FILED U.S. COURT OF AP P EALS E LEVEN T HC IRC U IT NOVEMB ER 3, 2006 THOMAS K. KAH

N CLERK

Honora ble Kenneth L . Ryskamp, United States District Judg e for the Southern District * of F lorida, sitting by

designation. [ P UB L I S H] I N THE UN I TE D STATE S C OU RT OF APPE ALS F O R T H E E L E V E N T H C IR C U IT

________________________ N o. 05- 16935

________________________ D. C . Do c k e tNo . 0 4 - 0 2 6 1 0 - C V- T - 2 6 E AJ G U L F C O A S T M E D I C A L S U P P L Y , I N C ., P la in tif f - A p p e lla n t, v ersu s SE CR ET ARY, DEPART M ENT OF HEALT H A N D H U M A N S E R V I C E S , D e f e n d a n t- A p p e lle e .

________________________ A pp ea l fr om the U ni t ed S t at es D i stri ctC ou rt f orthe M i ddl e D i s tr i c tof F l or i da

_________________________ ( N ove m b e r 3, 2006) B ef ore B L A C K and H U L L , C i rc ui tJudg es , and R Y S K A M P , D i stri ctJudg e. * P E R C U R I A M:We notethat tw o distri c t c ourt s h aveadd re sse d th eissue : MacKenzieMedic al Supply, 1 In c . v. Leav itt, 419 F. Supp. 2d 766 (D. Md. 2006) and Maximum Comfort, Inc. v. Thompson , 323 F. Supp. 2d 1060 (E.D. Cal. 2004). 2 A pp el l antG ul fc oastM edi ca l S up pl y ( G ul fc oast ) i s aF l ori da-bas ed supp l i er of du rabl e m edi ca l equi pm ent(D M E ), i ncl ud i ng m ot ori ze d w heel chai rs . A pp el l ee , the S ec re t ary of H ea l th and H um an S ervi ce s ( S ec re t ary) , adm i ni st er s the fe dera l M e d ic a r e p r o g r a m . T h e S e c r e ta ry d e te rm in e d th a t M e d ic a r e h a d o v e rp a id G ul fc oastfor w heel chai rs G ul fc oastsupp l i ed t o M edi ca re benefi ci ar i es betw ee n S e pt e m be r8, 2001, a nd F e brua ry 14, 2002. G ul f c oa s ts oughtj udi c i a l r e vi e w of the S e c r e t a ry ’ s de c i s i on i n the U ni t e d S t a t e s D i s tr i c tC our tf orthe M i ddl e D i s tr i c tof F l or i da , a nd the di s tr i c tc our ta f f i rm e d. T h i s ap p eal p resen t s an i ssu e o f fi rsti m p ressi o n i n th i s an d al l ci rcu i tco u rt s: w h e th e r , u n d e rP a r t B o f th e M e d ic a r e A c t, aD M E s u p p lie ru n e q u iv o c a lly e s t abl i s he s tha ts uc h e qui pm e nti s m e di c a l l y “ r e a s onabl e a nd ne c e s s a ry ” ( a nd there fore covered by P artB of the A ct ) by s ub m i tt i ng a “ ce rt i fi ca t e of m edi ca l nece ss i ty, ” or w hether the S ec re t ary m ayre qu i re the supp l i ert o sub m i taddi t i on al evi dence of m edi ca l nece ss i ty. W e f i nd the S ec re t ary has di sc re t i on t o requi re 1 a d d i t i o n a l s u b mi s s i o n s , a n d w e th e r e f o r e a f f i rm. I . B AC KG RO UN D3

P a r tB of the M e di c a r e A c ti s af e de r a l l y s ubs i di z e d, vol unt a ry e nr ol l m e nt h eal th i n su ran ce p ro g ram . 4 2 U . S . C . § § 3 9 5j t o 1 3 9 5 w -4 . P artB p ays a s u b s t a n t i a l p o r t i o n o f

th e h e a l th c o s t s i n c u rr e d b y th o s e e n r o l l e d i n th e p r o g r a m, i n c l u d i n g th e c o s t s o f

D M E s u c h a s w h e e l c h a i r s . 4 2 U . S. C. § 1 3 9 5 x ( n ) ; 4 2 C. F. R. § 410. 38( a ) - ( c ) . T he pr ogr a m i s a dm i ni s t e r e d by the C e nt e rf orM e di c a r e a nd M e d ic a id S e rv ic e s ( C M S ) , ad iv is io n s u p e rv is e d b y th e S e c r e ta ry . Se e g e n e r a lly U ni ted Stat es v. R &F

