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Expert Panel Significantly Revises Oregon's HCV Guidelines
A panel of hepatitis experts has significantly revised the hepatitis C virus (HCV) guidelines of the Oregon Department of Corrections.
Pursuant to the terms of the settlement resolving Oregon's Class Action HCV suit of Anstett v. State of Oregon , a Medical Review Panel (MRP) was appointed to evaluate and modify ODOC's written HCV guidelines. [See companion story].
On April 16, 2004, the MRP began reviewing ODOC's HCV guidelines for compliance with the community standard of care. The review process was stated to "be completed within 60 days or no later than June 6, 2004[,]" but took considerably longer than anticipated.
In modifying the guidelines the MRP "tried to take into account community practice in Oregon and correctional practice across the country. [It]...also considered how Hepatitis C issues are treated by both national and state bodies that allocate resources or make recommendations."
After disregarding the first 24 pages, the MRP utilized the ODOC's written guidelines as a template for revised guidelines. However, the MRP's revised guidelines represent a vast departure from the original guidelines in numerous important respects, including:
Liver Biopsies
The MRP indicated that liver biopsies are not necessary in every case. "The evidence regarding the relationship of liver histology and stage of disease is good. However, that evidence needs to be evaluated in the context of genotype and duration of disease. Treatment success is so common in genotypes 2 and 3 that liver biopsy is not worthwhile." Biopsies are recommended for genotype 1 patients who have had HCV for more than 15 years _ more than 10 years if there is a significant history of alcohol use _ or if the duration of disease is unknown.
Time Limits
Perhaps one of the most significant changes is the imposition of strict timelines for diagnosis and treatment. For all patients, "[t]he noninvasive diagnostic phase of the evaluation...should be done within 90 days" of the patient's request for testing.
Patients not requiring a biopsy "should be aware of treatment options and ODOC recommendations regarding treatment within 30 days of completion of noninvasive diagnostic testing or 120 days" of the patient's request for testing. If indicated, treatment should commence within this time.
For patients requiring a biopsy, it "should be completed within 60 days of the completion of noninvasive diagnostic testing or 150 days" of the patient's request for testing. "Patients...should be aware of treatment options and ODOC recommendations regarding treatment within 30 days of completion of liver biopsy or 180 days" of the patient's request for testing. If indicated, treatment should commence within this time.
The timelines are satisfied "if 90% of patients meet [these] standard[s]."
ALT Elevations
Prior to the MRP revisions ODOC required a minimum ALT elevation of at least two times the upper limit of the normal range before further workup of HCV antibodies would occur. Under the revised guidelines, however, any elevation of any liver enzyme level must receive further workup.
Hepatitis A&B Vaccinations
Prior to the revised guidelines, ODOC routinely failed to offer Hepatitis A and B vaccinations to HCV infected prisoners. Under the MRP guidelines, however, "[a]ll patients with chronic HCV infection should be vaccinated for Hepatitis A and B after appropriate informed consent."
Specialist Referrals
The previous ODOC guidelines made no reference to specialist referrals. The revised guidelines, however, indicated that "[p]atients with signs of cirrhosis should be referred to an outside specialist[ ]" and "Hepatitis C patients who are also positive for HIV should be referred to an HIV specialist."
Hepatitis C Interest Group
The MRP proposed "that ODOC organize a Hepatitis C Interest Group composed of ODOC practitioners with experience and interest in the evaluation and treatment of Hepatitis C patients. The Interest Group should include or have access to a hepatologist or gastroenterologist experienced in the treatment of Hep C patients." The MRP noted that "[c]urrently in the community all Hep C patients are treated by specialists or primary care doctors experienced in the treatment of Hepatitis C."
"The Group would provide a quality assurance function to the Hepatitis C diagnosis and treatment process[ ]" and the MRP stressed that it "is not meant to be a barrier" to diagnosis and treatment of HCV. The objectives of the Group include: (1) "Monitor[ing] the guideline process, providing approval for exceptions to the guidelines when appropriate[;]" and (2) "Supervis[ing] the treatment of Hepatitis C patients." Additionally, "[t]he Interest Group should function by consensus. Records should be kept regarding their decisions."
