Thompson v. Raiford Unopposed Motion for Leave to File Brief and Brief Amici Curiae in Opposition to Defendant's Alternative Motions to Dismiss and For Summary Judgment with Declarations

    UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF TEXAS 

DALLAS DIVISION

LOIS THOMPSON on behalf of and as next 
friend to TAYLOR KEONDRA DIXON, 
ZACHERY X. WILLIAMS, CALVIN A. 
THOMPSON and PRENTISS LAVELL 
MULLINS,

Plaintiffs,

PEOPLE UNITED FOR A BETTER 
OAKLAND, on behalf of its members; 
DENVER ACTION FOR A BETTER 
COMMUNITY, on behalf of its members; 
NEW YORK CITY COALITION TO END 
LEAD POISONING, on behalf of its 
members; ROBIN GOURLEY on behalf of 
and as next friend to BRYAN ALAN 
GOURLEY, WESLEY KYLE GOURLEY, 
BRIDGET MICHELLE GOURLEY, 
LINDA DANIELLE GOURLEY and 
BETSEY IRENE GOURLEY; TEARRAH 
ROBERSON on behalf of and as guardian 
ad litem to JUAN WILKINS; and MARY 
MARIE ROBERSON on behalf of and as 
guardian ad litem to ASHARD MOORE, 
JASON ROLLINS, ASHEA ROBERSON, 
and NASHEIKA ROBERSON,

CASE NO. 3-92 CV 1539-R

Civil Action

Class Action

UNOPPOSED MOTION FOR LEAVE 
TO FILE BRIEF AMICI CURIAE, 
BRIEF AMICI CURIAE IN 
OPPOSITION TO DEFENDANT  
UNITED STATES OF AMERICA’S 
ALTERNATIVE MOTIONS TO 
DISMISS AND FOR SUMMARY 
JUDGMENT; DECLARATIONS OF 
JOHN F. ROSEN, PAUL MUSHAK, J. 
ROUTT REIGART AND BILL LANN 
LEE

Proposed Plaintiff-Intervenors,

v.

BURTON F. RAIFORD, in his capacity as 
Commissioner of the Texas Department of 
Human Services,

The UNITED STATES OF AMERICA,

Defendants,

uLOUIS W. SULLIVAN, in his capacity as 
Secretary of the United States Department of 
Health and Human Services,

Proposed Additional Defendant.

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BRIEF AMICI CURIAE

TABLE OF CONTENTS

Interest of Amici .............................................................................................................................  1
Introduction ....................................................................................................................................  1
Summary of Argument ................................................................................................................. 2
Statement .........................................................................................................................................  3

A. The Extent of Lead Poisoning in Poor Children .................................................  3

1. Prevelence............................................................................................................ 3

2. Exposure..............................................................................................................  4

3. Symptoms ............................................................................................................ 6

B. The Appropriate Test for Poor Children .............................................................. 6

Argument ............................................................................................................................................ 8

A. The Plain Terms of the Statute Require A Blood Lead Test.............................  8

B. Legislative History Confirms that Congress Intended to Mandate A
Blood Lead Test to Screen For Lead Poisoning...............................................  10

C. The Agency Construction of the Statute Is Entitled to No Deference.............  11

D. The Remedial Purpose of the EPSDT Statute and the CDC Report Mandate
that Blood Lead Testing Be Required................................................................  14

1. The Remedial Purpose of the EPSDT Statute Requires Blood Lead
Testing ....................................................................................................  13

2. The CDC Statement Requires Blood Lead Testing .....................   13

Inappropriateness of Questioning and EP Testing for Screening . . 15

Indefinite Transiton Period.....................................................................  16

Conclusion.........................................................................................................................................  19

Affidavit of John F. R o se n ............................................................................................................  21

Declaration of Paul M ushak........................................................................................................... 126

Declaration of J. Routt Reigart ....................................................................................................276

Declaration of Bill Lann Lee ................................................................................   280

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TABLE OF AUTHORITIES

Cases: Pages:

American Tobacco Co. v. Patterson,
456 U.S. 63 (1 9 8 2 )...........................................................................................................  9, 11

Beltran v. Myers,
701 F.2d 91, (9th Cir.) ceret denied sub nom.,
Rank v. Beltran, 462 U.S. 1134 (1 9 8 3 )..............................................................................  9

Chandler v. Roudebush,
425 U.S. 840 (1 9 7 6 )............................................................................................................ 11

Chevron, U.S.A., Inc., v. Natural Resources Defense Council, Inc.,
467 U.S. 837 (1984).............................................................................................................. 12

Citizens Action League v. Kizer,
887 F.2d 1003 (9th Cir. 1989), cert denied,
494 U.S. 1056 (1 9 9 0 ) ............................................................................................................ 8

Consumer Product Safety Com’n v. GTE Sylvania, Inc.
447 U.S. 102 (1 9 8 0 )..............................................................................................................  8

EEOC v. Arabian American Oil Co.,
113 L.Ed.2d 274 (1991) ....................................................................................................  13

Fleetwood Enterprises, Inc., v. U.S. Department of Housing and Urban Development,
818 F.2d 1188 (5th Cir. 1987)..........................................................................................  12

Fort Stewart Schools v. Federal Labor Relations Authority,
495 U.S. 641 (1 9 9 0 )............................................................................................................ 12

General Electric Co. v. Gilbert,
429 U.S. 125 (1 9 7 6 )............................................................................................................ 13

K Mart Corp. v. Cartier, Inc.,
486 U.S. 281 (1 9 8 8 )............................................................................................................ 12

United States v. Chen,
913 F.2d 183 (5th Cir. 1990) ............................................................................................. 8

United States v. Moody,
923 F.2d 341 (5th Cir.) cert, denied, 112 S.Ct. 80 (1991)............................................... 8

West Virginai University Hospitals Inc., v. Casey,
111 S.Ct. 1138, 113 L.Ed.2d 68, (1 9 9 1 ) ....................................................................... 8, 11

Statutes and Regulations:

42 U.S.C. §1396d(r)(i)(B)(iv) ..............................................................................................  passim

42 U.S.C. §1396(a)(a)(43)..................................... ..........................................................................  9
42 U.S.C. §1396d(a)(4)(B) .............................................................................................................  9
42 U.S.C. §1396d(r)......................................................................................................................9, 11
16 C.F.R. pt 1303 ...................................................................................................................................
42 U.S.C. §1396d(a).......................... ............................................................................................ 10

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Pages:

Other Materials'.

