Defendant's Motion to Dismiss or for Summary Judgment and in Opposition to Plaintiffs' Motion for Temporary Restraining Order

    | ® _ 3 Se Dior 

  

IN THE UNITED STATES DISTRICT COURT 
FOR THE 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, 

Vv. Civil No. 3:92-1539-R 

BURTON F. RAIFORD, in his 

capacity as Commissioner of 
the Texas Department of Human 
Services, 

and 

THE UNITED STATES OF AMERICA, 

Defendants. 

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DEFENDANT UNITED STATES OF AMERICA'S MOTION TO DISMISS 
OR IN THE ALTERNATIVE FOR SUMMARY JUDGMENT AND IN OPPOSITION 

TO PLAINTIFFS' MOTION FOR TEMPORARY RESTRAINING ORDER 
AND PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT 

 



| + 3 

TABLE OF CONTENTS 

  

  

  

PAGE 

TABLE OF AUTHOR PIES. 0 ts vv a ie oa ite Saini ii 

I. INTRODUCTION. os elie tle iy ai 0 ov iui wai via tag igi yh tis 1 

Il. STATUTORY AND REGULATORY BACKGROUND vv iv eis oie a wien a 6 

A. The Medicald Program iv «+ oc oi vc Tete in vie % oie oie 6 

B. Early and Periodic Screening Diagnostic 
And Treatment Program. «uc sv cis « + 0% aie sa 7 

11. UNCONTROVERTED FACTS.» viv. « « 2 visite einiin oi vo range, 9 

A. HCFA's Previous Actions Regarding Screening 
Of Children For Elevated Blood levels . . . , + viv v's 9 

B. The 199) CDC. Statement” . . . . vos v0 vy vrs 12 

C. The September 1992 HCFA Guidelines . . . . uv 2 eo ov « '» 16 

IV, “BRGUMENT ANDI BUTHORITIES . v vv ve vie lie athe ag aie ai 21 

A. The Named Plaintiffs' Claims Should 
Be Dismissed Because They Have Not 
Suffered Any Injury And Thus Lack 
SANGIN ENS SUB le vrs ves mise a ia a a ha 21 

: ot Principles of Standing « +  . 2. oy vin ivi Niteita 21 

2. Plaintiffs Have Suffered No Injury As 
A Result of The New HCFA Guidelines .'. . «. . . , 24 

B. Plaintiffs' Complaint As To Defendant USA 
Should Be Dismissed For Failure To State 
Claim Upon Which Relief May Be Granted Or 
Alternatively, Summary Judgment Should Be 
Granted In Favor Of Defendant USA . . J + 8 guia, hy 28 

1. The HCFA Guidelines Are Consistent 
With The Medicaid Statute . . ot. Jiiip Jobe 28 

2. The HCFA Guidelines Give States The 

Option Of Using The EP Test For 
"Low Risk" Children Only & =. u...iiv Ww woe ow Tul, 33 

3. The HCFA Guidelines Are Consistent With 
The 11991 CDC Statement . ... gies Lo Lay Onan no 32 

- PS 

 



J 3 

  

C. Plaintiffs Have Failed To Satisfy The 
Requirements For Temporary Injunctive Relief . . . . . 34 

3. Standards for injunctive Relief . '. . . vv iu a 34 

2. Plaintiffs Do Not Have A Substantial 
Likelihood Of Success On The Merits . . . + oie . 36 

3. There Is No Substantial Threat Of 
Irreparable Injury If The Temporary 
Relief Plaintiffs Seek From Defendant 
USA IS NOC Granted « ov ov io vieciniv. on wiht igban di 37 

4. The Threatened Injury To Plaintiffs 
Does Not Outweigh Any Damage Preliminary 
Relief Might Cause To Defendant USA And 
PRE PUDIIC oo 3 oe eis is aie nin wail EE 38 

Be Plaintiffs' Motion Should Also Be 
Denied Because It Improperly Seeks 
To Alter The Status QUO « voc =v vo vv devo 40 

Vv. CONCLUSION te ts 8. Be ot i ie wee ea 42 

- 41 = 

 



¢ ¢ 

TABLE OF AUTHORITIES 

CASE(S): PAGE(S) 

Allen v. Wright, 468 U.S. 737 (1983) o eile Ne cities Laine sie Bly 23g 2D 

  

  

  

Allied Marketing Group, Inc. v. CDL Marketing, Inc., 
878 P.24.:806 (5th Cir. 1989) ies + wi Ye eet Sle, Ye yw 34, 35 
  

Anderson v. Douglas & Lomason Co., 
835 Pe2@ 128 {SLR CIT. 1088) vo viv le vieiiv vinnie eee 36 

  

Asarco v, Radish, 490 U.S, 605 (1989) + v vv «iv 0 vo vite vin ein 22   

Atkins v, Rivera, 477 U.8.:184. (1986) . + « viv. iv vw Ww Nd Joa i'e   

Brown v. Sibley, 630'F.2q 760 (Sth Cir. 1981) . iv « vivin sino 4927   

Canal Authority of the State of Florida v. 
Callaway, 489 F.2d 567 (53th Cir. FO74) ui oy vie esi ee Teak 3D 

  

  

Chemical Mfrs. Ass'n v. Natural Resources 
Defense Council, Inc., 470 U.S. 116 (1985) viva aie we ee 29 
  

  

Chevron, U.S.A., Inc. v. Natural Resources 
Defense Council, Inc., 467 U.S. 837 (1984) . . . .. + «ieee 28, 29 
  

  

DFW Metro Line Servs. v. Southwestern Bell 
Telephone Co., 901 F.24 1267 (5th Cir.), 
cert. denied, U.S. r 211 S.Ct. 519: (1990)... + + vv ev + 35 

  

  

  

Enterprise Int'l, Inc. v. Corporacion 
Estatal Petrolera Ecuatoriana, 
762 F.24 464 (5th Cir. 1585) nev vai we VEY eile 35,36 

  

  

Ethyl Coyp. Vv. E.P.A., 541-F.24 1 (D.C. Cir.), 

cert. denied, 426 U.S, 941 (19768)  .. + +. 0 hii, JU00 a0 
  

  

Ford Motor Credit Co. v. Milhollin, 
444 8U.8.0. 555 (1080) Rl. om. . an. 0 ie ae ea i a a ia 
  

Gladstone, Realtors v. Village of Bellwood, 
44] VeSei 91 {1970 4 ie ite wis v Tv ov 0 viene eae Ry ie yity * 
  

  

Harris vv. MeRae 4448 U.S. 207 (1980) i. i uns Ww dn otis a 

  

Harris v. Wilters, 596 F.2d 678 (5th Cir. 3979 . . «4d &iww vie Siay 

Holland America Ins. Co. Vv. Succession of Roy, 

777 FP.2Q5992  ({SLtNECIT. 1IBBY 'v "vv vilei va 2 0 a wim Bene 35.37 
  

- iii - 

 



Ra J 

Isquith v. Middle South Utilities, Inc., 
847 'P.24 186°(5th Cir. 1988)", . . « 's 
  

Lewis v. Hegstrom, 767 F.2d 1371 (9th Cir. 1985) 
  

Lopez v. Heckler, 725 F.2d 1489 (9th Cir. 1984), 
vacated on other grounds, 105 S.Ct. 583 (1984) 
  

  

Lujan v. Defenders of Wildlife, 
U.S. y 112:8. Ct. 2130: (1992) v .» 
  

Martin v. International Olympic Committee, 
740 F.2d 670 (Oth Cir. 1984) ovis oi v « = 
  

  

Martinez v. Matthews, 544 F.2d 1233 (5th Cir. 1976) 

Mississippi Power & Light Co. v. United Gas 
Pipe Line Co., 760 F.2d 618 (5th Cir. 1985) 
  

  

  

Public Citizen v. United States Dep't of Justice, 
491 U.S. 440 (1989) oie a ae ei WE Ca 

Schlesinger v. Reservists To Stop The War, 
418 U.S. 208 (1973) oe a a Te a 
  

Schweiker v. Gray Panthers, 
4830. CS, 34 {Y081Y >, JL. a 
  

Schweiker v. Hogan, 457 U.S. 569 (1982) 
  

Tanner Motor Livery, Ltd. v. Avis, Inc., 

316 F.24 804 (oth Cir.), 
cert. denied, 375 U.S. 821 (1963) 

  

  

Udall v. Tallman, 380 U.S. 1 (1965) 
  

United States wv. Rutherford, 
442 U.S, 544 (1979) i... 
  

University of Texas v. Camenisch, 
4510.8, 380 (1981): « vv v + 27% 
  

Valley Forge College v. Americans United 
for Separation of Church and State, Inc., 
454 U.S. 464 (1981) + 5. . i 

  

  

Warth v. Seldin, 422 U.S5. 490.1(1975) 
  

White 'v, Carlucci, 862 F.24 1209 (5th Cir. 1939) 
  

Whitmore v. Arkansas, 495 U.S. 149 (1990) 
  

- iy  



o 

STATUTES AND REGULATIONS 
  

42 U.S.C. 1396 

42 0.8.0. 8 13960: .. 

42 U.S.C. § 1396a(a) (10) (A) 

42 U.S.C. § 1396a(b) 

42 U.8.C.a 8 139600, a0 

42 C.F.R. § 1396d(a) (4) (B) 

42 U.S.C. 13964(r) . 

§ 

§ 

§ 

§ 

42 U.S.C. § 1396b(a) 

§ 

§ 

§ 

§ 42 U.S.C. § 1396a(a) (43) (A) 

42 C.F.R. 440.40(b) . 

MISCELLANEOUS 
  

Conference Report, H.R. 101-386, 
101 Cong. 1st Sess., p. 453 

 



o 

I. 

INTRODUCTION 
  

Plaintiffs, four children who are residents of West Dallas, 

Texas, purport to represent a nationwide class of all Medicaid- 

eligible children who are at risk for lead poisoning.! Plaintiffs 

contend that they have not been given the appropriate blood lead level 

assessment and treatment by the State of Texas. As to defendant USA, 

they contend that guidelines issued recently by the Health Care 

Financing Administration ("HCFA"), a component of the U.S. Department 

of Health and Human Services ("HHS"), which became effective on 

September 19, 1992, encourage states to test Medicaid-eligible 

children for lead poisoning by using a less sensitive blood test (the 

erythrocyte PEOtkpor HYP or "EP" test), which would not detect lead 

levels at the threshold at which concern is recommended by the Centers 

for Disease Control ("CDC"), rather than a more sensitive blood lead 

test. The continued use of the EP test, according to plaintiffs, 

contravenes a requirement of the Medicaid statute, 42 U.S.C. § 

1396d(r), for "blood lead level assessment" and is inconsistent with 

the October 1991 Statement of the CDC "Preventing Lead Poisoning in 

  

! Plaintiffs initiated this action on or about July 29, 
1992 against defendant Burton F. Raiford, in his official 
capacity as Commissioner of the Texas Department of Human 
Services. On or about August 6, 1992, plaintiffs filed their 
first amended complaint. Defendant United States of America 
("USA") has not been served with either the original complaint or 
the first amended complaint. On or about September 10, 1592, 
plaintiffs once again amended their complaint ("Complaint") to 
include the USA as a defendant. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 
TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 
PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 1 
   



  

o o« 

Young Children: A Statement By The Centers For Disease Control" and 

HHS' "Strategic Plan for the Elimination of Childhood Lead Poisoning" 

issued in February 1991, both of which recognize that the lead 

screening test of choice is now the blood lead test. 

Plaintiffs seek a sweeping mandatory, preliminary and permanent 

injunction to require that HCFA compel the states to use the blood 

lead test as the sole screening test for lead poisoning.? They also 

seek an order enjoining the federal government from supporting, 

allowing or financing the states' continued use of the EP test as a 

screening test for lead poisoning.’ 

  

2 It is only this form of relief which plaintiffs appear 
not to seek as preliminary relief from defendant USA. In 
addition, plaintiffs seek an order which would require HCFA to 
issue guidelines requiring that states retest all Medicaid- 
eligible children previously tested with the EP test with the 
blood lead level test. 

’ Plaintiffs also seek certain relief from defendant Burton 
Raiford, Commissioner of the Texas Department of Human Services. 
Specifically, plaintiffs seek a mandatory preliminary and 
permanent injunction to require the State of Texas to use the 
blood lead test as the sole screening device for lead poisoning 
statewide, and enjoin the State from using the EP test. 
Plaintiffs also seek an order requiring defendant Raiford to 
declare West Dallas and other geographic areas in the State of 
Texas high risk areas for children for lead poisoning, and notify 
all EPSDT providers that eligible children residing in such 
designated high risk geographic areas be given lead blood level 
assessments. In addition, plaintiffs seek an order requiring 
defendant Raiford to give effective notice and outreach of the 
availability of blood lead screening and treatment to all EPSDT- 
eligible children; and implement a case management program to 
ensure that lead screening and treatment is provided for all 
EPSDT-eligible children in accordance with the CDC guidelines. 
Finally, plaintiffs seek an order requiring defendant Raiford to 
retest, using the blood lead level test, all EPSDT-eligible 
children previously tested with the EP test. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =-- 2 
  

 



  

o « 

Defendant USA hereby opposes plaintiffs' Motion for Temporary 

Restraining Order and Preliminary Injunction Against the U.S.A. 

("Motion") and respectfully moves this Court for dismissal of 

plaintiffs' Complaint in its entirety. As a threshold matter, 

plaintiffs lack standing to bring this action. Plaintiffs suffer no 

injury from the HCFA guidelines. The injury of which they complain -— 

i.e., the State of Texas' alleged failure to perform a blood lead test 

and appropriate lead poisoning intervention -- does not stem from the 

challenged September 1992 HCFA guidelines. Indeed, those very 

guidelines would require that plaintiffs receive the blood lead tests 

they seek.? Granting the relief sought by plaintiffs from defendant 

USA would not redress plaintiffs' injury and would offer plaintiffs no 

relief not already offered by the very guidelines plaintiffs 

challenge. Furthermore, requiring HCFA to issue guidelines which 

mandate the states' use of the direct blood lead test (rather than the 

EP test) in all cases would not accomplish plaintiffs' intended result 

(i.e., universal use of the blood lead test), and may actually harm 

the plaintiffs themselves. Given the states' current capacity 

limitations for blood lead tests, requiring blood lead tests of all 

Medicaid-eligible children, without assigning priority according to 

whether the child 'is at "high risk" or "low risk," may result in 

  

* In accordance with the challenged HCFA guidelines, the 
four named plaintiffs would be deemed to be "high risk" for 
significant lead exposure. The HCFA guidelines require that the 
more sensitive blood lead test be administered for those children 
determined to be "high risk." 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 3 
  

 



  

. QC 

significant delays in providing blood lead tests (and necessary 

intervention) for "high risk" children such as plaintiffs. 

