Memorandum of Points and Authorities in Support of Plaintiffs' Motion for Partial Summary Judgement

    4
 

  

JOEL R. REYNOLDS 

JACQUELINE wif) i 

NATURAL RESOURCTS DEFENSE COUNCIL 
617 South Olive Street 
Suite 1210 
Los Angeles, California 90014 
(213) 892-1500 

JANE PERKINS 
NATIONAL HEALTH LAW PROGRAM 
2639 South La Cienega Boulevard 
Los Angeles, California 90034 
(213) 204-6010 

BILL LANN LEE 

KEVIN S. REED 

NAACP LEGAL DEFENSE AND EDUCATIONAL FUND, INC. 

315 West Ninth Street 

Suite 208 
Los Angeles, California 90015 
(213) 624-2405 

Attorneys for Plaintiffs 
Erika Matthews, et. al., 

(Continued on next page) 

UNITED STATES DISTRICT COURT 
NORTHERN DISTRICT OF CALIFORNIA 

ERIKA MATTHEWS, et al., CIV. NO. C-90-3620 EFL 

Plaintiffs, CLASS ACTION 
  

vs. MEMORANDUM OF POINTS 
AND AUTHORITIES IN 
SUPPORT OF PLAINTIFFS’ 
MOTION FOR PARTIAL 

KENNETH KIZER, 

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Defendant. SUMMARY JUDGMENT 

Date: June 21, 1991 
Time: 10:00 a.m. 

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MARK D. ROSENBAUM 

ACLU FOUNDATI OF SOUTHERN CALIFORNIA 

633 South Shatco Place 
Los Angeles, California 90005 
(213) 487-1720 

SUSAN SPELLETICH 

KIM CARD 

LEGAL AID SOCIETY OF ALAMEDA COUNTY 

1440 Broadway 

Suite 700 
Oakland, California 94612 
(415) 451-9261 

EDWARD M. CHEN 

ACLU FOUNDATION OF NORTHERN CALIFORNIA 

1663 Mission Street 
Suite 460 
San Francisco, California 94103 
(415) 621-2493 

Attorneys for Plaintiffs 
Erika Matthews, et al., 

/11/ 

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/141/ 

{111 

{1/44 

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TABLE OF CONTENTS 

  

  

» » Page 

INTRODUCTION. «ott tins snnininnisin svn snvommenas euvinmasneess wns 1 

STATEMENT ‘OF THE CASE.» caisv sv svvviainie ssleinsvvne vine elely du din nv 2 

A. California's Medicaid Program ....ssceeesvsne 2 

B. The Problem of Childhood Lead Poisoning....... 3 

C. Lead Blood Level Assessments Under Medi-Cal .. 5 

ARGUMENT * 0.00 0 0 0 0 Sie a iials ores wv ainivniein vinlode eine ula nine vinenie vane sn B 

I. THE PLAIN MEANING OF THE MEDICAID ACT, 
AUTHORITATIVELY CONSTRUED, REQUIRES BLOOD 
LEAD TESTING OF ALL ELIGIBLE CHILDREN 
ACES ONE TO PIVE:t1s cress trtssonssstrsasssnscens 7 

II. THE PLAIN MEANING OF THE MEDICAID ACT IS 
CONFIRMED BY THE LEGISLATIVE HISTORY OF 
THE EPSDT STATUTE, AS WELL AS BY 
LONGSTANDING REGULATORY AND MEDICAL GUIDANCE ..... 9 

III. THE DEPARTMENT'S INTERPRETATION IS 
ARBITRARY... +: Cone rining . cow rss cine FI 13 

CONCLUSION "vont sav es eo oo 0 ® ® eo e 0 0° 9 eo eo 0 ® eo oo . ® 20 

— i 

  

 



  

  

  

  

  
  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

i A TABLE OF AUTHORITIES{f]) 

2 Cases Page 

3 American Tobacco Co, v. Patterson, 456 U.S. 63 (1982) . . . 9 

4 Beisler v. C.F.R,, 814 F.2d 1304 (9th Cir. 1987) & +. . » +. 1B 

5 Beltran v. Myers, 701 F.2d 91 (9th Cir.) 
cert. denied sub nom. Rank v. Beltram, 462 U.S. 

6 1134 (1983) ‘ 2 

“ California Department of Health Services v. 
United States Department of Health and Human 

8 Servics, 853. F.2d 634 (Sth Cir. 1888) vv « ¢« sie « v + 5.0 9 

9 Citizens Action League v. Kizer, 887 F.2d 1003 
(9th Cir, 1989) LJ LJ LJ LJ LJ LJ [J LJ LJ LJ * LJ] . * LJ LJ LJ ° LJ * 7. 19 

10 Clark v., Kizer, 758 F.Supp. 572 (E.D. Cal. 1990) . « . « + 14 

11 Co Petro. Mktg. Group, Inc., 680 F.2d 566 
12 (Sth CAX. 1982) ot. oe a ov a a Taine sas vs iiniia vw o +» 1B 

13 Delancey v, E.P.A., 898 F.2d 687 (Oth Cir. 1987) . viv + « « 14 

14 [In_xe Oxborrow, 913 F.2d 751 (Sth Cir. 1990) . « . « + «+ + 18 

15 Markair, Inc. v. C.A.B., 744 F.2d 1383 
(Oth Cire 1984) iv ovis ov 0 0 0 viois sin sin wie isnie 19 

16 Mitchell v. Johnston, 701 F.2d 336 (5th Cir. 1983) . . . . 3 

17 Oregon O0.B.0. Oregon Health Services v. Bowen, 854 F.2d 
18 346 (Oth Cir, 11988) ys ov ov sv 0 oe ni sie oie sa 2 ase so » +» 14 

