B. Nationally Covered Indications
CMS has determined that the evidence is adequate to conclude that screening for chlamydia, gonorrhea, syphilis, and hepatitis B, as well as HIBC to prevent STIs, consistent with the grade A and B recommendations by the USPSTF, is reasonable and necessary for the early detection or prevention of an illness or disability and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B.
Therefore, effective for claims with dates of services on or after November 8, 2011, CMS will cover screening for these USPSTF-indicated STIs with the appropriate Food and Drug Administration (FDA)-approved/cleared laboratory tests, used consistent with FDA-approved labeling, and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations, when ordered by the primary care physician or practitioner, and performed by an eligible Medicare provider for these services.
Screening for chlamydia and gonorrhea:
- Pregnant women who are 24 years old or younger when the diagnosis of pregnancy is known, and then repeat screening during the third trimester if high-risk sexual behavior has occurred since the initial screening test.
- Pregnant women who are at increased risk for STIs when the diagnosis of pregnancy is known, and then repeat screening during the third trimester if high-risk sexual behavior has occurred since the initial screening test.
- Women at increased risk for STIs annually.
Screening for syphilis:
- Pregnant women when the diagnosis of pregnancy is known, and then repeat screening during the third trimester and at delivery if high-risk sexual behavior has occurred since the previous screening test.
- Men and women at increased risk for STIs annually.
Screening for hepatitis B:
- Pregnant women at the first prenatal visit when the diagnosis of pregnancy is known, and then rescreening at time of delivery for those with new or continuing risk factors.
In addition, effective for claims with dates of service on or after November 8, 2011, CMS will cover up to two individual 20- to 30-minute, face-to-face counseling sessions annually for Medicare beneficiaries for HIBC to prevent STIs, for all sexually active adolescents, and for adults at increased risk for STIs, if referred for this service by a primary care physician or practitioner, and provided by a Medicare eligible primary care provider in a primary care setting. Coverage of HIBC to prevent STIs is consistent with the USPSTF recommendation.
HIBC is defined as a program intended to promote sexual risk reduction or risk avoidance, which includes each of these broad topics, allowing flexibility for appropriate patient-focused elements:
- skills training,
- guidance on how to change sexual behavior.
The high/increased risk individual sexual behaviors, based on the USPSTF guidelines, include any of the following:
- Multiple sex partners
- Using barrier protection inconsistently
- Having sex under the influence of alcohol or drugs
- Having sex in exchange for money or drugs
- Age (24 years of age or younger and sexually active for women for chlamydia and gonorrhea)
- Having an STI within the past year
- IV drug use (for hepatitis B only)
- In addition for men – men having sex with men (MSM) and engaged in high risk sexual behavior, but no regard to age
In addition to individual risk factors, in concurrence with the USPSTF recommendations, community social factors such as high prevalence of STIs in the community populations should be considered in determining high/increased risk for chlamydia, gonorrhea, syphilis, and for recommending HIBC.
High/increased risk sexual behavior for STIs is determined by the primary care provider by assessing the patient’s sexual history which is part of any complete medical history, typically part of an annual wellness visit or prenatal visit and considered in the development of a comprehensive prevention plan. The medical record should be a reflection of the service provided.
For the purposes of this NCD, a primary care setting is defined as the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. Emergency departments, inpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities, clinics providing a limited focus of health care services, and hospice are examples of settings not considered primary care settings under this definition.
For the purposes of this NCD, a “primary care physician” and “primary care practitioner” will be defined based on existing sections of the Social Security Act (§1833(u)(6), §1833(x)(2)(A)(i)(I) and §1833(x)(2)(A)(i)(II)).
(6) Physician Defined.—For purposes of this paragraph, the term “physician” means a physician described in section 1861(r)(1) and the term “primary care physician” means a physician who is identified in the available data as a general practitioner, family practice practitioner, general internist, or obstetrician or gynecologist.
(I) is a physician (as described in section 1861(r)(1)) who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or
(II) is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in section 1861(aa)(5));
C. Nationally Non-Covered Indications
Unless specifically covered in this NCD, any other NCD, or in statute, preventive services are non-covered by Medicare.
Medicare coinsurance and Part B deductible are waived for these preventive services.
HIBC to prevent STIs may be provided on the same date of services as an annual wellness visit, evaluation and management (E&M) service, or during the global billing period for obstetrical car, but only one HIBC may be provided on any one date of service. See the claims processing manual for further instructions on claims processing.
For services provided on an annual basis, this is defined as a 12-month period.
(This NCD last reviewed November 2011.)