|
|
|
| ||
| ||
|
||
|
||
|
||
| ||||||||||||||||||||||||
SEPTEMBER 2007
Spotlight:
Perspective: Potential Legal Pitfalls of HCV Management in Corrections and How to Avoid Them
Joseph E Paris, PhD, MD, FSCP, CCHP Consultant Introduction Hepatitis C virus (HCV) infection is common among the incarcerated and it is generally agreed that inmates with risk factors for this infection should be offered testing for HCV.1-4 Such testing has been found to identify high numbers of HCV-infected inmates, but the role of correctional systems in the management of the HCV-infected inmate has been subject to considerable debate within prisons and jails, the professional and lay press and the courts. What follows is a description of the major legal aspects of HCV management in prisons and jails and a suggested set of rational approaches to avoid litigation. A rational HCV policy: Screening Given the high prevalence of HCV in correctional settings, correctional health care systems large and small need to offer HCV testing to all inmates reporting or evidencing positive risk factors for infection and should also have policies that permit inmates to request HCV screening. Mandatory HCV testing of inmates, like mandatory HIV testing, may have unintended negative consequences, such as discouraging testing and risking stigmatization, and should be avoided. Inmates who are confirmed to be HCV -infected should be counseled with respect to transmission potential and to the risks and benefits of HCV treatment. All HCV-infected persons should be offered vaccination for hepatitis A virus, hepatitis B virus and be screened for HIV infection. A rational HCV policy: Staging Once active HCV infection is diagnosed, assessment of HCV disease severity follows. The goals of disease staging are two-fold: to accurately assess the extent of liver damage for the benefit of the patient and physician and to aid in HCV treatment decision-making. Severity of liver disease can influence discussion of whether to initiate HCV therapy and also be a factor when deciding whether to continue or halt therapy when treatment related toxicities develop. A liver biopsy is often used to assess the status of HCV patients although alternative, non-invasive markers of liver disease are being developed and put into practice (see Main article). Depending on the liver architecture, a Grade and a Stage of liver pathology can be assigned by a pathologist. Grade is defined as a histologic assessment of necro-inflammatory activity (not fibrosis). The degree of fibrosis found is assigned a Stage. Different systems exist to assign these Grades and Stages numbers from 0 to 4 or from 0 to 6 (se HCV 101). The numbers have prognostic significance.5 While there are challenges to obtaining liver biopsies for inmates of some correctional systems including the need to transport to patients to outside medical facilities, the utility of this procedure is largely now accepted. Further, testing inmates for HCV and/or performing liver biopsies is not very expensive when compared to the potential costs of treating large numbers of HCV positive inmates with IFN-based therapies and other drugs.6 A rational HCV policy: Treatment In devising a rational HCV policy for either large or small correctional systems, physicians and managers need to have a clear idea of the medical goals sought. Authorities agree that the goal of HCV treatment is to achieve a Sustained Viral Response (SVR). SVR may not represent a true "cure". Rather, it may mark a cessation of viral activity and suppression of viral replication for prolonged periods. Cessation of viral replication has been associated with improvements in liver histology and enzymes. Although early studies of patients with SVR suggest possible lengthening of survival, a final word on survival is not in. Further complicating matters is the unclear natural history of HCV infection. This is one of the most controversial and hotly debated topics in hepatology today. There seems to be two extreme positions. For some, HCV infection is an indolent disease which may take 20-30 years to claim the lives of approximately 20% of those infected - especially if the patient drinks alcohol. Since inmates generally cannot obtain alcohol regularly, their liver disease would be more likely to progress slowly. Others feel that the HCV virus is aggressive, causes rapid liver disease progression (especially in patients co-infected with HIV) and may be fatal in 5 years or less. According to this way of thinking, in order to avoid severe morbidity and mortality patients must be treated as soon as possible. In a study of 123 HCV-infected patients who did not receive HCV therapy, serial liver biopsies showed that fibrosis scores progressed very slowly over the course of years.5 The authors extrapolated these findings to suggest that up to 50 years may elapse from initial HCV infection to advanced, potentially fatal cirrhosis of the liver. They concluded that the best predictors of fibrosis were the extent of serum ALT elevations and the degree of hepatocellular necrosis and inflammation on liver biopsy. Their conclusion: "Patients with normal ALT and mild histology can safely defer treatment" has been often cited by correctional medical authorities formulating rather restrictive inmate treatment eligibility policies. The impact of length of sentence prior to treatment approval A difficult question regarding inmate eligibility for IFN-based therapy is whether there is enough time to complete such treatment. The Federal Bureau of Prisons has led the way with policies and guidelines that required sufficient sentence time to complete the treatment. The rationale was predicated on the fact that it is generally difficult to ensure continuation of IFN treatment upon inmate release. An interruption