19 Pacificorp v. Bonneville Power Admin., 856 F.2d 94 
(Oth CiX. 1988) io vi +. so is ie o 0. v.00 e's ais u's vv 0% «14 

20 | pottgieser v. Kizer, 906 F.2d 1319 (9th Cir. 1990) . . 7, 14 

2) inane v. Botevan, 462:0.8. 00134 (1983) + vv + cu viii) 2 

22 Schweiker v. Gray Panthers, 453 U.S. 34 (1981) . . .. . . 2 

23 Stanton v. Bond, 504 F.2d 1246 (7th- Cir. 1974) ., «. . +. « +» 3 

24 lynited States v. 594,464 Pounds of Salmon, 871 F.2d 824 
25 (Sth Cix,. 1988) « «0 «a 0 o wine wie 0 oinileaVe nin o's ey | 

26 Vierra v. Rubin, 915 P.2d 1372 (9th Cir, 1980) .. . «. + 14, 19 

27 

28 

ii     
 



  

& Statutes 
  

42. U.S.C. § 1396a 

42 U.S.C. § 1396a(a) 

42 U.S.C. § 1396d(a) 

AU, 8.0, SG A3S6ALTY + oo + SE WE Ne SY, 

42 U.S.C. 8S 1396 

Miscellaneous 
  

135 Cong. Rec. § 13233 (October 12, 1989 1989) 
  

Explanation of the Conference Committee 
Affecting Medicare-Medicaid Programs Re: 
Omnibus Budget Reconciliation Act of 

1989 (H.R. 3299), reprinted in 
Medicare & Medicaid Guide (CCH), 

  

  

  
Extra Edition No. 603 (Dec. 15, 1989) + «¢ 4 ¢ « ov.» + 

HEW, A Guide to Screening-EPSDT and Medicaid (1974). 

HEW, Guide to Administration, Diagnosis 
and Treatment for the EPSDT Program under 

Madicaid (HEW 1977) « + 5 5 + os 5 o'» 

HEW, Information Memorandum, "New Technology Available 

in the Screening and Detection of Lead Poisoning and 

EPSDT" (1M-77-32 (MSA)) June 9, 1977), reprinted in 

Medicare & Medicaid Guide (CCH) ¥ 28,505. . . . ‘ 
  

  

HEW, Medical Assistance Manual, § 5-70-00 (June 28, 

1972) LJ * . * LJ LJ LJ L] LJ LJ LJ LJ LJ LJ LJ LJ LJ LJ * LJ LJ * 

Health Care Financing Administration 
State Medicaid Manual (April 1988) 
  

Hearing on HR 5700 Before the House 
Committee on Ways and Means, 90th 
Cong., 1 Sess., Pt. 1, at 189 (1967) 

  

  

Sutherland, 1A Statutory Construction 
§ 31.06 (Sands 4th ed. 1985) . . . . . . 
  

Welfare of Children H.R. Doc. #54, 
90th Cong., 1St Sess. (1967) + os « +. + «. sls 
  

iii 

11, 

e123 

12 

12 

.10 

.10 

.10 

  

 



  

27 

28 

  

SUMMARY OF ARGUMENT 
  

The Medicaid Act requires the Department of Health 

Services ("DHS") to provide "lead blood level assessment[s]" 

to eligible children as “appropriate for age and risk 

factors," as a mandatory "laboratory test." 42° U.8.C...§ 

1396d(r). Controlling federal authority contained in the 

State Medicaid Manual, California Dep't of Health Services v. 
  

United States Dep’t of Health and Human Services, 853 F.2d 634 
  

  

(9th Cir. 1988), refines the requirement: All Medicaid 

eligible children ages 1-5 must be screened using a lead blood 

test. DHS does not comply with this law, instead requesting 

providers merely to ask unspecified questions of children. 

The plain meaning of the statute and implementing 

  

regulations is dispositive. (Citizens Action League v. Kizer, 

887 F.2d "1003 (9th Cir... 1989). Requiring blood level 

assessment of all young children is consistent with 17 years 

of development of regulatory recommendations. Legislative 

history, moreover, is clear that Congress intended in 1989 to 

codify and expand regulatory authorities to make the Act more 

effective in early detection of childhood illnesses. 

DHS’'s refusal to implement testing of all young 

children is arbitrary. Mere questioning will not reveal a 

high blood lead content; only a test will do that. DHS’s 

approach cannot be squared with regulatory authority, opinions 

from the leading experts in the field, or statements by the 

DHS’s own representatives. Sutherland, 1A Statutory 
  

Construction § 31.06 (Sands 4th ed. 1985) (and cases therein). 
  

  

 



  
  

INTRODUCTION 
  

This case concerns the failure of Tne California Department 

of Health Services ("DHS" or "Department") to provide lead blood 

level assessments to Medi-Cal eligible children as required by the 

federal Medicaid Act ("Act"). This Act was amended in 1989 to 

require for all eligible children "lead blood level assessment 

appropriate for age and risk factors," as a mandatory "laboratory 

test." 42 U.S.C. § 1396d(r). Federal regulatory authority -- which 

the Department admits is controlling -- further refines this testing 

directive as to young children in conformity with the statute and 

current scientific knowledge to require participating providers to 

"[s]creen all Medicaid eligible children ages 1-5 for lead 

poisoning," and to conduct this screen by using a lead blood test. 

The Department, however, refuses to require periodic lead 

blood tests for eligible young children; rather, it takes the 

position that health care providers need only conduct an oral 

examination concerning a Medi-Cal eligible child, making no 

differentiation as to its special legal duty for children ages 1-5. 

This construction treats the specifically articulated federal 

requirements as if they had never been drafted. Furthermore, it is 

at war with undisputed medical facts: young children are especially 

vulnerable to lead, and lead poisoning, because it is asymptomatic 

in its early, still reversible stages, cannot be detected without a 

blood test. 