P ropert i es of

L ake C ou nt

y, Inc. , 4 3 3 F .3 d 1 3 4 9 , 1 3 5 1 ( 1 1 th C ir . 2 0 0 5 ) . P a r t B c o v e r a g e e x te n d s o n ly to th o s e m e d ic a l s e rv ic e s th a t a r e m e d ic a lly

“ r e a s o n ab l e a n d n e c e s s a ry ” f o rth e b e n e f

i c i a ry . 4 2 U . S. C. § 1 3 9 5 y ( a ) ; 4 2 C. F. R. § 4 1 1 . 1 5 ( k ) ( 1 ) . I n o r d e rt o a d mi n i s t e r , v a l i d a t e , a n d p a y c l a i ms ma d e u n d e rPa r tB, CM S c o n tr a c t s w i th r e g i o n a l , p r i v a t e i n s u r a n c e c a rr i e r s w h o a c ta s c l a i ms p r o c e s s o r s . 4 2 U .S .C . § 1 3 9 5 u ; se e R &F P ropert i es , 433 F . 3d a t1351. U pon re ce i ptof a c l ai m for pay m ent , the ca rr i erdeci des w hether the cl ai m ed se rvi ce s

“ w e r e m e di c a l l y ne c e s s a ry , w he the rthe c ha r ge s a r e r e a s onabl e , a nd w he the rthe cl ai m i s otherw i se covered by P artB . ” Sch w ei ker v. McC lu re , 456 U . S . 188, 191, 1 0 2 S . C t. 1 6 6 5 , 1 6 6 7 ( 1 9 8 2 ) ; se e 42 U . S . C . §§ 1395 l , 1 3 9 5 y ( a ) ; 4 2 C. F. R. § 4 0 5 . 8 0 3 . A m o n g o th er req u i rem en t s, M ed i care w i l l n o tp ay a cl ai m u n l ess a4

ph ys i ci an ce rt i fi es thatthe m edi ca l se rvi ce s w er e m edi ca l l y r equi re d. 42 U . S . C . § 1 39 5n (a )( 2)(B ). T o f a c ilita te c la im s p r o c e s s in g , th e M e d ic a r e A c t p e rm its D M E s u p p lie r s to d i s tr i b u t e t o p h y s i c i a n s a“ c e r t i f i c a t e o f me d i c a l n e c e s s i ty ” ( CM N ) . 4 2 U . S. C. § 1 39 5m (j )( 2)(A ). T he M edi ca re A ctdefi nes the C M N as “ a f orm or other doc um e ntc ont a i ni ng i nf orm a t i on r e qui r e d bythe c a rr i e rt o be s ubm i tt e d t o s how th a ta n i t e m i s [ me d i c a l l y ] r e a s o n ab l e a n d n e c e s s a ry . . . . ” 4 2 U . S. C. § 1 39 5m (j )( 2)(B ). P ursuantt o the M edi ca re A ct , supp l i er s of m edi ca l se rvi ce s are pe rm i tt e d t o f

i l l i n c e r t a i n por t i ons of the C M N i n a dva nc e t o m a ke i te a s i e rf or ph ys i ci ans t o com pl et e the re m ai nd erof the C M N . S peci fi ca l l y, supp l i er s are perm i tt ed t o i ncl ud e on the C M N (1) i dent i fy i ng i nform at i on abou tthe supp l i er a nd the be ne f

i c i a ry , ( 2) ade s c r i pt i on a nd pr oduc tc ode f orthe m e di c a l e qui pm e nt su p p li ed , an d (3 ) o th erad m in istrativ e in fo rm atio n n o t related to th e b en ef iciary ’s m edi ca l cond i t i on . 42 U . S . C . § 1 39 5m (j )( 2)(A ). T he part i al l y c om pl et ed form r e duc e s the a dm i ni s tr a t i ve bur de n on phy s i c i a ns , w ho ne e d onl y s uppl y the m e d i c a l i n f

o rm a t i o n o n th e C MN. F orr e a s ons of

a dm i ni s tr a t i ve e f

f i c i e nc y , c a rr i e r s typi c a l l y author i z e pa y m e nt on c l a i m s i m m e di a t e l y upon r e c e i ptof the c l a i m s , s o l ong a s the c l a i m s do not cont ai n g l ar i ng i rr egul ar i t i es . L at er , ca rr i er s c on du ctpo st -pay m entaudi t s t o v er i fy th a t th e p a y m e n ts w e r e p r o p e r . See 4 2 U .S .C . § 1 3 9 5 u ; 4 2 C .F .R . § 4 2 1 .2 0 0 ( a ) ( 2 ) .5

