Proposed Complaint in Intervention with Certificate of Service and Attached Letters

    UNITED STATES DISTRICT COURT 

NORTHERN DISTRICT OF TEXAS 

DALLAS DIVISION 

LOIS THOMPSON on behalf of and as next | CASE NO. 3-92 CV 1539-R 
friend to TAYLOR KEONDRA DIXON, 
ZACHERY X. WILLIAMS, CALVIN A. 
THOMPSON and PRENTISS LAVELL 
MULLINS, 

Plaintiffs, | Civil Action 

PEOPLE UNITED FOR A BETTER 
OAKLAND, on behalf of its members; 
DENVER ACTION FOR A BETTER . | Class Action 
COMMUNITY, on behalf of its members; 
NEW YORK CITY COALITION TO END [PROPOSED] 
LEAD POISONING, on behalf of its COMPLAINT IN INTERVENTION 
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, 

Plaintiff-Intervenors, 
Vv. 

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

The UNITED STATES OF AMERICA, 
Defendants, 

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

Additional Defendant.     

Introduction 
  

1. Plaintiff-intervenors People United for a Better Oakland, Denver Action for 

 



  

a Better Community, and New York City Coalition to End Lead Poisoning, whose members 

include parents and guardians of Medicaid-eligible children in the States of California, 

Colorado, and New York, as well as Medicaid-eligible children from North Carolina submit 

this complaint in intervention to join the original class action lawsuit against federal 

defendants filed by Medicaid-eligible children residing in Texas. Plaintiff-intervenors, 

Medicaid-eligible individuals and organizations whose members include parents of Medicaid- 

eligible children, are denied or are threatened with the denial by federal defendants of 

"screening services . . . which shall at a minimum include laboratory tests (including lead blood 

level assessment appropriate for age and risk factors)" for lead poisoning required by the Early 

and Periodic Screening, Diagnostic and Treatment (hereinafter "EPSDT") program of the 

Medicaid Act. 42 U.S.C. §§ 1396d(a)(4)(B) and 1396d(r). 

2 In particular, federal defendants have refused to require the use of lead blood 

level tests to screen for lead poisoning by States participating in the EPSDT Medicaid 

program, notwithstanding the Medicaid Act and even though the lead blood level test provides 

definitive information concerning the extent to which a child has been exposed recently to 

lead. Rather, they permit the States to use an inadequate screening procedure, the 

erythrocyte protoporphyrin (hereinafter "EP") test, which does not measure lead blood levels 

as required by the statute and which provides, at best, marginal information for about one out 

of seven or eight children indicating that a child may be lead poisoned. The federal 

defendants’ position was confirmed by their issuance of an EPSDT Medicaid guidance on 

September 16, 1992 permitting the use of the EP test to screen for lead poisoning. As a 

result, thousands of lead-poisoned, Medicaid-eligible children throughout the nation remain 

unidentified and, therefore, untreated notwithstanding the clear mandate of the Medicaid Act. 

3, Defendant United States of America, through additional defendant Louis W. 

Sullivan, the Secretary of the Department of Health and Human Services (hereinafter "HHS"), 

has declared that lead poisoning is the number one environmental health problem for children 

 



  

in the United States today. The incidence of lead poisoning is two to three times greater 

for poor, Medicaid-eligible children than for better off children. Fully 2/3 of African- 

American inner city children, for instance, are estimated to have been poisoned by lead. 

4. Exposure to lead in the environment causes a wide range of health problems. 

Young children and fetuses are especially sensitive to lead because their nervous systems are 

still developing and many of lead’s effects are observed in children at lower concentrations 

than in adults. Children exposed to lead may suffer from impairment of mental and physical 

development, anemia, hearing problems, and decreased levels of Vitamin D. Children 

exposed to lead are six times more likely to have a reading disability and seven times more 

likely not to graduate from high school than their peers. 