Even if the Court finds that plaintiffs possess the requisite 

standing to bring this suit, the case must be dismissed because 

plaintiffs' claims are wholly lacking in merit. Contrary to 

plaintiffs' allegations, the new HCFA guidelines do not contravene the 

statutory requirement of the Medicaid statute, 42 U.S.C. § 1396d(r), 

for blood lead level assessment. Section 1396d(r) defines lead 

screening as consisting of " (iv) laboratory tests (including lead 

blood level assessment appropriate for age and risk factors)." On its 

face, § 1396d(r) does not require "blood lead tests" as plaintiffs 

contend and plaintiffs offer nothing to indicate that Congress 

intended the term "lead blood level assessment" be to have the 

restrictive (and highly technical) meaning they ascribe to it. 

Plaintiffs' claims evidence a fundamental misunderstanding of the 

new HCFA guidelines. There is no merit to plaintiffs' assertion that 

HCFA's guidelines generally allow (indeed encourage) the use of the EP 

test. The guidelines require the blood lead test for all children 

determined to be at "high risk" of having elevated blood lead levels. 

States continue to have the option to use the EP test as the initial 

screening blood test only in those instances where, after a verbal 

assessment, the EPSDT provider deems the child to be "low risk."’ 

  

> Thus, plaintiffs' suggestion that the guidelines were 
intended to limit the federal government's financial obligations 
is ludicrous. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 
PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 4 
  

 



¢ o 

HCFA has, however, encouraged the most widespread use of the blood 

lead test and will share in the states' costs of screening all 

children (including those assessed as "low risk"), through the use of 

the blood lead test.S 

In addition, the new HCFA guidelines are consistent with the 1991 

CDC Statement. Plaintiffs' allegations to the contrary are 

groundless. Indeed, the HCFA guidelines were developed in 

consultation with the CDC, and the CDC itself has stated that the 

guidelines are consistent with the 1991 CDC Statement. See 

Declaration of Susan Binder, M.D. Chief, Lead Poisoning Prevention 

Branch, CDC, attached hereto as Exhibit "B," at q 19. 

Finally, for the same reasons that plaintiffs lack standing and 

have failed to state a claim for which relief can be granted, 

plaintiffs are not entitled to temporary injunctive relief. This is 

all the more true because plaintiffs seek mandatory preliminary 

injunctive relief which would alter the status quo, rather than 
  

maintain it, by forcing HCFA to rescind its current EPSDT lead 

screening guidelines and issue revised guidelines requiring states to 

administer the blood lead test for all Medicaid-eligible children. 

Thus, plaintiffs' Motion for temporary injunctive relief should be 

denied. 

  

® HCFA estimates that the majority of young Medicaid- 
eligible children will be assessed as "high risk" due to their 
physical living conditions. See Declaration of William McC. 
Hiscock, attached hereto as Exhibit "A," at <q 14. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 
TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 
JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 
MOTION FOR TEMPORARY RESTRAINING ORDER AND 
PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- § 
   



Na eo 

II. 

STATUTORY AND REGULATORY BACKGROUND 
  

A. The Medicaid Program 
  

Title XIX of the Social Security Act, commonly known as Medicaid, 

42 U.S.C. § 1396, establishes a jointly funded, cooperative federal- 

state program designed to "enabl[e] each State, as far as practicable 

under the conditions in such State," to furnish medical assistance to 

eligible individuals. 42 U.S.C. § 1396. See Atkins v. Rivera, 477 
  

U.S. 154, 165 (1986); Schweiker v. Hogan, 457 U.S. 569, 571 (1982); 
  

Harris v. McRae, 448 U.S. 297, 301 (1980). While the Medicaid program 
  

is voluntary, states that choose to participate must submit a state 

plan which fulfills all requirements imposed by the Medicaid statute 

and its implementing regulations. 42 U.S.C. § 1396a. See Schweiker 
  

Y. Gray Panthers, 453 U.S. 34, 36-37 (1981); Harris v. McRae, 448 U.S. 
  

  

at 301. The Secretary is obligated to approve a state plan that meets 

all federal requirements. 42 U.S.C. § 1396a(b). 

Upon approval of the state plan, a state becomes entitled to 

reimbursement by the federal government, termed "federal financial 

participation" ("FFP") for a portion of its allowable payments to 

hospitals, nursing homes, and other providers furnishing medical 

assistance to eligible recipients. 42 U.S.C. § 1396b(a). Both the 

state plans and the states' implementation of the plans are subject to 

oversight by the Secretary to ensure continued compliance with the 

federal requirements. 42 U.S.C. § 1396c. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 6 
   



  

 S s 
The day-to-day administration of state Medicaid programs is 

performed by the states, not by the federal government. Within the 

broad framework of federal requirements and oversight, the states 

operate their individual programs in accordance with state rules and 

criteria that vary widely. "As long as a State complies with the 

requirements of the Act, it has wide discretion in administering its 

local program." lewis v. Hedstrom, 767 F.24 1371, 1373 (9th Cir. 
  

1985) (citations omitted). 

The Medicaid statute, however, does mandate that, at a minimum 

participating states provide certain eligible groups with some 

specific services. 42 U.S.C. § 1396a(a) (10) (A). Apart from certain 

statutory requirements, each state chooses the services (and payment 

levels), and any additional groups (other than those mandated by the 

Act) for which it will provide coverage. Id. The states also have 

considerable discretion concerning the administrative and operating 

procedures they will use to implement federal requirements. See 

Harris v. McRae, 448 U.S. at 301. 
  

B. Early and Periodic Screening Diagnostic and Treatment Program 
  

The Medicaid statute mandates that states provide Early and 

Periodic Screening and Diagnostic and Treatment Program ("EPSDT") 

services to Medicaid-eligible individuals under the age of 21. 42 

U.S.C. §§ 1396a(a) (43) (A) and 1396d(a) (4) (B). In 1989, Congress 

amended the Social Security Act to define EPSDT services when it 

enacted the Omnibus Budget Reconciliation Act of 1989 ("OBRA 89"), 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS’ 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =- 7 
  

 



  

_ 3 eo 

Pub. L. 101-239,°103 Stat. 2106 (Dec. 19, 1989). Section 6403 of OBRA 

89 provided the definition of EPSDT services by adding § 1396d(r) to 

the Medicaid statute, effective April 1, 1990.’ 

In particular, section 6403 of OBRA 89, 42 U.S.C. § 1396d(r), 

defines screening services to include, at a minimum, 

(1) a comprehensive health and developmental 
history (including assessment of both physical 
mental health development), 

(11) a comprehensive unclothed physical exam, 

(1ii) appropriate immunizations according to age 
and health history, 

(iv) laboratory tests (including lead blood level 
assessment appropriate for age and risk factors), 
  

  

and 

(Vv) health education (including anticipatory 
guidance). 

(Emphasis added). 

HCFA provides instructional and interpretive guidance to the 

states through the "State Medicaid Manual," policy letters, and 

memoranda (which are sometimes known as "Action Transmittals"). These 

  

z The Secretary's regulation, promulgated before the 1989 
amendment and found at 42 C.F.R. § 440.40(b), generally defines 
EPSDT services, but does not define the services in detail. 
OBRA 89, § 6403, now 42 U.S.C. § 1396d(r), was derived from H.R. 
3299, '§ 4213. Conference Report, H.R. 101-386, 101 Cong. 1st 
Sess., p. 453. The Conference Report stated that the legislation 
"codifies the current regulations on minimum components of EPSDT 
screening and treatment, with minor changes," and provides that 
"screening must include blood testing when appropriate, as well 
as health education." (Emphasis supplied). The legislative 
history furnishes no additional guidance regarding tests or 
methods for screening. 

  

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 8 
  

 



  

¢ & 

materials reflect HCFA policy, and delineate how the states can comply 

with federal Medicaid law, including federal EPSDT requirements. See 

Declaration of William McC. Hiscock (the "Hiscock Declaration") at ¢ 

3, attached hereto as Exhibit "A." The EPSDT statutory provisions and 

the regulations are interpreted by the Secretary in the State Medicaid 

Manual. 

III. 

UNCONTROVERTED FACTS 
  

A. HCFA's Previous Actions Regarding Screening Of Children For 
Elevated Blood Levels 
  

Since the early 1970's, long before Congress amended the EPSDT 

statutory provisions to define EPSDT "screening" as explicitly 

including blood lead level assessments "appropriate for age and risk 

factors," HCFA consistently has advocated state screening of children 

under the EPSDT program for elevated blood lead levels. Hiscock 

Declaration at § 6 and HCFA State Medicaid Manual § 5-70-E (1) 

(June 28, 1972) ("all children between ages of 1-6 should be 

periodically screened for lead poisoning"), attached thereto as 

Exhibit v2.0 

HCFA has a longstanding commitment toward identifying and paying 

for the costs of treating Medicaid-eligible children that are found to 

have elevated blood levels. Hiscock Declaration at q 5.® To further 

  

® This commitment is reflected, for example, in HCFA's 1978 
policy decision to share in the states' costs of investigating 
sources of lead poisoning as a Medicaid "preventive" service. 
Hiscock Declaration at § 5 and HCFA Action Transmittal, 78-59 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =-- 9 
  

 



  

3 . 

that goal, HCFA considers and relies upon the evolving state of 

medical knowledge to form the basis of its EPSDT lead screening 

guidelines. Hiscock Declaration at § 7. HCFA collects this medical 

knowledge from various sources of medical expertise, including, most 

importantly, the CDC's periodic statements on "Preventing Lead 

Poisoning in Children." Hiscock Declaration at q 7.° HCFA also 

considers input from other governmental agencies (such as the Maternal 

and Child Health Bureau of the HHS Public Health Service) and from 

nongovernmental entities, such as the American Academy of Pediatrics 

and other public interest advocacy groups concerned with childhood 

lead poisoning and prevention issues. Hiscock Declaration at q 7. 

HCFA periodically revises its EPSDT screening guidelines to 

reflect the advances. in scientific knowledge of the effects of 

childhood lead poisoning. Hiscock Declaration at q 8. For instance, 

in 1972 the State Medicaid Manual guidelines advised state 

intervention and treatment of children when an EPSDT screen determined 

a child's blood lead level to be greater than 80 micrograms per 

deciliter ("mg/dL") of whole blood. Hiscock Declaration at q 8 and 

Exhibit 2 attached thereto at 16. By 1988, HCFA revised its EPSDT 

guidelines to require intervention when an EPSDT screen determined a 

child's blood lead level to be greater than 30 ug/dL. Hiscock 

  

(July 1, 1978) attached thereto as Exhibit "1." 

The CDC has issued four policy statements with respect to 
preventing childhood lead poisoning. Binder Declaration at q 5. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS’ 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 10 
  

 



¢ eo 

Declaration at ¢ 8. 

In 1985, CDC issued a policy statement with respect to lead level 

testing in children. Binder Declaration at § 5. The 1985 CDC 

Statement set forth the threshold for concern by pediatric health care 

providers at a blood lead level of 25 ug/dL of whole blood. Binder 

Declaration at § 5. The actions suggested by the 1985 CDC Statement 

ranged from periodic retesting to chelation therapy treatments in more 

severe cases of lead poisoning. Binder Declaration at § 5. In 

addition, the 1985 CDC Statement recognized the EP test as the 

screening test of choice for lead poisoning in children. Binder 

Declaration at ¢q 5. 

In 1990, consistent with the then current recommendations of the 

1985 CDC Statement on "Preventing Lead Poisoning in Children," HCFA 

required interventions when an EPSDT screen determined a child's 

elevated blood lead level to be greater than 25 ug/dL. Hiscock 

Declaration at § 8. Thus, in response to increased medical knowledge 

of the effects of elevated blood lead levels, HCFA has continuously 

lowered the blood lead level threshold at which it recommends or 

requires concern and follow-up by Medicaid health care providers. 

Hiscock Declaration at ¢q 8. 

Similarly, HCFA periodically revises its EPSDT screening 

guidelines to reflect available technological improvements in blood 

lead level assessments. Hiscock Declaration at € 9. In 1972, the 

agency did not establish any particular preferred test for EPSDT blood 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 11 
   



o« ol 

lead screening. Hiscock Declaration at § 9 and Exhibit "2" attached 

  

thereto. In 1988, however, HCFA recommended the EP test as the 

primary lead screening test under the EPSDT program. Hiscock 

Declaration at q 9. (Rather than directly measuring lead in the 

blood, the EP test indirectly assesses blood lead by detecting certain 

protein indicators of elevated blood lead levels, i.e. erythrocyte 

protoporphyrin. By contrast, the "blood lead test" directly measures 

bios lead levels. Hiscock Declaration at § 9; Binder Declaration at 

LA ) By April of 1990, HCFA's guidelines required, rather than 

merely recommended, a blood lead test where a child was found to have 

2 stlevatsg EP levels. Hiscock Declaration at § 9. Therefore, HCFA's 

guidelines have not only grown increasingly more stringent in setting 

blood lead level thresholds for concern, but they have also required 

increasingly more sensitive blood testing where medical knowledge 

indicated that such testing was appropriate. Hiscock Declaration at 

q 9. 

B. The 1991 CDC Statement 
  

In or about 1989, the CDC chartered an advisory committee to 

reevaluate a number of issues regarding childhood lead poisoning. 

