Robots To Start Drawing Blood – What’s Next?

As artificial intelligence (AI) grows, I am sure I am not the only one who has worried about the robots taking over the world and deciding humans are not necessary for their existence.

Well, with a U.S. Food and Drug Administration (FDA) approval last week, we might be one step closer to that happening. The FDA has now approved a robot phlebotomist. That’s right: a machine that can draw blood all by itself.

As described, the device guides the patient to position their arm, after which the patient or supervisor presses a button to start the blood draw. The robot then uses near-infrared light and Doppler ultrasound to locate a suitable vein and tell it apart from arteries. If no appropriate vein is found, the robot will not attempt the procedure.

Once a vein is identified, the robot proceeds through the remaining steps on its own: applying a tourniquet, preparing the skin, inserting and disposing of the needle, changing collection tubes, and placing a bandage. Just to make you feel better, there is a requirement for a human to supervise the robot, with a maximum of three robots per human. I mean, what could possibly go wrong with a robot holding a sharp object, acting independently?

Well, things do go wrong with other medical devices. And while it was not a robot, last week Abiomed reported a problem with a component in their Impella catheters that has led to 37 patient injuries and three patient deaths.

It is interesting that this report hit my email last week, as just the previous day I was at a hospital where we were discussing the upcoming demise of the Inpatient-Only List – and the effect on payment for complex cardiovascular procedures like the use of Impella.  

And while I could not tell them what the Centers for Medicare & Medicaid Services (CMS) was going to do when Impella comes off the list, I did mention that there was a recent publication in the New England Journal of Medicine showing that the use of Impella in high-risk planned complex stenting did not result in any clinical benefits. Of course, their jaws dropped, as they were quite proud of the excellent outcomes of their cardiovascular program.

Now, I did reassure them that one study does not mean that the use of Impella should be abandoned, but you know that Medicare and other payers will be watching closely for other studies supporting this conclusion – so they can stop paying for Impella use.  

Finally, I recently got a question from Julie in Oregon about billing for observation services. She must have had a lot of free time, as she was reading the state Medicaid regulations and found a clause reading that “a maximum of 48 hours of outpatient observation shall be reimbursed. An outpatient observation stay that exceeds 48 hours shall be billed as inpatient.”

Wow! As with the Medicare intent-to-admit policy in Chapter 1 of the Medicare Benefit Policy Manual, Oregon hospitals can get paid the inpatient rate for Medicaid patients even without formally admitting the patient as an inpatient. And the state regulations also note that Managed Medicaid plans must follow all Medicaid regulations, so they can’t get out of this. But of course, the plans may still try to argue that hospital care exceeding 48 hours was not necessary and try to deny payment.

So, now Julie needs to go back to her compliance and billing team and operationalize this. It often takes some convincing to get the coding team to code a claim as inpatient without an order for inpatient admission, but if the payer instructs you to do it, and it will result in higher payment, there is no reason not to.

And perhaps all of you should wade into your state Medicaid regulations and see if there are any hidden gifts like this.