ORLANDO -- Federal anti-kickback laws may be old, but they're still relevant, even with something very modern like health information technology (IT), , said here Thursday at the annual meeting of the Healthcare Information and Management Systems Society (HIMSS).
"So much technology in the healthcare space is to facilitate referrals," such as when one provider transmits information to another, said Grubman, an attorney at Chilivis, Cochran, Larkins & Bever, in Atlanta. "If those referrals wind up being reimbursed by a federal healthcare program, a company can violate the anti-kickback statute."
An 82-Year-Old Law
The anti-kickback statute, a version of which was and has been amended several times since with the introduction of Medicare and Medicaid, prohibits anyone from "knowingly and willfully paying, offering, soliciting, or receiving remuneration" in return for referring patients to services that are paid for by Medicare, Medicaid, and other federal healthcare programs.
The statute not only prohibits payments to providers, but also prohibits remuneration to beneficiaries, which means services like telemedicine and electronic health records (EHRs) might also be involved, Grubman noted.
Although the government says it wants to encourage technology growth in healthcare, "unfortunately sometimes what they don't realize is that regulations that have been on the books for years -- and are still applicable -- don't mesh well with the explosion of healthcare technology."
There are two ways technology could be implicated in violations of the anti-kickback rule, he continued. The first way is if technology is being given to a provider to be used to actually issue the referrals that are implicated in the act -- in bygone days this would mean if physicians are given fax machines to fax referral orders for which they get bonuses.
"There is lots of guidance [in the rule] that's related to fax machines, so we have to figure out how to apply [the fax machine guidance] to the provision of tablets or electronic health records [to doctors]," he said.
The second way is if a technology that is used in any way to facilitate referrals -- such as to provide the medical information to justify a referral order. "So if there's technology that can facilitate a referral between a physician and a hospital, or between a hospital and pathology lab, that technology potentially implicates the anti-kickback statute."
Safe Harbors Available
There is some good news, however, he said: The anti-kickback statute has many "safe harbors" that physicians' referral arrangements might fall into, which would protect them from prosecution under the rule, although physicians must make sure they comply with all of the provisions of each safe harbor. Some of the safe harbors include:
- Investment interest: If a physician invests in a health IT company and receives a return on that investment, that's not considered "remuneration" under the statute, according to Grubman.
- Equipment rental: Suppose a hospital leases some sort of healthcare equipment from the physician -- for example, the hospital rents a physician's MRI machine as needed for performing MRIs. "Well, what is the hospital doing in return? The hospital is paying the physician for the use of the MRI machine, and guess what? The physician is probably referring patients to that hospital," said Grubman. On its face, this arrangement appears to violate the anti-kickback statute, except that there is a "safe harbor" provision for it.
- Personal service agreements: This occurs when, for instance, a physician agrees to serve as a hospital's medical director in exchange for payment. Under the safe harbor, physicians can get paid to perform those services, as long as the payment is fair market value, the agreement is outlined in writing, and other provisions of the safe harbor apply, he said.
- Referral services: Sometimes physicians sign up for computerized referral services, in which a patient who is looking for a particular specialist can log onto a website, input their Zip code, and the website will come back with a list of providers. "Can a physician or other type of provider pay that website to list his or her name? If it weren't for the safe harbor, the answer would be no; it would be a violation of the anti-kickback statute because the website is facilitating referrals and the physician is paying to be listed," said Grubman. However, those types of referral services fall under a safe harbor -- under certain conditions. "What could trigger the anti-kickback statute is if the [arrangement stipulates that] every time a patient logs on and clicks you as their provider and we ... get you in touch with one another, you have to pay us $10. You can't do that," he said. "However, if every provider is paying the same amount of money to be part of this referral service, and that amount of money is dependent not on how many referrals you get, but instead on the cost to operate the referral service, then that's okay."
- Warranties: "Any sort of healthcare manufacturer or distributor providing a warranty to a provider for the services or items they are providing, that is okay so long as certain requirements are met."
- Discounts: These come into play a lot with pharmaceutical companies, said Grubman. "The pharmaceutical companies say, 'Hey, you're a huge health system; if you purchase some of our pharmaceuticals ... you start getting discounts the more you purchase.' Arrangements like that are okay if they meet all the applicable requirements."
- ePrescribing items and services: "This says that an entity can provide hardware, software, technology, or training used solely to receive and transmit electronic prescription information." Typically a hospital or large group practice is providing a doctor or doc group software, hardware, or training to the doctor, and the doctor is able to use that to transmit prescription information back to that entity. This is all right, "but that technology has to be used solely to transmit electronic prescribing information, period ... but if you give the provider an iPad [for this] and it also has Twitter, Instagram, and Facebook, that would not fall under this safe harbor."
- Electronic health record items and services: Hospitals can provide EHRs to providers and it won't violate the anti-kickback statute. However, "that safe harbor is phased out on Dec. 31st, 2021; the idea is everyone is going to have [an EHR] by then," said Grubman.
Intent is Key
Even if physicians do something that falls outside the safe harbor, they can't be convicted of violating the anti-kickback statute unless they can be shown to have "willfully intended" to do so. "They can't [convict you] if you were innocent and had no idea what you were doing," said Grubman. "So that means by law you do not have to fall under one of those safe harbors."
However, if at all possible, physicians should still aim to be under a safe harbor, since intent is an issue only a jury can deal with and most doctors probably don't want to undergo an investigation and a jury trial, he added. "If you're in a safe harbor and the government comes knocking on your door ... then your attorneys can say, 'We fit under the safe harbor here.'"
"But remember -- intent, intent, intent. That's what it comes down to."
Providers who are concerned about whether a particular financial arrangement might violate the anti-kickback statute can also seek an advisory opinion on the matter from the HHS Office of Inspector General (OIG), "but if they say no and you still do it, you're going to be in trouble," said Grubman.