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FOIA Number:
2006-0885-F
FOIA
MARKER
This is not a textual record. This is used as an
administrative marker by the WiUiam J. Clinton
Presidential Library Staff.
Collection/Record Group:
Clinton Presidential Records
Subgroup/Office of Origin:
Health Care Task Force
Series/Staff Member:
Carolyn Gat/yjennifer Klein
Subseries:
OA/ID Number:
5107
FolderlD:
Folder Title:
[Legal Audit Group]
Stack:
Row:
Section:
Shelf:
Position:
S
56
5
5
3
�Withdrawal/Redaction Sheet
Clinton Library
DOCUMENT NO.
AND TYPE
SUBJECT/TITLE
DATE
RESTRICTION
001. list
re: Legal Audit List - Clearance List (partial) (1 page)
05/14/1993
P6/b(6)
002. resume
re: Eleanor DeArman Kinney (partial) (1 page)
ad.
P6/b(6)
003. resume
re: Paul S. Ceja (partial) (1 page)
04/22/1993
P6/b(6)
COLLECTION:
Clinton Presidential Records
Health Care Task Force
Carolyn Gatz/Jermifer Klein
OA/Box Number: 5107
FOLDER TITLE:
[Legal Audit Group]
2006-0885-F
ip2651
RESTRICTION CODES
Presidential Records Act - |44 U.S.C. 2204(a)l
Freedom of Information Act - |5 U.S.C. 552(b)l
PI
P2
P3
P4
b(l) National security classified information ](bXl) of the FOIA]
b(2) Release would disclose Internal personnel rules and practices of
an agency l(bX2) of the FOIA]
b(3) Release would violate a Federal statute )(bX3) of the FOIA)
b(4) Release would disclose trade secrets or confidential or financial
Information 1(b)(4) of the FOIA]
b(6) Release would constitute a clearly unwarranted Invasion of
personal privacy 1(b)(6) of the FOIA]
b(7) Release would disclose Information compiled for law enforcement
purposes ](b)(7) of the FOIA]
b(8) Release would disclose Information concerning the regulation of
financial institutions ](b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
concerning wells ](bX9) of the FOIA]
National Security Classified Information 1(a)(1) of the PRA]
Relating to the appointment to Federal office |(aX2) of the PRA]
Release would violate a Federal statute |(aX3) of the PRA]
Release would disclose trade secrets or confidential commercial or
financial information ](a)(4) of the PRA]
PS Release would disclose confidential advice between the President
and his advisors, or between such advisors ]aXS) of the PRA]
P6 Release would constitute a clearly unwarranted Invasion of
personal privacy ](a)(6) of the PRA]
C. Closed in accordance with restrictions contained in donor's deed
of gift.
PRM. Personal record misfile defined in accordance with 44 U.S.C.
2201(3).
RR. Document will be reviewed upon request.
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121002/006
HRST AVENUE AT I6TH ?rmr. NEW YORK, NY 1C0O3 (su) 420 2000
May 3, 1993
To:
Legal R«vl9w Group
From: Kathryn M«yer ^|/>y^V^
Enclosed for your r«vl«w are digests of my notes from
Thursday's ina«ting and Barbara McGarey's notes from Friday's
meeting (unfortunately, Barbara's notes are partially illegible
I have tried to f i l l In the missing language where possible.) I t
strikes me that Barbara's notes include most of the issues froir;
Thursday, and that with some alight adit ing we could use h«r
draft as the document we submit, I also think that, given the
amount of flux that remains in the program, i t isn't worth
spending too much time refining these papers.
I can be reached at 212-420-2929.
AmUATBD WnW MOUNT 5INAJ SCMOOT. Of MHDICINE.
MKMBBK OF PEDBRATION OF JfeWISK PHILANTHK 'P1E8,
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BIMC LEGAL DIV
1^003/006
LEGAL REVIEW GROUP MINUTES — APRIL 29, 1993
A.
Legel Issues Raiaed By the Group
1. What standards and procedures w i l l be established to defino
"medioally necessary"? Will there be an administrativ© procee^?
Can states vary in t h e i r definitions?
2. How "governmental" muat the Health Alliances ("HA") be i n
order for them to be able to sot and c o l l e c t premiums? Do the
powers of the HA's constitute an unconstitutional delegation of
the federal taxing power? I s the answer different i f the HA i i a
state agency? I s the answer different i f the employer i a not
required to make contributions to the HA, merely denied the
deduatlbility of h i s premium costs? Should the HA ba a federal
agency?
3. What standards and procedures w i l l be established to
determine the setting of premiums?
4. What ERISA preemption issues are raised by using the HA's ^o
establish premiums for qualified plans?
5. What effect do the states' legal and constitutional
limitations on governmental taxing powers have on the a b i l i t y
the HA's to set and c o l l e c t premiums?
6.
To What extant does the federal program preempt state law?
B.
Legal issues Raised By Task Force Members
1. What options are available to the federal government i f a
state rafusas to comply with federal requirements? can the
federal government intervene and take over a state's program?
2.
IB there a better phrase than "medically neaessary"?
3.
Who can sue whom for what?
C.
Factual Issues Raised By the Group and Not Yet Answered
1. What exactly i a meant by the phrase "the Health Alliances
bear no r i s k " ?
2. How w i l l the HA's c o l l e c t premiums? HOW w i l l premiums be
collected from self-insured individuals?
3.
How w i l l the states' budgets be established?
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BIMC LEGAL OIV
WHITK UOOSE
. . . BIMC LBCAL Olv
Stored as legal.iss; rovJoou April 30, 1993
GENKRAT.
T.S5;M1:S ID£N1''ZFIED
BV LEGAL AUDIT GROUP
General
Wha-t doss pQd*r.'«l pi\:.'\t;utc have: ro include te eneuce
censlatenoy, 'foitwets^ and anfnmnTihn i ty oi the
program?
Hedioal MalpzacLlco/rorc KfrfOi'ffl
KQv can ve Kasp madir:nl mnlprnctios in tha state
oeurtsf
Enterprise
Llnb( Ut:yj wiLcn or without rmpn
Flans must nffsnr^^niT C'&^f.'l.stant with Stats ststutea
elMady in p; ace. cr",: ,•: lu ocfrsm croeting another layer?
What tort rnf'.'u';;i-< mnkft .'innpft - r,«p« on damages, oapa en
p l o i n t l f f a ' n^r^m'ieye' i^8i3M, iiiMiidaT:ory c o l l a t e r a l
o f f s e t , \ir\iffii'<; .::!-iUiic of llmixationo?
What private nausr'ii
ac.V.ion aire necdtisary?
What type &r i Mimploin 1:! cLflLrion w i l l davalop'/
Olsolosure v, l^ifernu^i (-cinttnt - vho.rft tn draw the
botwoon eonsv;:mc<f CLM p.ici.ent
Benefits
/aped
f i. •
line
: .ii.' i L i, uv of ueneti us
What i s meriieai^y w^c^aswy./i'i^dically appropriats i s eonaum«r/p.ch'arvrb <<|jinion or cos-c-sffscxivanesB fie
faetered into rneit'c^iIv AcocD<aory
appropriate
decision-m&Kiiig?
Will IndlvldvoJ v6rto ii».>v(ti<i in and ouc of oinplaymont with
larHtt flrmu (ao, m^onc^d bi> chanoR pi ans. assuming InrgA
f i r m KA docns'^"^
,,i :':it;:c v;i';h cciin* p l a n s ?
Should prorjrAm dfof.Asrr? «taw jiVatutory lanflufiBe or build
an nedicsXi V v^easlSttw>^i^^o<3^.tftIJLy.r^ppropriote?
Foderol/State
Inin-
i.ir:rj.-i.i Aui-liu: iLy for proqrsni
What l a the Uinicnt\^t'l(.i^;2il basi:^ tnr the tinancing of
the progre")'"
Probleme of Ui«^«.or>sti-tuti.c,ial tJ^-icyitrion ot T»xing
authority fu•^ ..
i iifni fJop.onding nn what entity I s
1£1004/00B
iflui^a,-vu«
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i
determining sno collecting benchmark premium.
Authority to r.^gulate cor.'sract betv>?Ben non-HA employers
and plans (pro^rv* propor as "'-o regulrs omployer plens
to eeeept QLL da.^eiK'.in!U.«. cci.iect data, e t c . )
Authority for
nc: ft^et© "paysack,"
10th Amendme:')':- Xss^e^
Issues regard;i.i ..j f; c:..t;cis' bBlanoed budget amendment
l e w i , "tnti-desfc'ici^-.'iny" lows
Federal Pre-emption
What State }.avus OBA^pre-errpcsd by tha pragr.-im?
Are State pobl-c.'V)«AJ?l:h auchurlties (suci-i t^n
communieabKi oiise**-**' r*jpori:.1,'.-ig rnquiremonv.ft, quarantine
and detent.lotN
lUifta:. pre-emipted by i.his program?
HOW do nati-'hi3k.^ c^occl I f,v of -^era regulations
state law? ^^.d ^ ro-^.n«")(i»?
pre-empt
Uegel Structure o; H.\
Za the HA a cj»ivof:?ftinsnt:il ii:i;ity (port of State Health
system or othSi- S+ttfttt siitxtyj
la
tha HA a rr^t»^-jsro.f i I- pri./^i:e corporation?
Dlf fer^^mt lagai ;prc k>.(if.nn.^; Fi..uii-t;jia depend incj on structure
and B'jthor:: L-^>{ of4WKA > .i ,e . unconsrj.tutlonol
delectation oF'^^o»/«-'""^rMi-:ncs.l regulatory authorities)
Bit:3.'Luaive v. Fiow-fti«<c!.iJsivp. HAS - how can o large firm
wh.f crli forms iris- '•'JOI*. IIA perform tho governniontal, quaelrisgulatory -•iiriCfe-/«.:n.s of tha MA, such as rntf* setting,
•^iwrtifioaticm .of plDn.?, 8v.-:hority to rejscv c e r t a i n
pXuxi i , and ^,^pri:.vOi..L of iua:o:- expenditures of plana?
Forum ot Dispute Ce-iolu-Ho^/hQc.-r- of Liabilil.y
Who sail BUG \>j\r>orr\
vjhrht
and in whnt fcirum?
What are pro<-a,ciiun8jS (;.,.«., ;:!n:«ndlng) and substantive
•tandards Xoc cA-Vsi^uLe r'fiir;clutiQn
ERISA
How does the- ^.rtgiJKMY;^ j; siiata i;c- ERISA
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DIV
Confidentiality
How do rederal .anA^ S+'aJflfc f0: laws ralijita to information
OOlleotion provi'&rQ.tnA of ,)i*ogram?
Provider qnnf,'dl<a*vtfai i ry > .'
How do inio>TY\CL+i"ar'i Ca I j,rtc ti'LPi prov.L8iohs r e l a t e to
current Fadftro^L .uM si^ie. f.mfidentiolity laws ( i . e , 42
U . S . C . 290,1 '
CD(\ttdK#kl 1 1 • ty of alcohol and drug abuse
treatinent
i• .
1983 Suite AgaxnsL; ^i-t-ioj£^
Transition
IB6U&.«--.
I
Anti-Trust/Anti-K>>''«^i='*^ 15S!JO, J '
Are there (fncsi'>S' S •'*ri?r.<i«e-:' in now program encouraging
provider c.-Qa^cro^-^'(yy-^ .OL,A .'inti-trust prohibitions i n
current PstidiinjsJl i^ci
.mw/
National Manda-ae. vs
-^-^t v,
What i a tho -cx^ev«K' ::.;i iite v n r i a b i l i t y which w i l l be
allowed i n , -finr- «:viar»j.»te, isuppjeinantal insurance,
supplementnl V-n«,.Rfe>7
R e s t r i c t i o n ev^
.1 •ii;.,;Jit-i'.nhrkoting raises questions
of llmltir.fj
1 ;j;|.i,iii;icn by plans or insurers consumers i:. •
i. li it jr •v'oriiiiisnt limiting the
Informatior, «.ga.ilatei-e^ i
iii,-iita plans.
121006/006
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SCOTT HAflSHBARGER
ATTORMVaetUAL
(617) rir'38eo
FACSIMILE COVER SHEET
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ho^^
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ORGANIZATION: A^^g^' "^^-iJC C
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t ^ ) 2'^Cl
[HAX)
fL^-
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FACSIMILE #:
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PAGES (INCLUDING COVER SHEET)
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tt202 P02
M E M O R A N D U M
TO;
Barbara McGarey
Deputy Director, Office of Technology
Transfer, NIH
FROM!
Barbara Anchony
Chief, Public Protection Bureau
Massachusetts Office of the Attorney General
One Ashburton Place
Boston, MA 02108
Telephone #: (617) 7^7-2200
Fax #: (617) 727-57e2
DATE:
May 3, 1993
Below axe some additional comments on the general issue^
list:
.1.
2.
Re:
Medical Malpractice/Tort Reform
a)
What i s disposition/redistribution of savings
generated by providing tort immunity Cor practitiohers?
b)
Are ths rights of consumers being inadvertently
curtailed by r e s t r i c t i n g tort claims to the health
plans? Are there instances where "enterprise
l i a b i l i t y " w i l l foreclose a right of action that t|he
consun\er may have had against an individual
practitioner? Shoul^a there be some language added to
insure that euch i s not the intent?
Forum of Dispute Resolution
a)
I s the federal claims dispute resolution syetsm
proposed intended co be an exclusive remedy?
b)
Ifl i t intended to preempt access to state agencies or
courts with respects to disputes about benefit
claims? This should be c l a r i f i e d .
BA/bt
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MEMORANDUM
TO:
I r a Magaziner
Larry Gostin
FROM:
Mark Barnes
\
DATE:
May
I
RE:
Public Health Services in the Health Care Reform PackSge
4, 1993
I would l i k e to c a l l to your attention a series of issv.es
related to state and local public health law and practice which, i
believe, require urgent attention during this l a s t stage of the
health reform review process.
I have serious concerns that the
range of public health interventions and services — from free
specialty c l i n i c s treating tuberculosis and sexually transmitted
diseases, to the non-clinical interventions of contact tracing,
directly-observed therapy for tuberculosis control, detention or
c i v i l commitment, and environmental inspection — have not beien
f u l l y considered or integrated into the health care reform
proposals.
This i s of conoern for two primary reasons:
first,
because a national health care reform package that does not
consider and include these services may have unintended preemptive
effects on these laws, regulations, and services; and second,
because not including these essential prevention services w i l l
hinder the overarching prevention and cost-efficiency goals of the
health care reform package. I have summarized below the areas of
concern and possible solutions,
I.
Public Health Specialty C l i n i c s and Treatment Systems
Since the l a s t decade of the nineteenth century, municipal ejnd
county health departments have established and operated systems of
disease-specific c l i n i c s whose primary purposes are not so much the
trgfitmgpt
af
individual paUents ia
tlis
interruption of
transmission
&£
infectious disease.
Interrupting dis lea
transmission takes place through two primary methods:
f i r ^ t,
treatment to render the patient non-infectious, and second, tjhe
triggering of contact tracing, contact evaluation, and offering of
treatment to others who have been exposed to the index pati.er t
For persons with sexually-transmitted diseases, for example, a
specialty sexually-transmitted disease c l i n i c treats, in some casjes
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pseudonymously, the infected patient, but also maintains on-sit«» a
corps of public health professionals who interview each pati€int
about previous sexual contacts and who then personally v i s i t tjhe
sexual contacts to offer counseling and treatment. Similarly,
public health tuberculosis c l i n i c s , treatment of patients to render
them non-infectious
i s accompanied by interviews and
c^se
management by public health professionals, to evaluate the conta
of index cases and to follow the index cases over time to ensdre
completion of anti-tuberculosis treatment.
For tuberculosis
patients, t h i s may include designating a public health worker to
observe the patient take his or her prescribed daily medication
a process referred to as "directly-observed therapy."
By interviewing and case managing these patients, and by
coupling,
on-site, individual treatment with public hea]|th
interventions, we not only can interrupt transmission, but we a] so
can achieve an economy of scale, simply by stationing our corps of
contact tracers and case managers at select locations instead of
throughout the health care system. Further, because treatment may
be given in these settings (as in publicly-run family plann i|ng
c l i n i c s and confidential Hiv testing s i t e s ) on an anonymous or
pseudonymous basis, some persons may come into treatment in th^se
c l i n i c s who otherwise might forego any treatment at a l l .
School-based health c l i n i c s at which children receive primary
care, preventive care and immunizations, and free-standing chi Id
and maternal health c l i n i c s , are other examples of specializ ed
public health c l i n i c s that serve preventive functions and that
promote the health not only of individual patients, but also of
others, including family members.
In these c l i n i c s as we 3|1/
economies of scale are achieved, and public health interventi ens
can be rapidly used, where indicated.
