OK, no more talk about Curmudgeon’s, because the Curmudgeon’s out there (and they know who they are) are complaining about being complained about.
Anyway, this blog is about Gossips, and where better to start than Ancient Greece: Aesop, who, for those not as old as me and who didn’t know him, was a slave in ancient Greece.
Reportedly he was a strikingly ugly slave, but a remarkable fabulist (yes, that’s a real thing). This brings to mind Red Green’s aphorism, “if the women don’t find you handsome, they should at least find you handy.”
At any rate, ugly Aesop’s anecdotes remained so well repeated over the years that Professor Ben Edwin Perry assigned numbers to them in the Perry Index. His best known fable about Gossips is Perry Index Number 488, The Eagle, the Sow, and the Cat. You can read it here. It graphically explains the hazards of gossip.
And how, the Curmudgeon’s ask, does this relate to 340B?
Easy: Just think about Infusion Centers and 340B, likely one of the most gossiped-about areas of the entire 340B universe.
This blog pertains to 340B Eligible Hospitals, including Critical Access Hospitals, Pediatric Hospitals, Cancer Centers, Disproportionate Share Hospitals, Rural Referral Centers, and Sole Community Hospitals, it does not pertain to FQHC’s, Ryan White clinics, or other 340B entities. In particular, it is important to those entities in more remote or rural locations because of the economic impact.
The reason this, and how it relates to infusion centers is important, is that a tremendous number of rural Hospitals provide infusion services for all the patients in their market area. Providing expensive infusion drugs to patients at the prevailing ASP+5% fee makes this economically difficult or even impossible for many rural Hospitals. In some situations, this means patients must drive hours to and from a location where they can get the infusion. In some instances, this means missed therapies and results in patient harm.
Conversely, the savings from 340B infusion center drugs make a dramatic difference in a rural facility’s ability to expand healthcare services. It’s important they take advantage of this opportunity (click here for more).
This blog advises you to use 340B in your infusion center, including patients referred in by outside providers, and it explains why and how.
So who’s saying what about Infusion Centers and 340B? A lot of people. Here are some examples what we hear about 340B and infusion centers;
- You gotta have a provider on staff, so we don’t use 340B unless. . .
- But the Mega Guidance says. . . (please! Mega Guidance is dead!)
- We have our medical director of the infusion center re-write each prescription
- Our CMO countersigns each order
- We don’t want to take a chance on diversion, so we use WAC
- What’s 340B?
In a room filled with ten people, there will be six different opinions on this topic, with four dissenters.
Differing interpretations of the HRSA patient definition create the problem. Part of the patient definition includes the provider. Compliance staff (me included) regularly remind everyone of the importance of having your providers be eligible medical staff members. This is a well-established HRSA rule, and non-eligible providers result in diversion findings in a HRSA audit. For this reason, 340B staff feel compelled to have a local medical staff member write the order for an infusion.
However, the specialists often writing the orders for an infusion center are not part of the local medical staff. This creates a dilemma for a number of facilities as they ty to reconcile the HRSA definition of an ‘eligible patient’ with what they provide. You can read the HRSA definition here on page 55157 Section C. Here is the paragraph causing the confusion and subsequent gossip:
the individual receives health care services from a health care professional who is either employed by the covered entity or provides health care under contractual or other arrangements (e.g. referral for consultation) such that responsibility for the care provided remains with the covered entity;
Apexus has an FAQ on it here. The controversy stems from what people consider a health care professional. Notice HRSA does not say Provider, but health care professional. That includes Nurses, Pharmacists and other professionals as defined by CMS. You can read it here. More to follow below.
To Squelch a Rumor, go to the Source
We need to gain consistent interpretation on Infusion Centers and 340B. In the ‘Why?’ section above we noted the Apexus FAQ and the CMS definition of a Health Care Provider. Combine this with the first aspect of a HRSA defined patient,
- the covered entity has established a relationship with the individual, such that the covered entity maintains records of the individual’s health care (you can read it hereon page 55157)
So long as your facility maintains the medical record that establishes the relationship, and documents the provision of care, you meet the criteria for eligibility. If you remain apprehensive, this can be confirmed via a consultation with your facility lawyer and the 340B Health legal staff (if you are not a member you should be, and if you are, the call is free). If you participate in one of the 340B Conferences, this question is routinely brought up with their legal team, and this is their consistent response.
This means your facility needs to do the following to be compliant in using 340B drugs in your Infusion Center:
- Define the following process in your Policy and Procedure;
- Document (key word, Document) the provision of care to the patient in a medical record. This means the following:
- Document pre-therapy care – this might include documentation of vital signs, notation of diagnosis, review of lab values, patient interview/education.
- Document the actual therapy – document the monitoring of the therapy and the patient’s response: if there any adverse effects, etc.
- Document post-therapy care: Assessment of patient status, vital signs, if there are any adverse effects.
- Maintain the documentation as per your facility’s policy and procedure.
- Educate the Infusion Center staff.
- Audit the records of your infusion center and track compliance until you feel comfortable there is routine compliance, then audit randomly.
Some will question if in fact all of these steps are necessary. After all, HRSA auditors have accepted Infusion Center 340B usage in situations where not all of these steps were met. Consider this a Best Practice process. If you embrace these steps, you can rest easy during a HRSA audit knowing you are well covered. This is especially important if you have a Manufacturer Requested Audit.
If you’ve been reluctant to use 340B in your infusion center, now is a good time to reconsider it. If you are, this is a great time to audit the process to be certain it is compliant. Like they say in the Nike commercial: 'Just Do It.'
Back to Gossiping
I know a few of you out there are worried about Fable #488. You clicked on the link, and your internet security blocked access. So here’s the fable:
An eagle had made her nest up high in an oak tree; meanwhile, in a hollow halfway up the tree, a cat had given birth to kittens; finally, at the foot of the tree there was a forest-dwelling sow and her litter of piglets. As it turned out, this fortuitous congregation was eventually destroyed by the cat's wicked and malicious scheming. First, she went to the eagle's nest and said, 'You are about to be destroyed, and so am I! Woe is me! You can see for yourself how the treacherous sow keeps digging in the dirt day after day: she plans to uproot the tree so that she will be able to attack our offspring down there on the ground.' After having scared the eagle out of her wits with these words, the cat then crept down to the den of the bristly sow. 'Your litter is in grave danger,' said the cat, 'because the eagle is ready to seize your little piglets as soon as you go out to look for food.' Having filled the houses of both the eagle and the sow with terror, the sneaky creature hid herself safely inside her hollow in the tree. She crept out at night on tiptoe, finding plenty of food for herself and her kittens, but during the day she only poked her nose out of her den, pretending to be afraid. Meanwhile, the eagle didn't stir from the branches since she expected some disaster and the wild sow would not venture out of doors, since she wanted to protect her home from the eagle's attack. To make a long story short: the sow and the eagle both died of hunger, together with their children, thus supplying the cat and her kittens with a bountiful feast.
Consider a personal war on gossip similar to the War on Drugs: Just say NO to Gossiping, but YES to 340B and your Infusion Center.