WHITE PAPER SERIES

Learning from Civil Rights Lawsuits:

Policies for Expanding
Hepatitis C Testing and
Treatment in United States
Prisons and Jails

white paper series

Learning from Civil Rights Lawsuits:

Policies for Expanding Hepatitis
C Testing and Treatment in United
States Prisons and Jails
APRIL 2023

A project of the Civil Rights Litigation Clearinghouse and
the University of Michigan Law School

Tessa Bialek, Clearinghouse Managing Attorney
& Dr. Matthew J. Akiyama, M.D., Associate Professor
Department of Medicine, Divisions of General Internal Medicine and Infectious Disease,
Montefiore Medical Center and Albert Einstein College of Medicine

This project and related materials are available for reading or download at clearinghouse.net/policy/1/22.
Materials include a large-print version of this document, as well as case summaries, litigation documents,
and other referenced resources.
© The Civil Rights Litigation Clearinghouse and the University of Michigan Law School. This paper may be
copied and shared for any purpose, for free or at cost, with attribution. The model policies in Part III of the
paper may be copied freely for any purpose with or without attribution, and may be freely adapted or amended
so long as adaptions are not attributed to the Civil Rights Litigation Clearinghouse and/or the authors.
A version of this white paper is forthcoming in Volume 57 of the University of Michigan Journal of Law Reform.

NHCN
~

NATIONAL HEPATITIS
CORRECTIONS NETWORK

ACCJH

Academic Consortium on
Criminal Justice Health

TAG

Treatment Action Group
The National Hepatitis Corrections Network and Treatment Action Group helped shape the recommended
policies in Part III of this white paper and endorse them for consideration and adoption. The Academic
Consortium on Criminal Justice Health and the National Viral Hepatitis Roundtable also endorse the
recommended policies for consideration and adoption.
Photo Credit: istock.com/Mindful Media

Executive Summary
Hepatitis C virus (HCV) is highly prevalent in United States prisons and jails, where rates
of infection are 10 to 20 times greater than national levels and where more than 30% of all
people living with HCV in the United States will spend time in any given year. Rates are especially high among people who inject drugs (PWID), a population whose members are also
likely to move between carceral settings and the community. Thus, addressing HCV among
incarcerated populations would have a significant effect on transmission of the virus both
inside and outside of confinement and is a crucial part of any HCV elimination strategy. Safe
and effective HCV treatment is available. Direct acting antivirals (DAAs), offered in an 8-12
week course of oral treatment, cure HCV in more than 90% of cases. Widespread testing and
treatment in prisons and widespread testing and treatment or linkage to community care in
jails is an essential public health approach. But testing and treatment in confinement lags
behind medical guidance and public health recommendations.
People incarcerated in prisons and detained in jails are entitled to adequate health care,
and the U.S. Constitution prohibits deliberate indifference to their serious medical needs. In
recent years, lawsuits filed by people with HCV in carceral facilities across the country have
alleged violations of federal law for failure to provide DAA treatment. Although litigation results
have been mixed, settlement agreements in states across the country have expanded HCV
testing and broadened access to DAA treatment. These settlement agreements reflect a
growing understanding that widespread testing and treatment is cost effective, avoids the
harmful health consequences of disease progression, and meaningfully reduces community
transmission.
This white paper recommends model policies for prisons and jails to expand HCV testing
and DAA treatment. The policy recommendations draw from relevant settlement agreements
and current medical guidelines, supplemented by input from public health experts, medical
professionals, and advocates. The paper proceeds as follows:
• Part I describes the HCV epidemic in United States prisons and jails, the recent
sea change in treatment protocols, and relevant clinical guidance and public health
recommendations.
• Part II sets out the legal landscape, including governing federal law and judicial
decisions interpreting that law in this context, and describes settlement agreements
in class action lawsuits addressing DAA access.
• Finally, Part III offers model policies for prisons and jails to expand testing and
treatment and to support successful outcomes for people with HCV in their custody.

