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us-ftc-advisory-opinions-db7b2c2c7d520e1809c1f03032c7d947•American Academy of Ophthalmology
American Academy of Ophthalmology
us-ftc-advisory-opinions-db7b2c2c7d520e1809c1f03032c7d947American Academy of OphthalmologyGuidance
re: Concerning provisions in a code of ethics regarding delegation of services to non-physician health care providers, arrangements for postoperative care, use of experimental procedures, and advertising.
i FEDERAL TRADE CQMMISSIBP;" WASHINGTON, D. C. 20580 J c r a l d A. J a e s b s , E s q . Ltfghton Conklin Lcmov Jacobs a n d B u c k l e y , C h a r t e r e d 2033 M Street, N.W. Washington, D,C. 2 0 8 3 6 mar Mr. Jaeobsr T h i s letter r e s p o n d s t o your request f o r a n advisory opinion concerning t h e p r o p o s e d code 0 6 e t h i c s of t h e h r i e a n Academy 01 Ophthalmology. The Academy, an organization of physicians -specimIizing i n medical a n d surgical @ a r c o f t h e eye, intends t o a d o p t r code of e l h i e s l o govern t h e professional e s n ~ u c lof i t s members. T h i s eode would become part of t h e A e a d e m y b t y y f a w s , t o which ophthalmologists a g r e e t o s u b s c r i b e when t h e y j o i n t h e organization. You have r e q u e s t e d a h e l t b c i s s i o n advise t h e Academy w h e t h e r t h e p r o p o s e d eo f cthicsL/ c ~ m g l l c sw i t h S e c t i o n S o f t h e Federal T r a d e ission A e t an 11 o t h e r bppli- cable s t a t u t e s & M i n i s t e r e d o r r e e d by t h e G * The laws e n f o r c e d b y t h e ission do n o t p r o h i b i t p r s f e s - sional a s s o c i a t i o n s from a d o p t i n g r e a s o n a b l e ethical esdcs d e s i g n e d t o p r o t e c t t h e p u b l i e , S u c h s e l f - r e g u l a t o r y a c t i v i t y s e r v e s Icgi- timate p u r p o s e s , a n d i n most e a s e s e a n b e e x p e c t e d t o b e n e f i t , r a t h e r t h a n t o i n j u r e , competition a n d esnsurner w e l f a r e . I n some i n s t a n c e s , however, p a r t i c u l a r ethical r e s t r i e l i o n s een u n r e a s o n - a b l y r e s t r i e l eompetilion a n d t h e r e b y v i o l a t e t h e a n t i t r u s t laws, The legality of ta p r o f e s s i o n a l a o c i e P g P s ethical r u l e s uhdea t h e a n t i t r u s t laws d e p e n d s u p o n t h e i r p u r p o s e s a n d c o m p e t i t i v e effesrs.21 The m a t e r i a l s a c c o m p a n y i n g y o u r request s t a t e t h a t t h e p u r p o s e sf t h e p r o p o s e d code of e l h i e s i s a e x c l u s i v e l y t o p r o t e c t a n d b e n e f i t p a t i e n t s sf o p h t h a l m o l o g i s t s w h o a r e members o f t h e A e a d e m y e n In a e e s r d a n e e w i t h i t s customary p r a e t i e e w h e n U Suhni t t e d on A u g u s t 3 1 , 1 9 8 2 a n d modified by your s u b m i s s i o n on J a n u a r y 1 7 , i983, L1 S e e National S o c f y of P r o f . E n g 9 r s v . U n i t e d S t a t e r , 435 U . S . ( 1 9 7 8 ) ; h e r i c a n Medical A s s % $ 9 4 F,T.G, 7 8 1 ( ' 1 9 1 9 ) .