of a few weeks would cause the loss of benefit of previously given treatments, with the need to restart the treatment course from the beginning and a risk that the treatment would still be effective. For Genotype 1 HCV (the most common in U.S. prisoners) 48 weeks was and is the recommended duration of IFN-based therapy. Since two, three, or more months may be needed to complete initial evaluations, only inmates with well over a year left in their sentences would qualify for IFN-based therapies. In jails, the vast majority of inmates are held for shorter periods. Therefore, they would not generally be eligible for HCV therapy. The exception would be the few inmates sentenced to jail terms of over a year. Unfortunately, some jail physicians would assume that most inmates are not be eligible and therefore do not initiate testing, counseling, vaccination, and other very necessary ministrations for any inmates. In prisons, the situation was somewhat clearer, because prisons house a number of inmates serving very long sentences who easily meet the length of sentence requirement. However, prisons also house substantial numbers of inmates with sentences of five years or less. Because of overcrowding, early release of these prisoners may occur at any time. In addition, many inmates regularly appear before Parole Boards and may unexpectedly be granted parole. It follows that, in some systems, state prisoners' length of stay may be hard (if not impossible) to calculate. In order to make rational decisions on IFN therapy, prison providers must understand the system of inmate release in use. Should HCV treatment be given by specialized consultants? As knowledge on HCV became more sophisticated, a number of Infectious Diseases (ID) and Gastroenterologists (GI) became HCV consultants. A major issue evolved for correctional physicians (Internists, Family Physicians) regarding whether to treat their own HCV inmate/patients or to refer them to specialists. Very few correctional Internists or Family Physicians have the training and expertise to perform their own liver biopsies. While in principle therapies for HCV are not that complex, they frequently require concomitant treatment with antidepressants, erythropoietin, granulocyte stimulating factor, and other stimulants of the blood forming organs. In many correctional systems, a division of labor evolved where HCV consultants would see the inmate/patients at time of performance of liver biopsy, IFN therapy initiation, and the management of any serious side effects of therapy. Primary care prison/jail physicians would follow the patients closely and would refer them to the consultants as clinically indicated. In a number of correctional systems, telemedicine became a very useful tool for HCV consult follow up. However, in this writer's experience, very few consultants would schedule an inmate/patient for liver biopsy or IFN treatment initiation unless they had seen the patient in person at least once. The concept of HCV Pre-Therapy Checklist At the beginning of this decade, a number of large correctional system physician/managers observed that physicians unfamiliar with HCV management may initiate IFN-based therapy for inmate/patients who were poor candidates by virtue of coexisting physical or mental health issues and adherence to therapy issues, among other reasons. These incorrect startups by inexperienced practitioners endangered patient health and greatly increased costs. For these reasons, and following the leadership of the Federal Bureau of Prisons Health Services, several large systems developed the concept of a Pre-Therapy Checklist. This list enumerated the various evaluations required for consideration of HCV treatment and also listed all the medical/mental health contraindications to IFN in a single sheet. The Georgia Department of Corrections (GDC) adopted this system in 2003. At the time, there were substantial benefits from this policy. Since pharmacists would not issue IFN to an inmate unless the Pre-Therapy Checklist was complete, the document became a road map guiding the workup. Items were completed in a sequence leading to liver biopsy. A consequence of the use of this system was that Inmates refusing one or more items listed in the Pre-Therapy Checklist were considered to be refusing therapy, as treatment required completion of the checklist evaluations. However, the Pre-Therapy Checklist approval-denial mechanism became a major litigation target. Although, intended as a checklist (a method to ensure that all necessary medical history and blood testing was documented and fell within certain parameters), inmates and plaintiff's attorneys have represented the checklist as a remote clinical consultation and that the approving physician was conducting a consultation without the benefit of a physical examination. Such a misconception has rendered the tool difficult to explain and implement. At this time, the author does not recommend its use. Discharge planning for inmates undergoing IFN therapy As discussed above, unexpected releases of inmates on IFN therapy may occur at any time. If the inmate knows his or her future county of residence, correctional health care staff should be ready to coordinate with the appropriate department of public health or other center for continued care. In this writer's experience, however, very few health deaprtments are set up to treat indigent HCV patients. Major IFN manufacturers have created HCV Patient Assistance Programs precisely for such patients to provide these medications to qualified patients. Consequently, upon learning that a given inmate on IFN may leave the institution, staff should provide the inmate with health record summaries and educate the inmate on medication storage and administration and the availability of patient