The maintenance of these public health c l i n i c systems se ems
e s s e n t i a l enough, based on h i s t o r i c a l and p r a c t i c a l experience, to
merit t h e i r preservation in the f i n a l health care reform proposall1.
Although the proposals cohtemplate the desighatioh of "essenti al
community providers" (ECPs) and a five (5) year phase-in period
tor
the ECPs' f u l l participation in local health plans, the proposal
do not address the issues of (1) ensuring the continued v i a b i l i s
of these publicly-run c l i n i c s after the phase-in period, based ty
on
their public health importance; (2) leaving options for developing
future specialty public health c l i n i c s , as diseases may emeige
whose infectious nature and a f f l i c t e d population indicate
usefulness of such c l i n i c s ; (3) ensuring sources of anonymous the
or
pseudonymous care when these c l i n i c s otherwise
must s eiek
reimbursement i n every case^by identifying the patient to his or
her health plan; and (4) ensuring the use of t r a d i t i o n a l publji c
health interventions such as counseling about contacts, case
management, and directly-observed therapy in the c l i n i c setting
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As potential solutions, I propose that the Task Force consider
the following:
1 .
For existing disease- or population-specific c l i n i g s ,
especially for those with particular preventive or public
health purposes, a l l health plans i n the c l i n i c s '
catchment areas should be required to reimburse t;he
c l i n i c s for services rendered to plan members, at
standardized rates. This guarantee of payment should be
extended beyond the five (5) year phase-in period. I f
these c l i n i c s do not provide quality care to patients,
then presumably their patient population and sources of
revenue would decline appropriately.
For patients who wish access these services on an
anonymous or pseudonymous basis; the health plans in the
catchment area would make periodic payments to these
c l i n i c s , based on the plans' shares of identifial^le
patients receiving services at the c l i n i c s .
3.
Patient-specific p\iblic health interventions offered by
health department o f f i c i a l s at these c l i n i c s , such as
case management, counseling about contact n o t i f i c a t i cn
disease prevention counseling, and directly-observ
therapy given in a c l i n i c setting, would be reimbui
under the health plans, as part of each persor.
comprehensive benefits package.
4.
Purely anonymous service c l i n i c s , such as anonymous U V
counseling and testing s i t e s , would continue to be funded
through federal, state and local prevention funds, and
not reimbursed through health plans,
II.
Public Health Interventions
Adjunct to C l i n i c Settings
In addition to purely voluntary interventions (counseli4g(
case management) offered i n public health c l i n i c s , public health
personnel i n these c l i n i c s are trained to offer and to provide a
range of other, more aggressive interventions. For tuberculos i s
patients, for example, these interventions can include f i e Id
outreach so that public health workers observe a patient receiving
his or her anti-tuberculosi^ medications voluntarily each day for
s i x (6) to nine (9) months, u n t i l the patient i s cured; givljng
these medications each day by v i s i t i n g the patient at home or in
other non-clinic settings; giving these medications to pat
:iert s
pursuant to a court or public health authority order to th e
patient; or even detaining the patient i n a r e s i d e n t i a l medi ca 1
setting so that the patient remains i n state custody, wii th
medications given every day, u n t i l cured. For sexually transmi ttjed
diseases, these more aggressive interventions can include con t^ct
tracing in the f i e l d and even public health orders for examinatl on
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or treatment. Similarly, for children with elevated blood lejad
l e v e l s , public health inspections of their homes or apartments are
immediately undertaken to identify and abate causes of lead
poisoning. This public health inspection process protects both the
index child, as well as other children in the child's family, fi|om
further lead ingestion and i l l n e s s .
Wild-1"
My understanding of the current reform proposals i s that they
would not regard these interventions as part of a comprehensijve
benefits package, even though these interventions are designed to
prevent disease transmission^to others and therefore are more cos teffective than the treatment whose sole intended beneficiary i s tihe
individual patient.
At the same time, however, such coerc ive
interventions for mental i l l n e s s , such as court- or physici a|nordered day treatment or involuntary c i v i l commitment, wou Id
apparently be reimbursable as part of psychiatric coverage in tjhe
comprehensive benefits package.
Conceptually,
t h i s i s an
inconsistency. Why should a tuberculosis patient who does not tajke
his or her medications and who needs the medical intervention of
c i v i l commitment u n t i l cure, both for his or her own health and ^or
the health of others, not (receive" that intervention, while tihe
involuntarily-committed psychiatric patient e s s e n t i a l l y receives an
entitlement to medically appropriate residential care?
Indeed, we have seen many instances recently of tuberculos i s
patients who have been hospitalized multiple times for the i r
disease, only because they have never had the kinds of publ i c
health follow-up support that would ensure their continx; ed
compliance with medications and their cure. These patients revolve
in and out of acute-care hospitals, receiving only episodic care
because that i s the sole type of care that tfi reimbursed by
existing funding streams.
Discharged from the hospital, they
return to the community, do not take anti-tuberculosis medications,
and reactivate their dised'se, harming themselves and others
Increasingly, these revolving rehospitalizations lead to the
development of drug-resistant strains of tuberculosis, making
treatment more d i f f i c u l t and much more expensive. Health reforms
must find ways to avoid these repetitive human and f i n a n c i a l costs.
VIA not
One could argue that other federal, state and l o c a l public
health funding streams should pick up the costs of these
interventions, as they have in the sexually-transmitted disease
(STD), tuberculosis and lead paint inspection contexts for many
decades.
Yet f a i l u r e to include these interventions in the
benefits package w i l l mean that many states and l o c a l i t i e s w i l l rot
employ them effectively, or at a l l , leading only to more cases of
infection, disease, and increased costs for individual treatment.
Further, some presenters to the legal audit group indicated that
states and l o c a l i t i e s w i l l be barred from adding supplemental
benefits to the comprehensive benefits package.
Since many of
these more aggressive interventions (directly-observed therapy,
intensive case management, c i v i l commitment with good care and
�SENT BY:D0H COMMR. OFFICE
5- 4-93 ; 8=17PM
2129640472-
202 456 7739;#13
nutrition, public health inspections for sources of environmental
pathogens) can easily be construed as great benefit to the
individual patient, i t i s unclear the extent to which states and
l o c a l i t i e s would be able to fund and offer such additional
intervention "benefits" to patients. Ultimately, however, the more
mandatory nature of these interventions means that only government
e n t i t i e s may undertake them; and p r a c t i c a l i t y and efficiency
dictates that these public health services should continue to be
centralized i n existing departments of public health.
In summary, then, my concern i s that the f u l l range of public
health interventions has not apparently been included in the
benefits package as "medically
appropriate"
or
"medically
necessary," even when these interventions are the most costeffective available for preventing future i l l n e s s and for treating
individual patients. Further, my concern i s that any bars to state
or l o c a l "add-ons" to the comprehensive package not be construed to
prohibit these non-clinical, " f i e l d " public health interventions,
including such "benefits" as intensive case management and daily
observation of patients' taking medication in their homes or other
non-clinic settings. My recommendations therefore are as follows:
1
I f prevention of future cost i s an overarching goal of
the reforms, then preventive non-clinical interventi cn s
such as case management, directly-observed therapy i n tlh e
f i e l d , preventive detention or c i v i l commitment, and
public health inspections to identify sources of
environmental pathogens, should be covered by
the
bertefits package, and should be reimbursable to the
health
or
social
services agency providing
the
intervention, to tjie extent that these interventions are
patient-specific
rather
than
non-individualize|d,
population-wide efforts.
2.
In any case, even i f these patient-specific interventicjns
are not covered, any bars to state or l o c a l "add-ons" to
the benefits package must be written so that there i s no
prohibition
of
these
necessary
public
health
interventions.
I f e x p l i c i t non-preemption were the
option chosen, there i s a pressing need, as I believe one
c l u s t e r group recommended, for a percentage set-aside of
plan premiums to fund these cost-effective interventions
This percentage would need to be adjusted to conform to
the widely varying public health needs of different
health alliance areas.
Areas with much higher public
health needs, as determined by epidemiologic evidence,
should receive proportionately higher percentages of
premium funds.
III.
The Integration of Public Health Prevention Strategies
into Health Care Delivery
�SENT BY:D0H COMMR. OFFICE
5- 4-93 ; 8=18PM
2129640472-
202 456 7739;»14
A third major area of concern i s the ways in which publi c
health prevention measures w i l l be integrated into the delivery of
medical care to individual patients in general ambulatory c l i n i c s,
private physicians' offices, and acute and
long-term calre
f a c i l i t i e s . For patients with tuberculosis, HIV/AIDS, sexuallJy
transmitted diseases, or other conditions e t i o l o g i c a l l y linked to
environmental conditions or " l i f e s t y l e " factors, and for patien ts
not i l l but who need preventive measures to avoid i l l n e s s , theJre
are a range of public health interventions that are indi.cated
These measures include case management and intensive follow- up
directly-observed therapy, contact evaluation and contact tracinjg
immunizations, prevention counseling and periodic counse ling
reinforcement, family counseling, and in extreme cases, preventive
involuntary confinement, especially for patients with multi-drug
r e s i s t a n t tuberculosis who w i l l not or cannot adhere to medication
regimens, even with case management.
Unfortunately, when patients with these conditions seek care
in settings other than specialty public c l i n i c s , we have d i f f i c u l t y
ensuring that these prevention interventions are integrated into
the delivery of medical care, even though we know that such
integration i s necessary to achieve overall reductions i n morbidity
and transmission.
Further, because they are often preventive
rather than curative, the integration of these interventions into
c l i n i c a l practice i s not generally susceptible to "outcorres
measurements." Yet according to the presentation to our legal
group by the quality assuI^ance and information system cluster
group, the Task Force i s apparently headed toward using "outcomes"
as the primary method of measuring quality of care.
Such a
yardstick i s , in my estimation and experience, i n s u f f i c i e n t to
gauge the most cost-effective public health interventions:
although perhaps counter-intuitive, public health success i s
measured, sometimes impossibly, by disease that does not occur,
rather than by disease successfully treated.
In the presentation made to our legal audit group by Arncld
Epstein and others, we also were told that quality of care
regulations, and even such areas as f i r e safety, patients' rights,
and "sanitation," would be standardized through federal regulations
applicable to a l l health care providers, but enforced through state
health delivery regulators. Presenters to our group seemed, at the
same time, unsure as to whether and how these standardized federal
regulations would preempt existing state and l o c a l health and
public health regulations, such as mandatory retention i n acvte
care f a c i l i t i e s and isolation of infectious patients. These pl4ns
r a i s e two primary areas of concern, and suggest two options;
1.
I f these federal regulations are crafted so as to preempt
existing state and local health and public health
regulations, then public health concerns and traditior.al
public health rules, from disease reporting to i s o l a t l on
to detention/retention
of
infectious patients to
�SENT BY:D0H COMMR, OFFICE
2129640472-
; 5- 4-93 ; 8=19PM ;
202 456 7739;#15
2.
frcnt
»n<5 iocal
' " l l t y of h^f'' effect a! ' ' ^ ' i " ' «nl
•>«ithcVre^|"? would thus ^oonV."
d ^ a l / r l ^ " ! ' <md
°^«3s, the r^^i
quality
^Sy'oorX^°' " " J \ j , % " i « o r y 5r,i^^ « f o ™
« r e c ^ C t i l " * ^ or 'chosen'"" *°
t^ar.'"..'""- arl°as
public health^T
federal reguirf® '"P^^on of
longrtfrr*^^ for delivert^!^^'"«'^ts Of ^ „^^^,^ health int^^^^^ ^ore
valuable
delivered^^.
f'o/j^^-V'^ °f ca'e r^'°"^
f^st include
Of pafcV."f^tion /contac*-
4."*^^"^ referral o^?^
«":£^i5¥a.iuy~... .......
t\\'i'^^'^iur\^^,«^^^^^^^^ -/e'fc^,-°"temp\^^^^^^
quality of
wouli^^^^^ ^^nefits^"!^f^« these s t e L ? ^^^^ividual ^''/^f^ration of
waste valuabie^^^^^^^' ^nd/or
^^^'"i^ursemen^^"^®- A l i
opportunities to V"""^^^^ of ca^l'"°?^^^'
to prevent disease
^^^^^^rda
mm-'
�SENT
BY:D0H
COMMR, OFFICE ; 5- 4-93 : 8:20PM :
2129640472-
202 456 7739:#16
�Withdrawal/Redaction Marker
Clinton Library
DOCUMENT NO.
AND TYPE
001. list
SUBJECT/TITLE
DATE
re: Legal Audit List - Clearance List (partial) (1 page)
05/14/1993
RESTRICTION
P6/b(6)
COLLECTION:
Clinton Presidential Records
Health Care Task Force
Carolyn Gatz/Jennifer Klein
OA/Box Number: 5107
FOLDER TITLE:
[Legal Audit Group]
2006-0885-F
jp2651
RESTRICTION CODES
Presidential Records Act - |44 U.S.C. 2204(a)|
Freedom of Information Act - |5 U.S.C. SS2(b)]
PI
P2
P3
P4
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an agency 1(b)(2) of the FOIA]
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b(4) Release would disclose trade secrets or confidential or financial
information 1(b)(4) of the FOIA]
b(6) Release would constitute a clearly unwarranted invasion of
personal privacy 1(b)(6) of the FOIA]
b(7) Release would disclose information compiled for law enforcement
purposes 1(b)(7) of the FOIA]
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financial institutions 1(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
concerning wells |(bX9) of the FOIA]
National Security ClassiHed Information 1(a)(1) of the PRA]
Relating to the appointment to Federal office 1(a)(2) of the PRAJ
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financial information 1(a)(4) of the PRAj
PS Release would disclose confidential advice between the President
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P6 Release would constitute a clearly unwarranted invasion of
personal privacy i(a)(6) of the PRA|
C. Closed in accordance with restrictions contained in donor's deed
of gift.
PRM. Personal record misfile defined in accordance with 44 U.S.C.
2201(3).
RR. Document will be reviewed upon request.
�REQUEST FOR APPOINTMENTS
To:
Officer-in-charge
Appointments Center
Room 060, GEOB
Please admit the following appointments on
far
.'fl^nae''
Mo^
Klein
^
nf
, Ifl
J)o>y)fif'.'C
(NAME OF rCRION TO BC VKITEOl
Pff/ay
(*«KNCV)
'
LEGAL AUDIT LIST
CLEARANCE LIST
Barbara Anthony - DOB:
Mark Barnes - DOB:
P6/(b)(6)
P6/(b)(6)
-
P6/(b)(6)
Margaret F a r r e l l - DOB
Ed Goldman - DOB:
P6/(b)(6)
P6/{b)(6)
Michael Graetz - DOB;
P6/(b)(6)
P6/(b)(6)
Angela Holder - DOB
P6/{bK6)
Barbara McGarey - DOB:
Kathryn Meyer - DOB:
P6/(b)(6)
Peter M i l l o c k - DOB:
Betsy Ryan - DOB:
P6/(b)(6)
P6/(b)(6)
Marjorie Shultz - DOB:
Rick Slowes - DOB
P6/(b)(6)
P6/(b)(6)
MEETING LOCATION
Requested by
Building.
Room No.
•^11
Time of Meeting.
thyvr^-i.^
Room Mr.
T>l>phntv.
Date of r>qtii»tt
^ I /
2^
U
j f j
Additions and/or changes made by telephone fhould ba limhad to VM» (S) namat or tan.
APPOINTMENTS CENTER: SIG/OEOB - 395«>4« or WHITE HOUSE - 466-6742
U N I T E D S T A T E S S E C R E T S E F . . .k..
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�CURRICULUM VITAE
ELEANOR DeARMAN KINNEY, J.D., M.P.H.
Indiana University School of Law — Indianapoli.s
735 West New York Street
Indianapolis, IN 46202
317-274-4091
EMPLOYMENT
Professor of Law, Indiana University School of Law ~ Indianapolis, Indianapolis, IN, Aug. 1990Present; Associate Professor of Law, Aug. 1988-Jul. 1990; Assistant Professor of Law, Aug.
1985-Jul. 1988; Visiting Assistant Professor of Law, Aug. 1984-Jun. 1985; Adjunct Professor of
Law, Jan. 1984-Jun. 1984. Professor of Public and Environmental Affairs, Part Time, Indiana
University School of Public and Environmental Affairs, 1993-Present.
Teaching areas: Health Law, Administrative Law, Insurance Law and Torts.
Recipient, The Best New Professor Award, Student Bar Association, 1986.
Director, The Center for Law and Health, Indiana University School of Law ~ Indianapolis, Jul.
1987- Present; Director, The Program for Law, Medicine and the Health Care Industry, Jul.
1986-Jun. 1987.