S. Lead poisoning, for the most part, is asymptomatic: early symptoms are mild 

and often mimic other common childhood disorders. As a result, the vast majority of pending 

cases go undiagnosed and untreated. 

6. The "Strategic Plan For the Elimination of Childhood Lead Poisoning" 

(hereinafter "Strategic Plan") issued by defendant Sullivan in February 1991, on behalf of 

HHS, states at pp. iii and xi: | 

Childhood lead poisoning has already affected millions of 

children, and it could affect millions more. Its impact on 

children is real, however silently it damages their brains and 

limits their abilities. 

Cw 

Today in the United States, millions of children from all 

geographic areas and socioeconomic strata have lead levels high 

enough to cause adverse health effects. Poor, minority children 

in the inner cities, who are already disadvantaged by inadequate 

nutrition and other factors, are particularly vulnerable to this 

 



  

disease. 

The Strategic Plan also notes that "many States do not conduct much screening or do not pay 

for environmental investigations for poisoned children" under their Medicaid EPSDT 

programs. Id. at p. 18. 

7. The Agency for Toxic Substances and Disease Registry, a subdivision of HHS, 

has reported that more than three million children --- one in six --- have levels of lead in their 

blood high enough to cause significant impairment of their neurological development. 

8. The Centers for Disease Control, the subdivision of HHS which provides 

guidance on medical and public health questions, in 1991 issued a statement entitled 

"Preventing Lead Poisoning in Young Children," finding that: 

Although all children are at risk, poor and minority 

children are disproportionately affected. Lead exposure is at 

once ! by-product of poverty and contributes to the cycle that 

perpetuates and deepens the state of being poor. 

ld. at 12. 

9, The Centers for Disease Control also found the harmful effects of lead 

poisoning at blood lead levels at least as low as ten micrograms per deciliter (ug/dL). The 

previous threshold had been 25 ug/dL. “As a result, the Centers for Disease Control stated 

that "the screening test of choice is now lead blood measurement" because "the erythrocyte 

protoporphyrin level [which is measured by the EP test] is not sensitive enough to identify 

children with elevated lead blood levels below 25 png/dL." Id at 2. The Centers for Disease 

Control also dictated the following treatment protocol: 

Community prevention activities should be triggered by lead 

blood levels > 10 ug/dL. Medical evaluation and environmental 

investigation and remediation should be done for all children 

with lead blood levels = 20 ug/dL. All children with lead blood 

 



levels = 15 pg/dL should receive individual case management, 

including nutritional and educational interventions and more 

frequent screening. Furthermore, depending on the availability 

of resources, environmental investigation (including a home 

inspection) and remediation should be done for children with 

lead blood levels of 15-19 ug/dL, if such levels persist. 

Jurisdiction and Venue 
  

10. The underlying civil action is authorized by 42 U.S.C. § 1983 to redress the 

deprivation under color of state law of rights, privileges, and immunities guaranteed by the 

Constitution of the United States or by act of Congress. This Court has jurisdiction pursuant 

to 28 U.S.C. §§ 1331 and 1343 (3) and (4). 

11 This civil action is authorized by 5 U.S.C. § 701 et seq. and 28 U.S.C. §§ 1331 

and 1361 to redress the deprivation by federal agency action of rights, privileges and 

immunities guaranteed by the Constitution of the United States or by acts of Congress, and 

to compel the individual federal defendant to perform his duty under the Medicaid Act. 

12, This Court has authority to grant declaratory relief pursuant to 5 U.S.C. § 702, 

28 U.S.C. § 2201, and Fed.R.Civ. P..57, to grant injunctive relief pursuant to 5S U.S.C. § 703, 

28 U.S.C. § 2202, and Fed.R.Civ. P. 65, and to issue relief in the nature of mandamus 

pursuant to 28 U.S.C. § 1361. 

13, The original plaintiffs reside in the Northern District of Texas and defendants 

named herein maintain offices in this District or are responsible for enforcing the laws 

relevant to this litigation in this District. 

