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

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