A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: immunization of adults. CMS notes that the applicability of these findings is only to the small portion of the disabled Medicare beneficiary population. Hepatitis B Virus (HBV) is a type of virus that affects the liver. Hepatitis B Virus (HBV) is transmitted by exposure to blood or blood-containing body fluids such as serum, semen or saliva. Given the number and availability of primary care practitioners and settings, we believe that Medicare beneficiaries will have ready access to the additional preventive service established under this NCD. USPSTF – United States Preventive Services Task Force, In 2004 the USPSTF first recommended screening for HBV infection in pregnant women at their first prenatal visit (A recommendation). They identified those expectant women who were HCV-infected and included their infants who could be followed through age 2 years, since screening is formally recommended either by Hepatitis C antibody testing at age 18 months or by Hepatitis C RNA PCR beginning at age 1-2 months. This JAMA Patient Page reviews the US Preventive Services Task Forceâs 2020 recommendation to screen for hepatitis B infection in adolescents and adults at increased risk (B recommendation). (B recommendation). All patients with cancer anticipating systemic anticancer therapy should be tested for hepatitis B virus (HBV) by 3 testsâhepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc) total immunoglobulin (Ig) or IgG, and antibody to hepatitis B surface antigen (anti-HBs)âprior to, or at the beginning of, systemic anticancer therapy. This text provides a concise yet comprehensive overview of autoimmune hepatitis (AIH). American Congress of Obstetricians and Gynecologists (ACOG). In addition, for each key question the authors assessed the internal validity of the 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. Hepatitis B and C â Reporting and Care. CMV – cytomegalovirus Hepatitis C Treatment Guidance Table 1. Thus, primary care practitioners may need to carefully evaluate the results of the screening test in determining the patient's overall treatment plan. (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. The American Society of Clinical Oncology updated their 2020 guidelines on hepatitis B and cancer screening. The analytic framework focused on "direct evidence that screening for HBV infection improves important health outcomes versus not screening and the chain of indirect evidence linking screening to improved health outcomes" for nonpregnant adults and adolescents. Primary care practitioners are characterized by their coordination of a patient's comprehensive healthcare needs. Screening for hepatitis B virus infection in pregnant women: evidence for the U.S. Preventive Services Task Force reaffirmation recommendation statement. References are updated (page 7). Also, you can decide how often you want to get updates. Primary Care: America's Health in a New Era 1996) and existing sections of the Social Security Act (§1833(u)(6), §1833(x)(2)(A)(i)(I) and §1833(x)(2)(A)(i)(II)) define primary care practitioners. Additionally, a "U.S. Food and Drug Administration–approved hepatitis B surface antigen (HBsAg) test followed by a licensed, neutralizing confirmatory test for initially reactive results should be used to screen for HBV infection. A report on recommended clinical preventive services that should be provided to patients in the course of routine clinical care, including screening for vascular, neoplastic and infectious diseases, and metabolic, hematologic, ... Screening for hepatitis B virus Infection in nonpregnant adolescents and adults: systematic review to update the 2004 U.S. Preventive Services Task Force recommendation. CMS notes that the USPSTF concluded "with moderate certainty" that HBV screening in asymptomatic, nonpregnant adolescents and adults at high risk for infection has "moderate net benefit" (LeFevre 2014). NCAId=283. These blood (a.k.a., serologic) markers are the HCV is spread by contact with the blood of an infected person. Its purpose is to inform the reader of the decision, the reasons for the decision and process followed, and provide a summary of the evidence considered. Persons born in countries and regions with a high prevalence of HBV infection (≥2%); U.S.-born persons not vaccinated as infants whose parents were born in regions with a very high prevalence of HBV infection (≥8%), such as sub-Saharan Africa and central and Southeast Asia;. Journal of clinical oncology: official journal of the American Society of Clinical Oncology, JCO2001757. Hepatitis C Screening Program. In its The 2014 USPSTF recommendation focuses on asymptomatic, nonpregnant adolescents and adults at high risk for HBV infection (including those at high risk who were vaccinated before being screened for HBV infection (LeFevre 2014). People living with chronic hepatitis B (HBV) receiving any systemic anticancer therapy should receive antiviral prophylaxis for the duration of anticancer therapy, as well as for at least 12 months after receipt of the last anticancer therapy. Pursuant to §1861(ddd) of the Social Security Act, the Secretary may add coverage of "additional preventive services" if certain statutory requirements are met. The formal request letter can be viewed via the tracking sheet for this NCA on the CMS