Because the Department contends that lead blood assessments 

are not mandatory, these tests are virtually never performed in 

California. During the last six months of 1990, for example, the 

Department tested only .0002% of the eligible children below age five 

  

 



  
  

living in the,State, As a result, tens of thousands of young 

children are needlessly placed at risk ofTiead poisoning each year, 

victims of a preventable disease that state and federal officials 

have called "the number one environmental health hazard facing 

children."! And the tragic effects of the disease are indisputable: 

decreased intelligence, impaired nervous system and cognitive 

development, kidney disease, anemia, sterility, convulsions, coma, 

and even death. 

Under the circumstances, and in the absence of a dispute 

as to any material fact underlying the legal claims that give rise 

to this motion, summary judgment is appropriate in this case. 

STATEMENT OF THE CASE 
  

A. California’s Medicaid Program 
  

In 1965, Congress enacted Title XIX of the Social Security 

Act, 42 U.S.C. §§ 1396 et seg., establishing a cooperative federal- 

state medical assistance program for the poor. See Beltran v. Myers, 
  

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

462 U.S. 1134 (1983). Commonly known as "Medicaid," each state's 

standards for providing assistance must be consistent with the 

"objectives of the Act," 42 U.S.C. § 1396a(a)(17), and must meet the 

"requirements imposed by both the Act itself and by the Secretary of 

Health and Human Services." Schweiker v. Gray Panthers, 453 U.S. 34, 
  

36-37 (1981). Seas 42 U.S.C. § 1398a. 

Federal law requires states participating in the Medicaid 

  

: Declaration ("Dec.") of Dr. John F. Rosen at 9¢ 4 
(Exhibit A, hereto); CHDP Provider Information Notice #91-6 from 
Director Kenneth Kizer to CHDP Providers Re: Lead Poisoning in 
Children « (March 12, 1991) (hereinafter "CHDP Provider 
Information Notice #91-6") (Exhibit C, hereto). See also Dr. 

  

Herbert L. Needleman Dec. at § 3 (Exhibit B, hereto). 

  

 



  
  

program to provide recipients with certain "essential" services, H.R. 

Rep. No. 213, ¥3th Cong., 1st Sess. 9-109 70 (1965), including a 

disease prevention program for children under age 21 called the Early 

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

42 U.S.C. 8§§ 139%6a(a)(43), d(a)(4)(B), and d(r). See Mitchell wv. 
  

Johnston, 701 F.2d 336, 340 (5th Cir. 1983); Stanton v. Bond, 504 
    

F.2d 1246 (7th Cir. 1974) (discussing mandatory nature of EPSDT 

benefit and specifically mentioning need for early detection and 

treatment of lead poisoning). Laboratory tests, including lead blood 

level assessments, are a required EPSDT benefit. 42 U.S.C. § 

1396d(r)(1) (iv) and, therefore, should be a component of California's 

Medicaid program. 

The State of California has elected to participate in the 

Medicaid program and, to that end, has established the California 

Medical Assistance Program, known as "Medi-Cal" and administered by 

DHS. Cal. Welf. & Inst. Code §§ 14005.1, 14090.1, 14051. DHS calls 

its EPSDT screening program the Child Health and Disability 

Prevention ("CHDP") Program. Calf. Welf. & Inst. Code § 10721; Cal. 

Health & Safety Code §§ 320 et seq. 

B. The Problem of Childhood Lead Poisoning 
  

DHS concedes that "lead poisoning is the most significant 

environmental health problem facing California children today[.]"? 

The problem exists because lead is pervasive in our society =-- in 

paint, gasoline, drinking-water pipes, printing inks, pigments used 

in toys, fertilizers, food cans, and soil. Rosen Dec. at § 5 

(Exhibit A, hereto). Poor and minority «children are 

  

2 

hereto). 
CHDP Provider Information Notice #91-6 (Exhibit C,   
 



  
  

disproportionataly affected by lead because they are more likely to 

live or visit older homes and homes with peeling paint, live with an 

adult who is exposed to lead, or live and play near industries likely 

to release lead. 1Id.; Needleman Dec. at § 3 (Exhibit B, hereto). 

While early lead toxicity is potentially reversible, the 

adverse affects of untreated lead exposure are wide-ranging. 

Needleman Dec. at 99 4-7; Rosen Dec. at 49 6-7. Severe lead exposure 

can cause coma, convulsions, and death. Id. Lower levels adversely 

affect the central nervous system, kidneys, reproductive system, and 

blood system. Id. Even very low blood lead levels are associated 

with decreased intelligence, stature, hearing acuity, and slowed 

neurobehavioral development. Id. Young children are especially 

vulnerable to these effects because their neurologic systems are 

still developing and because they tend to engage in hand-to-mouth 

behavior that leads to ingestion of lead. Needleman Dec. at § 3; 

Rosen Dec. at ¥ 5. 

To complicate matters, children, especially young children, 

generally exhibit no overt symptoms during the early stages of lead 

poisoning. Id.; CHDP Provider Information Notice #91-6 (Exhibit C, 

hereto). Thus, a lead blood level assessment is the only accurate 

and reliable method of screening for lead exposure. Needleman Dec. 

at § 7; Rosen Dec. at § 8. See also Deposition ("Depo.") of Dr. 
  

Maridee Gregory at 32, 43, 46-47; Range Depo. at 36-37. As even 

Defendant Kizer has recognized, "[t]lhe biggest problem is the 

awareness, getting doctors to test kids. . . . You have to test for 

it."? 

  

3 S.Roan, "High Number of Lead Poison Cases Found," L.A. 
Times, Aug. 30, 1990, A3, col. 1 (Exhibit D, hereto).   
 



  

C. Lead Blood Level Assessments Under Medi-Cal 
  

oll oe of the State’s needy, eligible children are 

obtaining lead blood level assessments through the Medi-Cal program. 

