Overview

• This program aimed to improve hepatitis C virus cure rates among patients in central Pennsylvania through close follow-up by a multidisciplinary team composed of physicians, clinical pharmacists, and nurse practitioners and coordinators.

Organization Name

Geisinger Health System

Organization Type

• Academic Medical Center
• Integrated healthcare system/network

National/Policy Context

• Chronic Hepatitis C infection affects 3.5 million Americans, with 2,967 confirmed new cases reported in 2016 and an estimated actual incidence of up to 40,000 new cases each year.
• Recent advances in hepatitis C treatment include new “direct-acting” antiviral medications that result in better outcomes, fewer side effects, and shorter treatment times (some as short as 8 weeks). However, many of these treatments are extremely expensive and require strict adherence in order to achieve a sustained virologic response.

Local/Organizational Context

• The Geisinger Clinic provides services to patients in counties with some of the highest rates of HCV infection in Pennsylvania. Many of these counties are located in rural settings in central Pennsylvania where access to health care is extremely limited.
• Data from the Pennsylvania Department of Health has shown that HCV is on the rise among young, white, injection-drug users and that there are profound racial disparities in age at liver cancer and death from HCV for HCV-affected patients.
• Not only has HCV testing in Pennsylvania not been appropriately targeted geographically and demographically, but it also has not been efficiently performed and regulated, especially among the highest risk populations.

Patient Population Served and Payor Information

• Patients seen at Geisinger Clinic are insured by the Geisinger Health Plan.
• For those unable to afford the cost of HCV treatment in this program, manufacturer-based copay assistance programs and grant money from public foundations was utilized.

Leadership

• Sandeep Khurana, MBBS – Medical Director, Liver Transplantation and Director of Hepatology, Geisinger Medical Center
• Sara Gaines, PharmD, BCPS – Clinical Pharmacist, Gastroenterology and Hepatology, Geisinger Medical Center
• Thomas H. Lee, MD, MSc –  Chief Medical Officer of Press Ganey, member of the Board of Directors of Geisinger Health System and Geisinger Health Plan
• Initially, the program was steered by physicians, but once the process was developed, the clinical pharmacists took the lead in maintaining and directing the process and day-to-day practice.

Funding

• Funding was provided by ProvenCare by Geisinger, a program started in February 2006 by Geisinger Health System featuring three key elements:
  • Strict reliance on evidence-based standards in medicine
  • Fixed-price financial mechanism to pay for certain procedures
  • High patient engagement/activation

Research + Planning

• A team was established to meet regularly with the aim of developing a treatment algorithm. Emphasis was placed on a collaborative practice agreement with input from physicians, pharmacists, and nurse practitioners and coordinators.
• Additional clinical pharmacists and nurse coordinators were hired to manage the patients adequately and to assist in the development of the care pathway.

Tools or Products Developed

• Smart tools: Clinical and informatics team members created smart tools to standardize documentation in the EHR. The development of these tools allowed care to be tracked at the individual and population levels and reduced the administrative burden by capturing the data necessary for prior authorizations.
• Patient tracker: To minimize the number of patients lost to follow-up, a list of all patients at various stages of care was created and made accessible to the entire team through the EHR.
• Tableau-based Hep C dashboard: A data visualization system was adapted that pulled data from Geisinger’s EHR system to track sustained virologic response rates (both overall and by genotype), fibrosis, therapy used, and other information for patients.

Training

• Once the treatment algorithm was developed, all care team members were familiarized with the workflow and trained in their respective roles for implementation.

Workflow Steps

• Once referred for HCV treatment, the patient is contacted by a nurse coordinator or a pharmacist, who explains the flow and structure of the program.
• The patient then undergoes blood testing, after which an in-person office clinic visit is scheduled (only one in-person clinic visit is required for this intervention).
• The patient attends the clinic visit, during which the clinical provider and staff explain the treatment regimen in detail and emphasize the importance of adherence to treatment and subsequent monitoring (i.e., blood work).
  • A treatment calendar is created for each patient to serve as a visual reminder of lab-work dates and medication refills. Follow-up lab tests are ordered and scheduled to provide a timeline for the patient. In addition, a nurse coordinator calls to remind the patient of any upcoming lab work.
• All follow-up evaluations are conducted via telephone calls scheduled at the patient’s convenience as well as via secure messaging through the patient portal (MyGeisinger).
• Additional outreach to the patient before prior authorization is initiated to ensure that the patient is “on board” with the plan and the lines of communication are open.
• Upon receiving medication, the patient is instructed to contact the office before initiating therapy. During this telephone encounter, the patient is again provided with instructions regarding drug administration, with an emphasis on the importance of taking the medication as prescribed as well as on pertinent drug interactions and their management.
• Subsequently, the clinical pharmacist contacts the patient to review the results, assess adherence, and manage adverse effects. This process continues until the patient is cured.

