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OMB Human Resources and Housing Branch
Attn: Carolyn Lovett
New Executive Office Building
Room 10235
Washington, DC 20503
RE: Advance Beneficiary Noticc
Documcnt Identifier: CMS-R-131
OMB Approval Number: 0938-0566
Dear Ms.Lovett:
I am writing to you to providc comment on the proposed Advance Beneficiary Notice
(ABN), Document Identifier CMS-R-13 I. While, generally speaking, we are pleased
with the chaygcs made to the form and find it to be more user-frimdly for both the
provider and beneficiary, one panicular item has raised concerns.
Section (G),Option I states, in part, "I u~dcrsiaadthat ~f Medicarc doesn't pay, I am
responsible for payment, but 1can appeal to Mcbwe by following thc directions on the
MSN. Tf Medicare does pay, you will refund any paymenu I made m you, lcss any copays or deductibles."
The statement "IMcdicare
f
does pay, you will refund any payments I made to you, less
any co-pays or deduc!ibles" holds r u e only if the provider has accepted assignment on
thc claim. A probiern arises wth the fact that tht ABN can apply to both assigned and
nonassigncd claims. Undm Medicare's rules of assignment, payment for covered
services is made directly to the provider: the provider may collect only the coinsurance
and deductible amounrs from the beneficiary. When assignment is not accepted,
Mcdicare payment is made to thc beneficiary: the provider may collect tl~ciractual charge
for the covered servioe from the patient. A en assignment is not accepted, the statement
"If Medicsc does pay, you wjll rehnd y payments T made to you. less any co-pays or
aed~tctiblcs"can not apply.
P
I
AMERICAN
SOCIETY FOR
MICROBIOLOGY
Public and Scienfijic AffI5irs Board
June 25,2007
OMB Humxi R:wura.% and Housmg Uranch
Attention: Carolyn Lovm
NEWExecutivr Ot'ficc Hullding
Room 10235
Wasbing~on.1 ' 20503
Dcar Ms. Lovett:
Thc American Society for Miaobiulogy (ASM) appwciatra the opportunif).' to rcvicw
and rarnment 011CMS-R- 13 1, Centers far Medicare and Medicaid Serviws; Agency
Information Collection Activities. Submissinn for OMB Rcvicw; Comment R e q ~
published Inday May 25,2007 in the Pederd Rcgi~~cr,
Volume 72, Number 1Dl, pages
29322 29323. Thc A9M nppases the implcmcntalron of 3 generic. all-p?lrpow
Advanacd Renefiolary l4oticc (ABN)wlridi would replace t4e lrlmratory spec~f~o
NjN
-
(CMS-R- 13 1-L)implemented in Jane 2002.
The ASM is thc Iaqcst, s-lc life sciences society Wicafed the advanccmcnt of the
rnicrobielogicd scirncrs and rhcir apphcdbon for the comxon good. The Socitiy
rcpresmrs approximately 42.000 rniorobiolvgirrs. includint .scimllsts and screoce
adnrir~istrafmswrking In a variety o(arru, including biomedical, crruiroiunental, and
clinical labomory fields Many uf out members have primrvy involvement in clinics1
lrhratory mcdiclnc including individuals dkrchg c 1 ' i a l micrnhiolaey or immunology
lab~atariru,
individuals Iiunaed or accwiitcd to perform such rating, jndustr).
rrptesenu3ves marksing products for uu,and re5earc:im lnvohred in dcvcloping and
evaluatjng tbc perfonnancc of new wcbnologies. 0x1clink4 l a b o ~ ~ mcmbcrs
~ry
nrr.
involved on a day-to-day baslr wid1 testing p~occdutesfor many :nfcc~~om
and
irnmunoIagic diseasca, rncludlng procedures baled on molccuhr diagnnstic tedmques.
Mnny of tllesz proudu.rc9 arc ravercd In existi- National and Local Coveragc
Ikcisions. Ihacfore, ASM members have a signifitam interest m ensurine that any
revisio~~s
to mlrrmr APNa bc noccssary, reasonable. and convenlenr for urr in a variety
l~bomoryseninss. F N e r , rhr wl~~plcxity
of lahnrstary lncdicinc renders it exatmely
i m p m t that ABNs for hboncory ~ervkcsbe dcsigncd ro cxhatlce beneficlay
understrdir~yof reasons for denial of'paymcnt Ior services.
The A9M he%
not holicvc that the elimination ofthc laboratory specific ABN will s m c
bcncficizry intrrr~t?lFIJIwn~plcxinfectious and munologic diseases, it Is not the
laborato~ywhich nolrIdes thc bcnef ciary a b u t tlx n i c d h l rafirmnlc for tests, t a t
pocdlms, md pnrrntial m a n s for non-coverage of t e s ~ .I m e a d the ordt~ing
physician or other authorized provider is responsible for this notification. The current
laboratory specific form clearly identifies the reasons for the denial of laboraiory tests as
one of rbree categories: mcdicd necessity, frequency, and inwsrigational/experimmtal
status. This allows an important distinction to be made bctwem laboratory serviccs and
otha rncdical sewices that is morc understandable to beneficiaries.
Furher: the ASM has other questions and concerns regarding the generic ABN proposal.
F i r s it is unclear whether there is a new req~utementthat laboratories acquire an ABN
when serviccs are never covered due to regulatory interpretations of Medicare statute.
Second, CMS has failed to give any reason why it has been deemed neoessary to
eliminate t l ~ claboratory spccific ABN which was discussed and agreed upon by
stakeholders in 2002. Third, laboratories 111at:have implmmted the laboratory specific
ABN (Form CMS-131-R-T,)will be required to make expensive and time consuming
adj-ents
to information technology systems, as wdl as il~vestsignificanl time and
effort in educating both laboratorians and ordering providers about the changes in the
ABN process, should the general, dI-purposc ABN be iinplemented.
In conclusion, the ASM secs no benefit to h e elimination of the laboratory specific ARN,
and in hd,foresees significant issues with the removal of this ARN and its replacement
with a generic ABN.
Thank you for the opponunity to provide comments
Sincerely,
Vickie S. Baselski, Ph.D.
Chair, Committee on Professional Affairs
Public and Scientific Affairs Board
a C3
KT-09-2007
M
6
.
FD
DMBlD IRA
14:25
1V2@2
395 5167
AMERICAN ASSOCIATION OF BIOANAL-YSTS
r ~ ) 6O
t i S~t r w F
~ ~ ~ i1200
te
Sa~ntLouis. Misw~rri
63101-1434 Phone: (314)141-145
~a:(j
14)241-1449- F-mail:asb&ab6q-Wb:-nab.orp
JUW 25,2007
mttns for W i ~ a r &
c McdiCQidS w b s
OfFirr af Stmtegic Operations and Kegul810ry A&?irr;
Division of Regulat~onsDevelopmcnr - C
Attenhon: Bonnie L. Hiirklcss
Ruorn C4-26-05
7500 Securily Boukrilrd
naltirnore. MD 21 244-1 8.50
RE:
Cammcnts on Revised CM8 Advaacc Beneficiary Notice (AH:*$)
Dear Ms.Harkless:
7hc Amcnarn hmcialiu~iof lltoan~st6(AAB)
-
r Mtionnl professional awrciation w h e
members arc drrect~r~.OW,
m m m ~\rpecvi~ors,
~sx:hdogista,4 t e c b i c i r n ~ in
c~m;muPdryclinical Lhmtonts r c s p d y submits the followirqj cummat* nlnfing to tbe
May 25, 2007 notice for additinnal public commiwt on the m e d Advance Bcnrficiary Notlee
(.-If) (CMS-R-131). We welcome thc oppamarlry tn p ~ ~ nwith
t t thc Centers for Medhxrt &
M d i w i d S w h (CMS), other Iaboramriang pmvidm. 3rd Medicarc ma in seeking to
devcltq-i and implomart Ihe most cfkctiva ABN and a-iated
insaucdonv h
r all rclcvm
stakcboldcn.
-
P r o p instructions for ABN u e arc esrcntial In ordrr to c o m m w the possible denial of
Modicam covcrqyz In kncfioihes fn rhc mnst cleat and ooncise hbiun pnsnblc. BsneGcim.es
alv, need and desorvr siguificant d v a ~ ~ nodce
c e abouf Mcd~cancoverage tu allow them lo make
an informal dccmon about whether tn p c c c d wib a partirulnr eounc of medical can:
We arc pleased lhar CMS dccidcd to keep a s p i f i c ALW for cllnical latrxaMv services.
However, we conhnuc to have othu specific concerns about hnotice.
Fint, AAR w d d like to cxprcss r m n c m wim dre additiun nfanoihcr ABN, bringing tbc tdtal
number of opfio~~\
to t h r c ~ .M B ' s kbtoric~
&cn serve paticuts whn haw their blood dram
1amthcr outpatient lbratoxy. Ir rs &b1e
a p o l b laborabry might we a d h t vmion of
the ABN. This .Lrcady hjs caused conhion orwng bene5chrics who do not uaderokd d y
t h y are 6rJng a new and M e r e n t ABN. B y d i n p : o rhtrd ABN, s w x n d "gcaedc" onc,
hent is the possibiliry of e v m furthm confusbn
Sccond, the w labtrratory and generic ABN firms do mt pmvidc crdliautt Bpzce fir I,
labmatory to list dl of Lhc @st5 that axe wbjm V) Naricmal Coverage Detmnhaticmwrs rNCU9'3
P. 06/23
Cov-ge. Dmrminujons ("LCDs"). Tbc. c u m l lalmrad~ryABN provides enough
h r a hhrahy to h t all of the NCD or LCD rests. Having, tbem l h d allow s t d r lo
aimply c k l e the NCD d u r LCD test whcn tbc racdid ncccssity does not Buppon the test
being ordeed. Filling in each of the mu, bowcva, will create an unnecwsary and t ~ m e
c9mM1rnine.+- Add&g more 3 p to h e form to allow iar all NCD add LCD tcs& b be Clarl
w o w bt a r ~ p imp*exncnt
r
to the ncrw l a h m d q and gcneric ABN firms. We belleve that
this is an imporbt point due 10 the fact Lhaa covenage detcnninnIions affect thc rcsulB of an
and
ABN.
W, AAR ~rmmmendsthnt CMS ratore the heatline Pm the NCD tern Lhll havc hqua~y
p ~ r ~ m n
in et
k
~ l a b r a t q ARN f k m and add it to the ntw gonaia hBN form The old
l a b o r o t ~ABN
~ ~ included the hendiry "Medicare docs not pay fbr thcx tm w otkn as this
(dcnkd a*tno kqucnt)." CcRain tests, such ra rhc Wemogl~btaAlC,are coddered rnedirzally
necesury by M d i v a t to be pc&nntd only cmcc cvcry three months. In msny cases. a
laboratory hos no way of howby how many ttncs Ihe p t i u ~ lt m ~r ~ ~ r i the
v d tcd In the part.
Sincc the @art
may have jlready mtt the frequency paramnar without the laburdbry',
Icnowlcdp, tbe labordr~rymay not bnvc him m her sign an hBN tmd uili end up paying for the
tut. 'Ikh d i for the NCD tests pmvide~a simple expl~tiurrTO thc Whrc benetie~ary
cbal ~ Ltest
Y hnq kqllcncy
that might not have b u n mn yet but if they have, rhe
bansflcluy will be r q m ~ i b l l efur payment.
F w t h though CMS claims that thcrc will not be a c a t ~eockredwith both new ABN fonzls,
&om will be a ~ ~ a gs f ~ o 4th
c ~W
g stafl b undcrlrtand and nrtficidy explain the new
AAN fbnns to Medicarc kncfioiuies. While AAB epprrchcs CMS' w i l l i i l r s s to ensun thtt
t& wmcmms of d ~ clinical
t
l a h a t a y community arc mat, we are not convinced that rhat will
be a signifimnt p i d v e ourcome fur paticu.~by creating dthcr of the new ARN forms.
F ' d y . AAB bclirvrs thrt thnc should be A n acc~fionf i clinical laboratories h m the ABN
roquircrnent Clinical labomorie~are unique &om other pro~tlen:ba;wre they do not or& any
woo they must be odered hy the trtating physician. Thanfon:, rhe labmawry has no scoess to
additional informadon at the time of s a v k . While AAR appreciates CMS' rccogmhon ot this
with a labonly AUN. thc fiwt thot labomark sre not in the same utqq cu: physicians or
0d-m provikn rantiru unarldrr?isul.
-
AAR .W&y
to work with CMS and ofbsr nakeklders to ensure that bolh
clinical
labomtory ABN and its associated in.structions meet thc llccds of Mcdi~arebonedkiaries,
pvidcra, d e r s . d hb~naorirnaIf you h v c xry quediou a h l t o w mrnmcntq, Hcax do
ml bcairrtr:[U wntact us.
Mark S. B i r e n h q PhD
Admimsaator
P.wl E r w . u ' L u .