website at https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=283 . They stated that the initial preventive physical exam (IPPE) or subsequent annual wellness visits (AWV) are not limited to Consequently, studies that evaluate screening test strategies are not as relevant and are less helpful to CMS. § 410.64. Recommendations for Identification and Public Health Management of Persons with Chronic Hepatitis B Virus Infection (CDC, MMWR, September 19, 2008) CDC Approved Slide Set on New Recommendations (PDF, 201 KB, 32pg.) CMS responds in detail to the public comments on a proposed national coverage determination when issuing the final national coverage determination. The USPSTF did not define an age range for "women" nor did the USPSTF (2009) focus on risk factors or other specific patient characteristics. The USPSTF has made recommendations on screening for other infections, including chlamydia and gonorrhea,8 HBV in nonpregnant adults and ⦠Household contacts or sexual partners of persons with HBV infection. Screening for HBV infection provides direct benefit to Medicare beneficiaries. all adults . In July of 2012, the grade definitions were updated to reflect the change in definition of and suggestions for practice for the grade C recommendation. The key questions focused on determining the benefits and harms of screening for HBV infection. CMS performed a literature search using PubMed on March 15, 2016 with the search terms "screening," "hepatitis b virus" and "human." THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel ... Antiviral therapy and management for cancer patients should follow national HBV guidelines, independent of cancer therapy, including management by a clinician experienced in HBV management for prevention of liver diseases such as cirrhosis or liver cancer. The field of HCV therapeutics continues to evolve rapidly and since the World Health Organization (WHO) issued its first Guidelines for the screening care and treatment of persons with hepatitis C infection in 2014 several new medicines ... Hepatitis C virus (HCV) causes liver disease and it is found in the blood of persons who are infected. We have further explained our reasoning for the requirement that the screening for HBV be ordered by a primary care practitioner within the context of a primary care setting in our responses to comments and in the analysis section of the decision memorandum. 2 The most important risk factor for HCV infection is past or current injection drug use. This 2008 report presented the CDC's recommendation and expanded its previous HBV testing guidelines. A MEDCAC meeting was not convened on this issue. The recommendations in this report supersede the U.S Public Health Service (PHS) guideline recommendations for reducing transmission of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) through organ transplantation (Seem DL, Lee I, Umscheid CA, Kuehnert MJ.PHS guideline for reducing human immunodeficiency virus, hepatitis B virus, and ⦠We are not indicating that the test itself must be performed by a primary care practitioner. You’re at high risk because you use or have used illicit injection drugs. 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)). Recommendations for Identification and Public Health Management of Persons with Chronic Hepatitis B Virus Infection (CDC, MMWR, September 19, 2008) CDC Approved Slide Set on New Recommendations (PDF, 201 KB, 32pg.) These recommendations are based on the Public Health England (PHE) guidelines Shooting up: infections among people who inject drugs in the UK, 2018 â An update, December 2019 [], The UK National Screening Committee (NSC) recommendation on hepatitis C screening in pregnancy [], and Hepatitis C: migrant health guide []; the World Health Organization (WHO) Guidelines for the care and ⦠4. Hepatitis B and C cause most cases of hepatitis in the United States and the world. The two diseases account for about a million deaths a year and 78 percent of world's hepatocellular carcinoma and more than half of all fatal cirrhosis. Nonetheless, given that there is an estimated 700,000 to 2.2 million people in the U.S. with chronic HBV infection (LeFevre 2014), the implementation of screening to identify HBV-positive persons followed by the prompt administration of antiviral treatment stands to significantly impact health outcomes. LeFevre et al. Since there is no definitive guidance on the frequency of screening for the high risk population, CMS has determined that repeated screening would be appropriate annually 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. Coordination of health services is especially important in the presence of the coexisting health issues of our Medicare beneficiaries. ACOG - American Congress of Obstetricians and Gynecologists National guidelines recommend that infants exposed to HCV be tested; however, it is unclear if these recommendations are being followed. Medicare provides coverage under Part B for hepatitis B vaccine and its administration, furnished to a Medicare beneficiary who is at high or intermediate risk of contracting hepatitis B. https://www.cms.gov/medicare-coverage-database/details/nca-view-public-comments.aspx? As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion. (This is a grade A recommendation)" (USPSTF 2009). See 42 C.F.R. primary care providers or in primary care