care programs. The first few weeks after release are a hectic time. The ex-inmate may need time for stabilizing his/her situation before being able to seek medical services. Issuing the exiting inmate 30 days of IFN-based medications plus an appropriate supply of syringes and needles is one way to ensure continued treatment while community care is being established.7 Strategies for preventing legal troubles This author has experienced a number of legal cases related to HCV care of prisoners. In a typical case, an inmate sued because after the finding of Stage 2 fibrosis on a liver biopsy and persistently normal ALT levels his IFN treatment was deferred, with continuing monitoring. Another inmate sued because he did not receive treatment. His liver biopsy had showed cirrhosis. He had florid ascites and had repetitive GI bleeding episodes. Another inmate sued because his IFN-based regimen had been delayed one year. Although he was eventually treated, he did not achieve SVR. His claim was that perhaps the earlier treatment would have increased his likelihood of achieving SVR. All of these inmates sued in Federal Court. None has prevailed. Still, these cases are time consuming, expensive to defend, and disturbing to all practitioners involved. It seems that HCV-related issues are like a legal lightning rod. In the author's opinion, as of 2007, the following so called "exclusions from IFN therapy", still in use in many jurisdictions, may be challenged in Court:
In a similar manner, exclusions solely due to a positive, remote history of psychiatric problems (including history of past suicide attempts) would not be acceptable in court. Instead, one would have to document that a given inmate would not be a good candidate for IFN-based therapies due to a contemporary psychiatric condition (or suicidality) that is not responding to appropriate treatment. These patients would be better candidates for therapy after psychiatric stabilization. Exclusions due to insufficient time to serve had been generally acceptable to the courts until a few years ago. The author has observed that a number of similar cases where he was involved as an expert witness for the defense had to be settled. It seems that defense attorneys, judges and juries are migrating towards the idea that IFN-based therapies should be started regardless of uncertainty of release date. The rationale is that correctional practitioners would not delay therapy for diabetes, cancer, anemia, and the like, solely based on duration of sentence. Treatment should be offered, the thinking goes, together with appropriate arrangements for continuity of care should the sentence be too short. Exclusions due to co-infection with HIV are no longer acceptable. The available literature clearly shows that these co-infected patients do achieve SVR (albeit less often).10 Likewise, compensated liver cirrhosis is no longer a valid reason for exclusion from treatment.11 With respect to the difficult issue of re-treatment, it seems that the non-correctional HCV specialists are routinely offering re-treatment to suitable candidates that failed a less powerful regimen in the past. The author believes that the standard of care in corrections should reflect that of the community. Conclusion HCV management has proved to be one of the more litigious areas of correctional health care. While litigation related to the management of the HCV-infected inmate cannot be completely eliminated it is evident that in order to avoid legal action or to prevail in litigation regarding HCV diagnosis and therapy of inmates one needs to construct a system of policies rooted in the available evidence. Such rational approaches to the management of this prevalent viral illness make for good sense and good medicine. The author was the Medical Director of the Georgia Department of Corrections (GDC) from 1996 to 2005. In collaboration with specialists, he wrote the GDC HCV Policies, versions of 1999, 2003, and 2004. These are available in electronic form directly from the author. Requests should be addressed to joeparis@pol.net. References: 1.Prevention and control of infections with hepatitis viruses in correctional settings. MMWR 2003;52( No.RR-1). 2.Altice FL, Bruce RD. Hepatitis C Virus Infection in US Correctional Institutions Current Science- Current Hepatitis Reports. 2004;3:112-18. 3. Cassidy WM. Hepatitis C in Corrections: Testing, Treatment and Co-infection. Infectious Diseases in Corrections Report. 2005;8(7):1-3. 4.Tripoli LC., Paris JE, Koretz RL. Hepatitis C Virus and its Relevance to Corrections. Chapter in the book Management and Administration of Correctional Health Care. Jacqueline Moore, Ph. D., RN, Editor. Civic Research Institute, Kingston, NJ, 2003. 5.Ghany MG, Kleiner DE, Alter H, et al. Progression of fibrosis in chronic hepatitis C. Gastroenterology. 2003;124(1):97-104. 6.Paris JE, Pradhan MM, Allen SA, et al. Cost of Hepatitis C Treatment in the Correctional Setting. Journal of Correctional Health Care. 2005;11(2):199-212. 7.Paris JE. Spotlight: Keys to Successful HIV Management in Corrections - Knowing the Patient and the Prison/Jail Environment. HEPP Report on Infectious Diseases in Corrections.2004;7(4):7. 8.Pearlman B, Paris JE. Hot Topics In Hepatitis C. HEPP Report on Infectious Diseases in Corrections.2004;7(6):1-4. 9.Spaulding A, Greene, C, Davidson, K., et al. Hepatitis C in State Correctional Facilities. Preventive Medicine. 1999;28:92-100 10.Cengiz C, Park JS, Saraf N, et al. HIV and Liver diseases: Recent clinical advances. Clinics in Liver Disease. 2005(9):647-66. 11.Fontana RJ, Everson GT, Tuteja S, et al. Controversies in the management of hepatitis C patients with advanced fibrosis and cirrhosis. Clinical gastroenterology and hepatology. 2004;2:183-97.
|
| |||||||||||||||||||||||
