[Federal Register Volume 62, Number 172 (Friday, September 5, 1997)]
[Rules and Regulations]
[Pages 46877-46879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23521]


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DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

[DoD 6010.8-R]
RIN 0720-AA33


Civilian Health and Medical Program of the Uniformed Services 
(CHAMPUS); Health Promotion and Disease Prevention Visits and 
Immunizations

AGENCY: Office of the Secretary, DoD.

ACTION: Final rule.

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SUMMARY: This final rule expands well-baby visits and immunizations to 
dependents under the age of six and improves access to preventive 
benefits for dependents age six and above to include health promotion 
and disease prevention visits in connection with immunizations, Pap 
smears, mammograms, and colon and prostate cancer screenings.

DATES: This final rule is effective October 6, 1997.

ADDRESSES: Office of Health Services Financing Policy, Department of 
Defense, Room 1B657 Pentagon, Washington, DC 20301-1200.

FOR FURTHER INFORMATION CONTACT:
Cynthia P. Speight, Office of the Assistant Secretary of Defense 
(Health Affairs), (703) 697-8975.

SUPPLEMENTARY INFORMATION:

A. Provisions of Proposed Rule

    On February 10, 1996, Pub.L. 104-106 was signed into law. Section 
701 of that law extends coverage of ``well-baby visits'' and 
immunizations for an additional three years, from up to two years of 
age to under six years of age. Section 701 also provides for additional 
preventive care services under the Basic CHAMPUS Program (see 
Sec. 199.4) for dependents six years of age or older. This rule 
implements provisions of Pub.L. 104-106 by changing ``well-baby care'' 
to ``well-child care'' and by providing for additional preventive care 
services for dependents six years of age or older. This rule improves 
availability of immunizations and other preventive services, 
particularly for children. While these services have previously been 
available in military hospitals and clinics, access has depended on 
proximity to military medical treatment facilities with available space 
and services. Access, therefore, has not been uniformly attainable for 
all beneficiaries. This rule improves access by authorizing coverage of 
these services by all TRICARE benefit options,

[[Page 46878]]

subject to their respective copay requirements. This rule also 
implements provisions of P.L. 104-201 by expanding preventive health 
care services covered by TRICARE/CHAMPUS to include colon and prostate 
cancer screening.
    These preventive services and immunizations are based on 
recommendations of the U.S. Preventive Services Task Force which 
participated in setting national health goals in the report Healthy 
People 2000. Broad goals set by Health People 2000 included an increase 
in the span of healthy life for Americans, reduction in health 
disparities among Americans, and access to preventive services for all 
Americans. This rule strengthens existing programs within the 
Department and contributes significantly to national efforts toward 
meeting these goals.

B. Public Comments

    The proposed rule was published on November 5, 1996 (61 FR 56929-
56930). We received one public comment. We thank the commenter; 
significant items raised by the commenter and our analysis of the 
comments are summarized below in the appropriate sections of the 
preamble.
    1. Screening Mammography. We received a comment expressing 
confusion regarding the provision relating to screening mammography for 
asymptomatic women 40 years of age and older and its correlation with 
the TRICARE/CHAMPUS Policy Manual. The commenter maintains that a 
baseline screening mammogram should be obtained by a woman at 35 years.
    Response: We agree that high risk women, especially those with 
family history of breast cancer in a first degree relative, should 
receive a baseline mammogram at 35, and have included this language. 
For asymptomatic women routine screening at age 40 is consistent with 
nationally recognized guidelines. The TRICARE/CHAMPUS policy manual has 
been modified to reflect this policy.
    2. Screening Mammography. The commenter pointed out that since 
October 1, 1994, the Mammography Quality Standards Act of 1992 (P.L. 
102-539) has required mammography facilities to be certified by the 
Secretary of the Department of Health and Human Services rather than 
the American College of Radiology.
    Response: We appreciate the comment and this change will be made in 
TRICARE/CHAMPUS policy manual.
    3. Cancer Screening Papanicolaou Test--Diagnostic Pap Smear 
Coverage. The commenter expressed concern that diagnostic Pap smear 
coverage would not be applicable to women under the age of 18.
    Response: All diagnostic Pap smears are covered regardless of age.
    4. Cancer Screening Papanicolaou Test--Women at Risk. Another 
comment we received recommended expanding the list of risk factors that 
increase the chances that a women will develop cervical cancer and 
necessitate close monitoring of her health status with an annual Pap 
smear.
    Response: We agree with this recommendation and have modified the 
final rule to expand coverage of Pap smears to include women who are at 
risk for sexually transmissible disease, women who have or have had 
multiple sexual partners (or if their partner has or has multiple 
sexual partners), and women who smoke cigarettes.
    5. Cancer Screening Papanicolaou--Test--Copayment. We received a 
comment expressing opposition to requiring beneficiaries to make 
copayments to obtain Pap smears.
    Response: For those who enroll in TRICARE Prime, there is no 
copayment for Pap smears. Sections 1079(b) and 1086(b) of Title 10, 
U.S.C. prevent the Department from waiving copayments for those who 
participate in TRICARE Extra or TRICARE Standard.

