Does the Stark Law Apply? - Health Care Conference Administrators

12 Pages·2001·0.14 MB·English

D o e s t h e S t a r k L a w A p p l y ?
A Q u i c k C h e c k l i s t f o r R e s e a r c h S i t e a n d
I n v e s t i g a t o r C o n t r a c t s
Ronald L. Wisor Jr.
Arent Fox Kintner Plotkin & Kahn
[email protected]
(202) 857- 6067
S t a r k L a w P r o h i b i t s …
1 . A P h y s i c i a n
2 . F r o m M a k i n g a R e f e r r a l
3 . O f a M e d i c a r e o r M e d i c a i d P a t i e n t
4 . T o a n E n t i t y t h a t F u r n i s h e s “ D e s i g n a t e d H e a l t h
S e r v i c e s ”
5 . I f t h e P h y s i c i a n h a s a F i n a n c i a l R e l a t i o n s h i p
w i t h t h e E n t i t y
6 . U n l e s s a n E x c e p t i o n A p p l i e s
Q u e s t i o n 1
(cid:216)
Are you dealing with Medicare or
Medicaid covered services?
– If no, Stark does not apply
– If yes, proceed to the next question
Question 2
(cid:216)
Are you an entity that furnishes one of the “designated
health services” covered by Stark?
– If no, Stark does not apply
– If yes, proceed to the next question
D e s i g n a t e d H e a l t h S e r v i c e s
(cid:216) Clinical laboratory services
(cid:216) Physical therapy services
(cid:216) Occupational therapy services
(cid:216) Radiology services, including magnetic resonance imaging,
computerized axial tomography, and ultrasound services
(cid:216) Radiation therapy services and supplies
D e s i g n a t e d H e a l t h S e r v i c e s ( con’t)
(cid:216) Durable medical equipment and supplies
(cid:216) Parenteral and enteral nutrients, equipment, and supplies
(cid:216) Prosthetics, orthotics, and prosthetic devices and supplies
(cid:216) Home health services.
(cid:216) Outpatient prescription drugs
(cid:216) Inpatient and outpatient hospital services
An “Entity” Furnishes DHS if…
§ …it is the person or entity to which Medicare makes payment.
§ As a result, pharmaceutical or medical device manufacturers
generally are not covered by the Stark law.
§ But if you do bill and receive payment for DHS, proceed to
next question.
Question 3
(cid:216) Will the arrangement create a “financial relationship” with a
physician, meaning an ownership interest or, more likely,
direct or indirect compensation to the physician?
– If no, Stark does not apply
– If yes, proceed to next question
Question 4
(cid:216)Does an exception apply?
– If no, Stark law prohibits referrals
– If yes, referrals are permitted
P e r s o n a l S e r v i c e s E x c e p t i o n
1. Written agreement
2. Term of at least 1 year
3. Compensation set in advance, consistent with fair market
value and not determined based on volume or value of
referrals or any other business generated between the
parties
4. Commercially reasonable and legitimate transaction