J e s a l d A, Jacobs, E s q , Page 2 cdnsldering a d ~ i ~ ~ r y relied opinion requests, t h e C s m i s s i o n has upon t h e Academy" s h a l m e n t as ts t h e good f a l l h p u r p o s e of t h e . eadc. T h u s , t h e C o m i s s i o n has focused i t s a t t e n t i o n on t h e p r o b a b l e e f f e c t s on eompelllion of t h e v a r i o u s p ~ o v l s l o n s c o n t a i n e d I n t h e Academy" p n s ~ p o s e d code of e t h i c s * The A c a d e m y f s p r o p o s e d code o f e l h i e s contains t h r e e sec- tions: 4 1 ) n P ~ i n c j p l e sof EORles," w h i e h a r c a s p i r a t i o n a l guide- l i n e s f o r professional conduel a n d a r e n o t cnfdrctable; ( 2 ) 'Rules sf E l h i c ~ , ~ w h i e h establish specific cnforec8blc standards of eon- d u e l foe' onrehers of t h e Aeademyi a n d ( 3 ) RABPrfnistralivc Proce- d u r e s , " which s a t f o r t h t h e s t r u c t u r e and operations o f t h e A c a d e m y P s E t h i c s mmitttt a n d t h e procedures f o r investigative a n d - d % s e i p l i n a r y p r o c e e d i n g s concerning e l h i e s c m p l a i n l s , a m b e r s f o u n d t o h a v e violated t h e r u l e s of e t h i c s m y be r e p r i m n d e d , suspended f r o m t h e A c a d m y f o r a definite lime period, o r per- manently e x p e l l e d , The e t h i c a l p r i n e l p n e s e x p r e s s t h e A e a Q m y 9 views r e g a r d i n g t h e d u t i e s of an ethical o p h t h a l m o l o g i s t , T h e y s t a t e , f o r c x m p l e , t h a t o p k t h a l r n o l s g i e a l s e r v i e e s m u s t be p r o v i d e d w i t h e m p a s s i o n a n d i n t e g r i t y , c o m p e t e n c e m u s t b e m a i n t a i n e d t h r o u g h e o n t i n b l e d . s t u d y s c o n f i d e n t i a l i t y sf patient e s m u n i e a b i o n s must be r c s p e e l c d , l e t s s h o u l d n o t exploit p a t i e n t s o r o t h e r s , o p h t h a l m o l o g i s t s d e l f e i e n l i n e h t l a a s t e r . s h o u l d be r e g o r l e d t o t h e proper ~ u l h o r i l f c s , a n d t h e p a t i e n t " w e l f a r e m u s t be t h e ophthalmologist% p r i m a r y e o n s i d e r a m l i o n , The G o m i s s i o n does n o t f i n d a n y significant t h r e a t Is corn- p e t i t i o n p o s e d by t h e s e g ~ ~ p ~ ~ e d EI g u i d e l i n e s , Is the C s i o n t s opinion t h a t adoption s f t h e proposed m P r i n c i p l t s of E t h i c s R f o r t h e p u r p o s e d e s c r i b e d by t h e Academy w o u l d n o t v i o l a t e tke F e d e r a l T r a d e C o m i s s i o n Act o r a n y other s t a t u t e e n f o r c e d by t h e C o m i s s i o n , The s e c o n d s e e t i o n o f t h e code contains t h e e t h i e a l r u l e s , w h i e h t h e Academy i n t e n d s l o e n f o r c e . As t h e i r t i t l e s i n d i c a t e , t h e s e r u l e s a d d r e s s various a s p e c t s of prsfessisnal csnduel: C o q e t e n c e Informed Consent Clinical Experiments a n d I n v e s t i g a t i v e P r o c e d u r e s O t h e r Opinions The I m p a i r e d O p h t h a l m o l o g i s t P r e o p e r a t i v e Assessmcnl D e l e g a t i o n sf Services . P o s t o p e r a t i v e Care
I - J e r a l d A. J a c o b s , E s q . Page 3 I * Medical a n d Surgical P r o c e d u r e s Je Procedures a n d Materials e r e g a l R e l a l l o n s h B p s L. C a m u n i e a l i o n s t o Colleagues Comunicatfons 60 t h e Publie Most o f t h e s e r u l e s do not r a i s e significant antitrust Issues, For e x m p l e p t h e Academy has p r o p o s e d r u l e s t h a t w ~ u l d a s s u r e t o patients s u c h important psolcetions as informed consent, careful preoperative evaluations, a n d a p p r o p r i a t e consultations, O t h e r ethical r u l e s i n t h e p r o p o s e d eodc prohibit psaetlecs t h a t c a u s e i n j u r y 8 0 patients, s u c h a s misreprcsentrllons of scsviecs performed o r t h e ordering of unnecessary procedures f o r pecuniary g a i n * Suck r u l e s a p p e a r u n l i k e l y t o Rave antdcompctitivc effects t h e p r o v i s i o n s a d d r e s s i n g clinical experiments a n d $ n v c s t i g a t i v c a n d mayD i n some instances, promote @owetition, A few of t h e e t h i c a l r u l e s -- because of t h e nature o f t h e r e s t r a i n t s t h a t t h e y impose -- require s e p a r a t e dfssussisn. These a r e p r o e e d u r c s , d e l e g a t i o n of sphthalmslogieal s c r v i e e s , p a s t o p e r a l i v e c a r e , a n d c o m u n i e a l i ~ n s t o t h e publie, R u l e C o f t h e Academy" proposed code r e