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Hepatitis C virus (HCV) can cause both acute and chronic hepatitis. The acute process is self-limited, rarely causes hepatic failure, and usually leads to chronic infection. Chronic HCV infection often follows a progressive course over many years and can ultimately result in cirrhosis, hepatocellular carcinoma, and the need for liver transplantation.
Of the estimated 2.7 million to 3.9 million persons (1999 to 2008 National Health and Nutrition Examination Survey data) chronically infected with HCV in the United States, 45% to 85% are unaware that they are infected. Identification of those with active infection is the first step toward improving health outcomes among persons with HCV infection and preventing transmission.
HCV testing is recommended in select populations based on demography, prior exposures, high-risk behaviors, and medical conditions. Recommendations for testing are based on HCV prevalence in these populations, proven benefits of care and treatment in reducing the risk of hepatocellular carcinoma and all cause mortality, and the potential public health benefit of reducing transmission through early treatment, viral clearance, and reduced risk behaviors.
HCV is primarily transmitted through percutaneous exposure to blood. Other modes of transmission include mother-to-infant and contaminated devices shared for non-injection drug use; sexual transmission also occurs but generally seems to be inefficient except among HIV-infected men who have unprotected sex with men. The most important risk for HCV infection is injection-drug use, accounting for at least 60% of acute HCV infections in the United States. Health-care exposures are important sources of transmission, including the receipt of blood products before 1992 (after which routine screening of blood supply was implemented), receipt of clotting factor concentrates before 1987, long-term hemodialysis, needle-stick injuries among healthcare workers, and patient-to-patient transmission resulting from poor infection control practices. Other risk factors include having been born to an HCV-infected mother, having been incarcerated, and having received a tattoo in an unregulated setting. The importance of these risk factors might differ based on geographic location and population. An estimated 29% of incarcerated persons in North America are anti-HCV positive, supporting the recommendation to test this population for HCV. Because of shared transmission modes, persons with HIV infection are at risk for HCV; sexual transmission is a particular risk for HIV-infected men who have unprotected sex with men. Recent data also support testing in all cadaveric and living solid-organ donors because of the risk of HCV infection posed to the recipient.
Antiviral therapy is the cornerstone of treatment of chronic HCV infection. Other general measures in the management of patients with chronic HCV include psychologic counseling, symptom management, dose adjustment of medications, and screening for complications of cirrhosis. The goal of antiviral therapy in patients with chronic HCV is to eradicate HCV RNA, which is predicted by attainment of a sustained virologic response (SVR). An SVR is associated with a 97 to 100 percent chance of being HCV RNA negative during long-term follow-up and can therefore be considered cure of the HCV infection. Attaining an SVR has been associated with decreases in all-cause mortality, liver-related death, need for liver transplantation, hepatocellular carcinoma rates, and liver-related complications, even among those patients with advanced liver fibrosis.
Evaluation To Guide Management Decisions
A. HCV Genotype
B. History of Prior Treatment
FDA Approved Anti-HCV Agents
Ledipasvir/sofosbuvir (HARVONI®) is indicated with or without ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection.
Sofosbuvir (SOVALDI®) is indicated for the treatment of genotype 1, 2, 3 or 4 chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen.
Simeprevir (OLYSIO®) is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection as a component of a combination antiviral treatment regimen.
Ombitasvir/paritaprevir/ritonavir + dasabuvir (VIEKIRA PAK™) is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1.
Daclatasvir (DAKLINZA™) is indicated for use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection.
Ombitasvir/paritaprevir/ritonavir (TECHNIVIE™) is indicated in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis.
Elbasvir/grazoprevir (ZEPATIER™) is indicated with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 or 4 infection in adults.
Ribavirin (COPEGUS®, REBETOL®) in combination with PEGASYS (peginterferon alfa-2a) is indicated for the treatment of patients with chronic hepatitis C (CHC) virus infection who have compensated liver disease.
Peginterferon alfa-2a (PEGASYS®) as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs, is indicated for the treatment of adults with chronic hepatitis C (CHC) with compensated liver disease. PEGASYS in combination with ribavirin is indicated for treatment of pediatric patients 5 years of age and older with CHC and compensated liver disease. PEGASYS monotherapy is only indicated for the treatment of patients with CHC with compensated liver disease if there are contraindications or significant intolerance to other HCV antiviral drugs.
Immediate Versus Delayed Therapy
Although most patients with chronic hepatitis C will benefit from treatment with antiviral medications, the magnitude of benefit will vary according to a number of factors. The primary consideration is stage of disease. Because the development of cirrhosis represents irreversible liver damage, preventing progression to cirrhosis is a primary treatment goal. Patients with established cirrhosis will also benefit from treatment in that further irreversible liver damage will be avoided, and the current level of liver function maintained.
