Health care providers can have a bumpy road ahead of them when it comes to launching a new service like palliative care, in part due to complex legal and regulatory requirements.
Before they launch a new program, operators must have a clear picture of their target population and the structure they want to build, according to Rachel Carey, counsel with the Virginia-based law firm Whiteford. Carey advises hospices establishing new services, pursuing acquisitions and other issues.
Hospice News spoke with Carey about the regulatory and legal obstacles that health care providers may encounter when setting out to build a new program and what they should do to prepare.
What are some of the legal and regulatory hurdles that a health care provider would have to cross when starting a palliative care program?
Where they start in terms of considering hurdles is probably just the baseline structure of how they want to set it up, and the enrollment, since a lot of them will be targeting Medicare reimbursement.
So if they’re looking at a home-based structure, a total home-based structure, or a clinic structure, or doing some sort of co-management arrangement with someone who’s already operating like a nursing facility, those are the sorts of things that you have to consider.
It definitely affects the staff that you’re going to need and the enrollment. Depending on if you decide to do a home health agency or a hospice, those [Medicare] Conditions of Participation will indicate the minimum staff you need to have.
And because of special scrutiny that’s cropped up for home health and hospice due to bad actors, sort of creating these and selling them off for various reasons, [the U.S. Centers for Medicare & Medicaid Services (CMS)] has limited the amount of times those can change hands. Certain states have had more moratoriums on issuing new licenses and things like that. So those are the sorts of hurdles they have to look at to start.
What are some questions they may face that they might not expect from regulators?
They will need ideas on their target population and data that support the need for an additional actor in the space.
When I work with sort of home- and community-based palliative care providers, I often have to remind them to look at having the data to support what operations they’re going to be moving forward with in terms of the target population and their needs.
Are there any kind of common missteps that providers sometimes make as they’re moving through this process?
There’s definitely all sorts of missteps in terms of everyday billing, but the financial piece is really where the missteps are. What you do see a lot in palliative care is a shift towards value-based arrangements. You really need to think that through and come up with the data and projections that seem reasonable. That would be the financial piece they would be doing upfront.
In terms of projections and data, you can make it say a lot of things. You can be very aspirational, but you need to know what’s actually possible in that realm.
One of the things that I always have to consider is the base structure, licenses and tax, and how this is being set up. Do you have an existing business that you are just adding on to, and how much do you want to sort of make sure you insulate that business from a new entity? Because if one starts to crumble and you haven’t insulated it enough, it could hurt your existing business.
Are there other external factors that could complicate this process or or prevent a palliative care program from getting off the ground?
The external factors that always come into play for palliative care is, unfortunately, the misconceptions around it.
It’s definitely a growing interest, and I think people in the long term care space are at the point where they are understanding it more, but there’s still a ways to go. That is probably the biggest external factor, the misconception of what these palliative care programs are.
Also, some home- and community-based programs are not as sophisticated as some of the other players in health care. So they may not have the logistics and data already set up.
What would be your most important piece of advice to a hospice, for example, that wants to start a palliative care program?
Definitely really try to get an idea of a specific target population, and try to get a plan for scalability that is realistic.
You probably do need some sort of advisor that has a better idea of the scalability piece. Community-based is definitely regional, and so the long term possibility of financial stability for a program is going to be that stability piece. Especially if you are limited on data, it would be best from a good advisor in the area.