Centers for Disease Control,
Statement on Preventing Lead Poisoning in Young Children (1991) ............  passim

Conference Report on H.R. 101-386,
101 Cong., 1st Sess. (1989)...............................................................................................  12

HHS, The Nature and Extent of Lead Poisoning in Children in the United States:
A Report to Congress (1 9 8 8 )...................................................................................  passim

HHS, Strategic Plan for the Elimination of Childhood Lead Poisoning (1991) . . . .  passim

H. R. Rep. No. 213, 89th Cong., 1st Sess. (1 9 6 5 ).....................................................................  9

McElvain, M.D., Orbach, H.G., Binder, S., Blanksma, L.A., Maes, E.F. and Krieg, R.M. 
"Evaluation of the Erythrocyte Protoporphyrin Test as a Screen 
for Elevated Blood Lead Levels," 1 1 9 / Pediatrics 548 (1991)...........................  10, 11

Report of the House Budget Comm, on H.R. 3299
101 Cong. 1st Sess., (Sept. 20, 1989) reprinted in 
Medicare and Medicaid Guide (CCH)
Extra Edition No. 596 (October 5, 1989) ........................................................  11, 12, 14

State Medicaid M anual..............................................................................................................14, 18

Welfare of Children,
H.R.Doc. No.54, 90th Cong., 1st Sess.7 (1967) ..........................................................  14

C:\DOC\THOMFSON\PLEADINGVAMICIMEM 111



UNOPPOSED MOTION FOR LEAVE TO 
FILE BRIEF AMICI CURIAE

Proposed plaintiff-intervenors People United for a Better Oakland, et al. seek leave to 

submit the attached brief amici curiae in response to federal defendant’s alternative motions 

to dismiss and for summary judgment. Leave should be granted for the following reasons:

1. Proposed plaintiff-intervenors are parents and guardians of Medicaid eligible 

children from North Carolina, and organizations that advocate adequate screening for lead 

poisoning whose members include parents and guardians of Medicaid eligible children from 

California, Colorado and New York.

2. Proposed plaintiff-intervenors have submitted a motion to intervene in the instant 

proposed nationwide class action to challenge federal defendant’s failure to comply with the 

requirements of the Medicaid statute for mandatory blood lead testing of poor children.

3. Proposed plaintiff-intervenors submit this brief amici curaie because federal 

defendants’ alternative motions may dispose of the issues on which they wish to be heard as 

plaintiff-intervenors while their motion to intervene is still pending.

4. Proposed plaintiff-intervenors and their counsel — the NAACP Legal Defense Fund, 

National Health Law Program and New York and North Carolina legal services offices — have 

experience which the Court may find of assistance. They also have obtained declarations from 

leading medical and public health experts on factual issues presented by federal defendant’s 

alternative motions.

5. Both plaintiffs and federal defendant consent to the filing of the brief.

6. Should the motion to intervene be granted, proposed plaintiff-intervenors adopt this 

brief as their response to federal defendant’s alternative motions.

////

////

////

////

////

////

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Wherefore, proposed plaintiff-intervenors request that leave be granted to file the

enclosed brief amici curiae. 

Dated: November 23, 1992

Respectfully submitted,

Edward B. Cloutman, III
Law Office of Edward B. Cloutman, III 
3301 Elm Street 
Dallas, TX 75226 
(214) 939-9222

Julius L. Chambers 
Alice Brown
NAACP Legal Defense & Educational 

Fund, Inc.
99 Hudson Street, Suite 1600 
New York, NY 10013
(212) 219-1900

Bill Lann Lee
Kirsten D. Levingston 
NAACP Legal Defense & Educational 

Fund, Inc.
315 West Ninth Street, Suite 208
Los Angeles, CA 90015
(213) 624-2405

Jane Perkins
National Health Law Program 
313 Ironwoods Drive 
Chapel Hill, NC 25716 
(202) 887-5310

Carlene NcNulty 
North State Legal Services 
114 West Corbin Street 
Hillsborough, N.C. 27278 
(919) 732-8137

Lucy Billings 
Marie-Elena Ruffo 
Bronx Legal Services 
579 Courtlandt Avenue 
(212) 993-6250

Edward B. Cloutman, III 
Texas Bar No. 04411000

By_________________________
Bill Lann Lee 

Attorneys for Amici
People United for a Better Oakland, et al.,

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BRIEF AMICI CURIAE

Interest of Amici

Amici are advocacy organizations whose members include parents and guardians of 

Medicaid eligible children from California, Colorado and New York as well as parents and 

guardians of Medicaid eligible children from North Carolina. They have submitted a pending 

motion to intervene as plaintiff-intervenors.

Amici parents and guardians, and parent and guardian members of amici organizations 

seek either to obtain effective screening for lead poisoning or to safeguard effective screening 

that is threatened by the actions of federal defendant. Amici are representatives of the 

proposed nationwide plaintiff class of poor children, and their parents and guardians.

Introduction

The key substantive issue before the Court is the meaning of the Medicaid Act 

provision that Early and Periodic Screening, Diagnostic and Treatment (hereinafter "EPSDT') 

program "screening services . . . shall at a minimum include laboratory tests including lead 

blood level assessment appropriate for age and risk factors" for lead poisoning. 42 U.S.C. 

§1396d(r)(l)(B)(iv). Conceding that a blood lead level test, which directly assesses lead blood 

levels, is "the test of choice" to screen for lead poisoning, USA motion 14, federal defendant 

nevertheless contends that it may permit the use of an erythrocyte protoporphyrin (hereinafter 

"EP") test, in combination with a verbal questionnaire for screening. This contention is 

advanced notwithstanding the finding of federal defendant’s expert, as well as all others who 

have studied the problem, that only a blood lead test can effectively detect lead poisoning and 

that the EP test fails to identify most children who have been poisoned by lead.

As we show below, the statutory language, legislative history and remedial purpose of 

the statute require that only a blood lead level test be used to screen for lead poisoning. 

Summary judgment for federal defendant should be denied, and the Court should entertain 

a summary judgment motion on behalf of plaintiffs and proposed plaintiff-intervenors.1

1Amici incorporate by reference plaintiffs’ arguments about standing. With respect to 
the propriety of a TRO or preliminary injunction, the Court may wish to defer any such 
ruling unless a summaiy judgment proves inadequate to protect the interests of plaintiffs 
and plaintiffs-intervenors.

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Summary of Argument

A. The terms of a statute are controlling unless they are unclear or ambiguous. In the 

case of §1396d(r)(l)(B)(iv), the Medicaid Act clearly, unambiguously specifies that a 

laboratory test to assess "lead blood level" or Pb-B is required under the EPSDT program. 

All the parties agree that the only laboratory test that directly assesses Pb-B levels is a blood 

lead test. The EP test, not a lead blood level test, cannot, as claimed by the government, 

provide an accurate "indirect" measure of lead blood level. It is in fact completely unreliable, 

identifying only one out of seven or eight children with toxic lead blood levels.