q u i r e s ophthalmologists t o obtain approval from R s d e q u a P e r e v f e w mechanisms" before u n d e r - r a k i n g a " c l i n i c a l e x p e r i m e n t " o r an " i n v e s t i g a t i v e p r o e e d u r e l W The o p k l h a l m o l o g i e a l p r o e c d u ~ e ss u b j e c t t o t h i s ~eguiscmcnta r c defined i n t h e r u l e , a s " t h o s e c o n d u c t e d t o d e v e l o p adequate inlornuntion on which t o base prognostic o r t h e r a p t u l i e decisions, o r t o determine etiology o r p a t h o g e n e s i s , i n eiseurnstanecs I n w h i c h insufficie68 i n f o r m a t i o n e x i s t s * " The r u l e does n o t r e q u i r e a parlleular t y p e o f review mechanism f o r a l l e a s e s , I n s u p p l e m e n t a l m a t e r i a l s , t h e Academy has indicated t h a t t h e eaneept of an " a d e q u a t e n review mechanism i s i n t e n d e d t o b e f l e x i b l e , a n d t h a t t h e r u l e h a s b e e n d r a f t e d I s permit u s e o f "infsrmaf" review mechanisms, s u c h ras a t e l e p h o n e c o n f e r e n c e with a c o l l e a g u e , w h e n formal review would be i r n p r r s ~ t i c a b l e ~The r u l e a l s o p r o v i d e s t h a t informed c o n s e n t l o r c l i n i c a l e x p e r i m e n t s a n d i n v e s t i g a t i v e procedures " m u s t recognize Dhcia special n a t u r e a n d r m i f i e a l i o n ~ ~ ~ A l t h o u g h u n n e c e s s a r i l y s t r i c t c o n t r o l s on t h e u s e of new oghlhalmologieal p r o c e d u r e s c o u l d u n r e a s o n a b l y restriel e m p e l i t i o n a n d i n n o v a t i o n , t h e Aeedemy- p r o p o s e d r u l e a p p e a r s Q o p r o v i d e s a f e - g u a r d s t o p a t i e n t s -- t o protect them from uncontrolled e x p c r i - mentalion -- w i t h no a p p a r e n t lessening of eompetilion, S e p i a u s
antitrust eoneerns would b e raised, of c o u r s e , r h o u % d t h e r u l e be applied I n a Q i s c r % m i n a t o r y manner t o d i s e ~ ~ a a g c i n n o - v f g ~ r o u sa n d v a t d v e eompctitors o r be otherwise a b u s e d i n an a t t m b t o r e s t r a i n l e g i t i m a t e c s q e t i t i o n . R u l e G a d d r e s s e s delegation o f e y e c a r e services, This r u l e d e c l a r e s t h a t certain e y e c a r c services may n s l . b e delegated l a n o n - physician h e a l t h c a r e p r o f e s s i o n a l s (referred t o by t h e Aeademy i n i t s r u l e as "auxiliary h e a l t h earc petssnncf@), Under t h e r u l e , n o n - d e l e g a b l e services a r t R I h e s c aspects of' eye c a r c w i t h i n t h e unique competence of t h e ophthalmologist gwhfeh do n o t include t h e s e p e r m i f l e d by Osw "Z bbc.r>er%srmedby s u x i l l a ~ f e s ) ~ ~ Materials aceom- p a n y i n g your r e q u e s t s t a t e t h a t t h e t e r m m a u x % 1 3 a r i t s e as used I n t h e code ineludes o g t m e t r l s t r , nurses, tcchnlclans, srthoptlsts a n d o t h e r s , R u l e G f u r t h e r p r o v i d e s t h a t w h e n an ogRIRalmolsglst m a i n - tains responsibility l o t h e patient f o r e y e e a r @ services not wwithin t h e u n i q u e competence of t h e these o p h t h a l m ~ l o g i s l , ~ s e r - viecs m y Be delegated l o q u a l i f i e d non-physician h e a l t h c a r c pro- fessionals w i t h a d e q u a t e supervision, R u l e G a d d r e s s e s p r a e l i e e arrangements between e p h t k a l m o l o g $ s t s a n d n o n - p h y s i c i a n h e a l t h e a r c p r o l t s s l s n a l s , a n d does not a p p l y t o arrangements b e t w e e n o p h t h a l m o l o g i s t s a n d o t h e r p h y s i e l a n s , since p h y s i c i a n s a r e n o t mauxiliarlcs.m The Gomlssisn u n d e r s t a n d s t h a t " r e r u l e w o u l d n o t p r e v e n t ophthalmologists lrm m a k i n g a r r a n g e m e n t s f o r d e l e g a t i o n o f eye @ a r e s e r v i c e s t o n o n - p h y s i e l s n s as long as t h o s e a r r a n g e m e n t s a r c s t r u c t u r e d and c a r r i e d out i n a e e o ~ d a n e ew i t h applicable s l a t e law, S t a t e laws r e g u l a t i n g h e a l t h e a r c p ~ o f e . s - sionals p e r m i t t h o s e n o n - p h y s i c i a n s t h a t t h e Aeademy has d e s c r i b e d as n a u x i l i e ~ i e s NLo p r o v i d e a v a r i e t y of e y e e a r c services, some- limes a s i n d e p e n d e n t p r a c t i t i o n e r s a n d I n o t h e r eases under t h e s u p e r v i s i o n of a licensed physician. U n d e r t h e code, s u c h services a r e n o r t h e a p k t h a l m o l o g i ~ t , ~ "witbin t h