Leasing Agreements between Hospitals and Physicians Draw Considerable Attention
Simple Tips to Help Compliance Professionals Understand Complex Standards and Improve Agreements
By now most hospitals are acutely aware that theย Office of Inspector General (OIG) has been focusingย enforcement to various types of arrangementsย involving physicians due to an enhanced opportunity forย abuse in this area. Leasing arrangements between hospitalsย and physicians can be a very complex regulatory andย enforcement area. There are many areas of risks and vulnerabilitiesย associated in light of the regulatory and enforcementย environment, particularly as it relates to theย federal anti-kickback statute andย Stark laws.
It has become very common now for a qui tam investigationย to be predicated upon allegations of violationsย of the anti-kickback statute.ย In the last issue of the Journalย of Health Care Compliance, I wrote about medical directorย advisory and director agreements. The other typeย of arrangement drawing considerable interest involvesย hospital leasing arrangements with physicians.
When our firm performs reviews of such agreements,ย we focus on about a dozen key standards from theย antikickbackย statuteย and Stark standards that can be used toย improve leasing agreements. Some of these standards can
be quite complex in analyzing; however, there are someย simple tests and tips offered herewith that can be doneย easily by compliance officers. It is important to note thatย this article will only touch on a few key issues and shouldย not be considered comprehensive on the subject.
In situations in which an entity leases either space orย equipment to referring physicians or other parties in aย position to influence referrals, the government wants toย ensure that the arrangement is not designed to create a
real or implied obligation to refer business in return forย any type of remuneration. In terms of leasing arrangements, remuneration could take the formย of rent payment that falls belowย fair marketย value (FMV)ย or the provision of free services.ย As Inspector General, I was responsibleย for the issuance of a safe harbor regulationย to provide guidance on what it wouldย deem to be leasing arrangements that complyย with the anti-kickback statute. This safeย harbor requires that the agreement meetย the following five standards:
- There must be a written lease agreement signed by both the physician and hospital.
- The lease must specify the covered premises or equipment.
- If access to the space or equipment is for periodic intervals, a schedule for the use and exact lease payments must be set out in advance.
- The lease may not be for less than one year.
- Total amount of payments must be set out in advance and based on FMV.
Any derivations from the safe harbor standards may raise a โred flagโ to a third-party reviewer of these arrangements. Strict adherence, however, to all five criteria of the safe harbor is not always necessary to ensure compliance with the anti-kickback statute. For example, the following deviations would probably be considered benign because they are clearly based on intent other than to induce referrals:
- Rent and charges for services not fixed in advance but fluctuate based on an objective, independent standard unrelated to volume of referrals or generation of business;
- Contracts that contain termination provisions permitting the term to end in less than one year, but the termination provisions are based on occurrence of circumstances unrelated to business generated or result from governmental requirements, including those for maintaining tax-exempt status of hospital or bonds issued for the hospital.
On the other hand, it is likely that the following would be considered indications of possible intent to induce referrals:
- Equipment and/or office leases are based on per-use or per-procedure payments or percentage of revenues;
- Incentive, volume, or performance based formulas for payment of personal services contracts;
- Terms of lease or personal services contracts are not consistent with prudent business practices;
- FMV of rentals cannot be supported by objective appraisals or market standards;
- Records maintained on sources of referrals.
A hospital should not proceed with aย transaction or arrangement that is indicativeย of intent to induce referrals. To ignoreย these warning signals could result in enforcementย actions.
Of all the issues noted above, the most critical factor to be addressed by far is FMV. This is a very broad catch-all exception. It pertains to any compensation resulting from an arrangement between an entity and a physician (or an immediate family member) or any group of physicians (regardless of whether the group meets the definition of a group practice) for the provision of items or services by the physician, family member, or group as long as the arrangement is set forth in an agreement that meets all of the following criteria:
- FMV is defined as the value of the property for general commercial purposes but does not permit consideration of proximity to referral sources in its determination.
- When determining FMV, it is critical that the hospital not take into account the volume or value of any referrals or business generated between the parties for which any part may be payable by Medicare or Medicaid.
- It is highly advisable for any hospital considering leasing space or equipment to physicians in a position to refer business to evidence FMV.
- The Office of Inspector General does not describe specifically the methods that should be employed to establish FMV.
- In order to be credible, FMV should be determined by objective standards and the determination should be made by an independent party able to make such determinations.
Although all this appears very complicated, it can be reduced to the two key issues of charging FMV for the space and that the space must be โcommercially reasonable.โ All leases with physicians, who refer business to the hospital, should include an evaluation addressing FMV and commercially reasonable standards.
This may not be as demanding as oneย would think in reading the law and attendantย regulations.ย CMSย has recognized theย imprecision inherent in seeking to ascertainย FMV and has stated it intended โto acceptย any method that is โcommercially reasonableโย and provides evidence that theย compensation is comparable to what is ordinarilyย paid for an item or service in theย location at issue, by parties in armโs-lengthย transactions who are not in a position to referย to one another.โ CMS has noted it alsoย would find acceptable an appraisal that theย parties have received from a qualified independentย expert.
When developing leasing arrangements with potential referral sources both the guidance arising from the anti-kickback statute and Stark laws should be integrated both in the lease agreement itself as well as supporting documents.