Consultant to the Congressional Office of Technology Assessment ("OTA") to study the Impact of State
Tort Reform on the Medical Malpractice System and Physician Behavior for OTA's study on Defensive
Medicine and the Use of Medical Technologies, Sept. 1992-Present; Consultant to the Administrative
Conference of the United States to conduct three studies: (1) The Medicare Appeals System for Coverage
and Payment Disputes, Dec. 1985-Dec. 1986; (2) Procedures for Making National Coverage Policy under
the Medicare Program, Apr. 1987-Dec. 1987; (3) Rule and Policy-Making in the Medicaid Program, Oct.
1988- Dec. 1990.
Principal Investigator on the following grants and contracts: Grant from The Robert Wood Johnson
Foundation to Study Barriers to Private Health Insurance for the Seriously 111, Sept. 1992-1994; Grant
from The Robert Wood Johnson Foundation for Planning Phase of a Demonstration of Quality Assurance
Strategies for Indiana's Community-Based, Long-Term Care Program, Sept. 1992-Aug. 1993; Grant from
The Robert Wood Johnson Foundation to Evaluate Indiana's Medical Malpractice Act, Jul. 1987-Jun.
1990; Grant from the AARP Andrus Foundation to Study Issues Regarding Medicare Appeals for Home
Health Services, Jul. 1988-Jun. 1989; Grant from the National Multiple Sclerosis Society to study barriers
to health insurance for individuals with disabilities and chronic disease, Oct. 1989-Oct. 1990; Contract
from the Indiana Department of Human Services to Study Indiana's Community and Home Option to
Institutional Care for the Elderly and Disabled (CHOICE) Program, Sept. 1989-Dec. 1990; Grant from
the Indianapolis Research Support Committee, Indiana University, to establish the Center for Law and
Health, 1986-1988; Contract with the Maryland Department of Health and Mental Hygiene to Study the
Organizational Structure of and Linkages between the Rate Setting and Health Planning Functions in
States with Mandatory Hospital Rate Setting Programs, May 1985-Aug. 1985.
�Assistant General Counsel, American Hospital A.ssociation, Chicago, I L , Aug. 1982-Jun. 1984.
Directed the State Legal Initiatives Program responsible for all state legislative, regulatory and judicial
issues for AHA's Office of Legal and Regulatory Affairs. Assisted in directing activities of AHA's
Office of Legal and Regulatory Affairs on federal health law issues. Served as Legal Advisor to AHA's
Office of Health Care Coalitions.
Program Analyst, Office of the Assistant Secretary for Planning and Evaluation/
Health, Department of Health and Human Services, Washington, DC, Jun. 1979-Jul. 1982.
Served as coordinator of legislation and regulations; principal analyst for capital financing and regulation
issues with work on Medicaid and civil rights issues.
Recipient of the Office for Civil Rights award for distinguished performance on the New York City
Health and Hospitals Corporation Investigation, May 1979-Sept. 1980.
Estate Planning Officer, Duke University Medical Center, Durham, NC, Sept. 1977-Jun. 1979. Tax
and estate planning work for donors to Duke University Medical Center.
Associate Attorney, Squire, Sanders & Dempsey, Cleveland, OH, Jun. 1973-Jul. 1977. Litigation
and corporate practice specializing in tort and medical malpractice issues.
Summer Intern, Legal Aid Society of Forsyth County, Winston-Salem, NC, Summer 1972. Designed
and implemented a program to improve legal services for the elderly poor.
EDUCATION
J.D., May 1973, Duke University School of Law, Durham, NC (Editorial Board, Duke Law Journal);
M.P.H., Dec. 1979, University of North Carolina School of Public Health, Chapel Hill, NC; M.A., May
1970, University of Chicago, Chicago, IL (Degree in Modern European History); A.B., Jun. 1969,
Duke University, Durham, NC (Graduation with Distinction in History).
ADMITTED TO PRACTICE
Supreme Court of Ohio, 1973; Supreme Court of North Carolina, 1977; United States District Court for
the Northern District of Ohio, Eastern Division, 1974.
PROFESSIONAL SERVICE
Major Service: Member, Executive Board, Indiana State Board of Health, 1989-1993 (Appointed by
Governor Evan Bayh); Member, Advisory Committee for Children with Special Health Care Needs
Program, Indiana State Department of Health (1993-Present); Vice Chair, Committee on Health, and Vice
Chair, Committee on Rulemaking, American Bar Association Section on Administrative Law and
Regulatory Practice, 1990-Present; Member, Subcommittee on Solutions, Indiana Commission on State
Health Policy, 1990-1992.
�Withdrawal/Redaction Marker
Clinton Library
DOCUMENT NO.
AND TYPE
002. resume
SUBJECT/TITLE
DATE
re: Eleanor DeArman Kinney (partial) (1 page)
n.d.
RESTRICTION
P6/b(6)
COLLECTION:
Clinton Presidential Records
Health Care Task Force
Carolyn Gatz/Jennifer Klein
OA/Box Number: 5107
FOLDER TITLE:
[Legal Audit Group]
2006-0885-F
.ip2651
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)|
Freedom of Information Act - [5 U.S.C. 552(b)|
PI
P2
P3
P4
b(l) National security classified information |(bXl) of the FOIA]
b(2) Release would disclose internal personnel rules and practices of
an agency 1(b)(2) of the FOIA]
b(3) Release would violate a Federal statute |(bX3) of the FOIAj
b(4) Release would disclose trade secrets or confidential or financial
information 1(b)(4) of the FOIA)
b(6) Release would constitute a clearly unwarranted invasion of
personal privacy |(bX6) of the FOIA)
b(7) Release would disclose information compiled for law enforcement
purposes 1(b)(7) of the FOIAj
b(8) Release would disclose information concerning the regulation of
financial institutions i(b)(8) of the FOIAj
b(9) Release would disclose geological or geophysical information
concerning wells |(bX9) of the FOIAj
National Security Classified Information 1(a)(1) of the PRAj
Relating to the appointment to Federal office |(aX2) of the PRA|
Release would violate a Federal statute |(aX3) of the PRA|
Release would disclose trade secrets or confidential commercial or
financial information |(aX4) of the PRA]
PS Release would disclose confidential advice between the President
and his advisors, or between such advisors |a)(S) of the PRA|
P6 Release would constitute a clearly unwarranted invasion of
personal privacy 1(a)(6) of the PRA|
C. Closed in accordance with restrictions contained in donor's deed
of gift.
PRM. Personal record misfile defined in accordance with 44 U.S.C.
2201(3).
RR. Document will be reviewed upon request.
�Other Service: Member, Subcommittee of Indiana State Legislative Committee to Study the Long-Term
Needs of Persons with Developmental Disabilities and Mental Illness, 1993-Present; Member, Strategic
Planning Committee, Visiting Nurse Service, Indianapolis, IN, 1988-Present; Board Member, Indianapolis Alliance for Health Promotion, 1987-1991; Indiana Advisory Board Member and Private
Judge, The Private Adjudication Center, Inc. (An affiliate of Duke University School of Law), 1987Present; Member, Government Affairs Committee, Community Service Council of Central Indiana, Inc.,
1989-1991; Board Member, Visiting Nurse Service, Indianapolis, IN, 1990-1991; Member, Govemment
Affairs Conmiittee, American Diabetes Association, 1989-1990; Board Member, American Diabetes
Association ~ Indiana Affiliate, 1987-1990; Member, Block Grant Advisory Committee, Indiana State
Board of Health, 1987; Site Visitor, ABA Accreditation Inspection of LLM Degree Program in Health
Law, Depaul University College of Law, Chicago, IL, 1989; Site Visitor, ABA Accreditation Inspection
for Proposed LLM Degree Program in Health Law, Loyola University, Chicago, School of Law, 1987;
Indiana University Institutional Review Board, 1985-1988; Chairperson, Committee on Membership and
ex officio member of the Executive Board, American Public Health Association, 1983; Co-Chairperson
of the Washington Local Health Law Forum of the Forum Committee on Health Law, American Bar
Association, 1982.
UNIVERSITY SERVICE
University committee service: University Affirmative Action Committee (1992-Present); Administrative
Review Committee for the Dean of Indiana University Medical School (1992-Present); Administrative
Review Committee for the Dean of the Law School (1993-Present).
Law school committee service: Dean Search Committee (1986-1987); Curriculum Committee (1986);
Student Affairs Committee (1984-1986; 1988-1990); Library Committee (1987-1988); Faculty
Appointments Committee (1989-1992); Building Committee (1992-Present); Library Conunittee (1992Present); Summer Salary Task Force (1992-1993).
PROFESSIONAL ASSOCIATIONS
American Bar Association, North Carolina State Bar Association; American Association of Law Schools;
National Health Lawyers Association; American Society of Law and Medicine; American Public Health
Association; Indiana Public Health Association.
MISCELLANEOUS
Director and Vice President, Triangle Biomedical Equipment, Inc., Durham, NC, 1977-Present; CoChair, Patrons Committee, 1991 Gala, American Diabetes Association, Indiana Affiliate, 1991; Board
Member, Festival Music Society, Indianapolis, IN, 1984-1988, Vice President, 1987-1988; Member of
China trip for federal health policy makers sponsored by the National Health Policy Forum, George
Washington University, Washington, DC, 1979.
PERSONAL
Husband: Charles M. Clark, Jr., M.D.
Children: Janet Marie, Brian Alexander & Margaret Louise
Birth Date:
P6/(b)(6)
�PUBLICATIONS
Kinney, Medical Practice Guidelines: Evolutionary Trends and Future Implications, in HEALTH CARE
DELIVERY AND TORT: SYSTEMS ON A COLLISION COURSE? (E. ROLPH, ED.), RAND, The Institute for
Civil Justice, 1991.
Kinney, The Role of Judicial Review in Medicare and Medicaid Program Policy: Past Experience and
Future Expectations, 35 ST. LOUIS UNIVERSITY LAW JOURNAL 759 (1991) (Health Law Symposium).
Kinney & Gronfein, Indiana's Malpractice System: No Fault By Accident?, 54 LAW AND CONTEMPORARY PROBLEMS 169 (1991).
Kinney, Gronfein & Gannon, Indiana's Medical Malpractice Act: Results of a Three Year Study, 24
INDIANA LAW REVIEW 1275 (1991).
Gronfein & Kinney, Controlling Large Medical Malpractice Claims: The Unexpected Impact of Damage
Caps, 16 JOURNAL OF HEALTH POLITICS, POLICY AND LAW 441 (1991).
Kinney, Legal and Ethical Issues in Mental Health Care Delivery: Does Corporate Form MaJce a
Difference, 28 HOUSTON LAW REVIEW 175 (1991).
Kinney, Rule and Policy-Maldng Under the Medicaid Program: A Challenge to Federalism, 51 OHIO
STATE LAW JOURNAL 855 (1990) (Insurance Law Symposium) (Based on: E. Kinney, Rule and PolicyMaking Under the Medicaid Program: A Challenge to Federalism, 1990 ACUS
. See ACUS
Recommendation 90-8, Rulemaliing and Policymaking in the Medicaid Program, 1 C.F.R. § 305.90-8).
Kinney, In Search of Bureaucratic Justice in the Medicare Program: Adjudicating Medicare Home
Health Benefits in the 1980s, 42 ADMINISTRATIVE LAW REVIEW 251 (1990).
Kinney, Setting Limits: A Realistic Assignment for the Medicare Program? 33 SAINT LOUIS UNIVERSITY
LAW JOURNAL 631 (1989) (Health Law Symposium).
Kinney & Wilder, Medical Standard Setting in the Current Malpractice Environment: Problems and
Possibilities, 22 U.C. DAVIS LAW REVIEW 421 (1989) (Health Law Symposium).
Kinney, National Coverage Policy Under the Medicare Program: Problems and Proposals for Change,
32 SAINT LOUIS UNIVERSITY LAW JOURNAL 869 (1988) (Health Law Symposium) (Based on: Kinney,
National Coverage Policy Under the Medicare Program: Problems and Proposals for Change, 1987
ACUS 833. See ACUS Recommendation 87-8, National Coverage Determinations under the Medicare
Program, 1 C.F.R. § 305.87-8).
Kinney, The Medicare Appeals System for Coverage and Payment Disputes: Achieving Fairness in a Time
of Constraint, 1 ADMINISTRATIVE LAW JOURNAL 1 (1987) (Based on: Kinney, The Medicare Appeals
System for Coverage and Payment Disputes, 1986 ACUS 339. See ACUS Recommendation 86-5,
Medicare Appeals, 1 C.F.R. §305.86-5).
�Kinney, Coordinating Rate Setting and Planning in States with Mandatory Hospital Rate Regulation:
What Makes a Difference? 8 JOURNAL OF LEGAL MEDICINE 397 (1987).
Kinney, Making Hard Choices under the Medicare Prospective Payment System: One Administrative
Model for Allocating Medical Resources under a Government Health Insurance Program, 19 INDIANA
LAW REVIEW 1151 (1986).
Kinney, Medicare Payment to Hospitals for a Return on Capital: The Influence of Federal Budget Policy
on Judicial Decision-Making, 11 JOURNAL OF CONTEMPORARY LAW 453 (1985).
Kinney & Lefkowitz, Capital Cost Reimbursement to Community Hospitals Under Federal Health
Insurance Programs, 7 JOURNAL OF HEALTH POLITICS, POLICY AND LAW 648 (1982).
Maynard & Kinney, The Statute of Limitations in Medical Malpractice Law, in DEFENSE OF MEDICAL
MALPRACTICE CASES ( D . HIRSCH, ED.). The Defense Research Institute, Inc., No. 4, 1977.
Comment, "The Know Your Customer" Rule of the NYSE: Liability of Broker-Dealers under the UCC
and Federal Securities Laws, 1973 DUKE LAW JOURNAL 489.
Other Articles
Kumar & Kinney, Indiana Lawmakers Face National Health Policy Issues, 25 INDIANA LAW REVIEW
1271 (1992).
Clark & Kinney, Standards for the Care of Diabetes: Origins, Uses and Implications for Third-Party
Payment, 15 DIABETES CARE 10 (Supplement 1, 1992).
Kinney, New Standards for the Standard of Care, LEGAL TIMES 22 (Supplement, Nov. 18, 1991).
Kinney, Murders and Madness: Medicine, Law and Society in the Fin de Siecle by Ruth Harris, 14
LEGAL STUDIES FORUM 435 (1990).
Kinney, Elderly Health Care: For Many, Insurance an Empty Promise, LEGAL TIMES, 16 (Jul. 25,
1988). Same article in the following papers: Kinney, Medicare is it Fulfilling its Promise? THE
RECORDER, 6 (Aug. 1, 1988); Kinney, Shedding Light on Medicare: Decisions on Coverage Need More
Input from Public, FULTON COUNTY DAILY REPORT, 2 (Jul. 27, 1988); Kinney, Government Must Stop
Making Rules on Medicare Coverage Behind Closed Doors, MANHATTAN LAWYER, 14 (Aug. 2-8, 1988).
(Kinney, What Health Care Should the Medicare Program Pay For? IU LAW-INDIANAPOLIS: ALUMNI
MAGAZINE OF THE INDIANA UNIVERSITY SCHOOL OF LAW-INDIANAPOLIS 11 (Summer 1989).
Kinney, Better Safe than Sorry: Federal Antitrust Laws have a Major Impact on Payment, Efficiency,
and Expansion Activities, MULTIES, Vol. 1, No. 2 (Jun. 1983).
Kinney, Federal Policy on Hospital Capital Investment: Review and Outlook, HOSPITALS, Vol. 55, No.
15 (Aug. 1, 1981).
�Reports and Monographs
E. KINNEY, THE IMPACT OF CURRENT AND PROPOSED TORT REFORM ON THE MEDICAL MALPRACTICE
SYSTEM AND PHYSICIAN BEHAVIOR (Background paper for the U.S. Congress, Office of Technology
Assessment, Study on Defensive Medicine and the Use of Medical Technologies, Apr. 1993).
E. KINNEY & K. JORDAN, THE SOCIAL CONTRACT FOR HEALTH CARE IN INDIANA: REPORT OF THE
SOLUTIONS SUBCOMMITTEE TO THE INDIANA COMMISSION ON STATE HEALTH POLICY (Jul. 1992).
E. KINNEY, S. STEINMETZ & J. RANDOLPH, BARRIERS TO PRIVATE HEALTH INSURANCE:
INDIVIDUALS WITH MULTIPLE SCLEROSIS AND THEIR FAMILIES
IMPACT ON
(Final Report to the National Multiple
Sclerosis Society, Oct. 1991).
E. KINNEY, S. STEINMETZ, R. SAYWELL & M. ROSENTRAUB, EVALUATION OF INDIANA'S COMMUNITY
AND HOME OPTION TO INSTITUTIONAL CARE FOR THE ELDERLY AND DISABLED
(CHOICE) PROGRAM
(Final Report to the Indiana Department of Human Services, Jan. 1991).