B. Legislative history is sparse but no less supportive of plaintiffs’ position. Prior to 

1989, the Medicaid Act did not specifically require lead blood level assessments as a 

mandatory part of the EPSDT screen. During the 1970’s the U.S. Department of Health and 

Human Services ("HHS") had instructed state Medicaid agencies that the EP test was to be 

used by EPSDT providers who decided to screen for lead poisoning. In 1988, however, the 

Agency for Toxic Substances and Disease Registry presented a pivotal report to Congress, The 

Nature and Extent of Lead Poisoning in Children in the United States: A Report to Congress 

(hereinafter "Report to Congress"), Exhibit B to Declaration of Paul Mushak (hereinafter 

"Mushak decl."), which quantified extensive levels of lead poisoning among poor children and 

also concluded: "Reliance on EP level for initial screening can result in a significant incidence 

of false negatives or failures to detect toxic Pb-B levels." Report to Congress II-9. The Report 

to Congress formally recommended to Congress that the EP test not be used to screen for lead 

poisoning. Just a year later, Congress passed amendments to the Medicaid Act which codified 

and changed the EPSDT program, specifically to add a laboratory testing requirement for 

"lead blood level assessment appropriate for age and risk factors." 42 U.S.C. 

§1396d(r)(l)(B)(iv).

C. The federal defendant’s construction of the statute is entitled to no deference in 

light of the unambiguous statutory language and legislative background. Moreover, this 

construction contradicts its other recent pronouncements on the subject, such as the 1991 

Strategic Plan for the Elimination of Childhood Lead Poisoning (hereinafter "Strategic Plan"), 

Exhibit B to Declaration of John F. Rosen (hereinafter "Rosen decl."), which declares that

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"blood lead measurements must be used for childhood lead screening instead of EP 

measurements." Strategic Plan 23 (emphasis added). Finally, the federal defendant’s position 

is simply incorrect as a factual matter. The federal defendant admits that neither a verbal risk 

assessment nor the EP test are able adequately to screen for lead poisoning. Yet, it asks the 

Court to accept that these two inadequate tests, combined together, somehow produce the 

valid "lead blood level assessment" that is required by Congress. The experts reject this 

approach -- as has the federal defendant itself by admitting that this scheme is to be used as 

an interim measure during an undefined transition to universal use of the congressionally- 

mandated lead blood level assessment for poor children.

D. The purpose of §1396d(r)(iv) is remedial and it is to be construed liberally to 

advance the overall goal of the EPSDT program to improve the nation’s health by early 

detection and prevention of childhood illnesses. If, as federal defendant concedes, the 

majority of Medicaid eligible children are at high risk for lead poisoning, §1396d(r)(l)(B)(iv) 

should be read to require blood lead testing to assess Pb-B levels consistent with the Statement 

on Preventing Lead Poisoning in Young Children issued in 1991 by the Centers for Disease 

Control (hereinafter "CDC Statement"), Exhibit 1 to Declaration of Sue Binder (hereinafter 

"Binder decl."). EP testing and verbal questioning (alone or in combination) are ineffective 

substitutes. Purported limited laboratory capacity is a mere pretext. See Declarations of John 

F. Rosen (Chairperson of the CDC’s Advisory Committee Childhood Lead Poisoning 

Prevention Advisory Committee); Paul Mushak (author of the 1988 Report to Congress)-, and

J. Routt Reigart (Chairman of the American Academy of Pediatrics Committee on 

Environmental Health) (hereinafter "Reigart decl.")

Statement

A. The Extent of Lead Poisoning in Poor Children.

1. Prevalence.

Lead poisoning, according to HHS, is "the most common and societally devastating 

environmental disease of young children." Strategic Plan xiv. Using the outdated definition 

of lead poisoning in 1988, the Report to Congress found that in 1984 2.4 million white and 

African-American pre-school children — 17% of all such children -  in metropolitan areas had

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projected toxic lead blood levels, and that 400,000 fetuses per year are at risk of being bom 

lead poisoned. See Mushak deck at 11 16; Rosen deck at 11 13.

Medicaid eligible children by definition are at high risk for lead poisoning. Their low 

income status is an indicator that they live in older, deteriorated or recently rehabilitated 

housing that has exposed them to lead paint. The 1988 Report to Congress, showed the 

incidence of lead poisoning is 2-3 times higher among other Medicaid eligible children than 

among other children of the same age. See Rosen deck at 11 30; Reigart deck at HIT 11-12; 

Hiscock deck at H 20.

Applying the CDC’s present 10 jxg/dL toxicity level to 1984 national data shows the 

following prevalence projections in America’s poor communities: In smaller cities with

populations less than one million, 79% of all children with family incomes below $6000 — 

91.6% of all African-American children — were projected to have lead levels exceeding the 

new CDC action level of 10 /xg/dL. In larger cities, 88% of all children with family incomes 

below $6000 — 96.5% of all African-American children -- were projected to be affected. For 

children living in smaller cities whose families earn between $6000 and $14,999, approximately 

67% had blood lead levels associated with early toxicity; 83% of African-American children 

in this category were affected. In larger cities, 78.5% of all children whose families earn 

between $6000 - $14,999 -- 92% of all African-American children — have lead levels at or 

exceeding the 10 /xg/dL level. Prevalence of blood lead levels above 5 /xg/dL, a level only one- 

half that for early toxicity, in poor children is virtually 100 percent. While corresponding 

prevalence for the current year, 1992, will be lower overall, it is likely that inner-city, poor 

children will show the least declines. See Mushak deck at HU 18 - 19.

According to the CDC Statement, "[although all children are at risk for lead toxicity, 

poor and minority children are disproportionately affected. Lead exposure is at once a by­

product of poverty and a contributor to the cycle that perpetuates and deepens the state of 

being poor." CDC Statement 12.

2. Exposure.

Ingesting lead particles can cause severe damage to the brain and central nervous 

system. Children from birth through age six years are by definition at risk from lead

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poisoning. Their normal hand-to-mouth activity causes more frequent ingestion of lead 

particles. More significantly, the developmental stages of children’s brains and nervous systems 

are particularly vulnerable. Environmental factors may put older children at risk. Ingestion 

of lead particles by pregnant women also causes damage to the developing fetus. See Rosen 

decl. at U 12 - 13; Mushak deck at H 10 - IT, Report to Congress 1, 10, III-12, IV-7; CDC 

Statement 7 - 12.

As detailed extensively in the 1988 Report to Congress, lead is pervasive in the 

environment. Children are exposed to lead from six environmental sources, three of which still 

persist as major sources or pathways: paint, dust/soil, and water. Lead in gasoline, foods, and 

stationaiy sources is declining in importance. Although residential use of lead-based paint is 

now banned, lead paint in existing housing remains the most widespread and dangerous high- 

dose source of lead exposure for young children. Lead paint remains in over 57,000 homes 

nationwide; 74% of all homes constructed before 1980 contain lead paint. Lead paint 

continues to be used on the exteriors of painted steel structures, such as bridges and 

expressways. Children living near such sites as expressways have been shown to have elevated 

blood lead levels. See Mushak deck at H 12; Rosen deck at 11 14; 16 C.F.R. pt 1303; CDC 

Statement 18.