e u n i q u e e o m p e l e n e e of a n d therefore t h e y may b e d e l e g a t e d . I t i s & ] s o . t h e C o m i s s ; i o n B s u n d e r s t a n d i n g t h a t t h e s u p e r v i s i o n requirement contained i n $ h e r u l e , applicable w h e n an ophthalmolo- g i s t r e t a i n s r e s p o n s i b i l i J y f o r e y e c a r c t h a t may be d e h e g a t e d , I s n o t i n , t e n d e d t o mandate a p a r t i c u l a r t y p e o r d e g r e e 01 s u p e r v i s i o n f o r a l l s i t u a t i o n s . S u p e r v i s i o n r c q u l r e m c n t s u n d e r s t a l e law v a r y grc&llg, a n d may r a n g e f r m d i r e e l , on-site s u p e r v i s i o n t o praeliee u n d e r s t a n d i n g o r d e r s or t e l e p h o n e eonsullalisn, The Aeaderny has indicated in s u p g l m e n l a r y m a t e r i a l s p r o v i d e d t o t h e C issisn t h a t t h e l e v e l of s u p e r v i s i o n required by t h e r u l e w i l l b e determined by
i J e r a l d A. J a c o b s , E s g , Page 5 r e f e r e n c e t o applieable s t a t e l a w , Fiwa%ly, t h e A e a d m y h a s s p e c i - f l c a l l j provided f o r f l e x i b i l i t y i n R u l e G by t h e l a s t sentence of t h e r u l e p w h i c h s l a t e s : "itrr sphthalms%oglst m y m a k e d i f f e r e n t r r r r n g m e n t s % O F t h e d e l e g a t i o n of eye c a r t i n special e l r c m - r t a w e e s , s u e h as emergencies, i f t h e p a t i e n t 9 welfare a n d r i g h t s a r t p l a c e d above a l l other e o n s i B e r a l i o n s m R Serious antitrust c o n c e r n s would, of eaurst, b e r a i s e d by an etfoierl r u l e t h a t u n r e a s o n a b l y fnterlcred with-legitimate esmpcli.- t i o n by ophthalmologists working I n eonjunction w i t h nsn-physician h e a l t h c a r c prsftsslsnals, o r prevented optometrists o r others f r o m p r o v i d i n g scrvdees t h a t they a r e legally a n d p r o f e s s i o n a l l y q u a l f - f f c d t o p r o v i d e , I t I s t h e C issionPs opinion* t h o u g h , based on I t s u n d e r s t a n d i n g s e t f o r t h above and t h e A e a d e m y f s suppIcmtntal assuranecs and explanations, t h a t Rulc C s h o u l d n o t have these e f f c e t s , Rule H a d d r e s s e s arrangements f o r e a r * lollawing e y e s u r g e r y , Like Rule G , i t eoncerns aspeels sf e y e c a r c -- i n t h i s partieulsr r u l e p o s t o p e r a t i v e eye c a r c -- t h a t a r e Rwilhin t h e u n i q u e e m - petenee of t h e oghthadmologist ( w h i c h do n o t i n e l u d e t h o s e permitted by l a w l o be performed by a u x i l i a r l e ~ ) , ~ R u l c H d e c l a r e s t h a t t h o s e a s p e c t s of p o s t o p e r a t i v e e y e @ a r cmust be p r o v i d e d either by t h e o p e r a t i n g opktkalmolsgisl o r by another opkthalmologist w i t h whom a r e f e r r a l a r r a n g e m e n t has been made, I d i s t h e C o m i s s I a n P s u n d e r - s t a n d i n g t h a t t h e Academy p r e f e r s t h a t t h e o p e r a t i n g ophthalmologist p r o v i d e t h e a s p e s t s of p o s t o p e r a t i v e e a r c covered by R u l c H, but t h a t , n o n e t h e l e s s , t h e code has been d r a f t e d I s l e a v e Aeadmg m m - b e r s f r e e l o r e f e r patients l o a n o t h e r ophthalmologist f o r t h i s p o s t o p e r a t i v e e a s e . The r u l e a l s o p r o v i d e s t h a t w h e n a p a t i e n t i s referred f o r p s s l o p e r a t i v e c a r e , t h e o p e r a t i n g o p h t h a l m o l o g i s t must m a k e t h e a r r a n g e m e n t s b e f o r e s u r g e r y , a n d t h e p a t i e n t a n d t h e o t h e r o p h t h a l - mologist m u s t a g r e e , The r u l e f u r t h e r d e c l a r e s t h a t l e e s f o r p o s t - o p e r a t i v e c a r e s h o u l d refleet t h e arrangements t h a t have b e e n m a d e , " w i t h advance d i s s l o s u r e t o t h e patleoteR F i n a l l y , R u l e H s t a l e s t h a t " d i f f e r e n t a r r a n g e m e n t s " f o r p o s t s p e r a l i v e eye c a r e may b e made f n m e r g e n e i e s o r o t h e r s p e c i a l c i r e m s t a n c e s , as l o n g as t h e patient" welfare a n d r i g h t s a r e t h e p r i m a r y c o n s i d e h a t i o n e Expla- nrlqry materials ~ c c m p a n g i n gyour request slate t h a t special c i r - e m s t a n c e s Inelude, l o r e x m p l e , csses i n w h i c h n s o p h t h a l m o l o g i s t I s a v a i l a b l e l a perform t h e p o s t o p e r a t i v e c a r c On t h e g e o g r a p h i c a r e a w h e r e t h e p a t i e n t r e s i d e s .
