The agency proposed several new safe harbors for physicians and hospitals that aim to ease compliance barriers and encourage health providers to focus on patients’ overall health.
However, the proposal explicitly excludes “pharmaceutical manufacturers, manufacturers, distributors, or suppliers of durable medical equipment, prosthetics, orthotics or supplies, and laboratories.”
The exclusion doesn’t apply to other medical technologies, like those related to patient monitoring, mobile and digital health, according to Bloomberg Law.
Devicemakers might not be excluded for long, though, as HHS has said it will study the kickback issue and figure out what types of devices, drugs or companies should get an exemption.
The proposal still has to go through a notice-and-comment period before it is finalized, and comments are due 75 days after the rule officially posts to the Federal Register.
Read the full article here.
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