W hen the ca rr i erdi sc ov er s thatan ov erpaym enthas occ urre d, the ca rr i erm ay s u s p e n d o rr e c o up p a y m e n t. 4 2 C .F .R . § 4 0 5 .3 7 1 ( a ) . A s uppl i e rdi s s a t i s f

i e d w i th the c a rr i e r ’ s r e s ol ut i on of ac l a i m m a y appe a l the d e c i s i o n th r o u g h ad e s i g n a t e d a d mi n i s tr a t i v e ap p e a l s p r o c e s s . 4 2 U . S. C. § 1 39 5ff( b)(1)( A ) ( i ncorpo ra t i ng by re fe re nce the appeal s proce ss un der the S oci al S e c u r ity A c t, 4 2 U .S .C . § 4 0 5 ( b ) ) ; see a l so 42 C . F . R . § 405. 801. A f t e re xhaus t i ng thi s a dm i ni stra t i ve process , the supp l i erm ayse ek j ud i ci al re vi ew by a f eder al di stri ctcourt . 42 U . S . C . § 1 39 5ff( b)(1)( A ) ( i ncorpo ra t i ng by re fe re nce the j ud i ci al re vi ew avai l abl e und erthe S oci al S ec uri ty A ct , 42 U . S . C . § 4 05 (g)) . I I . FA C TS G ul fc oasti s aF l ori da-bas ed supp l i erof D M E , i ncl ud i ng m ot ori ze d w h e e lc h a ir s . A t a ll r e le v a n t tim e s , th e M e d ic a r e c a rr ie ra d m in is te r in g P a r t B cl ai m s i n G ul fc oast ’ s r egi on w as P al m ett o G ov ernm entB enef i t s A dm i ni stra t ors (P al m ett o). A ft erre ce i vi ng consum ercom pl ai nt s and suspi ci ou s r es ul t s f rom st at i st i ca l a na l y s e s of

G ul f c oa s t ’ s c l a i m s , P a l m e tt o de c i de d t o audi tG ul f c oa s t . I n J une 2002, P al m ett o surveye d 3 0 rando m l y s el ec t ed benefi ci ar i es ou tof the 10 2 b enef i ci ar i es w ho re ce i ved a cert ai n type of pow erw heel chai r f rom G ul fc oastbetw ee nOf the 30 c laims audited by Palmetto, 6 wereinitially allowed by

Palmetto. Theref

ore, 2 before the ALJfor c onsideration were 24 c laims. The ALJdismiss ed one c laim and adjudicated theremaining23 c laims . 6 S e pt e m be r8, 2001, a nd F e brua ry 14, 2002. P a l m e tt o r e que s t e d m e di c a l r e c or ds of al l 30 benefi ci ar i es and i nt ervi ew ed 20 of the benefi ci ar i es (or thei r c ar egi vers ). B a s e d on i t s audi t , P a l m e tt o de t e rm i ne d tha tanum be rof the pa t i e nt s f

or w h o m G u lf

c o a s t h a d s u b m itte d c la im s f o rM e d ic a r e r e im b u r s e m e n t o f D M E d id notm e e tthe ne c e s s a ry c r i t e r i a . F ore xa m pl e , P a l m e tt o f ound tha ts e rvi c e s f

or22 of the be ne f

i c i a r i e s w e r e nots uppor t e d by doc um e nt s i n the i rm e di c a l r e c or ds a nd thatatl ea sthal f of tho se w ho se re cords w er e e xam i ned d i d n otneed a pow er w he e l c ha i r . P a l m e tt o ul t i m a t e l y c onc l ude d tha tG ul f c oa s tha d be e n ove rpa i d by $280, 573. 68. A M e di c a r e f a i rhe a r i ng of

