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

    1 { DANIEL E. LUNGREN, Attorney General 
of the State of California 

2 | CHARLTON G, HOLLAND, III 
Assistant Attorney General 

3. > Supervising Depuy A o 
u or ttorney Genera 

4 NE 
Deputy es General 

5 {1 2101 Webster Street, 12th Floor 
| Oakland, California 94612-3049 
6 Telephone: (415) 464-1173 

7 || Attorneys for Defendant 

8 UNITED STATES DISTRICT COURT 

iy NORTHERN DISTRICT OF CALIFORNIA 

10 

11 || ERIKA MATTHEWS AND JALISA ) No, C 90 3620 EFL 
MATTHEWS, by their guardian ad litem Lisa ) 

12 {| Matthews, and PEOPLE UNITED FOR A MEMORANDUM OF POINTS 
BETTER OAKLAND, On Behalf of AND AUTHORITIES IN 

13 || Themselves and All Others Similarly Situated, ) OPPOSITION TO PLAINTIFFS’ 
) MOTION FOR PARTIAL 

14 Plaintiffs, : SUMMARY JUDGMENT 

15 v. Date: June 21, 1991 
Time: Lo 00 AM 

16 | MOLLY COYE, MD I Director, California ) 
is Department of Health Services, 

Defendant, ) 
18 ) 

19 
oe INTRODUCTION 

x The issue raised by this case is whether the applicable statutory and 

” regulatory language of the Medicaid (or Medi-Cal) program requires a laboratory 

” testing of the blood of all Medi-Cal eligible children under the age of six for the 

5 presence of lead, Plaintiffs claim that such tests are required; the Defendant maintains 

that they are not. 
25 
” It is important to recognize that all parties are in agreement that lead 

27 | 
28 | 25(0) 1. Substituted for KENNETH W. KIZER, M.D., M.P.H., pursuant to F.R.C.P. 

DEFENDANT'S MPA (N OPPOSITION TO PLAINTIFFS: 1 
MOTION FOR PARTIAL SUMMARY JUDGMENT ;       

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poisoning is the most significant environmental health problem facing California 

children today and that early detection of elevated blood lead levels in young children 

is of singular importance in preventing or ameliorating a number of debilitating 

conditions which can last a lifetime. Plaintiffs believe that the law and good medical 

practice require universal blood lead testing of Medi-Cal children as a part of the Early 

and Periodic Screening, Diagnostic and Treatment (“EPSDT") Program; the 

Department of Health Services, however, maintains that while such children must be 

screened for risk of lead exposure (ie. the examining physician must physically 

examine the child for indications of lead poisoning and conduct appropriate inquiries 

into aspects of the child's medical history, environment and lifestyle which could - 

indicate a possibility of exposure to unhealthful amounts of lead) the decision of | 

whether or not to conduct an actual blood test is ultimately to be made by the | 

physician, 

As shown more fully below, the fundamental error of Plaintiffs’ arghment 

that universal testing is required lies in the fact that at each instance they simply! ignore 

or gloss-over the conditional language in the applicable statute and regulations, and set 

forth as canon that which is simply commentary, A brief but thorough examination of 

‘the language relied upon by Plaintiffs (with the conditional or modifying language 

highlighted) demonstrates the error of their arguments. 

Further, as the Court recognized at the April 8, 1991, Status Conference, 

the first question raised in this case -- and the one posed by Plaintiffs’ Motion for 

Summary Judgment -- is fundamentally one of law. Defendant believes that a decision 

against granting Petitioners a partial summary judgment would, of necessity, make the 

grant of a complete summary judgment in favor of the Defendant highly appropriate. 

Accordingly, the Court is requested to treat this reply as a cross-motion for summary 

judgment on behalf of Defendant. 