Lead deposited in soil or as dust does not biodegrade or decay since lead is a chemical 

element. Children playing around contaminated dust and soil will remain exposed indefinitely. 

The water distribution system can also pose a lead risk. Contamination of drinking water 

occurs in or near residences and schools when lead leaches into water from lead connectors, 

service pipes, lead-soldered joints, or lead-lined watercoolers. See Mushak deck at 111113 -14.

Lead entering the body from different sources and through different pathways presents 

a combined toxicological threat. Thus, multiple, low-level inputs of lead can result in 

significant aggregate exposure. See Mushak deck at 11 15. See Report to Congress 6 - 8 ,  

chapters VI & VIII.

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3. Symptoms.

Very severe lead poisoning (associated with lead levels at or above 80 p,g/dL) can result 

in coma, convulsions, profound mental retardation, and even death. At lower concentrations, 

lead mainly interferes with normal development of IQ and other neuro-behavioral measures 

in children; with the body’s heme-forming system, which is critical to the production of heme 

and blood; and with the vitamin D regulatory system, which involves the kidneys and plays an 

important role in calcium metabolism. See Mushak decl. at H 10; Rosen deck at H 16.

Lead poisoning is often asymptomatic in its early stages, and its symptoms are the same 

as many other childhood diseases and impairments. Lead toxicity produces altered behavior 

such as attention disorders, learning disability, and cognitive disturbances. Symptoms and signs 

of severe toxicity are fatigue, pallor, constipation, vomiting, and changes in consciousness 

(coma) due to early encephalopathy, which may lead to death. Mental retardation is a 

frequent result. See Rosen deck at U 17; CDC Statement 7-15.

According to currently published data, all cases of lead poisoning cause some persisting, 

irreversible brain damage, reduced IQ, delayed cognitive development, and other physical and 

mental impairments. Such effects occur at blood lead levels above and even below 10 /xg/dL. 

In fact, there is no apparent threshold. Lead causes adverse effects even below 2 /zg/dL. At 

least three longitudinal studies of young children in Boston, Cincinnati and Australia show that 

prenatal and early childhood exposure to lead has adverse effects at low exposure levels on 

a child’s IQ and other neurobehavioral measures, and that these effects persist into the school- 

age years. See Rosen deck at U 16; Mushak deck at U 11.

B. The Appropriate Test for Poor Children.

The only way to determine that lead poisoning is the cause of such symptoms and to 

bring them to a halt is to test for the level of lead in blood or Pb-B. According to all recent 

scientific studies, only direct measurement of blood lead concentration has the clinical and 

diagnostic capability to determine whether a child has lead poisoning. 1988 Report to Congress-, 

1991 Strategic Plan-, 1991 CDC Statement 41. See Rosen deck at 11 18. The parties agree that 

only a blood lead test directly measures Pb-B. See USA motion 12.

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Verbal questioning about a child’s possible exposure to lead does not provide a lead 

blood level assessment, nor can it elicit complete, definitive, or accurate data to indicate a 

child’s blood lead level. Many patients, especially Medicaid recipients, simply may not know 

all the answers to the verbal assessment questions. See Rosen decl. at 11 19, Mushak decl. at 

11 19; Reigart decl. at H 9. According to the CDC, "[t]he questions are not a substitute for a 

blood lead test." CDC Statement 42 (original emphasis).

A blood test that does not test for the level of lead in blood does not elicit complete, 

definitive, or accurate enough data either. The EP test is such a test. The EP test does not 

test for the level of lead in blood at all. In fact, it is only an indirect reflection of iron or lead 

status. For lead status, this test is an insensitive index of any blood lead values below 40 

/xg/dL. At blood lead values between 10 and 30 /zg/dL, EP measurements will totally fail as 

a screening method to identity the overwhelming majority (over 95%) of children whose blood 

lead levels fall in this danger zone. See Rosen decl. at U 20; Mushak decl. at 11 23 - 24; Reigart 

decl. at 11 10.

The EP test -  a low cost, high volume procedure -  is used to predict lead absorption. 

In children exposed to elevated concentrations of lead, the lead interferes with the body’s 

ability to make heme, which is used to carry oxygen when in the form of hemoglobin. Lead 

retards formation of heme from the protoporphyrin molecule and protoporphyrin builds up 

in the blood. The EP test measures this build up of protoporphyrin. It does not give directly 

discreet blood lead concentrations; rather, protoporphyrin levels are a surrogate indicator for 

the likelihood of elevated blood lead levels.

At the clinic operated by the Lead Poisoning Prevention Program at the Montefiore 

Medical Center, Bronx, New York, where Dr. Rosen has performed blood lead tests and EP 

tests together, there have been a significant number of cases where the EP test result was 

normal, and the blood lead level was above 25 /zg/dL. Such occurrences were demonstrated 

nationally by the Second National Health and Nutrition Examination Survey (NHANES II), 

in 1976-90. See Rosen declaration at 1121; Report to Congress V-31. Significantly, the data was 

analyzed and presented to Congress in the 1988 Report to Congress. O f 118 children with Pb-B 

levels above 30 /zg/dL (the CDC criterion level at the time of the NHANES II study), 47% had

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EP levels at or below 30 /xg/dL, and 58% had EP levels less than an EP cutoff value of 35 

/xg/dL. Report to Congress II-9. Of course, the CDC has revised the criterion level to 10 

jag/dL, an action which introduces even more false negatives into the EP test results. See 

Mushak decl at 11 24.

In sum, the EP test serves only to predict the presence of lead in the blood. It cannot, 

however, be used as a predictive surrogate for lead blood levels below 40 pgJtiL. The test does 

not act as a preventive test which allows the health care provider to detect lead poisoning at 

its early, more manageable stages. Rather, the EP test can only accurately predict that 

unacceptably high lead exposure and greater risk of more severe poisoning have already 

occurred. See Mushak decl. at 11 25.

For a pediatrician pursuing a diagnosis, the only responsible course of action is to carry 

out a test that provides safe and definitive results for all children, according to current 

standards of pediatric practice. A blood lead test provides definitive information concerning 

the extent to which a child has been recently exposed to lead. An EP test provides, only for 

one child out of seven or eight, at best, marginal information indicating that a child may be 

lead poisoned. For a pediatrician seeking a conclusive diagnosis, to perform such an 

unreliable test for lead poisoning is irresponsible pediatric practice. See Rosen decl. at H 22; 

see also Reigart decl. at 1111 10, 11 & 13; See Mushak decl. at 1111 23, 25 - 26.

Argument

A. The Plain Terms of the Statute Require A Blood Lead Test.

In construing a statute, we look first to the plain meaning of the statutory language. 

Consumer Product Safety Com’n v. GTE Sylvania Inc., 447 U.S. 102, 108 (1980). Terms used 

by a statute are to be given their ordinary, commonly understood meaning. United States v. 