f i c e ra f f i rm e d the ove rpa y m e nt a s s e s s m e n t. G ul f c oa s tappe a l e d the c a rr i e r ’ s de c i s i on be f or e a n a dm i ni s tr a t i ve l a w j udge (A L J) . G ul fc oastar gu ed thatbecause i tsubm i tt ed a C M N si gn ed by a physi ci an f o re a c h o f

th e c h a l l e n g e d c l a i ms , Pa l me tt o l a c k e d d i s c r e t i o n t o r e j e c tth o s e c l a i ms on the ba s i s of

a ddi t i ona l e vi de nc e . T he A L J r e j e c t e d G ul f

c oa s t ’ s a r gum e nta nd f ound tha tthe 30 audi t e d c l a i m s r e f l e c t e d a“ pa tt e rn of

e rr one ous bi l l i ng. ” T he A L J de t e rm i ne d tha tove rpa y m e nt s w e r e c orr e c t l y a s s e s s e d i n 17 c a s e s , but i nc orr e c t l y i n 6 othe r s , a nd the r e f or e or de r e d tha tthe t ot a l be r e c a l c ul a t e d by the 2P urs u ant t o 4 2 U. S . C . § 4 0 5 (g) , j u di ci alre v i ewo f th e S ec re t ary ’s d ec i s i o nre gardi n g a 3 claim for Me dicare bene fits is li mited to “whether thereis substantial evidenceto support the finding s of the . . . [Secreta ry], and whether thecorrect leg al standards wereapplied.” W ilson v. Ba rn ha rt, 28 4 F .3 d 1 21 9, 12 21 (1 1th Cir . 2 00 2) ; see42 U.S.C. § 1395ff(b)( 1)(A)(incorporating into MedicareAct the standa rd of review set forth in 42 U.S.C. § 405(g) ). We review de novo the district court' s determination of whether substantial evidencesupports the ALJ ' s decision. W ilson , 284 F.3d at 1221. 7 c a rr ie r . G u lf

c o a s t ap p e a le d to th e U n ite d S ta te s D is tr ic t C o u r t f o rth e M id d le D is tr ic t o f

F lo r id a , w h ic h a f

f irm e d . I I I . DI S CUS S I ON T he f a c t s e s t abl i s he d by the a dm i ni s tr a t i ve r e c or d a nd out l i ne d above a r e not i n d i sput e, and the sol e i ss ue before us i s aqu es t i on of l aw . G ul fc oastar gu es that 3 a s am a tt e rof

s t a tut ory c ons truc t i on, P a r tB of the M e di c ar e A c tdoe s notgi ve ca rr i er s or the S ec re t ary di sc re t i on t o requi re a s up pl i ert o sub m i taddi t i on al m e di c a l doc um e nt a t i on be y ond the C M N t o pr ove m e di c a l r e a s onabl e ne s s a nd n e c e s s ity . R a th e r , a c c o r d in g to G u lf c o a s t, th e C M N s ig n e d b y ap h y s ic ia n is l eg al l y su ffi ci en tt o v al i d at e a cl ai m u n d er P l an B . T h u s, b ecau se G u l fco ast subm i tt ed a s i gn ed C M N for e ac h o f the di sput ed cl ai m s, G ul fc oastcont ends that the S ec re t ary l ac ked d i sc re t i on t o rej ec ttho se cl ai m s on the basi s of the addi t i on al r e c or ds pr oc ur e d a nd i nt e rvi e w s c onduc t e d by the c a rr i e r , P a l m e tt o. G ul f c oa s t ’ s a r gum e ntr e l i e s a l m os te nt i r e l y on the M e di c a r e A c t ’ s de f i ni t i on of a“ c e r t i f i c a t e of m e di c a l ne c e s s i ty ” a s “ af orm orothe rdoc um e ntc ont a i ni ng i n fo rm at i o n req u i red b y th e carrier t o b e su b m i tt ed t o sh o w th atan i t em i s8

r e a s o n ab le a n d n e c e s s a ry f o rth e d ia g n o s is o rtr e a tm e n t o f illn e s s o rin

ju ry o rto i mp r o v e th e f

u n c t i o n i n g o f

ama l f o rme d b o d y me mb e r . ” 4 2 U . S. C. § 1 3 9 5 m ( j) ( 2 ) ( B ) . G u lf