[11] 

3.4 

DEFENDANT'S MPA IN OPPOSITION TO PLAINTIFFS a 
MOTION FOR PARTIAL SUMMARY JUDGMENT : 

81, 18san PAGE. B03 

  

 



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THE STATUTE DOES NOT REQUIRE LEAD BLOOD TESTING IN ALL IN STANCES 

A detailed treatise on the Medicaid/Medi-Cal law is unnecessary. As 

noted by Plaintiffs it is a joint Federal--State program providing certain basic health 

care services to those otherwise unable to afford them. The cost of the program is 

equally shared by the Federal and State governments, and the program is administered 

by the State according to Federal statutes, rules and regulations. | 

The sole statutory provision relied upon by Plaintiffs is found at 42 USC 

§ 1396d(r)(1)(B)(iv), a definitional section, which provides that EPSDT screening 

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

level assessment appropriate for age and risk factors) . . .." This quoted langudge is 

the hinge upon which Plaintiffs’ case swings -- and indeed it is a hinge for the 

highlighted language obviously allows for flexibility and movement, discretion and 

judgment on the part of the examining physician. Were this not so the highlighted 

language would be pure surplusage and an insult to the intelligence of the medigal 

community If the Congress had intended universal lead blood level assessments for 

EPSDT children it would not have inserted the phrase "appropriate for age and risk 

factors;" ending the parenthetical after the word “assessment” would have accomplished 

such a purpose. Similarly, if universal testing was intended only for the very young 

(i.e., under age six) EPSDT children the parenthetical would have stopped immediately 

after the phrase "appropriate for age;" the inclusion of the words "and risk factors" 

would seem to manifest a legislative understanding that this nation’s medical 

establishment has both the wisdom and integrity to do the right thing, as well asithe 

COMMON Sense not to waste the taxpayers’ money on laboratory tests for which there is 

  

2. Obviously no physician needs to be told to perform an "appropriate" test, or by 
implication not to perform an "inappropriate" test. "[A]ppropriate for age and risk 
factors” can only logically mean that a lead blood level assessment is only required 
when age and risk factors so indicate in the examining physician's best medical 
judgment, 

DEFENDANT'S MPA IN OPPOSITION TO PLAINTIFFS’ 
MOTION FOR PARTIAL SUMMARY JUDGMENT      



  

  

  

  

1 || no indication of need? 

2 Plaintiffs’ reliance on legislative history to buttress their position is equally 

3 || unavailing. Both the September 20, 1989, House Budget Committee Report on H.R. 

4 || 3299 (Plaintiffs’ Exhibit M) and the Conference Committee Report published 

5 || December 15, 1989 (Plaintiffs’ Exhibit U), contain conditional (or conditioning) phrases 

6 || such as "appropriate for age and risk factors" and "when appropriate.” These reports 

7 || can hardly be said to support the non-discretionary rule advocated by Plaintiffs. 

8 1 

9 | THE STATE MEDICAID MANUAL DOES NOT MANDATE UNIVERSAL TESTING 

10 The Health Care Financing Administration's State Medicaid Manual, § 

11 || 5123.2.D.1 is found at pp. 5-14 and 3-15 of Plaintiffs’ Exhibit N, Plaintiffs quote much 

12 || of the language of that section on page 8 of their brief; unfortunately they did not 

13 || quote it all. The ellipsis in the first paragraph of their quoted material stands in the 

14 | stead of two sentences -- one of them quite crucial. 

15 | In full, the section reads: 

16 DD. Appropriate Laboratory Tests.--Identify as statewide 
screening requirements, the minimum laboratory tests or analyses to be 

17 Dertrnd by medical providers for particular age or population groups. 
hysicians providing screening/assessment services under the EPSDT 

18 program use their medical judgment in determining the applicability of 
the laboratory tests or analyses to be performed. If wy laboratory tests | 

19 or analyses are medically contraindicated at the time o 
screening/assessment, provide them when no longer medically 

20 contraindicated, As appropriate, conduct the following laboratory tests: 

21 1. Lead Oddity screening Where age and risk factors 
indicate it is medically appropriate to perform a blood level assessment,’ 

22 a blood level assessment is mandatory. | Cy 
Screen all Medicaid eligible children ages 1-5 for lead 