Binder Declaration at § 6. The work of that advisory committee 

ultimately contributed substantially to the publication of the October 

1991 CDC Statement, "Preventing Lead Poisoning in Young Children: A 

Statement By The Centers For Disease Control" ("1991 CDC Statement"). 

Binder Declaration at § 6 and 1991 CDC Statement attached thereto as 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 
TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 
JUDGMENT AND IN OPPOSITION TO PLAINTIFFS 
MOTION FOR TEMPORARY RESTRAINING ORDER AND 
PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =-- 12 
  

 



  

¢ LJ 

Exhibit "1." The advisory committee members, representative of a wide 

variety of organizations and interests including physicians, state and 

local boards of health, hospitals, organizations dealing with housing 

and environmental issues, and a professional who represented 

laboratory interests, see 1991 CDC Statement, attached as Exhibit "1" 

of Binder Declaration at v, provided written advice and 

recommendations to the CDC regarding childhood lead poisoning 

prevention. Binder Declaration at q 6. Furthermore, the advisory 

committee received expert advice from a group of official consultants, 

who provided input for the advisory committee's written 

recommendations. Binder Declaration at ¢q 6. 

In addition to the written recommendations of the advisory 

committee, CDC eoneidersd comments from medical groups, including the 

American Academy of Pediatrics, representatives of companies who 

produce or use lead, drug manufacturers, and childhood lead poisoning 

prevention interest groups. Binder Declaration at § 7. Furthermore, 

before publishing the 1991 CDC Statement, CDC provided HCFA with draft 

materials for the 1991 CDC Statement, and received comments and 

suggestions from HCFA. Binder Declaration at q 8; Hiscock Declaration 

at 9 10. In addition, the CDC itself engaged in studies of childhood 

lead poisoning, the results of which are reflected in the 1991 CDC 

Statement. Binder Declaration at q 9. 

The 1991 CDC Statement differs from the 1985 CDC Statement in 

that it lowers the threshold for concern by pediatric health care 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 13 
  

 



  

¢ ® 

providers from the blood lead level of 25 ug/dL to 10 upg/dL. 1991 CDC 

Statement at 1; Binder Declaration at ¢ 12. The actions suggested as 

a result of such blood lead level results range from periodic 

retesting to community prevention activities to chelation therapy 

treatments in more severe cases of lead poisoning. 1991 CDC Statement 

at 3; Binder Declaration at q 12. The focus of the 1991 CDC Statement 

is on "primary prevention" -- i.e. preventing exposure to lead before 

children become poisoned. 1991 CDC Statement at 3, 4; Binder 

Declaration at q 12. The 1991 CDC Statement is intended to provide 

guidance and recommendations, rather than mandates, to pediatric 

health care providers, state and local public agencies for dealing 

with childhood lead poisoning. Binder Declaration at q 11. 

While the 1991 CDC Statement recognizes that the screening test 

of choice is now the blood lead test, because the EP test is not 

sensitive enough to identify children with blood lead levels below 25 

ug/dL, the 1991 CDC Statement also acknowledges the need for a 

transition period necessary to allow state health departments, health 

care providers and laboratories to reach adequate capacity for 

performing the blood lead test. 1991 CDC Statement at 41; Binder 

Declaration at q 13. To reach adequate capacity will require the 

acquisition of the necessary laboratory equipment and the hiring and 

training of appropriate personnel. Binder Declaration at q 13. 

During this transition or phase-in period to the use of the blood lead 

test as the primary screening method, the 1991 CDC Statement 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 14 
  

 



  

o ¢ 

recognizes that some programs will continue to use the EP test as a 

screening test. 1991 CDC Statement at 41; Binder Declaration at § 13. 

The 1991 CDC Statement further distinguishes between those 

children to be considered high-risk and low-risk for high-dose 

exposure to lead, and recommends the use of a series of questions 

designed to ascertain the risk level of a child, as well as the type 

and frequency of testing the child should receive. 1991 CDC Statement 

at 42-44; Binder Declaration at q 15. In addition, the 1991 cDC 

Statement recognizes that virtually all children are at risk for lead 

poisoning, and as a result, a phase-in of universal screening using 

the blood lead test for all children is recommended, except in 

communities where large numbers or percentages of children have been 

screened and found not to have lead poisoning. 1991 CDC Statement at 

2; Binder Declaration at § 16. The 1991 CDC Statement recognizes that 

full implementation of universal screening using the blood lead test 

will require the availability of cheaper and easier-to-use methods of 

blood lead measurement. 1991 CDC Statement at 2; Binder Declaration 

at § 16. The 1991 CDC Statement further recognizes that "[c]hildren 

at the highest risk should be given the highest priority for 

screening." 1991 CDC Statement at 39; Binder Declaration at q 16.!° 

  

© The CDC has rechartered a new advisory committee on 
childhood lead poisoning prevention which is scheduled to meet in 
or about Spring of 1993. Binder Declaration at q 17. At that 
time, the new advisory committee will consider whether to amend 
the current 1991 CDC Statement or issue a revised CDC report on 
lead poisoning prevention. Binder Declaration at q 17. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =-- 15 
  

 



  

o ¢ 

C. The September 1992 HCFA Guidelines 
  

HCFA's current EPSDT guidelines, which took effect on 

September 19, 1992, continue the trend of revising HCFA policy to keep 

up with the latest medical knowledge, and to incorporate increasing 

technological advances in blood lead level assessments. Hiscock 

Declaration at § 10. The new guidelines primarily are a response to 

the 1991 CDC Statement. Hiscock Declaration at § 10. CDC officials 

responsible for compiling the 1991 CDC Statement reviewed and 

commented upon drafts of HCFA's new EPSDT lead screening guidelines. 

Hiscock Declaration at q 10; Binder Declaration at 4 17. On 

December 6, 1991, several HCFA agency officials met with a CDC 

official who was one of the principal authors of the 1991 CDC 

Statement, Dr. Sue Binder, to discuss CDC's views on HCFA's draft 

EPSDT lead screening guidelines. Hiscock Declaration at q 10; Binder 

Declaration at q 17. In response to CDC's comments, HCFA made various 

revisions to the draft guidelines, and then circulated the revised 

drafts to various other governmental and private entities for comment. 

Hiscock Declaration at § 10. CDC expressed its view that the proposed 

HCFA guidelines were consistent with the 1991 CDC Statement. Hiscock 

Declaration at q 10; Binder Declaration at q 19. 

Other entities that reviewed and commented on drafts of HCFA's 

guidelines include the American Academy of Pediatrics; the Maternal 

and Child Health Bureau, Health Resources and Services Administration 

of the HHS Public Health Service; and an organization of the State 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 
TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 
JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 
MOTION FOR TEMPORARY RESTRAINING ORDER AND 
PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =-- 16 
  

 



o« ¢ 

Medicaid Directors' Association known as the Medicaid Maternal and 

Child Health Technical Advisory Group. Hiscock Declaration at § 11. 

Thus, in revising its EPSDT lead screening guidelines, HCFA received 

and considered input from an array of public and private organizations 

concerned with childhood lead poisoning. Hiscock Declaration at q 11. 

HCFA considered several factors in formulating its current EPSDT 

lead screening guidelines. Hiscock Declaration at § 12. HCFA noted 

that the 1991 CDC Statement recommends that health care providers 

should first verbally assess a child's risk of having elevated blood 

lead levels by asking a series of questions to determine the 

likelihood of a child's exposure to lead sources. Hiscock Declaration 

at € 12; Binder Declaration at § 15. The HCFA guidelines also require 

such an assessment. HCFA State Medicaid Manual, attached to 

Declaration of Michael M. Daniel in Support of Motion for TRO Against 

the USA ("HCFA guidelines") at § 5123.2(a). Depending upon the 

answers to questions in this "verbal ARsasaliont children are 

considered to be either at "high risk" or "low risk" of being lead 

poisoned. Hiscock Declaration at q 12.Y" 

In revising its EPSDT lead screening guidelines on lead testing 

for children, HCFA also took note that the 1991 CDC Statement 

recommended lowering the blood lead level threshold for which concern 

  

'I' Although the 1991 CDC Statement indicates that all 
children are at risk for lead poisoning, CDC and HCFA have both 
recognized that the highest priority should be reserved for those 
children with the highest blood lead levels. 1991 CDC Statement 
at 39; Hiscock Declaration at q 12; Binder Declaration at q 16. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS! 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =-- 17 
   



  

ol oo 

and follow-up is recommended from 25 ug/dL of whole blood to 10 ug/dL, 

1991 CDC statement at 1; Hiscock Declaration at ¢ 13, and acknowledged 

that the 1991 CDC Statement recommends screening through the use of a 

blood lead test rather than the EP test to assess blood lead levels 

lower than 25 ug/dL. 1991 CDC Statement at 2; Hiscock Declaration at 

q 13; Binder Declaration at § 13. However, HCFA also took into 

account CDC's recognition of the need for a "transition" period to 

move away from EP testing and move toward blood lead testing. Hiscock 

Declaration at q 13; see Binder Declaration at q 13. 

HCFA's revised guidelines incorporate CDC's methodology of using 

verbal assessments to determine "risk categories" of a child's 

likelihood of being exposed to dangerous levels of lead. HCFA 

guidelines at § 5123.2(a); Hiscock Declaration at § 14. Consistent 

with the 1991 CDC Statement, HCFA's guidelines bifurcate children into 

"high risk" and "low risk" categories for likelihood of lead exposure 

based upon the answers elicited in the verbal assessment. HCFA 

guidelines at § 5123.2(a), (b); Hiscock Declaration at q 14; see 

Binder Declaration at q 15. HCFA's guidelines mandate the most 

sensitive blood lead testing process for children determined to be at 

"high risk" of having elevated blood lead levels. HCFA guidelines at 

§ 5123.2(c); Hiscock Declaration at q 14. This requirement is 

consistent with the 1991 CDC Statement which recommends that the 

highest priority be reserved for those children with the highest blood 

lead levels. 1991 CDC Statement at 39; Hiscock Declaration at q 14; 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 18 
  

 



  

¢ eo 

see Binder Declaration at q 16. As a practical matter, HCFA believes 

that the majority of EPSDT-eligible children will be deemed to be at 

"high risk" for elevated blood lead levels due to the socioeconomic 

conditions that often circumscribe where Medicaid recipients reside. 

Hiscock Declaration at § 14 and Exhibit "3" attached thereto. 

In addition, while HCFA's revised EPSDT guidelines stress that 

blood lead testing is the preferred method for assessing blood lead 

levels of children deemed to be at "low risk," the guidelines give 

states the option of using either the blood lead test or the EP test 

as the initial screen for "low risk" children during the transition 

period. HCFA guidelines at Preamble; Hiscock Declaration at q 15 and 

Exhibit "3" attached thereto. HCFA made this pragmatic policy choice 

after considering coments from CDC and various organizations that 

indicated that many localities simply do not currently have the 

technology and/or the capacity available to universally conduct blood 

lead testing for all Medicaid-eligible children, both "high risk" and 

"low risk." Hiscock Declaration at q 15. 

Both the 1991 CDC Statement and HCFA's guidelines recognize the 

problems many communities face in moving away from EP testing and 

toward blood lead testing. 1991 CDC Statement at 2, 41; HCFA 

guidelines at Preamble; Hiscock Declaration at { 15 and Exhibit "3" 

attached thereto; Binder Declaration at q 13. However, the federal 

government (through HCFA), has encouraged the most widespread use of 

the blood lead test and will share in the costs of screening "low 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 19 
  

 



  

o« o 

risk" children through the use of the blood lead test, if, as HCFA 

recommends, states use this test. See HCFA guidelines at § 5123.2(c); 

Hiscock Declaration at § 15 and Exhibit "3" attached thereto. 

Even for this limited group of "low risk" children, states must 

use the blood lead test in instances of elevated EP test results. 

HCFA guidelines at § 5123.2(b); Hiscock Declaration at § 16. Where 

subsequent verbal risk assessments suggest increased lead exposure for 

children previously deemed "low risk," however, a blood lead test must 

be performed. HCFA guidelines at § 5123.2(b); Hiscock Declaration at 

q.16 17 

Since EPSDT-eligible children must be "periodically" screened for 

medical problems in accordance with a prescribed "periodicity 

schedule" set by each state, each and every EPSDT child should be 

evaluated for their risk of lead exposure at each periodic screening, 

and accordingly receive the test appropriate for their particular risk 

category. Hiscock Declaration at q 17. 

HCFA will continue to revise and update its guidelines in 

response to future guidance from the CDC and other organizations, and 

  

2 In the situation where a "low risk" child continuously 
resides in an area which a state or local health official 
declares lead-free, HCFA's guidelines require only verbal risk 
assessments of the child's likelihood of lead exposure, rather 
than a blood lead test or an EP test. HCFA guidelines at § 
5123.2 (a); Hiscock Declaration at q 17. Similar to other "low 
risk" children, however, if the verbal assessment indicates 
increased likelihood of lead exposure for this group of children, 
then states must use either a blood lead test or the EP test to 
determine blood lead levels. HCFA guidelines at § 5123.2{(b); 
Hiscock Declaration at q 17. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS’ 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 20 
  

 



o J 

  

as the technology necessary to perform the blood lead test becomes 

more universally available. Hiscock Declaration at q 19. 

Iv. 

ARGUMENT AND AUTHORITIES 
  

A. The Named Plaintiffs' Claims Should Be Dismissed Because They 
Have Not Suffered Any Injury And Thus Lack Standing To Sue 
  

i. Principles of Standing 
  

Article III of the Constitution confines the federal courts to 

adjudicating actual "cases" or "controversies" as a means of properly 

separating functions among the three branches of federal government. 

Asarco v. Kadish, 490 U.S. 605, 613 (1989); Allen v. Wright, 468 U.S. 
  