Collcp of American Pathologisrs
-
323 Waukrgau b a d , Norrhbeld. lllinois 600932750
$00-3234040
1anp;rhuurrrr.ay.org
Aduanring EccfpLLncs
OIVISION OF G o V I R U M ~ N T
AND PRaFE3SIONAL AFFAIRS
1350 1 Street, NW. Suate 300
Wxshington, DC 20005-3305
102-354-7100 FSZ 202-354-7155
-
800-39t99Q+ h n p n l ~ w . u p . o t ~
June 22.2007
Connie Lawen
OMB H u m Rrcources wd T3owing Branch
Nw E x r d v c Offir2 Uuilding
Wuhiagtors D.C. 20503
Attention: CMS R-131, Room 10715
.lM College of Arrwvxm Pathdogit& (CAP) approciabs the opportunity 10 wnnrncar on the
proposed c h m g ~to the Adv~nceBeneficiary Nonce of Noncovera* (ARN) publiqhcd in the
Mxy 2s. 2007 Federal Register. The CAT is a nrtirmal mtdic-al vecidry swciely reuresentlng
more than 16000 physicians who pncttce allatomic d m clinical pathology. CAP manbcrs
practice h i r specialry in clinical kbar&cricc, academic m d ; a
ruearch lahcuatories,
cornt~~urrity
hc byizals and fdwal and slate health facilities.
Medicaid S a i c e s (CMS)is pmposmg a number ot Fevisior~st o the
conten1 of and insmxt~onsfor Ibe AB% fum. In rhr suppo&~ st.dt~mcntCbfS clvified 607'11.~
t m c d t i e r tcgarding thr use of the new fonn; hnwcvar, CMS failed to address the e f f a of
now mandate to include n arst estimate for physicialr-otdcd labntatofl tests. 'fie CAP is
ooncmrd that rhe w form mndatcs tnclusion of an estimated cost instcad of n u h g lhr
infcrmsrlon optional, a is he ourreat ruIe for 1ablrator-y t e s k Thc CAP aks CMS KOwnfinn
rluc the inclusion af an sszkr~atcdcost f u ~lrrhoatory tcsttng is opdond and that the lack of an
~ ~ t i m a tcast
e ~ l wauut will not invalidate the ABN.
I h e CQlten fir Medicare I%
On rhe orrrenr ABN-L there is rlo column for F d t e d Cost, nlher, t h m Is lice further d m ~ .
on the fmfor esdmatd costs. Completion of this line is optional. Por the current ABN-J form
CMS pmvzdes drt Ikllowhg iustruaionr
.
"The user mag provide rhe pa~icntwith ~ X u
L timreJ. cost of the ilw a d o r
pan'en~mqy ask atout the cost wd jot down an nmounl in this
spec. Usns should respond to ~ u c hirqruncs ro ?he b a t of Ozeir abilfty. nre
lark ofan amorant on chic line, or an ;uUo~rntvrhicii is diWerem fiom the fiml
saviecs. The
actual wa, docs nor irrvalidare the AB~'."'
7
-
Mcdicara China Prwrr;eing Manuel.
CMS Pnh. 10004, Cbrpui 30. Scdon 50.5.7 (empbrdsadded).
Connie Lovdt
kne 22.2007
Page 2
The Form Iaatnrotioos released +th thc n w obmbiacd hm state for thC colum~for E s b t e d
Cost &at1.1"must ~ l l f ear cost estimate in Ws blank" (emphasis -dded) Thc inatnkctirn To
thc new form c l w l y mnke rhc cost esfimue a mandate; howcucr. C M S bib to adrltcqo thc
implication of a blsnk line or a discrepancy bctweent%e eshafed nnli aaud ooct
btc ledtimarc scrwns why n provider m y not he Ale lo include pn h ~ r cost
3 fm
laboram~yt ~ s b ~ ~
For
g ,exmple, au ordering cliniohnmy not have rrdily available a m m ar
wmplete c k u d lahnratory fee schedule. Moreover, thc cost e l e m m of cumplex non-routins
testing may be difficult lu estimate. The CAP lbk6 CMS tu makx column for
chdm3ted costs
optional far labcuatary rating services ancl to ccrnhnn that rhe la& of an e3timdcd 00,'t m ~ o ~ n t
or a discrq;uwy bctcvecn the edmated and acn~alcost3 will no1 invalidate the ucw combined
Term.
That
The College of American rxthologtsts ic pleued ro h u e the opporrunity ro cornmeid on these
cbangn and appmintes your cunsiderahm of our comments. Asly quwbons r t p d l n ~ the
:
oommeau &auld he d j ected
~
to D o m Meyer at 2 0 2 3 5 6 7 1 12 (&m,y@_cm).
Sincerely.
\
I
?BY Old
I
CLM&
I ~ E ~ C $ ~ V .FIW
L Cm R A l U l H R
i
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II
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Fagk S c m l RQ., S Jlta e 1
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Wq(r6
td ~ L 1%
995
U 19087-1704
9500
IFJJIDML~
fat 610 9% V56U
w.clmaq
UMB nc* O ~ U
OMB NIIIW
fWourctx and Housing Bt~anch
~ttarrion:C A Lovtn
~
NGW hecutivr Office Buihlitlg
Rmrn I @US
Wmhington DC 90503
nCar Me.bvctf
I=half of CLMA, the C l i n i 4 LPbordrory Mawgment ~rrSOcia[h,an
r\\iooals snd m a u l u n U
organimhon of more t h n 4,300 clinid labor&ry prof..
r e p n r a ~ thospitals,
.
independent cbniwl labratorits, phyqicim off^^
Isboxs~coier,skrlled nursing faclliu't.s,and m e d i d drrice c w i l p n l a , I am writing
in Fcspme tn thc May 2tr,h, 2007 Fukral hgi>l@ri ~ ) t i ~"Agc~rcy
e,
fnfom~ation
Cvlltction AGritics: Subtnbsion for O m Review; f-dnt
Rul~cd"
regar'ling thb Advancc Bendcjay Notice ufNollcovadp ( A m (mS-KI 3 1,
OMB:0978-O566)
C L W appreriatcs the iralusion of the summcuy of changes dor.!rmentin the
peckcr anachrrl a,tho FeArtat R c g i s ~ ni~ticc.
r
h was vet)' uscfiJ in dctrmrinirlg
whc~r:wc needed Id, focus our atrmdon whm rmewing dlc rcvistd Sons a d
mswctionr.
C1,mdots rrut have any ddrtional wrnmmts on thc brms and instructioas
dmnschcs at tlix time. wqrt to poim or\+a typ0-phic.d m r in the second Iinc
of Option I.
mtcnce cumttly rends "You may cullcct money b~rn
me now,
but I alvl I. want Medicare billed for an oficficialliccision c~npaymmt, which i s sent
ne
to me on il
Mcd~wreS t r r r t t n ~ r yNotice @ISM.''
this churlgc.
CLMA would likr ~ fcommer~t
i
nn the burtkil asociakd
s t a d in our first srt of commcnrs, wnenrly aany laborabrics and hospiU uusr
automad intormation .prstemt to J a c t wen an ABK is nrLwsary md d m will
ptlnr W! f u n with autulnahoslly ~n\cltedi n f o h o S~i m that s y a m are XX
up uhng rhc f o m r of the pmlous M N fonn, chuoe;ri w ~ l need
l to be msdc in
uricr ta arcc~rnnlodatcrhe new toms.
L
202 395 5157
pB10,23
I R E R I J O U ~ fQL
C U00W7OUfP00CE6SIONkLS
I Althmeh
I
II
9e9.01r4Fagle School Rd., SGtc 815
Waype, PA 33W7 1701
ii?l &LO W5 9sa3
fdx 610 995 OhhR
nwrr,cIma.org
rhc rcviscd forms baesd on the fisr round of public comc11Lswill makc
thin kansition easirt., tl~cindustry will still require 3 Wce or uvlsitiun puiud of
cuffjcicnt lengrh in nder to ~ n a k
cl~angesin thcsc ouloma~edsyrtsms, andlor for
amputex vendon u, make k s c chrngex. Ftam our n~unbcrs'cxperionm,
chrrngcs of this nsnus require signif can( rcsolrlrns ~ n r extendcd
l
tirnciimes to
inlplcmurt. Labotatory infrnmntion s y s m u e so divcrvc drat wz cnonnt ~ g g ~
to CMS r ylwilir: irtncframc, but urgc thc qenoym seek Input from rhc idustty
on this issue ard s d .I, iic~~lcn~mtatinn
timefinme that E reasonable b e d on the
informotion provided
In r.lnsmg, C1,M.A app~ci4testhe appomity to comment on ~hr:new' ABN form.
In addilivrr, we v v y much apprccintc the e f f m of CMS and irr staffin
~ccomodatingour s u ~ e s t i v ~aud
l r rcrnrnmcndations far the form8 md
insbruuhons. Our members and staff stand rrn~ly I aawm any questions or
onrx.mr that yau msy have regardingthese comments.
Please conurr Kmharinr I Aytrs. CLMA Dlrcctor of Lcgislntive and Regulatory
.Whirs. st ka~siiP.clma.orgor 61 0 995 9510 %r M u assistance.
JoAnnc Millntlrn
President
s t
OCT-09-2007
OMB/O IRQ
14:27
202 395 5167
COUNTY OF SUFFOLK
STEVE LEW
SUFFolK M I I N T Y CXCCUTIVE
DEPARTMENT OF HEALTH SERVICES
Jur 11- 14
2007
CMS. CbMce of 5lrc.ltagic O~erotionsand Regululory Aifoirc.
Unlsion 01 P.egululir.)ll\ OaveldDrnent C
Attcnlion: Bonrlia L. H n d ~ . t
Room 1 ;26-05
~
7500 Sccuntv Blvd.
Ealtimore. Maryland 21 24d-1850
Kcf: CMS-R-131 ABN
Dear MS.ha me^^:
IWOIJM
bke to takc this oppo~lur~ily
to moke the following comnler~laabout the newly drotted Advance
Eant+fir.iaryNotice of Noncoveraya [AEN). of which comments we beir rg orceptrrl until Junc 24.2w7:
we wnl~ld
Ilk6 to :ee one (1 ) lo1I11with I nhoratory and General combined, sl!~cificallyLoboraton/
r~nclServices a; tor Physldan Services.
2. The Sl-~nirh
version: :howid come out sirr~r.rll~~~~-~acrusjy
with the tnqlish venlons.
-
3.
The USMI-Cusfnrni~cble
bcctions on poya 7 ul )ha Pnrt-l Instruction$for Carners PhyGt~icicI r I* c~nd
Suppliers i r ISar.iion [. number 3 :hould have u clearer cla~cription
Ot what Can be CUStc~rrrimr-l
I-JY
tne phys~cior~
it1 r+fars17ce
to the ncwesl drafts.
4.
We would recurrli17endt h e Coniidcnt~al
Statement lanyur.rurt ha put back In a in the dder fotrr~,
5. W e would like to krww ll'edote or timelramc of when the lu11i15
will he approved ond ready for
USC
Thank vou. and rt vow
woulcl like lu ~~517t1-1cf
me.I can bc reached W ernalt.rl
.. .
Shdlie n w ~ r l i nMPS.RHI&CPnU
.
. . Medic; ll Records Admin~strator
Cc.
OMG Human Kesources UIIJHousing RmncR
Atfention Carolyn Lovett
New Gtccutive Office Bulldlng. Rw .i1 10235
wclrhington. UC 20.503
. .
F a x # (2021 3W6974
DIVISION OF PATIENT CARE SERVICES
225 R O ~0
N1 ;East.
~ I (auwa~qc.NV 11788 (63I) 883-3313 Fax (631')852-3031
P.12/23
Pancat Fmm& Sewice
P.0. Dow I47
Minneapolis M N 55440-0147
(612) 6726724 Fax: (612)472-6727
June 21,2007
UMB Humon Resources and H o u i n ~Branch
Attuuinn: Carolyn Lwctt
New Exu;utive O f i r e Duilding
Hoom 10325
Washingto% DC
Ro:
Fednd Register N d c c (72 FK ,NO 101,pp 29322-29723May 25,200'1 CCMC~~.~
for Mediaare sad MedicLJ S e r v i r . ~nepartmcnt
~,
o f H d t h and KUWI Serviceq
Rcvisjon of A d v w Beneficiary Notiu. of Noncovmge (ABW. Document Identifier
CMS-R-171 OMD 0338-05 66
Dear Ms.Loven;
Fslrvlcw Hrdth Servirm, which hss seven h q i t a l r in MLulesot~,wishclto thank you
br the oppomrniry to mumel11on the proposed d m g c a to rhe Advan- Beneficiary
Ncllice. Uur comments &reac bllows:
Sample U Lab ARN.
Lab pasomel prefer rht currcm La11ABN tormat s,it allows Ybr more cusbmizatron
It
Is felt that the proposed fbnnat d m nat &w ottiidcnt space to c u w fbr a11 of the
various Irrlv for which t k r c is a Medicare covmgc is%+ even if there u a font change.
Without havlng thir prqtrinted, them wll bc more ~xcbptiondab Tor Lab t h : and
pannnd to look up, which is a hinine issue m d wh~ohlends irseff tothe psdhility of
m
ts The proposal hrmm will mean mwe up front wnrk. Thc crusting forinst allows
bb to be more timr: efidcnt, while still amring l h the pauent ge+s?he c m d
information.
Samph G:
this is the ppreEkrtd fonnai far
d o c s a h a than lab. The other fm is too bagy nnd cluttered, and the srxlunent
"i~rm
or scm~crs"describes what will apprrr. ;II itan -I)". '1-beywould pro* ~t to
have wuther items tn fill id.