23 poisoning. Lead poisoning is defined as an elevated venous blood lead 
: A\ 5 level (i.e., greater than or equal to 25 micrograms per deciliter (ug/dl) 

J ~~ 3. Since lead poisoning is a purely environmental illness, if a child manifests no 

J L 26 || symptoms of lead poisoning and there is no indication whatsoever that he or she lives 
ls in a lead-rich environment then a circumstance exists where ". . . pediatricians may 
td 27 prudently consider their patients to be at little risk of lead toxicity . ..." American 

“Nag || Academy of Pediatrics, Statement on Childhood Lead Poisoning [1987] at p. 463, 
YY attached as Exhibit A to Dr. Gregory's Declaration. 

Ns DEFENDANT'S MPA IN OPPOSITION TG PLAINTIFFS i       MOTION FOR PARTIAL SUMMARY JUDGMENT 

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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 level measurements on 
children with elevated EP levels. 

Children with lead Josey require diagnosis and 
treatment which includes periodic reevaluation and environmental 
evaluation to identify the sources of lead. 

Again, one need only consider the regulation in its entirety, and with 

particular attention to the highlighted words to see that the decision as to whether or 

not to use a laboratory test, EP or venous blood, is one that ultimately resides with the 

examining physician, He or she is specifically granted that decision-making authority in 

terms that could not be more clear in the second sentence of the section, 

The fact that the administration of a lead blood test is discretionary with 

the physician is further made clear from a comparison between the language in | 

§5123.2.D relating to "Lead Toxicity Screening" (subsection 1) and the Anemia, Sickle 

Cell and Tuberculin "Test[s]" in subsections 2, 3 and 4, respectively. Not only do the 

regulation writers know the differences between a screening process and a testing 

process, they clearly know how to mandate a test when that is appropriate. ['Give a 

    

  

tuberculin test to every child who has not received one within a ye 

inescapable conclusion is that while 5 for tuberculosis you 

toxicity in all Medicaid eligible childre 

ly screen for|lead 

wnder six and, where medically-appropriate, an 

EP test is used as the primary screening test | 

By happy coincidence this makes eminent good sense. It both credits 

examining physicians with having the intelligence to know when a lead toxicity test is 

indicated (and when it is not), and results in a savings to the American and Californian 

        
4, It is also noted that Plaintiffs imply that New York City Coalition to End Lead 

Poisioning v. Koch, 524 N.Y.S.2d 314, 318-319 (S.Ct. 1987) supports their position that 
laboratory blood lead test is a required component of lead poisoning screening (Brief, 
fn. 11 at p. 11). This is simply not so. All that case stands for with regard to Federal 
regulations is a notation that screening for lead toxicity is required and that Plaintiffs 
therein had stated a cause of action that would withstand the City’s Motion to Dismiss. 
Further, the regulation cited by Plaintiffs herein their footnote 11 (42 C.F.R. § 
441,56[b][1][v]) does not even appear to be cited in the New York Court's opinion. 

DEFENDANT'S MPA IN OPPOSITION TO PLAINTIFFS’ 5 
MOTION FOR PARTIAL SUMMARY JUDGMENT 4 

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taxpayers by not imposing & requirement of performing useless lead blood tests in 

situations where there is no indication whatsoever of actual or potential lead toxicity. 

II 

HCFA SUPPORTS THE DEPARTMENT'S 
POSITION REGARDING LEAD TOXICITY TESTING 

Plaintiffs’ attempt to place the Federal Health Care Financing 

Administration on their side of the ledger is somewhat disingenuous®’ Included as 

Plaintiffs’ Exhibits V and W, respectively, are April 11, 1991, and May 7, 1991, letters 

from Charles Woffinden, Chief of the HHS Medicaid Operations Branch. In bath 

letters he determines that the State is in compliance with applicable minimum Federal 

requirements vis-a-vis lead toxicity screening, clearly reciting the Department's position 

in his second letter which corrects a misunderstanding in the first Plaintiffs’ 

suggestion that HCFA has undergone a "change in position” between the two letters is 

false and misleading -- HCFA would find that the Department was in compliance 

under either set of facts (i.e., screening which included mandatory EP tests or screening 

which did not), 

$41 

  

    

5. The Court's attention is respectfully directed to the accompanying Declarations 
of Dr. Gregory and Ms. Range wherein the Department’s view of good medical 
practice is discussed, and where it is demonstrated that the relief sought by Plaintiffs 
carries with it a considerable price tag. 