R. SAYWELL, M . ROSENTRAUB, E. KINNEY & S. STEINMETZ, PART I : A N OVERVIEW OF INDIANA'S
CHOICE PROGRAM (Report to the Indiana Department of Human Services, 1990).
E. KINNEY, A. ZIEGERT, C. MELFI & T. QUIGLEY, HOME HEALTH AGENCY RESPONSE TO THE
MEDICARE CLAIM DENIAL CRISIS OF THE 1980s (Final Report to the AARP Andrus Foundation, 1989).
E. KINNEY, HOSPITAL CHALLENGES TO STATE MEDICAID PAYMENT RATES SINCE THE OMNIBUS BUDGET
RECONCILIATION ACT OF 1981 (American Hospital Association, State Legal Developments Memorandum
No. 1, 1984).
AMERICAN HOSPITAL ASSOCIATION, STATE REGULATION OF PREFERRED PROVIDER ORGANIZATIONS:
A SURVEY OF STATE STATUTES (State Legal Developments Report No. 4, 1984) (Kinney with Kopit,
Rose & Shapiro).
AMERICAN HOSPITAL ASSOCIATION, STATE RATE-SETTING LEGISLATION: LEGAL ISSUES IN THE
NEGOTIATION AND IMPLEMENTATION OF A STATUTE (State Legal Developments Report No. 3, 1984
(Kinney with Ahern & Kopit)).
AMERICAN HOSPITAL ASSOCIATION, HOW STATES CAN OPT OUT OF THE FEDERAL MEDICARE DRG
SYSTEM: A SUMMARY OF LEGAL ISSUES (State Legal Developments Report No. 1, 1983) (Kinney with
Peterson & Kopit)).
AMERICAN HOSPITAL ASSOCIATION, MEDICAID PAYMENT FOR HOSPITAL SERVICES: PLAIN TALK ABOUT
WHAT HAS HAPPENED AND WHAT SHOULD BE DONE (Conference Proceedings, E. Kinney, ed. (1983)).
Kinney & Lefkowitz, Chapter I I : Legislative History, and Chapter VIII: Implications for Hospitals, in
B . LEFKOWITZ, HEALTH PLANNING: LESSONS FOR THE FUTURE (1983).
�MAJOR PROFESSIONAL PRESENTATIONS
1987: Major Planner and Speaker, Conference on Medicare Procedures, American Bar Association's
Commission on Legal Problems of the Elderly and the Administrative Conference of the United States,
Leesburg, VA, Oct. 1987; Luncheon Speaker, Conference on Medicare Appeals, National Senior Citizens
Law Center, Washington, DC, Oct. 1987.
1988: Panelist, National Advisory Council on Health Care Technology Assessment, Department of Health
and Human Services, Washington, DC, Jan. 1988; Moderator, Conference sponsored by Senator Dan
Quayle of Indiana on Health Insurance for the Uninsured, Indianapolis, IN, Mar. 1988; Speaker, Lecture
Series of the Class of 1988 on Medicine: Topics of the Future, Indiana University School of Medicine,
Indianapolis, IN, Apr. 1988; Panelist, Research Conference on Health Care Improvement and Medical
Liability, DHHS, Washington, DC, May 1988; Panelist, The Robert Wood Johnson Foundation Medical
Malpractice Program Annual Meeting, Washington, DC, May 1988; Panelist, TeKolste Forum, Indiana
Hospital Association, Indianapolis, IN, May 1988; Speaker on Medicare Recommendations,
Administrative Law Section of the American Bar Association, Toronto, Canada, Aug. 1988; Panelist,
Conference on Long Term Care, Indiana Fiscal Policy Institute, Inc., Indianapolis, IN, Sept. 1988;
Speaker, Symposium on Setting Limits: Medical Goals in an Aging Society, St. Louis University School
of Law, St. Louis, MO, Oct. 1988; Panelist, Health Law Forum, American Public Health Association,
Boston, MA, Nov. 1988; Panelist, Conference for Minority Recruitment, Indiana University School of
Law—Indianapolis, IN, Nov. 1988.
1989: Panelist, The Robert Wood Johnson Foundation Medical Malpractice Program Annual Meeting,
Seattle, WA, May 1989; Participant, Invitational Conference on Medical Quality and the Law, The
Roscoe Pound Foundation, Washington, DC, Jun. 1989; Presentation on Indiana's Medical Malpractice
Act, Medical-Legal Committee of the Marion County Medical Society and Indianapolis Bar Association,
Indianapolis, IN, Jul. 1989; Panelist, Conference on Families in Transition, Indiana State Board of
Health, Oct. 1989; Moderator, Workshop on In Sickness and in Health at the Indiana Conference on
Social Concerns: 1989 Legislative Forum, Indianapolis, IN, Nov. 1989.
1990: Testimony, Hearing of the Subcommittee on Aging of the Senate Labor and Human Resources
Committee on Public/Private Partnerships: Innovative Approaches to Long-Term Care of the
Subcommittee on Aging of the Senate Committee on Labor and Human Resources, Indianapolis, IN, Jan.
1990; Speaker, Legal and Ethical Issues in Mental Health Care Delivery: Does Corporate Form Make
a Difference? Conference on Mental Health Law, University of Houston, Houston, TX, Mar. 1990;
Speaker, Workshop on Access to Health Insurance, American Diabetes Association Annual Meeting,
Atlanta, GA, Jun. 1990; Speaker, Results of Evaluation of Indiana's Medical Malpractice Act, Annual
Meeting of The Robert Wood Johnson Foundation's Medical Malpractice Program, Washington, DC,
Oct. 1990; Moderator, Health Care Summit, Indiana State Medical Association, Indianapolis, IN, Oct.
1990; Speaker, Results of Medical Malpractice Evaluation, Board of Trustees, Indiana Hospital
Association, Indianapolis, IN, Oct. 1990; Speaker, Results of Medical Malpractice Evaluation, Committee
on Malpractice, Indiana State Medical Association, Indianapolis, IN, Oct. 1990; Speaker, Medical
Malpractice, Ethics for Lunch Series, Indiana University School of Medicine, Indianapolis, IN, Oct.
1990; Speaker, Uses and Abuses of Judicial Review: Litigation as a Political Strategy in the Medicare
and Medicaid Programs, at a Conference on Medicare and Medicaid: Litigating Payment, Access and
Rationing, St. Louis University School of Law, St. Louis, MO, Nov. 1990; Presentation, Medicaid
Rulemaking Recommendations to the Plenary Session of the Administrative Conference of the United
States, Washington, DC, Dec. 1990.
7
�1991: Speaker, Results of Medical Malpractice Evaluation, Medical/Legal Committee of the Indianapolis
Medical Society and Indianapolis Bar Association, Indianapolis, IN, Jan. 1991; Moderator for Task Force
on Risk Management/Quality Assurance Activities for a Conference on Issues in Medical Liability: A
Working Conference, convened by the DHHS Agency for Health Care Policy and Research, Washington,
DC, Feb.-Mar. 1991; Speaker, Results of Medical Malpractice Evaluation, Annual Meeting of the
Continental Gynecologic Society, Indianapolis, IN, May 1991; Presentation, Research in Medical
Malpractice to the Family Practice Fellows, Indiana University School of Medicine, Indianapolis, IN,
May 1991; Speaker, Annual Meeting of the Alumni Association of the Indiana University School of
Social Work, Indianapolis, IN, May 1991; Luncheon Speaker, Annual Meeting of the Visiting Nurse
Service of Indiana, Inc., Indianapolis, IN, May 1991; Moderator, Panel on Appropriate Standards of
Care, Conference on The Changing Health Care Delivery System and its Implications for Liability Law,
RAND Institute for Civil Justice, Dallas, TX, Jun. 1991; Presentation on Opportunities for Research,
Fellowship Training Program, Division of General Medicine, Indiana University School of Medicine,
Indianapolis, IN, Jul. 1991; Speaker, Health Care Law: Medical Malpractice and Selected Issues, Indiana
Law Update, Indiana Continuing Legal Education Forum, Sept. 1991; Speaker, Indiana Compensation
Act for Patients Workshop, Indiana State Medical Association, Bloomington, IN, Nov. 1991.
1992: Keynote Address, Perspectives of Medical Malpractice, Good Samaritan Hospital's Winter
Seminar, New Harmony, IN, Feb. 1992; Moderator, Panel on Medical Decision-Making by and for the
Terminally, Geriatric Education Center, Center for Law and Health and Health Law Society,
Indianapolis, IN, Feb. 1992; Commentator, Conference on Justice and Health Care, The Law-Medicine
Center of Case Western Reserve University School of Law, Cleveland, OH, Mar. 1992; Speaker,
Barriers to Health Insurance for Persons with Multiple Sclerosis, American Occupational Therapy
Association, Houston, TX, Mar. 1992; Testimony, Senator Dan Coats' Health Care Forum, Indianapolis,
IN, Apr. 1992; Speaker, Legislative Models on Malpractice, Conference on Conflict Resolution in
Medical Malpractice: History and Images of the Future, Wayne State University, Detroit, MI, May
1992; Speaker, Indiana Compensation Act for Patients Workshop, Indiana State Medical Association and
Indiana Hospital Association, Culver, IN, Jun. 1992; Speaker, Health Care Liability Costs, Indiana Public
Health Foundation, Inc., Indianapolis, IN, Aug. 1992; Testimony, Medical Malpractice, Interim Study
Committee on Insurance Issues, Indiana General Assembly, Indianapolis, IN, Aug. 1992; Presentation
on Opportunities for Research, Fellowship Training Program, Division of General Medicine, Indiana
University School of Medicine, Indianapolis, IN, Aug. 1992.
1993: Panelist, Panel on New Proposals on Professional Liability, National Leadership Conference,
American Medical Association, Atlanta, GA, Feb. 1993; Provocateur for Socratic Dialogue Panel, 1993
TeKolste Forum on Public Trust: Reclaiming or Preserving? Indiana Hospital Association, Indianapolis,
IN, May 1993; Speaker, Quality Assurance Strategies for Community-Based, Long-Term Care Programs,
Indiana Association for Home Care Annual Conference, Brown County, IN, May 1993; Speaker,
Proposed Regulations to Expand the Field for Private Accreditors, and Suits by Disappointed Applicants:
Due Process and Other Issues, Conference on Private Accreditation in the Regulatory State, American
Bar Association Section of Administrative Law and Regulatory Practice, Washington, DC, May 1993.
�Clinton Presidential Records
Digital Records Marker
aa^iMW.{«a'.8Mg}ia-5!MM«CtMIM
This is not a presidential reeord. This is used as an administrative
marker by the William J. Clinton Presidential Library Staff.
This marker identifies the place of a publication.
Publications have not been scanned in their entirety for the purpose
of digitization. To see the full publication please search online or
visit the Clinton Presidential Library's Research Room.
�V O L U M E 42
SPRING 1990
ADMINISTRATIVE
REVIEW
I N T H I S ISSUE
ST A IE ADMINISTRATIVE
POLICY FORMULATION
THE CHOICE OF LAWMAKING
ME THODOLOGY
hy Arthur Earl Bonfield
AND
IS EUROPE R E A D Y FOR THE ADMINIS ERA TIVE LAW
REMEDIAL REVOLU TION?—LITIGA TION BEFORE
N A T I O N A L C O U R T S OE T H E EEC MEMBER S l ATES
AND IN l ERIM RELIEF
by Enrique Alonso Garcia
AN ADMINISTRATIVE
LAW • MIGHT HAVE BEEN"—
CHIEF JUSTICE BURGER'S BOWSHER V. SYNAR DRAFT
by Bernard Schwartz
IN SEARCH OF BUREAUCRATIC J U S T I C E ADJUDICATING MEDICARE HOME H E A L T H BENEFITS
IN THE 1980s
by Eleanor D. Kinney
ABA SECTION OF ADMINISTRATIVE LAW & REGULATORY PRACTICE
MARSHALL-WYTHE SCHOOL OF LAW, COLLEGE OF WILLIAM & MARY
�Clinton Presidential Records
Digital Records Marker
mmm mmMmmiwmwamamammmmwnmmimimim
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marker by the William J. Clinton Presidential Library Staff
This marker identifies the place of a publication.
Publications have not been scanned in their entirety for the purpose
of digitization. To see the full publication please search online or
visit the Clinton Presidential Library's Research Room.
�OHIO STATE
LAW JOURNAL
Volume 51
Number 4
1990
Rule and Policy Making for the Medicaid Program:
^
A Challenge to Federalism
Eleanor D. Kinney
. . ..
4}
i
I- "7
•' . -.•
\
//
II
» 'I
�RPR 2 2
'93
PAGES:
PAGES
PAGE.001
17:47
1 r\
J
(not counting cover page)
TO;
FAX NUMBER:, M T C - , ^ - > 2 | ^
ATTEmiON:
FROM
WiUiam J Hughes, Chairman
House Select Committee on Agin.
712 House Annex I
^
Washington, D.C. 20515
Phone:
FAX Phone:
202-226-3375
202-225-5505
�Withdrawal/Redaction Marker
Clinton Library
DOCUMENT NO.
AND TYPE
003. resume
DATE
SUBJECT/TITLE
04/22/1993
re: Paul S. Ceja (partial) (1 page)
RESTRICTION
P6/b(6)
COLLECTION:
Clmton Presidential Records
Health Care Task Force
Carolyn Gatz/Jennifer Klein
OA/Box Number:
5107
FOLDER TITLE:
[Legal Audit Group]
2006-0885-F
jp2651
RESTRICTION CODES
Presidential Records Act -144 U.S.C. 2204(a)j
Freedom of Information Act - [5 U.S.C. 552(b)j
PI National Security Classified Information 1(a)(1) of the PRAj
P2 Relating to the appointment to Federal office 1(a)(2) of the PRAj
P3 Release would violate a Federal statute I(aK3) of the PRA]
P4 Release would disclose trade secrets or confidential commercial or
financial information 1(a)(4) of the PRA]
PS Release would disclose confidential advice between the President
and his advisors, or between such advisors |aX5) of the PRA|
P6 Release would constitute a clearly unwarranted invasion of
personal privacy 1(a)(6) of the PRAj
b(l) National security classified information |(bXl) of the FOIA]
b(2) Release would disclose internal personnel rules and practices of
an agency |(bX2) of the FOIA|
b(3) Release would violate a Federal statute |(bX3) of the FOIA)
b(4) Release would disclose trade secrets or confidential or financial
information |(bX4) of the FOIA]
b(6) Release would constitute a clearly unwarranted invasion of
personal privacy 1(b)(6) of the FOIAj
b(7) Release would disclose information compiled for law enforcement
purposes 1(b)(7) of the FOIAj
b(8) Release would disclose information concerning the regulation of
financial institutions 1(b)(8) of the FOIAj
b(9) Release would disclose geological or geophysical information
concerning wells |(bX9) of the FOIAj
C. Closed in accordance with restrictions contained in donor's deed
of gift.
PRM. Personal record misfile defined in accordance with 44 U.S.C.
2201(3).
RR. Document will be reviewed upon request.
�PfiGE.002
APR 22 '93 17:47
PAUL 8. CEJA
ADDRESS:
P6/(b)(6)
P6/(b)(6)
PHONE:
(202)
EDUCATION:
226-3375 (Work)
J.D., U n i v e r s i t y o f Colorado School o f Law
Boulder, CO.
B.A., Siena College, Loudonville, NY.
BAR MEMBERSHIP:
D i s t r i c t o f Columbia
Pennsylvania
EMPLOYMENT:
1988 — Present
8«l«ot CoBaittOtt on Aging
U.S. House of Representatives
RooB 712, Bouse Annex z
Washington, D.C. 20515
Duties; General Counsel. Responsible f o r
the l e g a l , o r g a n i z a t i o n a l , and a d m i n i s t r a t i v e
n a t t e r s i n v o l v i n g the Conanittee. P r i n c i p a l
l e g a l advisor t o the Conunittee Chairman.
Directed the Committee's review on issues
w i t h i n the Committee's j u r i s d i c t i o n a l areas.
Reviewed and developed p o l i c i e s , l e g i s l a t i o n
and regulations, and engaged i n o v e r s i g h t o f
f e d e r a l agencies. Organized nmnerous
hearings, d r a f t e d l e g i s l a t i o n and Committee
r e p o r t s , i n i t i a t e d and monitored s t u d i e s and
i n v e s t i g a t i o n s by the General Accotinting
O f f i c e . Represented the Committee Chairman,
and the Committee, a t various n a t i o n a l
conferences, for\ims, and workshops.
1985 — 1988
Office of tbe General Counsel
U.S. Department of Health and Human services
Region ZZZ
P.O. Box 1371C, 3535 xarket Street
Philadelphia, PA 19101
Duties: Assistant Regional Counsel. Worked
on l i t i g a t i o n f o r the Department o f Health
and Human Services. Prepared b r i e f s and
pleadings i n conjunction w i t h U.S. Attorneys
o f f i c e s , f o r siibmission t o U.S. D i s t r i c t
Courts and C i r c u i t Courts o f Appeals.
