Screening for Sexually Transmitted Infections (STIs) and High-Intensity Behavioral Counseling (HIBC) to Prevent STIs

Sexually transmitted infections (STIs) are infections that are passed from one person to another through sexual contact. STIs remain an important cause of morbidity in the United States and have both health and economic consequences. Many of the complications of STIs are borne by women and children Often, STIs do not present any symptoms so can go untreated for long periods of time The presence of an STI during pregnancy may result in significant health complications for the woman and infant. In fact, any person who has an STI may develop health complications. Screening tests for the STIs in this national coverage determination (NCD) are laboratory tests.

Under §1861(ddd) of the Social Security Act (the Act), the Centers for Medicare & Medicaid Services (CMS) has the authority to add coverage of additional preventive services if certain statutory requirements are met. The regulations provide:

§410.64 Additional preventive services

(a) Medicare Part B pays for additional preventive services not described in paragraph (1) or (3) of the definition of “preventive services” under §410.2, that identify medical conditions or risk factors for individuals if the Secretary determines through the national coverage determination process (as defined in section 1869(f)(1)(B) of the Act) that these services are all of the following: (1) reasonable and necessary for the prevention or early detection of illness or disability.(2) recommended with a grade of A or B by the United States Preventive Services Task Force, (3) appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

(b) In making determinations under paragraph (a) of this section regarding the coverage of a new preventive service, the Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such services and may take into account the results of such an assessment in making such national coverage determinations.

The scope of the national coverage analysis for this NCD evaluated the evidence for the following STIs and high intensity behavioral counseling (HIBC) to prevent STIs for which the United States Preventive Services Task Force (USPSTF) has issued either an A or B recommendation:

• Screening for chlamydial infection for all sexually active non-pregnant young women aged 24 and younger and for older non-pregnant women who are at increased risk,
• Screening for chlamydial infection for all pregnant women aged 24 and younger and for older pregnant women who are at increased risk,
• Screening for gonorrhea infection in all sexually active women, including those who are pregnant, if they are at increased risk,
• Screening for syphilis infection for all pregnant women and for all persons at increased risk,
• Screening for hepatitis B virus (HBV) infection in pregnant women at their first prenatal visit,
• HIBC for the prevention of STIs for all sexually active adolescents, and for adults at increased risk for STIs.

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:

• education,
• 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)).

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.)

01/2012 - Effective for claims with dates of service on and after November 8, 2011, CMS will cover screening for chlamydia, gonorrhea, syphilis, and hepatitis B with the appropriate FDA-approved lab tests used consistent with FDA-approved labeling and in compliance with CLIA regulations when ordered by a primary care provider and performed by an eligible Medicare provider for these services. This revision to the Medicare National Coverage Determinations Manual is a national coverage determination (NCD). NCDs are binding on all carriers, fiscal intermediaries,[contractors with the Federal government that review and/or adjudicate claims, determinations, and/or decisions], quality improvement organizations, qualified independent contractors, the Medicare appeals council, and administrative law judges (ALJs) (see 42 CFR section 405.1060(a)(4) (2005)). An NCD that expands coverage is also binding on a Medicare advantage organization. Effective date 11/08/2011. Implementation Date 02/27/2012. (TN 141) (CR7610)

03/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/07/2013 Effective date: 10/1/2015. (TN 1199) (TN 1199) (CR 8197)

05/2014 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/06/2014 Effective date: 10/1/2015. (TN 1388) (TN 1388) (CR 8691)

11/2022 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 11676) (CR12960)