6. Brief, at p. 19 

7. Plaintiffs’ reliance on Citizens Action League v. Kizer, 887 F.2d 1003, 1007 (9th 
Cir. 1989) to belittle the significance of HCFA’s support of the Defendant’s position is 
inapposite. Unlike the situation in Cirizens Action League, here the letters on their face 
evince the indicia of deliberative administrative review and understanding of the 
situation. Further, unlike Citizens Action League, HCFA is operating on its own: turf 
dealing in a subject matter "in which the agency possesses specialized expertise” and is 
interpreting its own regulations, Finally, the fact that the letter may have been written 

with this litigation in mind is not disqualifying, and Plaintiffs’ implication that it is 
simply misstates the holding of Citizens Action League. HCFA’s weighing in on the side 
of the Defendant in this litigation is certainly entitled to "considerable deference,” 

DEFENDANT'S MPA IN OPPOSITION TO PLAINTIFFS! 6 
MOTION FOR PARTIAL SUMMARY JUDGMENT 5    



  

  

“ ® : » 

2 THE DEPARTMENT'S POSITION IS CONSISTENT 
WITH ACCEPTABLE MEDICAL PRACTICE 

? Finally, Plaintiffs attempt to show that the Department’s position 

4 regarding lead toxicity sting is arbitrary and out-of-step with accepted medical 

practice. This is simply not true. As shown in Dr. Gregory's Declaration, the 

1 Department's position is consistent with the current position of the American Academy 

7 of Pediatrics, While that position is currently under review, the fact that the Academy 

: recognizes physician discretion in the use of lead toxicity tests for children in and of 

? itself belies any possible conclusion that the Department's position is arbitrary or that it 

2 represents unacceptable medical practice.’ 

¢ Reasonable minds can and do differ regarding the issue of universal 

i mandatory lead toxicity testing for young children, but as of today both the applicable 

4 J statute and regulations vest the decision in the examining physician. While screening of 

os © i EPSDT children under six is required by law, that is all that is specifically required by 

“lr - way of lead screening or testing unless indicated by a child's comprehensive health and 

X as developmental history or comprehensive unclothed physical examination. (See, HCFA 

Y Y State Medicaid Manual, §§5122 and 5123 [at p. 3-9, et seq.].) Thus both the 

NI G@ 2 Department and the regulations distinguish between what is required for children under 

EN 40 six years of age and those over Six.   
Lastly, Plaintiffs’ assertion at page 18 of their brief that the Department 

  

21 | 
5 has conflicting definitions of "lead poisoning” is simply nonsense. Lead poisoning 

% means a quantifible elevated level of lead in the blood. Period. Lead poisoning does 

24 8. It is clear from the respective Declarations of the Plaintiff's Dr. Rosen and the 
»s || Defendant's Dr. Gregory that a debate is currently underway in the American medical 

community’s public health establishments concerning universal childhood lead toxicity 
26 || testing (or some variant thereof). In this debate the Plaintiffs and their experts are 

admitted advocates for mandatory testing, whereas the Defendant as the chief public 
27 || health officer of the nation’s largest State is more clearly akin to a judge in this debate 
»g || OF a decision-maker. One senses a well-intentioned but inappropriate attempt to enlist | 

this Court in a battle within a highly specialized medical community. 

