1. Overcoming Barriers to Broad Hepatitis C Testing
Camilla S. Graham, MD, MPH
Division of Infectious Diseases
Beth Israel Deaconess Medical Center

2. Disclosures
Trek Therapeutics, Public Benefits Corporation

3. 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

4. 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

5. 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

6. Baby Boomers (Born in 1945–1965) Account for 76.5% of HCV in the US1
Estimated Prevalence by Age Group2
Birth Year Group
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
1990+
1980s
1970s
1960s
1950s
1940s
1930s
1920s
<1920
Number with chronic HCV (millions)
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, Milliman report was commissioned by Vertex Pharmaceuticals; 3. McGarry LJ et al. Hepatology. 2012;55(5):

7. Discuss: 25% of baby boomers already have cirrhosis
Misconception: Hepatitis C is slowly progressive so I have time to identify patients
Discuss: 25% of baby boomers already have cirrhosis

8. Discuss: It takes time to bring people into care
Misconception: If we find all of these undiagnosed people it will overwhelm our system
Discuss: It takes time to bring people into care

9. 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

10. 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

11. 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;

12. 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

13. 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 ) years
2.1
Van der Meer et al. JAMA 2012; 308:2584

14. 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

15. Screening in Clinic 3 with more advanced fibrosis 1,000 adult patients
330 baby boomers
10 HCV antibody positive
7 HCV RNA positive
4 with mild fibrosis
Efficiently identify birth cohort :
Electronic prompt
~1/3 of adults are in cohort
1 of 30 baby boomers
1 of 23 men baby boomers
1 of 12 African American men baby boomers
15%-30% of HCV antibody patients will spontaneously clear
Up to 25% of baby boomers may have
cirrhosis
75% of cirrhotic patients are men
Davis, Gastro 2010; 138: 513

16. Initial Hepatitis C Testing and Evaluation
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
Hepatitis C Antibody (HCV Ab)1
Positive (+)
Check HCV RNA (viral load)
Hepatitis C infection
Evaluation and referral
Negative (-)
STOP here if no concern for acute infection or severe immunosuppression. If so, check HCV RNA.
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.
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 ?
76% of the ~4 million people with HCV infection in the US are baby boomers
In the 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
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); Adapted from Winston et al. Management of hepatitis C by the primary care provider: Monitoring guidelines; 2010;

17. Discuss: It is the law and law trumps meaningful use
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

18. 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

19. 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
Bonder, Curr Gastro Rep 2014; 16:372

20. Continuum of Fibrosis/Cirrhosis in HCV
<7 kPa = Stage 0-1
7-9.5 kPa = Stage 2
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

21. 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)

22. 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”

23. 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

24. 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

25. Decide What Primary Care Will Do
Option 3: All above tasks plus check all labs needed for first assessment by HCV provider:
HCV RNA (viral load)
Fibrosure/FIB-4/APRI
HCV genotype/subtype
Fibroscan if Fibrosure >0.55
ALT, AST, Total bilirubin, Alk Phos, Albumin
ANA: autoimmune w/u if (+)
Creatinine and GFR
RPR
CBC with differential
HIV Ab if not done recently
INR
Fe2+, TIBC, ferritin
HBsAb, HBsAg, HBcAb: vaccine if all (-)
Abdominal ultrasound if likely cirrhosis for HCC
HAV total Ig: vaccinate if (-)
EGD if likely cirrhosis for varices

26. 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
support
Case management and navigator support

27. 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

28. BIDMC and the Role of EMR Prompts

29. 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 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

30. Complements Emergency Dept testing, outreach programs, etc.
Facilitate the Integration of Hepatitis C 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 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.

31. 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)
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 Ab and 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

33. HCV Antibody Test Volume Increased after EMR Prompt
Beth Israel Deaconess Medical Center, Boston, MA, Quality Outcomes Data, 6/5/14

34. More Women Tested for HCV but More Men are Anti-HCV Positive
Group
Number (%) Tested for HCV Ab
Anti-HCV Seroprevalence (%)
All Boomers
13,107
2.3%
Boomer women
7,555 (58%)
1.4% (34% of HCV Ab+ results)
Boomer men
5,552 (42%)
3.6% (66% of HCV Ab+ results)
All Non-Boomer
7,022
2.6%
Non-Boomer women
4,023 (57%)
1.9% (42% of HCV Ab+ results)
Non-Boomer men
2,999 (43%)
3.5% (58% of HCV Ab+ results)
Beth Israel Deaconess Medical Center, Boston, MA, Quality Outcomes Data, 6/5/14

35. Example of HCV Prompt in EPIC

36. Example: EPIC Resources
Pre-loaded content to support hepatitis C testing in the 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

37. 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:
Powerpoint presentation of interventions in EPIC to improve HCV testing
Project team support

38. 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

39. RI HCV Birth Cohort Prompt in EPIC
Courtesy of Lynn Taylor, Lifespan & RI Defeats Hep C

40. RI HCV Birth Cohort Prompt in EPIC
Courtesy of Lynn Taylor, Lifespan & RI Defeats Hep C

41. EMR prompts from other systems

42. 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

43. 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

44. FIB-4 Screening: Boston Healthcare for the Homeless - Centricity
Courtesy of Maggie Beiser, BHCHP

46. DISCUSSION