14. Intervention as of right by plaintiff-intervenors is appropriate pursuant to 

Fed.R.Civ.P. 24(a)(2) and permissive intervention by plaintiff-intervenors is appropriate under 

Fed.R.Civ.P. 24(b)(2).  



Prior Demand 
  

13. Plaintiff-intervenors’ counsel requested that federal defendants comply with 

plaintiff-intervenors’ requests for relief, but defendant Sullivan declined. See attachments A 

and B. 

Parties 

16. Plaintiff-intervenor People United for a Better Oakland (hereinafter 

"PUEBLOQ") is a multi-racial unincorporated organization whose membership is comprised 

primarily of parents and guardians of Medicaid-eligible children in the State of California. 

One of PUEBLO’s purposes is to advocate adequate screening for lead poisoning. Pursuant 

to a stipulation for settlement entered in Erika and Jalisa Matthews and PUEBLO v. Molly 

Coye, N.D. Cal. 90-3620 EFL (approved October 17, 1991), Medicaid-eligible children of 

PUEBLO’s members and other California residents have been provided screening for lead 

poisoning using a lead blood level assessment. As a result of federal defendants’ refusal to 

require lead blood level assessment testing under the EPSDT program, the Medicaid-eligible 

children of PUEBLO’s members are threatened with the denial of lead blood level screening 

for lead poisoning notwithstanding the Matthews settlement. 

17. Plaintiff-intervenor Denver Action for a Better Community (hereinafter "ABC") 

is a multi-racial unincorporated organization whose membership is comprised primarily of 

parents and guardians of Medicaid-eligible children living in the State of Colorado who have 

been denied lead blood level assessment tests to screen for lead poisoning. One of ABC’s 

purposes is to advocate adequate screening for lead poisoning. 

 



  

18. Plaintiff-intervenor New York City Coalition to End Lead Poisoning 

(hereinafter "NYCCELP") is an unincorporated membership organization whose members 

include parents and guardians of Medicaid-eligible children throughout New York City who 

have been and are being threatened with the denial of lead ploed assessments to screen for 

lead poisoning. One of NYCCELP’s purposes is to educate and advocate for the families of 

Medicaid-eligible children to obtain proper lead poisoning screening through New York 

State’s Medicaid program. For almost eight years NYCCELP has been litigating this issue. 

Almost six years ago, before Congress enacted 42 U.S.C. § 1396d(r)(1), NYCCELP obtained 

a court ruling requiring appropriate and sufficient lead poisoning screening under the federal 

  

EPSDT program in New York City. N.Y.C. Coalition to End Lead Poisoning v. Koch, 524 

N.Y.S.2d 314, 318-19 (Sup. Ct. 1987), affd, 526 N.Y.S.2d 918 (1st Dep’t 1988). NYCCELP 

has now moved for " permanent injunction requiring New York State and New York City to 

provide proper, accurate lead blood tests under the Medicaid program, based on New York’s 

failure to follow federal law. Id., Index No. 42780/85, Plaintiffs Motion for Specific 

Enforcement (filed May 18, 1992; argued Oct. 19, 1992). Federal defendants’ policy will 

thwart the progress NYCCELP’s members have made toward adequate lead blood level 

screening. 

19. Plaintiff-intervenors Bryan Alan Gourley, age seven, Wesley Kyle Gourley, age 

six, Bridget Michelle Gourley, age four, and twins Linda Danielle and Betsey Irene Gourley, 

age three, are Caucasian children eligible for Medicaid benefits who reside in North Carolina. 

They intervene through their mother, plaintiff-intervenor Robin Gourley. Because of their 

Medicaid eligibility, the Gourley children are entitled to lead blood level tests for lead 

poisoning through the EPSDT program, but they have not received any. 