Contents
I. Hepatitis C Virus in United States Prisons and Jails: A Crisis and
an Opportunity �������������������������������������������������������������������������������� 1
A. An Overview: Hepatitis C Virus Prevalence in United States Prisons and Jails �� 1
B. A Treatment Sea Change: From Interferon to Direct Acting Antivirals ������������� 2
C. Medical Standard of Care: Universal Testing and Early-Stage DAA Treatment ��� 3
D. Lagging Implementation of Universal Testing and Treatment in
Prisons and Jails ���������������������������������������������������������������������������� 6

II. The Legal Landscape �������������������������������������������������������������������� 9
A. The Eighth Amendment Standard: Deliberate Indifference to
Serious Medical Need ���������������������������������������������������������������������� 9
B. Litigation Challenging the Prioritization of DAA Treatment ����������������������� 10
C. Class Action Settlement Agreements: Toward Universal
Testing and Treatment�������������������������������������������������������������������� 11

III. Model Policies ����������������������������������������������������������������������������

14

Statement of Purpose and Guiding Considerations ������������������������������������ 14
1. Universal Opt-Out Screening for HCV ��������������������������������������������� 15
1.1 Universal Opt-Out HCV Screening ������������������������������������������� 15
2. Medical Evaluation and Consultation ��������������������������������������������� 17
2.1 Medical Evaluation and Consultation for Patients with HCV Viremia ��� 17
2.2 Enrollment in Substance Use Treatment and Support ������������������� 19
3. Provision of Treatment and Linkage to Community Care ���������������������
3.1 Provision of DAA Treatment ��������������������������������������������������
3.2 Proper and Improper Considerations for Treatment ����������������������
3.3 Linkage to Community Care ��������������������������������������������������

20
20
21
22

4. Education for Patients while Incarcerated and upon Release ���������������� 24
4.1 HCV Education ����������������������������������������������������������������� 24
5. Recordkeeping ������������������������������������������������������������������������ 25
5.1 Maintenance of Records ������������������������������������������������������ 25

6. Staffing and Staff Training ���������������������������������������������������������� 26
6.1 Staffing to Support HCV Care ������������������������������������������������ 26
6.2 Staff Training������������������������������������������������������������������� 26
7. Updates to Guidance and Protocols ����������������������������������������������� 27
7.1 Regular Updates to Guidance and Protocols ������������������������������� 27
8. Definitions ������������������������������������������������������������������������������
8.1 [Entity]����������������������������������������������������������������������������
8.2 Medical Staff ��������������������������������������������������������������������
8.3 Staff ������������������������������������������������������������������������������

27
27
27
27

Endnotes ������������������������������������������������������������������������������������������

28

Acknowledgements ������������������������������������������������������������������������

49

Appendix: How to Use the Civil Rights Litigation Clearinghouse �����

50

I. Hepatitis C Virus in United States
Prisons and Jails: A Crisis and an
Opportunity
Hepatitis C virus (HCV) affects millions of people in the United States, and infection rates
are rising. HCV disproportionately affects people in prisons and jails, where rates of infection are magnitudes higher than in the community. If left untreated, HCV can have severe
consequences, including death. Fortunately, HCV can be cured in most people. Direct-acting
antiviral (DAA) treatment is effective and safe, with minimal side effects and a relatively
short course of treatment. Costs of DAA treatment continue to decrease. Current medical
guidance unambivalently recommends universal opt-out testing and DAA treatment for HCV
without restrictions. But most carceral system practices fall short of this recommendation
and, where DAAs are available, prioritize treatment for people with advanced liver disease.
This is a missed opportunity. Prisons and jails offer a crucial opportunity to test for and
treat HCV in the early stages of the disease, among a high-risk, high-prevalence population,
simultaneously minimizing harm to individual patients and reducing community transmission.

A. An Overview: Hepatitis C Virus Prevalence
in United States Prisons and Jails
Hepatitis C is a virus that infects the liver.1 HCV is spread through contact with blood from
a person who is infected, most often through sharing needles used to prepare and inject
drugs.2 For up to 20% of people exposed to the virus, HCV is a short-term, “acute” illness from
which they spontaneously recover—but during the period of often asymptomatic infection,
they may nonetheless spread the virus to others.3 Those who do not spontaneously recover
develop long-term, “chronic” infection, during which the liver becomes progressively more
damaged. Chronic HCV can be lifelong if not treated and may cause serious health problems,
including: fibrosis of the liver, when scar tissue replaces healthy tissue, reducing liver function;
cirrhosis, when scar tissue takes over most of the liver; liver failure; liver cancer; and death.4
Moreover, active HCV infection increases a person’s susceptibility to other illnesses, including chronic kidney disease,5 depression,6 neurological disorders,7 malignancies,8 and other
extra-hepatic manifestations.9 Disease trajectory is unpredictable, and the rate of disease
progression varies from person to person.10 But without treatment, HCV has high rates of
morbidity and mortality.11
It is estimated that 2.4 million people in the United States are living with HCV, but that number
may be as high as 4.7 million; approximately half of people living with the virus do not know
that they are infected.12 The incidence of HCV in the United States is increasing; the rate of
new infections reported to the Centers for Disease Control and Prevention (“CDC”) in 2018
was four times that reported in 2010.13 The increased prevalence has been most pronounced