C. Provisions of Final Rule

    This final rule expands well-baby visits and immunizations to 
dependents under the age of six and improves access to preventive 
benefits for dependents age six and above to include health promotion 
and disease prevention visits in connection with immunizations, Pap 
smears, mammograms, and colon and prostate cancer screenings. Minor 
administrative changes have been made as a result of interagency 
comments.
    We modified the final rule to include physician assistants and 
family nurse practitioners in the group of providers who can receive 
reimbursement for preventive services as part of the well-child care 
program. In addition, we modified the provision pertaining to periodic 
health supervision visits under the well-child care program. 
Specifically, we defined ``periodic'' according to American Academy of 
Pediatrics (AAP) guidelines and included mental health assessment, risk 
assessment for lead exposure, and breastfeeding and nutrition 
counseling to the services covered under the periodic health 
supervision visits.

D. Regulatory Procedures

    Executive Order 12866 requires that a regulatory impact analysis be 
performed on any significant regulatory action, defined as one which 
would have an annual effect on the economy of $100 million or more, or 
have other significant effects.
    The Regulatory Flexibility Act requires that each federal agency 
prepare a regulatory flexibility analysis when the agency issues 
regulations which would have a significant impact on a substantial 
number of small entities. This final rule is not a significant 
regulatory action under E.O. 12866, nor would it have a significant 
impact on small entities. In addition, this final rule does not impose 
new information collection requirements for purposes of the Paperwork 
Reduction Act of 1980 (44 U.S.C. 3501-3511).

List of Subjects in 32 CFR Part 199

    Claims, Handicapped, Health insurance, Military personnel.

PART 199--[AMENDED]

    According, 32 CFR part 199 is amended as follows:
    1. The authority citation for part 199 continues to read as 
follows:

    Authority: 5 U.S.C. 301; and 10 U.S.C. Chapter 55.

    2. Section 199.2(b) is amended by removing the definition for 
``well-baby care'' and adding the definition for ``well-child care'' in 
alphabetical order as follows:


Sec. 199.2   Definitions.

* * * * *
    (b) * * *
    Well-child care. A specific program of periodic health screening, 
developmental assessment, and routine immunization for dependents under 
six years of age.
* * * * *
    3. Section 199.4 is amended by revising the heading of (c)(2), and 
revising paragraphs (c)(2)(xiii), (c)(2)(xvi), (c)(3)(xi), (g)(37), and 
(g)(47) to read as follows:


Sec. 199.4   Basic program benefits.

* * * * *
    (c) * * *
    (2) Covered services of physicians and other authorized profession 
providers.
* * * * *
    (xiii) Well-child care.
* * * * *
    (xvi) Routine eye examinations. Coverage for routine eye 
examinations is limited to dependents of active duty members, to one 
examination per calendar year per person, and to services rendered on 
or after October 1, 1984, except as provided under paragraph (c)(3)(xi) 
of this section.

