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OIG Issues Legitimately Helpful Compliance Guidance
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| President Reagan famously quipped that “The nine most terrifying words in the English language are, ‘I’m from the government and I’m here to help.’”
But, oddly, very oddly, what if the government is here to help?
Earlier this month, the Office of Inspector General of the U.S. Department of Health and Human Services (“OIG”) issued an extremely helpful, plain language “General Compliance Program Guidance” (“GCPG”) providing information about relevant federal laws, compliance program infrastructure, OIG resources, and other information useful to understanding health care compliance.
In this article, we’ll focus on one of the extremely helpful elements of the GCPG, in which the OIG expands on previous guidance for assessing whether an arrangement that does not satisfy an Anti-Kickback Statute (“AKS”) safe harbor constitutes a problematic arrangement, i.e., one that likely violates the AKS.
The GCPG sets outs a list of key questions to help in the analysis. Although the GCPG is not binding on any individual or entity (and, certainly, not on the OIG), the questions are a window into the OIG’s thought process. Accordingly, the questions serve as nonbinding guidance in conducting one’s own vetting of a proposed arrangement.
The key questions, edited for presentation, follow:
1. Nature of the relationship between the parties.
What degree of influence do the parties have, directly or indirectly, on the generation of federal health care program business for each other?
2. Manner in which participants were selected.
Were parties selected to participate in an arrangement in whole or in part because of their past or anticipated referrals?
3. Manner in which the remuneration is determined.
Does the remuneration take into account, either directly or indirectly, the volume or value of business generated?
Is the remuneration conditioned in whole or in part on referrals or other business generated between the parties? Is the arrangement itself conditioned, either directly or indirectly, on the volume or value of Federal health care program business? Is there any service provided other than referrals?
4. Value of the remuneration.
Is the remuneration fair market value in an arm’s-length transaction for legitimate, reasonable, and necessary services that are actually rendered?
Is the entity paying an inflated rate to a potential referral source? Is the entity receiving free or below-market-rate items or services from a provider, supplier, or other entity involved in health care business?
Is compensation tied, either directly or indirectly, to Federal health care program reimbursement?
Is the determination of fair market value based upon a reasonable methodology that is uniformly applied and properly documented?
5. Nature of items or services provided.
Are the items and services actually needed and rendered, commercially reasonable, and necessary to achieve a legitimate business purpose?
6. Federal program impact.
Does the remuneration have the potential to affect costs to any of the Federal health care programs or their beneficiaries?
Could the remuneration lead to overutilization or inappropriate utilization?
7. Clinical decision making.
Does the arrangement or practice have the potential to interfere with, or skew, clinical decision making?
Does the arrangement or practice raise patient safety or quality of care concerns?
Could the payment structure lead to cherry-picking healthy patients or lemon-dropping patients with chronic or other potentially costly conditions to save on costs?
8. Steering.
Does the arrangement or practice raise concerns related to steering patients or health care entities to a particular item or service, or steering to a particular health care entity to provide, supply, or furnish items or services?
9. Potential conflicts of interest.
Would acceptance of the remuneration diminish, or appear to diminish, the objectivity of professional judgment?
If the remuneration relates to the dissemination of information, is the information complete, accurate, and not misleading?
10. Manner in which the arrangement is documented.
Is the arrangement properly and fully documented in writing?
Are the parties documenting the items and services they provide? Are the entities monitoring items and services provided?
Are arrangements actually conducted according to the terms of the written agreements (when written to comply with the law)?
***
Although there are multiple AKS safe harbors, many arrangements do not fit completely within one. In order for a safe harbor to apply, complete conformity with its requirements is mandatory.
However, and very importantly, under the AKS, there is no requirement that an arrangement fit within a safe harbor to be legal – the key issue is whether the arrangement violates the terms of the statute itself. [This is the antipode of Stark Law compliance in which an arrangement that does not fit within a safe harbor is per se illegal.]