Conducted o r a l arguments before U.S. C i r c u i t
Courts o f Appeals. Drafted memoranda on
l e g a l issues o f concern t o the Department.
�APR 22 '93 17:47
1979 —
1984
PAGE.003
Center on Social welfare Policy and Law
1029 Vermont Avenue, H.W. Suite 850
Washington, D.C. 20005
Duties: Monitored and analyzed l e g i s l a t i o n
and r e g u l a t i o n s . P a r t i c i p a t e d i n
Congressional committee hearings and markups. Prepared comments on proposed
r e g u l a t i o n s . Provided research f o r
l i t i g a t i o n . Assisted Congressional s t a f f .
Met w i t h representatives o f n a t i o n a l
organizations.
1977 —
1979
U.S. Bouse of Representatives
Congressional Hispanic caucus
House Annex 2
Washington, D.C. 2 0515
Duties: Legislative/Legal Assistant.
Provided l e g a l and l e g i s l a t i v e research.
Developed the l e g a l s t r u c t u r e o f t h e
Congressional Hispanic Caucus. A s s i s t e d i n
l i a i s o n a c t i v i t i e s w i t h other Congressional
o f f i c e s , f e d e r a l agencies, and t h e White
House.
1975
Department of the Army
Office of the Judge Advocate General
Fort Carson, CO
Duties: Legal A s s i s t a n t . A s s i s t e d m i l i t a r y
defense attorneys i n t h e p r e p a r a t i o n o f cases
f o r c o u r t m a r t i a l . Provided l e g a l research.
Carried out f a c t u a l i n v e s t i g a t i o n s .
ADDITIONAL QUALIFICATIONS:
Member, National Hispanic Bar Association
Student Attorney, Legal Aid and Defender Program
u n i v e r s i t y o f Colorado School o f Law: Advised and represented
c l i e n t s i n c i v i l and c r i m i n a l cases.
References a v a i l a b l e on request.
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MEMORANDUM
TO;
Jcmiifer Klii\e
FROM:
Margaret Farrell
RE:
Legal Audit - Questions
DATE:
May 3,1993
I have posed some questions about the Health Care Task Force options
that we may want to circulate to the Legal Audit group. Again, I would preface
the questions with as clear an articulation as we can come up with about the
purposes of their audit.
The auditors cannot be asked to react to all of the combinations and
permutations of options discussed last week. If they arc asked only to sketch the
boimdaries witiiin wliich all options must operate, I am afraid we will get very
general, not very useful, comments. Thus, for the purposes of tliis exercise. I
would ask them to assume that certain basic elements of a reform package arc
included in proposed legislatioii, even though these elements could change in the
next several weeks. That is, rather than preface each question with a statement of
assumptions , I would ask the Legal Auditors to assume that legislation is
proposed that would enact a combination of the major options being considered
by the Task Force. In order for them to focus on fairly concrete issues, we could
change the assumptions upon which individual questions arc based. For
example, we might ask a question that assumes that Plans could sell policies with
additional benefits and that they could not. If certain features of the reform we
ask them to assume are not part of the final package, we can take that into
account in evaluating and using their comments, or we could follow up,putting
more questions to thom based on the changes.
I would ask that the auditors assume that reform legislation would require
the compulsory purchase of standard he^ilth insurance coverage (to be
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determined at the federal level) by all individuals (employed, self-employed, and
unemployed) and employers (i.e.of less than a size to be determined by each
state for themselves and their dependents. Employers would be required to
contribute 80% of the benchmark premium charged in each Health Alliance area
for standard benefits. Employees would be required to pay the balance. Selfemployed and unemployed individuals be required to pay 100% of the cost, with
80% of the cost to unemployed workers being paid by a state/federal
unemployment compensation program. All would be permitted to deduct from
their taxable income, their expenditures up to the benchmark premium price.
Low income individuals would receive a state/federal subsidy amounting to the
difference between the benchmark price an a given percentage of their gross
income. Employers would also receive a subsidy after they had paid 7% of their
total payroll for employee health insurance.
Health insurance would be sold by Plans (providers that assume risk by
accepting capitation payments) and by at least one indemnity, fee for service plan
in each area. Health care would be provided by physicians, hospitals, and other
providers who sell their services through Plans or directly to patients iiisured by
an indemnity plan. Alliances(one not for profit or public agency in each
geographic area designated by the state) would bargain with Plans, on behalf of
their subscribers, for the lowest price each plan can provide mandated coverage
to its er\rollees at a community rate (i.e. the rate at which that plan could serve a
population reflecting the risk level of the geographically relevant commuruty).
Open enrollment periods would guarantee each Alliance subscriber the choice of
enrolling in any Plan offered by the Alliance at a benchmark premium, based on
the lowest or some average rate at which all those Plans offer the standard
benefit package. Plans would be paid by the Alliance a "risk adjusted" rate
reflecting the enrollment of higher or lower risk people that compose the
community as a whole.
Admimstration of the program would be shared by the state and federal
governments, with the federal goverrunent responsible for setting the standard
benefit package, determine the size of the subsidy, establishing standards for
Alliance and Plans, designating a uniform data collection system, creating
voluntary practice guidelines, conducting technology assessment States would
be responsible for certifying and supervising Alliances, setting standards
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through licensure for Plans and providers, collecting and reporting uniform data
and enforcing state laws not preempted by the new legislation such as insurance
regulations. In states that failed or refused to carryout such state functions, the
federal government may withhold federal funds, withhold federal subsidies,
withhold favorable tax treatment for individuals and businesses in the state,
operate the Alliance system itself and/or set insurance and provider prices.
Finally, in an effort to control prices, the federal goverrunent may limit the
subsidy it wrill pay for low income individual insurance to a percentage of a
benchmark premium that conforms to federally set budget caps or capped
increases in the benchmark price.
On the basis of these assumptions and the discussions that they had last
week about the options, I would ask broadly:
• Whether, because of their legal consequences, the health care reform
proposal will not have the effects they are expected and hoped to have.
• What private rights of action (implied or under 42 USC 1983) for
Alliance subscribers. Plan enrollees and patients will be or should be created by
the new legislation? What private rights of action for such persons should the
reform legislation preclude?
• What private rights of action for Plans against providers, enrollees and
the Alliance are or should be created? precluded?
• What private rights of action for Alliances against the State, subscribers.
Plans and providers does/should the reforms create? preclude?
• What administrative and judicial procedures should be created to settle
disputes that arise among all the players - subscribers. Alliances, Plans, providers
and the state and federal governments?
• What state laws will necessarily be preempted by the reforms; should
be preempted and thus expressly addressed by reform legislation; and should
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not be preempted. E.g. state antitrust laws, malpractice laws, liceitsure,
irisurance regulation, securities laws, I IMO laws and anti-networking laws.
• What are the constitutional boundaries within which the Congressional
legislation must operate with respect to 1) enlisting state efforts in carrying out
the reform, 2) providing adjudicatory procedures for the resolution of disputes,
3) delegating rulemaking authority to federal and state bodies; 4) taxing and
delegating taxing authority to state and quasi-pubUc bodies.
More specifically, I would group some questions this way:
National Governance
Assuming there was interest in establishing an independent National
Health Board:
1. Can Congress prohibit President from reviewing NHB budget and/or
rulemaking?
2. Could NHB be an "off budget" agency?
3. Can Congress veto NHB action through joint resolutions?
4. Can Congress require the President to permit the NHB to lobby its own
budget before Congress?
State-Federal Relations
What constitutional provisions govern the procedural rights of states to
proceed against the federal government for violation of federal statutes? i.e. to
what process is a state due in such disputes? What forum must be provided,
what notice, hearings etc.? Are the procedures different if the state claims that
the federal goveniment has violated the Constitution? Can Congress control the
jurisdiction of Article III courts to hear such disputes? i.e. Could a federal
administrative procedure be created to determine the compliance of states with
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federal plan requirements with no judicial review, or with limited judicial review
under the APA?
Assuming some states may not find federal funds a sufficient incentive to
join the new program, does the tenth amendment prohibit federal legislation
requiring states (as opposed to the federal government) to 1) license providers in
accordance with federal standards; 2) regulate health insurers doing business in
the state; 3) pay part of the cost for the purchase of health insurance for low
income individuals? New York v. United States, 112 S. Ct. 2408 (1992)(tenth
amendment restrictions).
Can the federal government enforce maintenance of effort commitments
made by states with balanced budget requirements in their constitutions? What
action can the federal government constitutionally take in states that cannot
make such commitments? North Carolina ex rel. Morrow v. Califano, 445 F.
Supp. 532 (E.D.N.C. 1977)(federal spending powers may condition receipt of
funds on state legislation held to violate N.C. constitution) - but how about in the
absence of federal spending powers?
Is there a point at which exercise of Congressional spending powers
would be seen as coercive and thus violative of state rights under the tenth
amendment? i.e.. if the federal government made all federal funding (health
funds, highway funds, education funds, etc.) dependent on a state cooperating in
the reform program, including its "agreement" to exercise state sovereign
prerogatives as directed by the federal government, could such legislation
withstand a tenth amendment challenge?
Can federal legislation create a federal causes of action (e.g. against Plains
for provider negligence) that can be enforced only in state courts? Jones Act
precedent?
Can the federal government impose a federal payroll tax to collect funds
to be spent by the states that have qualified plans and not at all in states which
do not? State workman's compensation model? Equal protection issues?
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Does equal protection permit the federal government to provide favorable
tax treatment for private contributions to the purchase of health insurance only
in states that have a qualified plan?
Does equal protection permit the federal government to pay subsidies to
individuals and business only in states that have qualified plans?
Federal Legislative Issuer
Can the federal government proliibit the piurchase, outside of Alliances, of
services found not efficacious, but not harmful? e.g. Laetrile - rationality
standard? Docs such a prohibition implicate a substantive due process right to
obtain treatment of ones choice.
Do elements of the Clinton plan requirement amendment of ERISA
to regulate self insuring plans? McGann v. H&H Music, 946 F.2d
401 (5 th Cir. 1991)
to permit states to regulate self-insuring employers. Metropolitan
Life Ins. v. Massachusetts, 471 U.S. 724 (1985).
to narrow the definition of "insurance" in order to narrow the area
for state regulation Royal Drug, U.S. (19 );
Pilot Life V. Dedeaux, 107S,Ct. 1549(1987).
to permit indigent subsidies to be paid out of premiums paid by
exempted large firms. Recent New Jersey and New York
cases invalidating state rate setting and indigent care pools
as they apply to ERISA plans.
Does Parker Brown antitrust iminunity for state action cover the actions of
Alliances? Health Plans? Providers certified and qualified by states who seek to
cooperate with each other to jointly provide services (HIV treatment and
preventative education) not economical to provide separately? Cf. National
Gerimedical I-Iosp. & Gerontology Center v. Blue Cross of Kansas City, 452 U.S.
378 (1981).
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Would federal legislation providing that all individuals are entitled to
subsidized health insurance on the basis of income create an individual
entitlement to such, enforceable under 43 U.S.C. § 1983? Under implied cause of
action theories? Cort v. Ash 422 U.S. 66 (1975). Through a writ of mandamus?
Can/should such causes of action be limited? Recent Souter case.
Would providers. Health Plans and Alliances also have §1983 causes of
action to enforce statutorially determined conditions of their participation in the
program? If the market for their services is restricted or eliminated by the new
programs? Wilder v. Virginia Hospital Assoc., 110 S. Ct. 2510 (1990).
Can federal funds be used to provide more benefits, such as education and
training, for minorities and women in those fields, such as primary care, where
those characteristics might be reasonably related to their abiHty to provide
appropriate care to those in need of health care? I.e. affirmative action for benefit
of patients, not for benefit of the providers of the favored treatment.
Would the immunization of good faith, quality assurance determinations
in the Health Quality Improvement Act of 1986 (42 U.S.C. 11101 et seq (1987)
from defamation and antitrust attack apply to Plans (or Alliances) so as to
miiumize their malpractice enterprise liability? Cf. Patrick v. Burget, U.S.
(1988); FTC v. Indiana Federation of Dentists, 476 U.S. 447 (1986).
Does the due process clause or the 7th amendment prohibit federal
legislation eliminating or capping malpractice actions against providers? Boyd v.
Bulala 647 F. Supp. 781 (W.D. Va. 1986), 877 F.2d 1191 (4th 1989) Would it
violate state constitutions? If it docs, is there any reason that state constitutional
provisions would not be preempted? Garnett v. Renton School District No. 403,
CA No. 91-36036, 61 U.S.L.W. 1137 (March 23,1993). Could it be regarded as a
direct infringement of state sovereignty - i.e. telling the states how they are to
regulate private action? or is it a standard exercise of commerce power that
preempts inconsistent state laws?
Federal Regulatory Issues
I
/
I
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Does the authority of Alliances (public or private)to set benchmark
premiums constitute rulemaking authority and thus raise non-delegation issues?
Would it if there is a guiding "intelligible principle" providing legislative policy?
Does it constitute non-delegable taxing authority? Cf. National Cable Television
Assn, V. United States, 415 U.S. 336,342 (1974).
Does the due process clause permit a private non-profit Alliance to finally
determine individual entitlement to federal proscribed benefits, without state or
federal administrative or judicial review? By a Plan? Medicare private fiscal
intermediary precedents ~ McClure and Gray Panthers, supra. Are due process
requirements met if the Alliance making final individual coverage
determinations is a state agency but no judicial review is permitted?
What due process rights are enrollees entitled to when Alliances and/or
Plans make benefit coverage determinations? What notice, hearings, judicial
review are constitutionally required? Mathews v. Eldridge, 424 U.S. 319 (1976);
Schweiker v. McClure, 456 U.S. 188 (1982); Gray Panthers v. Schweiker, 652 F.2d
146 (D.C. Cir. 1980). Are federal due process requirements met by state
administrative procedures and state judicial review alone?
Does the APA exception for rulemaking concerning "matters relating to ...
benefits" or "interpretive rules and policy statements" 5 U.S.C. § 553(b) apply to
NHB and agency rulemaking defining the scope of benefits? coverage? budgets?
technological assessment? Can that exception be waived by legislation?
Does the Constitution, due process, permit NHB rulemaking be exempt
from the APA requirements? Morton v. Ruiz 415 U.S. 199 (1974)?
Would federal legislative requirement that some subscriber/plan and
Alliance/plan disputes be settled by mandatory, binding arbitration violate the
7th amendment guarantee of a jury trial? Boyd v. Bulala, supra. Or does the
workman's compensation model of consent and waiver apply?. Would it violate
the "take care" provision of Article II requiring execution of the laws be carried
out by executive officers? See OLC opinion that it does. Or, does it
imconstitutionally infringe on the judicial function? would subscriber consent to
/
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mandatory binding arbitration in the Alliance context be a fiction if all Plans
required it?
Is enterprise liability tantamoimt to strict liabiUty? How can "adverse
events" be defined for enterprise liability and compensation purposes? Can
enterprise liability be frustrated through use of patient consent and waiver
forms? Assuming enterprise liability applies to approved Health Plans and plans
selling outside the Alliances, can federal legislation infringe on a patients right to
contract for treatment outside Alliances ~ i.e. the right to treatment as a matter of
substantive due process ~ by prohibiting patient consent to waive enterprise
liability as a condition to treatment?
State Legislative Issues
Do individuals and providers need a statutory cause of action for
negligent disclosure of confidenhal information collected under the national data
collection system envisaged, or are current state laws protecting privacy (e.g.
defamation etc.) sufficient? Should the federal privacy protections applying to
Medicare information be extended?
State Regulatory Issues.
Docs state law (judicial common law) imposing due process requirements
on the procedures of private organizations making determinations affecting
livelihood need to be expressly preempted, if Alliances and Plar\s are permitted
to adjudicate the rights of providers to participate in the new system.? Pinsker v.
Pacific Coast Society of Orthodontists, 75 Cal. Rpt. 712 (Ct. App. 1969) Falcone v.
Middlesex County Medical Soc'y, 34 N.J. 582,170 A.2d 791 (1961) or, can
Alliances and Plans be required to provide procedures that will meet such due
process requirements?
Do most state Administrative Procedure Acts provide judicial review for
the actions of private bodies carrying out state functions (See Calif, code
provisions to that effect) and if so, would/should such acts apply to Alliances?
Plans?
