11/01/2019

More About New Stark and Anti-Kickback Rules

Guest Article Provided by Elizabeth Hogue, Esq.

On October 9, 2019, the U.S. Department of Health and Human Services (HHS) issued two proposed rules that include significant changes in regulations under the so-called Stark Law and the federal Anti-Kickback Statute (AKS). These changes are in the form of additional exceptions under the Stark Law and safe harbors or exceptions under the AKS.

We are presenting a teleconference on the new rules on November 13, 2019, 1:00 to 2:30 pm EST. Click here for a registration form. If the link doesn't work, please email the above address and we will send you a registration form.

In the meanwhile, here are key provisions of the new rules under the AKS:

• New safe harbor that allows providers to furnish items and support to patients to improve quality of care and health outcomes and efficiency; such as in-kind items and services to support patient's compliance with discharge and plans, and services to address unmet social needs that affect health
• New safe harbor that protects financial arrangements between providers related to payment models developed by the Centers for Medicare & Medicaid Services (CMS)
• New safe harbor that allows donations of cybersecurity technology and services
• Changes to the current safe harbor for personal services and management contracts to increase flexibility with regard to outcomes-based payments and part-time arrangements
• Revisions to the meaning of "set-in-advance" so that it is unnecessary to determine total payments when entering into arrangements with referral sources
• Changes to the existing safe harbor for warranties, including the definition of "warranty" and protections for bundled warranties for one or more items and related services
• Changes to existing safe harbors for local transportation that expand and modify mileage limits for rural areas to seventy-five miles and allow for more transportation for patients discharged from inpatient facilities

Here are key provisions of the new rules under the Stark Law:

• Establishes a new exception that allows for payments of no more than $3,500 per calendar year to referring physicians in exchange for services actually provided by physicians
• Establishes new exception for donations of cybersecurity technology and related services to referring physicians
• Changes in the definitions of and standards related to "commercially reasonable," "volume or value," "other business generated," and "fair market value"
• Grace periods for signatures on contracts during the first ninety days of arrangements
• Clarification of exclusive use under the space rental exception

As they say in infomercials, "and there's more!" Stay tuned!

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