Statutory Terms for Medical Screenings and Recommendations

    Statutory Terns. 
  

Blood lead testing of young medicaid recipient children is 

required by statute as construed by authoritative regulatory 

material. 

The Early and Periodic Screening, Diagnosis and Treatment 

Program (EPSDT) was created by 1967 amendments to Title XIX of 

the Social Security Act, making health "screening" of children 

part of the "medical assistance" benefit of state Medicaid 

programs. Section 1905 (a) (4) (B), 42 U.S.C. § 1396(d) (a) (4) (B). 

[E]ffective July 1, 1989, such early and 
periodic screening and diagnosis of 
individuals who are eligible under the plan 
and are under the age of 21 to ascertain 
their physical or mental defects, and such 
health care treatment, and other measures 
to correct to ameliorate defects and 
chronic conditions discovered thereby, as 
may be provided in regulations of the 
Secretary. 

The Medicaid amendments of 1989 (H.R. 3299) added a new 

subsection that screening "shall at a minimum include . . . 

laboratory tests (including lead blood level assessment 

appropriate for age and risk factors)." Section 6403 (a), 42 

U.8.C. § 1396(d)(r) (i). 

After the enactment of the 1989 amendment, the Health Care 

Financing Administration of the Department of Health and Human 

Services (HCFA), which administers the EPSDT program, pursuant 

to § 1396(d) (a) (4) (B) regulatory authority, has issued the 

following changes to the State Medicaid Manual: 
  

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

  

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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: 

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 ervthrocyte 

protoporphyrin (EP) level (greater than or 
equal to 35 ug/dl of white 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). 

Defendant Kizer admits that he is bound by the HCFA State 

Medicaid Manual, see depositions of Marilee Gregory, p. 
  

{ ) and Ruth Range, Pp. __ ( ). 

Legislative History 
  

The 1989 amendment to the EPSDT statutes on mandatory lead 

testing codify and expand 17 years of regulatory development on 

lead testing of young children. 

1. Original Broad Remedial Intent. Congress enacted the 
  

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underlying EPSDT statue with a broad remedial intent. President 

Johnson originally proposed the EPSDT program as part of a 

comprehensive package of programs for American 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. President Lyndon B. 

Johnson, Welfare of Children, H.R. Doc. No. 54, 90th Cong., 1st 
  

Sess. 7 (1967). The President declared that the long-range 

  health of the nation required a program to, inter alia, 

"discover, as early as possible, the ills that handicap our 

children." Id. 

During hearings on the legislation, Secretary John Gardner 

of the then Department of Health, Education and Welfare 

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. 570 Before the H. Com. on Ways and Means, 90th 
  

Cong., 1 Sess., pt. 1, at 189 (1967). 

2. Requlatory Testing Recommendations. Although the EPSDT   

statute did not specify blood level testing, such testing has 

consistently been recommended by federal EPSDT regulators for 

17 years before the 1989 amendment, with the recommendations 

generally becoming more rigorous over time. 

After the enactment of the EPSDT program, skeletal 

implementing regulations were issued which did not specify the 

 



  

screening required by the EPSDT statute. 36 Fed.Reg. 214009, 

November 9, 1971 (originally codified in 45 CFR §§ 249.10(a) (3) 

and (b) (4) (ii). On June 28, 1972, however, HEW issued a Program 

Regulation Guide, MSA-PRG-21, on implementation of the EPSDT 

program as part 5 of the Medical Assistance Manual, the 
  

predecessor to the HCFA State Medicaid Manual. The Program 
  

Requlation Guide contained a specific recommendation, but not 
  

a mandate, that all young children should be periodically 

screened for a "determination of blood lead levels." Id. at 

E.1. 

1. 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 
be screened when medically indicated. The 
principal source of childhood lead 
poisoning is lead-based paint, but 
pollution of the environment from such 
things as burning lead batteries and 
repeated exposure to fall-out particles of 
lead that get into the soil and are 
ingested by a child may also result in lead 
poisoning. Early identification and prompt 
treatment of symptomatic and asymptomatic 
(over 80 mg/100 milliliters of whole blood) 
cases can prevent the serious sequelae of 
lead poisoning, such as mental impairment, 
mental retardation and involvement of the 
central nervous system. Venous or 
capillary blood samples may be used, 
depending on local laboratory facilities. 

  

Id. This recommendation for testing of all young children was 

carried forward in subsequent editions of the Medical Assistance 
  

Manual and later the State Medicaid Manual. 
  

 



  

Other regulatory material was initially narrower in scope, 

but subsequently broadened. The American Academy of Pediatrics 

published A Guide to Screening-EPSDT Medicaid (HEW 1974) to 
  

assist state and local agencies and providers implementing the 

EPSDT program in 1974. The Guide suggested criteria for 

determining which testing procedures to use for EPSDT screening, 

specifically recommending screening for undue lead absorption 

of all children who lived or frequented older homes or were 

exposed to industrial pollution. Id. at 188. Such children 

were to be screened several times between the ages of 1 and 3. 

