According to the World Health Organization, “Health policy refers to decisions, plans, and actions that are undertaken to achieve specific health care goals within a society.”1 Health policy may serve to outline priorities, but it can also be restrictive by discouraging aspects of healthcare not felt to be high priority. This influence may grow as attempts are made to control healthcare expenses, particularly under the Affordable Care Act (ACA), which broadens healthcare coverage and federal support. Simply stated, healthcare guidelines and recommendations can afford significant effect because they serve as the evidence to either enforce or ignore medical testing, both as a result of their intrinsic credibility and by affecting reimbursement. In this article, we discuss the various organizations in the United States that develop healthcare policy and guidelines. We focus on the recent recommendations for hepatitis C virus (HCV) screening put forward by these agencies and the potential effect of these documents.
Healthcare guidelines and recommendations have broad-reaching impact. They serve as the evidence to enforce medical testing by establishing a bar for standard of care through their intrinsic credibility but also by affecting reimbursement. In this article, we discuss the various organizations in the United States that develop healthcare policy and guidelines. We focus on the recent recommendations for hepatitis C virus (HCV) screening put forward by these agencies and the potential effect of these documents. Additional discussion is provided on the recent draft HCV screening recommendations provided by the United States Preventive Services Task Force (USPSTF), comparison of these to the Centers for Disease Control and Prevention (CDC) guidelines, and professional societies' response to these. Conclusion: As written, the USPSTF recommendations may reduce physician adoption of HCV screening in the 1945-1965 birth cohort as advocated by the CDC. Conflicting guidelines may further confuse providers and the public. This will ultimately hinder recognition of chronic HCV in an otherwise easily identifiable, high prevalence group, allowing progression of disease at a time when therapeutic advances make cure a realistic opportunity for many. (HEPATOLOGY 2013 )
Hierarchy of Health Policy
Multiple federal and nonfederal agencies are involved in the development of health policy, healthcare guidelines, and recommendations.
The Department of Health and Human Services (DHHS) is the principal agency for protecting the health of Americans. Multiple operating divisions exist within the DHHS (Table 1) and these include the Agency for Healthcare Research and Quality (AHRQ) as well as the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). The AHRQ, which sponsored the development of 19 clinical guidelines prior to 1996, no longer publishes independent guidelines. Instead, they are integral to the functioning of the U.S. Preventive Services Task Force (USPSTF). Both the CDC and NIH issue guidelines, recommendations, or statements regarding healthcare practice.
|Administration for Children and Families|
|Administration for Community Living|
|Centers for Medicare and Medicaid Services|
|U.S. Food and Drug Administration|
|Health Resources and Services Administration|
|Indian Health Service|
|NIH/National Cancer Institute|
|Substance Abuse and Mental Health Services Administration|
In addition to the DHHS, the Institute of Medicine (IOM) is the health arm of the National Academies, an independent, nonprofit organization outside of government that also provides unbiased and authoritative advice to decision makers and the public. The IOM is charged with addressing the nation's most pressing questions about health and healthcare.
The current administration has placed significant emphasis on preventative services as an important avenue to curb overall healthcare expenditures; however, this concept is far from novel. The USPSTF was authorized by congress in 1984 and is supported by the DHHS. Using evidence-based medicine, this task force generates recommendations about clinical preventive services for all Americans. Specifically, the USPSTF attempts to identify which preventative services should be routinely incorporated into primary care. The USPSTF does not conduct its own research, but aims to make recommendations based on rigorous review of existing evidence.
The USPSTF consists of an independent group of nonfederal experts in prevention who are appointed by the director of the AHRQ. Although the AHRQ provides administrative, research, technical, and communication support to the USPSTF, the two are independent organizations. The USPSTF recommendations do not require AHRQ or DHHS approval.
The public may nominate a new topic for review or request reconsideration of a topic through the USPSTF website (http://www.uspreventiveservicestaskforce.org/tftopicnon.htm). Nominations are considered by the group at meetings held three times a year. Once selected, the members create a research plan, compile an evidence report, develop a recommendation, and disseminate the recommendation. Each step preceding dissemination of the final recommendation includes a period for public comments.2 The USPSTF provides the basis for recommended preventative services under the ACA.
