Stark in-office Exceptions - to Referrals - Stark Law Exceptions
When contemplating a particular transaction the following is often the common methodology and analysis for purposes of Stark Law Exceptions and the Anti-Kickback Rules: 1-The inoffice exceptions to Stark for ancillary services has several essential requirements and restrictions relating to: The designated health services that can be provided in the medical practice (because only certain specific types of designated health services are allowed to be furnished under this exception) – referred to here as “Service Restrictions”;
2-Who provides or supervises the services in the practice — the “Performance and Supervision Test”;
3-Where the services are furnished — the “Building” or “Site of Service” Test;
4-How the designated health services are billed — the “Billing Test” ; and
5-The additional requirement that any medical practice other than a true solo physician practice must qualify as a bona fide “Group Practice” for Stark law purposes — the “Group Practice Requirement”.
Conflict of Interest Check – Stark – Anti-Self-referral Laws – Mechanical Application
I. STARK LAW SUMMARY
Stark Law Analysis: the steps in a Stark Law analysis generally follow this order:
1) Is the service provided to a patient covered by Medicare or Medicaid?
2) Is the service provided to the Patient a DHS? (Designated Health Services includes lab services, therapy, radiology and imaging services)
3) Is the service provided by an “entity”? (“Entity” includes the party that receives the payment for the service and that “performs” the services.)
4) Pursuant to a “referral”? (“Referral” is a request by a physician for an item or service for which payment may be made under Medicare.)
5) From a “physician”?
6) With whom the entity has a “financial relationship”?
7) What entity is the one “billing” Medicare or Medicaid, and how is it related to the patient/physician?
If the answer to all of these questions is “yes”, then the financial relationship between the entity and the referring physician must meet one of the exceptions provided by the statute and regulations.
– DHS – Designated Health Services includes inpatient/outpatient hospital services, prescription drugs, lab services, therapy, radiology and imaging services.
– “Entity”- includes the party that receives the payment for the service and that “performs” the services.
– “Referral” – is a request by a physician for an item or service for which payment may be made under Medicare.
– “Physician” – is a MD, DO, DDS, Podiatrist, Optometrist, Chiropractor; thus physician assistants, nurse practitioners, CRNAs, physical and speech therapists and other mid-level licensed providers are not “physicians”.
– “Financial Relationship” – is any ownership or investment interest (including equity, debt, or other means) in the entity providing the DHS.
Exceptions to Stark:
– Bona Fide Employment relationship (with or without a contract), but cannot pay based on volume.
– In-Office Ancillary Services.
Exception Requirements – the services must be personally furnished or supervised by the referring physician, or physician who is a member of the same group practice as the referring physician. The services must be furnished in the same building (certain rules regarding number of hours building is occupied per week apply). The services must be billed by the physician performing or supervising the service, under the assigned physician or group practice billing number. These rules are commonly referred to as supervision, building and billing requirements. The physicians are deemed to “stand in the shoes” of their practice.
I. ANTI-KICKBACK STATUTE SUMMARY
The Federal Anti-Kickback Statute (AKS) overlaps with Stark Law, but AKS requires proof of intent and is broader than Stark Law. The AKS specifically prohibits anyone from knowingly and willfully offering or paying on te one hand or soliciting or receiving on the other hand any remuneration to induce or in return for (1) referring an individual to a person for furnishing of any item or service payable in whole or in part by a federal health care program; or (2) purchasing, ordering, or arranging for any good or service payable under the federal healthcare program. In order to avoid the violation there must be a written agreement in place that contemplates the very specific service or activity even if it is sporadic or part-time, in exchange for fair and reasonable compensation, and the agreement must be at least one year long.
Florida's Anti-Kickback Statute, F.S. §456.054(2), states: “[i]t is unlawful for any health care provider or any provider of health care services to offer, pay, solicit, or receive a kickback, directly or indirectly, overtly or covertly, in cash or in kind, for referring or soliciting patients.”
II. Florida Patient Brokering Act, Fla. Stat. §817.505(1)
The Florida Patient Brokering Act prohibits “any person, including health care providers or health care facility to:
(a) Offer or pay any commission, bonus, rebate, kickback, or bribe, directly or indirectly in cash or in kind, or engage in any split fee arrangement, in any form whatsoever, to induce the referral of patients or patronage to or from a health care provider or health care facility.
(b) Solicit or receive any commission, bonus, rebate, kickback, or bribe, directly or indirectly in cash or in kind, or engage in any split fee arrangement, in any form whatsoever, to induce the referral of patients or patronage to or from a health care provider or health care facility.
(d) Aid, abet, advise, or otherwise participate in the conduct prohibited under paragraphs (a) through (c). “
The Patient Brokering Act, is unlike the Federal AKS, and it applies no matter the source of the payment; there are certain exemptions from this rule such as the group practice exceptions.
Here is the actual statute:
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