T k conrenvur of most d t h c poople responding ib
Gacral Comments:
if xelectcd, tctls us not to bill Medicare. In ~rurlyi n m c e ~
a sccondazy payer
whnher the provider hills nr lets thc patient bill the payer wiU rarp~irethat there bc a
dental fromMedicare before they will consider thc claim. We could pur a norice in
"dditional information"that ape& 10 this, however the concern is tbot h would appear.
rhar we arc leading the patient to choose option 1, and it has a l r d y hem stated that "we
Option 2,
-
-
Cammerns m CMS
Changes to the Advance Beneficiary Notice
cinmt a b u a box for pun. Since some providers &I n q not are thEy rcquir84 to bill
the mcondary gryM, Ch$S muld still add la^^ regarding this rului.remcnt, such ns"
Note: if you have a ~ l h ainuunllce,
r
you should ehcck to see If they rquim a denial fiom
MrAcarc: before considering your claim". Then when the patient rcvicwb rho 3 options,
he or she will h o w that if they o h o m oprion 2. they may not be ahle to get paid for thc
sewi~t)
by the toconby payer.
We would a1.w like to point out that should the padent cluinae option 2, $this is one noncovered item urnon$ many other tests, particularly in 8 h u e hospital-baceds n i n g or
Large olinic a*
It will be liniullr to pull out one tst m not biU to W i c u e . Also, if
we are ahle to do this. lt h
a bmn our experience thnl tlir paricnt will compare rhe
h a q i ~orI diaic bill to the MSN, ~d t a &will w t c ~ 1 1 that
s we hilled hc~ncotly.
rhey do not remember that they said thy did not wanz something billed.
Nulifier: In ?he1nstrucfioa3, C M S indilhyl w~ploycesor ahcontracb32s of the
hoti6~
may deliver d ~ eABN. 'Ihe concern is t
h same notifiers may delegatt this
firnation to someone who is not qualified u a w t r paticat quesclons. Not all uxiyloyees
or nibcontr&cbmare dinical stan. We believe that ifthe notificr delegat@ the delivery
of the ABN, it must be ddegatd to other aaffqualified k, w w e r a ptimt'r qucsnoas.
ortbu wch qualified ~taff'urthe nntifia be avaikble tn the tvtm that thne are qummon.c
OQer: W e like the plain 1;rn.qusge and the st&lrmcnt "we csnnat choose a box for you*'.
Thank yoo for the uypomlnity tn mmmcnt.
Corporate Officc
400 Stinson nlvd NE
Minneapolis, MN 5f413
Univcrsify of Mi~eSOtaMedical Cmer, Pairview
Fairview Scn~thcinleHospdal
P W i w Ridgw Huspital
Pairview Northland Regional Hospirirl
Fairvim Lakes Kegional Medical Cemer
Fairview Red Wing I'hspital
Unher~kyMedical Gnla, Mesab~
8/61 N. ~naumuIUI
i
- -
nuau
Fax 414456-74 1 1
[email protected]
CMS
O U i of Stratdd~
Opxati~m~q
and Replawry AfFain
Divisian rrf RcslPfion Develnp~nmt C
Attention: Bonnie L W e s s
Room c4.2605
-
7500 Sccurjty Boulevard
Baldmare, WD 21241- It50
- A h n e e Bcnefitiuy Nt~~icc
of Noncovoratpt (AIIN)
h rerpns+ U the call for c o w m publiGbed in (heF e w bgistor on May 25,2007, we Da
f c c - p ~ d ~ l cubinitting
fy
ramark reyrding praposed c b a p e i to tbc ~dvaoccdk e t i c i n r y Nari~s
Xoneovamee (AB(ABN).
We cncomge CMS to c l w that wllen an ABF is pmvidd under m sxreptiun to
the probibition of routine AEN5. the claim r~ecdnot bc s u b m i d ro CMS, and IO r~roipfnircnkcmatke
drlivcry means for ABNa.
I>rrcot Supply Equiprncnt IS the narinn's !uzcst supplier of dunblc med~crlqu~ymcnrto the US loug
telm wc profwrioir. O u r corc business is provldmng equipment to ck~llcdnunkg facilities. assisted
ltving centcr~and ~ntiurriogcare reriremcr~~
cornmunill~for rheir roe in providing ccue to their patients
and w s i k r ~Occ~s~onnlly,
.
often at tbc requost of our lmg tonn cart provider cwtomarq we also .tell
products to co~~wxrtcrs
through strictly private-pay fxoouctions. Wc am a v i r l u ~dimibutor
l
of eqidymt
and we neither owu nor operm any nole fronts, warehouses or imnufacturina kilitics When s
cuqtomn ordm a pmciuct, we emm rhe I I L ; ~ o u ~ ~ C Mwho
Q
then dmpships !he itan w our cuscomn.
The purprw of'thc~dvmcedBerltficiary Notice of Noncmeragt is $0 inform tltt censurntr that products
or M c e s dwy A r e about to T ~ C Q ~nay
V ~ n o t or w ~ l a01
l k p i t 1 for by Medicare. nris a l l m me
contrd
n u d e r TP* welid OM8 oenwnl munba br rhtr inhmn8libn eoll.cuun h 69314rM Thr c;mr wqused w m p 1 . u ?Iw i i , f o m d w dltuim is m m + d w
8Ya17c 7 mlnwrr ~YXNPOCU.mdudint t
h EmC io revle* ~sSm.Mm~s,
r a d *rluinc jyr m s n u m , d v c r the d m I>&&
md
md r w i a hr
infmm~runuDrnim U MU hs*c mmmuvu ernc:mlne ;ht w r w y nT.hc t h e usmale or r w i e m : m im@mvm6%# bnn. -6
-HI (0: Cm.1.M
Stsvriw nnuL.rstd. .\on.
Rwen ~.'tzars\cc ORinr. Bv1rti~~uc.
btq18nd 21zw.1
UO
~ o r mCMS H-L?II
SAUFLE G
~orm
ipproved
c
m-
OM~TGX!~S~-OS~~-
;is Scvcl:slr Sv?
I*%
2;L!ljd ,-9559
r~c
Janr:
E high
€ i u i w L.I~MMP
OM3 IfurnanRwurces and Huuuinc Drench
AUn. Cnrolyn 1.ovc:t
New Executivc Oficr A~lilding
Roam lUZ'335
W~uhiri~rc~n,
n6 20503
1'Re llcspice m~ciauon u:.4rnmica (HAA) is a national orya1i~aiin1.r
represen1il~gl~osplcesand their thousands ufc*lrce;lvcrs From ~ C ~ the
S Scuu~~try
We apprec:ate Lile opporr~rnityto conlmenl on the Cmtw ~ I I Mcdlcuc
I
Sc
Medica~dScrvicss (CMS)proposed L ~ h a t ~ Collection:
on
Advancc
Brne5ciary Nl~t;oeot Noncoverage (ABh7). Vnclrr CFR. 41 1.40qb)and (c) mJ
4 1 1.403(d)(2) and (0a wr:iticn nohcc is reqMred To be provirlml tc-#inform
ljn~~cfitiztlts
in dvnnce of potenhi ]lability for peynlent.
I rndcr Section 1879 of&= Social Saunty Act, a physician, provider ,~miAihoncr
or s1.1ppli.crnf items or services pmicipntlny iu thr. Medicarc Progrm. may bill a
,Medicare beneilcizry for il.ctrlsor 3crviccS usually covcred w l d u Mrdrcarc. but
Jeilirrl In an individual case undc; sPecifir. 3tatutory cxc:ufions, if they infircru th;
beneficiary, ~ r ioi.
r ;n fimishinz the senice, I b l Medicarc. i.c likcly to deny
paymenl.
HAA ~uishc~;
1'1 ll~ankCMS and O m for their e l f o ~ l ntn mnlcc thc new fonn
easier to under~tand.W c alsrr apprcuatc thc p l m e d aansiliul~p c r i d . 'Ihc
ofticia( 11fIcchange to "Advance Barieficvlry Notice of Noncoverat;e" is hclpfirl
in convty5ng !hr !~l~r;msc
o t thc notice, It is anticipated that TTosp~ccswi!l
infrcqucntly have the need to use fhc:ARN, flowcvcr, we believe the butdm fnr
hospices 1s gcatcr than csdtnated,
A t nafcd 111 the lunificarion, "3. hlp~c.)vcd
lntbrntatiou Technology, AaNs IT*.
vnuxlly y b e n as hard copy noti? during irr.-pcmnn paticnt mmur.Lers." For
inpalien! setrings, tlusliices almost aiway must explaa euvrtagc ~SXUES to
nr.\plcnuof the Medicare hospice bn~ufitand their familylprimary c a r e ~ u r r .
The rs(iolard M r . tor this is about 20 r n i a u ~ st, cxplain why thc sewice
rcquectad would not bc: c:over cd by Medicare. ;he purpose of lilt A H N and thcir
(C~:-Y& 1q-
Again, w e thank you for Ihc q?portunib tfi comment.
,'
J net E.Xcigh
a
GREATER L A W E T T E
HEALTH
SERVICES
Home hspflal H m HwM Care
S t (:!ere Hone Healb C3m
June 72.2007
Ccr,tcrs for Medicare & Medicaid Services
Uepanmcnt of Health and Human SLPJCC;
XftcnrionCMS-1 54 l -P
P 0 hx8012
Baltrmorc, M D 21244-8012.
Ks:CMS-1541-P Medicare Trogm; Elvlt~cHcnlth Prospective Paynienl Sys~cm
Kcfinc~nenrand Rate U p d for
~ C:nlcndur Year 2008
1 apprcnrtc rho ucpnunityprovidc comments on the proposed n~lefor rctinemm~tof the
Homc SIcitlth Ymspectivc Pnyn~enrSyslcrrl (1'15) and d ~ I-ate
e upda1.e for lnOB that Was
prlblishcd on May 4, 2007.
Dtcrewe in St~ndardRate:
My tirst wncwl~is llrc mcumption that the obsc~vcdincrease irr cjclc mix wcisJlt is due to'
behaviural chtu~gesby I-IonreHealth agcncics nnd not to an mcreaso in patla! acuity.
Thc Homc Call? indwlry has spcnt mony hours and rcsourccs developing ;lbet!@
undc~staridmgo f 111sOASiS tool arrd tl7.e cxpeclaliolls nt'Lhe OASIS s u t h m and of CMS
m completing the tool. Tl~ctc3ultiny increa.%cIn c s o mix is a rcqult of improvcd
cduaf.ion resulting in vnproved uarracy Gorubinrd rviUl an inarrsc in aeuiry of trclmc!
care patin~tsmtdcnced by decreased hospital lmgth nf stay lor m y cornn)nn home care
dia~~xosie.
an incre~sein nulnbcrs of putienar nerm in homo carr with rur$icr: wour~dsand
an inc~easein patients rcqulring rehzbilkfivc t h e r ~ rnvices.
y
CMS has implicitly
~cknowlec1ge.lthis lac in findirty it ncccscary to pcnali~ehosp;falsfbr early di~nljs~al
to
homc mrc m their DRG payment lor sclccted diagm~is.AddIUomlly. :hc limo p@riurl
\lacd G thc basts lor cornpictison did naaC lvlcc into occoutit ~hxtprior m the
i~nl>lcmcnt~tion
o11hcBalanced Rudgrt Acl or 1997, venlpuciure was o qudifyiny skill
for homr. health care r t ~ dmany parirnts who qualified firr home care uldrx the
vcnipucwr benefit reccivcd haine hcilth aide t ~ l c c as
s the ]nos intense rcllvk~.in acir
home c a e delivery. rllc decreafie in honx hcsla aide .service$ ltur is rilcd as one
justiti~itiorlFor thc finding that the case rnix wc~yhlincrmsc: i s nor clinically drivcn is a
rvs111tof rhe ve:rip~r:iurccxclusiu~j,
and nor "gamixig". The "finding" rhal: the majority of
the incrr;sc In cat mix weigh1 is duo Lo flomc hcnlrh a~enricu"g.adx~g"thc aptem j s
r-apricious md gunidre to an iadl~~rry
ths~h a ken grear pains ro lcam what CMS
t w p e ~ nof it jnrl iu comply. This j~tsl&rncnt
is aot cunsixtcn! with rhc accompanyi~y
-
-
-.
Home Holp~talHome Healrh Care
7415 Galam Slrpcl.1. S i l e LQ2W
Lefayeue. IN 47904
(785) 449-5046
Fa* (766) 4 9 - d l P2
-.
.--
.. -
-
-
St. Clam Hame Ue&t~C a e
.
1630 LaIayeno Rd suite 1UO
Cf3wfordsville. IN 4%3
(766) 3t24114
C J X (765) .%4-8779
TOTRL P .23
LABORATORY, INC.