Under the MRP guidelines, all genotype 1 patients would have their cases evaluated by the Interest Group. "If the patient or provider feels strongly that treatment is indicated [when the guidelines indicate otherwise]...[the] case should be referred to the Hepatitis C Interest Group for review." Additionally, "[t]reatment should be supervised by the Hepatitis C Interest Group."
Substance Abuse Treatment
The ODOC guidelines previously mandated that if there was any medical or criminal history of substance abuse, no further workup of HCV would occur until the patient provided proof of recent completion of several months of substance abuse treatment." However, ODOC failed to make substance abuse treatment available until prisoners were within one year of release, at which time they were no longer eligible for HCV treatment because they had less than eighteen months to serve.
The MRP made several important changes here. First, the MRP stressed that ODOC "needs to provide substance abuse treatment for Hepatitis C patients[.]" Second, HCV infected prisoners are now required to be "active in drug/alcohol recovery" if there is a "medical or criminal history of substance abuse within [the previous] two years." The prisoner need be active for only one month to receive further HCV workup, but must continue substance abuse treatment throughout the course of HCV evaluation and treatment, or until successful completion.
Contraindication Documentation/Follow-up
Previously, HCV treatment was denied if the physician believed there had been substance abuse within the previous six months, but no evidence of abuse was required. Under the revised guidelines, this contraindication must be based upon actual evidence, including "self report, positive drug screen, possession, [or] rule violation[.]" Additionally, the previous guidelines made possession of tattoo equipment a contraindication to treatment, but under the revised guidelines only an actual new tattoo within the previous six months precludes treatment.
Under the previous guidelines, prisoners were routinely denied workup and treatment due to unspecified or ever-shifting contraindications to treatment, which would never be re-evaluated once found. The MRP remedied this problem by indicating that documenting and "actively addressing" contraindications "is imperative." While "no further revaluation will be necessary until or unless the contraindications resolve," the revised guidelines specify that "routine follow-up to assess contraindications should occur at appropriate intervals. If contraindications do resolve, the patient should be re-evaluated for treatment." Additionally, "[p]atients should receive summary of testing done, reason for treatment contraindication and education regarding next steps given contraindication."
Pegylated Interferon
Previously, ODOC routinely failed to treat HCV with pegylated interferon because it is more expensive than regular interferon. The revised guidelines provide, however, that "[a]ll patients should be treated with pegylated interferon and ribavirin[.]"
Non-Termination of Treatment
"Patients already on interferon or interferon and ribavirin at the time of...entry into custody will be maintained on the drug if tolerated."
Treatment Availability
For genotype patients, the revised guidelines provide that treatment "is most clearly indicated for consideration for individuals with Stage 3 fibrosis [severe liver disease] with any degree of inflammation [on liver biopsy], who meet the other criteria. "Patients with Stage 2 fibrosis-moderate liver disease _ may be eligible for treatment depending on other characteristics. Treatment generally "is not indicated in individuals with Stage 1 fibrosis _ mild liver disease. Rather, the revised guidelines recommend monitoring with "re-biopsy in 5-10 years as an alternative[.]" Patients with Stage 4 fibrosis _ Advanced, Compensated Cirrhosis _ may improve with treatment and treatment should be offered in conjunction with consultation with a gastroenterologist. Finally, Stage 4 fibrotic patients with Decompensated Cirrhosis are unlikely to improve with treatment. Therefore, treatment is not generally recommended.
Over all, the MRP's revised HCV guidelines are a vast improvement over the previous ODOC guidelines and they are now, quite possibly, the most progressive prison HCV guidelines in the nation. Many ODOC prisoners who were previously denied proper diagnosis and treatment are beginning to receive care which comports with the community standard of care, under the MRP's guidelines.
We will continue to significant developments in Oregon's HCV litigation and treatment. See: Anstett v. State of Oregon, USDC D OR, Case No. 01-CV-1619-BR.