In addition to the government-sanctioned recommendations, most academic societies generate evidence-based guidelines to help establish and maintain a minimum standard of care. There may be a lack of consensus in these recommendations, and it is unknown how to prioritize these or which will be the most influential.
Evolution in the Recommendations Regarding How to Identify HCV
HCV is clearly an important public health problem. In 2007, HCV eclipsed human immunodeficiency virus (HIV) as a cause of mortality in Americans.3 Liver cancer, of which HCV is a major cause, is one of the only malignancies in the United States that continues to increase in incidence, whereas little has been done to affect the prognosis outside of liver transplantation (LT).4
As a result, HCV, with and without liver cancer, is the major reason for LT.5 Equally important is the realization that this is avoidable. HCV is one of the few viruses that can be effectively cured with antiviral therapy. Nearly 80% of treatment-naïve individuals infected with HCV can achieve sustained virologic response (SVR), which is an effective cure.6-9 SVR has not only been associated with improved quality of life, but has also been shown to decrease the risk of cirrhosis, decompensated liver disease, and liver cancer. Even extrahepatic benefits have been linked to SVR, such as decreasing the risk of diabetes mellitus. More recently, SVR was associated with a reduction in all-cause mortality.10
In 2010, an IOM study concluded that both viral hepatitis B and C were underrecognized as serious public health problems, and thus, programs for prevention, control, and surveillance were underfunded. Improving surveillance and awareness was considered paramount.11
In response to the IOM report, Assistant Secretary for Health Dr. Howard Koh organized a working group with the charge to address the IOM recommendations. In 2011, the DHHS published: “Combating the Silent Epidemic of Viral Hepatitis, Action Plan for the Prevention, Care and Treatment of Viral Hepatitis.”12 In this document, it describes the ACA as presenting an opportunity to “improve patient access to viral-hepatitis-related prevention, care and treatment services.” However, it also recognizes that the ACA prevents cost sharing with the patient only for preventative services with USPSTF grade A or B recommendations. Full implementation of the action plan includes an increase to 66% of those aware of their hepatitis C infection, with particular emphasis on those at risk. Baby boomers are specifically listed as a target population. In addition, a key goal is to “identify persons infected with viral hepatitis early in the course of their disease.” Implicit in this goal is the removal of barriers to testing. The report also recognizes that several institutes produce testing guidelines. A key strategy to improve testing rates includes coordinating efforts across agencies.
The CDC has recommended screening high-risk individuals for HCV since 1998.13 It has long been recognized that risk-based screening has failed to identify even a minority of those infected with HCV. This is likely related to the clinician's reluctance to address a sensitive topic and the patient's reluctance to identify potentially rare and distant behaviors for which they are ashamed. This is further highlighted by the fact that 45% of those infected deny any high-risk behavior.14
In addition, a recent CDC review found that only 2.6% of patient records at four major medical centers had risk information such as injection drug use or transfusion before 1992, highlighting the inadequacy of relying solely on a risk-based approach to HCV. Furthermore, only 26.5% of those with identified risk factors who should receive screening of HCV based on 1998 CDC guidelines, received it.15
On August 17, 2012, the CDC modified their 1998 HCV screening guidelines to include a one-time HCV test for all adults born during 1945-1965, independent of risk factors. Analysis of the 1999-2008 National Health and Nutrition Examination Survey data confirmed that the prevalence of anti-HCV in this cohort is 5 times higher than other birth years. Thus, whereas this birth cohort represents 27% of the U.S. population, it accounts for more than 75% of the total prevalence of HCV in the United States.14 In addition, it is estimated that they will account for 73% of HCV-related mortality. The number needed to screen to prevent a death in this group is 607. Birth cohort screening has the potential to identify >800,000 persons, the majority of which are unaware of HCV infection, and will improve mortality in this group. Those with anti-HCV were recommended to have nucleic acid testing to verify viremia, receive a brief alcohol screen and intervention, if appropriate, and be linked to care with an individual familiar with HCV treatment.