During fiscal year 1989-90, for example, only 283 lead blood tests 

were provided to Medi-Cal eligible children under age five.‘ Only 117 

tests were provided to this group of children during the last six 

months of 1990.° By comparison, there were over 570,000 Medi-Cal 

eligible children below age five living in California during this 

time.® | 

Moreover, fully two-thirds of the Medi-Cal reimbursed lead 

level assessments tests were performed in a single county among 

Asian-American children and were given by a single provider,’ called 

an "aggressive" tester by the Department. CHDP Provider Information 

Notice #91-6 (Exhibit C, hereto). Although an estimated 67% of 

African-American inner city children, nationwide, suffer from lead 

toxicity, Rosen Dec. at ¥ 4, only two lead blood tests were provided 

during fiscal year 1989-90 to African-American children under age 

  

‘ DHS, Statewide: Fiscal Year 1989-90 Ethnicity by Age 
Group by Funding Source by Lead Test (Feb. 15, 1991) (Exhibit 
  

  

E, hereto). 

5 DHS, Statewide: July 1990 thru January 1991 Ethnicity 
by Age Group by Funding Source by Lead Test (Feb. 15, 1991) 
  

  

(Exhibit F, hereto). 

5 DHS Medical Care Statistics Section, California's 
Medical Assistance Program Annual Statistical Report Calendar 

  

      Year 1989, at Table 20 (Exhibit G, hereto). 

7 DHS, Fiscal Year 1989-90 Provider Number by Age Group by 
Funding Source by Lead Test: County of Residence = Santa Clara 
  

  

(Feb. 15, 1991) (Exhibit H, hereto).   
 



  
  

five living in Los Angeles County’ -- the county with the highest 

concentration OY African-Americans in the Yate.’ 

Defendant Kizer admits that "insufficient consideration" 

is presently being given to lead poisoning during EPSDT evaluations 

and that "essentially no routine childhood screening for lead ha[s] 

been conducted in California since the late 1970’s." CHDP Program 

Information Notice #91-6 (Exhibit C, hereto). Persons in the 

Department responsible for the EPSDT/lead assessment program concede 

they have no idea of the numbers of children who obtain lead blood 

level assessments, nor have they made any inquiry to discern the 

numbers of tested or affected children. Range Depo. at 28-33, 38 

(Exhibit J, hereto); Gregory Depo. at 23-24, 28 (Exhibit K, hereto). 

  

$ DHS, Fiscal Year 1989-90 Ethnicity by Age Group By 
Funding Source by Lead Test: County of Residence = Los Angeles 

(Feb. 15, 1991) (Exhibit I, hereto). 

9 

  

  

DHS Medical Care Statistics Section, California Medical 
Assistance Program Annual Statistical Report Calendar Year 1989, 

  

  

at Table 29 (Exhibit G, hereto). 

  

 



  

ARGUMENT 
  

I. THE ®. MEANING OF THE oe» ACT, AUTHORITATIVELY 

CONSTRUED, REQUIRES BLOOD LEAD TESTING OF ALL ELIGIBLE 

CHILDREN AGES ONE TO FIVE. 

  

  

  

Construction of a congressional statute or its implementing 

regulations starts with the plain meaning of the law. Pottgieser v. 
  

Kizer, 906 F.2d 1319, 1322 (9th Cir. 1990); Citizens Action League 
  

v. Kizer, 887 F.2d 1003, 1006 (9th Cir. 1989). This plain meaning 
  

  

controls unless Congress has clearly expressed a contrary legislative 

intention. United States v. 594,464 Pounds of Salmon, 871 F.2d 824, 
  

825-26 (9th Cir. 1989). 

Lead blood level assessment of Medicaid recipient children 

is required by the plain terms of the Medicaid Act as recently 

amended and authoritatively construed. The EPSDT Program, which was 

created by 1967 amendments to Title XIX of the Social Security Act, 

"is the most important publicly-financed preventive child health 

program ever enacted by Congress, and the benefits that it offers are 

unparalleled." Health Care Coverage for Children: Hearing Before the 

Senate Committee on Finance, 101st Cong., lst Sess. 24 (statement of 

Kay A. Johnson, Director, Children’s Defense Fund Health Division) 

(June 20, 1989) (Exhibit L, hereto). EPSDT requires mandatory, 

medical screening for poor children to diagnose their "physical or 

mental defects" as early as possible. 42 U.S.C. § 1396d(a)(4)(B) 

("EPSDT statute"). 

In 1989, Congress noted that the increasing numbers of poor 

children mean that the "EPSDT benefit will become even more important 

to the health status of children in this country." Report of the 

House Budget Committee on H.R. 3299 (Sept. 20, 1989), reprinted in 
  

Medicare & Medicaid Guide (CCH), Extra Edition No. 596 (Oct. 5, 1989) 
  

  

 



  

at 398 (Exhibit M, hereto). Thus, it amended the EPSDT statute to 

add a new definTtional subsection requiring, in part, that screening 

"shall at a minimum include . . . laboratory tests (including lead 

blood level assessment appropriate for age and risk factors)." 42 

U.S.C. § 1396d(r)(l)(iv). That Congress specifically mentioned lead 

blood laboratory testing in the Medicaid Act as the only statutorily 

required laboratory test illustrates its importance: because, for the 

most part, Congress has chosen instead simply to list broad 

categories of services (e.g., hospital services, physician services, 

laboratory tests) rather than enumerate specific procedures by name. 

Compare 42 U.S.C. § 1396d(r)(1)(iv) with 42 U.S.C. §§ 1396 et. seq. 

The Health Care Financing Administration ("HCFA") of the 

United States Department of Health and Human Services ("HHS"), which 

administers the EPSDT program, issued changes to the State Medicaid 
  

Manual to implement the 1989 amendments. Those changes further 

defined the timing and nature of the statutory screening requirement 

in light of current scientific knowledge: 

Appropriate Laboratory Tests. Identify as statewide 
screening requirements, the minimum laboratory tests or 
analyses to be performed by medical providers for 
particular age or population groups.... As appropriate, 
conduct the following laboratory tests: 

1. Lead Toxicity Screening. - Where age and risk factors 
indicate it is medically appropriate to perform blood level 
assessments, a blood level assessment is mandatory. Screen 
all Medicaid eligible children ages 1-5 for lead poisoning. 
Lead poisoning is defined as an elevated venous blood lead 
level (i.e., greater than or equal to 25 micrograms per 
deciliter (ug/dl) with an elevated erythrocyte 
protoporphyrin (EP) level (greater than or equal to 35 
ug/dl of whole blood). In general, use the EP test as the 
primary screening test. Perform venous blood measurements 
on children with elevated EP levels. 