20. Plaintiff-intervenors Juan Wilkins, 19 months old, Ashard Moore, six years old, 

Jason Rollins, 11 years old, Ashea Roberson, 12 years old, and Nasheika Roberson, 16 years 

 



  

old, are African American North Carolina residents eligible for Medicaid services. Plaintiff- 

intervenor Juan intervenes through his guardian ad litem Tearrah ‘Roberson, and the 

remaining children intervene through their guardian ad litem Mary Marie Roberson. In 1992, 

plaintiff-intervenors’ public housing unit was found to contain lead paint on the window sills 

and doorways. Plaintiff-intervenors Ashard, Jason, Ashea and Nasheika, sought lead blood 

tests at the local health department and were administered the EP test. Plaintiff- intervenors 

were not given readings of their lead blood levels but Ashard, Ashea, and Nasheika were told 

that they are anemic --- a sign that they might be lead poisoned. Plaintiff-intervenor Juan has 

not been offered a lead blood test. 

21. Defendant United States of America administers the EPSDT program through 

HHS the federal agency charged with the administration of the program under the Medicaid 

Act. Additional defendant Louis W. Sullivan, the Secretary of HHS, is sued in his official 

capacity. Under defendant Sullivan’s supervision, HHS has failed to implement lead blood 

level assessment testing for Medicaid-eligible children. in violation of the Medicaid Act. The 

joinder of defendant Sullivan is proper under Fed.R.Civ.P.19(a) and 20(a). 

Class Action Allegations 
  

22. Plaintiff-intervenors represent a class of all Medicaid-eligible children presently 

residing in the United States. 

23. As of 1989, there were 10 million Medicaid-eligible children residing in the 

United States. The class of all these persons is so numerous that their joinder is 

impracticable. 

24. Plaintiff-intervenors’ allegations that defendants have violated the Medicaid Act 

involve questions of law or fact common to the class. 

25. The factual and legal assertions upon which plaintiffs-intervenors’ claims are 

based are identical to the basic factual and legal claims asserted on behalf of the class. 

26. The claims of plaintiff-intervenors and organizational plaintiff-intervenors’ 

 



  

members’ Medicaid-eligible children are typical of the claims of the class. 

27, There is no conflict between the plaintiff-intervenors and the plaintiff class. 

Plaintiff-intervenor individuals and organizations seek the same injunctive relief on their own 

behalves or on behalf of their members as is sought on behalf of the class. Plaintiff- 

intervenors are represented by competent counsel. Plaintiff-intervenors therefore will 

adequately represent the interests of the plaintiff class. 

28. Defendants have acted or refused to act on grounds generally applicable to the 

class thus making appropriate final injunctive relief or corresponding declaratory relief with 

respect to the class as a whole. 

First Claim for Relief---Violation of Medicaid Act 
  

29. Plaintiff-intervenors incorporate by reference paragraphs 1-28. 

30. The Medicaid program was established in 1965 by Title XIX of the Social 

Security Act, 42 U.S.C. 8.1396 et seq., as a cooperative federal-state medical assistance 

program designated to furnish medical assistance to certain poor people. The program is 

administered by the States, subject to mandatory federal statutory requirements. While 

participation in the Medicaid program is voluntary, States that choose to participate must 

fulfill all requirements imposed by the Medicaid Act, including the requirements of the 

EPSDT program. 42 U.S.C. §§ 1396d(a)(4)(B) and 1396d(r). 

31, The Medicaid Act requires "screening services . . . which shall at a minimum 

include laboratory tests (including lead blood level assessment appropriate for age and risk 

factors)." 42 U.S.C. § 1396d(r)(1). 

32. Defendant Sullivan implements the requirements of the Medicaid Act 

applicable to the States through regulations and guidelines, notably the "State Medicaid 

Manual" (hereinafter "Manual") of HHS Health Care Finance Administration. 