  

737, 750 (1984); Valley Forge Christian College v. Americans United 
  

for Separation of Church and State, Inc., 454 U.S. 464, 471 (1982); 
  

Flast v. cohen, 392 U.S. 83, .94 (1967). See U.S. Const. art. III, §   

2. The doctrines that surround the "case and controversy" requirement 

therefore rest on the principles that govern an independent judiciary 

in our democratic government. Allen, 468 U.S. at 750; Valley Forge, 
  

454 U.S. at 471-72; Warth v. Seldin, 422 U.S. 490, 498 (1975). 
  

Considering such principles, the Supreme Court in Allen stated 

that "(t)he Art. III doctrine that requires a litigant to have 

‘standing' to invoke the power of a federal court is perhaps the most 

important of these doctrines." Allen, 468 U.S. at 750. And in fact, 

"the standing inquiry requires careful judicial examination of a 

complaint's allegations to ascertain whether the particular plaintiff 

is entitled to an adjudication of the particular claims asserted." 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 21 
  

 



  

Id. at 752. 

To determine whether a particular plaintiff has standing to bring 

an action, federal courts look to both the constitutional and 

prudential limitations of the standing doctrine. See Allen, 468 U.S. 
  

at 751; Valley Forge, 454 U.S. at 471. In order to have standing   

under Article III of the Constitution, a plaintiff must satisfy a 

three-prong test by alleging (1) an injury that is (2) fairly 

traceable to the defendant's allegedly unlawful conduct, and (3) 

likely to be redressed by the requested relief. Allen, 468 U.S. at 

751; Valley Forge, 464 U.S. at 475. The Supreme Court has recently   

explained this requirement in Lujan v. Defenders of Wildlife: 
  

First, the plaintiff must have suffered an "injury 
in fact" -- an invasion of a legally-protected 
interest which is (a) concrete and particularized 
and (b) "actual or imminent, not 'conjectural' or 
'hypothetical.'" Second, there must be a causal 
connection between the injury and the conduct 
complained of -- the injury has to be "fairly 
. trace[able] to the challenged action of the 
defendant, and not . . th[e] result [of] the 
independent action of some third party not before 
the court." Third, it must be "likely," as 
opposed to merely "speculative," that the injury 
will be "redressed by a favorable decision." 

U.S. ¢ 112.8. Ct. 2130, 2136 (1992) (citations omitted). 

The injury must be one that is distinct and palpable. Gladstone, 
  

Realtors v., Village of Bellwood, 441 U.S. 91, 100 (1979); Warth v. 
  

  

Seldin, 422 U.S. at 501. See also Allen, 468 U.S. at 752; Schlesinger 
  

  

V. Reservists Comm. To Stop The War, 418 U.S. 208, 218 (1973). 
  

The party who invokes federal jurisdiction bears the burden of 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 22 
  

 



  

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establishing these elements. Lujan, 112 S. Ct. at 2136. Since these 

elements are an indispensable part of plaintiff's case, "each element 

must be supported in the same way as any other matter on which the 

plaintiff bears the burden of proof" with particularized allegations 

of fact. 1Id.; Warth, 422 U.S. at 501-02. If, after an opportunity to 

provide such particularized allegations of fact, "standing does not 

adequately appear from all materials of record, the complaint must be 
  

dismissed." Warth, 422 U.S. at 501-02 (emphasis added). "A federal   

court is powerless to create its own jurisdiction by embellishing 

otherwise deficient allegations of standing." Whitmore v. Arkansas, 
  

495 U.S. 149, 155-56 (1990). 

As explained in detail below, plaintiffs do not meet the 

requirements of standing to sue on their own behalf (or on behalf of 

the class which they purport to represent). The injury of which they 

complain does not stem from HCFA's issuance of the challenged 

guidelines and cannot be redressed by rescission of these guidelines 

or any other relief plaintiffs request from defendant USA. 

Accordingly, the Court should therefore dismiss plaintiffs' Complaint 

for lack of jurisdiction. 

2. Plaintiffs Have Suffered No Injury As A Result of The New 
HCFA Guidelines 
  

The four named plaintiffs allege that they live near a battery 

crushing and lead product fabrication plant located in West Dallas. 

Complaint at q 24. Under the challenged HCFA guidelines, all 

Medicaid-eligible children should be given a verbal assessment to 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 23 
  

 



4 dg 

determine whether they are at "high risk" or "low risk" for exposure 

to dangerous lead levels. Plaintiffs! response to at least one of the 

verbal assessment questions listed in the new HCFA guidelines -- "Does 

your child live near a lead smelter, battery recycling plant, or other 

industry likely to release lead . . . .?" -- should clearly be in the 

affirmative. See HCFA guidelines at § 5123.2(a). Under the new HCFA 

guidelines, "[i]f the answer to any question is positive, a child is 

considered high risk for high doses of lead exposure." HCFA   

guidelines at § 5123.2(b) (emphasis in original). As a result, all 

four plaintiffs would be considered at "high risk" of having elevated 

blood levels. Since the HCFA guidelines require that the most 

sensitive blood lead test be administered for those children 

determined to be at "high risk," plaintiffs should receive the blood 

lead test they desire. See HCFA guidelines at 5-15; Hiscock 

Declaration at q 14. These plaintiffs therefore will not be injured 

by the application of the new HCFA guidelines. In fact, plaintiffs 

will only benefit from their application. Not only is there no 

"concrete and particularized" injury that these plaintiffs would 

suffer as a result of the application of the new HCFA guidelines, 

there is not even a threat of a "conjectural or hypothetical" injury 

from those guidelines. 

In addition, the requested injunctive relief would not redress 

any alleged harm to plaintiffs. In order to establish redressability, 

plaintiffs must show that "relief from the [alleged] injury [is] 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 
TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 
JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 
MOTION FOR TEMPORARY RESTRAINING ORDER AND 
PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 24 
   



  

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'likely' to follow from a favorable decision." Allen v. Wright, 468 
  

U.S. at 751. Or, in the recent phraseology of the Supreme Court, 

plaintiffs must show some "potential gain" from the relief requested. 

Public Citizen v. United States Dep't of Justice, 491 U.S. 440, 451   

(1989). Plaintiffs seek to enjoin defendant USA, both preliminarily 

and permanently from supporting, allowing or financing the states' use 

of the EP test as a screening test for lead poisoning, and to require 

the federal defendant to mandate that states use the blood lead test 

as the sole screening device for lead poisoning. They also seek to 

enjoin HCFA's September 19, 1992 guidelines, and to require that HCFA 

issue guidelines requiring that states retest all Medicaid-eligible 

children previously tested with the EP test with the blood lead test. 

Complaint at q 73. Yet the four named plaintiffs will fare no better 

as a result of the granting of this extraordinary relief. The injury 

of which they complain -- i.e., the State of Texas' alleged failure to 

perform a blood lead test and appropriate lead poisoning intervention 

—= cannot be redressed by enjoining the challenged September 1992 HCFA 

guidelines. To the contrary, those guidelines require a blood lead 

test and appropriate intervention in the circumstances alleged by 

plaintiffs, and granting the relief sought by plaintiffs from 

defendant USA would offer them no additional relief. 

Furthermore, requiring HCFA to issue guidelines that require the 

states' use of only the blood lead test would, in all likelihood, have 

little or no practical effect. The HCFA guidelines take into account 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 
TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 
JUDGMENT AND IN OPPOSITION TO PLAINTIFFS’ 
MOTION FOR TEMPORARY RESTRAINING ORDER AND 
PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =-- 25 
  

 



  

oo 4 

the requisite "transition" period needed for all states to move away 

from EP testing and move toward universal blood lead testing for all 

Medicaid-eligible children, while mandating that children at "high 

risk" receive the blood lead test now. See HCFA guidelines at § 

5123.2 (c); Hiscock Declaration at ¢ 13. 

The states cannot immediately develop full capacity for blood 

lead testing. Indeed, the relief plaintiffs seek may actually harm 

them. In drafting its new EPSDT lead screening guidelines, HCFA 

carefully considered the fact that many states and localities 

currently do not have the technology and/or the capacity available to 

conduct universal blood lead testing. See Hiscock Declaration at 

qf 15. As a result, during the transition period to eventual universal 

blood lead testing of all Medicaid-eligible children, HCFA has made a 

conscious and pragmatic policy choice to allow states to continue use 

of the EP test in limited circumstances. See Hiscock Declaration at 

1 19 and Exhibit "3" attached thereto. While states are currently 

undergoing the necessary transition to eventual universal blood lead 

testing, HCFA has reserved the highest priority of testing using the 

blood lead test for those children, like plaintiffs, who are assessed 

as "high risk." See HCFA guidelines at § 5123.2(c); Hiscock 

Declaration at q 14." Given the states' current capacity 

  

3 plaintiffs, who should clearly receive the blood lead 
test pursuant to the new HCFA guidelines, cannot claim to have 
suffered the same injury as those "low risk" children for whom 
the guidelines do not mandate use of that test. Once the Court 
concludes that the proposed class representatives lack individual 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS’ 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 26 
  

 



  

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limitations, requiring blood lead testing of all Medicaid-eligible 

children, without assigning priority according to whether the child is 

at "high risk" or "low risk," may result in significant delays in 

blood lead testing (and necessary intervention) for "high risk" 

children such as plaintiffs.! 

B. Plaintiffs' Complaint As To Defendant USA Should Be Dismissed For 
Failure To State Claim Upon Which Relief May Be Granted Or 
Alternatively, Summary Judgment Should Be Granted In Favor Of 
Defendant USA 
  

Even if the Court finds that plaintiffs possess the requisite 

standing to bring this suit, plaintiffs have nevertheless failed to 

state a claim upon which relief may be granted, and their Complaint 

should be dismissed pursuant to Federal Rule of Civil Procedure 

  

standing, "the proper procedure . . . is to dismiss the 
complaint, not to deny the class for inadequate representation or 
to allow other class representatives to step forward." Brown Vv. 

  

Sibley, 650 F.2d 760, 771 (5th Cir. 1981). Because standing is a 
jurisdictional prerequisite, dismissal on standing grounds is to 
take place before class certification issues are ever reached. 
Id. As a result, plaintiffs' Complaint should be dismissed. 

4 Finally, plaintiffs lack standing to seek an order which 
would require HCFA to issue guidelines requiring that states 
retest all Medicaid-eligible children previously tested with the 
EP test with the blood lead level test. See Complaint at q 73. 
Since EPSDT-eligible children must be periodically screened for 
medical problems in accordance with a prescribed "periodicity 
schedule" set by each state, each EPSDT child -- even those 
previously tested with the EP test -- should be evaluated for 
their risk of lead exposure under the new HCFA guidelines. 
Hiscock Declaration at § 17. As a result, many Medicaid-eligible 
children, including these plaintiffs, who previously received an 
EP test under the old HCFA guidelines should now receive the 
blood lead test in any event. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =-- 27 
  

 



  

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12(b) (6). Alternatively, because there is no genuine issue as to any 

material fact, summary judgment should be granted in favor of 

defendant USA in accordance with Federal Rule of Civil Procedure 56. 

3. The HCFA Guidelines Are Consistent With The Medicaid Statute 
  

The Supreme Court has "long recognized that considerable weight 

should be accorded to an executive department's construction of a 

statutory scheme it is entrusted to administer . . . ." Chevron, 
  

U.S.A., Inc. v. Natural Resources Defense Council, Inc.,, 467 uU.s. 837, 
  

844 (1984) (citations omitted). See also Chemical Mfrs. Ass'n v. 
  

Natural Resources Defense Council, Inc., 470 U.S. 116, 125 (1985) (a   

statutory interpretation by an agency charged with applying the 

statute is entitled to "considerable deference."). "To sustain the 

[agency's] application of [a] statutory term, we need not find that 

its construction is the only reasonable one, or even that it is the 

  

> Federal Rule of Civil Procedure 12(b) (6) allows courts 
discretion as to whether to consider "matters outside the 
pleading" such as affidavits, and courts may or may not elect to 
convert a Rule 12(b) (6) motion into a motion for summary judgment 
pursuant to Rule 56. See Isquith v. Middle South Utilities, 
ing., 847 F.24 186, 193 -n.3 (5th Cir. 1938) (citing 5 C. Wright & 
A. Miller, Federal Practice and Procedure § 1366 (1969)). As a 
result, the Court has the discretion to exclude the Hiscock and 
Binder declarations accompanying defendant USA's 12(b) (6) motion 
and simply dismiss the action based on the Complaint and the 
attachments thereto. Even if the Court, in its discretion, 
chooses to consider the Hiscock and Binder declarations in 
deciding the legal issues before it, thereby converting defendant 
USA's motion to dismiss into a motion for summary judgment 
pursuant to Federal Rule of Civil Procedure 56, summary judgment 
should be granted in defendant's favor as there are no genuine 
issues of material fact, and defendant USA is entitled to 
judgment as a matter of law. 

  

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS’ 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 28 
  

 



_¢ & 

result we would have reached had the question arisen in the first 

instance in judicial proceedings." Udall Vv. Tallman, 380 U.S. 1, 16 
  

(1965) (citations omitted); accord Chevron, 467 U.S. at 844-45; Ford 
  

Motor Credit Co. v. Milhollin, 444 U.S. 555, 566 (1980); United States   

  

v. Rutherford, 442 U.S. 544, 553-54 (1979).   

Moreover, the Secretary of HHS need not prove that the method 

chosen is the only, or even the best, means to accomplish the 

regulatory objective, only that "the agency decision was rational and 

based on consideration of the relevant factors." Ethyl Corp. Vv. 
  

E.P.A., 541 F.2d 1, 36 (D.C. Cir.), cert. denied, 426 U.S. 941 (1976) 
  

(citations omitted). 

Contrary to plaintiffs' allegation, the new HCFA guidelines do 

not contravene the statutory requirement of the Medicaid statute, 42 

U.S.C. § 1396d(r), for lead testing. Section 1396d(r) defines lead 

screening as consisting of " (iv) laboratory tests (including lead 
  

blood level assessment appropriate for age and risk factors) ." 
  