J e r a l d A. J a c o b s , E s g . Page 6 = R u l e H a d d r e s s e s aspects o f p o s t o p e r s n t i v e eye c a r e falling within t h e r a n g e o f services t h a l o n l y p k y s l c f a n s a r t q u a l i f i e d by law t o p c ~ l o r n r , POF c x m p l c , t h e r u l e would n o t p r e v e n t o p h t h a l m s ~ c g i s t s f r m a r r a n g i n g f o r optometrists t o grovlde p o s t o p e r a t i v e eye c a r c s e r v i e e s consistent w i t h s t a l e law, 'It appears, however, t h a t t h e r u l e c o u l d a f f e c t p o s t o p e r a t i v e c a s e arrangements w i t h p h y s i c i a n s w h o a r c not ophlhatnologisls, The question a r i s e s w h e t h e r Rule H 9 s identilieallon sf s m e p o s t o p e r a - tive eye c a r t s e r v i e c s a s " w i t h i n t h e unique c m p c t c n c c o f t h e ophthalmologistm m i g h t unreasonably p r e v e n t Academy members from r e f e r r i n g patients t o qualified physicians who a r c n o t s p e c i a l i s t s i n ophthalmology, tither i n d i v i d u a l p r i v a t e praetdtfsncrs o r t h o s e i n h e a l t h maintenance srganizatlons a n d other group settings, u r e m e n l s mong e o m e t i t o r s t o exelude a n o t h e r g r o u p o f competitors from a m r k c t a r e h i g h l y suspect under t h e antitrust laws. T h u s , I f R u l e H were a. s t r i c t prohjbitfon t h a t had t h e e f f e c t of categorically e x e l u d i n g non-ophlhalmsloglst physieians f r m s m e a s p e c t s o f m e d i c a l p r a e t i e c , i t m i g h t r a i s e serious a n t i t r u s t qucs- lions. I t u n d e r s t a n d i n g , however, t h a t is t h e C ~ m i s s i o n ~ s bht Academy bas e n d e a v o r e d t o p r o v i d e f o r f l e x i b i l i t y f n Rulc H e One c x m p l c of t h i s f l e x i b i l i t y i s t h e l a s t scntcnec of t h e r u l e , u h 4 c h p r o v i d e s f o r other r e f e r r a l a r r a n g e m e n t s I n "opeeial e i r e m - stances." m o t h e r a r e a o f l l c x i b l l l l y involves t h e determination o f what e y e c a r c functions a r e unique t o ophthalmology, The C s m i s s i s n u n d e r s t a n d s t h a l f l i s t h e A c a d e m y ' s position t h a t t h e p r e c i s e e y e e a r c f u n c t i o n s d e m e d t o be "wtthin t h e u n i q u e competenee of t h e ophthalmologist" will v a r y depending upon t h e c i r c m s t a n e t s invalvtd, A l t h o u g h t h e p r o p o s e d code d e f i n e s aa msphthalmoPogisB" a s " a physician who i s e d u c a t e d a n d t r a i n e d t o p r o v i d e msdieal a n d surgical c a r e of t h e e y e s and r e l a t e d s t r u e - t u r c s , " s t a t e s t a t u t e s e n d regulations d o n o t d e f i n e a r e a s sf medical s p e e i a l i z a b i o n , s u c h a s ophthalmology, and t h u s do n o t d e l i n e a t e an a r e a sf m e d i c i n e t h a t might be e o n s i d e r e d "within t h e u n i q u e c o m p e t e n c e of t h e o p h t h a l m o l o g i s t e n Niorasvtr, t h e Academy s t a t e s i n i t s e x p l e n a t o r y m a t e r i a l s s u b m i t t e d w i t h t h e p r o p o s e d c o d e t h a t i t i s n o t seeking t h r o u g h i t s e o d t of t d h i e s t o d e f i n e t h e a p p r o p r i a t e scope of practice sf h e a l t h c a r e p e r s o n n e l , R a t h e r , t h e s e s u p p l e m e n t a r y m a l e r i a l s s e t f o r t h a flexible a p p r o a c h , a n d s l a t e t h a l I n determining w h a t eye care s e r v i e e s f a l l w i t h i n t h e special s p h e r e of % h e ophthalmologist, t h e AeaQmy will l o o k t o " t h e e i r e m s t a n e e s o f eaek situation" and " w h a t e v e r governing mandatory o r v o l u n t a r y e r e d e n t i a l i n g meshanisms m i g h t e x i s t , @ T h u s , as t h e Csmisrisn u n d e r s t a n d s i t , R u l c EI w o u l d n o t p r e c l u d e an Aeademy