Because of the long natural history of chronic hepatitis C infection, patients with early disease, ie those without evidence of cirrhosis, will not likely be harmed if there is a delay in initiating antiviral medication. The potential harm in delaying therapy is that irreversible liver damage will develop during the period of treatment delay. If patients are closely monitored for signs of disease progression, and if treatment is initiated before the onset of irreversible liver damage, outcomes of treatment are likely to be the same as for immediate treatment.
Before an antiviral therapeutic regimen will be approved, patients seeking treatment for Hepatitis C must be evaluated and treated by a Board Certified Gastroenterologist, Board Certified Infectious Disease Specialist, or a Transplant Hepatologist or by a Nurse Practitioner-Board Certified whose collaborating physician is a Board Certified Gastroenterologist, Board Certified Infectious Disease Specialist, or Transplant Hepatologist. This evaluation will be for 6 months, unless the patient meets the criteria for immediate treatment specified in section B.1. below.
Antiviral therapeutic regimen must be ordered by a Board Certified Gastroenterologist, Board Certified Infectious Disease Specialist, or a Transplant Hepatologist or by a Nurse Practitioner-Board Certified whose collaborating physician is a Board Certified Gastroenterologist, Board Certified Infectious Disease Specialist, or Transplant Hepatologist.
A. Medical Management of Chronic Hepatitis C
Medical management of patient infected with hepatitis C must include ALL of the following interventions before antiviral medications will be considered for coverage:
1. Documentation of the following:
a. HCV RNA level
2. Additional testing: Patients should be tested for HIV, Hepatitis B, and Hepatitis A.
3. Depression screening and counseling: Patient should be screened for depression and counseling and support groups should be offered.
4. Lifestyle counseling and discussions about the routes of HCV transmission, including:
a. Avoidance of sharing toothbrushes, dental or shaving equipment
5. Alcohol and substance use counseling: Patients should be counseled that alcohol promotes the progression of chronic HCV and abstinence should be recommended. Evidence of counseling for abstinence from alcohol and substance use for a minimum of 3 months is required.
6. Medications: All non-steroidal anti-inflammatory drugs should be avoided.
7. Other GI disease assessment: Patient with cirrhosis should be screened for esophageal varices by upper GI endoscopy. They should also undergo surveillance for hepatocellular carcinoma.
8. Vaccinations: Standard immunizations for age, pneumococcal vaccination, Hepatitis A and B vaccinations, unless already immune.
9. Co-morbidities: Counseling about the fact that obesity and uncontrolled diabetes promote fibrosis should occur.
1. Immediate treatment with antiviral medications may be considered medically necessary for patients infected with hepatitis C virus meeting the medical management criteria above during the course of treatment and one or more of the following documented high risk conditions:
• Advanced fibrosis
2. Treatment with antiviral medication may be considered medically necessary in patients infected with hepatitis C virus but without a documented high risk condition after 6 months of medical evaluation and management as outlined in section A. above.
3. Treatment with antiviral medications is considered not medically necessary for terminally ill patients (life expectancy less than 12 months) due to other co-morbid conditions.
A sustained virologic response (SVR) 12 weeks after completion of therapy is required and must be submitted to BCBSMS upon request.
Prior authorization is required.
Formulary Agent(s) Patient Population
A. Genotype 1
1. Treatment-Naïve without cirrhosis AND
B. Genotype 4, 5, or 6
1. Treatment-naïve without cirrhosis or with compensated cirrhosis OR
C. Liver Transplant Recipients
1. Genotype 1 or 4 regardless of treatment status without cirrhosis or with compensated cirrhosis AND
D. Decompensated Cirrhosis
1. Genotype 1 regardless of treatment status AND
Sovaldi + Ribavirin:
A. Genotype 2
1. Combination with ribavirin
B. Hepatocellular Carcinoma Awaiting Liver Transplant
1. Combination with ribavirin
*Patient must not have decompensated cirrhosis for this regimen
Daklinza + Sovaldi:
A. Genotype 3
1. Without cirrhosis AND
Zepatier is non-formulary and only considered medically necessary for patients with severe renal impairment (Stage 4 or 5 Chronic Kidney disease as indicated by eGFR of <30 mL/min/1.73 m²) or end stage renal disease requiring hemodialysis.
A. Genotype 1
1. Genotype 1a without NS5A polymorphism
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [ie, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
11/19/2003: Approved by external gastroenterology consultants
12/18/2003: Code Reference section completed
11/02/2005: Description section updated, Off Label Uses and Renal carcinoma deleted. Policy section updated; changed preferred provider to CuraScript.