[[Page 46879]]

    (3) * * *
    (xi) Well-child care. Benefits routinely are covered for well-child 
care from birth to under six years of age. These periodic health 
examinations are designed for prevention, early detection and treatment 
of disease and consist of screening procedures, immunizations and risk 
counseling.
    (A) The following services are covered when required as a part of 
the specific well-child care program and when rendered by the attending 
pediatrician, family physician, certified nurse practitioner, or 
certified physician assistant.
    (1) Newborn examination, heredity and metabolic screening, and 
newborn circumcision.
    (2) Periodic health supervision visits, in accordance with American 
Academy of Pediatrics (AAP) guidelines, intended to promote the optimal 
health for infants and children to include the following services:
    (i) History and physical examination and mental health assessment.
    (ii) Vision, hearing, and dental screening.
    (iii) Developmental appraisal to include body measurement.
    (iv) Immunizations as recommenced by the Centers for Disease 
Control (CDC).
    (v) Pediatric risk assessment for lead exposure and blood lead 
level test.
    (vi) Tuberculosis screening.
    (vii) Blood pressure screening.
    (viii) Measurement of hemoglobin and hematocrit for anemia.
    (ix) Urinalysis.
    (x) Health guidance and counseling, including breastfeeding and 
nutrition counseling.
    (B) Additional services or visits required because of specific 
findings or because the particular circumstances of the individual case 
are covered if medically necessary and otherwise authorized for 
benefits under CHAMPUS.
    (C) The Deputy Assistant Secretary of Defense, Health Services 
Financing, will determine when such services are separately 
reimbursable apart from the health supervision visit.
* * * * *
    (g) * * *
    (37) Preventive care. Preventive care, such as routine, annual, or 
employment-requested physical examinations; routine screening 
procedures; except that the following are not excluded:
    (i) Well-child care.
    (ii) Immunizations for individuals age six and older, as 
recommended by the CDC.
    (iii) Rabies shots.
    (iv) Tetanus shot following an accidental injury.
    (v) Rh immune globulin.
    (vi) Genetic tests as specified in paragraph (e)(3)(ii) of this 
section.
    (vii) Immunizations and physical examinations provided when 
required in the case of dependents of active duty military personnel 
who are traveling outside the United States as a result of an active 
duty member's assignment and such travel is being performed under 
orders issued by a Uniformed Service.
    (viii) Screening mammography for asymptomatic women 40 years of age 
and older, and for high risk women 35 years of age and older, when 
provided under the terms and conditions contained in the guidelines 
adopted by the Deputy Assistant Secretary of Defense, Health Services 
Financing.
    (ix) Cancer screening Papanicolaou (PAP) test for women who are at 
risk for sexually transmissible diseases, women who have or have had 
multiple sexual partners (or if their partner has or has had multiple 
sexual partners), women who smoke cigarettes, and women 18 years of age 
and older when provided under the terms and conditions contained in the 
guidelines adopted by the Deputy Assistant Secretary of Defense, Health 
Services Financing.
    (x) Other cancer screenings authorized by 10 U.S.C. 1079.
    (xi) Health promotion and disease prevention visits (which may 
include all of the services provided pursuant to Sec. 199.18(b)(2)) may 
be provided in connection with immunizations and cancer screening 
examinations authorized by paragraphs (g)(37)(ii) of this section or 
(g)(37) (viii) through (x) of this section.
* * * * *
    (47) Eye and hearing examinations. Eye and hearing examinations 
except as specifically provided in paragraphs (c)(2)(xvi) and 
(c)(3)(xi) of this section, or except when rendered in connection with 
medical or surgical treatment of a covered illness or injury.
* * * * *
    Dated: August 29, 1997.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 97-23521 Filed 9-4-97; 8:45 am]
BILLING CODE 5000-04-M