Budget Details

• Cost of developing or adapting a streamlined EHR system to allow for close patient follow-up
• Cost of hiring clinical pharmacists, nurse coordinators, nurse practitioners, and other staff such as data analysts, researchers, and health plan representatives to implement intervention
• Costs associated with advertisement, patient recruitment, and patient outreach for intervention

Where We Are

• The pilot is complete.

Outcomes

• Sustained virologic response rates: Percentage of patients “cured” with suppressed viral load at 12 weeks after completion of therapy.
  • Among patients treated with the ProvenCare model at Geisinger, the sustained virologic response rate at 12 weeks after completion of therapy was 94%, compared to 56% among those insured by Geisinger Health Plan but treated at non-Geisinger facilities.
• Program adherence: Percentage of patients completing the treatment algorithm and not lost to follow, as determined based on insurance claims data and manual chart review
  • Only 3.6% of patients treated with the ProvenCare model at Geisinger were lost to follow-up, compared with 44% of patients lost to follow-up among those treated at non-Geisinger facilities but insured by Geisinger Health Plan.
• Patient satisfaction: Although not explicitly measured, patients appeared to be very appreciative of the respect for their time and close follow-up throughout treatment, as often verbalized during telephone encounters (especially upon being notified that they had been cured).
• Provider satisfaction: An internal survey of 12 clinical providers using a 5-point scale
  • 10 providers rated their satisfaction as a 5 (very good) and 2 providers rated it as a 4 (good).

Future Outcomes

• The team is currently assessing the impact of the model on the reduction in HCV-induced cirrhosis and associated morbidity as well as on health care costs.
• Implementation of this model has led to pointed contracting and may have led to discounted drug pricing with some vendors, although this is only speculation.

Benefits

• This program demonstrated clear improved outcomes with respect to higher sustained virologic response rate and lower proportion of patients lost to follow-up, compared to treatment at outside facilities.
• This indicates that the ProvenCare model enables a very high rate of patient follow-up and adherence to treatment. It also provides an effective method to track patient status in real time through close follow-up and documentation.
• Positive anecdotal feedback from patients is a good sign of improved communication and enhanced patient engagement and buy-in.
• Self-reported satisfaction among clinical providers also bodes well for long-term success and sustainability of the program.

Unique Challenges

• Achieving consensus regarding treatment candidacy and choice of medications (protease inhibitor vs. non-protease inhibitor-based therapy) required several meetings among all clinical providers.
• Specific strategies and guidelines were necessary for the management of more complex patients who were actively using illicit substances or alcohol and patients with cirrhosis who were candidates for transplantation.
• The workflow had to be adjusted as techniques to assess liver fibrosis have changed over time. Although liver biopsy is the gold standard, it is not mandatory. Previously, screening blood tests were used; however, as mandated by various health insurances, this practice was abandoned in favor of ultrasound elastography, which led to changes in patient scheduling and in the work flow of various team members. These changes were frequently communicated to Geisinger Health Plan liaisons, which improved efficient treatment authorization.

Sources

• Khurana, Sandeep, et al. “Enhanced Cure Rates for HCV: Geisinger ProvenCare Approach.” NEJM Catalyst, New England Journal of Medicine, 11 July 2018, catalyst.nejm.org/geisinger-provencare-hcv-cure/.
• “Disease Burden from Viral Hepatitis A, B, and C in the United States.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 17 May 2018, www.cdc.gov/hepatitis/statistics/DiseaseBurden.htm.
• “How Geisinger Achieved a 94% HCV Cure Rate, in 5 Steps.” The Daily Briefing, Advisory Board, 17 July 2018, www.advisory.com/daily-briefing/2018/07/17/geisinger-hcv.
• Boktor, Sameh, and Charlie Howsare. “Epidemiology of Hepatitis C in Pennsylvania .” A Leadership Summit on HCV Policy in Pennsylvania. 1 May 2015, Pennsylvania Department of Health.