  

  

  

  

  

HCFA, State Medicaid Manual, § 5123.2(D) (incorporating revisions 
  

contained in HCFA transmittals of April and July 1990) (emphases     
 



  
  

added) (Exhibit N, hereto). 

DHS itself admits that it is bound by the Manual'’s terms, 

see Range Depo. at 34-35, 46 (Exhibit J, hereto); Gregory Depo. at 

62-64 (Exhibit K, hereto). DHS also admits that the specific 

portions of the Manual quoted above dictate how the Department must 

screen children for lead. Range Depo. at 46 ("Q.: But, I take it, 

with respect to them [the specific provisions quoted above] as 

guidelines, you would take them as controlling the way you carried 

out your duties; is that right? A: Yes."). The State Medicaid 
  

Manual, moreover, has been recognized by the courts as the 

authoritative regulatory guidance on implementation of the Medicaid 

Act's requirements and, as such, binding on participating states. 

See, e.q., California Department of Health Services Vv. United States 
  

  
Department of Health and Human Services, 853 F.2d 634, 640 (9th Cir. 

1988) ("Even though State sets forth a reasonable argument . . . the 

‘interpretation of an agency charged with the administration of a 

statute is entitled to substantial deference’ [citations omitted]."). 

These authorities unequivocally establish the Department’s 

duty to provide lead blood level assessments, and the Department’s 

failure to do so cannot be reconciled with its legal obligations 

  

  

  

    

  

under the Medicaid program. 

11. THE PLAIN MEANING OF THE MEDICAID ACT IS CONFIRMED BY THE 

LEGISLATIVE HISTORY OF THE EPSDT STATUTE, AS WELL AS BY 

LONGSTANDING REGULATORY AND MEDICAL GUIDANCE. 

The federal courts have long recognized that consideration 

of legislative history is inappropriate where, as here, the statutory 

language is plain and unambiguous. See, e.qg., American Tobacco Co. 

v. Patterson, 456 U.S. 63 (1982). In this case, however, the 

legislative history reinforces and confirms the statute’s terms.   
 



  

Indeed, the 1929 amendment to the EPSDT statute on mandatory lead 

level assessments codified and expanded almost two decades of 

regulatory development in the area of lead testing of young children. 

Congress enacted the underlying EPSDT statute with a broad 

remedial intent to "discover, as early as possible, the ills that 

handicap our children." President Lyndon B. Johnson, Welfare of 
  

  

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

During hearings on the legislation, HEW Secretary John Gardner 

explained that "under our proposed amendments, all children in low- 

income or medically indigent families would be assured periodic 

screening. . . , particularly in the preschool years." Hearings on 
  

H.R. 5700 Before the House Committee on Ways and Means, 90th Cong., 
  

) Sess., Pt. 1,.8t 189 (1967). 

Although the EPSDT statute did not specify blood lead level 

assessments, such assessments have consistently been recommended by 

federal EPSDT program regulators for 17 years before the 1989 

amendment, with the recommendations becoming generally more rigorous 

over time. In 1972, the Department of Health, Education and Welfare 

("HEW"), predecessor agency to HHS, included a discussion of the 

EPSDT program as part of the Medical Assistance Manual, the 
  

predecessor to the HCFA State Medicaid Manual. HEW, Medical 
  

Assistance Manual § 5-70-00 (June 28, 1972) (Exhibit O, hereto). 
  

  Under the heading "Lead Poisoning Screening," the Program Regulation 

Guide contained a specific recommendation, but not a directive, that 

  

1 president Johnson originally proposed the EPSDT program 
as part of a comprehensive package of programs for children, 
pointing out that over 3.5 million medically-needy children 
under five did not receive help under public medical care 
programs and that over a million more children needed treatment 
under the crippled children’s program. 

10   
 



  
  

all young chilgaen should be periodically gareened and older children 

as medically indicated for a "determination of blood lead levels" in 

order "to identify which children may have had undue exposure to 

lead-based paint and other sources of lead poisoning." Id. at § 5- 

70-20. See also id. at 5-70-20E.4.E. The recommendation for testing 
  

of all young children was carried forward in subsequent editions 

until the recommendation was changed to a directive after the 1989 

amendments to the EPSDT statute.' 

Other regulatory or medical guidance was initially narrower 

in scope, but subsequently broadened. The American Academy of 

Pediatrics and HEW published A Guide to Screening-EPSDT Medicaid (HEW 
  

1974), which recommended repeated lead screening of all children ages 

one to three who lived or frequented older homes or were exposed to 

industrial pollution. Id. at 188 (Exhibit Q, hereto). The Guide 

recommended two blood tests as the "methods for use in screening for 

undue lead absorption." Id. at 189. 

In 1977, however, an HEW Information Memorandum amended the 
  

Guide to abandon a selective testing approach, recommending screening 

2 
of all children ages one to three.!? After noting that excessive lead 

  

11 
    

See, e.q. HCFA, State Medicaid Manual § 5122.5.d (April 
1988) ("All EPSDT eligible children, ages 1-5 should be screened 
for lead toxicity, using the erythrocyte protoporphyrin (EP) 
test as the primary screening test.") (Exhibit P, hereto). HCFA 
also issued regulations to implement the EPSDT program in 1984 
which included within the screen "appropriate laboratory tests," 
42 C.F.R. § 441.56{(P)(1)(v). This regulation has been 
interpreted by at least one court to require lead poisoning 
screening. New York City Coalition to End Lead Poisoning Vv. 
  

