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This article discusses the barriers to hepatitis C testing and provides strategies to overcome them. It includes information on the prevalence of hepatitis C among baby boomers, misconceptions about the disease, barriers to treatment, and management guidelines for healthcare providers.
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Overcoming Barriers to Broad Hepatitis C Testing Camilla S. Graham, MD, MPH Division of Infectious Diseases Beth Israel Deaconess Medical Center
Disclosures • Trek Therapeutics, Public Benefits Corporation
Overcoming Barriers to HCV Testing • Identify what would convince people responsible for doing HCV testing that testing helps solve their problem • Convince these testers that it is urgent to test people now • Identify misconceptions and fears and address them or help develop solutions • Showcase successes
Audiences • Primary care providers • Internal medicine MD, DO, NP, PA • Nurses • Other front line staff • Specialists who also do primary care • Administrators who determine priorities • Lab directors • IT staff
Misconception: My patients don’t have undiagnosed hepatitis C Discuss: Hepatitis C is common and uniform testing of baby boomers plus risk based testing can identify them
<1920 1.6 1920s 1930s 1940s 1950s 1960s 1970s 1980s 1990+ 1.4 1.2 1.0 0.8 0.6 0.4 0.2 0 Baby Boomers (Born in 1945–1965) Account for 76.5% of HCV in the US1 Estimated Prevalence by Age Group2 Number with chronic HCV (millions) Birth Year Group An estimated 35% of undiagnosed baby boomers with HCV currently have advanced fibrosis (F3-F4; bridging fibrosis to cirrhosis)3 1. Centers for Disease Control and Prevention. MMWR. 2012;61:1-32; Adapted from Pyenson B, et al. Consequences of Hepatitis C Virus (HCV): Costs of a baby boomer Epidemic of Liver Disease. New York, NY: Milliman, Inc; May 18, 2009. http://www.milliman.com/expertise/healthcare/publications/rr/consequences-hepatitis-c-virus-RR05-15-09.php Milliman report was commissioned by Vertex Pharmaceuticals; 3. McGarry LJ et al. Hepatology. 2012;55(5):1344-1355.
Misconception: Hepatitis C is slowly progressive so I have time to identify patients Discuss: 25% of baby boomers already have cirrhosis
Misconception: If we find all of these undiagnosed people it will overwhelm our system Discuss: It takes time to bring people into care
Barriers to HCV Treatment Not Just Due to Payer Restrictions • 7,658 MassHealth members with HCV • PCC members continuously enrolled 12/6/13-7/30/14 with an ICD-9 code for HCV • No recent evidence of HCV treatment • 1,075 (14%) members approved for sofosbuvir-containing regimens over first ~15 months • >90% of PAs approved
Misconception: The treatment is too expensive so I am going to wait until the price is lowered Discuss: There are many interventions that can be done to help keep people healthy and get them ready for treatment
Hepatitis C Diagnosis has been Made: What to Discuss with the Patient • Do not donate blood. May donate organs to others with HCV • Do not share personal items that might have small amounts of blood • Toothbrushes, razors, nail-grooming equipment • HCV is not spread by hugging, kissing, food or water, sharing utensils, or casual contact • Stop or reduce alcohol use • If using illicit drugs, stop using. If continued, do not share needles, syringes or any works • If in short term, multiple or MSM relationships, use latex condoms. No condom use is recommended for long-term monogamous heterosexual couples • Maximum incidence rate of HCV sexual transmission estimated about 1 new infection per 190,000 sexual contacts per year (Terrault, Hepatology. 2013; 57(3):881) • Limit Tylenol to 2 gm a day and discuss all other medications (including OTC and herbal ) with a provider • Check exposure status for hepatitis A and B and vaccinate if needed Adapted from Winston et al. Management of hepatitis C by the primary care provider: Monitoring guidelines; 2010 http://www.hcvadvocate.org/hepatitis/factsheets_pdf/PCP_web_10.pdf