10114 Woodfield Lane St Louis, MO 63132
(314) 432-5030 (800) 737-5030
June 22,2007
Centers f o r Medicare & Medicaid Services
O f f i c e o f Strategic Operations and Regulatory Affairs
Division o f Regulations Development - C
Attention: Bonnie L. Harkless
Room C4-26-05
7 5 0 0 Security Boulevard
Baltimore, MO 21244-1850
Faxed to: Cardyn LovsW (202) 395-6974
RE; Comments on Revised CMS Advance Beneficiary Notice (ABN)
Dear Ms. Harkless:
Our company, Biological Technology Laboratory, Inc., (BioTec h Lab) is a regional
laboratory serving over 300 nursing facilities as well as many physicians and outpatients. We respectfully submit t h e following comments relating t o t h e Notice
dated May 25,2007 f o r additional public comment on the revised Advance
Beneficiary Notice (ABN) (CMS-R-131). We welcome t h e opportunity t o partner
with t h e Centers for Medicare &Medicaid Services (CMS), other laboratories,
providers, and Medicare carriers in seeking t o develop and implement t h e most
effective ABN and associated instructions for all relevant stakeholders.
Proper instruct ions f o r A B N use are essential in order t o communicate t h e possible
denial o f Medicare coverage t o beneficiaries in t h e most clear and concise foshion
possible. Beneficiaries also need and deserve significant advance notice about
Medicare coverage t o allow them t o make an informed decision about w h e t h e r t o
BioT~chLab Comments t o CMS
Revised ABN
P q e 1of 3
Mailing: RO. Box 460 Bmnson. MO 65615-0660
Slrippin~: 106 Industrial Park Driw Hoilisteer, MO 65672
Business: (417) 334-6586 Far: (417) 337-5519
EMERGENCY: 9-I-I
May 31,2007
OM0 Human Resources and Housing Branch
Attention:'Caroiyn Lovett
New Executive Office Building
Roam 10235
Washington. DC 20503
Re: Advance Beneficiary Notice of Noncwerage comments
OMW: 0938-0566
Document Identifier: CMS-R-131
At an ambulance service provider the Advanoed Beneficiiry Notice (ABN), creates 2 great burdens on
our ambulance service. The first k i n g that the arnbulaw* mew is expected to know billing pactioes.
The second betng me form is in paper format and the signature cannot be captured elecbrmically.
Our patients do not came ido an office to seek treatment where the business oFkz personnel can
discuss cover&-a nonavered treab-nent. Our crews are trained on patient care and have a great
responsibility'for providing-thatpatient cale. They should not be required to also know what is ahwed
and not covered based on eactpatient's insurarice coverage. Furthermore,o m times the ambulance
mew does not know wt~othe patient's primary insinanceis until after the transport has ended as they are
focused on patient care and not billing. Often times they do not ever know what insurance the patient
has. This information is frequently obtained after the transport. EMTALA laws require treatment in the
emergency room before knowing patient insurance information. Why should Ute patent care before their
arrival at ihe ER,differ? It should not also be the ambulaoce crews' responsibiliiy to be able to figure out
base rates and mileage charges mat a patient would be liable for if they choose the treatment. The crew
should not be delayed on scene explaning Medicare's billing practices as this could delay emergency
ambulance services to another patient. These patients dcm't always call for that unreasonableambulance
service during regular business hours. When their 'atheter is dislodged at midnight or on Saturday. they
call then for the.Sc~b2.Beneficiaries should be pfovidedwith a policy manual that explains insurance
coverage and exclusions regardless of the type of insurance. Then if the insurance denies, the patient is
responsible.
Our regmal CMS offrce has indicated that the ABN cannot be part of our electronic software system. I
was advised by CMS that "There has never been policy to accept electronic signatures on ABNs,nor
would vre have such a pobcy unless benefciaries requested it.' As we now have an electronrc patient
care reporting system. it would be practical for our forms and s~gnaturesto be part of the system. rather
Man stored somewhere separately.
- Melissa stifflev
Office Manager
Taney county Ambulance District
24 Hour Paramedic Service
COt4T It4UE FROM PREU IOUS PQGE
004
June 4,2007
OMB Human Resources and Housing Branch
Attention: Carolyn Lovat
New Executive Office Building
Room 10235
Washington, DC 20503
Dear Ms. hvett:
The American Association for Clinical Chemistry (AACC) wclcomes the opportunity to provide
input to the Office of Management and Budget (OKB) regarding the Centers for Medicare and
Medicaid Services (CMS) revised Advance Bendiciary Noticc (ABN). In general, we oppose
the adoption of this new form and suggest that the current laboratory-specific ABN remain in
place.
'In 2002, CMS and the laboratory community worked closely to develop a laboratory-specific
ABN, which was acceptable to all parties-CMS, clinical laboratories, physicians and
boneficiaies alike. We believe our joint efforts were very succcssful. The final document was
concise; flexible and easily understood by patients. Thus, we are perplexed by CMS's current
plan to elirniaptc the laboratory ABN now that it has been successfully implemented and is
wid~y-h11sr.+:- tC; yT -e
h
1
1
s
..
~
~
~
To date, CMS has not Gvided a rational; for creating a single ABN. AACC is concaned that
the introduction of this generic fonn would increase the administrative burdens and corn to
laboratories, which would need to re-educate physicians and patients, as well as make additional
changes to their computer systems. In addition, we believe the new form would confuse patients
without providing any appreciable improvement in Iiealth administration. AACC urges OMB to
oppose the revised ABN and urge CMS to withdraw it.
By way of background, M C C is the principal association of professional laboratory soientists-including MDs, PhDs and medical technologists. AACC's members develop and use chemical
concepts, procedures, techniques and insmrummtation in health-related investigations and work in
hospitals, independent laboratories and the diagnostics industry worldwide. The AACC provides
international leadership in advancing the practice and profession of clinical laboratory science
and its application to health care.' If you have any questions, please call me at (504) 568-428 1, or
Vince Stine, PhD, Director, ,Government'~ffairs,at (202) 835-8721.
Sincerely,
Larry Broussardi PhD
President-Elect, AACC
OCT-09-2007
14:11
OMB/O I RA
202 395 5167
P. 06/34
ITtGWIbQ11G
-
-.-
CMS
\
1..
Office of Smtegic Operations and ~ e g u l a m ~ffairg'
y
--'
Division of Regulations DeveIopment - C
Attention: Bonnie L. Harkless
Roam C4-26-05
7500 S&ty Blvd.
Baltimore, Maryland 21244-1850
,L
q T MGMA
................._._......
.
I
_
A m e r l o n tollev of McdlOl Pnctict Exetutivet
....... ........................
......
McdicdCroup Management Auociatlon
-.....,...............-.... ..............,.,.....,...,.........,..~.......,...........,,........
.........,.......................,.......
.........I
a
.
Center for Medicare & Medicaid Services
OMB Human Resources and Housing Branch
Attention: Carolyn Lovett
New Executive Office Building
Room 10235
Washington, DC 20503
Re: Agency Information Collection Activities: Submission for OMB Review
Comment Request (CMS-R-13
1)
Dear Ms. Lovett:
The Medical Group Management Association (MGMA)is pleased to submit the
following comments in response to the Agency Information ColIection Activities:
Submission for OMB Review Comment Request (CMS-R-1311, published in the May
25, 2007 Federal Register. We appreciate the Centers for Medicare &Medicaid
Services' (CMS)outreach to the provider community and the willingness to
participate in constructive dialogue to improve this particular administrative aspect
of the Medicare program. We Iook forward to continuing our collaborative work on
this and other administrative simplification issues.
MGMA, founded in 1926, is the nation's principal voice for medical group practice.
MGMA's nearly 21,000 members manage and lead some 12,500 organizations in
which almost 270,000 physicians practice. Our individual members, who include
practice managers, clinic administrators and physician executives, work on a daily
basis to ensure that the financial and administrative mechanisms within group
practices operate efficiently, so physician time and resources can be focused on
patient care. MGMA offers the following critiques and recommendations related to
these proposed revisions.
nr*bpUARTes
1MlnvernessRrrace Ead
Engkuood, C 0 80112.5306
MGMA applauds CMS'attempt to simplify the administrative process by
combining the existing ABNs; however, there are elements of the proposed
version that further complicate the process. In addition, the overall revisions to
the forms will increase the administrative burden and cost for providers.
phone: 303.799.1111
fax: 303.643.4d39
COVERMMENI
&FAIPS
MGMA appreciates CMS'acceptance of MGMA's previous recommendations in
comments submitted on April 23, 2007 regarding the first series of proposed
revision to the ABN. OveralI, the font on the ABN has inueased to make the form
3eadable for both physician practices and patients. &so, the proposed revised ABN
Ioes not include the itemizing of services, which is a significant benefit to the
dminisrrative process. This will allow practices to bill services as bundles, thus
ubling practices to combine the cost of services and items for procedures. By
mdling, patients will be able to view the total cost of procedures which will
cilitate their decision regardmg whether or not to receive sexvices.
GMA is pleased that CMS added the word "option" next to the three choices
1717 Pcnn$yIvrniaAwnu.2
Nonh West. Suite 600
Washington, DC 20006
phone: 202.293.3450
fax: 302.193.2787
that beneficiaries are offered. This additional language will positively impact
patient care by clearly outlining the beneficiaries' core options. While there is a
benefit to the proposed language revisions, the proposed form continues to
contain an excessive amount of information and instruction for d l populations.
The simple "yes" or "no" options provided on the current formsare easier for
practices to explain and for beneficiaries to understand.
MGMA values CMS elimination of Section H entitled "Other Insurance to
consider for billing." The proposed revision of "Additional Information" in
Section H is a positive change that will allow providers and beneficiaries the
ability to include the necessary information required for the billing process on
one form. We applaud CMS for following MGMA's recommendation to maintain
the wording in the note section regarding CMS'wiUingness to pay for
item(s)lsentice(s)lIaboratorytest(s).
MGMA commends CMS for the information added within the Section G title box.
This information will help clarify financid procedures for beneficiaries. MGMA
suggests that CMS change the wording in this section from "we" to "the provider"
to allow for greater clarity. Additionally, MGMA appreciates the notice to patients
stating that this is just an opinion and not an official decision. This verbiage
provides beneficiaries with clarity on the legality of the ABN.
MGMA supports CMS' decision to change the phrasing of the note from "You
need to make a choice about receiving these laboratory test or health care items
or services" to "If Medicare does not pay for things listed below, you may have to
pay."
MGMA has several other conce.rns with the proposed ABN revision, including:
In Section A, CMS changed the wording from "supplier1provider"to
"notifier," which may cause some confusion. MGMA requests that CMS
maintain the original wording.
In Section C,the language continues to lack clarity on whether Section C is
for the National Provider Identifier (NPI) or the beneficiary's identification
number.Supporting docurnenn state that it is for the beneficiary; however, it
needs to be clearly stated that the section is seekng information for
beneficiaries on the ABN.
MGMA understands CMS'god in combining the forms; however, the
purpose is lost if Section D is left for practices to complete or fitled in with
either Ytem(s)/Senice(s)"or "Iaboratory service(s)",which then provides for
three versions of the ABN, thus diminishing the intent of the revision.
M.GMA request replacing the phrase "ltcm(s)/Service(s)" where it appears in
the document with "ltem(s)lService(s)lTest(s)".
-
CMS attempted to simplify the wording above the box which explains
sections DlE and F. MGMA is concerned that the wording is too simple.
MGMA recommends removing the last sentence which reads "We have
estimated about how much you may have to pay under 'Estimated Cost' to
help you decide whether or not to receive the care listed."
Because multiple items, services and procedures may be ~ncludedon one
'\
3une 11,2007
?
OM0 Human Resources and Housiog Branch,
Attention: Carol Lovett
New Executive Ofice Building
Room 10235
Washington, DC 20503
Dear Ms. Lovett
Thank you for taking comments on the proposed revisions for the Advance Beneficiary
Notice (ABN). Enclosed please find a letfer detailing comments we made previously.
I suggest removing Option 2 froamthe finalized ABN form. Ibelieve allowing this option
could lead to abuses by the provider community and could cause beneficiaries to pay
more for medical services than is required by Medicare rules and regulations. I n
addition, the inclusion of Option 2 takes away from the original intent of the form. The
provider should use the form to n o t i i pab'ents on a case-by-case basis when they
anticipate Medicare will deny items and services based on the patient's specific
condition.
The combination of the ABN ancl Notice of Exclusion of Medicare Benefits (NEBM) is not
beneficial to the beneficiary corr,rnunity. The design and intent of the forms are for two
completely different types of denials. The NEMB is simply a reminder for the
beneficiary that Medicare statutorily excludes a service. There are publications specific
to the beneficiary community, silch as the Medicare.gov website and the "Medicare and
You" handbook to indicate the non-covered status of these services. Since this is
information the beneficiary should know, the form is voluntary for the provider.
Beneficiaries trust the staff in their doctor's ofices and are dependent upon them for
their medical care. A beneficiaqr is reluctant to report a provider office for any type of
possible violation fearing the pravider will be angry and will not continue to treat them.
A provider office can present the inforrnati~nin a myriad of ways that would encourage
the patient to choose Option 2. This possible manipulation of the discussion could
cause a patient to pay the physician office for services in which the patient does not
have responsibility.