33. Recent amendments to the Manual, which became effective on September 19, 

1992, permit the continued use of the EP test ("States continue to have the option to use the 

 



  

EP test as the initial screening blood test."). The Manual permits the use of the EP test 

although it acknowledges that lead poisoning is harmful at levels at least as low as ten pg/dL 

and that "[t]he erythrocyte protoporphyrin (EP) test is not sensitive for lead blood levels below 

25 pg/dL." 

34. Defendant Sullivan’s 1991 "Strategic Plan" at p. 40, stated "At present it is much 

cheaper and easier to perform an EP test than a blood lead measurement; however, the EP 

test is not a useful screening test for blood lead levels below 25 pg/dL." The Strategic Plan 

correctly forecast that the Centers for Disease Control would lower the level of lead blood 

that would be harmful below 25 ug/dL in 1991 and stated that: 

This change will mean that blood lead measurements must be 

used for childhood lead screening instead of EP measurements. 

Id. at 23 (Emphasis added). 

3s. Defendant Sullivan had earlier issued a report entitled "The Nature and Extent 

of Lead Poisoning in Children in the United States: A Report to Congress," in 1988, which 

analyzed the existing research on the reliability of the EP test as a screening test for lead 

poisoning and concluded, at p. II-9: "[R]eliance on EP level for initial screening can result in 

a significant incidence of false negatives or failures to detect toxic Pb-B [lead blood] levels." 

36. The actions of federal defendants refusing to require use of lead blood level 

assessment tests and permitting the States to use the EP test to screen for lead poisoning 

under the EPSDT program violate the Medicaid Act and are substantially unjustified. 

37 By refusing to require the States to use a lead blood level assessment test to 

screen for lead poisoning under the EPSDT Medicaid program and permitting the States to 

use the EP test, federal defendants have deprived plaintiffs-intervenors of rights, privileges, 

and immunities guaranteed by the Constitution and laws of the United States. 

Second Claim for Relief --- Mandamus 
  

38. Plaintift-intervenors incorporate by reference paragraphs 1 through 37. 

10 

 



39, By failing to require the States to use a lead blood level assessment test to 

screen for lead poisoning under the EPSDT Medicaid program and permitting the States to 

use the EP test, federal defendants have failed to perform a clear mandatory duty required 

by a specific provision of the Medicaid Act, 42 U.S.C. §§ 1396d(a)(4)(B) and 1396d(r)(1). 

40. Plaintiff-intervenors are therefore entitled to an order compelling performance 

of the mandatory duty to require use of lead blood level assessment tests to screen for lead 

poisoning under the EPSDT Medicaid program. 

Third Claim for Relief --- Injunction 
  

41. Plaintiff-intervenors incorporate by reference paragraphs 1 through 40. 

42. Unless restrained by the Court, federal defendants will continue to deny or 

threaten to deny plaintiff-intervenors lead blood level assessment tests required by the 

Medicaid Act, 42 U.S.C. §§ 1396d(a)(4)(B) and 1396d(r)(1), to screen for lead poisoning. 

43. Plaintiff-intervenors have no plain, speedy or adequate remedy at law. The 

refusal of federal defendants to require the States to use lead blood level assessments tests 

to screen for lead poisoning therefore should be enjoined. 

Fourth Claim for Relief --- Declaration 
  

44. Plaintiff-intervenors incorporate by reference paragraphs 1 through 43. 

45. There is a dispute bétween plaintiff-intervenors and federal defendants under 

the Medicaid Act in that plaintiff-intervenors claim and contend that the federal defendants’ 

conduct described above violates the Medicaid Act and Mandamus Act and in that plaintiff- 

intervenors are informed and believe and thereupon allege that federal delinduis contend 

in all respects to the contrary. 

46. A declaration of the correct interpretation of the Medicaid Act therefore is 

necessary and appropriate to determine the respective rights and duties of the parties.  