settings. Hepatitis B vaccination is recommended for all medically stable infants weighing 2,000 g (4 lb, 6 oz) or more within 24 hours of birth, unvaccinated infants and children, and unvac- Neither the CDC nor the clinically-based guidelines from the professional societies addressed the issue of screening frequency in this particular population. the initial contact for patients within a complicated health system. Annals of Internal Medicine 2014;161:58. Weinbaum CM, Williams I, Mast EE, et al. Read the clinical considerations section of USPSTF Recommendation Statement. Viral hepatitis screening guideline before biological drug use in rheumatic patients. A number of commenters stated that because beneficiaries may not initially go to a primary care provider, a separate appointment with a different provider may be required, which is seemingly incongruent with the promotion of care coordination and efficiency. Sign up to get the latest information about your choice of CMS topics in your inbox. At the time of admission to a hospital, birth center, or other delivery setting, women with unknown HBsAg status or with new or continuing risk factors for HBV infection (such as injection drug use or evaluation or treatment for a sexually transmitted disease) should receive screening." U.S. Preventive Services Task Force Recommendations for HBV, "The USPSTF recommends screening for HBV infection in persons at high risk for infection. Screening for HBV infection is recommended for asymptomatic, nonpregnant adolescents and adults at high risk for HBV infection and for 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. This may be defined as the ability of the test to give a positive finding when the individual screened has the disease or abnormality under investigation. Is the evidence sufficient to determine that screening for HBV infection is recommended with a grade of A or B by the USPSTF? CMS - Centers for Medicare & Medicaid Services These are the first WHO guidelines on testing for chronic HBV and HCV infection and complement published guidance by WHO on the prevention, care and treatment of chronic hepatitis C and hepatitis B infection. guidance on HCV screening with two new major recommendations: (1) all adults aged 18 years and older. ESRD – end stage renal disease The estimated mortality rate for persons with chronic HBV infection and cirrhosis or HCC is 15% to 25%. 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. CMS notes that the USPSTF concluded that "there is high certainty that the net benefit of screening pregnant women for HBV infection is substantial" (USPSTF 2009). "The USPSTF recommends screening for hepatitis B virus (HBV) infection in pregnant women at their first prenatal visit. The new USPSTF Recommendation Statement aligns with the Centers for Disease Control and Preventionâs (CDC) Recommendations for the Identification of Chronic Hepatitis C Virus Infection Among Persons Born During 1945â1965 , issued in 2012. We further conclude that compliance by testing laboratories with CLIA regulatory requirements provides an additional, on-going safeguard for screening test quality. Diagnosis of chronic HBV infection is characterized by persistence of HBsAg for at least 6 mo" (LeFevre 2014). El-Serag H, McGlynn KA, Graham GN et al. These studies assess the effects of the preventive ", The USPSTF also noted that "Screening for HBV infection by testing for HBsAg should be performed in each pregnancy, regardless of previous hepatitis B vaccination or previous negative HBsAg test results.". HBc – hepatitis B core antigen ", Lok et al. CMS reviewed the USPSTF recommendations and performed its own review of the evidence. future assessments of screening. Adults with chronic hepatitis B. Please enable "JavaScript" and revisit this page or proceed with browsing CMS.gov with This NCD does not require the testing be done by the primary care provider/practitioner. Department of Veterans Affairsâ Viral Hepatitis for Health Care Providers includes information on A, B, and C screening and treatment. This edition contains updated information in histopathology, immunosuppressive therapy and infectious problems for the transplant patient. "JavaScript" disabled. USPSTF Guideline: Screening for Hepatitis B in Nonpregnant Adolescents and Adults. aged â¥18 years, except in settings where the prevalence of hepatitis C virus (HCV) infection (HCV RNA-positivity) is <0.1%* Hepatitis C screening among pregnant women in every pregnancy Section Navigation. CMS included in the evidence section the most recent screening recommendations from the USPSTF for pregnant women (USPSTF 2009) and for nonpregnant adolescents and adults (LeFevre 2014). ", Reducing Incidence and Prevalence of HBV Infections. Annals of Internal Medicine 2014;161:58. Doylestown, PA 18902 However, many of those with chronic hepatitis C do not even know they are infected. Back to Screening for Hepatitis B Virus (HBV) Infection, http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/hepatitis-b-in-pregnant- women-screening, (http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/hepatitis-b- virus-infection-screening-2014), https://www.guideline.gov/content.aspx?id=12627, https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=283. The recommendations are informed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework, an