Based on my experience as a Medicare Provider Outreach and Education (POE) analyst,
Ibelieve that providers could use Option 2 to collect inappropriate amounts from
beneficiaries. These items and services could include denials based on the Correct
Coding Initiative, Skilred Nursing Facility (SNF) Consolidated billing, or items or services
--Tr
~UW-a
-
Wisaonsin PhysiciansSenlce Insurance Corpolalbn rewin, as a CMS conlracted u m c r
P.O. BOX1787 Madison, WI 53701 Phone 608-221-4711
considered bundled. Some pro~riderofices have stated in education forums that they
provide an ABN to all patieks as a protection for their office. We continue to provide
education to stop this abuse. Option 2 indicates the provider does not have to submit
theclaim to Medicare. Option :!does not allow a beneficiary many options in
addressing any abusive situation.
Section 1879 of the Social Security Act provides protection for the beneficiary. A
provider is responsible for knowing the rules and regulations for Medicare items and
services. Therefore, a provider should know whether to anticipate payment from
Medicare.
Both theABN and the NEMB provide information to the beneficiary community on
possible denials by Medicare. The ABN is specific for otherwise covered items and
services that Medlcare will not allow for this patient's specific situation. The NEMB is a
simple reminder for patients of never covered services.
Thank you for your time in considering my comments. If you have any questions or
concerns, please do not hesitah? to contact me.
Ellen Berra
Senior Analyst
Provider Outreach & Education
Wisconsin Physicians Service (MIPS) Medicare
(618) 998-5247
,ellen. berra@wr>sic.com
1
American Academy of
June 19,2007
OMB Human Resources and Housing Branch
Attention: Cuolyn Lovett
New Executive Office Building, Room 10235
Washingtos DC 20503
Re: CMS-R- 13 I
Vice Speaker
lash k p Pfabry
SunAVI~OII~O,
1i.r~
Dear Ms.Lovett,
I am writing on behaIf of the American .Academy of Family Physicians (AAFP),
which represents nearly 94,000 family physicians and medical students nationwide.
Specifically. I am writing u, offer our comments in response to the request for
information on the Advance Beneficiary Notice of Nonmverage (ABN) as published
in the Federal Register on May 25,2007.
Estimated Burden
As v e noted in the previous comment period, the estimated burden appears to be
seriously underestiwed. The Centers for Medicare and Medicaid Services (CMS)
noted that comments to this effect were anecdotal only. This is me because it is
CMS which has the data to substantiate a better estimate of this burden. CMS has in
the past indicated the ability to track modifier usage firom claims data when
invesdgatinp the use of modifiers such as 25 and 59. This same data should be
available to indicate the number of claim by unique physician and provider identifier
which contained the GA modifier indicating that an ABN was on file. T h i b number
o f claims should then be increased by approximately onathird to acwunt for those
beneficiaries who elect to not receive the service or to not have a claim filed.
Division of this number by the number of unique physician and provider identifiers
should provide a better estimate of the burden per noser. Family physicians, of
whom ova 90%provide in-officelaboratory services, will provide far more ABN's
than, for example, surgical specialists who & nut have in-office lab at all. Thus, thr:
AAFP continues to maintain that the estimated burden for many family physiaans is
underestimated by 50 to 150 times.
We also again note that the total cost per notifier of $69.39 does not a p e with the
statistics provided and significantlyunderestimates the burden. If the estimated total
cost o f delivering the ABN's is $326,255,502.00 and notifiers will deliver 40,302,506
Mu;((
Cnrrhalm. M O
Physician Manhn)
ried1.L A h r &
June 19,2007
M F P Comments on Advance Beneficiary Notice
Page 2
ABN's each year (or 3 1.7 ABN 's p cr notifier per year) as indicated in nurnbet 2 ofthe
supporting statement, then the burden would be $256.62 per notifier.
Further, CMS noted that the work of activities such as researching coverage policies that are not
solely required by the ABN are not always part ofpreparing and delivering the notice, and
moreova, are general responsibilities of those panticipatingin Medicare. This may be we.
However, sorne portion of these gene.raJ respmibilities of participating in Mediare should be
attributed to the burden associated with delivering the notice. If noc where is the burden of these
activities accounted foi!
Trzrnsition Burden
We agreewith wmmenters who noted other concurrent CMS initiatives invoIving physicians
that require significant operational resources (e.g., the National Provider Identifier (NPI)
initiative), and asked fbr a reasonable period of time in which to transition h m the cumnt ABN
to the new notice. We note that the NPI initiative is one of several initiatives faced by physicians
in 2007 including transition to the new CMS 1500 form and preparation for the Physician
Quality Reporting Initiative. We appreciate CMS's agreement rhat a reasonable W t i o n period
is necessary and that this issue will be addressed prior to final approval of the new ABN.
Use of Sinple ABN
We note that the simplification ofone ABN form has been lost to the creation,ofone form with
three versions. There are, in essence, three hrms with minor differences. The generic version of
hfbrm which leaves field D blank should meet the needs of all physicians and providers and
avoid amfusion. However,the reasons Medicare may not pay which are included on the
laboratq version o f the ABN might be included on the generic version in lieu of a separate
form. The three reasons given could be modified as follows to be inclusive of senrices other thnn
laboratory tests:
6
b
Medicare does not pay for these @)
for your condition.
as often as ordered for you
Medicare docs not pay for these (D)
Medicare does not pay for expaimentaI or research use @)
This would allow for one version of the ABN fonn which could be used for many purposes as
was indicated in the original request for wmrnents.
OCf-09-2087 14:13
OrlB/~l
I RR
202 395 5167
GO
oo
FAIRVIEW
Fairoiew Health Services
Patient Financial Senices
P.O. Box 147
Minneapolis MN 55440-0 147
(6 12) 672-6724 Fa: (612)-672-6727
June 21,2007
OMB Human Resources and Housing Branch
Attention: Carolyn Lovett
New Executive Office Building
Room 10235
Washington, DC
L
\
- -
Federal Register Notice (72 FR ,No 101, pp 29322-29323 May 25,2007 Centers
for Medicare and Medicaid Services, Department of Health and Human Senrices;
Revision of Advance Beneficiary Notice of Noncoverage (ABN); Document Identifier
CMS-R-13 1 OMB 0938-0566
Re:
I
Dear Ms.Lovett;
Fairview Health Senrices, which has seven hospitals in Minnesota, wishes to thank you
hr the opportunity to comment on the proposed changes to the Advance Beneficiary
Notice. Our comments are as follows:
Sample L/Lab ABN:
Lab personnel prefer the current Lab ABN format as it allows for more customization. It
is felt that the proposed format does not allow sufficientspace to customize for all ofthe
various tests for which there is a Medicare coverage issue, even if there is a font change.
W~thouthaving this preprinted, there will be more exception data for lab tech and
personnel to look up, which is a training issue and which lends itself to the possibiliry of
enors. The proposed fbnnat will mean rnore up fiom work. The existing fbrmat allows
lab to be more time efficient, while still ensuring that the patient gets the correct
information.
Sample G:
The consensus of most of the people responding is that rhis is the preferred fonnat for
services other than lab. The other form is too busy and cluttered, and the ststement
"items or services" describes what wiI1 appear in item '73''. They would prefer not to
have other items to fill in.
General Comments:
Option 2, if seiected, tells us not to bill Medicare. Ln many instiinces, a seconday payer
whether the provider bills or lets the patient bill the payer will require that there be a
denial h r n Medicare before they will consider the claim. We could put a notice in
"additional infomation" that speaks to this, however the concern is that it would appear
that we are leading the patient to choose option I , and it has already been stated that "we
-
-
P. 13/34
OCT-09-2007 14:14
OMB/O IRA
202 395 5167
Comments to CMS
Changes to the Advance Beneficiary Notice
cannot choose a box for you". Since some providers do not, not are they required to bill
the secondary payer, CMS could still add language regarding this requirement, such as "
Note: if you have another insurance, you should check to see if they require a denial from
Medicare bdbre considering your claim". Then when the patient reviews the 3 options,
he or she will know that if they choose option 2, they may not be able to get paid for the
service by the secondary payer.
We would also like to point out that should the patiear choose option 2, if this is one noncovered item among many other tests, pd.cularly in a large hospital-based settixi1 or
large clinic setting, it will be difficult to pull out one test to not bill to Medicare. Also, if
we are able to do this, it has been our experience that the patiem will compare the
hospital or clinic bill to the MSN, and then it will generate calls that we billed incorrectly.
They do not remember that they said they did not want something bilIed.
Notifier: In the instructions, CMS indicates tb?employees or subcontraaon of the
notifier may deliver the ABN. The concern is that some notifiers may delegate this
hnction to someone who is not qualified to answer patient questions. Not all employees
or subcontractors are clinical staff. We believe that if the notifier delegates the delivery
ofthe ABN, it must be delegated fo other staff qualified to answer a patient's questions,
or that such qualified stsffor the notifier be available in the event that there are questions.
Other: We like the plain language and the statement "we cannot choose a box for you"
Thank you for the opportmity to comment.
~o&liance Specialist
Fairview Health Services
Corporate Office
400 Stinson Blvd NE
Mnneapolis, Mh' 554 13
University of Minnesota Medical Center, Pairvim
Fairview SouthdaleHospital
Fairview Ridges Hospital
Fairview Northland Regional Hospital
Faimew Lakes Regional Medical Center
Fairview Red Wing Hospital
University Medical Center, Uesabi
P. 14/34
June 22,2007
OMB Human Resources and Housing Brach
Atternion: Cruolyn Loren
New Executive Office Building. Room 10235
Weshington, DC 20503
Re: Advance Beneficiary Notice, FonnNumber CMS-R-'131 ( O m :0938-0566)
Dear Ms.Lovett:
The hmerial College ofRadiology (ACR).rcgrcsentibg over 32,000 di-srif
radiologins,
intaventional radiologists,radiarion mcologists,nuclear medicine physiciaa and medical physicists, is
pleased KO submit a second comment on the proposed revi~ionto thc Medicare Advanced Bmcficiary
Notice of Non-cavcrage (ABN)in response to the request for comments.initially published in the Fcdaal
Register on Februm 23,2007 and for the second time an May 25d: 2007.
The ACR is plssed to see that CMS is working on the ACR's recommended changes on he M N .We
would like to rcittrste a recomma~dationmade in our 1% comment letter about rhe ABN.
In our firs1 comment Icl~er.we suggested the inclusion of languagc directin8 patienrs to their referring
physician before making thtir f i decision. In particular, this would encourage the pdem to discuss the
treatment options wirh his&er rcferriiag physician before dccliaipg tlx atament. Language such as "If
you are not clear ar lo why your doctor ordered this specific tcsr, if there i s zn dtcmativt rert. or if your
doctor knew it may not be covered hen please c o n m your doctor" can encourage the paricn~to obraia
fuUlv information from he referring physicia
The ACR i s concerned about the umplication of potenual lhbiliry of radiologists not providing Qe ordered
opt out from receiving care. When
the patient stltcu oprion 3, it also leaves radialogisrs with the responsibility of irrf6rming the &ring
physician that the patient has selected oprion 3. This can b t burdensome. Thc~efon,the ACR
recommextdr adding l a n p g c on the ABN that direca patients to the refuring physician to discuss
exam because the padat sclecls option 3, which eosbles the patient to
tnzaunalt opuons.
We appzeciate rhc second opportunity TO cammat on zhe revised ABN. The ACR 1001sfopmrd to a
ccmtinuing dialoguc 4th CMS officials about these and otha issues affecting radiology. If you b e any
questions a coinrnnrs on this letm, please contact Helen Olkaba a 800-227-5463 ext 41 32 or via email
at holkb&acr.org.
Respecdully submitted.
Harvey L. Neirnan. MD,FACR
Executiv e Director
cc:
Michelle Shortt, CMS
Bonnie L Harkless, CMS
John A, Patti, MD FACR Chair. ACR Commission on Economics
Bibb Allen JR., M13, FACR, Vice-Chair, ACR Commission on Economics
Pamela Kassing, ACR
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Friday, June 22,2007
OMB Desk Officer
OMB Human Resources and Housing Branch
Attention: Carolyn Lovett
New Executive 6ffice Buildiqg Room 10235
Washington, DC 20503
FAX Number 202 395 6974
Re: CMS R 131 Proposed Revision to Advance Beneficiary Notice
Dear Ms. Lovett:
The American Academy of Dermatology is requesting that the comment period for this document
revision be extended at least another 30 days or a new comment period of 60 days be provided.
We are deeply ancemed that any revision to form CMS-R-131 Advance Beneficiary Notice
succeed in making it simpler and easier for Medicare beneficiaries to understand the care and
billing options that are being presented to them.
While we believe that the current ABN and Lab ABNs can be effectively combined. we are very
concerned tnat the sequence and tert of the information being presented on this t o m are not being
provided in an easily understood fashion..We bdieve that the instructions to the beneficiary as well
as the choices being presented could be clearer. Certain parts of the text continue to be redundant
andlor unnecessary. We do not support thecurrent draft revised Advane Beneficiary Notice
forms.
Consideration should also be given to providing this form to a benefciary on a per service basis
rather than a potential list of up to six services and a form that does not support the beneficiaries'
ability to chooselselect sewices to receive and services to reject If six services are listed, how does
a beneficiary indicate that he or she wishes to receive three and rejea three? How would they
indicate the application of the three Options(G) to one or more of the services listed?
We are also concerned with !he proposal to eliminate the Notice of Exclusions From Medicare
Benefits. We believe h i s form has proven to be an effective and frank method of explaining that
Medicwe does not pay for everything and that specific items and services, especially those that
are clearly cosmetic in nature, are not billable to Medicare. We strongly recommend that this form
be retained.
