Judy Alberto: Oncologists Need to Be Careful They Are Not in Violation of Stark Law


Judy Alberto, MHA, RPh, BCOP, director of clinical initiatives at the Community Oncology Alliance, discusses the importance of making sure oncology practices are educated about their value-based enterprise exception when mailing patients their cancer medications.

Mid-May is when oncology practices need to ensure they are not violating the Stark law by mailing oncology medications, says Judy Alberto, MHA, RPh, BCOP, director of clinical initiatives, Community Oncology Alliance.


What topic did you talk about when you cohosted a webinar on Davis Enterprise and why is it important to COA?

With the public health emergency that will be ending in May, we were made aware that CMS has put out an FAQ alerting practices that, when they mail order their oncology medications, that would be in violation of the Stark law. And so, while they've been protected up to this point—and prior to that there was an in-office ancillary exception—this will not be covered under that. What we're looking at is the value-based enterprise exception, that when a practice is able to document that they meet certain criteria for value-based enterprise, that they will be permitted to still continue to mail order oncology prescriptions out to their cancer patients.

How many practices will be affected by this?

Oh, quite a few, any community practice. If they're mailing prescriptions and they’re pharmacy owned or they’re provider owned, then they could be in violation of Stark exception by mailing this out. So quite a few will definitely be impacted. Any medically integrated pharmacy will be impacted by this.

What is the time frame for all of this?

Mid-May is when—we call it a PHE, which is the public health emergency—when that's lifted on or about May 11, that's when we're going to start to have to worry about this. We're trying to get practices educated and set up prior to that date. And it is really important that they use a legal counsel to do this. So, while we'll provide that information for them, they will need to work with a lawyer to make sure that they're documenting and, like I said, hitting certain criteria for this value-based enterprise exception.

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