�HAY- 5-93 WED 10:32
WESTERN PSYCH
FAX NO. 6811261
P.02
University of Pittsburgh
Medical Center
Center for Medical Ethics
3900 ForOes Avenue
PiUSburgh. PA 15260
412-648-1384
Fax: 412-848-2649
Alan Melsel, JD
Director
Cenlar for Medical Ethics
To:
Jennifer Klein
From:
Alan Meisel
Date:
May 5, 1993
^iles?W^r^\^*'^^?"'^
with very many
SJf
^°
^ ^ ^ a l auditors," i n large part because i
yo2^?)^But\:r«^/°°^
'
^
I K V ' to
' ^^^^
s ? e mi\tn'is be?
you.l) But here's some stuff
think about. B yHope
h e l p ftoo
il.
"CONSCIENTIOUS OBJECTION"
I f reproductive health services are included i n the basic olan
but a l l professionally qualified individuals i n the A S I arS as a
w??^L?LTr^^"°^'/"^^^^^"^
provide somS or a U o l ?hem
w i l l patient haye a right to have the service provided by the
? r o J i d e " ? ? r s e w i i e f ^ professionals have a r i ^ h t to ? e ? L e ' ? o
JreatSpj;?^?i!? f ^ ^ ^ f "^^^^H^ obliged to continue to provide a
t o ^ oS™^^
i s already i n process - eg, ventilatory support
^ e a ? t ? S a ? ^ ? 5 ^ ^ ^ ^ ^ ^ " J '".^^^
continuation of treatment h a f
di?iciTv^
S^^" refused (eg by the patient through an advance
ha^e a r L h ?
I ^ ^ ^ f i ^ y authorized surrogate), w i l l the patient
Si^hln
L P ? ^^l^J^"^^ treatment discontinued nonethelesS?
%
""^^^
^^^^^
"° °ther physician w i l l i n g to
terminate treatment (within the AHP? outside the AHP)?
^Latm^^J^'''^^" feels morally obliged to discontinue to provide a
t J ! ^^^^^ 7"
ventilatory support to a comatose patient — but
the provision of treatment has been requested (eg by the patient
sSr?o^ate? "^T??'?H^'"f^'"" °"
^
ai?LrLeS
oro^?SS
J l i ^ 11^ patient have a right to have the treatment
i?
physician's stance? within the AHP? what
t(witnin
^ i t M n the
t i S AHP?
?Sp?^^^f
physician
w i l?l i n g to provide treatment
outside
the AHP)
usu!nv^Ti-So,7r'' l^^^^""' ^''^
^° ^he above questions are
usually (though not always) unclear. I s there anything about the
C o u i S ^ n r !^^\^«<3^i^«^ C l a r i f i c a t i o n i n the legisYa^ion or tha?
would seem to change the balance of equities?
�HAY- 5-93 WED 10:32
May 5,
Page 2
WESTERN PSYCH
FAX NO. 6811261
P.03
1993
STATE ANTITRUST LAWS
MEDICARE/MEDICAID FRAUD AND ABUSE PROVISIONS
assuTn?^^''?^^; i£
""^^^^ "^^'^ t°
"'ade i n these statutes
for soSI p e ? L ? : r t ? m : ^ o r " ' " ^ - ^ r ^ - k s " i n some'^^rm
necessa?v ?o
J2n ^ permanently? w i l l the arrangements
necessary to create AHPs run afoul of these provisions?
NATIONAL PRACTITIONER DATABANK
SaS?i2icnerDlta£aiU?
°'
^°
^^^--^
INTERNAL REVENUE CODE
?La?™^n?'o5^r^?fw''^^^ ''^^'^ ^° ^« contemplated i n the tax
emotovov^
insurance benefits both i n the case of
a^loSed
«°^^ver, w i l l so-called Flex Plans be
allowed to continue, eg to provide the use of tax-sheltered
l l l T l ^ T i l T ^ ^ ^ ' " J ^ ^ ^ " ^ i^enefits not inc?Gded i n t i e basic
premiiml'foS
f ^ ^ ^ " ^ ' transportation to appointments,
etc^? ? l f x p J l n f e J L S ^ f J h
deductibles, co-insurance,
drm^£V\?
?o use ? f oaJ for 2?}°^?'
"
employer'
insurance.^
medical expenses not covered by health
PRACTICE GUIDELINES AND MALPRACTICE
dfv?^?Lri'^^"^^^''y Y^^"®'
^^y' s^°^ld adherence to or
co^formaScf ST.E^'^^i^^ guidelines play i n establishing ?o
?^
yf^?
departure from the standard of care i n
?o eJSouJaL\'^^^^^^°"I
^ ^ ' ^ ^ ^ ^ l goveriment? I S order
t h i s ' ^ J i l const??.?- ^ ^ ^ ' ^ J ^ ^ ! guidelines, attempt to l e g i s l a t e
Of
ffi^lD^actLrr^Ji^
^°
especially i f other aspects
comply??
^""^ voluntary (though with incentives to
�'
Lot / f i j
(fCi
^-
Pai
iCintj
hn
MEMORANDUM
Date:
A p r i l 27, 1993
To:
Jennifer Klein
From:
B i l l Sage
Subject:
Questions f o r Legal A u d i t Group
Assuming t h a t a dual d e l i v e r y system (some c a p i t a t e d , some
f e e - f o r - s e r v i c e ) w i l l e x i s t f o r some t i m e , how can safe
h a r b o r s or o t h e r pronouncements/assurances w i t h respect t o
f r a u d & abuse or a n t i t r u s t be e s t a b l i s h e d t o a v o i d
" c h i l l i n g " e f f i c i e n t i n t e g r a t i o n f o r c a p i t a t e d care b u t n o t
open t h e door t o abuses i n c o - e x i s t i n g f e e - f o r - s e r v i c e ?
Assuming t h a t s t a t e s and h e a l t h a l l i a n c e s w i l l have p r i m a r y
r e s p o n s i b i l i t y f o r h o l d i n g plans accountable f o r q u a l i t y
w i t h i n a budget, how can the f e d e r a l government i n s p i r e
p u b l i c c o n f i d e n c e i n t h e q u a l i t y o f t h e o v e r a l l system
w i t h o u t d u p l i c a t i n g work or c r e a t i n g unnecessary
bureaucracy?
3.
5.
Assuming t h a t h e a l t h plans ( i ) are r e q u i r e d t o d i s c l o s e " a l l
m a t e r i a l i n f o r m a t i o n " t o consumers i n e n r o l l m e n t documents
as a way t o f o s t e r consumer c h o i c e , and ( i i ) are p r o h i b i t e d
from f r a u d u l e n t or m i s l e a d i n g d i s c l o s u r e ( i n c l u d i n g
a d v e r t i s i n g ) , should t h e r e be a p r i v a t e r i g h t o f a c t i o n ? I f
so, what should t h e remedies be?
Assuming t h a t a unique p a t i e n t and p r o v i d e r i d e n t i f i c a t i o n
number i s needed t o assure i n t e g r i t y o f i n f o r m a t i o n i n t h e
new system, what l e g a l c o n s i d e r a t i o n s should a t t a c h t o t h e
s e l e c t i o n and use o f t h a t i d e n t i f i e r ? What i f t h e s o c i a l
s e c u r i t y number i s used as t h e p a t i e n t i d e n t i f i e r ?
Assuming t h a t h e a l t h plans are intended t o be f u l l y l i a b l e
f o r n e g l i g e n t i n j u r i e s t o e n r o l l e e s caused by a f f i l i a t e d
p r o v i d e r s ( " e n t e r p r i s e l i a b i l i t y " ) , how should t h e l i a b i l i t y
be c r e a t e d so t h a t m a l p r a c t i c e a c t i o n s s t i l l a r i s e i n s t a t e
court?
Assuming t h a t the f e d e r a l government chooses t o encourage
c e r t a i n general t o r t reforms a f f e c t i n g medical m a l p r a c t i c e ,
but does n o t choose t o preempt s t a t e law, how should
i n c e n t i v e s be c r e a t e d t h a t induce s t a t e s t o enact t h e
d e s i r e d reforms? What i f s t a t e c o u r t s have p r e v i o u s l y h e l d
s i m i l a r reforms t o be u n c o n s t i t u t i o n a l ?
�7.
Assuming t h a t the f e d e r a l government chooses t o preempt
s t a t e laws t o accomplish c e r t a i n g e n e r a l t o r t reforms
a f f e c t i n g medical m a l p r a c t i c e ( e . g . a noneconomic damage
c a p ) , b u t does n o t d e s i r e t o preempt e x i s t i n g schemes t h a t
may, i n v a r i o u s ways, be more "defendant f r i e n d l y , " how can
i t preempt " s e l e c t i v e l y " ?
Assuming t h a t the f e d e r a l government d e s i r e s t o c o n d i t i o n
payment o f graduate medical e d u c a t i o n funds t o achievement
of r e s u l t s ( s p e c i a l t y mix, d i v e r s i t y , t r a i n i n g i n
ambulatory/community s i t e s ) r a t h e r than j u s t f u n d i n g any
r e s i d e n t i n an a c c r e d i t e d t e a c h i n g h o s p i t a l , what would be
the best way t o s e t these c r i t e r i a , update them and a l l o c a t e
funds w i t h o u t unnecessary bureacracy?
9.
Assuming t h a t s t a t e p r a c t i c e a c t s f o r p h y s i c i a n s , nurses and
o t h e r p r o v i d e r s o f t e n e r e c t p o l i t i c a l b a r r i e r s t h a t prevent
c o s t - e f f e c t i v e d e l i v e r y o f s e r v i c e s , what type o f f e d e r a l
preemptive l e g i s l a t i o n could best "open up" p r a c t i c e w h i l e
s t i l l p r o t e c t i n g p a t i e n t s ? Would l e g i s l a t i o n dependent on
non-governmental p r a c t i c e d e s c r i p t i o n s ( e . g . p r o f e s s i o n a l
a c c r e d i t i n g bodies) c r e a t e a d e l e g a t i o n problem?
tp.
'
Assuming t h a t r a c i a l and e t h n i c d i v e r s i t y i s a goal i n
f u n d i n g t r a i n i n g programs f o r d o c t o r s and o t h e r p r o v i d e r s ,
what types o f g o a l s / t a r g e t s / r e q u i r e m e n t s f o r d i v e r s i t y
should be e s t a b l i s h e d and how much can f u n d i n g f o r the
o v e r a l l t r a i n i n g o f p r o v i d e r s depend on meeting these
criteria?
�QUESTIONS
FOR THE LEGAL AUDITORS
1.
Assuming t h a t t h e s t a t u t e c r e a t e s a s t r u c t u r e o f " u n i v e r s a l
access" s h o u l d a c i t i z e n a l l e g i n g d e n i a l o f access, i . e .
r e j e c t i o n by an AHP have an immediate remedy?
Should t h e s t a t u t e t a l k about a " r i g h t " t o h e a l t h care?
Should p r o o f o f " r e f u s a l t o e n r o l l " t r i g g e r t h e r i g h t ?
Should any o t h e r a c t i o n by t h e HIPC o r t h e AHP t r i g g e r t h e
right?
What p o s s i b l e range o f a c t i o n s , by whom, c o u l d r a i s e t h e
specter o f the v i o l a t i o n o f t h i s r i g h t ?
How s h o u l d t h e p a t i e n t / c o n s u m e r proceed, w i t h what r i g h t s
and what p r o t e c t i o n s ?
What remedies s h o u l d be a v a i l a b l e t o t h e consumer?
Should t h e i n a b i l i t y o f t h e HIPC o r t h e AHP t o have persons
s k i l l e d i n t h e language o f t h e c o n s u m e r / p a t i e n t be h e l d t o
be a d e n i a l o f s e r v i c e ?
What o t h e r c i r c u m s t a n c e s might be h e l d t o be tantamount t o
denial?
2. Assuming t h a t undocumented persons w i l l n o t be covered i n t h e
system, b u t t h a t t h e y m i g h t have r e l a t i v e s o r c h i l d r e n who would
be:
Should undocumented persons who a p p l y f o r coverage f o r t h e i r
c h i l d r e n o r r e l a t i v e s be p r o t e c t e d from i n v e s t i g a t i o n s by
the INS?
Should any r e c o r d s o f t h e HIPC o r t h e AHP be a v a i l a b l e t o
the INS o r t o any o t h e r government s e r v i c e ?
3.
Assuming t h a t t h e s t r u c t u r e o f t h e h e a l t h p l a n s and t h e
r e l a t i o n s h i p o f t h e HIPCs and t h e AHPs w i l l be l a r g e l y a m a t t e r
of s t a t e p o l i c y :
What s t a n d a r d s s h o u l d t h e F e d e r a l government have t o d e c i d e
whether o r n o t a s t a t e has f a i l e d t o f u l f i l l i t s
obligations?
What remedies s h o u l d t h e F e d e r a l government have a v a i l a b l e
to enforce the d i r e c t i v e s of the statute?
4.
Assuming t h a t t h e b e n e f i t package w i l l s p e c i f y c a t e g o r i e s o f
s e r v i c e s and w i l l n o t s p e l l o u t t h e e n t i r e menu o f " m e d i c a l l y
necessary and a p p r o p r i a t e " s e r v i c e s , how s h o u l d disagreements
over c o v e r e d s e r v i c e s be r e s o l v e d ?
Should t h e r e be a mandatory " m e d i a t i o n " process w i t h i n t h e
AHP?
At what p o i n t s h o u l d a p a t i e n t have access t o an independent
h e a r i n g o f f i c e r , and s h o u l d t h a t be i n t h e c o n t e x t o f a
" f a i r h e a r i n g " o r i n some o t h e r s e t t i n g ?
5.
Assuming t h a t t h e r e i s an appeal process, how s h o u l d i t be
t r i g g e r e d and how s p e c i f i c s h o u l d a s t a t u t e be about t h e r i g h t s
�o f t h e p a t i e n t s and t h e o b l i g a t i o n s o f t h e AHPs?
I n g e n e r a l s h o u l d t h e s t a t u t e be more o r l e s s s p e c i f i c about
t h e r i g h t s , d u t i e s and o b l i g a t i o n s o f t h e HIPCs and t h e AHPs
, o r s h o u l d many o f t h e d e t a i l s be l e f t t o t h e
r e g u l a t o r y process?
6.
What new remedies, i f any, s h o u l d be a v a i l a b l e t o p h y s i c i a n s
o r o t h e r h e a l t h c a r e p r o v i d e r s who a l l e g e d i s c r i m i n a t i o n on t h e
b a s i s o f r a c e , d i s a b i l i t y o r s e x u a l p r e f e r e n c e as t h e reason f o r
t h e d e n i a l o f t h e i r r e q u e s t t o j o i n an AHP as a p r o v i d e r ?
7. What remedies, i f any, s h o u l d be a v a i l a b l e t o an AHP t h a t i s
not s e l e c t e d by a HIPC as an approved plan?
Should t h e s t a t u t e s p e c i f y t h e c r i t e r i a f o r t h e d e c i s i o n o f
a HIPC t o approve o r d i s a p p r o v e o f t h e p l a n s u b m i t t e d by any
s p e c i f i c AHP?
Could t h e s t a t u t e s p e c i f y t h e s e c r i t e r i a and s t i l l l e a v e
maximum room f o r s t a t e e x p e r i m e n t a t i o n and r e g u l a t i o n ?
I f t h e s t a t u t e does n o t s p e c i f y t h e r o l e o f t h e HIPCs i n
s e l e c t i n g AHPs how w i l l u n i f o r m n a t i o n s t a n d a r d s on t h i s
most b a s i c element o f t h e p l a n be s u s t a i n e d ?
8.
Assuming t h a t most disagreements a r e r e s o l v e d a t t h e l e v e l
o f t h e AHP, what i n f o r m a t i o n s h o u l d be g a t h e r e d and d i s s e m i n a t e d
to t h e general p a t i e n t population?
Should t h e AHP be r e q u i r e d t o r e p o r t t h e r e s u l t s o f t h e
m e d i a t i o n s ( i n schematic form w i t h o u t p a t i e n t names o r
recognizable c h a r a c t e r i s t i c s - - i . e . , Pre-natal t e s t f o r
C y s t i c F i b r o s i s DENIED) and i f so how o f t e n and t o whom?
Should t h e AHP be bound i n anyway by t h e outcome o f s i m i l a r
d i s p u t e s i n l i k e circurtistances? I f so, how so? I f n o t what
w i l l prevent d i s c r i m i n a t i o n against less aggressive o r
h o s t i l e patients?
Should t h e AHP be r e q u i r e d t o p r o v i d e a f o r m a l w r i t t e n
n o t i c e o f d e n i a l i f t h e r e q u e s t f o r s e r v i c e s i s denied? I f
an e x i s t i n g s e r v i c e i s reduced o r t e r m i n a t e d and t h e p a t i e n t
or f a m i l y objects?
9.
Should t h e AHP be r e q u i r e d t o have a s t a t e d and d i s s e m i n a t e d
p o l i c y on c o n t r o v e r s i a l b i o e t h i c a l i s s u e s , i . e . , a b o r t i o n ,
t e r m i n a t i o n o f c a r e f o r t h e t e r m i n a l l y i l l , where s t a t e law would
p e r m i t a range o f p o l i c y o p t i o n s ? I f so s h o u l d t h i s be r e q u i r e d
by s t a t u t e o r by r e g u l a t i o n ?
