CMS Pub. 100-03, ch. 1, § 210.6

A. General

Hepatitis B Virus (HBV) is transmitted by exposure to blood or blood- containing body fluids such as

serum, semen or saliva. HBV infection attacks the liver and leads to inflammation. An infected person

may initially develop symptoms such as nausea, anorexia, fatigue, fever and abdominal pain, or may be

asymptomatic. An acute HBV infection may become a chronic infection and progress to serious and

potentially life-threatening complications including cirrhosis, liver failure, hepatocellular carcinoma and

death.

Pursuant to §1861(ddd) of the Social Security Act, the Secretary may add coverage of "additional

preventive services" if certain statutory requirements are met.

B. Nationally Covered Indications

Effective for services performed on or after September 28, 2016, CMS has determined that the evidence

is sufficient to cover screening for HBV infection with the appropriate U.S. 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 beneficiary's primary care physician or practitioner within the context of a primary care setting, and

performed by an eligible Medicare provider for these services, for beneficiaries who meet either of the

following conditions.

1. A screening test is covered for asymptomatic, nonpregnant adolescents and adults at high risk for

HBV infection. "High risk" is defined as persons born in countries and regions with a high

prevalence of HBV infection (i.e., ≥ 2%), US­born persons not vaccinated as infants whose

parents were born in regions with a very high prevalence of HBV infection (i.e., ≥ 8%),

HIV-positive persons, men who have sex with men, injection drug users, household contacts or

sexual partners of persons with HBV infection. In addition, CMS has determined that repeated

screening would be appropriate annually only for beneficiaries with continued high risk (i.e., men

who have sex with men, injection drug users, household contacts or sexual partners of persons

with HBV infection) who do not receive hepatitis B vaccination.

2. A screening test at the first prenatal visit is covered for pregnant women and then rescreening at

time of delivery for those with new or continuing risk factors. In addition, CMS has determined

that screening during the first prenatal visit would be appropriate for each pregnancy, regardless

of previous hepatitis B vaccination or previous negative HBsAg test results.

The determination of "high risk for HBV" is identified by the primary care physician or practitioner who

assesses the patient's history, which is part of any complete medical history, typically part of an annual

wellness 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 decision memorandum, a primary care setting is defined by 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, 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 decision memorandum, a "primary care physician" and "primary care

practitioner" will be defined consistent with existing sections of the Social Security Act (§1833(u)(6),

§1833(x) (2)(A)(i)(I) and §1833(x)(2)(A)(i)(II)).

§1833(u)

(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.

§1833(x)(2)(A)(i)

(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

Effective for claims with dates of service on and after September 28, 2016:

- Medicare beneficiaries who are symptomatic, or who have already been diagnosed with

HBV infection, or who are nonpregnant and have already received a hepatitis B vaccination

are non-covered.

D. Other

Medicare coinsurance and the Part B deductible are waived for this "additional preventive service."

(NCD updated September 2016)

210.7 – Screening for Human Immunodeficiency Virus (HIV)

(Rev. 190, Issued: 02-05-16; Effective: 04-13-15; Implementation: 03-07-16 - non-shared A/B MAC edits; 07-05-16 - CWF analysis and design; 10-03-16 - CWF Coding, Testing and Implementation, MCS, and FISS Implementation; 01-03-17 - Requirement 9403.04.9)

A. General

Human Immunodeficiency Virus (HIV) is an infection caused by a retrovirus that affects the immune

system. HIV infection causes acquired immune deficiency syndrome (AIDS), a disease which severely

compromises an individual’s immune system. It is currently generally accepted that antiretroviral therapy

(ART) has significantly reduced HIV-associated morbidity and mortality throughout the world and the

United States, and has transformed HIV disease for many, into a chronic, manageable condition. There is

also evidence that the use of ART is associated with a substantially decreased risk for transmission of the

virus to uninfected persons.

Effective January 1, 2009, the Centers for Medicare & Medicaid Services (CMS) is allowed to add coverage

of “additional preventive services” through the national coverage determination (NCD) process if certain

statutory requirements are met, as provided in 42 C.F.R. §410.64 (CMS began covering HIV screening

effective December 8, 2009). One of those requirements is that the service(s) be categorized as a Grade A

(strongly recommends) or Grade B (recommends) rating by the United States Preventive Services Task

Force (USPSTF). The USPSTF gives a Grade A recommendation to screening for HIV in:

• All adolescents and adults between the ages of 15 to 65 years,

• Younger adolescents and older adults who are at increased risk of HIV infection, and,

• All pregnant women.

B. Nationally Covered Indications

Effective for claims with dates of service on and after April 13, 2015, CMS has determined that the evidence

is adequate to conclude that screening for HIV infection for all individuals between the ages of 15 and 65

years, as recommended with a Grade of A by the USPSTF, is reasonable and necessary for early detection of

HIV and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

CMS shall cover screening for HIV with the appropriate U.S. Food and Drug Administration (FDA)-

approved laboratory tests and point-of-care tests, used consistent with FDA-approved labeling and in

compliance with the Clinical Laboratory Improvement Act (CLIA) regulations, when ordered by the

beneficiary’s physician or practitioner within the context of a healthcare setting and performed by an eligible

Medicare provider for these services, for beneficiaries who meet one of the following conditions:

1. Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual, voluntary

screening for all adolescents and adults between the age of 15 and 65, without regard to perceived risk.

2. Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual, voluntary

screening for adolescents younger than 15 and adults older than 65 who are at increased risk for HIV

infection. Increased risk for HIV infection is defined as follows:

Men who have sex with men,

Men and women having unprotected vaginal or anal intercourse,

• Past or present injection drug users,

• Men and women who exchange sex for money or drugs, or have sex partners who do,

• Individuals whose past or present sex partners were HIV-infected, bisexual, or injection drug users,

• Persons who have acquired or request testing for other sexually transmitted infectious diseases,

• Persons with a history of blood transfusions between 1978 and 1985,

• Persons who request an HIV test despite reporting no individual risk factors,

Persons with new sexual partners,

• Persons who, based on individualized physician interview and examination, are deemed to be at

increased risk for HIV infection. The determination of “increased risk” for HIV infection is

identified by the health care practitioner who assesses the patient’s history, which is part of any

complete medical history, typically part of an annual wellness visit and considered in the

development of a comprehensive prevention plan. The medical recommendation should be a

reflection of the service provided.

3. A maximum of three, voluntary, HIV screenings of pregnant Medicare beneficiaries: (1) when the

diagnosis of pregnancy is known, (2) during the third trimester, and, (3) at labor, if ordered by the

woman’s clinician.

C. Nationally Non-Covered Indications

Effective for claims with dates of service on and after April 13, 2015:

-Medicare beneficiaries with any known diagnosis of an HIV-related illness are not eligible for this

screening test.

-Medicare beneficiaries between the ages of 15 and 65 who have had a prior HIV screening test within 1

year are not eligible for HIV screening (i.e., at least 11 full months must have elapsed following the month in

which the previous test was performed in order for the subsequent test to be covered).

-Medicare beneficiaries younger than 15 or older than 65, at increased risk for HIV-related illnesses, who

have had a prior HIV screening test within 1 year are not eligible for HIV screening (i.e., at least 11 full

months must have elapsed following the month in which the previous test was performed in order for the

subsequent test to be covered).

-Pregnant Medicare beneficiaries who have had three specified screening tests within each respective term of

pregnancy are not eligible for further HIV screening during their pregnancy.

D. Other

N/A

(This NCD last reviewed April 2015.)