  

Praver for Relief 
  

47. Plaintiff-intervenors seek the following relief against federal defendants Louis 

W. Sullivan and United States of America: 

a. a preliminary and permanent injunction enjoining federal defendants 

from giving effect to the State Medicaid Manual and revisions that permit the States to use 

the EP test as a screening test for lead poisoning; 

b. a mandatory order compelling defendant Sullivan to require use of lead 

blood level assessments as the screening test for lead poisoning; 

C, a permanent injunction enjoining the operation and effect of any United 

States Department of Health and Human Services regulations or guidelines which permit the 

use of EP tests to test for lead poisoning instead of lead blood level assessment tests; 

d. a permanent injunction and mandatory order that compels defendant 

Sullivan to require the States to use lead blood level assessment tests and to test, using lead 

blood level assessment tests, each Medicaid-eligible child the States have failed to test or have 

tested with EP tests instead of lead blood level assessment tests; 

Cc. an award of attorney’s fees, litigation expenses, costs and such other 

relief as may be appropriate; and 

f. such other relief as may be appropriate. 

Dated: October 21, 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 

12 

 



: & 
» 

  

(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 
1815 H Street, N.W. 
Suite 705 
Washington, DC 20006 
(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 
Bronx, N.Y. 10451 
whe ag 992-6250 

  

    
  Fx fot Lee | 

Attorpeys Plaintiff-Intérvenors 
PUEBLO, ABC, NYCCELP and individual 
plaintiff-intervenors 

13 

 



CERTIFICATE OF SERVICE 

  

  

Undersigned counsel for proposed plaintiff-intervenors certifies that copies of the 
Proposed Complaint in Intervention was served on counsel for the parties by telefacsimile and 
by United States mail, first class postage prepaid, to: 

Michael M. Daniel, P.C. 

3301 Elm Street 

Dallas, TX 75226-1637 

(214) 939-9229 (telefacsimile) 

Edwin N. Horne 

Assistant Attorney General 
General Litigation Division 
P.O. Box 12548 
Capital Station 
Austin, TX 78711-2548 
(512) 447-0511 (telefacsimile) 

Alina S. Kofsky 
Sheila Lieber 

Department of Justice 

Federal Programs Branch, Civil Division 

901 E Street, N.W. 

Washington, D.C. 20530 

(202) 616-8470 (telefacsimile) 

This 21st day of October, 1992. 

  

Kirsten D. Levingstoft/ J 

 



SE rE ves FROM NARCP L.A. 

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National ,.@ 3: 2. {7 HR To i “Be £ 

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NAACP LEGAL DEFENSE 99 Hudson Streét AIRY 2. J iN 

AND EDUCATIONAL FUND, INC. New York, ¥ Y, ool = db 25: SA ax: 6-7592 

itd ee TOEFENSE AND 
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July 15, 1992 ; 

The Honorable Louis W. Sullivan 
Secretary 
United States Department of Health and Haden Services 
200 Independence Avenue, SW 
Room 615F | 
Washington, D.C. 20201 

Re: Failure by HCFA to Implement CDC Statement on Preverising Lead 
Poisoning in Young Children | a : 

Dear Ssorstesy Sullivan: 

The purpose of this letter is to bring to your attention a sonilieint problem 
in the implementation by the Health Care Finance Administration (HCFA) of the 
October 1991 Statement on Preventing Lead Poisoning in Young Children issued 
by you and the Centers for Disease Control (CDC). Theé Legal Defense Fund has 
been monitoring the implementation of the CDC Statement because of the great 
number of poor African-American children affected by lead poisoning 

We request that you instruct HCFA to follow ‘the CDC Statement and 
discontinue the use of the erythrocyte protoporthyrin (EP) test to screen for lead 
poisoning. Only the venous blood lead test as dictated by the DC Statement 
shouid be used. PIE 