Moody, 923 F.2d 341, 347 (5th Cir.), cert, denied, 112 S.Ct. 80 (1991); United States v. Chen, 

913 F.2d 183,189 (5th Cir. 1990); Citizens Action League v. Kizer, 887 F.2d 1003, 1006 (9th Cir. 

1989), cert denied, 494 U.S. 1056 (1990). Where the statutory language is clear and 

unambiguous, consideration of legislative history and other extrinsic guidance is unnecessary. 

See, e.g., West Virginia Univ. Hospitals, Inc., v. Casey, 111 S.Ct. 1138,113 L.Ed.2d 68, 83 (1991) 

("[w]here, as here, the statute’s language is plain, ‘the sole function of the court is to enforce

C:\DOC\THOMPSON\PLEADING\AMICIMEM 8



it according to its terms.’") (citation omitted); American Tobacco Co. v. Patterson, 456 U.S. 

63, 68 (1982).

The instant case concerns the EPSDT provisions of the Medicaid Act, which was passed 

by Congress in 1965 as a cooperative federal-state medical assistance program for the poor. 

See Beltran v. Meyers, 701 F.2d 91, 92 (9th Cir.) cert denied sub nom., Rank v. Beltran, 462 U.S. 

1134 (1983). The federal law requires states participating in the Medicaid program to cover 

certain "essential" services for recipients, H.R. Rep. No. 213, 89th Cong., 1st Sess. 9 - 10, 70 

(1965), including a disease and developmental disability prevention program for children under 

age 21 known as the Early and Periodic Screening, Diagnostic and Treatment ("EPSDT') 

program. 42 U.S.C. 1396a(a)(43), d(a)(4)(B), and d(r).

The EPSDT program requires, inter alia, mandatory medical screening of poor children 

to diagnose their "physical or mental defects" as early as possible. 42 U.S.C. 1396d(a)(4)(B). 

In 1989, Congress amended the EPSDT statute to specify that EPSDT screening services were 

to include, at a minimum, "laboratory tests (including lead blood level assessment appropriate 

for age and risk factors)." 42 U.S.C. 1396d(r)(l)(B)(iv). It is this latter phrase which the 

federal defendant would have the court ignore.

The term "lead blood level," a scientific term, refers to the amount of lead in blood. 

The federal defendant concedes that only a blood lead test "directly" measures lead blood 

levels. USA Motion at 12, Hiscock deck at 11 9, Binder deck at 11 14.

Notwithstanding the plain language, federal defendant argues that the statutory 

language does not require a blood lead test on two grounds. It first contends that Congress 

did not intend to give such a "narrow, technical meaning" to the statutory term "lead blood 

level." USA motion 29. Plaintiff-intervenors disagree. Had Congress not meant to bind the 

agency to coverage of the lead blood test, it needed to mandate no requirement beyond 

"laboratoiy testing," thus leaving federal and state authorities free to decide which type of tests 

to cover. Congress, of course, specifically mandated a lead blood level assessment.

That Congress specifically mentioned lead blood laboratory testing in the Medicaid Act 

is compelling in its own right. For the most part, Congress has chosen simply to list broad 

categories of services (e.g., hospital services, physician services) rather than enumerate specific

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procedures by name. Compare, 42 U.S.C. 1396d(r)(l)(B)(iv) with, 42 U.S.C. 1396d(a). When 

it included a statutorily-required laboratory test in an otherwise generally drawn Medicaid 

statute, Congress surely chose its terms carefully and deliberately.

Federal defendant also argues that the EP test is an "indirect" assessment of lead blood 

level. USA motion 12. Again, plaintiff-intervenors disagree. Notably federal defendant, 

however, fails to inform the Court that shortly before drafting §1396d(r)(l)(B)(iv), the House 

Committee on Energy and Commerce was informed by HHS in its 1988 Report to Congress 

that "reliance on EP level for initial screening can result in a significant incidence of false 

negatives and failure to detect toxic Pb-B levels", and received the recommendation that the 

EP test should be replaced by the blood lead test. Report to Congress 11-9.

With the lowering by the CDC of the toxicity level to 10 /xg/dL, the EP test is even 

more unreliable.

Since erythrocyte protoporphyrin (EP) is not sensitive enough to identity more 
than a small percentage of children with blood lead levels between 10 and 25 
/xg/dL and misses many children with blood lead levels > 25 /xg/dL . . . 
measurement of blood lead levels should replace the EP test as the primary 
screening method.

CDC Statement 41; see also 2 ("Because the erythrocyte protoporphyrin level is not sensitive 

enough to identity children with elevated blood lead levels below 25 jixg/dL, the screening test 

of choice is now blood lead measurement.") Indeed, federal defendant’s expert, Dr. Binder, 

is not only an author of the Report to Congress, with its admission that the significant number 

of false negatives invalidates the EP test for screening, but an author as well of the very study 

that the CDC cited in support of its assertion that the EP test is too insensitive to screen for 

lead blood levels between 10 and 25 jxg/dL. See CDC Statement 41, 49, citing McElvaine, 

M.D., Orbach, H.G., Binder, S., Blanksma, L.A., Maes, E.F. and Krieg, R.M., "Evaluation of 

the Erythrocyte Protoporphyrin Test as a Screen for Elevated Blood Lead Levels," 119 J. 

Pediatrics 548 (1991) (hereinafter "McElvaine, Orbach, Binder"), Exhibit A  to Declaration of 

Bill Lann Lee (hereinafter "Lee decl."). That study concluded that: "The sensitivity of the EP 

test is . . .  good for identifying children with vefy high Pb-B levels, those who most urgently 

need follow-up. For identification of the children with Pb-B levels of 10 to 25 /xg/dL, another 

screening method, probably Pb-B measurement, will be needed." McElvaine, Orbach, Binder

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at 550. In fact, the EP test overall will only identity one out of seven or eight children with 

lead poisoning at the levels the CDC now considers toxic. Rosen decl. at U 22.2

Neither the oral questions nor the EP test, alone or in combination, is a substitute for 

the blood lead test. Had Congress intended to permit the use of the EP test, it could easily 

have done so by substituting "erythrocyte protoporphyrin level" for the statutory phrase "blood 

lead level" in § 1396d(r) or adopting HHS’ contemporaneous Medicaid guidance which 

expressly identified the (EP) test as "the primary screening test." See Hiscock decl. at H 9. 

Congress, however, did neither. Instead, it opted for a laboratory test to assess lead blood 

level. See, e.g., Chandler v. Roudebush, 425 U.S. 840, 848 (1976) ("‘The plain, obvious and 

rational meaning of a statute is always to be preferred to any curious, narrow, hidden sense 

that nothing but the exigency of a hard case and the ingenuity and study of an acute and 

powerful intellect would discover.’").

B. Legislative History Confirms that Congress Intended to Mandate A 

Blood Lead Test to Screen For Lead Poisoning.

Legislative history analysis is unnecessary where, as here, the terms of the statute are 

clear and unambiguous. Casey, 113 L.Ed.2d at 83; Patterson, 456 U.S. at 68. The available 

legislative history, however, merely confirms the statute’s plain meaning.

