Transcript Overcoming Barriers to Broad HCV Testing

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
Number with chronic HCV (millions)
Baby Boomers (Born in 1945–1965)
Account for 76.5% of HCV in the US1
1.6
Estimated Prevalence by Age Group2
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0
<192
0
1920s
1930s
1940s
1950s
1960s
1970s
1980s
1990+
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/consequenceshepatitis-c-virus-RR05-15-09.php
Milliman report was commissioned by Vertex Pharmaceuticals; 3. McGarry LJ et al. Hepatology. 2012;55(5):1344-1355.
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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 12/6/137/30/14 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
–
•
•
•
•
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
–
•
•
Toothbrushes, razors, nail-grooming equipment
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
12
• 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
10-year Cumulative Incidence Rate
SVR (Cure) Associated with
Decreased All-Cause Mortality
29.9
26
21.8
8.9
Van der Meer et al. JAMA 2012; 308:2584
5.1
2.1
530 patients with
advanced fibrosis,
treated with interferonbased therapy, and
followed for 8.4 (IQR 6.41.4) years
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
1,000
adult
patients
Efficiently identify
birth cohort 19451965:
• Electronic
prompt
330
baby
boomers
~1/3 of
adults are
in 19451965
cohort
10
HCV
antibody
positive
•
•
•
1 of 30 baby
boomers
1 of 23 men
baby boomers
1 of 12 African
American men
baby boomers
7 HCV
RNA
positive
3 with more
advanced
fibrosis
4 with mild
fibrosis
15%-30% of
HCV antibody
patients will
spontaneously
clear
Up to 25% of
baby boomers
may have
cirrhosis
75% of cirrhotic
patients are
men
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Davis, Gastro 2010; 138: 513
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
Why Test People Born Between 19451965?
• 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
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
Hepatitis C Antibody
(HCV Ab)1
Negative (-)
STOP here if no concern for acute
infection or severe immunosuppression.
If so, check HCV RNA.
Positive (+)
These people are NOT chronically infected.
Check HCV RNA
(viral load)
Negative (-)
•
Positive (+)
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.
Hepatitis C infection
1Example
Evaluation and referral
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
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)
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
16
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
Bonder, Curr Gastro Rep 2014; 16:372
ALV 10.7.13
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
Continuum of scores (in kPa)
Bonder, Curr Gastro Rep 2014; 16:372
70+ kPa
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:
HCV RNA (viral load)
HCV genotype/subtype
ALT, AST, Total bilirubin, Alk Phos,
Albumin
Creatinine and GFR
CBC with differential
INR
HBsAb, HBsAg, HBcAb: vaccine if
all (-)
HAV total Ig: vaccinate if (-)
Fibrosure/FIB-4/APRI
Fibroscan if Fibrosure >0.55
ANA: autoimmune w/u if (+)
RPR
HIV Ab if not done recently
Fe2+, TIBC, ferritin
Abdominal ultrasound if likely
cirrhosis for HCC
EGD if likely cirrhosis for varices
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 and the Role of EMR Prompts
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 19451965 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 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
HCV Antibody Test Volume Increased after
EMR Prompt
Boomers
Average = 1192
tests/4 weeks
1600
EMR
prompt
1400
1200
CDC 19451965 testing
guidelines
1000
800
600
Average = 303
tests/4 weeks
Average = 438
tests/4 weeks
Boomers
400
200
3/1/2014
1/1/2014
11/1/2013
9/1/2013
7/1/2013
5/1/2013
3/1/2013
1/1/2013
11/1/2012
9/1/2012
7/1/2012
5/1/2012
3/1/2012
1/1/2012
0
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
Group
Number (%) Tested for
HCV Ab
Anti-HCV Seroprevalence (%)
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)
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)
All Boomers
All Non-Boomer
Beth Israel Deaconess Medical Center, Boston, MA, Quality Outcomes Data, 6/5/14
Example of HCV Prompt in EPIC
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
• Powerpoint presentation 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
EMR prompts from other systems
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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
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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
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DISCUSSION
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