Koch, 524 N.Y. 8.24 314, 318-19 (S.Ct. 1987). 

12. HEW, Information Memorandum, "New Technology Available 
in the Screening and Detection of Lead Poisoning and EPSDT" (1M- 
77-32(MSA)) (June 9, 1977), reprinted in Medicare & Medicaid 
Guide (CCH) ¥ 28,505 (Exhibit R, hereto). 

  

  

11   
 



  
  

exposure "can god does have serious and yr - irreversible effects 

on the development of the central nervous system" of younger 

  
children, the Information Memorandum declared that most poisoned 

children "do not have overt symptoms of the disease [which] . . . can 

only be detected by screening the child" and that, "the majority of 

the children served by the EPSDT Program are in the high risk group" 

of those who live in or near poorly maintained old housing. Id. The 

Information Memorandum, therefore, recommended that all young 
  

children would be tested at least once using the then-newly developed 

and inexpensive erythrocyte protoporphyrin ("EP") blood test. 

The same year the Information Memorandum was issued, the 
  

Academy of Pediatrics and HEW prepared A Guide to Administration, 
  

Diagnosis and Treatment for the EPSDT Program under Medicaid (HEW 
  

1977) (Exhibit S, hereto) as a revision of the 1974 Guide. Because 

"[c]lassical symptomatic lead poisoning is generally not seen," the 

Guide to Administration recommended that all children through five 
  

years of age as a routine matter should receive an EP blood test for 

lead poisoning. Thus, when Congress considered the 1989 amendments, 

both the federal EPSDT regulators and the Academy of Pediatrics 

recommended blood lead level testing of all young children. 

The legislative history of the 1989 amendments clearly 

indicates congressional intent generally to codify and expand the 

mandatory elements of the EPSDT program. Recognizing that “the 

benefit package has never been described in detail in the statute,” 

Congress explained that "many [states] still do not provide to 

children participating in EPSDT all care and services allowable under 

federal law." 135 Cong. Rec. S 13233 (October 12, 1989) (Exhibit T, 

hereto). The House Committee Report, therefore, required that 

12 

  

 



  
  

"screening serygces must, at a minimum, include . . . laboratory 

tests (including blood lead level assessment appropriate for age and 

risk factors)." Report of the House Budget Committee on H.R. 3299 

(Sept. 20, 1989), reprinted in Medicare & Medicaid Guide (CCH), Extra 
  

Edition No. 596 (Oct. 5, 1989) at 398 (Exhibit M, hereto). The 

Conference Committee, following the House bill, noted with approval 

that the House bill had "codified the current regulations on minimum 

components of EPSDT screening. . . with minor changes," but 

"provide[d] that screening must include blood testing when 

appropriate." Explanation of the Conference Committee Affecting 

Medicare-Medicaid Programs Re: Omnibus Budget Reconciliation Act of 

1989 (H.R. 3299), reprinted in Medicare & Medicaid Guide (CCH), Extra 
  

Edition No. 603 (Dec. 15, 1989) at 453 (emphasis added) (Exhibit U, 

hereto). 

This legislative history is fully consistent with the plain 

meaning of the law. From the inception of the EPSDT program, changes 

in requirements for health care providers have all been in the 

direction of expanding recommendations for testing so as to prevent 

or treat lead poisoning at the earliest stage feasible. As 

longstanding medical guidance makes clear, this objective can only 

be met in the area of lead poisoning in young children by using a 

blood level assessment. Any construction of statutory requirements 

to mean less than blood level testing of all Medi-Cal eligible young 

children would be contrary to two decades of regulatory development, 

capped by the 1989 Congressional amendments and authoritative 

construction of the statute contained in the State Medicaid Manual. 
  

III. THE DEPARTMENT'S INTERPRETATION IS ARBITRARY. 
  

DHS contends that, under the Medicaid Act, a doctor need 

13   
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S
 
 
A
A
A
A
A
 

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only conduct a verbal screen of the child and that lead blood 

assessments, however valuable, are simply a matter of discretion. 

Range Depo. at 47, 54-55 (Exhibit J, hereto) ("Providers are 

requested or directed to assess all children for risk of lead burden” 

but have not been given the specific questions to ask). 

The Department’s position is invalid because it is "not 

reasonably related to the purposes of the statute [and directives] 

it seeks to implement." Vierra v. Rubin, 915 F.2d 1372, 1376-80 (9th 
  

Cir. 1980). See Pacificorp v. Bonneville Power Admin., 856 F.2d 94, 
  

97 (9th Cir. 1988); cf. Oregon 0O.B.O. Oregon Health Services v. 
  

Bowen, 854 F.2d 346, 350 (9th Cir. 1988)." Particularly in the area 

of health and human services, courts in this circuit have often 

invalidated departmental constructions of statutes and regulations 

that collide with legislative purpose. See, e.q., Vierra v. Rubin, 
    

915 F.2d at 1376 & n.2 (and cases cited therein); Pottgieser v. 
  

Kizer, 906 F.2d 1319, 1323 (9th Cir. 1990); Delaney v. E.P.A., 898 
  

F.2d 687 (9th Cir. 1987); Clark v, Rizer, 758 F.Supp. 572 (E.D. Cal. 
  

1990). 

  

> Here, deference to DHS’s position is doubly unwarranted 
because neither the EPSDT statute nor the State Medicaid Manual 
delegates authority to the states to define or otherwise 
determine for themselves what constitutes a screen for Medicaid 
eligible children ages 1-5 for lead poisoning. See, e.q., 
Kenaitze Indian Tribe v. State of Alaska, 860 F.2d 312, 316 (9th 
Cir. 1988)("Most fundamentally, unlike a federal agency, the 
state is delegated no authority [by the statute] .... Deference 
is not appropriate”). While state Medicaid agencies do have 
flexibility in deciding which groups of the poor they will 
cover, 42 U.S.C. §§ 1396a(a)(10), what optional services they 
will offer, 42 U.S.C. §§ 1396a(a)(10) and 1396(d), and, to a 
certain extent, which income and resource eligibility standards 
they will use, 42 U.S.C. §§ 139%6a(a)(10)(c) and (a)(17), no room 
is left for the possibility of fifty possibly widely divergent 
approaches to medical screens for the national problem of lead 
toxicity in young children. 