(Emphasis added). On its face, § 1396d(r) does not require "blood 

lead tests" as plaintiffs contend and plaintiffs offer nothing to 

indicate that Congress intended the phrase "lead blood level 

assessment" to have the narrow, technical meaning plaintiffs ascribe 

to it. See Complaint at q 70. In fact, the Conference Report to OBRA 

89, § 6403, now 42 U.S.C. § 1396d(r), stated that the legislation 

"codifies the current regulations on minimum components of EPSDT 

screening and treatment, with minor changes," and provides that 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 29    



  

_¢ & 

"screening must include blood testing when appropriate, as well as 
  

health education." Conference Report, H.R. 101-386, 101 Cong. 1st 

Sess., p. 453 (emphasis supplied). The legislative history furnishes 

no additional guidance regarding types of blood tests or other methods 

for screening.!® As plaintiffs correctly point out, the Secretary of 

HHS, the CDC and HCFA have all consistently recognized that the blood 

lead test is the preferred mode for blood lead level assessments of 

children. See Complaint at qq 63, 64 and 68; HHS' "Strategic Plan for 

the Elimination of Childhood Lead Poisoning" (February 1991) at 23; 

Binder Declaration at q 13 and Exhibit "1" attached thereto; Hiscock 

Declaration at § 15; HCFA guidelines at Preamble. The blood lead test 

is not the only test for assessing blood lead levels, however. 

Moreover, Congress clearly stated that "age and risk factors" 

should be taken into account in determining the blood lead level 

assessment "appropriate" for each Medicaid-eligible child. HCFA's 

approach under the new EPSDT lead screening guidelines takes into 

account the "appropriate for age and risk factors" aspect of § 

1396d(r). HCFA has followed the recommendations of the 1991 CDC 

Statement and has established a framework within which a verbal 

assessment is first given to determine what type of blood lead level 

  

® It should also be noted that at the time Congress 
considered and passed OBRA 89, CDC recommended the EP test as the 
test of choice. Moreover, it would be anomalous, given the basic 
structure and operation of the Medicaid program, which gives 
states latitude in determining the services to be provided, for 
Congress to tell states not only that children's lead levels must 
be assessed, but also to mandate a particular test. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 30 
  

 



  

& ® 

assessment is most appropriate in light of such factors as age and 

risk for exposure to lead. See Hiscock Declaration at q 14; Binder 

Declaration at q 15. Therefore, the challenged HCFA guidelines do not 

contravene the Medicaid Act. 

2. The HCFA Guidelines Give States The Option Of Using The EP 
Test For "Low Risk" Children Only 
  

Plaintiffs contend that the HCFA guidelines, which became 

effective on September 19, 1992, continue to sanction the use of the 

EP test as the primary screening test for lead poisoning in young 

children throughout the country. Complaint at § 62. In drawing this 

erroneous conclusion, plaintiffs ignore the plain language of the new 

HCFA guidelines as well as their context. As explained in the Hiscock 

Declaration, under the guidelines, the first step for an EPSDT 

provider is to conduct a verbal assessment for each Medicaid-eligible 

child in order to determine "risk categories" (i.e., a child's 

likelihood of being exposed to dangerous levels of lead). Hiscock 

Declaration at q 14. If even one of the questions enumerated in the 

guidelines is answered in the affirmative, that child is automatically 

considered to be "high risk." See HCFA guidelines at § 5123.2 (b). 

HCFA's guidelines require the blood lead test for children determined 

to be at "high risk" of having elevated blood lead levels. HCFA 

guidelines at § 5123.2(c); Hiscock Declaration at q 14. If all verbal 

assessment questions are answered in the negative, that child is 

considered to be "low risk," and the EPSDT provider is then given the 

option to administer the blood lead test or the EP test. HCFA 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 31 
  

 



  

OC o 

guidelines at Preamble; Hiscock Declaration at ff 15. As a result, 

states continue to have the option to use the EP test as the initial 

blood lead level screening test only in those instances where, after a 

verbal assessment, the EPSDT provider deems the child to be "low 

risk," and further determines to administer the EP test rather than 

the blood lead level test. See HCFA guidelines at Preamble; Hiscock 

Declaration at q 15." 

3. The HCFA Guidelines Are Consistent With The 1991 CDC 
Statement 
  

Contrary to plaintiffs' contention, the new HCFA guidelines are 

consistent with the 1991 CDC Statement. While the 1991 CDC Statement 

recognizes that the lead screening test of choice is now the blood 

lead test because the EP test is not sensitive enough to identify 

children with blood lead levels below 25 ug/dL, see Complaint at q 68, 

plaintiffs conveniently fail to mention the portion of the 1991 CDC 

Statement which acknowledges the need for a transition period until 

the recommendations of the 1991 CDC Statement can be implemented 

fully. 1991 CDC Statement at 41; Binder Declaration at q 13 and 

Exhibit "1" attached thereto. The 1991 CDC Statement recognizes that 

this transition period is necessary to allow state health departments, 

  

7 The federal government will nevertheless share in the 
states' costs of screening "low risk" children through the use of 
the blood lead test, and has encouraged states to use the more 
sensitive test in all cases, as well as to increase their blood 
lead testing capacities so that they will eventually be able to 
perform universal blood lead testing for all Medicaid-eligible 
children. See Hiscock Declaration at § 19 and HCFA letter to 
State Medicaid Directors attached as Exhibit "3" thereto. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =-- 32 
  

 



  

OC 6 

health care providers and laboratories to reach adequate capacity for 

performing the blood lead level test, which will require the 

acquisition of the necessary laboratory equipment and the hiring and 

training of appropriate personnel. 1991 CDC Statement at 41; Binder 

Declaration at ¢ 13. 

The 1991 CDC Statement itself recognizes that during this 

transition or phase-in period which should culminate in the eventual 

use of the blood lead test as the primary screening method, some 

programs will continue to use the EP test as a screening test. 1991 

CDC Statement at 41; Binder Declaration at q 13. Recognizing the need 

for this transition period, and completely consistent with the 1991 

CDC Statement, HCFA has given states the option to use the EP test in 

certain circumstances (i.e., for "low risk" children only) under the 

new HCFA guidelines. See HCFA guidelines at Preamble. The basic 

premise of plaintiffs' Complaint -- that the HCFA guidelines ignore or 

are inconsistent with the 1991 CDC Statement -- is simply wrong.' 

Indeed, the HCFA guidelines were developed in consultation with the 

CDC and the CDC itself has stated that the guidelines are consistent 
  

with the 1991 CDC Statement. ee Binder Declaration at q 19.7 

  

® In any event, plaintiffs could not present a claim for 
relief based on the allegations (even if true) that the HCFA 
guidelines are inconsistent with the 1991 CDC Statement. That 
statement is not binding on HCFA, or for that matter, or anyone. 
It is merely a recommendation. See Binder Declaration at ¢ 11. 

' In addition, the HCFA guidelines are fully consistent 
with HHS' "Strategic Plan for the Elimination of Childhood Lead 
Poisoning" issued in February 1991. Both recognize that the EP 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =-- 33 
  

 



OC &« 

C. Plaintiffs Have Failed To Satisfy The Requirements For Temporary 
Injunctive Relief 

  

  

For the same reasons that plaintiffs lack standing and have 

failed to state a claim for which relief can be granted, and for 

additional reasons as well, plaintiffs are not entitled to temporary 

injunctive relief. Plaintiffs' request for injunctive relief should 

therefore be denied. 

1. Standards for Injunctive Relief 

As the Fifth Circuit has recognized, preliminary injunctive 

relief is an extraordinary and drastic remedy, and should be granted 

only when the movant, by a clear showing, carries the burden of 

  

persuasion. Allied Marketing Group, Inc. v. CDL Marketing, Inc., 878 

F.2d 806, 809 (5th Cir. 1929); White v. Carlucci, 862 F.24 1209, 1211 
  

(5th Cir. 1989); Holland America Ins. Co. Vv. Succession of Roy, 777 
  

F.24:992, 997 (5th Cir. 1985); Enterprise Int'l. Inc. v. Corporacion 
  

Estatal Petrolera Ecuatoriana, 762 F.2d 464, 472 (5th Cir. 1985).   

Accordingly, "[t]he decision to grant a preliminary injunction is the 

exception rather than the rule." Mississippi Power & Light Co. 
  

v. United Gas Pipe Line Co., 760 F.2d 618, 621 (5th Cir. 1985). In 
  

order to obtain the extraordinary remedy of temporary injunctive 

relief, the movant must "by a clear showing, carr([y] the burden of 

persuasion," White, 862 F.2d at 1211, as to four elements. The movant 

  

test is not a useful screening test for blood lead levels below 
25 pug/dL, and that blood lead testing is the preferred method for 
lead screening of all Medicaid-eligible children. See HHS report 
at 23, 40; HCFA guidelines at Preamble. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 34 
  

 



& &® 

must demonstrate 

(1) a substantial likelihood of success on the 
merits exists; 

(2) a substantial threat of irreparable injury 
exists if the preliminary relief is not granted; 

(3) that the threatened injury to the movant 
outweighs any damage preliminary relief might 
cause to the opponent; and 

(4) that the relief sought will not disserve the 
public interest. 

DFW Metro Line Servs. v. Southwestern Bell Telephone Co., 901 F.2d 
  

1267, 1269 (5th Cir.), cert. denied, U.s. , 111 8, CL. E519 
  

(1990); Allied Marketing, 878 F.2d at 809; Enterprise Int'l, 762 F.2d 
  

  

at 471; Canal Authority of the State of Florida v. Callaway, 489 F.2d 
  

567, 572-73 (5th Cir: 1974). "'[T]lhe movant has a heavy burden of 

persuading the district court that all four elements are satisfied, '" 

and "if the movant does not succeed in carrying its burden on any one 

of the four prerequisites," preliminary relief may not be granted. 

Enterprise Int'l, 762 F.2d at 472 (citations omitted). Accord 
  

Anderson v. Douglas & lomason Co., 835 F.2d 123, 133 (5th Cir. 1988). 
  

Plaintiffs are unable to satisfy any of the prerequisites for 

preliminary injunctive relief in this case. As a result, plaintiffs’ 

Motion should be denied. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =-- 35 
   



¢ o 

2. Plaintiffs Do Not Have A Substantial Likelihood Of Success 
On The Merits Of Their Claims Against Defendant USA 
  

As defendant USA has previously demonstrated, plaintiffs are 

unlikely to succeed on the merits of their claims against defendant 

USA for several reasons. First, plaintiffs lack the requisite 

standing to maintain those claims since they are unable to demonstrate 

any concrete injury fairly traceable to the challenged HCFA 

guidelines. Furthermore, the injunctive relief plaintiffs have 

requested against defendant USA would not redress any alleged harm 

plaintiffs may have suffered in any event. Second, plaintiffs' claims 

that the new HCFA guidelines are contrary to the provisions of the 

Medicaid statute and the 1991 CDC Statement are without merit. As 

defendant USA has previously demonstrated, the new HCFA guidelines are 

consistent with the provision of 42 U.S.C. § 1396d(r) which calls for 

"lead blood level assessments appropriate for age and risk factors." 

Moreover, CDC itself has recognized that the HCFA guidelines are 

consistent with its 1991 CDC Statement. 

3. There Is No Substantial Threat Of Irreparable Injury If The 
Temporary Relief Plaintiffs Seek From Defendant USA Is Not 
Granted 
  

For the same reasons plaintiffs lack the requisite injury to 

confer standing to sue the federal defendant, they cannot show a 

substantial threat of irreparable injury if the new HCFA guidelines 

remain in effect. In fact, rather than suffering any injury as a 

result of the new HCFA guidelines, plaintiffs, who, under the new 

EPSDT lead screening guidelines, are considered at "high risk" for 

lead poisoning, will only benefit from the verbal assessment and 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 36 
   



  

¢ w 

testing framework of the HCFA guidelines. 

Furthermore, as the Fifth Circuit has noted, "[s]peculative 

injury is not sufficient; there must be more than an unfounded fear on 

the part of the applicant." Holland America Ins. Co., 777 F.2d at 
  

997. Plaintiffs' alleged fear that as they "continue in the EPSDT 

screening system they may never receive the appropriate blood lead 

test," Motion at 6, is mere speculation on their part. The new HCFA 

guidelines specifically require that these four plaintiffs receive 

blood lead tests. Thus, if plaintiffs fail to receive these tests, it 

is despite HCFA's new guidelines, not because of them.” Plaintiffs 

have therefore failed to demonstrate a substantial threat of 

irreparable injury if their requested injunctive relief as to 

defendant USA is not granted. 

4. The Threatened Injury To Plaintiffs Does Not Outweigh Any 
Damage Preliminary Relief Might Cause To Defendant USA And 
The Public 
  

While plaintiffs would suffer no injury if their request for 

injunctive relief from the defendant USA is denied, and in fact, would 

only benefit from the application of the new HCFA guidelines, 

defendant USA and the individual states would be damaged by the relief 

plaintiffs seek. HCFA to issue guidelines which mandate the use of 

the blood lead test exclusively would not, as discussed earlier, 

ensure more accurate lead level assessments. The states could not 

  

2 Any continued failure or refusal by the State of Texas to 
administer the blood lead test as to these named plaintiffs would 
contravene the HCFA guidelines. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 37 
  

 



  

¢ J 

follow such guidelines given the absence of the technology and/or 

capacity of states presently to perform universal blood lead tests for 

all Medicaid-eligible children. The carefully considered HCFA 

guidelines take into account the requisite transition period needed 

for all states to reached full capacity to perform universal blood 

lead tests on all Medicaid-eligible children. Given the current 

limited capacity of states to perform the more sensitive blood lead 

test, to enjoin the new HCFA guidelines, even temporarily, would 

likely result in "low risk" children receiving no lead testing at all 

(while states abandon the EP test but are still unable to provide the 

blood lead test),? or in delaying the use of the more sensitive blood 

lead test for "high risk" children (while states attempt to use their 

limited blood lead testing capacities for all Medicaid-eligible 

children, regardless of whether they are "high risk" or "low risk"). 

Indeed, plaintiffs themselves might be forced to endure additional 

delays in obtaining the blood lead test in Texas which they (as "high 

risk" children) should now clearly be entitled to receive under the 

new HCFA guidelines. 