I f by s t a t u t e what language might
be a p p r o p r i a t e ?
�REGULATORY RELIEF
Over the years, layers of federal regulation have been established that impose unreasonable burdens on
physicians' practices, often duplicating private sector activities. These regulations are often not cost
effective and significantly increase the cost of medical care. Medicare is one of the most complex
laws, with literally thousands of pages of regulations, instructions and directions. Peer Review
Organizations (PRO) have the authorization to begin review in every physician's office. The National
Practitioners Data Bank is expensive and does not provide the necessary operational safeguards to
ensure confidentiality. EPA regulates disposal of medical waste. OSHA regulates workplace safety.
The Americans with Disability Act has established new requirements on physicians, both as employers
and in the area of pubUc accommodations. The Clinical Laboratory Improvement Act of 1988
regulates over 100,000 physician practices, is overly complex and will increase the cost of medical
care and create new barriers to access. Even the Federal Communications Commission is estabUshing
requirements which are of doubtful benefit.
While taken individually, each regulation is well intended, the practical effect is a regulatory overload
that is often impossible to deal with. Regulations emanate from multiple sources with multiple goals
that do not always work when applied to the physician's practice. Many agencies do not have
adequate experience in the health care area or physician practice in general and are not sensitive to the
unique challenges faced in a physician's practice. Multiple enforcement agencies, unclear standards,
rules that are not tailored to the individual's circumstances all lead to hassle,frustrationand anger. It
also must be recognized that regulatory requirements raise the costs of providing health care services
and divert resources from direct provision of necessary care.
Recommendation:
Create a Presidential commission to review the multiple regulatory burdens
that impact on the health care system and physicians. Such a commission
should inventory the regulations and rules now applicable, analyze them from
a cost-effectiveness standpoint, appropriateness of the requirement and make
recommendations for the elimination of unnecessary, inappropriate, duplicate,
ineffective or overly costly regulations and coordinate the implementation and
enforcement of the remaining items.
We have also developed conmients on specific regulatory areas that now are causing problems for
physicians. Below is a discussion of some of these regulatory problems and suggestions for reform in
the following areas:
Clinical Laboratory Improvement Amendments of 1988 (CLIA)
Peer Review Organizations (PRO)
National Practitioner Data Bank (NPDB)
Occupational Safety and Health Administration (OSHA)
Americans with Disabilities Act (ADA)
Medicare Administrative Burdens
�Clinical Laboratory Improvement Amendments of 1988 (CLIA)
CLIA regulates all clinical laboratory testing, wherever provided, no matter how simple. Expensive
compliance requirements are forcing some physicians to close their labs rather than put up with
inspections, paperwork and daily administrative requirements. This massive regulatory program,
effecting hundreds of thousands of sites, was developed due to problems with certain cytology tests,
specifically pap smears. However, the authorizing legislation went way beyond pap smears to cover
all testing, no matter where provided, without clear docimientation that there was a major problems
that needed to be addressed.
Initial regulations were so out of touch with reality, that over 60,000 comments were filed and major
changes have been made. In many cases, it appears the goal of accurate tests has taken a back seat to
meeting bureaucratic requirements. What is important is not whether the person performing the test is
a high school graduate or has an associate degree from a jimior college. What is important is that the
test is done correctly with accurate results and that the patient gets the care they need. Proficiency
testing should be the key as well a recognition of private accreditation efforts.
Although many changes have occurred since the CLIA regulations were first published in 1989,
physicians remain concemed about the following problems:
PHYSICIAN TEST CATEGORY
Problem:
Federal statutes and regulations must not deny a physician the right to practice
medicine by implicitly establishing unprecedented and unwarranted federal licensure or
certification standards. In many cases, however, the requirements of the CLIA
moderately complex category are forcing physicians to discontinue necessary testing in
their offices. Consequently, patient access to needed laboratory tests may be unduly
restricted and burdens on patients, including delayed diagnosis or prolonged treatment
and increased travel time, and repeat office visits, resulting in additional health care
costs may occur.
Solution:
The criteria we recommend to establish an expanded and modified category of
waivered tests that are provided by physicians in their offices as follows:
1.
Establish a range of tests based on the physician's training and experience and
performed by or under the direction and control of the physician, and
2.
Ensiu-e prompt test results to provide quality medical care and/or to avoid
additional burdens on the patient which could result in noncompliance with the
request for the test; and
Ensure low risk of erroneous results through the training or experience of the
physician performing or supervising the test, successful participation in a
proficiency testing program for the specific test and examination of the full
history and records of the patient along with direct observation of the patient.
�There is no specific predetermined list of tests for this recommended broad category.
With the apphcation for a "physician" certificate, each physician will identify specific
tests that he or she will personally perform or closely supervise. These tests could
include tests otherwise foimd in any other category except for cytopathology. In
addition, the physician will submit documentation indicating successful participation in
an independent proficiency testing program, if available, for each non-waivered test
listed on the certificate. The fee for this certificate should be no more than $150.
The following standards would appjx to the broad "physician" category:
1.
The physician must successfully complete a proficiency testing program, if
available.
2.
Quality controls and Commission on Office Laboratory Assessment (COLA) or
other accreditation are strongly encouraged.
3.
Tests must be consistent with the physician's specialty, training or experience.
4.
Tests must be physician interpreted with no other personnel involved except
those under the physician's direction and control.
5.
Laboratories would be subjected to on-site inspection if suspected of being out
of comphance with the certificate.
This new physician category would allow physicians to practice medicine without
inappropriate federal intrusion and at the same time ensure that patients have access to
high quality laboratory tests.
DEEMED STATUS
Problem:
At this time, laboratories do not have a clear option of selecting a private accrediting
entity such as the Commission on Office Laboratory Accreditation or the College of
American Pathologists. The lack of granting "deemed" status to private entities has
created confusion and uncertainty. We understand that entities seeking "deemed"
status have submitted applications several months ago. These entities are constantly
getting requests from the Health Care Financing Administration (HCFA) for additional
information. The most recent request concemed the new physician category. Since
the CLIA regulations are constantly evolving, these requests could continue
indefinitely.
Solution:
HCFA should immediately issue "deemed" status to qualified private accrediting
entitieFwhcThave already submitted their applications. HCFA must ac( on the
information that they currently have and issue "deemed" status to qualified entities to
avoid further complicating a very complex process. We urge that HCFA give this
issue the highest priority and issue "deemed" status to qualified entities immediately.
�PATIENT ACCESS
Problem:
Currently, the regulations provide no consideration of problems of patient access to
laboratory services in "health professions shortage," "underserved" or "rural" areas.
Laboratories in these areas would have to close if they find it fmancially impossible to
comply with the regulations or if there is an inadequate supply of trained personnel.
At best, these patients would have to travel a great distance with added expense and
great inconvenience or suffer delay in receiving results as samples are transported to
qualified laboratories. Under these conditions some patients might elect not to have
the laboratory tests performed-possibly jeopardizing their health. Modifications to the
regulations are imperative to assure patients continued access to laboratory services in
"health professions shortage," "underserved" or "rural" areas.
Solution:
An ^ception to the CLIA regulations also should be given to laboratories which are
the "sole_£ommimit^
laboratory services, so that such services remain
reasonably available in a geographic area. This special classification should be similar
to the "sole community hospital" exception provided under Medicare Part A (Section
1886(d)(5)(C)(ii) of the Social Security Act). Consideration in determining a "sole
community" laboratory should be given to such factors as isolated location, weather
and travel conditions, and the absence of or accessibility to an independent laboratory
in the area.
FINANCIAL IMPACT
Problem:
While physicians beUeve that high quality laboratory tests are essential, we believe that
some of the proficiency testing (PT), quality control (QC) and quality assurance (QA)
requirements as proposed are too expensive to be practical for all laboratories.
Solution:
For moderately complex laboratories, the QC requirement should be reduced from
twice to once per day and that PT events (the number of times the laboratory is tested)
should be reduced from three to two per year. This would save approximatelv $110
million per year. Since most of the financial burden of CLIA will be borne by
physicians who provide in-office testing, this would alleviate much of the fmancial
burden for these physicians and still provide adequate safeguards for padents.
"SHARED" LABORATORIES
Problem:
Confusing infonnation conceming "shared" laboratories has been given by HCFA and
clarification is needed. At one time, HCFA indicated that one certificate was
necessary for each physician "sharing" laboratory equipment with other physicians.
Later, the decision was reversed and now HCFA indicates that each physician in a
"shared" laboratory situation who submits a Medicare claim form for a laboratory test
needs an individual certificate.
7
�Solution:
A single CLIA ID number should be utilized by^ll physicians using the jgme
laboratory for their testing. CLIA was designed to regulate toboraMy_sgryices,CLIA
was not enacted to regulate the^individuals^ordMj^
from the laboratory.
Whether the physicians are organized in a formal group practice or are merely
"sharing" laboratory equipment should make no difference for CLIA purposes as long
as there is only a single laboratory. To require each physician to have a different
CLIA ID number is not supported by the stamte and would cause the laboratory to
imdergo several redundant inspections as well as incur redundant fees for proficiency
testing (PT), and quality control (QC).
ANNOUNCED INSPECTIONS
Problem:
The Secretary of Health and Human Services clearly indicated in a press release on
September 1, 1992 that the physician would have 3 days notice prior to an inspection.
However, survey guidelines and recent discussions with HCFA indicate that physicians
may not receive 3 days notice. HCFA has indicated that notice is only to be given if
patient care would be at jeopardy because of the inspection.
Solution:
The CLIA regulations need to clarify that the physician's office will not be subjected
to unannounced routine inspections. An imannounced CLIA inspection in a
physician's office will always dismpt patient care. The regulations at Section
493.1175(a), Section 493.1777(a) and Section 493.1780(a) should be modified by
adding a sentence that states: "Physicians' offices will be given 3-day advance notice
of a routine inspection. If a complaint has been received or a problem is suspected,
then the inspection of the physician's office may be unannounced."
CLINICAL LABORATORY IMPROVEMENT ADVISORY COMMITTEE (CLIAC)
Problem:
The breadth and scope of the CLIA regulations and the impact of these regulations
have on the practice of medicine need to be continually assessed to determine whether
there is any measurable impact on the quality of laboratory testing and medical care.
Solution:
Charge the CLIAC with the responsibility of evaluating program operation, making
recommendations for modifications in regulations and other program requirements and
evaluate the impact of the program.
Problem:
Although the physicians support the use of CLIAC to implement CLIA, more CLIAC
members should be physicians with experience with in-office laboratory testing.
Solution:
Since the largest newly regulated population under CLIA are physicians who perform
in-office laboratory testing for their patients, the majority of the members of CLIAC
should be these physicians who have direct knowledge and expertise with in-office
laboratory testing. Positions should be identified for physicians who have in-office
laboratories.
�Peer Review Organizations (PRO)
Enacted as a federal watchdog over physician practices, the PRO program started out as very intrusive
and burdensome on physician practices. Individual case review and pre-approvals for certain
conditions created a level of animosity that will be difficult to overcome.
Many improvements were incorporated into the final version of the Fourth Scope of Work, resulting in
a PRO program focused primarily on education instead of punitive actions. However, the following
issues still need to be resolved.
PRO DENIAL OF PAYMENT FOR SUBSTANDARD QUALITY CARE
Problem:
The Consolidated Omnibus Budget Reconciliation Act of 1985 gave PROs the
authority to deny Medicare payments for services provided that are determined by a
PRO to be of substandard quality. On January 18, 1989, HCFA published a proposed
rule in the Federal Register detailing its plan for implementing this provision of the
Medicare law. HCFA's proposed regulations, for various reasons, have not yet been
implemented. On November 3, 1992, HCFA pubUshed an annoimcement in the
Federal Register indicating that "final action" on the proposed 1989 rule was "pending
the resolution of complex policy issues."
Solution:
HCFA should not implement a final mle for PRO denial of "substandard quaUty care"
until its has redrafted its proposed rule in a manner consistent with the spirit and
requirements of the current PRO Fourth Scope of Work, and until it has provided the
medical community with an adequate opportunity to conduct discussions with HCFA
on the appropriateness and direction of such regulations.
PRO AMBULATORY REVIEW
Problem:
The Omnibus Budget Reconciliation Act of 1986 called for PROs to review the care
provided to Medicare patients in physicians' offices. Following that legislative
mandate, HCFA funded three pilot projects to test the viabiUty of altemative
approaches to PRO ambulatory review. At this time, however, HCFA has no firm
timetable for implementing PRO review of physicians' offices.
Solution:
Enact amendments to the PRO law that would repeal the legislation authorizing
physician office reviews. If repeal is unsuccessfiil, such review should not be
expanded_beyond the pilot stage until HCFA has^deinonstrated that its review
methodologies are focused, based on medically sound processes and outcomes, and
consist^t^wTth the educaSonal, non^unitive^proach in the current f K U hourth
Scope of Work. Reviewing the care in hundreds of thousands of physicians' offices
would be a massive, expensive imderlaking that would divert resources from providing
services to patients.
�PRO PREPROCEDURE REVIEW
Problem:
HCFA has made an administrative decision to eliminate 100 percent PRO
|
preprocedure/readmission review of 10 surgical procedures in die Fourth Scope of
/
Work. However, federal legislation remains in force that requires PROs to conduct I
such review.
Solution:
Urge Congress to repeal the appUcable legislation mandating 100 percent review of at |
least 10 surgical procedures.
ATTESTATION REQUIREMENTS
Problem:
Attestation requirements for hospital discharges and their use by the PRO program
create unnecessary burdens for physicians. Annual written certification is required for
primary and secondary diagnoses and procedures pertaining to each case, and failure to
so attest results in a mandatory PRO denial to the hospital. Improper attestations by
physicians may result in civil monetary penalties. Each physician must annually sign a
written acknowledgment that she or he is aware of the penalties for improper
attestation, which the hospital maintains on file. If the PRO finds improper or
outdated statements on file, it may result in payment denial for all care associated with
physician orders executed by such physician.
Solution:
To reduce the administrative burden, the attestation requirement should be required
only when hospital privileges are granted. Any additional requirements should only
involve verification as to the legibiUty of the signature and to ensure that the signature
matches the attestation.
PHYSICIAN REVIEWER EDENTITIES
Problem:
As currently drafted, the Fourth Scope of Work does not require PROs to reveal the
identities of PRO physician reviewers. Instead, it requires that PROs only assess the
potential impact on physician reviewers if the names of individual reviewers are
disseminated to physicians under review. Physicians remain frustrated by the
anonymity granted to PRO reviewers by HCFA and their inability to confront their
accusers (a basic tenet of American due process).
Solution:
Support changes in regulations and the Fourth Scope of Work to require PROs to
release to physicians imder review the identities of PRO physician reviewers.
National Practitioner Data Bank (NPDB)
The National Practitioner Data Bank was created to deal with the problem of physicians and other
health care practitioners losing their license or privileges in one state and moving to another.
However, the legislation went way beyond that problem and established elaborate reporting
requirements well beyond licensure actions. The Act also failed to recognize that there was a private
�8
sector activity with the Federation of State Medical Licensing Boards that dealt with the perceived
problems of physicians moving between states.
Problem:
The data bank is another example of the federal govemment initiating a new activity
rather than utilizing existing mechanisms at the state level and in the private sector.
Man;y individuals involved in the credentialing area have expressed doubts as to
whether the NPDB provides significant benefits, especially in light of its costs and
additional burdens.
Solutions:
Consider a private sector altemative such as the service of the Federation of State
Medical Licensing Boards.
Review its operation focusing on cost-effectiveness and matters relating to
confidentiality.
If the NPDB is not privatized, reduce die existing burden by enacting legislation to
establish a $30,000 threshold for reporting of medical liability payments.
Do not impose user fees for practitioners who self-query to determine the accuracy of
the data regarding their files.
Occupational Safety and Health Administration (OSHA)
Physicians recognize that employees have a right to a safe work place, but it is clear that OSHA has
very little, if any understanding of the operation of physician practices. Regulatory requirements that
may be appropriate for large institutions or where high risk procedures are performed, are not always
necessary for other settings.
Problem:
OSHA has imposed very strict and biudensome workplace and record keeping
standards for physicians offices that in many cases are unrealistic to the risk posed.
OSHA has previously issued press releases after inspecting physicians' offices Uiat
were inflammatory.
Solutions:
There is a conflict between the bloodbome pathogens recordkeeping
requirements and the general OSHA recordkeeping requirements that
makes it impossible to fully comply with both regulations. OSHA
acknowledged part of this problem in the preamble to the bloodbome
pathogens regulation and stated that the general recordkeeping
requirements would be amended. Such an amendment was never
made, and OSHA officials now explain it will not be done.
