I have a point of clarification - if I have a patient that is needing an injectable medication administered (Apretude, Yeztugo, Invega Sustenna, Uzedy, Depo Provera, Testosterone IM, etc) that requires reconstitution and clinic administration, is it a violation of the Stark act to make the patient order it from my on-campus, health system owned pharmacy? We have a clinic policy that now prohibits brown bagging due to concerns of medication stability/tampering, and I was told that all clinic administered injectable meds have to be ordered and purchased through our pharmacy on site and can't leave the building or we can't give them due to liability reasons. I get the reasoning.
My concern is - Isn't this a violation of the Stark Act? I don't own the pharmacy, but my health system does. Therefore, don't I have a financial stake in it, and forcing them to order a med from one specific pharmacy in order to administer it in clinic seems like an exact violation, unless I am misunderstanding? If the clinic itself bought the med, then held and administered it to patient and billed it (like with the joint viscosupplementation or osteoporosis meds model, or vaccines), then that would be "buy and bill", and is therefore ok?
Anybody with any experience with drug administration models want to chime in? I'm just concerned that the policy in place might actually get us in hot water legally.
I keep reading different state policies/opinions on "brown bagging", "White bagging", and "Buy and Bill" policies.
My understanding is that yes, you are in violation because you are not offering other pharmacies. That said, it is only illegal and will result in problems if you are a private clinic.
Still, go to internal compliance and legal with your concerns.
I plan to in the morning. I’ve brought it up at meetings to be ignored and told “it’s policy for patient safety reasons”
Just document it in an email and you’re done. “Thank you for meeting with me regarding my concerns about restricting patient access and the legal consequences. I feel much better after having been assured that this is legal and compliant. Because I know you hold the highest ethical standards….”
Don’t lay it on that thick I guess.
I think you can likely get around this by telling pts they can either get it at your pharmacy or any other pharmacy willing to directly deliver to your office.
This seems like the most logical work around, but we know how far logic goes these days…
Makes sense. Chain of custody could be a problem if something comes from outside w/o direct delivery
Our office does this … we don’t have an in house pharmacy but patients can use “any” pharmacy that will deliver to us (in practice, there’s precisely one in the area… but hey, we don’t own it!)
I’m not a lawyer no legal advice. But Stark law specifically refers to financial interest and self referrals where you have a financial stake. If you don’t get paid to do and do not have a stake in this process, then usually no. This is in the same realm of a hospital giving meds to patient, or health system referring within themselves to their own specialists. (Why can’t a patient order a medication from an outside pharmacy, bring it into the hospital during hospitalization, and get that administered?)
I have no ideas about the legality, but I’m in Nebraska and I’ve had multiple patients press to do this and it was honored and they were able to bring in home meds (including OTCs) that had to be verified by pharmacy and then we administered them.
Yes continuation of home meds is one thing, but more as in, patient not wanting to use hospital pharmacy, and ordering “vancomycin” or “vasopressin”, dobutamine from external pharmacies, bring it in and have the floor or ICU administer that. Like what OP described it’s more an implied occasion and not truly forcing them to do it, but realistically that’s the only way.
Thank god your hospital is sane. I have worked at one where it was prohibited to give outside meds. And of course biologics for Crohns/UC aren’t on formulary. So the genius outcome of that was - prolonged hospital stay turned quiescent IBD into a crohns flare
That’s ridiculous!
Disclaimer, not legal. I was part of this healthcare system in admin when this went down. Not the same, but somewhat similar. Many physicians went down. Every physician who put in a med order or lab was also named whether they were directly involved or not. The list was quite long.
The stark laws are very complex. The “kickbacks” can be interpreted in different ways.
https://www.justice.gov/archives/opa/pr/missouri-hospitals-agree-pay-united-states-34-million-settle-alleged-false-claims-act
https://www.scribd.com/document/275066132/Mercy-Settlement-Agreement
I dont think this case applies unless the physicians are being told they will get a bonus for sending prescriptions to this pharmacy or their compensation will somehow be affected by using (or not using) the internal pharmacy.
Our physicians that were named with the exception of the two whistleblowers, were completely unaware of the violation. Feds still named them in the suit. Basically, anyone put ordered anything via their infusion center, IV meds, labs, etc…all went down.
It sounds like, "Clinic impoperly paid bonuses to physicans that improperly took into account the value of the physicains' refferals of patients to the Clinic for certain ancillary services."
Perhaps physicians were unaware of certain bonuses they were getting and weren't asking questions about it either (or pretended to look the other way).
The provider in question should confirm with their employer that their compensation is not impacted by the use (or lack of use) of the in-house pharmacy should absolve them of any stark violations.
This is called clear bagging, a spin-on white bagging. Means you're filling it from a specialty pharmacy within your own institution and then administering it. It is legal? Yes. Is it sleezy and another example of consolidation? Also yes.
Stark does not apply.
Steering patients toward a health-system–owned pharmacy can raise Stark and anti-kickback questions, even without personal ownership. Many systems justify it under safety and handling policies, but the arrangement must fit a recognized exception. Compliance or legal review is essential.
Agree, needs compliance and legal review. A note for others also that there are different regulations for compounded medications (as opposed to reconstituted medications) which can get even more complex and require state pharmacy & FDA review on top of Stark and anti-kickback.
This is not illegal unless your employer is changing your compensation based on your use (or lack of use) of the internal pharmacy.
I think this is illegal, but I'm definitely not a lawyer and I don't do much admin stuff these days, not enough to feel confident interpreting the law.
That said... I'm in outpatient private practice and we don't have the injection volume to merit buy and bill. We can't limit the pharmacies we order from because it's all dictated by insurance. We order through the specialty pharmacy that each ins plan dictates.
If we tried to force people to one pharmacy only, we'd have a ton of coverage issues and pts would refuse the med.
It also seems like a scam that Caremark insurance only goes through Caremark pharmacy, but what do I know?!
No, it's not. The reason is that the patient is free to get it filled anywhere. The restriction is only that they cannot have it administered at your office unless it was filled here.
No different than our policy that we do not allow inpatients to use their own medications unless we do not carry it. Totally legal.
I feel like this might be a better question for r/legal