DEFENDANT'S MPA IN OPPOSITION TO PLANTIFFS: 5 
MOTION FOR PARTIAL SUMMARY JUDGMENT       

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not mean "a No A as charged by 9 A verbal examination is 

but one tool used by the examining physician to develop the child's comprehensive 

health and developmental history, which in part determines whether a blood lead level 

test is medically warranted. The Department’s position is fully consistent with sound 

medical practice and the legislative purpose underlying the EPSDT Program. | 

CONCLUSION 

For the reasons advanced above, and for such other reasons as may be 

proper, summary judgment on the question of whether the law requires the | 

Department to mandate universal blood lead testing of EPSDT children under the age 

six should be decided against Plaintiffs and for Defendant, Defendant believes that 

such a decision would in effect end this litigation subject to a possible appeal, 

Dated: June 7, 1991 Respectfully submitted, 

RRL E JNORIR 
Atto CN 

5 ttl 
Deputy Attorney General 

Attorneys for Defendant 

fo:\vmrwyw\ matthews. mipa) 

  

9. Nor does "[a]pplication of DHS’ policy" mean that it "finds the term ‘lead 
poisoning’ to mean verbal examination , . . ." [Brief, at p. 18, 11. 13-13] 

DEFENDANT'S MPA IN OPPOSITION TC PLAINTIFFS’ 8 
MOTION FOR PARTIAL SUMMARY JUDGMENT . 

‘al 18342 PAGE. 8Ao 

  

 



DEC TION OF SERVICE 

  

Case Name: Erika Matthews, et al. v. Molly Coye 

Court No: U.S.D.C., Northern District No. C-90-3620 EFL 

I declare that: 

I am employed in the County of Alameda, California. I am over the age of 18 years 
and not a party to the within entitled cause; my business address is 2101 Webster Street, 
12th Floor, Qakland, California 94612-3049, 

On June 7, 1991, 1 served the attached 
  

MEMORANDUM OF POINTS AND AUTHORITIES IN 
OPPOSITION TO PLAINTIFFS’ MOTION FOR PARTIAL 
SUMMARY JUDGMENT 

DEFENDANT'S STATEMENT TO UNDISPUTED MATERIAL FACTS IN 
OPPOSITION TO MOTION FOR PARTIAL SUMMARY JUDGMENT 

[PROPOSED] ORDER RE PARTIAL SUMMARY JUDGMENT 

DECLARATIONS OF MARIDEE GREGORY, M.D. AND RUTH §. RANGE 

in said cause by placing a true copy thereof enclosed in a sealed envelope with postage 
thereon fully prepaid, in the United States Mail at Oakland, California, Bydvessed | hy 
follows: 

JANE PERKINS 
National Health Law Program 
2639 §. La Cienega Blvd. 
Los Angeles, C4 90034 

MARK ROSENBAUM 

ACLU FOUNDATION OF S0U THERN CALIFORNIA 
633 South Shatto Place 
Los Angeles, California 90005 

I declare under penalty of perjury that the foregoing is true and correct, and that this 
declaration was executed at Oakland, California, on June 7, 1991. 

(Date) 

LARRY E. JEFFERSON ris Jahr 
(Typed Name) A(Sighatys) 

  

  

  

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DANIEL E. LUNGREN, Attorney General 
of the State of California 

CHARLTON G. HOLLAND, III 
Assistant Attorney General 

STEPHANIE WALD 
Supervising Deputy Attorney General 

HARLAN VAN WE Y 
Deputy Attorney General 

2101 Webster Street, 12th Floor 
Qakland, California 94612-3049 
Telephone: (4135) 464-1173 

Attorneys for Defendant 

UNITED STATES DISTRICT COURT 

NORTHERN DISTRICT OF CALIFORNIA 

No. C 90 3620 EFL 

DEFENDANT'S STATEMENT OF 
UNDISPUTED MATERIAL 
FACTS IN OPPOSITION TO 
MOTION FOR PARTIAL 
SUMMARY JUDGMENT 

Date: June 21, 1991 
Time: 10:00 AM 

ERIKA MATTHEWS AND JALISA 
MATTHEWS, by their guardian ad litem Lisa 
Matthews, and PEOPLE UNITED FOR A 
BETTER OAKLAND, On Behalf of 
Themselves and All Others Similarly Situated, 

Plaintiffs, 

Y. 