mehber f r m r e f e r r i n g patients t o a non-ophthalmological specialist f o r p o s t o p e r a t i v e e y e c a r e , as l o n g a s t h e i n d i v i d u a l p h y s i c i a n P s training and c x p e r l e n e c q u a l i f i e d h i m o r h e r t o p r o v i d e t h e parti- cular p o s t o p e r a t i v e s e r v i e c s , I n l i g h t o f t h i s I l e x i b i O i t y , I h t G o m i s s i o n eonelodes t h a t R u l e H i s a reasonable r u l e t h a t eould p r o v i d e valuable protection t o e o n s m e r s * AS long as i t i s a p p l i e d f a i r l y a n d sbjeelively, a n d i s n o t interpreted m o r e b r o a d l y t h a n necessary l o aekieve i t s Eegi- timate g o a l , i t s h o u l d n o t unreasonably impair csmpetltism, Careful attention will have t o be p a i d t o interpretation and enforcement of R u l e H, because t h e l a c k o f o f a n y e l e a r definition f o r n a ~ p e c t ~ e y e c a r e within t h e unique competence sf t h e o p h t h a l m o l o g i s t R may make t k r u l e s u s c e p t i b l e l o abuses I n applieatioa. Obviously, i f t h e e f f e c t of' t h e r u l e were t o f m t d e new and p o t e n t i a l l y cost-effective m e t h o d s f o r t h e d e l i v e r y of qualily eye c a r e o r t o e x e l u d e u n a c s - s o n a b l y I m i l y physicians o r o t h e r doctors I r m certain aspects o f medical practice, serious antitaust c o n c e r n s w o u l d be a e l s t d . None- t h e l e s s , Based on t h e a v a i l a b l e i n f o r m a t i o n , i t appears t h a t adop- t i o n o f R u l e H would not pose an unlawful t h r e a t t o eornpctlbjcsn o r 8 e o n s m e r w e 1 t a r e , ~ o m u n i e a l i o n sIs t h e Public Rule M s e t s f o r t h s e v e r a l r e s u i r m e n t s f o r a d v e ~ t i s l n aa n d o t h e r c o m u n i e a t i a n s l o t h e p u b l 1 6 , The r u l e bans f a l s e 0 ; deeep- t i v e c a m u n i c a t i o n s , b o t h affirmative m i s r e p r e s e n t a l i o n s a n d m i s - r e p r e s e n t a t i o n s a r i s i n g from t h e failure t o disclose a m l e r i a l f a e l , I t does not ban a n y gertieular form of e s m u n l e a l i s n , s u c h as testimonials O P p i e t o r i a l representations; r a t h e r , i t p r o v i d e s t h a t t h e s e a n d s t h e r f o r m s of e o m u n i e a t i o n s m u s t n o t convey f a l s e o r d e c e p t i v e information. R u l e M a l s o p r o h i b i t s certain s p e c i f i c t y p e s o f r e p r e s e n t a - t i o n s . The r u l e b a n s eomunieations t h a t : " a p p e a l $ 0 an i n d i - v i d u a l " saxxietg i n an e x c e s s i v e .or unfair wayw; R e r e a t e u n j u s t i f i e d e x p e e t a t i o n s of r e s u l t s " ; "misrepresent an o p h t h a l m o l o g i s t 3 e r e - d e n t i a l s , training, experience or a b i l i t y m ; or "contain material elaims sf s u p e ~ i o r i t y t h a t cannot be s u b s t a n t i a l e d e n The- p ~ o v i s i o n s e l a b o r a t e en t h e r u l e ' s general p r o s c r i p t i o n of f a l s e o r deceptive e o m u n i e a t i s n s , W i t h r e s p c e t l o a p p e a l s t o rnxiity, t h e Academy has t a k e n i n t o aecount t h e I a e t t h a t infor- matiqn on h e a l t h e a r @ t o p i c s may o f t e n c r e a t e anxiety a n d has d r a f t e d t h e r u l e l o m k e c l e a r t h a t i t i s aimed a t t h o s e e o m u n i - earions t h a t u n f a i r l y s r o p p r e s s i v e l y c a u s e anxiety, The @ o m i s s i o n
