(1.) All Contracts Should Be In Writing
The Stark Law comes with many exceptions, many of which revolve around the definition of a financial relationship. Additionally, many of the exceptions look at the agreement that you have made with the person to whom you are referring patients. There are various facts that will be looked at to determine if your medical relationship falls within the definition of “financial relationship.”

In order to be able to provide a thorough explanation of the relationship you have with another person, the best practice is to have any agreements put in writing. This means that you should enter into a written contract.

Because the purpose of a written contract is to detail the agreement, you could defend accusations against you by showing your contract. As you will see below, many of the exceptions require that certain agreements must exist to fall outside of the definition of a financial relationship.

(2.) Payment for Services Should Be For Fair Market Value
If you enter into an agreement, to fall within one of the exceptions of the Stark Law, generally the payment or cost must be at fair market value.

Fair market value is the value for services or goods that would be comparable to the value on the open market. Essentially, fair market value is looking at what you agreed to pay for services versus what others are paying for the services under the same or similar market circumstances. 

This means that if you are have paid more or less than the fair market value, you will unlikely be covered by one of the Stark Law exceptions. The reason to require a fair market value is to eliminate any question about whether any special referral agreements have been made. For example, if you are accused of referring patients to a doctor, prosecutors may look into any agreements that the two of you may have. If they find that you have rented equipment which would fall under 42 CFR 411.357(b) they will look to see the price you paid for the use of that equipment, and if the price is too low, you could be accused of referring patients to a practitioner who owns the equipment in exchange for a lower use rate.

Alternatively, if you were paying too high of a cost for the use of the equipment, you could be accused of accepting referrals from the practitioner who is referring patients to you. Here it would look like the referral is improper and fall under the Stark Law because you are paying for the referrals by paying more for the use of the equipment.

(3.) Lease Agreements Should Be For Fair Market Value
Even though you may have an agreement for the lease of office space, there could be a chance that you not considered to have a financial relationship with the person on the other end of the agreement and referrals may not be prohibited by the Stark Law. 

According to 42 CFR 411.357 (b) if you are renting office space where the rent is for fair market value and the cost of rent does not take into account the volume of services performed nor the number of referrals made, then you may be compensated for referrals.

Example
In 2013 a Colorado hospital that had locations in Montana settled with the United States Government for violating the Stark Law. It was alleged that when physicians made referrals to the hospital, the hospital lowered the value of their leases to below fair market value. The lower value was applied towards the officers, services maintenance for offices, and rent for the land on which a building sat.[1] 

In this example, the reason that no exception would apply is that the value of the lease went below fair market value. In addition, the value of the rent was based on the number of referrals that the physicians were making to the hospitals.

(4.) Isolated Incidents Should Be Kept To A Minimum
There could be instances when you make a one-time referral to someone whom you have a financial relationship with; however, you could fall within one of the exceptions if this referral was a one-time incident.

Under 42 CFR 411.357 (f) you could be excluded for the application of the Stark Law if you make a referral to another practitioner, regardless of your financial relationship, if the referral was a one-time incident. In this instance, the writing requirement does not apply. 

However, the amount of enumeration will be scrutinized, and if it is found that the enumeration was not commercially reasonable, then you could be accused of violating the Stark Law. Additionally, for this exception to apply, this must truly be an isolated incident. Specifically, there cannot be any more referrals within six months in order for this to be classified as an isolated incident.