The Guide recommended two blood tests, the blood lead 

determinations and "free erythrocyte protoporphyrin" tests, as 

the "methods for use in screening for undue lead absorption." 

Id. at 189. 

On June 9, 1977, the Guide to Screening was amended to 
  

recommend screening of all young children in an Information 
  

Memorandum, 1M-77-32 (MSA) entitled "New Technology Available in 
  

the Screening and Detection of Lead Poisoning and EPSDT." The 

  Memorandum contained information developed by the EPSDT program 

and the Centers For Disease Control. CCH Medicaid Manual, New 

Developments § 28,505(1977). After noting that excessive lead 

exposure "can and does have serious and largely irreversible 

effects on the development of the central nervous system" of 

younger children, the 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 Memorandum recommended that 
  

all young children would be tested at least once using the then- 

newly developed and inexpensive erythrocyte protoporphyrin (EP) 

blood test to assess the need for more testing. 

In light of the data we have received from 
EPSDT programs and the CDC data, it is 
obvious that programs which look for 
children with undue lead absorption, find 
children requiring medical attention. In 
order to determine how much of a problem 
there is in the 1 through 5 years of age 
group, each state program should plan to 
include testing procedures in their 
screening requirement so that each child is 
tested at least once. 

In 1977, the same year the Memorandum was issued, the 
  

  

Academy of Pediatrics prepared A Guide to Administration, 

Diagnosis and Treatment for the EPSDT Program under Medicaid 
  

(HEW 1977) as a revision of the 1974 Guide to Screening. The 
  

Guide to Administration noted that although 2.5 million children 
  

younger than age six were at risk for undue lead absorption and 

that approximately 600,000 would be affected by the disease, 

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

The Guide to Administration 64-65 recommended that all children 
  

younger than six as a routine matter should receive an EP blood 

test for lead poisoning. 

All children 1 through 5 years of age 
should receive an erythrocyte 
protoporphyrin test. If the results are 60 
ug/dl or more, the child should receive a 
blood lead test. If the blood lead is less 
than 30 ug/dl, the child should receive a 

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hematologic evaluation to determine if the 
child is iron deficient or suffering from 
another porphyria. However, if the blood 
lead is 30 ug/dl or more, the child should 
be considered to have undue lead 
absorption. Both the erythrocyte 
protoporphyrin and blood lead tests can be 
performed readily on a finger prick sample. 
In view of the known difficulty in carrying 
out blood lead level determinations, only 
experienced, proficient laboratories should 
be utilized. 

Thus, when Congress considered the 1989 amendments, both the 

State Medicaid Manual and the Academy of Pediatrics Guidelines 
    

recommended blood lead testing of all young children. 

3. The 1989 Amendments 
  

The legislative history of the 1989 amendments indicates 

that Congress generally intended to specify and improve the 

mandatory elements of the EPSDT benefit package. 

The EPSDT benefit package has never been 
described in detail in the statute. There 
have arisen questions regarding the content 
of the program . . . Additionally, while 
states have always had the option to do so, 
many still do not provide to children 
participating in EPSDT all care and 
services allowable under federal law . . . 

Cong. Rec. ‘8S 13233 (October 12, 1989). The House 

Committee Report noted that while "[t]he EPSDT benefit is not 

currently defined in statute," the House bill required that 

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

tests (including blood lead level assessment appropriate for age 

and risk factors)." Rep. 101-247 of the H. Com. on the Budget 

H.R. 3299, Omnibus Budget Reconciliation Act of 1989, 101st 

Cong., 1st Sess. (1989).  



The Conference Committee, followed the House bill with 

respect to mandatory blood lead testing. In particular, the 

Conference Report 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." 

(emphasis added). 

As discussed above, blood lead testing of young children 

has been recommended on a consistent but expanding basis by 

EPSDT regulatory authorities for 17 years prior to the passage 

of the 1989 amendment. The interpretation of the 1989 

amendments set forth in HCFA's State Medicaid Manual is thus 
  

consistent with the intent of the 1989 statutory amendments to 

codify and expand regulatory recommendations for blood testing 

for lead screening of all young children. Any narrower 

interpretation would be contrary to the existing regulatory 

recommendations and, therefore, at odds with the intent of 

Congress to at least codify --, and in the case of blood lead 

testing, to expand --, existing regulatory screening directions. 

Given the asymptomatic nature of the disease, a narrower 

interpretation would violate as well the fundamental intent of 

the EPSDT statute to "discover, as early as possible, the ills 

that handicap our children."