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in states most affected by the opioid epidemic,14 with studies pointing to “substantial, simultaneous increases” in acute HCV and admissions for opioid injection.15 As injection drug use
continues to drive new infections, rates among young people, in particular, are on the rise.
The CDC’s annual HCV data continues to show highest rates of new infection, and lowest
treatment rates, among adults under 40.16
HCV is disproportionately prevalent in United States prisons and jails compared to the general
population. Recent studies show that among incarcerated populations, HCV antibody positivity rates, which indicate exposure to HCV, range from 12 to 34%, more than 20 times the
national rate.17 Estimates suggest that approximately 30% of all individuals living with HCV
in the United States spend time in a carceral setting in a given year.18 These high rates of
HCV in prisons and jails can be attributed primarily to the ready transmission of HCV through
injection drug use and the high rates of incarceration among people who inject drugs (PWID).
Insufficient access to harm reduction measures and non-commercial tattooing practices
may contribute to new transmission within carceral settings.19 The effects ramify outside
prisons and jails. The young PWID driving high rates of new infection in the United States
are also a population more likely to be in and out of prisons and jails, likely without knowing
that they have contracted and may be spreading HCV. Recent short-term incarceration is
associated with an elevated risk of HCV acquisition among PWID.20 And more than 90%
of people with HCV in prisons and jails are eventually released, risking further community
transmission.21 Moreover, HCV is disproportionately deadly in incarcerated populations. In
2019, the HCV-related death rate for people in United States prisons was more than double
the rate for the overall population, and more than 1000 people died in prison of HCV-related
causes between 2013 and 2019.22

B. A Treatment Sea Change: From Interferon
to Direct Acting Antivirals
Until about a decade ago, a medication called interferon was necessary for HCV treatment.
A synthetic version of interferon, which is made naturally by the body’s immune system,
was given in the form of an injection to stimulate the immune system against the virus. By
2011, the most common treatment regimen involved pegylated interferon, administered
via weekly injection, combined with a daily oral dose of ribavirin, over a course of 24 to 48
weeks.23 This regimen produced wide-ranging results, with sustained virological response
(or HCV cure24) in anywhere from 30 to 90% of patients, depending on HCV genotype and
stage of liver disease.25 Barriers to interferon-based treatment were significant. Pre-treatment
usually required virus genotyping and staging to determine treatment course.26 Side effects
could be severe, including flu-like symptoms, lowered white blood cell or platelet counts, and
depression and other mood disorders.27 Moreover, interferon and/or ribavirin were contraindicated for many people.28
During the interferon era, HCV treatment was often not offered at all in prisons and jails. Even
when offered, barriers to treatment were exacerbated in those settings. For example, before

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determining whether treatment could begin, many systems required liver biopsies and/or
genotyping,29 procedures that can be more complicated, and more often delayed, for people
in custody than for those in the community. Some carceral systems required psychological
screening before initiating treatment.30 State prison systems often required a minimum
remaining sentence of 15 to 18 months to ensure completion of treatment and follow up,
precluding treatment for people with less, or uncertain, time remaining on their sentences.31
As one federal court of appeals described eligibility for treatment in a state prison system
during that period: “The selection of patients for interferon treatment is highly individualized
and depends upon many factors. . . . [E]ven if the appropriate threshold levels of inflammation
and fibrosis are present, treatment may be inappropriate if the patient is too young or too old,
had a previous organ transplant, or suffers from depression, other mental health problems,
heart disease, or untreated chemical dependency.”32 Moreover, as of 2008, most states had
not established any program or protocols for HCV treatment in their prison systems.33
In 2011, the HCV treatment landscape began to transform. That year, the U.S. Food and Drug
Administration began approving DAA medications for HCV to be administered in combination with interferon.34 And in 2014, the FDA began approving DAA drugs as a stand-alone
treatment option.35 DAAs directly target HCV at various stages of the viral life cycle to inhibit
virus production.36 DAAs are now widely available, safe, and highly effective across genotypes. More than 90% of people with HCV can be cured with an 8- to 12-week course of oral
DAA therapy.37 Side effects are minimal, as are contraindications. DAA treatment requires
minimal pre-treatment testing and is easily administered through daily pills. DAA treatment
not only cures HCV in the vast majority of patients, it also reduces community transmission.
Recent studies show that successful DAA treatment is preventive; that is, DAA treatment
scale up is associated with reduced overall HCV incidence.38 DAA treatment has also proven
cost-effective, reducing overall disease rates and avoiding expensive later-stage care.39 This is
increasingly true as the costs of DAA treatment continue to decrease.40 DAAs have replaced
interferon as the universal standard of care for HCV.41