J c r a l d A. Jacobs, E r q , Page 8 un-dcrslands t h a t t h i s provision w i l l be enforced r e a s o n a b l y a n d . o b j c e l f v c l g , l o a v o i d discouraging t h e d i s s e m i n a t i o n of v a l u a b l e I~fsrmationt o e s n s m e r s , The ban on e o n a n u n l c a t i ~ ~ n st h a t , " e r e a t c u n j u s t i f i e d e x g e e t a t i o n s c s l " r c s u l l s m p r o h i b i t s d e c e p t i v e repre-. sentatlens r e g a r d i n g t h e likely r e s u l t s of o p k l h a l r n o l o g l c a l t r e a t - m e n t , The l a s t two pravlslons i d e n t i f i e d above address f a l s e o r misleading statements a b o u t t h e q u a l f f i c a l l o n s of an ophlhal- nnologist. The Cowmission n o t e s t h a t %Re r u l e prohfbits Rmalcrial elaims of superiority t h a t c a n n o t be s u b s l a n t l a t c d " a n d docs n o t contain a b a n on mseP%-laudatsryH o r AscBb-aggrandizlngm statements, Finally, R u l c M contains two d i s c l o s u r e requgremcnts, D i s e l s - sures r e g a r d i n g s a f e t y , c b f i e a c y , a n d t h e a v a i l a b i l i t y of a l t e r n a - t i v e s m u s t be m d c 2 % a comuniealion r e f e r s t o " b e n e f i t s o r other a t t r i b u t e s o f ophlhalmlc proecdures o r produels t h a t involve s i g n i - lieant risks,* a n d i n # m e c a s t s descriptions or assessments of a l t e r n a t i v e treatments m u s t be g i v e n , . Ira a d d i t i o n , a eomunieation m u s t I n c l u d e a d i s e l s s u r c t h a t i t m r c s u l t s I r m p a p e n t by an o p h r h a l m o l o g i ~ t , ~ i s t h e ease a n d i t Is not o b v i o u s from when t h i s t h e n a t u r e , f o r m t , o r m c d i m of t h e c ~ m u n i c r l i o n ~ The - m i s s i o n u n d i r s t a n d s t h a t a l l sf t h e disclosures i d e n t i - f i e d i n t h e r u l e a r e required o n l y w h e n ' a t e e s s a r y l o a v o i d dcecp- t i o n . The Aeademy h a s s p e e i f i e a l l y r ~ p r e s e n t c d t h a t t h e d l s c l ~ s u r c r e q u i r e m e n t s w i t h respect l o e o m u ~ i e a t i o n st h a t " r e f e r t o b e n e f i t s o r o t h e r a t t r i b u t e s of ophthalmic p r o c e d u r e s o r p r o d u e t s t h a t involve significant risksR a r e i n t e n d e d a n d w i l l be construed by t h e Aeadcmy t o r e q u i r e diselosures o n l y t o t h e e x t e n t ncecssarg t o p r e v e n t d e c e p t i o n sf t h e publie* The G ission a l s o u n d e r s t u d s t h a t m e r e identifieation sf an ophthalmic proetdurc or produet t h a t i n v o l v e s s i g n i f i c a n t r i s k s , without r e f e r e n c e t o i t s b e n e f i t s o r o t h e r q u a l i t a t i v e a t t r i b u t e s , w i l l nsl t r i g g e r t h e d i s c l o s u r e r e q u i r e m e n t , F u r t h e r m o r e , t h e Academy has r e p r e s e n t e d t h a t an a d v e r t i s e m e n t f o r r o u t f n c eye c x m i n a t i o n s , s u e h as R s a f e g u a r Q y o u r h e a l t h ; g e t y o u r e y e s c h e e k e d ; c a r e f u l a n d t h o r o u g h eye e x m i n a t i o n s by a p p o i n t m e n t , " w o u l d n o t n e e d t o eonlain t h e d i s e l o s u r e s i d e n t i - f i e d i n R u l c M e Similarly, t h e diselosuac eequirsmenls of t h e r u l e would n o t be t r i g g e r e d by a e o m u n i c s t i o n t h a t a d v e r t i s e d t h e f i t t i n g o r provision o f eonlaet lenses a n d n o t e d s u c h a t t r i b u t e s as improved a p p e a r a n e c , user o r e ~ m f o r t ~ I n e ~ p e n s f ~ e n ~ ~ s ~ Based on i t s u n d e r s t a n d i n g of Aufc M and t h e Acaderny" s u p p l e - menla'l assurances a n d e x p l a n a t i o n s , t h e C o m i s s l o n belleves t h a t t h i s rul'e does not pose sn u n r e a s o n a b l e t h r e a t l o e m p e l l t i s n o r e o n s m e r s , R u l e s t h a t a r e tailored t o p r e v e n t f a l s e o r d e c e p t i v e a d v e r t i s i n g s e r v e t o enhance the c o m p e t i t i v e p r o c e s s and p r o v i d e