As plaintiffs correctly recognize in their Motion, ending 

childhood lead poisoning is a national policy of the highest priority 

  

21. Although HCFA recognizes that the EP does not detect 
blood lead levels of less than 25 ug/dL, it nonetheless does 
detect higher blood lead levels and is useful for identifying 
those children who, despite a "low risk" verbal assessment 
nevertheless show a very elevated blood lead level and therefore 
require further screening and intervention. 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 38 
  

 



¢ eo 

for defendant USA. See Motion at 7. HCFA clearly is committed to 

  

this goal and the agency's commitment to the diagnosis and treatment 

of lead poisoning among Medicaid-eligible children is most aptly 

reflected in the new HCFA guidelines. The new guidelines represent a 

rational and pragmatic balance between the current lack of technology 

and/or capacity of states to conduct universal blood lead tests, and 

the recognition that, while blood lead tests of all such children is 

desirable, the highest priority for testing should continue to be 

those children with the highest risk of lead poisoning. The HCFA 

guidelines support and further the CDC's own recommendations in the 

1991 CDC Statement. Plaintiffs' request that HCFA require states to 

begin universal blood lead testing immediately is not only an 

impractical and ahrealiscic solution, but a true disservice to the 

public interest in effectuating a smooth transition to eventual 

universal blood lead testing for all Medicaid-eligible children 

nationwide. 

5. Plaintiffs' Motion Should Also Be Denied Because It 
Improperly Seeks To Alter The Status Quo 
  

In addition to plaintiffs' inability to satisfy the prerequisites 

for preliminary injunctive relief as demonstrated above, because the 

requested injunction would alter the status quo by forcing HCFA to 
  

rescind it current EPSDT lead screening guidelines and issue revised 

guidelines requiring states to administer the blood lead test, see 

Motion at 5, plaintiffs bear an even heavier burden. The purpose of 

preliminary relief is to preserve the status quo ante litem pending 
  

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 39 
  

 



  

« ¢ 

full resolution of the controversy on the merits. University of Texas 
  

Vv. Camenisch, 451 U.S. 390, 395 (1981); Lopez v. Heckler, 725 F.2d 
  

  

1489, 1509 (Sth Cir. 1984), vacated on other grounds, 105 S.Ct. 583 
  

(1984). "Given this limited purpose, and given the haste that is 

often necessary if . . . [the relative positions of the parties] are 

to be preserved", the preliminary injunction hearing is not 

transformed into a trial on the merits. University of Texas Vv. 
  

Camenisch, 451 U.S. at 395. As a result, courts are "extremely   

cautious" about issuing preliminary injunctions when such relief would 

change the legal landscape that existed immediately prior to the 

moving party's request. Martin v. International Olympic Committee, 
  

740 F.2d 670, 675 (9th Cir. 1984). Nor is it proper, by altering the 

status quo on an emergency injunction motion, to grant the plaintiff   

the full relief to which he or she may be entitled if successful on 

the merits at the conclusion of the trial. Id. See also Tanner Motor 
  

Livery, Ltd. v. Avis, Inc., 316 P.2d4 204, 808 (9th cir.), cert. 
  

denied, 375 U.S. 821 (1963). 

It is indisputable here that plaintiffs' Motion, if granted, 

would alter -- rather than preserve -- the relative positions of the 

parties in this case. Granting plaintiffs' requested injunctive 

relief here would, in effect, improperly give plaintiffs virtually all 

of the final relief they seek on the merits from defendant USA. 

This principle is particularly applicable when plaintiffs here 

seek to have defendant USA ordered to take action by requesting a 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =-- 40 
  

 



¢ ¢ 

mandatory injunction. The Court of Appeals for the Fifth Circuit, 

recognizing the gravity of a mandatory injunction, has stated that 

"[m]andatory preliminary relief, which goes well beyond simply 

maintaining the status quo pendente lite, is particularly disfavored, 
  

and should not be issued unless the law and the facts clearly favor 

the moving party." Martinez v. Matthews, 544 F.2d 1233, 1243 (5th 
  

  

Cir. 1976). Accord Harris v. Wilters, 596 F.2d 678, 680 (Sth Cir. 

1979) (only in rare instances is the issuance of a mandatory 

preliminary injunction proper). 

As defendant USA has demonstrated, since neither the facts nor 

the law in this case favors plaintiffs' claims, plaintiffs not only 

have failed to satisfy the stringent prerequisites for injunctive 

relief, but have failed to meet the heightened standards for a 

mandatory injunction. As a result, plaintiffs' Motion should be 

denied. 

Vv. 

CONCLUSION 
  

For the foregoing reasons, the Court should dismiss plaintiff's 

Complaint in its entirety because plaintiffs lack standing to bring 

this action. Alternatively, the Court should dismiss plaintiffs’ 

Complaint for failure to state a claim pursuant to Federal Rule of 

Civil Procedure 12(b) (6), or because there is no genuine issue as to 

any material fact, grant summary judgment in favor of defendant USA in 

accordance with Federal Rule of Civil Procedure 56. Finally, the 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 41 
   



¢ * 

Court should deny Plaintiff's Motion for a Temporary Restraining Order 

and Preliminary Injunction. 

Dated: October 16, 1992 Respectfully submitted, 

STUART M. GERSON 

Assistant Attorney General 

MARVIN COLLINS 

United States Attorney 

MARY ANN MOORE 

Assistant United States Attorney 
Texas Bar No. 14360400 

if Fk 

“SHEILA LIEBER J 
  

Cilins ol Kefebg a 
ALINA S. KOFSKY [ 7 7 
  

Attorneys, Department of Justice 
Federal Programs Branch, Civil 

Division 
901 E Street, N.W., Room 1010 

Washington, D.C. 20530 
(202) 514-4523 

(202) 616-8470 (Fax #) 

ATTORNEYS FOR DEFENDANT 
UNITED STATES OF AMERICA 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS’ 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 42 
   



J ® 

  

OF COUNSEL: 

HENRY R. GOLDBERG, Deputy Chief 
Counsel for Litigation 

DAVID V. PEERY, Attorney 

Office of the General Counsel 
Department of Health and 

Human Services 

Room 500, East Highrise Building 
6325 Security Boulevard 
Baltimore, MD 21207 
(410) 965-8871 
(410) 966-5187 (Fax #) 

DEFENDANT UNITED STATES OF AMERICA'S MOTION 

TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 

JUDGMENT AND IN OPPOSITION TO PLAINTIFFS' 

MOTION FOR TEMPORARY RESTRAINING ORDER AND 

PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT =-- 43 
  

 



o ¢ 

  

CERTIFICATE OF SERVICE 
  

I hereby certify that on this 16th day of October, 1992, a copy 

of Defendant United States of America's Motion to Dismiss or in the 

Alternative for Summary Judgment and In Opposition to Plaintiff's 

Motion for Temporary Restraining Order and Preliminary Injunction, and 

Memorandum in Support, was served on the following individuals listed 

below, via certified mail, return receipt requested: 

Laura B. Beshara 

Michael M. Daniel 
MICHAEL M. DANIEL, P.C. 

3301 Elm Street 

Dallas, Texas 75226-1637 

Edwin N. Horne a 
Assistant Attorney General 
Office of the Attorney General 
State of Texas 
P.O. Box 12548 

Capitol Station 
Austin, Texas 78711-2548 

ih wr) tis Ll drt 
MARY \ANN MOORE Wh 

‘ 

  

DEFENDANT UNITED STATES OF AMERICA'S MOTION 
TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY 
JUDGMENT AND IN OPPOSITION TO PLAINTIFFS 
MOTION FOR TEMPORARY RESTRAINING ORDER AND 
PRELIMINARY INJUNCTION AND MEMORANDUM IN SUPPORT -- 44 
  

 



   



  

4 o 

UNITED STATES DISTRICT COURT 

FOR THE NORTHERN DISTRICT OF TEXAS 

LOIS THOMPSON, on behalf of and 

as next friend to TAYLOR DIXON, 

et al., 

Plaintiffs, 

Vv. Civ. A. No. CA3-92-1539-R 

BURTON F. RAIFORD, 

Commissioner of the Texas 
Department of Human Services, 

and 

THE UNITED STATES OF AMERICA, 

Defendants. 

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DECLARATION OF WILLIAM McC. HISCOCK 
  

I, WILLIAM McC. HISCOCK, declare: 

l. I am the Chief of the Special Initiatives Staff, 

Medicaid Bureau, Health Care Financing Administration ("HCFA"), 

U.S. Department of Health and Human Services ("HHS"). "I have 

been employed by HCFA for thirteen years. I supervise an office 

of six people. 

2. My responsibilities as Chief of the Medicaid Bureau's 

Special Initiatives Staff include assisting the agency's 

implementation of particular aspects of the Medicaid program, 

including the agency's implementation, in accordance with 42 

U.S.C. § 1396d(r) and 42 C.F.R. §§ 441.50 - 441.62, of the Early 

and Periodic Screening, Diagnostic and Treatment ("EPSDT") 

program. In this capacity, I also act as a liaison between the 

Medicaid Bureau and other governmental agencies, such as the HHS 

DECLARATION OF WILLIAM HISCOCK 1 

 



  

Lg 3 

Public Health Service Centers for Disease Control ("CDC"), that 

have closely related responsibilities with HCFA for administering 

federal health-related programs. I have been involved in 

formulating HCFA's policies concerning EPSDT screening of 

children for elevated blood lead levels since 1979. The 

statements made herein are based upon my personal knowledge and 

upon information made available to me in the course of my 

official duties. 

3. HCFA provides instructional and interpretive guidance to 

the states through the "State Medicaid Manual," policy letters, 

and memoranda (which are sometimes known as "Action 

Transmittals"). These materials and the State Medicaid Manual 

reflect HCFA policy, ahd delineate how the states can comply with 

federal Medicaid law, including federal EPSDT requirements. 

4. TI have reviewed plaintiffs' Second Amended Complaint in 

this lawsuit, plaintiffs' motions for a temporary restraining 

order and preliminary injunction, and their papers in support of 

these motions. TI am familiar with plaintiffs' allegations in 

these documents regarding plaintiffs' challenge to HCFA's revised 

State Medicaid Manual guidelines concerning EPSDT screening for 

elevated blood lead levels. 

5. HCFA has an enduring and longstanding commitment toward 

identifying and paying for the costs of treating Medicaid 

eligible children that are found to have elevated blood lead 

levels. This commitment is reflected, for example, in HCFA's 

1978 policy decision to share in the states' costs of 

DECLARATION OF WILLIAM HISCOCK 2 

 



  

& & 

investigating sources of lead poisoning as a Medicaid 

"preventive" service. HCFA Action Transmittal, 78-59 (July 1, 

1978), attached as FExhibit "1." 

6. Since the early 1970's, HCFA consistently has advocated 

state screening of children under the EPSDT program for elevated 

blood lead levels, long before Congress amended the EPSDT 

statutory provisions in 1989 to define EPSDT "screening" as 

explicitly including blood lead level assessments "appropriate 

for age and risk factors." See, e.g., HCFA State Medicaid Manual 
  

§ 5-70-E (1) (June 28, 1972) ("all children between ages of 1-6 

should be periodically screened for lead poisoning"), attached as 

Exhibit "2." Indeed, in 1989 Congress amended the EPSDT statute 

to incorporate then-existing HCFA policy, as reflected in HCFA's 

EPSDT regulations, and HCFA's State Medicaid Manual EPSDT program 

guidelines. See HCFA State Medicaid Manual § 5122 (April 1988) 

(containing language similar to 1989 Congressional amendments, 

now codified at 42 U.S.C. § 1396d(r)). 

7. In pursuing its commitment to ensure that childhood lead 

poisoning of Medicaid eligible children is promptly detected and 

treated, HCFA considers and relies upon the evolving state of 

medical knowledge to form the basis of the agency's EPSDT lead 

screening guidelines. HCFA discerns this medical knowledge from 

various sources of medical expertise, including, most 

importantly, the CDC's periodic statements on "Preventing Lead 

Poisoning in Children." HCFA also receives input from other 

government agencies (such as the Maternal and Child Health Bureau 

DECLARATION OF WILLIAM HISCOCK 3 

 



_¢ __¢ 

of the HHS Public Health Service) and from nongovernmental 

entities, such as the American Academy of Pediatrics and other 

public interest advocacy groups concerned with childhood lead 

poisoning and prevention issues. 

8. HCFA periodically revises its EPSDT screening guidelines 

to reflect the advances in knowledge of the effects of childhood 

lead poisoning. For instance, in 1972 the State Medicaid Manual 

guidelines advised state intervention and treatment of children 

when an EPSDT screen determined a child's blood lead level to be 

greater than 80 micrograms of lead per deciliter ("ug/dL") of 

whole blood. Exhibit 2 at 16. By 1988, HCFA revised its EPSDT 

guidelines to require intervention when an EPSDT screen 

determined a child's blood lead level to be greater than 30 

ug/dL. In 1990, consistent with the then current recommendations 

of the 1985 CDC Statement on "Preventing Lead Poisoning in 

Children," HCFA required interventions when an EPSDT screen 

determined a child's elevated blood lead level to be greater than 

25 ug/dL. Thus, in response to increased medical knowledge of 

the effects of elevated blood lead levels, HCFA has continuously 

lowered the blood lead level threshold at which it recommends or 

requires concern by health care providers. 

9. Similarly, HCFA periodically revises its EPSDT screening 

guidelines to reflect available technological improvements in 

blood lead level assessments. In 1972, the agency did not 

establish any particular preferred test for EPSDT blood lead 

screening. See Exhibit 2. In 1988, however, HCFA recommended 

DECLARATION OF WILLIAM HISCOCK 4  



  

« o 

the erythrocyte protoporphyrin ("EP") test as the primary lead 

screening test under the EPSDT program. (Rather than directly 

measuring lead in the blood, the EP test indirectly assesses 

blood lead by detecting a protein indicator of elevated blood 

lead levels, i.e. erythrocyte protoporphyrin. By contrast, the 

"blood lead test" directly measures blood lead levels.) By April 

of 1990, HCFA's guidelines required, rather than merely 

recommended, a blood lead test where a child was found to have 

elevated EP levels. Therefore, HCFA's guidelines have not only 

grown increasingly more stringent in setting blood lead level 

thresholds, but the agency guidelines have also required 

increasingly more sensitive blood lead testing where medical 

knowledge indicated that such testing was appropriate. 