C. Medical Standard of Care: Universal Testing
and Early-Stage DAA Treatment
The American Association for the Study of Liver Diseases and the Infectious Diseases Society
of America together promulgate HCV Guidance: Recommendations for Testing, Managing,
and Treating Hepatitis C (“AASLD/IDSA guidance” or “guidance”). This guidance offers “up-todate recommendations to healthcare practitioners on the optimal screening, management,
and treatment for persons with HCV infection in the United States, considering the best
available evidence,”42 including recommendations for HCV testing and treatment in prisons
and jails.43 It is updated regularly—most recently in October 2022—to reflect new data from
peer-reviewed research.44
The AASLD/IDSA guidance is the predominant guide to appropriate HCV care in the United
States. The CDC presents the AASLD/IDSA guidance as “Clinical Guidelines” for HCV screening

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and management.45 The most recent (March 2021) version of the Federal Bureau of Prisons’
(FBOP) Clinical Guidance on the Evaluation and Management of Hepatitis C Virus (HCV)
Infection—guidance on which many state prison systems base their own HCV treatment
protocols—credits the January 2021 AASLD/IDSA guidance for its own 2021 revisions toward
a simplified approach to testing and treating.46 (Note, however, that the FBOP guidance does
not fully align with the AASLD/IDSA guidance.) And although the legal significance of the
guidance remains contested,47 several courts have recognized the AASLD/IDSA guidance
as the standard of care that should guide HCV treatment in carceral settings.48
Universal Testing: The AASLD/IDSA guidance recommends one-time, routine, opt-out HCV
testing for all people age 18 and older, and periodic repeat HCV testing for people with risk
activities, exposures, or conditions, including “persons who were ever incarcerated.”49 The
guidance recommends that prisons and jails implement opt-out HCV testing.50 Generally,
universal screening is recommended “because of the known benefits of care and treatment
in reducing the risk of” serious illness or death, as well as “the potential public health benefit
of reducing transmission through early treatment, viral clearance, and reduced risk behaviors.”51 Moreover, numerous studies confirm that routine, one-time testing for all adults is cost
effective because it identifies “a substantial number of HCV cases that would otherwise be
missed.”52 Routine testing offers significant health care cost savings, “even when linkage to
HCV treatment after testing [is] poor and the rate of HCV reinfection among injection drug
users [is] high.”53 Studies similarly demonstrate that routine HCV testing for people with risk
exposure is cost effective “because of increasing HCV incidence and prevalence among
people who inject drugs and the decreasing cost of DAA therapy,” and because many people
at greatest risk for infection and transmission do not report “their highly stigmatized risk
activities.”54 In that context, universal testing both casts a wider net and reduces the stigma
of risk activity-based testing.
The guidance’s support for universal testing aligns with the recommendations of other national
health organizations. The CDC advises screening all adult patients at least once in their
lifetime, as well as routine periodic testing for people with risk factors.55 The U.S. Preventative Services Task Force’s Recommendation Statement on Screening for Hepatitis C Virus
Infection in Teens and Adults similarly recommends one-time screening for all adults ages
18-79, as well as periodic screening for people at continued risk.56
Unrestricted Treatment: The AASLD/IDSA guidance recommends DAA treatment for “all
patients with acute or chronic HCV infection, except those with a short life expectancy that
cannot be remediated” by treatment.57 It explains: “[b]ecause of the many benefits associated with successful HCV treatment, clinicians should treat HCV-infected patients with
antiviral therapy with the goal of achieving [virologic cure], preferably early in the course of
chronic hepatitis C before the development of severe liver disease and other complications.”58
Early treatment is associated with better outcomes, including higher likelihood of cure and
mortality reduction.59 Numerous studies have shown meaningful reduction in liver-related
mortality when HCV is treated at the earliest stages.60 The AASLD/IDSA guidance makes
clear that DAA treatment can and should be provided in prisons and jails, and that testing