Pursuant to the terms of the settlement resolving Oregon's Class Action HCV suit of Anstett v. State of Oregon , a Medical Review Panel (MRP) was appointed to evaluate and modify ODOC's written HCV guidelines. [See companion story].
On April 16, 2004, the MRP began reviewing ODOC's HCV guidelines for compliance with the community standard of care. The review process was stated to "be completed within 60 days or no later than June 6, 2004[,]" but took considerably longer than anticipated.
In modifying the guidelines the MRP "tried to take into account community practice in Oregon and correctional practice across the country. [It]...also considered how Hepatitis C issues are treated by both national and state bodies that allocate resources or make recommendations."
After disregarding the first 24 pages, the MRP utilized the ODOC's written guidelines as a template for revised guidelines. However, the MRP's revised guidelines represent a vast departure from the original guidelines in numerous important respects, including:
Liver Biopsies
The MRP indicated that liver biopsies are not necessary in every case. "The evidence regarding the relationship of liver histology and stage of disease is good. However, that evidence needs to be evaluated in the context of genotype and duration of disease. Treatment success is so common in genotypes 2 and 3 that liver biopsy is not worthwhile." Biopsies are recommended for genotype 1 patients who have had HCV for more than 15 years _ more than 10 years if there is a significant history of alcohol use _ or if the duration of disease is unknown.
Time Limits
Perhaps one of the most significant changes is the imposition of strict timelines for diagnosis and treatment. For all patients, "[t]he noninvasive diagnostic phase of the evaluation...should be done within 90 days" of the patient's request for testing.
Patients not requiring a biopsy "should be aware of treatment options and ODOC recommendations regarding treatment within 30 days of completion of noninvasive diagnostic testing or 120 days" of the patient's request for testing. If indicated, treatment should commence within this time.
For patients requiring a biopsy, it "should be completed within 60 days of the completion of noninvasive diagnostic testing or 150 days" of the patient's request for testing. "Patients...should be aware of treatment options and ODOC recommendations regarding treatment within 30 days of completion of liver biopsy or 180 days" of the patient's request for testing. If indicated, treatment should commence within this time.
The timelines are satisfied "if 90% of patients meet [these] standard[s]."
ALT Elevations
Prior to the MRP revisions ODOC required a minimum ALT elevation of at least two times the upper limit of the normal range before further workup of HCV antibodies would occur. Under the revised guidelines, however, any elevation of any liver enzyme level must receive further workup.
Hepatitis A&B Vaccinations
Prior to the revised guidelines, ODOC routinely failed to offer Hepatitis A and B vaccinations to HCV infected prisoners. Under the MRP guidelines, however, "[a]ll patients with chronic HCV infection should be vaccinated for Hepatitis A and B after appropriate informed consent."
Specialist Referrals
The previous ODOC guidelines made no reference to specialist referrals. The revised guidelines, however, indicated that "[p]atients with signs of cirrhosis should be referred to an outside specialist[ ]" and "Hepatitis C patients who are also positive for HIV should be referred to an HIV specialist."
Hepatitis C Interest Group
The MRP proposed "that ODOC organize a Hepatitis C Interest Group composed of ODOC practitioners with experience and interest in the evaluation and treatment of Hepatitis C patients. The Interest Group should include or have access to a hepatologist or gastroenterologist experienced in the treatment of Hep C patients." The MRP noted that "[c]urrently in the community all Hep C patients are treated by specialists or primary care doctors experienced in the treatment of Hepatitis C."
"The Group would provide a quality assurance function to the Hepatitis C diagnosis and treatment process[ ]" and the MRP stressed that it "is not meant to be a barrier" to diagnosis and treatment of HCV. The objectives of the Group include: (1) "Monitor[ing] the guideline process, providing approval for exceptions to the guidelines when appropriate[;]" and (2) "Supervis[ing] the treatment of Hepatitis C patients." Additionally, "[t]he Interest Group should function by consensus. Records should be kept regarding their decisions."
