Subject: Newsflash: CMS and OIG Issue Coordinated Proposed New Stark and AKS Rules

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Newsflash:
CMS and OIG Issue Coordinated Proposed New Stark and AKS Rules

Earlier today, October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued proposed rules in connection with Stark and the federal Anti-Kickback Statute (“AKS”).

The impetus for the proposals is to facilitate innovative agreements for coordinating care in connection with a shift to a value-based health care system.

The CMS proposal purports to reduce unnecessary regulatory burden on physicians and other providers engaged in coordinating care, while at the same time, protecting patients from being steered to less convenient, lower quality, or more expensive services due to prohibited physician financial and investment interests. 

A fact sheet on CMS proposal is available here.

The proposed CMS rule is available here.

The proposed rule from the OIG in connection with the AKS creates new safe harbors for remuneration in connection with care coordination arrangements aimed at improving quality and outcomes, value-based arrangements with substantial downside financial risk, and value-based arrangements with full financial risk.

Additionally, the OIG has proposed a new safe harbor for CMS sponsored innovation models as well as modifications to the existing safe harbor for personal services and management contracts, adding flexibility for part-time arrangements and outcomes-based payments.

The proposals incorporate other changes as well.

The OIG’s proposed rule is available here.

Once the proposals are officially published in the Federal Register, a 75-day period begins within which the public can present comments to the regulatory agencies.

We’ll bring you commentary and updates as events unfold.

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