approach that provides guidance and tools to define the research questions, conduct the systematic review, ... Data is insufficient to recommend routine anal cancer screening with anal cytology 2; Hepatitis B Screening: All MSM should be tested for HBsAg, HBV core antibody, and HBV surface antibody 12; Hepatitis C Screening: All adults over age 18 years should be screened for hepatitis C except in settings where the hepatitis C infection (HCV) positivity is < 0.1% 13 Hepatitis B Foundationâs Clinical Guidelines for Pediatric HBV. AST – aspartate aminotransferase Executive Summary accessed on March 29, 2016 at http://books.nap.edu/openbook.php?record_id=5152&page=1. As we state in section VII of this decision memorandum, the USPSTF conducts rigorous reviews of the evidence to create evidence-based recommendations for preventive services in the primary care setting. While IFN is given for a finite duration, nucleos(t)ide analogues are administered for many years and often for life. This reconfirmation was accomplished after commissioning a systematic review by AHRQ that searched for large, high-quality studies related to HBV screening in pregnancy that have been published since the 2004 USPSTF recommendation with the goal of determining the benefits and harms of screening for HBV infection (Lin 2009). Recommendations for Hepatitis C Screening. 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. The article states a few risk factors for hepatitis B reactivation. While some preventive services, such as the IPPE and AWV are specifically provided for in statute, screening for HBV in adults is established through the NCD process pursuant to §1861(ddd) of the Social Security Act. Chronic hepatitis C: US prevalence of chronic hepatitis C (CHC) viral infection: 1999-2002: 1.3% or about 3.5 million people in the US. for hepatitis B virus (HBV) infection in pregnant women at their first prenatal visit. CMS encourages appropriate HBV vaccination. Consistent with 1862(l)(3)(B), CMS provides 30 days for public comment on the aforementioned proposal. Pursuant to §1861(ddd)(1) of the Social Security Act, CMS may add coverage of "additional preventive services" if certain statutory requirements are met. Is the evidence sufficient to determine that screening for HBV infection is appropriate for individuals entitled to benefits under Part A or enrolled under Part B? Medicare also covers yearly repeat screenings if youâre at high risk. Recommendations for identification and public health management of persons with chronic hepatitis B virus infection. Accessed on March 29, 2016 at http://www.aafp.org/patient-care/clinical-recommendations/all/hepatitis.html. The decision memorandum alerts the public of our intent to implement the decision at some point in the future. USPSTF 2012 Clinical Preventive Services Guide. The Hepatitis C GUIDELINES Pocketcard⢠is endorsed by the American Association for the Study of Liver Diseases (AASLD) and is based on the latest AASLD guidelines. 1A. ", 6. There is at least moderate certainty that the net benefit is small. In addition to universal screening for hepatitis C, the guidance emphasizes universal treatment. Clinical practice guidelines are deï¬ned as ââsystemati-cally developed statements to assist practitioner and patient decisions about appropriate heath care for spe-ciï¬c clinical circumstances.ââ1 These guidelines on autoimmune hepatitis provide a data-supported approach to the diagnosis and management of this dis-ease. Inconsistency of findings across individual studies. 2A. Specificity. ", "USPSTF found convincing evidence that universal prenatal screening for HBV infection substantially reduces perinatal transmission of HBV and the subsequent development of chronic HBV infection. The USPSTF Procedure Manual can be found at http://www.uspreventiveservicestaskforce.org/Page/Name/methods-and-processes. CMS receives 50 comments. As we have explained previously, CMS may add coverage of "additional preventive services" if certain statutory requirements are met. CMS notes however that none of these organizations address the applicability of these findings specifically to the majority of Medicare beneficiaries, which is persons 65 years of age or older. Reporting Requirements. The authors performed a systematic review based on evidence obtained after a literature search (January 2001 to March 2008) and reference lists of retrieved articles. IOM. We note that the USPSTF recommendations for this screening preventive service are based on either risk factors or pregnancy status and therefore would be applicable to any Medicare beneficiary who is an adolescent or adult. The authors did not find new evidence regarding the benefits or harms of screening for HBV infection in pregnant women but noted that "previously published randomized trials support the 2004 USPSTF recommendation for screening" (Lin 2009). 410.63. PRACTICEGUIDELINE AASLD Guidelines for Treatment of Chronic Hepatitis B Norah A. Terrault,1 Natalie H. Bzowej,2 Kyong-Mi Chang,3 Jessica P. Hwang,4 Maureen M. Jonas,5 and M. Hassan Murad6 See Editorial on Page 31 Objectives and Guiding Principles Chou et al. In 2010, the highest rate of new HBV infections was among persons age 30 to 39 years (2.33 cases/100,000 population), with males and black persons at highest risk.
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