Under the MRP guidelines, all genotype 1 patients would have their cases evaluated by the Interest Group. "If the patient or provider feels strongly that treatment is indicated [when the guidelines indicate otherwise]...[the] case should be referred to the Hepatitis C Interest Group for review." Additionally, "[t]reatment should be supervised by the Hepatitis C Interest Group."
Substance Abuse Treatment
The ODOC guidelines previously mandated that if there was any medical or criminal history of substance abuse, no further workup of HCV would occur until the patient provided proof of recent completion of several months of substance abuse treatment." However, ODOC failed to make substance abuse treatment available until prisoners were within one year of release, at which time they were no longer eligible for HCV treatment because they had less than eighteen months to serve.
The MRP made several important changes here. First, the MRP stressed that ODOC "needs to provide substance abuse treatment for Hepatitis C patients[.]" Second, HCV infected prisoners are now required to be "active in drug/alcohol recovery" if there is a "medical or criminal history of substance abuse within [the previous] two years." The prisoner need be active for only one month to receive further HCV workup, but must continue substance abuse treatment throughout the course of HCV evaluation and treatment, or until successful completion.
Contraindication Documentation/Follow-up
Previously, HCV treatment was denied if the physician believed there had been substance abuse within the previous six months, but no evidence of abuse was required. Under the revised guidelines, this contraindication must be based upon actual evidence, including "self report, positive drug screen, possession, [or] rule violation[.]" Additionally, the previous guidelines made possession of tattoo equipment a contraindication to treatment, but under the revised guidelines only an actual new tattoo within the previous six months precludes treatment.
Under the previous guidelines, prisoners were routinely denied workup and treatment due to unspecified or ever-shifting contraindications to treatment, which would never be re-evaluated once found. The MRP remedied this problem by indicating that documenting and "actively addressing" contraindications "is imperative." While "no further revaluation will be necessary until or unless the contraindications resolve," the revised guidelines specify that "routine follow-up to assess contraindications should occur at appropriate intervals. If contraindications do resolve, the patient should be re-evaluated for treatment." Additionally, "[p]atients should receive summary of testing done, reason for treatment contraindication and education regarding next steps given contraindication."
Pegylated Interferon
Previously, ODOC routinely failed to treat HCV with pegylated interferon because it is more expensive than regular interferon. The revised guidelines provide, however, that "[a]ll patients should be treated with pegylated interferon and ribavirin[.]"
Non-Termination of Treatment
"Patients already on interferon or interferon and ribavirin at the time of...entry into custody will be maintained on the drug if tolerated."
Treatment Availability
For genotype patients, the revised guidelines provide that treatment "is most clearly indicated for consideration for individuals with Stage 3 fibrosis [severe liver disease] with any degree of inflammation [on liver biopsy], who meet the other criteria. "Patients with Stage 2 fibrosis-moderate liver disease _ may be eligible for treatment depending on other characteristics. Treatment generally "is not indicated in individuals with Stage 1 fibrosis _ mild liver disease. Rather, the revised guidelines recommend monitoring with "re-biopsy in 5-10 years as an alternative[.]" Patients with Stage 4 fibrosis _ Advanced, Compensated Cirrhosis _ may improve with treatment and treatment should be offered in conjunction with consultation with a gastroenterologist. Finally, Stage 4 fibrotic patients with Decompensated Cirrhosis are unlikely to improve with treatment. Therefore, treatment is not generally recommended.
Over all, the MRP's revised HCV guidelines are a vast improvement over the previous ODOC guidelines and they are now, quite possibly, the most progressive prison HCV guidelines in the nation. Many ODOC prisoners who were previously denied proper diagnosis and treatment are beginning to receive care which comports with the community standard of care, under the MRP's guidelines.
We will continue to significant developments in Oregon's HCV litigation and treatment. See: Anstett v. State of Oregon, USDC D OR, Case No. 01-CV-1619-BR.
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Related legal case
Anstett v. State of Oregon
| Year | 2004 |
|---|---|
| Cite | USDC D OR, Case No. 01-CV-1619-BR |
| Level | District Court |
| Injunction Status | N/A |