10. HCFA's current EPSDT guidelines, which took effect on 

September 19, 1992, continue this trend of revising HCFA policy 

to keep up with the latest medical knowledge, and to incorporate 

increasing technological advances in blood lead level 

assessments. HCFA's current guidelines primarily are a response 

to the latest of CDC's periodic revisions to its Statement on 

childhood lead poisoning, "Preventing Lead Poisoning in Children: 

A Statement by the Centers for Disease Control," October, 1991 

(the "1991 CDC Statement"). I and various HCFA officials 

consulted with CDC officials continuously during the drafting of 

the 1991 CDC Statement. Similarly, various CDC officials 

responsible for compiling the 1991 CDC Statement reviewed and 

commented upon preliminary drafts of HCFA's current EPSDT 

DECLARATION OF WILLIAM HISCOCK 5 

 



  

4 &« 

screening guidelines. On December 6, 1991 I and several other 

HCFA personnel met with a CDC official who was one of the 

principal authors of the 1991 CDC Statement, Dr. Sue Binder, 

Chief of CDC's Lead Poisoning Prevention Branch, to discuss CDC's 

views on HCFA's EPSDT lead screening guidelines. In response to 

CDC's comments, HCFA made various revisions to the draft 

guidelines, and then circulated the revised drafts to various 

other governmental and private entities for comment. It is my 

understanding, based on my conversations with CDC personnel 

including Dr. Binder, that CDC believes HCFA's revised guidelines 

are consistent with the approach endorsed by CDC in its 1991 CDC 

Statement. I have read the Declaration of Dr. Sue Binder filed 

in this action, which confirms this understanding. 

11. Other entities that reviewed and commented on drafts of 

HCFA's EPSDT lead screening guidelines include the American 

Academy of Pediatrics; the Maternal and Child Health Bureau, 

Health Resources and Services Administration, HHS Public Health 

Service; and an organization of the State Medicaid Directors 

Association known as the Medicaid Maternal and Child Health 

Technical Advisory Group. Thus, in revising its EPSDT lead 

screening guidelines, HCFA received and considered input from an 

array of public and private organizations concerned with 

childhood lead poisoning. 

12. HCFA considered several factors in formulating its 

current EPSDT blood lead screening guidelines. HCFA noted that 

the 1991 CDC Statement recommends that health care providers 

DECLARATION OF WILLIAM HISCOCK 6 

 



  

_ ® 

should first verbally assess a child's risk of having elevated 

blood lead levels by asking a series of questions to determine 

the likelihood of a child's exposure to lead sources. Depending 

upon the answers to these questions in the "verbal assessment," 

children are considered to be either at "high risk" or "low risk" 

of being lead poisoned. Although the 1991 CDC Statement 

indicates that all children are at risk, HCFA was cognizant of 

CDC's recommendation that the highest priority should be reserved 

for those children with the highest blood lead levels. 

13. In revising its EPSDT lead screening guidelines, HCFA 

also took note that the 1991 CDC Statement recommended lowering 

the blood lead level threshold for which concern and follow-up is 

recommended from 25 'ug/dL of whole blood to 10 ug/dL. The 1991 

CDC Statement, therefore, recommends screening through use of a 

blood lead test rather than the EP test to assess blood lead 

levels at levels lower than 25 ug/dL. While the 1991 CDC 

Statement notes that the EP test is not sensitive for blood lead 

levels at the lower ranges for which the CDC recommends concern 

by health care providers, the 1991 CDC Statement recognizes that 

not all programs currently have the capacity to conduct universal 

blood lead testing. Accordingly, HCFA took into account CDC's 

recognition of the need for a "transition" period to move away 

from EP testing, and move toward blood lead testing. HCFA's 

revised EPSDT screening guidelines, therefore, constitute a 

synthesis of input from various organizations, balanced by the 

DECLARATION OF WILLIAM HISCOCK 7 

 



  

_¢ & 

pragmatic reality of the limited availability of the technology 

to perform universal blood lead testing. 

14. HCFA's revised guidelines incorporate cps methodology 

of using verbal assessments to determine "risk categories" of a 

child's likelihood of being exposed to dangerous levels of lead. 

Consistent with the 1991 CDC Statement, HCFA's guidelines 

bifurcate children into "high risk" and "low risk" categories for 

likelihood of lead exposure based upon the answers elicited in 

the verbal assessment. HCFA's guidelines mandate the most 

sensitive blood lead testing process for children determined to 

be at "high risk" of having elevated blood lead levels. This 

requirement is consistent with the 1991 CDC Statement which 

recommends that the highest priority be those children with the 

highest blood lead levels. As a practical matter, HCFA believes 

that the majority of EPSDT eligible children will be deemed to be 

at "high risk" for elevated blood lead levels, due to the 

socioeconomic conditions that often circumscribe where Medicaid 

recipients reside. 

i5. Further, while HCFA's revised EPSDT guidelines stress 

that blood lead testing is the preferred mode for blood lead 

level assessments of children deemed to be at "low risk," the 

guidelines grant states the option of using either the blood lead 

test or the EP test as the initial screen for "low risk" children 

during the transition period. HCFA made this pragmatic policy 

choice after considering comments from CDC and various 

organizations that indicated that many localities simply do not 

DECLARATION OF WILLIAM HISCOCK 8 

 



  

oC \¢ 
currently have the technology available and/or the capacity to 

universally conduct blood lead testing for all Medicaid eligible 

Children, both "high risk" and "low risk." The 1991 CDC 

Statement recognizes the problems many communities face in moving 

away from EP testing and toward blood lead testing. In light of 

the practical realities of the nonavailability of universal 

blood lead testing capacity in some communities, HCFA's 

guidelines grant states the option of using the EP test as the 

initial screen only for "low risk" children during the phase-in 

of universal blood lead testing. However, the federal government 

(through HCFA) will share in the costs of screening "low risk" 

children through the use of blood lead test. In other words, 

HCFA will provide federal financial participation for all states 

use of the blood lead test to screen for lead poisoning, 

regardless of the individual child's lead poisoning risk 

assessment. 

16. Even for this limited group of "lov risk" children, 

states must use the blood lead test in instances of elevated EP 

test results. But where subsequent verbal risk assessments 

suggest increased lead exposure for children previously deemed at 

"low risk," a blood lead test must be performed. 

17. In the situation where a "low risk" child continuously 

resides in an area that a state or local health official declares 

to be lead-free, HCFA's guidelines require only verbal risk 

assessments of the child's likelihood of lead exposure, rather 

than a blood lead test or an EP test. But, similar to other "low 

DECLARATION OF WILLIAM HISCOCK 9 

 



o ® 

risk" children," if the verbal assessment indicates increased 

likelihood of lead exposure for this group of children, then 

states must use either a blood lead test or EP test to determine 

blood lead levels. If a state chooses to use an EP test on this 

group, and that test indicates elevated blood lead levels, then a 

blood lead test must be performed. Thus, because all EPSDT- 

eligible children must be "periodically" screened for medical 

problems in accordance with a "periodicity schedule" set by the 

state, each and every EPSDT child should be evaluated for their 

risk of lead exposure, and accordingly receive the appropriate 

blood lead level assessment. 

18. HCFA's guidelines currently stress that blood lead 

testing is the preferred method of EPSDT lead screening for all 

Medicaid eligible children. As a result, HCFA will share in the 

costs of paying for universal blood lead tests for all EPSDT 

children in all instances. But given the existing technological 

limitations of such testing, HCFA's policy choice to grant states 

the option of using the EP test in certain limited instances 

represents a realization of the very practical problems of 

available resources that certain states face. HCFA seeks to 

retain state flexibility in EPSDT screening, and emphasizes that 

the September 19, 1992 guidelines are merely another in a 

continuing series of phases of Medicaid guidance on EPSDT blood 

lead screening. 

19. HCFA has recently issued a policy letter to all State 

Medicaid Directors which clarifies the limited instances in which 

DECLARATION OF WILLIAM HISCOCK 10  



  

OC 1 § 
states have the option of using the EP test during the transition 

period. Exhibit "3." This letter emphasizes HCFA's commitment 

to sharing in the costs of universal blood lead testing for all 

EPSDT children, and also reemphasizes that blood lead tests are 

preferred for all Medicaid eligible children. 

20. In sum, HCFA's EPSDT lead screening policy has kept 

pace with the evolving medical knowledge of the effects of 

childhood lead poisoning. HCFA will continue to revise and 

update its guidelines in response to future guidance from the CDC 

and other organizations, and as the technology necessary to 

perform the blood lead test becomes universally available. 

21. In accordance with 28 U.S.C. § 1746, I declare under 

penalty of perjury ‘that the foregoing is true and correct, and 

certify that the attached Exhibits 1-3 are true and correct 

copies. 

-— 

Dated: October /5 1992 at Baltimore, Maryland. 

(dds 
WILLIAM McC. HISCOCK 
  

DECLARATION OF WILLIAM HISCOCK 11 

 



  

o a 
5-70-00 p. 15 

  

  

Assistance     
  

  

Services and Payment in Medical Assistance Programs 
  

Early and Periodic Screening, Diagnosis, and Treatment of ¢ 
  

-70-20 

Eligible Individuals Under Age 21 
  

E. 

f. 

Be 

i. 

Screening (Continued) 
  

Vision Testing. Administer a vision screening test appropriate 
to the child's age. Consultation by ophthalmologists and 
optometrists can be of help in determining the type of tests 
to be used and the criteria for determining when a child should 
be referred for diagnostic examination, 

  

Hearing Testing. Administer a hearing screening test appropriate 
to the child's age. Consultation on suitable tests for screening 
and on methods of administering the tests should be obtained from 
audiologists or from State health or education departments, 

Anemia Test. The most easily administered test for anemia is 
a microhematocrit determination from venous blood or a finger- 
stick, This should be done on all children or, if possible, 
a hemoglob.in concentration which will give a more accurate 
determination of anemia should be done. 

  

  

Sickle Cell Test. Check all Negro children for sickle cell trait, 
This may be done with a sickle cell preparation or a hemoglobin 
solubility test. If a child has been properly tested once for . 
sickle cell disease, he does not have to be tested again. 

Tuberculin Test. Give a tuberculin test to every child:who hag   

not had one within one year. 

Urine Screening. Carry out a rapid urine screening on all 
  

children for the presence of sugar, albumin and bacteria. i 

Lead Poisoning Screening. It is not possible to identify which 
  

children may have had undue exposure to lead-based paint and other 
sources of lead poisoning, except by determination of blood- lead 
levels, Therefore, all children between the ages of 1-6 should be 
periodically screened for lead poisoning, Children 6 and over should 

MSA- PRG-21 
EXHIBIT 1 to HISCOCK DECL 6-28-72 

  

  

  

 



   
5-70-00 p. 16 

3 | 

    
  
  
  

  

  

  

  

Medical a 
: 

- 

ply jance 

| @ 

Past 5. Services and Payment in Medical Assistance Programs 
: 

5-70-00 Early and Periodic Screening, Diagnosis, and Treatment of 
  

  

Eligible Individuals Under Age 21 

  

5-70-20 E. Screening (Continued) 

be screened when medically indicated. The principal source 
’ 

of childhood lead poisoning i8 lead-based paint, but pollution 

of the environment from such things as burning lead batteries   
lead poisoning. Early identification 

and prompt treatment 

of symptomatic and asymptomatic (over 80 mg/100 milliliters 
73 BE 

of whole blood) cases can prevent the serious sequelae of 
i 

lead poisoning, such as mental impairment, mental retardation 

and involvement of the central nervous system. Venous OT 

capillary blood .samples may be used, depending on local 

laboratory facilities. 

    
m, Nutritional Status. Physical and laboratory determinations 

carried out in the screening process will usually yield 

information useful in assessing nutritional status. Of par- 

ticular imphrtance are measurements of height, weight, head 

circumference and hemoglobin concentration or hematocrit. A 

child having any detectable nutritional deficiencies should 

be referred to a nutritionist or public health nurse for 

consultation. 
: : 

n. Immunization Status. The screening progras presents an 

excellent opportunity to ascertain a child's immunization 

status, a major tool in preventing disease and disability. 

. During the screening process, assess the child's {immunization 

status; i.€., whether he has been imaunized against diphtheria, 

pertussis, tetanus, polio, measles, rubella, and mumps, and 

whether he is in need of booster shots, When it is available, 

the child's immunization record should be brought to the 

screening center. 1f immunization OT updating of {mmunization 

is needed, provide the immunization OT updating at the screening 

center or make sure it is done through the facility or provider 

to whom the child goes for child health supervision. 

  
  

  
  MSA-PRG-21 

6-28-72   



   
basic 

04-gg 04-88 EARLY AND PERIODIC SCREENING, DIAGNOSIS " TREATMENT 5122(Cont.) 
  

3. Appropriate Vision Testing. - Administer an age-appropriate vision 
  

| assessment. Consultation by opthalmologists and optometrists can help determine the 

  

type of procedures to use and the criteria for determining when a child should be referred 

for diagnostic examination. 

4. Appropriate Hearing Testing. - Administer an age-appropriate hearing 

assessment. Obtain consultation and suitable procedures for screening and methods of 

administering them from audiologists, or from State health or education departments. 

  

5. Appropriate Laboratory Tests. - Identifying as Statewide screening 

requirements the minimum laboratory tests or analyses to be performed by medical 

providers for particular age or population groups. Physicians providing 

screening/assessment services under the EPSDT program use their medical judgement in 

determining the applicability of the laboratory tests or analyses to be performed. If any 

laboratory tests or analyses are medically contraindicated at the time of 

screening/assessment, provide them when no longer medically contraindicated. As 

appropriate, conduct the following laboratory tests: 

  

a. Anemia Test. — The most easily administered test for anemia is a 

mierohematoecrit determination from venous blood or a fingerstick. 
  

b. Sickle Cell Test. — Diagnosis for sickle cell trait may be done with 

sickle cell preparation or a hemoglobin solubility test. If a child has been properly tested 

once for sickle cell disease, the test need not be repeated. 