Briefly stated, HCFA is in the process of preparing ¢ guidelines for State 
Medicaid program directors that indicate that state programs may continue to use 
the EP test to screen for lead poisoning. The use of this EP test potentially will 
leave hundreds of thousands of children effectively unscreened for lead poisoning. 
HCFA is recommending the EP test despite the fact that it is not. sensitive enough 
to test for poisoning at the new lower levels established by. the CDC. “According to 
the CDC, screening should be done using the venous blood lead test. Unless 
HCFA’s guidance to State Medicaid officials is altered, HCFA will frustrate 
implementation of the screening that CDC has established as standard medical 
practice for poor; Medicaid-eligible children, the very group that | 1s at greatest risk 
of poisoning by lead. i 

ATT A 

Regions Offices 

iin 4+ Tbe NAACP Legal Defense & Educational Fund. Inc. (LDF) 13 nat pare oy Suite 301 Sasi 20 
wctible for (JS. of the National Association {or the Advancement of Colored Peapic te BT 1Z75 R Streec, NW M3 West Ninth Sere 

Tméone 1ax purposes. {NAACP) although LDF was founded by the NAACP and shares 11s GIT ys Washmeton, XC 20005 law Angeles. TA wins 

 



FR Solaray FROM NaQCP LL .49. 

  

The Honorable Louis W. Sullivan 

July 15, 1992 

Page 2 

Almost a year ago, the CDC Statement lowered the level of blood lead 

sufficient to trigger medical and public health intervention from 25 micrograms per 

deciliter to 10 ug/dL. The reason for lowering the threshold was that "the scientific 

evidence showing that some adverse effects occur at blood lead levels at least as low 

as 10 ug/dL in children has become sO overwhelming and compelling that it must be 

. a major force in determining how we approach childhood lead exposure.” CDC 

Statement at 1. At levels above 10 ug/dL, frequent rescreening. and possible 

community intervention is called for,-with greater intervention at: progressively 

higher levels. Id. at 44-46. A complete medical evaluation, and identification and 

‘elimination of environmental lead sources, is required beginning with test results of 

Q0ug/dL. Id at 46. As a result, the CDC Statement declared that: 

Since erythrocyte protoporphyrin (EP) is not sensitive 

enough to identify more than a small percentage . of 

children with blood lead levels between 10 and 25 ug/dL 

and misses many ‘children with blood lead levels = 25 

pg/dL . . . measurement of blood lead ievels should 

replace the EP test as the primary screening method. 

CDC Statement at 41 (citing, McElvaine MD, Orbach HG, Binder S. Blanksma, LA, 

Maes EF, Krieg RM. [Evaluation of the erythrocyte protoporphyrin test as a screen 

for elevated blood lead levels, Chicago, Illinois, 1988-1989. J. Pediatr (in press) 

~ 19p1]); see id. at 2 ("Since the erythrocyte protoporphyrin level is not sensitive 

enough to identify children with elevated blood lead levels below about 25 ug/dL, 

the screening test of choice is now blood lead measurement."). 

_ In the attached draft letter, HCFA has given: State Medicaid program 

directors accurate guidance on the implementation of the CDC Statement with one 
major exception. The exception, however, is a glaring error. Acknowledging that 
the blood lead test is "the test of choice” and that "the EP test is not a sensitive 

indicator for blood lead levels below 25 ug/dL," the HCFA draft (at 2) nevertheless 
permits the EP test to be used for screening as an alternative to the venous blood 
lead test when verbal assessment indicates absence of high risk. Id. at 2, 4, attached 
chart entitled "EPSDT Lead Screening Requirements." ©. 

es ‘According to the CDC, the problem with continued use of the EP test is that 

it is "not sensitive enough to identify more than a small pércentage of children with 

 



So ! hen [CP UCA SE FRUM NAACP L.A. 
pa 

» FAGE . B04 

  