Thank you in advance for your consideration. If you nave questions regarding this request, please
cantact Norma L. Border at 847 240 1814, nborde@!ad.orq,
Respectfully.
Brett Coldiron. MD, FAAD, FACP
ChairlAAD Health Care Finance Committee
Charles N. Kahn ID
President
\
June 25,2007
SEhT VLA FACSTMXX AND U.S. MAIL
Ms. Carolyn Lovett
OMB Human Resources and Housing Branch
New Executive Office Building
Room 10235
Washington,DC 20503
:
CMS-R-231 (OM&: 09384566); Agency Info~tna&~on
CoUedion Actihhties:
Proposed CoUeCLiok; uComment &guest -Advance Beneficiary NO* of
Noncoveraee (ABN)
Dear Ms. Lovetr:
The Fedention of American Hospitals ("FAH") is the national represtntarivc of investor-owned
or managed community hospitals and health systems throughout the United States. Our members
include teaching and non-teaching hospitals in urban and rural p m of the United States. We appreciate
the opportllnity to comment an rhe Centers for Medicarc & Medicaid Services' ("CMS')Notice, issued
in accordance with the Papenvork Reduction Act of 1995, regarding the renewal o f an agency
information collection activity involving the Medicare Advance Beneficiary Notice of Noncoverage
("ABW). (See 72 Fed. Reg. 29,322 (May 25,2007).)
L
Combination of the Advance Benefiaarv Notice and the Notice of E$clusion from
Medicare Benefjts
The proposed revisions to the ABN include combin- rhe current General Use ABN (Form
CMS-R-131-G)and the Laboratory Use ABN (Fonn CMS-R-13 I-L) into a single nolice, called the
Advance Beneficiary Notice of Noncoverage. In addition, according to the proposed form's
insuucdons, this single genaal notice would be used in place of the Notioe of Exclusion fiorn Medicare
Benefits (NEMB) to provide voluntarynotification of financial liability.' The FAH supports
the Fonns CMS-R- 13 1-Gand CMS-R- 13I -L, and appreciates the agency's
action to streamline the
ABN process to use one form
However, for several reasons discussed below, we do not believe the ABN and NEMB forms
and related processes should be combined. First the instructions for the revised form state that notifies
"must complete the ABN as described below, and deliver the notice to the affected beneficiary.. T h i s
means that a completed ABN form is mandatory if a provider wishes to bill Medicare and hold the
beneficiary liable should Medicare deny payment. Conversely, completion of the WM13 fonn for
statutorily excluded services or services that do not meet the definition of a Medicare benefit is optional,
and the provider may bill the beneficiary for such services even if an NEMB is not completed.
."
Also, the billing rules for statutorily excluded services (NEMB)and non-medically necessary
services (ABN) are not equivalent. When an ABN is obtained for services that the provider does not
believe are medically necessary, the provider must bill the services toMedicare in order for the
Medicare Contractor m make a coverage determination. When reporting ABN services to Medicare, the
semices are lisud as dovered with occurrence code 32 andlor the GA modifier presenr on rhe claim.
Medicare Claims Processing Manual (CMSPub. 100-04), Chapter 1, $5 60.1.2 and 60.4.1.
If a provider decides to obtzin an NEMB for statutorily excluded services and the provider
submits a claim to Medicare, the services are reported as,non-coveredwith the GY modifier.The
Medicare adminisnative contractor always will deny these services. Medicare Claims Processing
Manual (CMSPub. 100-04), Chapter 1, 4 60.3.1.
If the f o n s are cambmed and both non-medicallynecessary and starutorily excluded services
are included on the same ABN, the provider billing process would be more difficult, e-g., determining
which services require the GA modifier versus the GY modifierwhen borb were on the same ABN. In
addition, CMS billing rules state that ABN and demand billing should not be on the same chim.
Medicare Claims Processing Manual (CMSPub. 100-041, Chapter 1, $ 60.3.1.
As a result, because the'specificrcquirments for obtaining the two f o m diffcr, we believe it is
not reasonable to combine the forms and related billing processes, and doing so is likely to create
confusion in the provider and beneficiary communities.
Accordingly, we believe that Option 2 should be removed from Section G of the proposed ABN
form because it appears to apply only to statutorily excluded sen-ices.
If CMS decided to continue with isplan to combine the ABN and NEMB forms, the billing
instructions for these two distinct types of items or services in the Medicare Claims Rocessing Manual,
Chapter 1, Section 60 and Chapter 30, Section 90 will need to be revised. In accordance with revisions
to these rules, Medicare claims processing systems also would need to be evaluated and potendally
m&ed to process and adjudicate claims appropmtely. Also, providers would necU to implcmcnt
system changes, develop new processes, and furnish extensive education.
The amount of time nccded LO publish new rules, update claims processing systems and conduct
provider education should be considered when detmining an effective date of the new JIBNform. At
'
11 h also not clear from the proposed fonn and accompanying instructions wherhez tbc single general notice would
replace the &can
Dental Assochuon NEMB wcd fbr dmul e x c l u ~ k and
s the American Podia& Mcdicsl
Association MMB used for foot c u c exclusions undcr Medicsc. While t k i e farms art not publjsked by CMS, rhcy
are d e w t d snd approved by the agency and are used as pan of ihc NEMB p~occss.
v
a minimum, we estimate that this is likely to take as long as six months to accomplish.
~baefme,
f:
CMS decides to move fonuard with this proposal, we request a significant m i t i o n period to allow
both providers and Medicare con~ctorsto modify their operations to implement these changes.
IL
0\
hI
Iaterprttivc Rules To Implement the New ABN
The proposed Farm Insuuctions for the Advance Beneficiary Notice ofNoncoverage (ABN)
stare that:
[Olnce the new ABN approval process is completed, CMS will issue more detailed lirstmctions
on the use of the ABN in Its OR-lheMedicare Claims Processing Manual. hblication 100-04,
Chapter 30. In addition, note that rt.kctedpolicy on billing and coding of claims, and as well as
coverage detminurions, isjound elsewhere in the CMS manun1 syszem or website.
We request that CMS involve the provider community when developing the detailed instructions
regarding use of the new ABN fonn. By doing so, CMS would be able to address provider questions
and areas of confision within the instructions versus leaving these areas open to provider interpretarion.
We request that as CMS is developing the derailed instructions, that they also review the policies
regarding billing and coding of claims that are fbund elsewhere in CMS materials to ensure that no
conflicting infomation is disseminated.
For example, the following information is found in various material published by CMS
regarding non-covered observation services:
ABNs may nor be used to shijf liabili~ro a bene.ciary in the case of services or item for which
@I payment is b d e d into otherpaymems; that is, where tk benejciaty would ofhenvise nor
be liablefor payment for the service or irem because bundIedpayment is made by Medicare.
Using an RBNto collectfrom a henefm'ary wherejidl payment is made on a bundled basis
would constitute double billing. An ABNmay be used to shift liability to a beneficiary in the c u e
of services or itemsfor which puriial puymenr b bundled into other payments; rhar is, where
part of the cost is nor included in he bundledpaymenr made by Medicare, (Medicare Claims
Processing Manual, Chapter 30, Section 50.7.7.6 .QBNs and Bundled Payment)
-
Becaure observation is normally packaged and the additional hours over eight are packaged for
separatelypayablc observation, the above statements indicate that it would not be appropriate to obtain
an ABN or NEMB and bill the beneficiary for the non-covered hours.
Ija hospiral htends toplace or rerain a bengficiary in observationfor a noncovered service. it
must give rhe beneficiav proper written advance notice of noncgverage under limitation on
2iabilityprocedur.e~(see Pub. 100-04. Medicare Claim Processing Manual; Chapter 30,
"FinancialLiability Protecrions, " $20, at
h t t ~ : / hcms.
. h ~ . ~ o v / ~ a ~ d ~ w n 1 o a d s / c l modf
~ 0for
4 ch3j 50 m
. t i o n regarding
Limitation On Liability (LOL)Under 91879 Where Medicare ClafmsAre Disallowed).
(Medicare Benefir Policy Manual, Chapter 6, Section 20.5 Outpatient Observation Services)
-
The abve guidelines suggest that we should be obtaining ABNs and billing the patient for
noncovcred observation.
In addition, cunent instructions in the Medicare Claims Prooessing Manual,Chapter 4,Section
290.5 - Services Not Covered as Observation Services state:
fie hospitai should billfor the period o/medically necessary obsemation and ahould also
submit non-covered services according to billing instwtions in the Medicare Claims
Processing Manual, Pub 100-04, Chpler 1, $60.1.2. Ho9~ital~
should submit a non-covered
charge amount equal ro he toral chargefor each service and should use modifier -GY or
condition code 21 as appropriate.
These differing statements have resulted in various provider interpretations regadmg the
appropriateness of the use of ABNs for observation smites.
IIL
Header
Regarding completion of the Header of the new ABN form, the instructions state: "lf
appropriate, the name ofmore than one entity may be given in the norifier area, such as when the
ordering and rendering providers dzffer, as long as this is clearly conveyed u, the b e ~ c i a rfor
y
purposes of responding to questions."
Since the rendering provider is ultimately responsible for obtaining ABNs and billing Medicare
b r such services, we do not recommend that both the ordtring and renderiq providers be listed in the
H U section. Listing both providers may be confusing to the beneficiary.
XV.
Estimated Cost
Reowding Section F Estimated Cost, the instructions for the revised form state, 'Wotifiers must
e n t a a cost estimate in this blank for the items or services described in Blank (D)." Fonn Instructions at
p. 3. Current instructions (Medicare Claims hcessing Manual, Chapter 30, Section 50.5.7) regarding
Estimated Cost state:
f31e user may provide the patient with an estimated cost of the items a n d h services. Thepatien1
may ask about the cost andjot down an amount in this space. Users should respond to such
inquiries to the best oftheir ability. Dte lack of an amounr on this line, or an amowrl which is
dtxerent from the final actual cost. does not invalidate the ABN; an ABN will not be considered
to be defective on that basis. In the case of an RBN which includes multiple item a d o r
services, ir is permissible for the user to give &mated ammntsjor the individual items and/or
servlces rarher than an aggregate estimate ojcos&. Amounts mny be provided either with the
description 01
items and services or on the "Estimated Cost" line.
We would ask CMS to clarify whether the Estimated Cost is mandatory. In addition, we request
that CMS define if an estimate i s different from the actual cost, how much variance is allowed before
the ABN would be considered defective. We also ask rhat CMS provide additional ,@dance regarding
what constitutes a "good faith estimate."
V.
P ~ t i o n Box
s
The proposed instructions state:
r a heneficicuy choose.7 to receive some, but not all of the items or service3 that are subject of
the notice, the items and services in Blank 0)
that they do not wish to receive may be crosuc?d
out, ifthis can be done in a way that also clearly strikes the reason(s) and cosr informorion in
Blanks (E) and (F)that correspond to that care. Ifthis cannot be done clearly. a new ABN musr
be prepared.
We do not feel that it is appropriate to cross out those items that the beneficiarychooses not to
receive without firtber action. This does not allow the beneficiary to choose an option fram Section G
of the form. In the scenario where there are multiple savices lined on the ABN and the beneficiary
chooses to receive some but not all of the services, a new ABN should be created; therefore allowing the
beneficiary to choose Option 1 on the form for the services that they do not want to receive and either
Option 2 or 3 on the other fonn for those services that they want to receive.
a
Option 1
We request that CMS clarify their intent regarding the use of Option 1. If this is an option that
the beneficiary can choose for statutorily excluded services, how would providers bill for a coverage
decision? Currently statutorily excluded services are reported as non-coverd and Medicare Contractors
do not review these services to determine coverage. lfpoviders were ra report st;rtutorily excluded
senices as covered, how would Medicare Conttactors h o w that the provider recognizes these sewices
as non-covered and is not seeking reimbursement h r n the Medicare progrom?
W e request that CMS clarify their intent regaruse of Option 2. Can beneficiaries choose
this option for statutorily excluded services and also those services rhat are not medically necessary
according to a local coverage decision or national coverage decision? If a beneficiary chooses Option 2
for a service that is not covered according to a Iocal coverage decision or narional coverage decisions,
the provider would be m a h the
~ ultimate ooverase decision as no claim would be submitted to the
Medicare con-.
From an editorial consistency perspective, we suggest changing the statement, "You may ask to
be paid now as I am responsible for payment" to "I understand that I may be asked to pay now as I am
responsibIe for payment."
c
Option 3
In order to provide clear ,pidance to the beneficiary, we suggest that the statement 'I undtrstand
with this choice I am not responsible for payment," be revised to read '7 ununderndthat with this choice
1.will not receive the semi=, I am not responsible for payment.. . "
VI.
Additional Information
To clarify the Medicare covexage decision p c e s s , w e suggest changing the lan,auage in the
Additional Information section from "This notioe gives our opinion, not an official Medicare decision"
to "Based on Medicare coverage guidelines, this notice gives our opinion and is not an official Medicare
decision. Please note that Medicare does not make pre-service coverage decisions."
VII.