Management of Patients with Hepatitis C and Cirrhosis • Every 6 month screening for liver cancer • Usually ultrasound • Consider CT or MRI if highly nodular liver; first exam • Screening for esophageal varices • Repeat every 1 -3 years depending on results • Counsel on symptoms of hepatic encephalopathy • Vaccination for HAV, HBV, pneumococcus • Counseling around medication use to avoid overdose or adverse events (including common drugs like Tylenol and NSAIDS) • Counseling about complete abstinence from alcohol • Evaluation for antiviral treatment • Cure of HCV can reduce liver failure and liver cancer, even in patients with cirrhosis (+/- HIV coinfection) • Possible referral for liver transplant services http://www.aasld.org/practiceguidelines/pages/guidelinelisting.aspx
SVR (Cure) Associated with Decreased All-Cause Mortality 29.9 26 21.8 10-year Cumulative Incidence Rate 8.9 5.1 530 patients with advanced fibrosis, treated with interferon-based therapy, and followed for 8.4 (IQR 6.4-1.4) years 2.1 Van der Meer et al. JAMA 2012; 308:2584
Misconception: There are too many prompts already and I don’t have time to deal with this Discuss: For baby boomers this is a one-time, inexpensive blood test that can be done with other routine labs
Screening in Clinic 3 with more advanced fibrosis 1,000 adult patients 330 baby boomers 7 HCV RNA positive 10 HCV antibody positive 4 with mild fibrosis • Efficiently identify birth cohort 1945-1965: • Electronic prompt • 1 of 30 baby boomers • 1 of 23 men baby boomers • 1 of 12 African American men baby boomers Up to 25% of baby boomers may have cirrhosis 75% of cirrhotic patients are men ~1/3 of adults are in 1945-1965 cohort 15%-30% of HCV antibody patients will spontaneously clear Davis, Gastro 2010; 138: 513
Initial Hepatitis C Testing and Evaluation STOP here if no concern for acute infection or severe immunosuppression. If so, check HCV RNA. • Who Should Be Tested for Hepatitis C? • New: Anyone born between 1945 and 1965 should be tested once, regardless of risk factors • In addition, patients with the following risk factors: • Elevated ALT (even intermittently) • A history of illicit injection drug use or intranasal cocaine use (even once) • Needle stick or mucosal exposure to blood • Current sexual partners of HCV infected persons • Received blood/organs before 1992 • Received clotting factors made before 1987 • Chronic hemodialysis • Infection with HIV • Children born to HCV-infected mothers Negative (-) Hepatitis C Antibody (HCV Ab)1 Positive (+) • These people are NOT chronically infected. • Detectable HCV Ab with negative HCV RNA can occur with spontaneous clearance of infection ( about 25% of people exposed to HCV will clear; verify HCV RNA negative in 4 to 6 months) or with treatment of HCV. Negative (-) Check HCV RNA (viral load) Positive (+) Hepatitis C infection • 1Example ICD-9 codes for HCV antibody testing: • V73.89: screening for other specified viral disease • 790.4: nonspecific elevation of levels of transaminase; use if patient ever had an elevated ALT • Why Test People Born Between 1945-1965? • 76% of the ~4 million people with HCV infection in the US are baby boomers • In the 1945-1965 cohort: • All: 1 out of 30 • Men: 1 out of 23 • African American men: 1 out of 12 • Up to 75% do not know they have HCV • 73% of HCV-related deaths are in baby boomers Evaluation and referral • Counsel Patients with HCV Infection About Reducing Risk of Transmission • Do not donate blood, body organs, other tissue, or semen • Do not share personal items that might have small amounts of blood (toothbrushes, razors, nail-grooming equipment, needles) and cover cuts and wounds • HCV is not spread by hugging, kissing, food or water, sharing utensils, or casual contact • If in short term or multiple relationships, use latex condoms. No condom use is recommended for long-term monogamous couples (risk of transmission is very low) • What Can Happen to People with Hepatitis C? • It is important to identify if patients have cirrhosis • Patients with cirrhosis are at risk for liver cancer (HCC) and liver decompensation (ascites, variceal bleed, hepatic encephalopathy, jaundice) • Hepatitis C is curable, and cure reduces the risk of severe complications, even with cirrhosis • Refer patients to a specialist who has experience treating hepatitis C to see if they need treatment • Initial Management • Evaluate alcohol use (CAGE, AUDIT-C) and recommend stopping use • Vaccinate for hepatitis A and hepatitis B if not previously exposed • Evaluate sources of support (social, emotional, financial) needed for HCV treatment Smith BD et al. MMWR. August 17, 2012/61(RR04); 1-18. Adapted from Winston et al. Management of hepatitis C by the primary care provider: Monitoring guidelines; 2010; http://www.hcvadvocate.org/hepatitis/factsheets_pdf/PCP_web_10.pdf