  

  

  

14   
 



  

  

In this case, the Department’s cgatention that a minimally 

adequate lead SCreening program need not =nclude lead blood level 

assessments is arbitrary on its face. First, this position is 

dangerously at odds with the nation’s principal experts in the 

subject area of lead toxicology who uniformly agree that screening 

for lead poisoning in young children requires, at minimum, periodic 

determinations of blood lead levels, impossible without measurement 

of blood lead content.'* As explained by Dr. John F. Rosen, Chairman 

of the Centers for Disease Control’s Advisory Committee on Childhood 

Lead Poisoning Prevention: 

7. Most [lead] poisoned children ... have no 
symptoms. As a result, the vast majority of lead 
poisoning cases go undiagnosed and untreated. 
Because of this and the fact that early lead 
toxicity is reversible, monitoring of blood lead 
levels of young children through periodic 
screening is absolutely essential. Once 
detected, lead poisoning and related health 
effects can often be treated and, in many cases, 
measures can be undertaken to detect and 
eliminate the source of exposure. Screening 
programs have had a tremendous impact on reducing 
the occurrence of symptomatic lead poisoning in 
the United States. 

8. Measuring blood lead content is the most 
accurate and reliable method of screening for 
recent lead exposure. Blood lead level testing 
is essential to adequate lead screening programs, 
in part because an oral assessment of risk 
factors is totally unreliable to identify 
toxicity in young children. Only direct 
measurements of lead in blood can establish the 
presence or absence of recent excessive exposure. 
For all children, I am not aware of any protocol 
for lead screening satisfying accepted 
professional standards that fails to include 
periodic blood lead level tests. In my opinion, 
periodic screening by blood lead measurement 

  

  

  

  

  

  

  

  

    "* When it amended the EPSDT statute in 1989, Congress 
noted the importance of expert opinions when determining 
appropriate preventive child care. 42 U.S.C. §1396d(r)(1)(A)(1) 
requires consultation with "recognized" medical organizations). 

15   
 



  

shoulg be conducted at least onge per year for 
any ld under the age of six b use virtually 
all young children -- especially those who are 
poor -- are at risk for lead poisoning. For 
children considered to be at high risk for lead 
exposure due to positive testing results or 
environmental or other factors, blood lead 
testing should be conducted, at the very least, 
every three to six months. To do otherwise would 
be unconscionable in light of what we now know 
of the effects of lead at relatively low exposure 
levels. 

  

  

  

Rosen Dec. at 991 7-8 (emphasis added) (Exhibit A, hereto). See also 
  

Needleman Dec. at § 7 (Exhibit B, hereto) ("A lead screening program 

that failed to require such periodic lead blood testing would, in my 

opinion, be both unsound and inadequate"). 

Second, the Chief of the California Children Services 

Branch of the Department, Dr. Maridee A. Gregory, admitted that "the 

routine type of screening that is done" in California --the mere use 

of physician interviews -- "might not find anything because of the - 

- type of screening that’s being done," Gregory Depo. at 43 (Exhibit 

K, hereto), and that "blood lead is the definitive test." Id. at 

46." 

Ruth Range, Chief of the State’s Regional Operations 

Section of CHDP, conceded similarly that the purpose of the EPSDT 

program as it relates to exposure to lead for Medi-Cal eligible 

children is "[t]o identify any child with an elevated blood lead 

level, and treat and remove that lead from the environment." Range 

    15 She stated that in separate DHS studies of lead 
poisoning in young children in California communities of 
Oakland, Wilmington, and Compton, unrelated to the EPSDT 
program, blood lead level screens were automatically 
administered to all children, explaining that "[w]henever you're 
assessing or truly trying to evaluate whether a child has a lead 
problem, you have to do blood lead." Id. at 46 (emphasis 
added). 
  

16   
 



  
  

Depo. at 31 (Exhibit J, hereto). Range defined "elevated blood 

level" as anytiiing more than 25 microgram® of lead per deciliter of 

blood, id. at 31-32, a circumstance that is discernible only with 

laboratory testing. She further testified that between 25-50 

micrograms per deciliter, a child suffering from lead poisoning 

"would not be necessarily symptomatic," and below 25 would 

"[p]robably not [be symptomatic], or they would be very subtle,” 

defining this latter condition as "[p]robably symptomatology that 

would not be identified as resulting from lead." Id. at 36. See 

also id. at 37 (testifying as true for children below the age of 

five). 

Third, the Department’s position that it need only ask 

unspecified questions of all eligible children and their families is 

unacceptable because it ignores entire portions of the State Medicaid 
  

Manual’s screening requirements for young children. Under the 

Department’s protocol, children ages one through five are "screened" 

for lead poisoning in just the same way as children ages six and 

above; DHS thereby interprets the law to prescribe no different 

procedures for separate age classifications of eligible children. 

Pursuant to DHS’s construction, therefore, the screening sentence 

might as well be deleted or amended simply to read, "[s]creen all 

Medicaid eligible children." The State Medicaid Manual does neither. 
  

If the directive to screen young children means anything, it must 

mean that DHS is required to make distinctions between the screening 

for lead poisoning for children ages 1-5 and that conducted for older 

children. Regulatory language must, of course, be construed so as 

to render no provision surplusage or redundant, and to give effect, 

if possible, to every word used. See Sutherland, 1A Statutory 
  

17   
 



  

  

  

Construction §,31.06 (Sands 4th ed. 1985) ("It is obvious, that 
  

inasmuch as a regulation is a written instlument the general rules 

of interpretation apply."). See, e.9., In re Oxborrow, 913 F.2d 751, 
  

753-54 (9th Cir. 1990); Beisler v. C.F.R., 814 F.2d 1304, 1307 (9th 
  

Cir. 1987); In re Co Petro. Mktg. Group, Inc., 680 F.2d 566, 569-70 
  

(9th Cir. 1982). 