Using the National Committee on Prevention Priorities standards, screening the birth cohort and treating those with HCV compares well in terms of cost effectiveness with other preventative measures, such as colorectal cancer screening, hypertension screening, and influenza or pneumococcal vaccine recommendations. In addition, the cost effectiveness of pairing birth cohort screening with direct-acting antiviral-based triple therapy is comparable to cervical cancer or cholesterol screening.16
The USPSTF provides recommendations through a grading system that describes the strength of the recommendation as well as the recommendations for practice (Table 2).
|Grade||Definition||Suggestions for Practice|
|A||The USPSTF recommends the service. There is high certainty that the net benefit is substantial.||Offer or provide this service.|
|B||The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.||Offer or provide this service.|
|C||Note: The following statement is undergoing revision. Clinicians may provide this service to selected patients depending on individual circumstances. However, for most individuals without signs or symptoms, there is likely to be only a small benefit from this service.||Offer or provide this service only if other considerations support offering or providing the service in an individual patient.|
|D||The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.||Discourage the use of this service.|
|I Statement||The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.||Read the clinical considerations section of the USPSTF Recommendation Statement. If the service is offered, patients should understand the uncertainty about the balance of benefits and harms.|
In 2004, the USPSTF recommended against routine screening for HCV infection in asymptomatic adults who are not at increased risk of infection.17 These same recommendations cited inadequate evidence to recommend screening those at high risk of infection. This recommendation was arrived at because of the lack of evidence, at the time, that treatment of HCV resulted in improved long-term outcomes and only “limited evidence” that HCV treatment was effective in preventing cirrhosis in asymptomatic individuals. In addition, potential harms of screening were suggested to outweigh the benefits.
In December 2012, the USPSTF issued a new draft recommendation on “Screening for Hepatitis C Infection in Adults” and accepted public comments until December 24.18 The new recommendations included support for screening for HCV infection in adults at high risk of infection (grade B), but failed to match the strong CDC recommendation for screening of individuals in the 1945-1965 birth cohort and instead provided a grade C recommendation. The grade B recommendation for screening high-risk individuals is largely based on the improved efficacy of treatment and the linkage of treatment to improved clinical outcomes. The American Association for the Study of Liver Disease and seven other national societies responded during the comment period strongly supporting the grade B recommendation for screening adults at high risk, but requesting the recommendation for birth-cohort screening be changed to grade B.
The USPSTF analysis arrived at the grade B recommendation for screening adults at increased risk based on the following factors:
- 1.HCV infection in the United States is important and a major public health issue. The prevalence of positive HCV antibody (Ab) in the United States is 1.6% or 4.2 million persons.19 Nearly 80% of these individuals will have chronic infection.20 Chronic HCV infection results in cirrhosis, hepatocellular carcinoma (HCC), and is the leading cause for LT in the United States. Half of the recently observed 3-fold increase in incidence of HCC is related to HCV infection.21 An estimated 15,106 deaths were caused by HCV in 2007. HCV has superseded HIV as a cause of death in the United States.3 Individuals born between 1946 and 1965 account for approximately three quarters of HCV infections and HCV-related mortality.14 Additionally, though not considered by the USPSTF, chronic HCV infection also increases mortality from extrahepatic diseases.22
- 2.Testing with HCV Ab has a high diagnostic accuracy for HCV, and noninvasive testing has a good diagnostic accuracy for cirrhosis. Current generation HCV Ab testing as well as newer point-of-care testing methods have a high degree of accuracy in detection of HCV infection.17, 23 Furthermore, noninvasive testing methods associated with an area under the receiver operating characteristic curve of 0.80-0.91 for cirrhosis are widely available at a low cost.18 As a result, false positives are uncommon and level of disease severity can be determined with minimal risk.
- 3.There is inadequate evidence of harms of screening for HCV. Potential harms associated with screening surround the psychosocial effects of a positive screen; however, studies have not convincingly shown this to be the case.24, 25
- 4.Treatment of HCV results in high rates of sustained virologic response (SVR). Current treatment regimens result in SVR in three fourths of patients with genotype 1 HCV undergoing treatment, many of whom qualify for reduced duration of therapy.26, 27 Patients with other genotypes may have even higher rates of SVR. Additional therapies in development will likely result in all oral regimens, even higher rates of SVR, and decreased side effects.28, 29 These treatment options are anticipated to be commercially available within the coming year.