Section 1396d(r)(l)(B)(iv) was added to the EPSDT statute by the Energy and 

Commerce and Ways and Means Committees. Report of the House Budget Comm, on H.R 

3299 101 Cong. 1st Sess., (Sept. 20, 1989), reprinted in Medicare and Medicaid Guide (CCH), 

Extra Edition No. 596 (Oct. 5, 1989) (Explanation of the Energy and Commerce of Ways and 

Means Committees Affecting Medicare-Medicaid Programs) (hereinafter "House Report"), 

Exhibit B to Lee decl. Noting that "[t]he EPSDT benefit is not currently defined in statute" 

the House Report explained that the Committee bill amended the statute to specify that 

"screening services, at a minimum, include . . . laboratory tests (including lead blood level

2Dr. Binder’s study found that, at 10 /xg/dL, the EP test identified more children with 
elevated lead blood level, 26%, but failed to identify fully 74% of the poisoned children. 
McElvaine at 549 (table II). The study noted, however, that the population studied may 
have exhibited iron deficiency, which is also detected by the EP test, resulting in possibly 
skewed results. Id. at 549 - 50.

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assessment appropriate for age and risk factors)." House Report at 399.

The obvious reason for the amendment was the July 1988 Report to Congress in which 

HHS specifically recommended to the House Energy and Commerce Committee that the EP 

test, which HHS permitted State Medicaid authorities to use for screening under the EPSDT 

program, should be abandoned as a screening test for lead poisoning because it failed to detect 

toxic lead blood levels. See Report to Congress II-9.

The House Committee bill was accepted unchanged by the Conference Committee, and 

the Conference Report adds little to the legislative history. It briefly explained that the package 

of EPSDT amendments "[cjodifies the current regulations on minimum components of EPSDT 

screening . . . ,  with minor changes. Provides that screenings must include blood testing when 

appropriate, as well as health education." Conference Report on HR 101-386, 101 Cong. 1st 

Sess. 53 (1989). The report’s characterization of the "lead blood level assessment" provision 

as a minor change is understandable because one laboratory test was merely being substituted 

for another. While the Conference Report refers generically to "blood testing," the reference 

appears to be a short-hand contraction used in the course of contrasting testing with the public 

education component of screening rather than a studied gloss on the meaning of the statutory 

term or a covert attempt to render superfluous the statutory terms "lead level."

C. The Agency Construction of the Statute Is Entitled to No Deference.

An agency construction of a statute that conflicts with the plain language and legislative 

history of a statute is entitled to no deference. Fort Stewart Schools v. Federal Labor Relations 

Authority, 495 U.S. 641, 645 (1990).

If, upon examination of "the particular statutory language at issue, as 
well as the language and design of the statute as a whole," KMart Corp. v.
Cartier, Inc., 486 U.S. 281, 291 (1988), it is clear that the [agency] interpretation 
is incorrect, then we need look no further, "for the court, as well as the agency, 
must give effect to the unambiguously stated intent of Congress." Chevron 
[U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837,] 842-43 
[(1984).] If, on the other hand, "the statute is silent or ambiguous" on the point 
at issue, we must decide "whether the agency’s answer is based on a permissible 
construction of the statute." Ibid.

See also, Fleetwood Enterprises v. HUD, 818 F.2d 1188, 1193 (5th Cir. 1987).

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In the instant case, no deference is due to the agency’s interpretation of the statute 

because Congress spoke clearly and unambiguously about the meaning of §1396d(r)(l)(B)(iv). 

See supra. Moreover, the present position of HHS that the terms "lead blood level assessment" 

permit use of the EP test conflicts with its prior statements. See EEOC v. Arabian American 

Oil Co., 113 L.Ed.2d 274, 287-88 (1991); General Electric Co. v. Gilbert, 429 U.S. 125, 141 

(1976) (level of deference depends upon consistency with earlier pronouncements as well as 

thoroughness of consideration and validity of reasoning). The 1988 Report to Congress stated 

that the EP test should be abandoned because it produced many false negatives and failed to 

detect toxic lead blood levels. The Strategic Plan declared that when the lead blood toxicity 

level was lowered, as it was later in 1991, "blood lead measurements must be used for 

childhood lead screening instead of EP measurements." Strategic Plan 23. In addition, the 

CDC Statement termed the blood lead test the "screening test of choice" for the detection of 

lead poisoning. CDC Statement 2.

Deference, in any event, would be anomalous because the statute was designed to 

correct the very practice, use of the EP test, that HHS’ erroneous construction would 

reimpose.

Federal defendant also argues at some length that HHS has a longstanding 

commitment toward identifying and paying for the cost of treating lead poisoned Medicaid 

eligible children, USA motion 9. The record of HHS speaks for itself. Congress enacted 

§1396d(r)(l)(B)(iv) to change an HHS practice because the agency resisted acting upon the 

recommendation of its own 1988 Report to Congress that the EP test should not be used. What 

HHS seeks in this case is to continue using a test that even its own expert has found produces 

so many false negatives that it fails to identify most children with toxic Pb-B levels.

While it is true that HHS historically has revised its EPSDT agency guidance following 

CDC changes, USA motion at 10-11, the agency has by no means hastened to do so. HHS 

waited three years before lowering the lead toxicity level for poor, at-risk children in response 

to the 1985 CDC Statement. Id. And then, HHS lowered the toxicity level for Medicaid 

eligible, at-risk children to 30 /xg/dL although the CDC had lowered it significantly for all 

children to 25 /xg/dL.

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The failure of HHS to comply with §1396d(r)(l)(B)(iv), unfortunately, is not 

unprecedented. As the director of HHS Medicaid Bureau admitted in responding to the 

protests of plaintiff-intervenors’ counsel; "in the past neither Medicaid’s EPSDT program nor 

any other program have been successful in screening for lead poisoning a sufficient proportion 

of children." Letter of Christine Nye to Julius L. Chambers, dated August 10, 1992, 

Attachment B to the proposed Complaint in Intervention.

D. The Remedial Purpose of the EPSDT Statute and the CDC Report Mandate that Blood

Lead Testing Be Required.

1. The Remedial Purpose of the EPSDT Statute Requires Blood Lead Testing. 

Congress enacted the underlying EPSDT statute with the remedial intent of "discovering], as 

early as possible, the ills that handicap our children." President Lyndon B. Johnson, Welfare 

of Children, H.R.Doc. No.54, 90th Cong., 1st Sess.7 (1967). In 1989, the House Committee 

explained that §1396d(r)(l)(B)(iv) was necessitated by the fact that "[t]he EPSDT benefit is, 

in effect, the nation’s largest preventive health program for children" and would become "even 

more important to the health status of children in this county" "as Medicaid coverage of poor 

children expands." House Report 398. The remedial nature of the EPSDT program is highly 

significant in the context of lead poisoning. "Lead poisoning, the most common and societally 

devastating environmental disease of young children, is entirely preventable." Strategic Plan 

xiv.