As a result, most arrangements must be analyzed in a broader manner. Can they be made to fit partially within a safe harbor, not to gain safe harbor protection, which as mentioned, would not be available, but to provide some sort of cold comfort? And, it being the overall, bottom line question, is there a high probability that the arrangement does not violate the AKS itself? That is where the new guidance, the GCPG, becomes of practical, even if not binding, benefit.
Remember, the AKS is a criminal statute, and a violation requires intent. However, intent can be inferred from the facts.
Any arrangement that potentially implicates the AKS must be carefully vetted.
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| | | | Wisdom. Applied. - 180: "But Everyone's Doing It!" Not a Great Defense to Compliance Violations
The speed limit’s 70 mph. I’m not going to tell you how fast I’m going, but I’m going with the flow of traffic, which is traveling at a lot more than the speed limit. Would a defense of, "but everyone is speeding" actually work?
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| | All Things Personal
Departing Charleston, South Carolina, I kept hearing a gate agent make the same announcement over and over as she moved from gate to gate to assist with departing flights. It went something like, “Flight such-and-such to such-and-such a place is about to depart. The door will be closing in five minutes and will not be reopening.”
Years ago, if you got to a plane a little bit late, they’d reopen the door. After all, the plane was still sitting there. And sometimes it was still sitting there 10, 15, even 20 minutes later until it finally backed away from the gate.
So, why don’t they reopen doors any longer?
The reason is that airlines can claim an on-time departure based upon when the door closes, even though the plane is still sitting there for another 10, 15, or 20 minutes.
On-time departure measurement is a prime example of efficiency over efficacy. Efficiency is doing something the right way (i.e., as to method and time). Efficacy is doing the right thing the right way.
So it’s efficient for the airline to close the door in order to maximize on-time departure scores even if it means not letting a slightly late and very upset passenger board the plane. Of course, what they really did was game the system. There’s no score in the game for pissing off a passenger. Of course, she may never fly on that airline again, but that’s not (or so the gate agent believes) the gate agent’s problem.
Think about this in the context of healthcare. You’re told that such-and-such is the measure by which you’ll be paid an incentive bonus. But does it really make sense? Is it really the right thing to do?
Consider whether it’s simply efficient but not at all efficacious.
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strategic concerns?
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| | Podcast Compilation Greatest Hits - Manage Your Practice Edition
We've curated our most popular podcasts on managing your practice into our second compilation album.
Sit back, enjoy, and think about your future.
Listen here. |
| | | | | | We all hear, and most of us say, that the pace of change in healthcare is quickening. That means that the pace of required decision-making is increasing, too. Unless, that is, you want to take the “default” route. That’s the one is which you let someone else make the decisions that impact you; you’re just along for the ride. Of course, playing a bit part in scripting your own future isn’t the smart route to stardom. But despite your own best intentions, perhaps it’s your medical group’s governance structure that’s holding you back. In fact, it’s very likely that the problem is systemic. The Medical Group Governance Matrix introduces a simple four-quadrant diagnostic tool to help you find out. It then shows you how to use that tool to build your better, more profitable future. Get your free copy here.
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| | | Whenever you're ready, here are 4 ways I can help you and your business:
1. Download a copy of The Success Prescription. My book, The Success Prescription provides you with a framework for thinking about your success. Download a copy of The Success Prescription here.
2. Be a guest on “Wisdom. Applied. Podcast.” Although most of my podcasts involve me addressing an important point for your success, I’m always looking for guests who’d like to be interviewed about their personal and professional achievements and the lessons learned. Email me if you’re interested in participating.
3. Book me to speak to your group or organization. I’ve spoken at dozens of medical group, healthcare organization, university-sponsored, and private events on many topics such as The Impending Death of Hospitals, the strategic use of OIG Advisory Opinions, medical group governance, and succeeding at negotiations. For more information about a custom presentation for you, drop us a line.
4. If You’re Not Yet a Client, Engage Me to Represent You. If you’re interested in increasing your profit and managing your risk of loss, email me to connect directly. |
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