- 5.SVR is associated with reduction in all-cause mortality. SVR is defined as durable eradication of HCV and connotes cure of infection.8, 9 Achievement of SVR, which occurs in the majority of patients on current therapies, results in reduction of liver-related mortality30 and a reduction in all-cause mortality.10 SVR also reduces risk of hepatic decompensation31 and rates of HCC.32-36 Newer evidence, which was not considered by the USPSTF, suggests that SVR is associated with a significant reduction in all-cause mortality (hazard ratio [HR] = 0.26; P < 0.001) and reduced risk of liver-related mortality or transplantation (HR, 0.06; P < 0.001).37
- 6.Harms associated with HCV treatment are small. Half of patients treated for HCV may experience adverse effects; however, the majority of these resolve with cessation of therapy, if needed.
These data support the following: Testing for HCV is accurate and identifies disease in an asymptomatic state. Effective treatment regimens are available that reduce mortality, and the harms associated with this approach are small. These findings apply to individuals with identified risk factors as well as those within a high-prevalence birth cohort.
For birth-cohort screening, the USPSTF arrived at a grade C recommendation as a result of the lower prevalence in this patient population and therefore a potentially lower “net benefit.” However, risk-based screening has failed to identify 70% of infected persons in the United States. Furthermore, the recommendation specifically states that: “It [USPSTF] bases its recommendations on the evidence of both the benefits and harms of the service, and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment.” However, screening a lower prevalence group with modalities that have minimal potential harm can still result in net benefit. This approach may lead to increased costs, but this factor was specifically not considered by the USPSTF in the formulation of the recommendation. Furthermore, even if considering cost, studies have found birth-cohort screening to be highly cost-effective at a cost of $15,700-$35,700 per quality-adjusted life-year saved.16 Thus, even within the USPSTF's own framework, the recommendation for birth-cohort screening is discrepant and not consistent.
The USPSTF grade C recommendation is in stark contrast to the recent draft recommendation to screen individuals between age 15 and 65 for HIV, regardless of risk (grade A).38 There is an estimated HIV prevalence in this group of <0.5%, in contrast to the higher prevalence of HCV in the 1945-1965 birth cohort. However, despite this, a grade A recommendation is offered for HIV screening. Further justification for the HIV recommendation is based on the notion that “screening for HIV based on risk factor assessment alone may miss 20% to 25% of HIV-positive individuals who report no risk factors.” This is even more true of HCV infection, where the majority of patients are unaware of infection and risk-based screening fails to identify them.
Using solely a risk-based approach relies on the recollection of potentially rare and distant behaviors by the patient and the questioning of a sensitive topic by the physician. This narrow approach fails to identify most patients infected with HCV, many of which are within the 1945-1965 birth cohort and not correctly identified as having risk factors. By stating, “for most individuals without signs or symptoms there is likely to be only a small benefit from this service,” the grade C recommendation also incorrectly implies that asymptomatic individuals would not benefit from diagnosis and treatment. Conversely, these are the patients who will benefit most, before the development of symptomatic liver disease. In addition, most cost savings will result from identification of disease at an early stage when disease-specific healthcare expenditures are reduced and rates of cure are highest.39
Potential Impact of USPSTF Recommendations
If left unchanged, the USPSTF grade C recommendation has the potential to reduce physician adoption of screening patients born between 1945 and 1965 as well as decrease reimbursement for screening of these persons. This will result in reducing access to life-saving therapies for the most easily identifiable group with a high prevalence of HCV. In addition, the ACA prohibits cost sharing with the patient for those tests given a grade A or B recommendation by USPSTF.40 Thus, an additional cost barrier will affect those within this birth cohort, thereby rendering screening less effective. Last, discordant recommendations from two different federally supported agencies will serve only to confuse providers and patients.
HCV therapy is highly effective and will soon transition to a less-toxic regimen with few contraindications. Given the established morbidity and mortality associated with HCV, identifying infected individuals at a time before advanced disease is imperative. Once HCV causes end-stage liver disease, the risk of death is much higher as are the healthcare costs of those with advanced liver disease.41
Although consensus is difficult, duplication of guidelines among various agencies wastes resources and generates confusion for patients and providers. The USPSTF draft recommendation on HCV fails to support the CDC and seems to contradict the IOM and U.S. Department of Health and Human Services Action Plan for the Prevention, Care and Treatment of Viral Hepatitis. Without revision, these recommendations will have far-reaching consequences for our population.