c o a s t a r g u e s th a t th is s ta tu to ry p r o v is io n u n a m b ig u o u s ly m a nda t e s tha taC M N a l one e s t abl i s he s the r e a s onabl e ne s s a nd ne c e s s i ty of m e d ic a l e q u ip m e n t, le a v in g th e S e c r e ta ry n o d is c r e tio n to r e q u ir e as u p p lie rto s u b m i ta d d i t i o n a l p r o o f o f m e d i c a l n e c e s s i ty . Gu l f c o a s ta s k s u s t o f

o l l o w a C al i fo rn i a d i stri ctco u rt ’ s ru l i n g th at“ [t ] h e S ecret ary’ s co n t en t i o n th atC o n g ress p r o v id e d h im w ith th e au th o r ity to d e c id e w h a t d o c u m e n ta tio n m a y b e r e q u ir e d to de t e rm i ne the m e di c a l ne c e s s i ty of D M E c onf

l i c t s w i th the pl a i n m e a ni ng of § 1 39 5(j )( 2)(B ). ” M

ax i m um C om

f or t , I nc . v . T hom ps on , 323 F . S upp. 2d 1060, 10 67 -68 (E . D . C al . 20 04 ). A cc ordi ng t o the M a xi m u m C o m

f o rt c o u r t, § 1 39 5m (j )( 2)(B ) “ pl ai nl y s peci fi es thatC on gres s i nt ended thatw hat ever i nform at i on m aybe re qu i re d b y c arri er s f rom supp l i er s t o sho w the m edi ca l nece ss i ty a nd re as on abl enes s of D M E m ustbe cont ai ned i n a C M N . ” I d. a t1068. In consi deri ng G ul fc oast ’ s c on t ent i on thatthe S ec re t ary’ s a ct i on s w er e c ontr a ry t o the M e di c a r e A c t , w e a r e m i ndf ul tha t“ c ons i de r abl e w e i ghts houl d be a c c o r d e d to a n e x e c u tiv e d e p a r tm e n t’s c o n s tru c tio n o f as ta tu to ry s c h e m e it is e n tru s te d to a d m in is te r .” Ch evro n U . S. A . , In c. v. N

a tu ra l R eso u rces D ef

en se C ou nci l , Inc. , 46 7 U . S . 83 7, 84 4, 10 4 S . C t . 27 78 , 27 82 (198 4). U nd er Che v r on ’s9

tw o- s t e p appr oa c h, w e f i r s ta s k “ w he the rC ongr e s s ha s di r e c t l y s poke n t o the pr e c i s e que s t i on a ti s s ue , ” r e m ovi ng the i nt e rpr e t a t i on of the s t a tut ory pr ovi s i on f r o m th e a g e n c y ’s d is c r e tio n . I d. a t 8 4 2 , 1 0 4 S . C t. a t 2 7 8 1 . O n ly if th e s ta tu te “is s ile n t o ra m b ig u o u s w ith r e s p e c t to th e s p e c if ic is s u e ” w ill w e p r o c e e d to Che v r on ’ s s e c ond s t e p a nd a s k “ w he the rthe a ge nc y ’ s [ i nt e rpr e t a t i on] i s ba s e d on a perm i ss i bl e c on struct i on of the st atut e. ” I d. a t 8 4 2 - 4 3 , 1 0 4 S . C t. a t 2 7 8 1 - 8 2 . G ul f c oa s ti ns i s t s tha tthe S e c r e t a ry ’ s pos i t i on f a i l s on the f

i r s ts t e p of

the Che v r on a n a ly s is . A c c o r d in g to G u lf c o a s t, § 1 3 9 5 m (

j) ( 2 ) ( B ) u n a m b ig u o u s ly r e m o v e s f

r o m th e S e c r e ta ry a n y d is c r e tio n to r e q u e s t a d d itio n a l m e d ic a l n e c e s s ity d o c u m e n ta tio n b e y o n d aC M N . See M a xi m u m C o m

f o rt , 323 F . S upp. 2d a t1075 (a ss ert i ng that§ 1 39 5m (j )( 2)(B ) the pl ai n l angu age of the M edi ca re A ctre qu i re s th a t “a n y a n d a ll in f

o rm a tio n r e q u ir e d f

r o m s u p p lie r s to m a k e am e d ic a l n e c e s s ity d e te rm in a tio n m u s t b e c o n ta in e d in aC M N ” ) . C ontr a ry t o G ul f