Fear: (IT/EMR) We have too many other initiatives to work on this right now Discuss: It is the law and law trumps meaningful use
Fear: My patients weren’t treated well when they saw a HCV provider before, are scared of liver biopsy/treatment, don’t want to wait Describe: All support resources in place to help PCPs; modern HCV management
FibroScan - Transient Elastography • Ultrasound determines velocity of shear wave in m/s, which is proportional to liver stiffness in kilopascal (kPa) • Entire process requires 15 to 20 minutes, provides immediate results • Falsely elevated results: • High ALT (>100) • Eating within 2 hours ALV 10.7.13 Bonder, Curr Gastro Rep 2014; 16:372
Continuum of Fibrosis/Cirrhosis in HCV <7 kPa = Stage 0-1 7-9.5 kPa = Stage 2 9.5-12.5 kPa = Stage 3 >12.5 kPa = Cirrhosis >20 kPa = Increased risk liver-related complications 70+ kPa Continuum of scores (in kPa) Bonder, Curr Gastro Rep 2014; 16:372
Strategies to Improve Testing • Educate medical students and residents, who will then encourage their attendings • Bag lunch programs for people to share cases • Lectures to review ongoing testing data and outcomes • Identify unexpected problems and help develop solutions (iterative)
Address All Stakeholder Concerns • Clinical Pathology (if hospital-based lab) • Expected volume of tests • Reflex HCV RNA testing for all anti-HCV reactive tests • Additional lab order sets • Outside vendor (Quest, LabCorp) • Negotiate “package deals”
IT/EMR Support • Provide algorithm for testing • Example at NVHR.org • EPIC already has birth cohort testing support built in but will need refinement for specific health settings • Educate EMR approval committee • Identify areas that need more support • Follow up from ED or inpatient testing • Lab sets, template notes, patient handouts
Decide What Primary Care Will Do in Each Health Setting • Option 1: Anti-HCV antibody testing with confirmatory HCV RNA and refer all RNA+ patients to HCV providers • Options 2: Also assess alcohol and drug use, refer to care if needed, address mental health issues, basic counseling on transmission risk reduction, vaccinate for HAV and HBV if not immune, assess insurance status and refer for case management if needed
Decide What Primary Care Will Do Option 3: All above tasks plus check all labs needed for first assessment by HCV provider:
Decide What Primary Care Will Do • Option 4: Identify primary care champions who will become HCV providers • Accept referrals from other PCPs • Use clear guidelines, templates • ECHO/Telemedicine support • Email support • Case management and navigator support
EMR Prompts Are an Important Component of Improved HCV Testing • National Viral Hepatitis Roundtable has a working group on baby boomer HCV testing and linkage to care (NVHR.org) • Participants share best practices, screen shots of EMR prompts, educational materials, and other aides. • EPIC, AllScripts and Centricity are represented currently
BIDMC/CareGroup Experience • Network of academic hospitals, primary care practices, community health centers that share a common electronic medical record system • 5,500 clinicians and ~1.5 million patients • Implemented a prompt in EMR for a one-time anti-HCV test in all patients born from 1945-1965 who had no prior record of testing, while continuing risk-based testing • Went live on June 4, 2013 • In the first ten months, we tested a total of 20,000 people for HCV
Facilitate the Integration of Hepatitis C 1945-1965 Birth Cohort Screening Prompts into EMRs in Each State • Simplest, least expensive way to test a portion of the HCV Ab+ population • Only detects patients in the 1945-1965 cohort who attend medical (primary care) visits • Misses at-risk youth, those who are unengaged with routine health care, those with unconvinced clinicians • Complements Emergency Dept testing, outreach programs, etc.