Burden Estimate
we believe the Burden Estimate is undersrated in several aspects. While we do not disagree
with the seven minutes on average to deliver an ABN,but do not feel tkat the estimate accurately
includes all aspects of the process. 1n addition to delivering the ABN, thcre are additional steps during
.-
'J
the billing and collection process that are affected by the ABN. We believe that each claim that includes
services for which an .4BN has been obtain& takes m additional five minutes to process by the
provider. Also, if Medicate denies the ABN swvice, the provider will incur additional casts to collect
&e funds fiom the beneficiary, including producing patien? billing statmmts and follow-upphone calls.
Also, the estimated volume of ABNs delivered is based on the current ABN €om and does not
appear to be inclusive of the volume ofNEMBs delivered.
'
We would request that the Burden Estimate be recalculated taking these points into
consideration
We appreciate the oppoxmnity to comment on this infomation collection activity and hope that
the agency carefully considers the comments in this letter. Ifappropriate,we would welcome the
opportunity to meek at your convenience, to discuss our views. If you have any questions, please feel
free to contact me or Jeffrey Micklos of my staff at (202) 6261500.
Respectfbll y submined,
cc:
Bonnie L. Harkless
Division of Regidations Development-C
Office of Strakgic Operations and Regulatory Affairs
Centen for Medicare 8 Medicaid Sewices
Room C4-26-05
7500 Security Boulevard
Baltimore, MD 2 1244- 1850
OCT-09-2887
14: 17
202 395 5167
OMB/O I RA
P.23/34
ACLA
June 25,2007
me
f
Officc of Management and Budget ("OMR")
Human Resources and Housing Brdnch
Attention: Carolyn Lovetl
New Executive Office Building
Room 10235
Washington, DC 20503
Re: Advance Beneficiary Notiw of Noncoveraye ("ABN") (CMS-K-:31)
Dear Ms. Lovett:
The American Clinical Laborarory Association (".ACLA') is pleased to 1 ave this opportunity to
submit our comments with regard to the Agency In~ormarionCollecfiun Actf dies: Submission for
OMB Review; Comment Requesl (the "CommentRequest") on the new Advancc Beneficiary Notice of
Noncoverage (''AUN) for the noncoverage of certain Medicarc services to bent ficiaries. 72 Fed. Rce.
29322 (May 25, 2007). ACLA is an association representing clinical labor rtories throughout thc
country, including local, regional, and national laboratories. ACLA mernbl n frequently rely on
ARNs, thus, our mcmbers are directly affected by the proposed changes. The Cl lmrnent Request in the
FedcraI Registcr invires interested parsons to submit comments on the burden es 5mate of thc proposed
information collection or my other aspect of this collection of information. As a result, reflecting the
views of its members, ACLA is taking this opportunity to commenr on the v a ~ious issues created by
the new ABN.
ACLA expressed its views to the Centers for Medicare & Mcdica ,d Services ("CMS")
regarding the Agency Information Collecrion Acrlviries: Proposed Collection; i romrnent Request. 72
Fed. & 8167 (Feb. 23, 2007). While CMS has made some of the requested changes based on the
initial commcnl period, the revisions still do not address many of our qu :stions and concern.
Accordingly, wc are sgain submitting comments regarding the new ABN 1 Yrm, many of which
reiterate our earlier comments to CMS, as well as emphasizing our goal to maintain the existing
laboratory-specific ABN ("ABN-L").
-
I-
Introduction
With thc standardization of thc ARN in 2002, AUNs becamc a more sigl ificarlt, md common,
part of the Medicare billing process. In its materials, CMS cstimates tha~over #-Omillion N3Ns may
bc delivered annually, rvld even that number seems conservative. ABNs arc par icularly imponant for
laboratory services because many laboratory tests are subject to National Col ?rage Dctcrminations
("NCDs")and Local Coverage Determinalions ("LCDs")),which can result in thl delivery of an ABN,
if thc requiremenis of the NCD or LCD arc not met - a not infrequent oc :urrence. Moreover.
laboratories are often in a difficult position wit11 regard to GUNS because they r :ly on physicians and
their staffs to provide noticc to Medicare beneficiaries that Medicare is likely t I deny paymmt for a
particular service, KO obtain the signed ABN, and to forward it t o the labc atory. Given thcse
circumstances, the ABN must be structured LO ensure that it can be easily under: toad by bencficiaries
and completed appropriately by physicians.
1250 H Sweet,
N.W.* Suite 880 Washington. DC 20005
(202) 687-9466 Fax (202) 6637.2050
Office of Management and Hudget ("OMB")
June 25,2007
Page 2
While ACLA members appreciate CMS' effort to accoinutodate the need for a laboratoryspecific Al3N by including in tht information collection paperwork a ve sion of the ARN for
laboratory-specific use ("Sample L'3, we still see no reason to eliminate the I xisting ABN-L, which
has worked s~tccessfullyfor beneficiaries, physicians and laboratories. Further because the Samplc L
form is not an improvement on the existing ABN-L for tho reasons we describ :below, it is now even
more unclear as to CMS' purpose for replacing the existing ABN-L with . nother ABN form for
laboratory-spccific use. Thus, in spitc or CMS' effort to create a version 01 thc ABN form that is
specific for laboratory services, ACLA is still concerned that the Samplc L So m will be less clcar to
beneficiaries, morc vulnerable to physician mor, and the source of increased .onfusion and costs for
all those involved.
a
As explained more fully below, laboratories worked eacnsively with C VS in 2002 to develop
s form h a t would be clcar to all. CMS has provided no reason why that form, which was spcciiically
developed to meet the needs of beneficiaries, laboratories, and physicians, is no onger appropriate.
TI.
General Concerns
In 2000-02, ACLA member laboratories worked extensively with CMI sbff to create a clcar,
concise, and beneficiary-fiiendly ABN-L to be used by physicians for labore :ory-spccific resting in
lieu of the ABN ronn for gencral use ("ABN-G"). The ABN-L was creat :d with the bcnefjt of
beneficjay focus groups to ensure Medicare beneficiaries' understanding o f .he ibnn. As a result,
specific language, font size, and formats were considered before the ABN-Lwa ;approved. The valuc
of having had beneficiaries and the laboratory industry involved in tlie develol ment of the ABN-L is
evidenced by its practicality, clarity, and eftectivcness.
The effectiveness of the ABN-L is of parricular importance to labon tories because often a
laboratory will have no dircct contact with the beneficiary. Consequently, lab lntories are extremely
dependent on thc language of M3Ns for beneficiaries' understanding of their fi lancial responsibilities
and the convenience of ABNs to ensure physicians' proper cornplction of the f ~rm.Thc ABN-L was
designed to specifically meet thcsc needs. It recognized that there wcrc only Iw e reasons that a lab
tcst is denied by Mcdicare medical necessity, frequency, and invesrigational/c. :perimental. 'I'hus. the
A13N-L permits laboratories to list the tests that could be denied, and ro specify 1 IC possible reasons for
such denial. . This allowed laboratories to print the ABN-Lf m s in dvance, c st om ired to particular
1,CDs in cffect in a geographic area, and to cnsure that the reasons for the pol :ntial denial would be
oncs that Medicarc would recognize. As noted, this process has worked quite WI 11.
-
Wc see no reason to diminate the current ABN-I, given its success, and CMS has provided no
rationale for creating the new Sample L form to be uscd for laboratory scrvicec. While we arc aware
h t under the Paperwork Rcducrioi~Act of 1995 ("PRA") CMS is required t 1 1 reapprove the ABN
with a notice and public comment pcriod, there is no requirement that a new 4BN form bc created.
Although CMS has indicated that many of its changes are bascd on comments and suggestions from
both notifiers and beneficiaries, we find it difficult to believe that this is tlie form that notifien or
beneficiaries had envisioned for laboratory services, and CMS has failed to a~iculatethe specific
reasons why such comments and sugestions justiry the specific changes ptoposc d.
\J
Office of Management and Budget ("OMB)
June 25,2007
Page 3
As we will discuss in further detail below, the Sample I. form will r e d in unnecessary burden
and confusion to bcncficikes, physicians, and laboratories. Thus, it is neither necessary nor
reasonable to replace the existing ABN-L with the Sample T, fonn, which hss w ~ k e deffectively.
Csmrncrrts Rcgardipg the Burden of the Sarnnlc L ~ o r m
As mentioned above, we find no rationale for revising thc ABN-L, lhich is working quite
effectively, by creating a version of the new ABN form specific for laboraroric! . In fact, as part of the
Cornmcnt Request and supporting documents, CMS bas not even attempted to provide a rationale for
eliminating the existing ABN-L. Because we see no valid reason for CMS 1 > go ronvatd with this
effort. we can foresee no benefit that would outweigh the significant burdens th; t we discuss bclow.
-*1;irsr CMS provides in \he Supportin3 Statement for the new ABN form that an average of 3 1.7
ABNs will be delivered each ycar p a notifier. CMS arrived at this number b determining the total
univcrsc of ABNs and then dividing that number by he total number of physi :ians and practitioners.
Elowever, this process is clearly flawed. The usc of A3Ns will vary significa ~tlyby the specialty of
the physician. For example, in the laboratory context, many typcs of physicia ~swill never utilize an
ABN because they do not order tcsting services. Thus, the use of A13Ns is lib Ly concentrated among
only a few specialties. As a result, the 31.7 figure piveil by CMS fiils to accoL nt for the disparities in
iu use. While somc physicians probably give out a few ABNs, other physicii ns will likely give out
hundreds a year. Thus, the burdm of moving to a new ABN form will b : far greater for these
physicians. Specifically, adopting the new Sample L form will result in unnt cessary adrniais~ativc
and implementation costs for both physicians and laboratories on a far grcat :r scale Ihm has been
envisioned by CMS.
,
Second in ordcr to effectively implement the Samplc L fornl, physicia 1s and their staffs will
need to be educated with respect to the new requirements of the form. For lab ~ratoryservices, it will
be up to laboratories themselves to explain to physicians and their M s how t > fill out thc Sample L
form and how it has changed horn h e existing ABN-L. This educalional effort will not only require a
significant amount of time, but it will also impose a signifjcant financial burden w Iaboratories. Tt will
also impose additional costs to physicians and their praclices, who wi 1 now struggle with
understanding the Sample L forrn, and how it applies to laboratory services. Ch 'S docs not account for
these cons in the burden estimate included in its Supponing Suttement.
-9
--
Third bccause the new format will makc completing the form unnecessarily difficult and
burdensome and will make it far more complicated to crcatc a software pro3 tm tliat will create thc
appropriate fonn when necessary, thc changes will result in an incrcasc in n mber of forms being
completed inconcctly or l
o
r being completed at all.
The ABN-L was standardi-red to a sufficient degree so that laboratot ies could automate its
we, triggering a blank ARN whenevcr thcrc was a valid basis for concluding thz I Medicare might deny
paymenl.' The cusrent hBN-L was formatted vertically so thal each laborator] test could bc listcd in
the applicable reason column. That format allowed different labormxy tcst . to be -arrayed in the
proper column according to the reason applicable to the spccific test. For spacin g reasons, this allowed
several tcsts to be included in an ordcrly fashion without any confusion. Indee 1, i T a laboratory knew
-
We have enclosed w o samplc ABN-L forms *om member hboratories at the end of our comn :nu \o illustrxtethis point.
Office of Management and 13udgct ("OMB")
June 25,2007
Page 4
'
that the carria bad LCDs for 10 laboratory tests that required diagnosis coc cs. then the laboratory
I en the physician could
could list those 10 tests under the column for 'Wot Medically Necessary." T
simply check off the appropria~etest when he or she bclicved h a t Medicare wc uld not pay for the test
with that infomalion.
The Sample L form, however, makes that simple procedure far more d fficult becausc it is set
up diffixenfly, and rcquires that all of the tests be listed in one column. Then, .he reason for each tcst
must be sct up on that same line horizontally. As a result, notifies will be r q t ired to ensure &at tcsts
match up horizontally with the corresponding reason codes and estimated costs T l ~ ehorizontal nanvc
of the box will bc problematic because not only does that limit the number of tc its that can be included
in the box, but tests &at could be denied for more Illan one reason ( e . ~ . , requcncy and medical
necessity) will need to be repeated in the l i r s ~column for each reason of nor xverage. In addition,
ensuring that the tcsts are lined up appropriately will place additional burdens f >rautomation purposes
and pre-printed forms. Although it is possibie that the tests could bc listed, ir will then be up to thc
physicians and their sraffs ta complete the reason column across from each tesl, which will have 10 be
completed by hand, and, therefore will bc prone to manual error. Evcn with t le use of gridlines, thc
formatting of the new Sample L form presenrs anumber of logistical issues.
Further, a typical existing ABN-L includes, on average, 3 tests for each IBN. But, the ABN-L
is desiged to accommodate more than the average number of tests, wh ch occurs hqumtly.
'l'ypically, these tests are denicd for reasons of frequency and/or medical neces, ity. Depending on h e
carrier, there can be as many as 50 types of tests that are denied for thcse reas ms. Most often, thesc
tests include, for example, pap screening, lipid panels, and colorectal wrlcer sc .eening. The layout of
the ABN-L - which allowed numerous tests to be included in esch column, under the appropriate
reason made it easy to fit all of the informazion in a clcar t'ashion on a sin::le page. This will be
difficult to do with the Sample L and, as a rcsul~,additional pages will bc rcquir :d. As such, additional
formatting chwges will be required to ensure that thc attached sheets model the Sample L fonn, which
will increare the cosrs of productior~,transmittal, and storage. Although CM2 has indicated that the
Sample L form can be customized into legal size and the use of attachments is permitted to allow for
additional space, this additional burden on noufiers is umcccssary, considering that thc cxisting ARNL is more than cffcctive.