Using a blood lead test would plainly advance the remedial objective of the EPSDT 

program by improving preventive health care for the nation’s poor children. It will also 

advance the specific remedial purpose of §1396d(r)(iv) to reform HHS’s practice of using an 

ineffective test to screen those most at risk for lead poisoning. The EP test will do neither.

2. The CDC Statement Supports Immediate Blood Lead Testing of Medicaid Eligible 

Children.

Federal defendant also erroneously argues that the testing scheme in the September 

1992 State Medicaid Manual fully complies with the 1991 CDC Statement. On the one hand, 

reliance upon the 1991 CDC Statement is misplaced: It is Congress’ 1989 mandate to the 

Medicaid agency in 42 U.S.C. 1396d(r)(l)(B)(iv) that is at issue in this case, not a CDC

C:\DOC\THOMPSON\PLEADING\AMICIMEM 14



Statement which was adopted two years later. On the other hand, the CDC Statement is a 

ringing endorsement of Congress’ 1989 action and is binding as the authoritative expression 

of the testing protocol deemed "appropriate for age and risk." Thus, the CDC Statement’s 

declaration that all children between the ages of 6 and 72 months should be screened at least 

twice using a blood lead test at age 6 - 12 months and 18 - 24 months, CDC Statement at 43, 

is dispositive as to the "appropriate" testing schedule for very young children under the statute.

The CDC Statement is also binding because it embodies current medical standards of 

pediatric practice. Dr. John Rosen, the Chairperson of the CDC’s Childhood Lead Poisoning 

Prevention Advisory Committee, which produced the CDC Statement, states in the attached 

declaration that "[t]he Statement was prepared with primary medical care providers foremost 

in mind, so they could glean the current, essential standards of pediatric practice in a readily 

digestible form." Rosen decl. at 11 24.

For a pediatrician pursuing a diagnosis, the only responsible course of 
action is to carry out a test that provides safe and definitive results for all 
children, according to current standards of pediatric practice. A blood lead test 
provides definitive information concerning to what extent a child has been 
recently exposed to lead. An EP test provides, at best, marginal information 
only for the one child out of seven or eight indicating that a child may be lead 
poisoned. For a pediatrician pursuing a conclusive diagnosis, to perform such 
an unreliable test for lead poisoning is irresponsible pediatric practice.

Id. at H 23; see also U 36. Dr. Rosen’s co-chair, Dr. J. Routt Reigart, who is also Chairman

of the American Academy of Pediatrics’ Committee on Environmental Health, concurs.

Reigart decl. at 11 9 ("Although the American Academy of Pediatrics’ revised report is not yet

completed, one recommendation that will certainly come from the Committee is that there is

a need for more testing. Lead poisoning cannot be detected absent a blood test; a series of

questions cannot verify blood lead levels.").

The CDC Statement testing requirements also embody current public health standards.

See Mushak decl. at 1111 20 - 31.

Inappropriateness o f Questioning and EP Testing for Screening. Federal defendant 

erroneously contends that the scheme of verbal assessment questioning to establish "low" and 

"high" risk and EP testing of "low" risk children complies with the CDC Statement. According 

to Dr. Rosen,

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[A]s Chairperson of CDC’s Advisory Committee, I can state that it was 
not our intent to suggest to Medicaid providers that the use of a questionnaire 
should determine whether children, particularly in the most vulnerable age 
group of 6 - 36 months, should receive a blood lead test. The CDC Statement 
is unequivocal that for this population, a blood lead test must be conducted at 
least once by the time a child reaches 12 months and again by 24 months of 
age, even if the responses to the assessment questions indicate the child is at 
"low risk" of lead poisoning. CDC Statement 43. The CDC screening schedule 
is based on the fact that children’s blood lead levels increase most rapidly at 6 - 
12 months and peak at 18 - 24 months. Id. at 42. The incidence of high blood 
lead levels among this population is so high, it makes little sense to try to 
ascertain with a questionnaire who within this group is at "high risk." See id. at 
Figure 6 - 1. The CDC Statement explicitly states that for this group the 
questionnaire is not a substitute for a blood lead test. Id. at 42.

Rosen deck at H 35, see also U 36; see Reigart deck at 11 9

According to the CDC Statement, all children between 6 and 72 months are at risk from

lead poisoning, CDC Statement 42. The limited purpose of a high or low risk categorization

in the CDC Statement is to establish the schedule for follow-up screening and intervention,

id. at 43-45, not to trigger a system of triage for initial screening. Following up an initial EP

test with a blood lead test if the EP test score is high does not cure the inability of the initial

EP test to detect lead poisoning.3

Indefinite Transition Period. Driven by concerns for administrative convenience and cost 

savings, federal defendant has focused upon that portion of the CDC Statement that recognizes 

the need for a transition to universally mandated use of blood lead testing. It uses this 

language to support its contention that limited laboratory capacity for processing blood lead 

tests in some states justifies permitting any state Medicaid program to continue to use EP tests 

for "low" risk cases during a transition period of undefined length. USA motion at 19.

Federal defendant provides no substantiation of any lack of laboratory capacity or its

3The CDC Statement does contain language about elevated EP results being followed 
with a blood lead test to determine if lead poisoning is responsible for the elevation. CDC 
Statement 48. However, the elevated EP results to which the CDC Statement referred are 
those at or above 35 /xg/dL, i.e.., levels at which the EP test is sensitive, not at lead blood 
levels of 10-25 fig/dL for which "the EP test is not a sensitive test." Id. The limited 
purpose of the follow-up blood lead test dictated by the CDC is to determine if the 
elevated EP result is caused by lead poisoning or some other health condition, such as iron 
deficiency. Id. It is not to detect where there is a false negative EP result, the essential 
defect of the EP test. See Mushak deck at 11 25 ("[T]he EP test does not act as a 
preventive test which allows the health care provider to detect lead poisoning at its early 
more manageable stages. Rather, the EP test can only accurately predict that unacceptably 
high lead exposure and greater risk of more severe poisoning have already occurred").

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extent. Dr. Rosen, in any event, establishes that the purported lack of laboratory capacity is 

a mere pretext.

I cannot fathom why, more than a year after the CDC Statement 
dictated blood lead tests as the reasonable standard of medical practice, a 
state’s medical care providers’ capacity of performing the tests, particularly if 
reimbursable under the Medicaid program, would be limited.

The laboratory capacity certainly exists among the large commercial 
laboratories, such as Roche, MetPath, or Smith Kline. Similar capacity must 
exist at State and local public laboratories. The large commercial laboratories 
are located around the country and routinely assess blood samples of Medicaid 
patients in-state or out-of-state. These laboratories can process the blood lead 
results of any children in the Medicaid program and be reimbursed by the 
Medicaid program. See Declaration of William Hiscock 1111 15, 18.

