill, now you’re off the hook,” he said. “We’ll allow you to work with private vendors who can take the risk for buying the drugs in a way that isn’t possible today. But if you’re part of a much larger practice that’s able to drive a better deal than you could on your own, or want to band together with other practices to do the purchasing, then you can do that, too.”

He continued: “Next is the launch of the actual proposed rule, followed by the rule itself, which, I’ll remind you, is just a model.”

However, despite it being a model under test from the Center for Medicare & Medicaid Innovation, the advanced notice of proposed rule making that was issued in October 2018 suggested that participation in the so-called International Pricing Index model would be mandatory.

AGA is pleased about Secretary Azar’s commitment to ensuring Medicare beneficiaries will continue to have access to and coverage of medications that work for them. Patients should not be forced to switch to a therapy that they have already failed if they change insurance plans. Read more about AGA’s advocacy for similar federal legislation at http://ow.ly/2t3030nLbcB.

AGA, in conjunction with other physician specialty organizations, continues to advocate for changes in the Stark Law to allow physician practices to participate in advanced payment models in the Medicare program that will improve care coordination and patient outcomes.

gtwachtman@mdedge.com

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