-
Because of the way the f m i s oganizcd. it will be far more diffic ult for laboratories to
establish software programs that will automatically create the appropriale for n for the physician ro
present to the patient. As a result, physicians or their staffs may not complete fc rms in their entirety or
m a y complete forms incorrectly. Not only does this preclude the laboratory fro n billing Medicarc for
the noncovered item or servicc, where appropriate, but it will also increase the lucstions and inquiries
h a t will result. Ilhe laboramry will havc to spend time trying to contact the ph! sician or thc patieill to
resolve such qucstions. In addition, it is likely that contractors will end up havj ~gto mediatc disputes,
as they did before the ABN was s~andardizedin 2002, concerning whethcr or no an ARN i s valid.
beneficiaries are likcly ro be confused by the changes to the new Sample I- fonn,
including the new language. As we have rncntioned, the existing ABN-L w cs developed with.thc
valuable assistsncc and input of beneficiaries. Through the use of beneliciary f: cus groups, the ABN1, was crafted to ensure that bcncficiaries are adequately notified of any potenti 11fmancial obligations
for a noncovered irem or service. To this end, the ABN-L took into account apl ropriate font stylc and
Ofice of Management and Budget ("OMB")
June 25,2007
Page 5
size, formatting suucture, and providcd the three clear, concise and swldard re s o n s for noncoverage.
The new Sample L form, however, has a different format and font style, as w 211 as the options &om
which the beneficiary must select. As a result of these changes, the physician ( r practitioner will need
ro take cxtra time to cxplain the Sample I. form to beneficiaries and beneficiar es may have diif culty
understanding the new provisions. Further, beneficiaries will likcly inquire a ; to why the ABN has
changed surd may be reluctant to sign the form altogether.
Rfth. the adoption of the Sample L form will impose a significar 1 financial burden on
laboratories, particularly d t u i y thc initial stagcs of implerncntation. This is true because once
labordtories rcceive a test specimen and valid request, laboratories typically n:II the tcst. Even if the
laboratory realized that (he ABN was invalid at that point, thc laboratory wa i d not usually refrain
fiom running the test, both because of thc potential liability if the patient later juffcred injury and the
laboratory had failed to run rhc test, and because, ethically, most Iaborarories t. eliwe the rest must bc
run oncc the laboratory 1x1s received the ordcr and the specimen, even if it nay not ultimately be
billable. Moreover, usually, the ABH is not actually reviewed for correctness u ltil the billing process,
which occurs after the test has been run. Tl~us,each time the ncw Sunple I . form is not properly
complcted or not submitted at all. laboratorics will be forced to absorb the cast of the noncovered
laboratory smice. Furthcr, the Comment Recluest and its supporting document, fail to account for the
significant costs that laboratorics would need lo incur to change their ABP forms, which would
include reprogramming of software and systems, printing costs, and lost i~ vcstmmts in cxisting
inventories of paper ABN-Ls.
IV.
Comments on Specific As~ectsof the Sample t Forg
Wc have outlined our w n c w with rcspecl to specific aspects of thc new Sample I. form
below.
A Cost Estimates
The Sample L form includes a separate column for "Estimated Cosr. .iccording to the Form
Instmctions, "[n]otifiers musr enter a COSI v.vrimare..." on the form. This requirc ment is diffcrcnt lrom
the ABN-L becausc although rhcre is a &signaled space on the fonn for esti nated cost, CMS had
suled that this was not a requirement in its response to comrncnts to the propose 1 ABN-L. In responsc
to a comment requesting that CMS delcte the "cost estimate" requirement, CMS stated that "(tJhe lack
of an amount on this 1ine, or an amount which is different froin the f m l actual cc st, does not invalidate
the ABN; an ABN should not be considered to be defective on that basis." Tr many cases, as CMS
rccopnized, physicians arc simply not aware of what tlie cost may be and. tL us, cannot fill in that
space. Inclusion of this information as a required item will increasc question! aboul b e validity of
many ARNs.
"
.
As such, it should not be required tha~physicians determine the cost of th :noncovered items or
smices included on the ABN for thc ABN to bc valid, and this column should be removed from thc
Sample L fonn. If physicians bclieve that they are required to submit estimate( costs for the fonn to
be valid, they may forego completing the fonn alrogelher. Further, beneficiaries may bc overwhelmed
estimated cosl of a
by all of the estimated costs on the form. If beneficiaries are interested in
-
2
-
CMS, Cornmenu and Responses, Paperwork Reduction Package CMS-R-I
3 I Advance Benefici uy Notice (ABN).
Office of Management and Budge1 ("OMB")
June 25,2007
Page 6
laboratory test, he or she may request rhat idormation from thc physician, whit h is curren~lythe case.
If there is, however, a space on the form for estimated costs, CMS should I lake clear, at least for
laboratory tests, that a physician would only need to complae this section of tk e form if the physician
is aware of such costs.
In addition. CMS should clarify its meaning of a "good faith" estin .ate of costs. This is
important because, as noted above, physicians and their staffs are responsible fi a completing the ABN
form. Accordingly, laboratories do not have the opporh~nity10 complete this ponion of the ABN 10
indicate a good faith estimate of cost and, therefore, laboratories should not t e forced ro absorb rhe
costs of noncovercd terns should physicians and their staffs not complete the scl tion correctly or at all.
Moreover, the ABN-L did not request an itemized cost of each laboratory te: t. l h e ncw Sample L
form, however, sccms to encourage a listing of itemized costs by semice, but 1 m i t s the bundling of
costs under certain circumstances. If CMS iniends to rcquirc estimated cosu a ~d permil the bundling
of these costs, we strongly encourage that CMS make clear the circumstances, if any, when bundling
would be permitted.
B.
Options
The ABN-L includes the following two options fm bcneficiaries to selcc
(I) Yes. 1 wanr ro receive these loboraroy rests.
(2) No. I b e decided nor 10 receive these luboraroly rests.
-
The new Samplc L rorm includes an addiuonal oprion "2. I waptf the luborarory tests listed
above. bur do nrrt bill Medicare. You may ask 10 be paid now as 1 am respc ruible .for payment. I
cannot appeal ifMedicare is nor billed " We find this option to be both unnece ;sary and confusing to
beneficiaries. That is, it is unlikely t h a a beneficiary would not want Medicare to make a
detennination as to whether the item or service was covered by Medicare. 'Ilhe I aclusion of this option
may mislead beneficiaries into paying for an item or scrvice without realizing ~h ~t Medicarc would not
be billed for the item or service and be required to make a determination of t overage. This option
allows Medicare to no! pay for a scrvice that may, in fact, be covered, bt t that thc beneficiary
misguidedly decided to pay for himself or herself. We find this to be unacccpt ~ble. There should be
no option included on the ABN fonn that attemp\s to deny beneficiaries the right to payment for
services that may bc covered by Medicare. As such, we beliwe t h a ~option 2 )n thc Sample L form
should bc eliminated.
Further, we find that the discussion with respect to payment may be con \sing to bcneficiaries
who may be expecting to pay the laboratory immediately afrer tcsting. For exam ple, in the frrst option,
the description states that ''I want the laboratory tests IisleJ above. You muy c dlecr moneyfiorn me
now, bur I also want Medicare billed for an oficiul decision on payment, wh, ,ch is sent to me on u
Medicare Sunzmary Norice (MSN). I undersrand that if Medicore doesn ;' pay I am responrible for
paymenr, bur I can appeal ro Medicare hy follow in^ [he directions on the MSN I f Medjcare does pay.
you will refund amy paymen1.r 1made to you, less co-pays or dehctibles. " Ou . membcr laboratories
typically do not collect payments from beneficiaries at patient service centcrs. Thus, we rccomma~d
that CMS make clear that payment is to be collected at the time of specimen col lcction or testing only
ar thc option of the laboratory. This change will ensure that beneficiaries are a ware that they will be
Onice of Management and Budget ("OMB")
June 25,2007
Page 7
required to make a payment only if the laboratory rcqwsts such payment. FUR1 er, any reference to copays or deductibles should be dcleted from the form, since there arc no co- 3ays or drductibles for
Medicare Part B clinical laboratory services.
V
Conclusion
Tn closing, ACLA does not agree that rlre new Samplc L form is needed for laboratory tests and
believcs that beneficiaries and physicians arc quite satisfied with the existing 4BN-L and would find
the Somplc L form confusing and inadequate. If a new f o m is to bc developer ,however, wc strongly
believe that the OMB should seek additionsl input from the laboratory ndustry and Medicare
beneficiaries before cre.ating a new ABN fom specific to lliboratories, and ve again urge CMS to
conduct beneficiary focus group studies to ensure that significant changes 411 bc understood by
beneficiaries, as this was a critical component to the successful d c s i p of thc ABN-L. Wc worked
closely wirh CMS in the past to develop an effective laboratory-specific ABN, ad we would welcomc
the opportunity to meet with the OMB andfor CMS again, to msurc that ally I uture ABN is eff'ective
for beneficiaries, physicians, and laboratories.
lf you have any furthm questions or commcnts, do not hesitatc to conuc us.
Alan Mertz
Prcsiden~
Enclosures: Samplc ABNs
, ..
KS Removal Stub Location
,,....
Peticnt's Name
Medicare tJ (HlCN):
ADVANCE BENEFICIARY NOTICE (ABN)
I
I
NOTE: You need t o make a choice a b o u t receiving these l a b o r a t o q Tests.
We expect that Medicaro will not
for the laboratory tenjs) that are described below.
Medicare does not pay for all of W u r health care C O ~ Medicare
.
only pays for a verod items
end services when Medicare rules ere met.The fact rhat Medicare may not pay fo ' a particular
item or service does not mean rhat you should not receive it. There m a y be a go( d reason your
doctor recommended it. Right now, in your case, Msdicars probably will not I lay for the
laboratory test(s1 indicated below for the following rbasons:
Mtdicaro does not I 3vfor lhmr t8sE
Media.. doe@w m a w f o r there t e s a for "our condition
---L-I
I
I
Pap Smei r
CEA
cBC
4180 Digoxin
457
Ferritin
6%'
a Hemoglobin AlC
A96 0
571
7573
7600
1
Culture. Urine Routine
395
h e IDB
1
II Other n
0.
.
urner u
, I-.
lu:CO(lrlD;h1m:
Iron. Tom1
E Iron ~ o t )IBC
. x Sat
#
Lipid Panel
5363
PSA, Dx
e a r 7 0 PTWIINR
763
PTT, Acrivsrrd
699
fSH
36127n TSH w/Retlex T-4 Free
when norl
.-
-
A . ~ _ .
1
Other
Other
Other
Other
n Liquid-Ba 4 Pep with or
fl -,. --,.U ..---
u . ..
u
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The purpose of this form is to help you make en informed choice about whether c not you
want to receive Ihese laboratory tests. knowing that you might have to pay for tht m yourself.
B e f o you
~ make a aecision ebour your options. you should read this 0rrtlrt3 no1 ice earetullv.
Ask us to explain. it you don't u n d e m n d why Medicare probably won't Day.
Ask u8 how much these laboratory rests will cost you (Estimated Co& S- , I- . i n case you have to pay for them youtself or Through other insurance.
PLEASE CHOOSE ONE OPTION. CHECK ONE BOX. S16N 81DATE YOUR :HOICE.
Option 1. YES. I want to recoive these laboratory teas.
I understand that Medicare will not decide whether to pay unless 1 receive these 1 lboretory
tesrs. Please submit m y claim to Medicare. 1 understand that you may bill me for nboratory
tests and that I may have t o pay the bill while Medicare is making its decision.
If Medicare d o t s pay,you will refund to me any pryrnenta I made to you that are I ue t o me.
If Medicare denies payment, Iagree to ha personally and fully responsible for pa) rnent.
That it, Iwill pay personally, either out of pocket or through any other Insurance 1 qat I have.
I undeotand I can sppeel Medicare's decision.
n Option 2.
NO.
I hare decidad nor t o recmivs thars laborntoy t n u t r
1 will not receive these laboratory rests.1 undersland that you will not be eble to St brnit e
claim t o Medicare and That 1will no1 be able to appeal your opinion That Medicare won't pay.
1 will notify my doctDr who ordered these laboratory tests mat I did nor receive th !m.
1
Date
Siqnatum of matiant or nor-k acting on patien :'s bahetf
NOTEYoor h e a informltionmllb kept confidm6al. Any information that W D collect abon you In ths tom will
be kept conf~denti~I
in our offlces. If a claim is submitled to Medicare, your heslth information on r L fonn may brt
shsred with Mtdicam.Your health rnformntion which Medicare sees will be kept conYdential by M tdicare.
OM0 Approval NO 0938-0566 Fofm No. CMS-R-131-L
_,. .Screened Box measures:
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| File Type | application/pdf |
| File Modified | 2007-10-09 |
| File Created | 2007-10-09 |