CDC’s 1991 Statement did allow a "grace period" for transition from EP 
to blood lead testing. As Chairperson of CDC’s Advisory Committee, I can 
state that our intent was to provide a transition of up to a year for state and 
local agencies to order proper equipment and implement blood lead 
measurements as the diagnostic test for childhood lead poisoning. One year is 
more than twice the time required to mount such a laboratory capability de 
novo, including the time required to order an instrument, train a technician, and 
set up a reporting system. The transition period was not intended to be a 
bureaucratic vacation to extend until the next CDC Statement is issued. The 
next CDC Statement, like the last, may not be issued for another six years or 
more.

Although HCFA’s policy to reimburse any blood lead tests that are 
performed eliminates cost as a factor, blood lead testing is not expensive 
anyway.4 Throughout the Montefiore Medical Center-Albert Einstein College 
of Medicine complex, including all their satellite clinics, we have established 
that the total cost per blood lead test does not exceed $12 - 13. Colleagues’ 
findings in Pennsylvania, West Virginia, and North Carolina confirm these 
results. One need only check the rates from the commercial mass laboratories 
to find their charges in the same range.

4Of course, concern about cost savings is clearly a motivating factor here. The EP test 
costs Medicaid less than $10, while a blood lead test costs between $10 - $15, depending on 
volume and economies of scale. Mushak deck at 11 28. So long as the EP test is used, the 
federal defendant saves on its laboratory testing expenditures -  particularly in light of the 
fact that providers are already using the EP test to detect other childhood conditions, such 
as iron deficiency. Such cost concerns do not, however, provide adequate justification for 
the continued use of the EP test for lead poisoning in young Medicaid eligible children. 
Because of its unreliability for accurately predicting elevated Pb-B below 40 ;u.g/dL level, 
the EP test is probably a waste of money for lead absorption prediction. Id. And, as 
noted in the 1988 Report to Congress, direct lead blood level assessment is particularly cost - 
effective in the long run. This was demonstrated by comparing data on the costs of 

treating children who are poisoned because early lower levels of lead intoxication were not 
detected by screening with the costs of testing. In the example used in the Report, the ratio 
of medical costs to child screening costs was an astounding 50:1 in 1986 dollars (about 
$20,000 to $25,000 per child in 1992 health care dollars). Id. at 29, 31.

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Rosen decl. at 1111 25-27, 29; Mushak deck at 11 28.5 Dr. Mushak, an author of the Report to 

Congress comes to the same conclusion from a public health perspective. Mushak decl. at 11 

20 ("Delaying blood lead testing of Medicaid eligible children is . . . not justified by concerns 

regarding laboratory capacity.").

The CDC called for a transition to blood lead testing over a year ago. Over three years 

have passed since Congress mandated lead blood level testing as part of the EPSDT screen. 

HHS’s current policy for lead screening is unacceptable and is, in fact, premised upon an 

acknowledgement that what it is doing is wrong. In the September 1992 State Medicaid 

Manual, HHS allows that the EP test is now an "inappropriate" test to detect lead poisoning. 

It recognizes that lead blood levels cannot be assessed by asking questions. And, it states that 

a lead blood test is the test of choice when measuring blood lead levels. Yet, it uses 

statements contained in the later-adopted CDC Statement to excuse a testing scheme for the 

poor that delays indefinitely implementation of the Congressional mandate for blood lead 

testing. As established by the experts, the question of the appropriate test for lead exposure 

and lead poisoning in Medicaid children is not arguable on cost or other logistical grounds 

involving laboratory capacity, see Rosen decl. at 1111 25 - 29; Mushak decl. at U1I 29 - 31; Reigart 

decl. at U 13. Such arguments do not justify the federal defendant’s failure to require reliable 

lead blood level testing of the very group that all participants in this case agree is most at risk 

of and tragically damaged by lead poisoning. The federal defendant has failed to meet its 

burden of showing why further delay — now in the form of an indefinite transition period — 

should be allowed.

////

5Even if these nationwide resources were somehow not available in a 
particular area, it is not overly difficult or costly to develop independent 
laboratory capacity, as we did years ago at Montefiore Medical Center. The 
laboratory can be staffed with a laboratory technician and a clerk-typist with 
a computer. The required instrumentation currently runs approximately 
$60,000 - 75,000, plus $10,000 in consumables per year. This country 
certainly has the technology to perform universal blood lead tests for all 
Medicaid eligible children.

Rosen decl. at 11 30.

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Conclusion

For the above reasons, amici proposed plaintiff-intervenors request that the Court deny 

federal defendant’s alternative motions to dismiss and for summary judgment.

Dated: November 23, 1992

Respectfully submitted,

Edward B. Cloutman, III
Texas Bar No. 04411000
Law Office of Edward B. Cloutman, III
3301 Elm Street
Dallas, TX 75226
(214) 939-9222

B y________________________________
Edward B. Cloutman, III

Julius L. Chambers 
Alice Brown
NAACP Legal Defense & Educational 

Fund, Inc.
99 Hudson Street, Suite 1600 
New York, NY 10013
(212) 219-1900

Bill Lann Lee 
Kirsten D. Levingston 
NAACP Legal Defense & Educational 

Fund, Inc.
315 West Ninth Street, Suite 208 
Los Angeles, CA 90015
(213) 624-2405

By____________
Bill Lann Lee

Jane Perkins
National Health Law Program 
313 Ironwoods Drive 
Chapel Hill, NC 25716 
(202) 887-5310

B y ________________________
Jane Perkins

Carlene NcMulty 
North State Legal Services 
114 West Corbin Street 
Hillsborough, N.C. 27278 
(919) 732-8137

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Lucy Billings 
Marie-Elena Ruffo 
Bronx Legal Services 
579 Courtlandt Avenue
(212) 993-6250

By___________________________
Lucy Billings

Attorneys for Amici
People United for a Better Oakland, et al

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DECLARATION OF BILL LANN LEE

I, BILL LANN LEE, declare and say:

1. I am one of the counsel for the amici curiae and the proposed plaintiff- 

intervenors People United for a Better Oakland, et al.

2. Attached hereto as Exhibit A is a true and accurate copy of McElvaine, M.D., 

Orbach, H.G., Binder, S., Blanksma, L.A., Maes, E.F., & Krieg, R.M., Evaluation of the 

Erythrocyte Protoporphyrin Test as a Screen for Elevated Blood Lead Levels, 119 J. of 

Pediatrics 548 (1991).

3. Attached hereto as Exhibit B is a true and accurate copy of Report of the 

House Budget Comm, on H.R. 3299, 101 Cong., 1st Sess. (September 20, 1989), reprinted in 

Medicare and Medicaid Guide (CCH), Extra Edition No. 596 (October 5, 1989) ( pp. 398 - 410.

I declare under penalty of perjury that the foregoing is true and correct.

Executed the 23rd day of November, 1992, at Los Angeles, California.

Bill Lann Lee

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