c oa s t ’ s a s s e r t i on a nd the hol di ng i n M a xi m u m C o m

f o rt , the M e di c a r e s t a tut e doe s notuna m bi guous l y pr e c l ude the S e c r e t a ryf r om r e qui r i ng a su p p l i er t o su b m i ti n fo rm at i o n b eyo n d a C M N t o p ro v e m ed i cal reaso n ab l en ess a n d n e c e s s ity . F ir s t a n d f o r e m o s t, § 1 3 9 5 m (

j) ( 2 ) ( B ) d o e s n o t s ta te u n e q u iv o c a lly thata C M N i s the o n ly doc um e nt a t i on tha tm a y be r e qui r e d of s uppl i e r s t o s how m e di c a l ne c e s s i ty . S e c t i on 1395m ( j ) ( 2) ( B ) s i m pl y de f

i ne s aC M N a s “ af

orm or10

other docum ent ” c on t ai ni ng i nform at i on show i ng m edi ca l nece ss i ty. O n i t s f ac e, the s e c t i on s i m pl y doe s notc ont a i n a ny e xpl i c i toruna m bi guous w or ds of ex cl u si v i ty –S ect i o n 1 3 9 5 m (j )(2 )(B ) d o es n o td efi n e a C M N as “ the f orm ” or“ the o n ly f orm ” c ont a i ni ng “ a ll

i nform at i on ” or “ ex clusi ve i nform at i on ” of m edi ca l n ecessi ty. G ul fc oastfa i l s t o d ra w ou r a tt ent i on t o any other s ec t i on of the M edi ca re A ct thatst at es , or even sugg es t s, thatthe S ec re t ary m ayno tre qu i re thata s up pl i er s uppl e m e ntaC M N w i th othe rdoc um e nt a t i on. T hus , G ul f c oa s t ’ s a r gum e nta s ks us t o c ons true § 1395m (

j ) ( 2) ( B ) , ade f

i ni t i on s ubs e c t i on of

the A c t , a s pe r f

orm i ng a s ubs t a nt i ve f

unc t i on notde l i ne a t e d e l s e w he r e . A s pe r s ua s i ve l y r e a s one d by the di s tr i c tc our ti n M

a cKe n z ie Me d ic a l Su

p p ly, I n c . v . L e a v itt , 419 F . S upp. 2d 766, 7 7 1 ( D . M d . 2 0 0 6 ) , th e s u b s e c tio n th a t d e f in e s “c e r tif

ic a te o f m e d ic a l n e c e s s ity ” is a n unl i ke l y pl a c e f

orC ongr e s s “ t o m a nda t e tha tthe C M N s e rve a s the e xc l us i ve a n d f in a l d o c u m e n ta tio n r e q u ir e d f o rp r o o f o f m e d ic a l n e c e s s ity .” I n f a c t, n e ith e r§ 1 3 9 5 m (

j) ( 2 ) n o ra n y o th e rp r o v is io n e v e n r e q u ir e s th a t a s u p p lie rs u b m it aC M N to th e c a rr ie r . S e c tio n 1 3 9 5 m ( j) ( 2 ) ( A ) p r o v id e s th a t a m edi ca l equi pm entsupp l i er“ m aydi stri bu t e” a C M N t o p hysi ci ans, and then r e s tr ic ts th e in f

o rm a tio n th e s u p p lie rm a y c o m p le te o n aC M N . I n o th e rw o r d s , a C M N i s a n opt i ona l pr e - pa y m e ntt ool de s i gne d pr i m a r i l y t o r e duc e pape rw ork a nd11

t o s tr e a m l i ne the pr oc e s s i ng of c l a i m s . S e c t i on 1395m ( j ) ( 2) ( A ) r e s tr i c t s the supp l i er ’ s abi l i ty t o fi l l ou ta C M N i n adv ance , no do ub ti n o rdert o ensure that C M N s a r e n o t ab u s e d . I t w o u ld b e in c o h e r e n t to c o n s tru e § 1 3 9 5 m ( j) ( 2 ) , a subsec t i on re stri ct i ng the use of C M N s and cl ea rl y i nd i ca t i ng thatthey a re v o lu n ta ry , to a ls o m a k e C M N s th e e x c lu s iv e m e a n s f o rp r o v in g m e d ic a l n e c e s s ity . Se e al s o 42 U . S . C . § 1 39 5x (n) ( st at i ng thatP artB coverage e xt ends t o p ow er w he e l c ha i r s “ w he r e the us e of s uc h ave hi c l e i s de t e rm i ne d t o be ne c e s s a ry on the ba s i s of the i ndi vi dua l ’ s m e di c a l a nd phy s i c a l c ondi t i on” butm a ki ng no m e nt i on of C M N s a s p r o o f