vc1'1uablc c o n s u e r grctcctlon. C a r e s h o u l d b e exercised, o f e o u r s e , t o e n s u r e t h a t I n t e r p r e t a t i o n and c n f s r c m c n l of t h e r u l e does not have t h e c f f e e t sf s u p p r e s s i n g n o n d e e e p t i v e a d v e r t i s i n g o r o t h e r unieations I s t h e publie. l t i s opinion, b a s e d on t h e foregoing a n d t h e t h e ~ o m i s s i o n ~ s Academy's s u p p l m t n t a l a s s u r a n e c s a n d explanations, %Rat a d o p t i o n o f t h e proposed "Rules of Ethics" would n o t v i o l a t e t h e Federal T r a d e issioo Aet o r a n y o t h e r l a w s e n f o r s c d by t h e issisn, The ission nates t h a t t h e Academy has stated t h a t ajm i s t o m a s s u r e t h a t t h e code 6 s i n t e r p r e t e d a n d e n f o r c e d objtetively and with fairness,' T h i s i s essential, f o r even t h e most carefully d r a f t e d clhleal r u l e s can e r e a t e antitrust probIems $ 1 t h e y a r t a6ustde Rule K, f o r exismple, declares t h a t an sphbhalms~sgislm u s t n o t l e t h i s o r h e r elinisal j u d p e n a a n d p r a e t i c c be a f f e c t e d by c o m e r c i a 1 interests, T h i s rune could r a i s e serious eoneerns 1 B Bt were b r o a d l y interpreted t o e f f e c t r f l a t ban on certain t y p e s o f ~ c g S I i m a t ce o m e r e i h l r e l a t i o n s h i p s . The f i n a l s e c t i o n of t h e p r o p o s e d code of t t h l e s B c s e r i b e s t h e a * i n i s t r a l i v e p r s e e d u r e s t h a t w i l l be u s e d I s i m p l e m e n t t h e tthieal r u l e s , The procedures e s t a b l i s h e d by t h e e o d c inelude: notice t o t h e aeeused of t h e e x i s l e n e e of an i n v e s t i g a t i o n ; o p p o r t u n i t y f o r 8 h e a r i n g ; r i g h t t o c o u n s e l ; o p p o r t u n i t y l o e r o s s - e x m i n e w i t n e s s e s a n d o f f e r e v i d e n c e ; r i g h t t o a p p e a l an a d v e r s e decision; and pre- s e r v a t i o n o f a w r i t t e n record, Courts Rave h e l d t h a t when m m b e r s h i p i n rn,srganization of competing f i r m s or i n d i v i d u a l s c o n f e r s a significant e o q c t i t i v e a d v a n t a g e , d i s c i p l i n a r y measures s u e h a s suspension o r termination may n e t be imposed without a d e q u a t e p r o c e d u r a l s a f e g u a r d s , The p r o p o s e d eade p r o v i d e s significant p r o c e d u r a l s a f e g u a r d s , I t i s t h e @ s m i s s i o n 9 s oppinion t h a t a d o p t i o n a n d use of t h e " A h i n i s t r a t i v e P r o s e d u r e s H contained i n t h e proposed code w o u l d n o t v i o l a t e t h e ' a n t i t r u s t l a w s o r a n y o t h e r l a w s e n f o r c e d by t h e G Ascsrdingly, t h e C o m i s s l o n caneludes t h a t a d o p t i o n of t h e h e r l e a n Aeademy sf Ophthalmology" p r o p o s e d eode of e l h i e s would n o t v i o l a t e Seetion 5 sf t h e F e d e r a l T r a d e G ission A c t o r a n y o t h e r s t a t u t e e n l o r e e d by t h e C o n m i s s i o n , T h i s a d v i s o r y o p i n i o n , like a l l t h o s e i s s u e d by t h e G o m i s s i o n , fs limited t o t h e p r o p o s e d , e o n d u c t described i n t h e p e t i t i o n b e i n g c o n s i d e r e d , I t d o e s n o t , o f eourse, constitute a p p r o v a l f o r specific instanecs sf I m p l e m e n t a t i o n of t h e code t h a t m y become t h e s u b j e c t of litigation b e f o r e t h e C o m i s s i o n o r a n y e o u r l , s i n c e i n t e r p r e t a t i o n s and e n f o r c e m e n t of
J e r a l Q A * J a c o b s , E s q , Page I @ t h e code fw gartieular sjtuations m y p r o v e f o Cause dignffieant i n j u r y ts csrngstltdsn a n d c o n s w e r s , a n d t h e r e b y v i o l a t e t h e Federal Trade G o m i s s l s n Act. The C o m l s s l o n m l n t a f n s t h e r l g h t t o reeon- r i d e r t h e q u e s t i o n s involved a n d , w i t h notiec t o t h e r e q u e s t i n g party i n a e e o r d a n e e w i t h Section l 5 3 ( b 1 o f t h e C s m l s s l o n 8 s R u l e s o f Braelice, I s r e s c i n d o r revoke i t s opinion I n t h e event t h a t i q 9 e m e n t a t i o n of t h e proposed code of ethics results I n significant anlieompetillve c f f e e t s , should t h e purposes of t h e code o r a n y o f i t s i n d i v i d u a l p r o v i s i o n s be f o u n d n o t t o be legitimate, o r s h o u l d t h e p u b l i c interest otherwise s o require,
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