Steps to Implement Birth Cohort HCV Testing • Build a core team: Primary Care, Infectious Disease, Hepatology, Database Management, and Clinical Pathology • Implement a one-time electronic prompt for anti-HCV antibody testing for all patients born from 1945 through 1965 who have no record of HCV antibody testing • One-page educational tool for providers and one for patients(samples at KNOW MORE HEPATITIS/CDC and NVHR.org) • Email notification to affected clinicians • HCV nurse educator • Help facilitate patient referral in the Liver Center and Infectious Diseases Clinic • Slide deck for presentations to primary care providers about HCV (sample at NVHR.org) • Collaboration with Laboratory Services • Expand capacity for increased volume of HCV Aband RNA tests • Add language to results page (or a second prompt) for all positive HCV antibody tests informing clinicians to order an HCV RNA test to determine the presence of active HCV infection • Generates a report of all positive HCV antibody tests for follow up
HCV Antibody Test Volume Increased after EMR Prompt Beth Israel Deaconess Medical Center, Boston, MA, Quality Outcomes Data, 6/5/14
More Women Tested for HCV but More Men are Anti-HCV Positive Beth Israel Deaconess Medical Center, Boston, MA, Quality Outcomes Data, 6/5/14
Example: EPIC Resources • Pre-loaded content to support hepatitis C testing in the 1945 - 1965 birth cohort into the foundation system • Need to turn the functioning on as is, or with modifications • Uses the Health Maintenance reminders (modifiers) and Population Management tools • Standing orders for anti-HCV antibody test, patient reminders sent out to MyCharts, and development of reporting workbenches
Example: EPIC Resources • EPIC Earth • EPIC "Community Library" has e • Examples of hepatitis C decision support programs from other EPIC users • EPIC podcast for providers about hepatitis C decision support: • https://userweb.epic.com/Thread/32100 • Powerpointpresentation of interventions in EPIC to improve HCV testing • Project team support
Epic - Possible Approaches Alert patients through their PHR, e.g. MyChart Allow front desk staff to schedule the tests Nursing Clinical Alerts (POC) or Nursing Worklist of patients meeting the criteria (outside POC) Physician active alerts, POC alerts such as BPA’s Health Maintenance Reminders – viewable by nurse, physician, and patient Population Management – generate a report of patients meeting the criteria and adding a standing future order go all patients in the list (bulk orders) or add a Health Maintenance Reminder to all of the patients Test the alerts before they are viewable to the end users Overdue results folders
RI HCV Birth Cohort Prompt in EPIC Courtesy of Lynn Taylor, Lifespan & RI Defeats Hep C
RI HCV Birth Cohort Prompt in EPIC Courtesy of Lynn Taylor, Lifespan & RI Defeats Hep C
AllScripts Hepatitis C Prompt Drexel’s “C a Difference” developed the following AllScripts alerts to help providers adhere to CDC Hepatitis C testing recommendations 1) All individuals who were born between 1945 and 1965 who have not been previously tested for HCV will have this alert in the chart: For these patients, type “hcvscreen” to order HCV antibody screening with reflex confirmatory PCR quantitative testing Courtesy of Stacey Trooskin, Drexel & HepCAP
AllScripts Hepatitis C Prompt 2) All individuals who have had a reactive HCV antibody test or have an ICD-9 code consistent with chronic HCV infection, but have not had confirmatory PCR quantitative testing in the last 5 years will have this alert: For these patients, type “hcvconfirmatory” or “hcvconfirm” to order HCV RNA PCR quantitative testing Courtesy of Stacey Trooskin, Drexel & HepCAP
FIB-4 Screening: Boston Healthcare for the Homeless - Centricity Courtesy of Maggie Beiser, BHCHP