11/4/2005: Code Reference section updated, HCPCS codes J8499, J9213, J9214 moved from the CPT4 code section in the table to the HCPCS code section, a deletion date of 6/30/2005 was added to codes J9213 and J9214; HCPCS codes S0145 and S0146 added with an effective date of 7/1/2005; the Non-Covered Codes table was deleted from the policy.
11/2005: Approved by Pharmacy & Therapeutic (P & T) Committee.
6/29/2006: CuraScript fax number changed from 1-877-462-6234 to 1-866-239-5502
5/5/2008: Ribavirin dosing information updated
01/01/2009: CuraScript preferred provider information removed. BCBSMS information added
12/29/2008: Code Reference section updated per 2009 CPT/HCPCS revisions
4/14/2009: Policy statement updated to reflect retreatment guidelines
8/18/2009: Policy updated: Policy statement updated to include statement Peg-Intron® may be considered medically necessary only after failed treatment (nonresponder or relapser) with Pegasys®. Dosing Genotype 1, 2 and 3 deleted.
10/21/2010: Policy description unchanged. Policy statement updated regarding Infergen dosing.
09/15/2011: Policy revised to add Incivek® and Victrelis® and criteria for treatment with triple therapy.
04/01/2014: Policy statement updated regarding treatment with Sovaldi®. Removed deleted HCPCS codes J9213 and J9214 from the Code Reference section.
03/06/2015: Effective 03/15/2015. Policy extensively re-written. Policy description updated regarding HCV prevalence, transmission, and treatments. Policy statement updated with the following: 1) Before an antiviral therapeutic regimen will be approved, patients seeking treatment for Hepatitis C must be evaluated and treated by a Board Certified Gastroenterologist, Board Certified Infectious Disease Specialist, or a Transplant Hepatologist or by a Nurse Practitioner-Board Certified whose collaborating physician is a Board Certified Gastroenterologist, Board Certified Infectious Disease Specialist, or Transplant Hepatologist. This evaluation will be for 6 months, unless the patient meets the criteria for immediate treatment. 2) Antiviral therapeutic regimen must be ordered by a Board Certified Gastroenterologist, Board Certified Infectious Disease Specialist, or a Transplant Hepatologist or by a Nurse Practitioner-Board Certified whose collaborating physician is a Board Certified Gastroenterologist, Board Certified Infectious Disease Specialist, or Transplant Hepatologist. 3) Medical management requirements added. 4) Criteria added to state when immediate treatment with antiviral medication may be considered medically necessary. 5) Added requirements for a SVR 12 weeks after completion of therapy. 6) Added not medically necessary policy statement for terminally ill patients. 7) Added statement that Harvoni® and Sovaldi® are the formulary treatment regimens for HCV infection. 8) Added table of Antiviral Medication Treatment Regimens by genotype. Definition of "medically necessary" and "investigative" updated in the policy guidelines. Added HCPCS codes J9213, J9214, and S0148 to the Code Reference section and removed J9212 and S0146.
06/18/2015: Policy statement regarding direct or indirect assessment of natural history and stage of the liver disease clarified. Fibrosis stage can be assessed directly or indirectly through history, physical exam, medically necessary laboratory tests, or medically necessary imaging studies (eg, ultrasound, magnetic resonance imaging, computed tomography scan). Multianalyte assays with algorithmic analyses (eg, FibroSURE™ FibroSpect) are considered investigational for the evaluation or monitoring of patients with chronic liver disease. The use of non-invasive imaging, including but not limited to transient elastography (eg, FibroScan), magnetic resonance elastography, acoustic radiation force impulse imaging (ARFI; eg, Acuson S2000), or real-time tissue elastography, is considered investigational for the evaluation or monitoring of patients with chronic liver disease. Added link to the Non-invasive Techniques for the Evaluation and Monitoring of Patients With Chronic Liver Disease medical policy.
08/21/2015: Code Reference section updated for ICD-10.
05/26/2016: Policy number added.
07/11/2016: Policy updated to include Olysio®, Viekira Pak™, Daklinza™, Technivie™, and Zepatier™. Policy description updated regarding FDA approved Anti-HCV agents. Policy statement regarding medical management of Chronic Hepatitis C was revised to make the following changes: 1) to state that fibrosis stage can be assessed directly or indirectly 2) to remove the statement regarding multianalyte assays with algorithmic analyses, and 3) to change "Diet" to "Alcohol and substance use counseling." Policy section regarding Antiviral Medication Treatment Regimens revised to remove table and list treatment by Drug, Genotype, and Patient Population. Sources section updated.
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.