The Honorable Louis W. Sullivan 

July 15, 1992 
Page 3 

blood lead levels between 10 and 25 pg/dL and misses many children with blood 

lead levels = 25 ug/dL." (CDC Statement at 41). By permitting continued use of 

the EP test despite knowledge of its limitations, HCFA purposefully compromises 

the principal thrust of your CDC Statement to lower the threshold of lead poisoning 

to 10 pg/dL, and to identify and treat many undiagnosed young children presently 

suffering from lead poisoning. BL 

There are two mitigation measures contained in the HCFA draft, neither of 

which suffices. First, the draft requires that only a blood lead test be administered 

when verbal assessment establishes high risk. However, the CDC statement from 

which the questions set forth in the verbal assessment are derived unequivocally 

provides: "The questions are not a substitute for a bleod lead test.” CDC 

Statement at 42 (emphasis in original). The limited purpose of a high or low risk 

categorization is to establish the schedule for subsequent screening and follow-up. 

Id. at 43-45. Second, the draft requires that an elevated EP result above 10 png/dL 

must be confirmed with a blood lead test. However, confirmatory blood lead test 

does nothing to cure an initial EP result that is underinclusive. As noted above, 

underinclusivity is the key defect in the use of the EP test at such low levels. The 

CDC Statement does contain language about elevated EP results being followed 

with a venous blood lead test to determine if lead poisoning is responsible for the 

elevation. CDC Statement at 48. However, the elevated EP results to which the 

CDC Statement referred are those at or above 35 g/dL; i.e., levels at which the EF 

test is sensitive, not at low levels where it is not sensitive. . 

Moreover, the HCFA draft purports to put in place only an indeterminate 

_ "transition period" scheme. HCFA proposes no end date for continued use of the 

EP test. However, it is now fully nine months since the CDC Statement was issued, 

time enough for State Medicaid authorities to have made the adjustments necessary 

to increase their capacity to perform venous blood lead testing, which is the only 

reason the Statement contemplates for “temporary” use of the EP. See CDC 

Statement at 41. 
: ey 

~. Last, the HCFA draft refers to limited state ‘resources. However, the... 

Medicaid-eligible population of young children is not a demographic category at low 

risk. Itis a category of poor and minority children who are at high risk and who 

ue the most rigor in screening. The CDC Statement is eloquent in its point 

that: 

Loi ds 

 



  

hie BO Be AY EER FROM NAQCP L.A 

The Honorable Louis W. Sullivan 

July 15, 1992 
Page 4 

Although all children are at risk from 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 at 12. Lead poisoning, unhappily, is a civil rights issue. 

For the above reasons, the HCFA draft should be reformulated to eliminate 

the use of the EP test to screen for possible lead poisoning under the Medicaid 

program. Only the venous blood lead test should be utilized: Please feel free to call 

me if I can be of further assistance. : ii 

Sincerely, 

Y i L. Chambers 
irector-Counsel 

JNCism - 
Attachments 

cat Assistant Secretary James Mason 

William Toby, HCFA 

 



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> : ULEAK IMENT OF HEALTH & HUMAN SERVICES % .- ‘Health Care Financing Administratio 

    

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6325 Security Boulevary ? Baltimore, MD 21207 

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Ms. Julivs I, -Chambers 
Diréctor-Coniisel 

| NAACP Legal Defense By | - and Educational Fund, Ini. AURll Re 99 Hudson, Street, Suite 1600 4 ey HB on “New York! N.Y. “10013-2897 

Dear Mr, Chambers: 

policy as well asiolir understanding of ‘the statement of the Centers for Disease Coutrol, (CDC); 

recommends varios blood touts 1 all Cases. Our draft indicated that it was the © frst phase of gilidance to the States. If CDC revises its statement on preventing Es 2 clifktood lead: poisonirig, we would anticipate additional revisions. © 

screening test: of ohaice, the erythrocyte protoporphyrin (EP) test will still be used in those cireunistances where laboratory capacities for blood lead testing are not sufficient, Since the CDC statement did not put specific timeframes on the use of 
: h the: EP test; we are not in a position to do so.