Coverage Policy Manual
Policy #: 2011023
Category: PPACA Preventive
Initiated: September 2010
Last Review: June 2022
  PREVENTIVE SERVICES FOR NON-GRANDFATHERED (PPACA) PLANS: HYPOTHYROIDISM SCREENING IN NEWBORNS

Description:
The Federal Patient Protection and Preventive Care Act was passed by Congress and signed into law by the President in March 2010.  The preventive services component of the law became effective 23 September 2010. A component of the law was a requirement that all “non-grandfathered” health insurance plans are required to cover those preventive medicine services given an “A” or “B” recommendation by the U.S. Preventive Services Task Force.  
 
Plans are not required to provide coverage for the preventive services if they are delivered by out-of-network providers.
 
Task Force recommendations are graded on a five-point scale (A-E), reflecting the strength of evidence in support of the intervention.  Grade A: There is good evidence to support the recommendation that the condition be specifically considered in a periodic health examination.  Grade B: There is fair evidence to support the recommendation that the condition be specifically considered in a periodic health examination.  Grade C: There is insufficient evidence to recommend for or against the inclusion of the condition in a periodic health examination, but recommendations may be made on other grounds.  Grade D: There is fair evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.  Grade E: There is good evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.
 
Those preventive medicine services listed as Grade A & B recommendations are covered without cost sharing (i.e., deductible, co-insurance, or co-pay) by Health Plans for appropriate preventive care services provided by an in-network provider.  If the primary purpose for the office visit is for other than Grade A or B USPSTF preventive care services, deductible, co-insurance, or copay may be applied.
 

Policy/
Coverage:
Screening for congenital hypothyroidism in newborns is covered once per lifetime for members of “non-grandfathered” plans without cost-sharing (i.e., deductible, co-insurance, or co-pay).
 
The appropriate ICD-10 codes to report these services are Z00.110, Z00.111 and Z13.29..
 
This service is typically billed in the hospital, however, if billed by the medical provider, the codes that may be used to report laboratory testing for congenital hypothyroidism are CPT 84443 (TSH), 84436 (T-4 or T-4 total), 84437 (Thyroxine-neonatal and 84439 (T-4).  HCPCS code S3620 may also be used to report this service. When the primary purpose of the service is the delivery of an evidence-based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be billed with Modifier ‘-33’.  The correct coding as listed for both ICD-10 and CPT or HCPCS codes are also required.
 
 

Rationale:
The U.S. Preventive Services Task Force (USPSTF) recommends screening for congenital hypothyroidism (CH) in newborns (Grade A recommendation).
 
The USPSTF recommendations include the following information:
 
    • Primary congenital hypothyroidism occurs in approximately 1 of every 3,000-4,000 newborns in the United States. In the absence of prompt diagnosis and treatment, most persons with this disorder will develop various degrees of neurological, motor and growth deficits, including irreversible mental retardation.
    • In the U.S., most state-based screening programs utilize serum thyroxine (T4) and/or thyroid-stimulating hormone (TSH) performed on capillary blood collected from a heel stick and adsorbed onto filter paper.
    • Early detection of CH by neonatal screening and appropriate treatment substantially improves neurodevelopmental outcomes for affected persons.
    • Positive test results, whether true positive or false positive, cause anxiety in parents. For some parents, this anxiety may be considerable.
    • The USPSTF concludes that there is high certainty that the net benefit is substantial.
    • This recommendation applies to all infants born in the U.S. Premature, very low birth weight and ill infants may benefit from additional screening because these conditions are associated with decreased sensitivity and specificity of screening tests.
    • Screening for CH is mandated in all 50 states and the District of Columbia, though methods of screening vary. There are two main methods used in the U.S.: Primary TSH with backup T4; and primary T4 with backup TSH. A few states use both tests in initial screening. Clinicians should become familiar with the tests used in their area and the limitations of the employed screening strategy. For example, a primary TSH method may be falsely negative in low and very low birth weight infants with CH because of delayed elevation in TSH. Additionally, few states currently screen for centrally-mediated congenital hypothyroidism. Families should be provided with appropriate information about newborn screening tests, including the benefits and harms of screening. They should be aware of the potential of a false positive test, and the process required for definitive testing. Nationally, only 1 in 25 positive screening tests are confirmed to be CH.  Normal newborn screening results for CH should not preclude appropriate evaluation of infants presenting with clinical signs and symptoms suggestive of hypothyroidism.
    • Infants should be tested between 2 and 4 days of age. Infants discharged from hospitals before 48 hours of life should be tested immediately before discharge. Specimens obtained in the first 24-48 hours of age may be falsely elevated for TSH regardless of the screening method used.
    • Primary care clinicians should ensure that infants with abnormal screens receive confirmatory testing and begin appropriate treatment with thyroid hormone replacement within 2 weeks after birth. Children with positive confirmatory testing in whom no permanent cause of CH is found (such as lack of thyroid tissue on thyroid ultrasound or thyroid scan), should, at some time point after the age of 3 years, undergo a 30-day trial of reduced or discontinued thyroid hormone replacement therapy to determine if the hypothyroidism is permanent or transient.
 

CPT/HCPCS:
84436Thyroxine; total
84437Thyroxine; requiring elution (eg, neonatal)
84439Thyroxine; free
84443Thyroid stimulating hormone (TSH)
S3620Newborn metabolic screening panel, includes test kit, postage and the laboratory tests specified by the state for inclusion in this panel (e.g., galactose; hemoglobin, electrophoresis; hydroxyprogesterone, 17 d; phenylalanine (pku); and thyroxine, total)

References: PPACA & HECRA: Public Laws 111-148 & 111-152. The Patient Protection and Affordable Care Act.

Screening for Congenital Hypothyroidism.(2011) U.S. Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/uspstf/uspscghy.htm. Last accessed May 2011.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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