MOLLY COYE, M.D., Director, California 
Department of Health Services, 

Defendant. 

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Pursuant to Local Rule 220-7, Defendant hereby submits the following 

statement of undisputed material facts in opposition to Plaintiffs’ motion for summary 

| judgment: 

1. In 1965, Congress enacted Title XIX of the Social Security Act, 42 

U.S.C. §§ 1396-1396u, establishing a cooperative federal-state medical assistance | 

program designed to provide necessary medical services to poor people. Known ‘as 

"Medicaid," the program is administered by the state and federal governments, subject 

to mandatory federal statutory and regulatory guidelines. 

Proof: Complaint 1 16; Answer 1 9. 

2, At the federal level, the Medicaid program is implemented by the 

DEF'S. STMNT. OF UNDISPUTED MATERIAL FACTS 1 
IN OPP. TO MNT. FOR PARTIAL SUMMARY JUDGMENT 

gl Coed FRGE. O11 

  

   



  

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U.S, Department ei and Human Services’ Wn Financing Administration 

(HCFA). HCFA issues mandatory, controlling guidelines to the statés through 

regulations and the State Medicaid Manual. 

| Proof: - Complaint § 20; Answer 1 12. 

i The State Medicaid Manual is controlling. 

Proof: Range Depo., at 34-35, 46 (Exh. J); Gregory Depo., at 62-64 

(Exh. K). 

4, Federal Medicaid law requires states, including California, to 

provide a range of "mandatory" health care benefits to poor persons, including Early 

and Periodic Screening, Diagnostic, and Treatment (EPSDT) services to children under 

age 21. Lead blood screenings are a mandatory part of the EPSDT program for 

children ages 1 through 5, 42 U.S.C. § 1396d()(1); State Medicaid Manual § | 

51232.D.1, | : 

Proof: Complaint 1 20; Answer ¥ 12. 

5. The State of California has elected to participate in the Medicaid 

program and established the California Medical Assistance Program, commonly dalled 

"Medi-Cal." In California, the EPSDT Program is also referred to as the Child Health 

and Disability Prevent (CHDP) Program. | 

Proof: Complaint ¥ 16; Answer f 9. 

6. Defendant Molly Coye, M.D. is the duly appointed Director of the 

State Department of Health Services (DHS). DHS is the state agency responsible for 

administration of the Medi-Cal EPSDT/CHDP Program. Defendant Coye’s duties 

include supervision and control of the Medi-Cal program so as to secure full 

compliance with the governing laws. 

Proof: Complaint 1 12; Answer ¥ 7. 

7 The decision of whether or not to physically test a Medicaid/Medi- 

Cal participant child’s blood for the presence of elevated lead levels is a medical 

decision to be made by the examining physician based upon age and risk factors, 42 

D&EF'S. STMNT. OF UNDISPUTED MATERIAL FACTS ” 
IN OPP. TO MNT. FOR PARTIAL SUMMARY JUDGMENT - 

"31 18:45 POSE. BIE 

  

 



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U.S.C. § 1396d(r)(1)(B)(iv); State Medicaid Manual § 5123.2.D.1; Gregory Dec. at 11 

4, 8 and 9. 

8. The American Academy of Pediatrics recognizes that mandatory 

blood lead level testing may not be appropriate in all circumstances. Gregory Dec. 11 

6 and 7. 

DATED: June 7, 1991 Respectfully submitted, 

DANIEL E. LUNGREN, Attorney General 
of she State of California 

Tle 
E. lw. 

Deputy Attorney General 

Attorneys for Defendant 

(S5\ vi wys\ Frntthawa. und) 

DEFS. STMNT. OF UNDISPUTED MATERIAL FACTS 3 
IN OPP. TQ MNT. FOR PARTIAL SUMMARY JUDGMENT 

PAGE .Q13