A related recordkeeping matter concems the requirement in the
bloodbome pathogens standard that employee medical records be
maintained for at least thirty years. This is extremely biudensome for
the small practice that may have a high level of turnover.
�Another example of employee medical records which must be
maintained for at least 30 years after employment is the retention of
material safety data sheets (MSDSs) as required by the hazard
communication standard. The 30 year retention requirement is imduly
burdensome on physician practices. Also, material safety data sheets
should not be required for products, such as bleach or vinegar, that can
be bought in grocery stores.
OSHA has expanded its regulation of infection control by requiring
employers to adopt work practices and provide equipment to prevent
the transmission of TB. There are several "guidelines" on TB conti-ol,
but no clear regulations. Physicians tiierefore caimot anticipate what
OSHA inspectors might be looking for, and may in fact, disagree with
the recommendations of the particular set of guideUnes being appUed
by the inspector. OSHA should be required to go through the
rulemaking process prior to enforcing TB control measures in
physician offices, except for a few, noncontroversial, clearly
communicated requirements. OSHA should also avoid expensive self
contained respiratory systems until the clear risk and benefit can be
estaWished.
Codify OSHA's pohcy of only inspecting physician offices in response
to complaints, and not to conduct special emphasis inspections (ie.
when there is no reason to beUeve their is a violation) of physician
offices.
In cases when an iaspection is warranted, OSHA inspectors only
should cite violations of specific standards and not cite the general
duty clause (which requires that employers fiunish a workplace free
from recognized hazards but contains no guidance as to how that
general duty should be met) so that physicians have notice and an
opportunity to comply with specific OSHA requirements.
The bloodbome pathogens standard permit the off-site laundering of
uncontaminated uniforms and imcontaminated personal protective
equipment, however some OSHA compliance officers are enforcing the
contaminated laundry requirements in the context of imcontaminated
laundry. OSHA inspectors should be directed to allow reasonable offsite laundering of uncontaminated material.
Americans with Disabilities Act (ADA)
Problem:
The American with Disabilities Act has created an entire new set of federal regulatory
issues for the physician's practice. These relate to the physician's obligations as an
employer and as a public accommodation. One of the major problems with ADA
regulations is that the regulatory requirements are not well articulated. It is expected
�10
that these issues will be resolved only through expensive litigation. Clear federal
enforcement standards should be established and made available so that people
required to comply with the law understand the requirements.
Solutions:
Provide clear regulatory guidance to physicians and others as to what they are
expected to do to comply with ADA.
Require Medicaid reimbursement for sign language interpreters
required by Medicaid patients.
Expand tax incentives available to physicians who make expenditures
for the purpose of creating greater accessibility to facilities for
individuals wiUi disabilities. Specifically expansion of the Disabled
Access Tax Credit to cover all of tiie costs associated with the
provision of interpreters. This could be accompUshed by eliminating
the minimum and maximum dollar amounts in the existing tax credit
(between $250 and $10,250) and calling for an increase in the tax
credit from 50% of the expenditure to 100% of the expenditure.
Review regulatory requirements for their impact on physician offices and other small
business. For example, the FCC has required that all telephone headsets in workplaces
be hearing aid compatible by May 1, 1994. (For workplaces over 20 employees, the
conversion must take place by May 1, 1993). AU phones manufactured before August
of 1989 must be checked to see if they comply. [Note: This is not an ADA
requirement, but stems from the Hearing Aid Compatibility Act of 1988.]
Medicare Administrative Burdens
The Medicare program is one of the most complicated and confusing programs administered by the
Federal govemment. The statute covers hundreds of pages, and there are tens of thousands of pages of
regulations, instmctions, decisions and other determinations. HCFA has attempted to resolve various
regulatory burdens but more needs to be done. Each year, physicians are faced with increased layers
of requirements and inconstant implementation.
To further improve Medicare-physician relations, the foUowing issues merit special attention.
PRACTICING PHYSICIAN ADVISORY COMMITTEE
Problem:
The Practicing Physician Advisory Committee was created by the Congress to review
new regulatory proposals and provide the input of physicians on implementation
issues. While a good idea, the Committee has not properly utilized by HCFA. The
agendas of the Committee have been relegated to relatively minor items, with the real
issues of concem to physicians not being addressed. The Committee has the talent in
its membership to facilitate resolution of many problems facing physicians in the
Medicare program.
.
�11
Solution:
Instinct HCFA to use the Practicing Physician Advisory Committee to review all major
Medicare regulations and policy decisions and make recommendations for
improvement, consolidation or elimination of the existmg body of rules and regulation.
Provide adequate staff to the Committee to conduct tiiis review m a timely fashion.
DISCLOSURE OF COVERAGE CRITERIA
Problem:
Medicare has utUization, coverage and screening criteria for review of claims fliat it
keeps hidden from physicians. This creates tiie situation where claims are challenged
or denied based on the results of a |1>lack_box" review. Physicians are kept in tiie dark
as to what the program considers proper and the credibility of the criteria is questioned
because they are not held up to scientific scmtiny and review. Congress authorized a
demonstration project for release of the criteria to see the impact on physician
behavior, but no report has been issued. Since these criteria relate to medical care
issues, it is only fair that physicians be informed of the review criteria and have a
chance to evaluate the accuracy of the standards.
Solution:
Make available to physicians and their representative professional organizations all
medical review employed by carriers and PROs to review Medicare claims.
DOWNCODING
Problem:
Arbitrary downcoding by carriers has been one of the major problems experienced by
physicians. Based on analyses of physician coding practices, carriers have sometimes
changed a physician's assigned level of service to a lower level. In such downcoding
situations, Uie carriers would usually allege that physicians in tiie area routinely used
two or three levels of service and did not routinely provide higher level services.
Regardless of what the physician coded, and not based on a review of the records, the
carrier would reassign the physician's services at a lower level.
Solution:
Codes should be altered only after a review of the documentation and after notification
to the physician. Prior to a final determination to downcode, carriers should request
additional information from the physician.
DUE PROCESS/MEDICARE AUDITS
Problem:
The use of "sampling" and exU-apolation have proven to be particularly onerous as the
civil monetary penalties allow for an assessment of twice the inappropriate charge plus
a $2,000 fme for each incident. This penalty quickly adds up as the carrier, by statute,
can go back at least four years (there is no time limitation for instances of fraud). The
lack of an adequate due process appeal procedure under these circumstances is
especially oppressive.
Such sample audits are often accompanied by coercive audit letters to physicians
stating that repayment must be forthcoming immediately or they may be subjected to a
blanket audit of all claims submitted for the previous fours years.
�12
Solution:
Physicians strongly object to this heavy handed approach and believes that carriers
transcend the limits of their authority by proceeding in this manner. In supporting the
"anti-hassle" legislation, extrapolation should be used only to identify claims for which
payment may be disallowed. Further, if the physician requests that the claims at issue
be identified individually, the carrier may not recoup or offset payment amounts or
charge interest until an appeal is heard at the ALJ level.
LIMITING CHARGE ENFORCEMENT
Problem:
In many cases, mistakes in the limiting charges have occurred because carriers did not
have adequate lead time to notify physicians of changes in the new physician payment
system. Also, carriers supplied physicians with some of the charge limits, but not for
aU services. So physicians had to do their own calculations for the unlisted services.
In addition, some services which were separately billed, are now "bundled" by the
carriers into a single global fee. This "bundling" results in a lower Medicare fee and a
lower limiting charge. Since physicians do not receive the "Explanation of Medicare
Benefits" they may never know that Medicare payment and the allowed charge were
less than they anticipated.
In spite of these problems, HCFA hastightenedenforcement by more aggressively
requiring physicians to refund overpayment to Medicare beneficiaries.
Solution:
Physicians do not condone over-charging tiie patient and supports appropriate
enforcement of the relevant statute. However, we are concemed that the physician
may be imduly penalized for an inadvertent error. Prior to enforcing penalties and/or
sanctions or notifying the beneficiary, physicians should be properly informed as to the
problem and given an opportunity to object (with full due process) or correct the enor.
Experience shows that physicians, once aware of any problem, wUl act responsibly.
MEDICARE SECONDARY PAYER
Problem:
Under Section 1862(b)(2) of the Social Security Act, the carrier can refuse to
reimburse the physician for a Medicare claim if the beneficiary has not filled out and
submitted a questionnaire designed to determine whether Medicare is a secondary or
primary insurer. This denial of payment penalizes the physician for the beneficiaries'
inaction—sometiiing over which the physician has no control.
Solution:
This policy is unfair and should be curtailed. Instead, the carriers should gather
information on insurance directiy from the beneficiary with no penalty placed on the
physician.
CONTRACTOR FUNDING
Problem:
We are particularly concemed that cost per claim reductions in HCFA's contractor
funds will hamper HCFA's efforts to enhance canier-physician relationships. HCFA
should be encouraged to assure that claims processing is efficient and cost effective.
At the same time, HCFA must not short change needed educational efforts to increase
physicians' knowledge about claims processing requirements.
�13
Solution:
Adequate funding for competent staff and outi-each activities such as "SOO" telephone
service is essential. HCFA must aggressively pursue adequate contractor funds to
properly administer the Medicare program.
CARRIER FEES
Problem:
Pressures on restraining carrier administrative costs have resulted in consideration of
passing legitimate program costs on to the physicians through user fees. For example,
carriers in some geographic areas reportedly have charged physicians for information
necessary to comply with the Medicare program such as obtaining a unique identifier
number (UPIN), responding to inquiries, and providing information used in the
medical review of services. HCFA has proposed
a fee for each paper claim filed, or for an error in filing a claim, and charging for an
appeal of a denial of a claim.
Solution:
The Medicare system was designed as an entitlement insurance program, not a user
supported system. Therefore, HCFA should be prohibited from charging physicians
for claims processing functions.
CARRIER PERFORMANCE
Problem:
Many times physicians and/or medical societies are fmstiated in their relationship with
the Medicare carriers in that there is no recourse if a Medicare carrier violates or does
not fulfill its Medicare contract. The only action that can be taken is to protest to
HCFA and HCFA's only major recourse is to terminate the carrier's contract. No
intermediate action or sanction is available to an aggrieved beneficiary or provider.
Solution:
Medical societies should be allowed to submit evaluations and information conceming
the canier's performance to the Secretary of Healtii and Human Services. This
information should be considered in the annual canier performance evaluation.
In addition, we also beUeve that a new policy of intermediate sanctions be estabUshed
if a carrier fails to carry out policies established through regulation, carrier manual, or
regional and central office transmittal, a hearing process to correct this should be
aUowed at the request of any individual (includmg a physician) or representational
organization (including a medical society). For a hearing to be held, damages must be
at least $500 (claims could be aggregated). If a carrier is found to have violated the
contract, the Secretary should order the carrier to compensate the aggrieved
individuals.
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Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
Health Care Task Force Records
Creator
An entity primarily responsible for making the resource
White House Health Care Task Force
Is Part Of
A related resource in which the described resource is physically or logically included.
<a href="https://catalog.archives.gov/id/10443060" target="_blank">National Archives Catalog Description</a>
Description
An account of the resource
<p>This collection contains records on President Clinton’s efforts to overhaul the health care system in the United States. In 1993 he appointed First Lady Hillary Rodham Clinton to be the head of the Health Care Task Force (HCTF). She traveled across the country holding hearings, conferred with Senators and Representatives, and sought advice from sources outside the government in an attempt to repair the health care system in the United States. However, the administration’s health care plan, introduced to Congress as the Health Security Act, failed to pass in 1994.</p>
<p>Due to the vast amount of records from the Health Care Task Force the collection has been divided into segments. Segments will be made available as they are digitized.</p>
<p><a href="http://clinton.presidentiallibraries.us/items/browse?advanced%5B0%5D%5Belement_id%5D=43&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=2006-0885-F+Segment+1"><strong>Segment One</strong></a><br /> This collection consists of Ira Magaziner’s Health Care Task Force files including: correspondence, reports, news clippings, press releases, and publications. Ira Magaziner a Senior Advisor to President Clinton for Policy Development was heavily involved in health care reform. Magaziner assisted the Task Force by coordinating health care policy development through numerous working groups. Magaziner and the First Lady were the President’s primary advisors on health care. The Health Care Task Force eventually produced the administration’s health care plan, introduced to Congress as the Health Security Act. This bill failed to pass in 1994.<br /> Contains 1065 files from 109 boxes.</p>
<p><a href="http://clinton.presidentiallibraries.us/items/browse?advanced%5B0%5D%5Belement_id%5D=43&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=2006-0885-F+Segment+2"><strong>Segment Two</strong></a><br /> This segment consists of records describing the efforts of First Lady Hillary Rodham Clinton to get health care reform through Congress. This collection consists of correspondence, newspaper and magazine articles, memos, papers, and reports. A significant feature of the records are letters from constituents describing their feelings about health care reform and disastrous financial situations they found themselves in as the result of inadequate or inappropriate health insurance coverage. The collection also contains records created by Robert Boorstin, Roger Goldblatt, Steven Edelstein, Christine Heenan, Lynn Margherio, Simone Rueschemeyer, Meeghan Prunty, Marjorie Tarmey, and others.<br /> Contains 697 files from 47 boxes.</p>
<p><a href="http://clinton.presidentiallibraries.us/items/browse?advanced%5B0%5D%5Belement_id%5D=43&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=2006-0885-F+Segment+3"><strong>Segment Three</strong></a><br /> The majority of the records in this collection consist of reports, polls, and surveys concerning nearly all aspects of health care; many letters from the public, medical professionals and organizations, and legislators to the Task Force concerning its mission; as well as the telephone message logs of the Task Force.<br /> Contains 592 files from 44 boxes.</p>
<p><a href="http://clinton.presidentiallibraries.us/items/browse?advanced%5B0%5D%5Belement_id%5D=43&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=2006-0885-F+Segment+4"><strong>Segment Four</strong></a><br /> This collection consists of records describing the efforts of the Clinton Administration to pass the Health Security Act, which would have reformed the health care system of the United States. This collection contains memoranda, correspondence, handwritten notes, reports, charts, graphs, bills, drafts, booklets, pamphlets, lists, press releases, schedules, newspaper articles, and faxes. The collection contains lists of experts from the field of medicine willing to testify to the viability of the Health Security Act. Much of the remaining material duplicates records from the previous segments.<br /> Contains 590 files from 52 boxes.</p>
<p><strong><a href="http://clinton.presidentiallibraries.us/items/browse?advanced%5B0%5D%5Belement_id%5D=43&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=2006-0885-F+Segment+5">Segment Five</a></strong><br /> This collection of the Health Care Task Force records consists of materials from the files of Robert Boorstin, Alice Dunscomb, Richard Veloz and Walter Zelman. The files contain memoranda, correspondence, handwritten notes, reports, charts, graphs, bills, drafts, booklets, pamphlets, lists, press releases, schedules, statements, surveys, newspaper articles, and faxes. Much of the material in this segment duplicates records from the previous segments.<br /> Contains 435 files from 47 boxes.</p>
<p><strong><a href="http://clinton.presidentiallibraries.us/items/browse?advanced%5B0%5D%5Belement_id%5D=43&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=2006-0885-F+Segment+6">Segment Six</a></strong><br /> This collection consists of the files of the Health Care Task Force, focusing on material from Jack Lew and Lynn Margherio. Lew’s records reflect a preoccupation with figures, statistics, and calculations of all sorts. Graphs and charts abound on the effect reform of the health care system would have on the federal budget. Margherio, a Senior Policy Analyst on the Domestic Policy Council, has documents such as: memoranda, notes, summaries, and articles on individuals (largely doctors) deemed to be experts on the Health Security Act of 1993 qualified to travel across the country and speak to groups in glowing terms about the groundbreaking initiative put forward by President Clinton in his first year in the White House. <br /> Contains 804 files from 40 boxes.</p>
Publisher
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William J. Clinton Presidential Library & Museum
Identifier
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2006-0885-F
Text
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Paper
Dublin Core
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Title
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[Legal Audit Group]
Creator
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Task Force on National Health Care
White House Health Care Task Force
Carolyn Gatz
Jennifer Klein
Identifier
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2006-0885-F Segment 2
Is Part Of
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Box 10
<a href="http://clintonlibrary.gov/assets/Documents/Finding-Aids/2006/2006-0885-F-2.pdf" target="_blank">Collection Finding Aid</a>
<a href="https://catalog.archives.gov/id/12093616" target="_blank">National Archives Catalog Description</a>
Provenance
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Clinton Presidential Records: White House Staff and Office Files
Publisher
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William J. Clinton Presidential Library & Museum
Format
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Adobe Acrobat Document
Medium
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Preservation-Reproduction-Reference
Date Created
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2/6/2015
Source
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42-t-12093616-20060885F-Seg2-010-004-2015
12093616