  

c. Tuberculin Test. — Give a tuberculin test to every child who has not 

received one within a year. 
  

d. Lead Toxicity Screening. — All EPSDT eligible children, ages 1-5 

should be screened for lead toxicity, using the erythrocyte protoporphyrin (EP) test as the 

primary screening test. Children with any elevated EP (greater than, or equal to, 50 

micrograms per deciliter of whole blood) should receive a blood lead test. Children with 

both an elevated EP and an elevated blood lead (greater than, or equal to, 30 micrograms 

per deciliter) require diagnosis and treatment, which includes environmental 

epidemiologic services to identify the source of lead, and periodic re-evaluation. 

  

e. Others. — In addition to the the tests above, there are several other 

tests to consider. Their appropriateness are determined by an individual's age, sex, 

health history, clinical symptoms and exposure to disease. These include a urine 

screening, pinworm slide, urine culture (for girls), serological test, drug dependency 

screening, and stool specimen for parasites, ova and blood. 

6. Dental Screening Services. - Although an oral examination may be part of a 

physical examination, it does not substitute for examination through direct referral to a 

dentist. The judgement that dental treatment is or is not necessary can only be made by 

a dentist. It is the intent of the regulation not to disrupt continuous, comprehensive 

dental care situations, but rather to encourage and develop them. 

  

Rev. 2 5-11 

EXHIBIT 2 TO HISCOCK DECLARATION 

  

   



_¢ 
Health Care Financing Administration 

  

6325 Security Boulevard 

Baltimore, MD 21207 

MEDICAID BUREAU 

Dear State Medicaid Director: 

The purpose of this letter is to clarify certain aspects of the lead screening 

requirements published in the September 1992 revision of the State Medicaid 

Manual (SMM), Part 5, for the Early and Periodic Screening, Diagnostic, and 

Treatment (EPSDT) program. 

We consulted with the Centers for Disease Control (CDC) and other organizations 

prior to revising our instructions, and we continue to consult with CDC about 

developments in the capacity for screening and for performing blood lead tests. 

We believe that our published guidelines are consistent with the CDC statement, 

Preventing Lead Poisoning in Young Children (October, 1991). 
  

Effective September 19, 1992, States are required to screen all Medicaid eligible 

children between the ages of 6 months and 72 months of age at their next 

scheduled EPSDT screening for lead poisoning. Screening consists of both a verbal 

risk assessment and a blood lead level assessment. A child answering "yes" to one 

or more of the risk assessment questions is determined to be at high risk, and a 

blood-lead test must be performed. A child answering "no" to all questions is 

determined to be at low risk, and may receive either a blood-lead test or an 

erythrocyte protoporphyrin (EP) test. We believe that most Medicaid eligible 

children will be at high risk for lead poisoning. 

We consider all children between the ages 6 through 72 months to be at risk for 

elevated blood lead levels. In the vast majority of cases, HCFA expects Medicaid 

eligible children will receive a blood lead test. Children who live in a community 

officially declared "lead free" by a State or local health authority and answer "no" to 

all risk assessment questions, do not need a blood lead level assessment. However, 

such a child must still receive a verbal risk assessment at every periodic screen to 

determine if any changes have occurred which would change the child's risk status. 

Although our SMM instructions are only the first phase in a transition period, and 

take into account the currently available state of the art of lead screening 

technology, I am aware that concerns have been raised over the continued use of 

the EP test, even for children who are at low risk. Direct blood lead testing is the 

preferred mode of ascertaining blood lead levels for all Medicaid eligible children, 

and Federal financial participation is available for any Medicaid expenditures for 

that purpose. While the EP test is not as sensitive as tests which directly measure 

EXHIBIT 3 TO HISCOCK DECL  



oC Le 

Page 2 - State Medicaid Director 

blood lead levels, it is easier and somewhat less expensive to perform than the 

blood-lead test. In addition, the EP test will identify most children with blood lead 

levels at or above 25 micrograms per deciliter, for whom medical interventions are 

clearly indicated. We recognize, as does CDC, that not all communities currently 

have the technology and laboratory capacity to perform blood-lead tests on all 

children, while they do have the capability of performing the EP test. We do not 

believe it appropriate to wait until a simpler and cheaper blood-lead test is 

available, and permit many lead poisoned children to go undetected in the interim. 

Thus, our instructions require initial blood lead testing for those children assessed 

to be at high risk. The EP test is allowed only for low risk children, although the 

blood lead test is preferred. 

I am asking the HCFA regional office staff to help you implement the revised 

policy, and to identify and work through any barriers you may encounter. 

Acknowledging that States require time to develop the needed capacities, CDC is 

currently pursuing research and development efforts to develop instrumentation and 

protocols for simpler blood-lead tests. At this time, we cannot set a firm date for 

the end of the transition period. As research and development efforts progress and 

capacity becomes available, we will be providing further guidance which will 

culminate with the requirement for blood lead testing of all Medicaid eligible 

children, whether at high or low risk. 

I hope this letter clarifies our recent instructions on lead screening. 

Sincerely yours, 

At 
Christine Nye 

or Director 

cc: 
All Regional Administrators 

All Associate Regional Administrators 

Division of Medicaid  



   



  

_¢ « 

IN THE UNITED STATES DISTRICT COURT 
FOR THE 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, 

Vv. Civ. A. No. CA3-92-1539-R 

BURTON F. RAIFORD, in his 

capacity as Commissioner of 
the Texas Department of Human 
Services, 

and 

THE UNITED STATES OF AMERICA, 

Defendants. 

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DECLARATION OF SUE BINDER, M.D. 
  

I, Sue Binder, M.D. declare the following to be true and correct: 

1. I am the Chief of the Lead Poisoning Prevention Branch, 

Division of Environmental Hazards and Health Effects, National Center 

for Environmental Health and Injury Control, Centers for Disease 

Control ("CDC"), Public Health Service, U.S. Department of Health and 

Human Services ("HHS"). My office is located at Mailstop F42, Room 

1342, 4770 Buford Highway, Atlanta, Georgia 30341-3724. In my 

position as Chief of the Lead Poisoning Prevention Branch, I am 

responsible for developing and Sipienenting CDC policies and programs 

in non-occupational lead poisoning prevention. I supervise 

DECLARATION OF SUE BINDER, M.D. -- Page 1 
  

 



4 _¢ 

approximately 30 employees, whose duties include overseeing grants to 

  

state and local childhood lead poisoning prevention programs, 

conducting epidemiologic studies of critical issues in childhood lead 

poisoning prevention, conducting surveillance for blood lead levels in 

children, and assisting other government agencies and the private 

sector in issues related to nonoccupational lead poisoning prevention. 

The operating budget of the Lead Poisoning Prevention Branch was $18.7 

million in Fiscal Year 1992. I assumed my current position in 1990. 

2 I hold an M.D. degree from Tufts University School of 

Medicine in Boston, Massachusetts. I have been involved with lead 

poisoning prevention activities since 1989, and with environmental 

public health issues since 1984. I have authored and co-authored 

several articles in professional medical journals regarding childhood 

lead poisoning. I was one of the principal authors of the October 

1991 CDC statement, "Preventing Lead Poisoning in Young Children: A 

Statement By The Centers For Disease Control" ("1991 CDC Statement"), 

and the February 1991 HHS Report to Congress, "Strategic Plan For The 

Elimination Of Childhood Lead Poisoning." Furthermore, I have given 

numerous professional presentations across the country on childhood 

lead poisoning. 

3. The statements made herein are based upon my personal 

knowledge and upon information made available to me in the course of 

my ottictal duties. 

4. I am generally familiar with plaintiffs' allegations that 

HCFA's September 19, 1992 State Medicaid Manual guidelines ("HCFA 

guidelines") are inconsistent with the 1991 CDC Statement. 

DECLARATION OF SUE BINDER, M.D. -- Page 2 
  

 



o _d 

5. In accordance with 42 U.S.C. § 241, the CDC has issued four 

  

policy statements with respect to preventing childhood lead poisoning. 

In 1985, CDC issued a policy statement with respect to lead level 

testing in children. The 1985 CDC Statement set forth the threshold 

for concern by pediatric health care providers at a blood lead level 

of 25 micrograms per deciliter ("ug/dL") of whole blood. The actions 

suggested by the 1985 CDC Statement ranged from periodic retesting to 

chelation therapy treatments in more severe cases of lead poisoning. 

In addition, the 1985 CDC Statement recognized the erythrocyte 

protoporphyrin ("EP") test as the screening test of choice for lead 

poisoning in children. 

6. In or about 1989, the CDC chartered an advisory committee to 

reevaluate a number of issues regarding childhood lead poisoning. The 

work of that advisory committee ultimately contributed substantially 

to the publication of the 1991 CDC Statement, a copy of which is 

attached hereto as Exhibit "1." The advisory committee members, 

representative of a wide variety of organizations and interests 

including physicians, state and local boards of health, hospitals, 

organizations dealing with housing and environmental issues, and a 

professional who represented laboratory interests, see Exhibit "1" at 

v, provided written advice and recommendations to the CDC regarding 

childhood lead poisoning prevention. Furthermore, the advisory 

committee received expert advice from a group of official consultants, 

who provided input for the advisory committee's written 

recommendations. 

7. In addition to the written recommendations of the advisory 

  

DECLARATION OF SUE BINDER, M.D. -- Page 3 

 



4 _¢ 

committee, CDC considered comments from medical groups, including the 

  

American Academy of Pediatrics, representatives of companies who 

produce or use lead, drug manufacturers, and childhood lead poisoning 

prevention interest groups. 

8. Furthermore, before publishing the 1991 CDC Statement, CDC 

provided the Health Care Financing Administration ("HCFA") with a 

draft of the 1991 CDC Statement, and received comments and suggestions 

from HCFA. 

9. The CDC itself has engaged in studies of childhood lead 

poisoning, the results of which are reflected in the 1991 CDC 

Statement. 

10. I served as one of the principal authors of the 1991 CDC 

Statement. In addition, I synthesized the advice and recommendations 

of the advisory committee and other interested parties and government 

agencies, and consulted with the appropriate CDC officials 

knowledgeable in this area in order to ensure that the 1991 CDC 

Statement was consistent with CDC policy. 

11. The 1991 CDC Statement is intended to provide guidance and 

recommendations, rather than mandates, to pediatric health care 

providers, state and local public agencies for dealing with childhood 

lead poisoning. 

12. The 1991 CDC Statement differs from the. 1985 CDC Statement 

in chat Tit lowers the threshold for concern by pediatric health care 

providers from the blood lead level of 25 ug/dL to 10 ug/dL. The 

actions suggested as a result of such blood lead level results range 

from periodic retesting to community prevention activities to 

DECLARATION OF SUE BINDER, M.D. -- Page 4 
  

 



  

&( Le 

chelation therapy treatments in more severe cases of lead poisoning. 

The focus of the 1991 CDC Statement is on "primary prevention" -- i.e. 
  

preventing exposure to lead before children become poisoned. 

13. While the 1991 CDC Statement recognizes that the screening 

test of choice is now the blood lead test since the EP test is not 

sensitive enough to identify children with blood lead levels below 25 

pug/dL, the 1991 CDC Statement also acknowledges the need for a 

transition period until the recommendations of the 1991 CDC Statement 

can be implemented fully. The 1991 CDC Statement recognizes that this 

transition period is necessary to allow state health departments, 

health care providers and laboratories to reach adequate capacity for 

performing the blood lead level test. (To reach adequate capacity 

will require the aequisition of the necessary laboratory equipment and 

the hiring and training of appropriate personnel.) During this 

transition or phase-in period to the use of the blood lead test as the 

primary screening method, the 1991 CDC Statement recognizes that some 

programs will continue to use the EP test as a screening test. 

14. The EP test is an indirect assessment of lead levels in 

blood since it measures the chemical erythrocyte protoporphyrin whose 

level in blood rises when lead is present. By contrast, the blood 

lead level test is a direct assessment of lead levels in blood, using 

one of two electrochemical techniques to assess lead levels -- anodic 

toning voltammetry or atomic absorption spectroscopy. 

15. The 1991 CDC Statement further distinguishes between those 

children to be considered high-risk and low-risk for high-dose 

exposure to lead, and recommends the use of a series of questions 

DECLARATION OF SUE BINDER, M.D. -- Page 5 
  

 



o _d 

designed to ascertain the risk level of a child, as well as the type 

and frequency of testing the child should receive. 

16. In addition, the 1991 CDC Statement recognizes that 

virtually all children are at risk for lead poisoning, and as a 

result, a phase-in of universal screening using the blood lead level 

test for all children is recommended, except in communities where 

large numbers or percentages of children have been screened and found 

not to have lead poisoning. The 1991 CDC Statement recognizes that 

full implementation of universal screening using the blood lead level 

test will require the availability of cheaper and easier-to-use 

methods of blood lead measurement. The 1991 CDC Statement further 

recognizes that the highest priority should continue to be those 

children with the highest blood lead levels. 

17. In 1991, I was contacted by HCFA agency officials to 

discuss HCFA's proposed guidelines with respect to lead testing in 

children. During 1991 and 1992, my staff and I discussed drafts of 

HCFA's guidelines regarding lead testing of children with HCFA agency 

officials on at least two occasions. On or about December 6, 1991, I 

met with William Hiscock and other HCFA agency officials to provide 

verbal comments on behalf of the CDC to HCFA with respect to the 

proposed HCFA guidelines. 

18. The CDC has rechartered a new advisory committee on 

childhood lead poisoning prevention which is scheduled to meet in or 

about Spring of 1993. At that time, the new advisory committee will 

consider whether to amend the current 1991 CDC Statement or issue a 

revised CDC report on lead poisoning prevention. 

DECLARATION OF SUE BINDER, M.D. -- Page 6 
   



  

o oC 

19. CDC believes that the final HCFA guidelines, which became 

effective on September 19, 1992, are consistent with the 1991 CDC 

Staterent. 

20. Pursuant to 28 U.S.C. § 1746, I declare under penalty of 

perjury that the foregoing is true and correct to the best of my 

knowledge, and certify that Exhibit "1" attached hereto is a true and 

correct copy. This declaration was executed on the 8 day of 

October, 1992, at Atlanta, Georgia. 

  

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