o f s u c h n e c e s s ity ) . T o th e co n trary, th e au d i t i n g p ro v i si o n s o f P artB co n v i n ce u s th atC o n g ress u n a m b ig u o u s ly c o n te m p la te d th e S e c r e ta ry ’s au th o r ityto r e q u ir e s u p p lie r s to su b m i tm ed i cal d o cu m en t at i o n b eyo n d a C M N t o p ro v e m ed i cal reaso n ab l en ess a nd ne c e s s i ty . T he A c te m pow e r s c a rr i e r s t o “ m a ke s uc h audi t s of the r e c or ds of pr ovi de r s of

s e rvi c e s a s m a y be ne c e s s a ry t o a s s ur e tha tpr ope rpa y m e nt s a r e m a de u n d e rth is p a r t.” 4 2 U .S .C . § 1 3 9 5 u ( a ) ( 1 ) ( C ) ; see a l so 42 C . F . R . § 4 21 . 20 0(e) (r equi ri ng that“ [t ] he ca rr i erm ustaudi tthe re cords of provi ders t o w ho m i tm akes M edi ca re P artB paym ent s, t o ass ure thatpaym ent s are m ade properl y” ). If , as G ul f c oa s ts ugge s t s , the c a rr i e r s a nd the S e c r e t a ry ha ve no di s c r e t i on t o r e que s ta ny e vi de nc e of

m e di c a l ne c e s s i ty apa r tf r om the C M N s a l r e a dy s ubm i tt e d by the12

s uppl i e r s , s uc h audi t s w oul d be r e nde r e d us e l e s s . M or e ove r , w e r e w e t o a dopt G ul f c oa s t ’ s pos i t i on, the S e c r e t a ry w oul d e f f e c t i ve l y l a c k the di s c r e t i on t o de ny a ny c l a i m s o l ong a s as uppl i e rc oul d f i nd aphy s i c i a n–e ve n adi s hone s tor in c o m p e te n t o n e – to s ig n aC M N . A c c o r d in g ly , w e a g r e e w ith th e d is tr ic t c o u r t, a n d w e c o n c lu d e th a t w h e n th e M e d ic a r e A c t is r e a d a s aw h o le , it u n a m b ig u o u s ly pe rm i t s c a rr i e r s a nd the S e c r e t a ry t o r e qui r e s uppl i e r s t o s ubm i te vi de nc e of m e d i c a l n e c e s s i ty b e y o n d aC MN. H ow e ve r , e ve n i f

the M e di c a r e A c tw e r e a m bi guous on thi s i s s ue , the S e c r e ta ry ’s in te rp r e ta tio n o f its au th o r ity u n d e rth e M e d ic a r e A c t is p e rm is s ib le . S e c tio n 1 3 9 5 f

f ( a ) a f f o r d s th e S e c r e ta ry d is c r e tio n to m a k e d e te rm in a tio n s w ith r e s pe c tt o be ne f

i t s unde rP a r tB of

the A c t . 42 U . S . C . § 1395f f ( a ) . G i ve n the S e c r e t a ry ’ s di s c r e t i on unde r§ 1395f f ( a ) , a s w e l l a s the l a ngua ge of § 1395( m ) (

j ) ( 2) a n d th e c a rr ie r s ’ au th o r ity to c o n d u c t p o s t- p ay m e n t au d its p u r s u a n t to § 1395( a ) ( 1) ( C ) , P a l m e tt o a nd the S e c r e t a ry a c t e d r e a s onabl y i n a s s um i ng the autho ri ty t o requi re addi t i on al do cum ent at i on fr om G ul fc oast . B ec ause M edi ca re i s a“ c om pl e x a nd hi ghl y t e c hni c a l r e gul a t ory pr ogr a m , ” j udi c i a l de f e r e nc e t o the S e c r e ta ry ’s d is c r e tio n a ry d e c is io n s in th is a r e ais a ll th e m o r e w a rr a n te d . Sa r a s o ta Me m ’ l H o s p . v . Sh a la la , 6 0 F .3 d 1 5 0 7 , 1 5 1 1 ( 1 1 th C ir . 1 9 9 5 ) . AF F I RME D.