Third, DHS’ interpretation of the State Medicaid Manual 
  

makes no sense because it requires the term "lead poisoning" to mean 

one thing in one part of the provision and something quite different 

thereafter. Specifically, the Wanual states: "Screen all Medicaid 

eligible children ages 1-5 for lead poisoning. Lead poisoning is 

defined as an elevated venous blood lead level ...." HCFA, State 

Medicaid Manual § 5123.2(D) (Exhibit N, hereto). Application of DHS’ 
  

policy, then, finds the term "lead poisoning" to mean a verbal 

examination when it is first used, but to mean a lead blood 

assessment when it is used immediately thereafter. This position 

simply makes no sense. Significantly, "lead poisoning," as 

deliberately defined within the Manual, is a term capable -- indeed, 

only capable -- of determination by means of blood level assessment. 

"Lead poisoning," as thus specified within the Manual, can never be 

ascertained unless a medical blood test is administered to discover 

whether there actually exists "an elevated . . . blood lead level" 

above a designated microgram per deciliter standard. Especially 

where, as DHS concedes, lead poisoning in young children may well be 

asymptomatic, no mechanism short of blood analysis for lead content 

can ever truly achieve the objective of "[s]creen[ing] ... for lead 

poisoning" as so fixed by the Manual’s definition. It is certainly 
  

no accident, therefore, that the lead screening paragraph appears in 

18   
 



  

  

the section entjtled "appropriate laboratory tests.” To adopt a 

different definition of "lead poisoning," as Giecessarily follows from 

DHS’ definition of screening when applied to young children, 

therefore, impermissibly frustrates the deliberate policy of the 

Manual. See Vierra v. Rubin, 915 F.2d 1372, 1376-80 (9th Cir. 1980); 
  

Marksir, Inc..yv. C.A.B., 744 F.2d 1383, 1385 (Sth Cir. 1984). 
  

  

Finally, DHS’ view does not comport with the "minimum 

Federal requirements" articulated in a letter dated April 11, 1991 

from Charles Woffinden, Chief of the HHS Medicaid Operations Branch 

to the California CHDP Branch. (Exhibit V, hereto). In it, the HHS 

official described what he deemed compliance with the EPSDT statute 

and the cited HCFA transmittals. Although not entitled to deference, 

and even though apparently misinformed as to DHS’s actual practice, 

the letter is nevertheless instructive regarding HHS’ candid view of 

the "minimum Federal requirements" that "all Medi-Cal eligible 

children ages 1-5 are to be screened for elevated blood lead levels 

through the performance of an ‘FEP’ test."'S 

Under these circumstances, the Department’s refusal to 

  

18 Subsequent to this letter, counsel for the Department 
apparently had a discussion with an employee of HHS, Gregory 
Depo. at 58-59, which resulted in issuance of a second letter, 
which appears to reverse the opinion stated in the first letter 
in light of the discussion with DHS counsel. Letter from 
Charles A. Woffinden, Chief HHS Medicaid Operations Branch, to 
Michael Quinn, Research Manager CHDP (May 7, 1991) (Exhibit W, 
hereto). Although no explanation for the change in position is 
given, the letter concludes that the Department meets "minimum 
Federal requirements" even though it "does not routinely perform 
the FEP test for all children 1-5 years of age." Id. This 
letter is clearly entitled to no deference from this Court. It 
was only written for purposes of this litigation; moreover, it 
lacks the candid appraisal of the Department’s lead policy that 
was reflected in HHS’ earlier letter. See, e.q., Citizens 
Action League v. Kizer, 887 F.2d 1003, 1007 (9th Cir. 1989) 
(letter written for purposes for litigation entitled to no 
deference). 

  

  

19   
 



test poor, young children for lead poisoning is entitled to no 

deference. Ny as a matter of clear st®Rutory interpretation, 

  

3 longstanding medical standards, and common sense, its self- 

serving construction of its obligations under federal law must be 

  

4 

5 rejected and summary judgment granted in favor of plainciffs.V 

6 CONCLUSION 

. For the reasons set forth above, plaintiffs respectfully 

g [request that this Court grant their Motion for Summary Judgment 

9 and enter the accompanying proposed order. 

  

Dated: May 43, 1991 Respectfully submitted, 

1 Natural Resources Defense Council 
12 National Health Law Program 

ACLU Foundation of Southern California 
13 NAACP Legal Defense and Educational Fund 

Legal Aid Society of Alameda County 
14 ACLU Foundation of Northern California 

15 By: (pel R Cenoldds ap 
Jéel R. Reynolds 
Natural Resources Defense Council 16 S 

17 By: Qin onto oni 
(Jans Perkins 
ational Health Law Program 

3% By: 72 Jeok DD Foson bucive sor 
Mark D. Rosenbaum 
ACLU Foundation of Southern California 

20 By: Bell ofan Aoi 
Bill Lann Lee a ” 

  

  

  

  

2) NAACP Legal Defense and Educational Fund 

22 By: Ale (zl of 
23 Kim Card 

Legal Aid Society of Alameda County 

24 

25 
'” See Fed. R. Civ. P. 56(d); Retail Clerks Union Local 

261648, AFL-CIO v. Hub Pharmacy, Inc., 707 F.2d 1030, 1033 (9th 
Cir. 1983). See also Celotex Corp. v. Catrett, 477 U.S. 31%, 

2701323 (1966) (moving party may rely upon "the pleadings, 
depositions, answers to interrogatories, and admissions on file, 

28 ltogether with the affidavits, if any"). 

  

  

  

20