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and treatment in those settings, and linkage to community care upon release, are key to HCV
elimination efforts.61 This recommendation aligns with recent CDC and World Health Organization guidance recommending testing and treatment in primary care locations, including
carceral settings, in order to maximize access.62
Since DAA treatment first became available, the infrastructure necessary to implement universal treatment has lagged: many health care systems lack the staff, funding, and protocols to
rapidly treat every patient with HCV.63 Moreover, the high market price of DAA drugs made
rapid treatment for all prohibitively expensive. In 2014, Sovaldi, one of the first drugs approved
for DAA treatment, cost $1,000 per pill and about $84,000 for a typical course of treatment.64
In the early era of DAAs, medical guidance and practice therefore often prioritized treatment
for those with the most advanced liver disease.
But prices have fallen markedly since then. In 2019, Gilead, the originator company for several
DAA drugs began offering “authorized generics,” marketed by a subsidiary company, at a list
price of $24,000 for a course of treatment.65 By 2020, the cost of WHO-recommended DAA
drugs in the United States ranged from approximately $17,965 to $111,659 per course of
treatment, with course-of-treatment costs less than $27,000 for at least three of the major
DAAs on the market.66 Now, years after the introduction of DAA treatment for HCV, prices are
down to $20,000 and lower per course of treatment in the United States. It seems likely that
costs will continue to decrease—indeed, elsewhere in the world, DAAs are available for $60 per
course of treatment, which is more in line with estimated manufacturing cost-based prices
that, since the early days of DAA treatment, have generally been less than a couple hundred
dollars per course of treatment, and sometimes far lower.67 But even at this point treatment
is clearly cost effective.68 Even as early as 2014, when drug costs were at their highest, DAA
treatment was shown to save money over the long run by reducing the need for higher-cost
later-stage interventions like cirrhosis treatment and liver transplants.69
As prices have continued to fall and studies repeatedly confirm the safety and efficacy of DAA
treatment, medical guidance and practice has explicitly shifted away from prioritization.70 The
current AASLD/IDSA guidance explains that, at this juncture, there “have been opportunities
to treat many of the highest risk patients and accumulate real-world experience regarding
the tolerability and safety” of DAA treatment regimens.71 Moreover, data demonstrates “the
many benefits, both intrahepatic and extrahepatic, that accompany HCV eradication.”72 For
those reasons, the guidance no longer recommends prioritization, and instead promotes
DAA treatment for all except those with short life expectancies that cannot be remediated
with treatment.73
Supporting Recommendations: Finally, the AASLD/IDSA guidance offers recommendations
to support the success of testing and treatment programs. These supporting recommendations include: counseling; interventions to facilitate cessation of alcohol consumption;
evaluation for other conditions that can accelerate liver fibrosis, including Hepatitis B and HIV;
vaccination against Hepatitis A and B; and education about how to prevent HCV transmission
to others.74 In jails, the guidance recommends coupling testing and treatment with counseling and linkage to follow-up community healthcare.75 In prisons, the guidance recommends
“harm reduction and evidence-based treatment for underlying substance use disorders.”76
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MEDICAID COVERAGE FOR EARLY-STAGE DAA TREATMENT
In the Medicaid context, states and courts alike have recognized the benefits to earlystage DAA treatment. In 2015, the Centers for Medicare & Medicaid Services issued a
letter to state Medicaid coordinators characterizing DAA treatment for chronic HCV as
“effective, clinically appropriate, and medically necessary,” and reproaching states for
limiting treatment to beneficiaries with more advanced fibrosis.77 Thereafter, several
state Medicaid programs removed categorical barriers to treatment;78 and in some
states that did not do so voluntarily, courts required such expansion of coverage.79
As of 2022, fibrosis restrictions for treatment remain in only two states; in all other
states, early-stage DAA treatment can be covered for Medicaid recipients (although
other restrictions, such as prescriber requirements, may still apply).80

D. Lagging Implementation of Universal Testing
and Treatment in Prisons and Jails
In the early years after the introduction of DAAs, treatment rates in United States prisons
and jails were dismal. A study of state prison systems found that, of the 41 states reporting
data, less than 1% of incarcerated people known to have HCV were receiving any form of
treatment as of January 1, 2015.81 That same study noted that routine testing was generally
not conducted; only 16% of responding prisons provided universal (opt-out) antibody testing
upon admission.82 During this time, medical guidance and practice prioritized patients with
the greatest need, including those with advanced liver fibrosis.83 Carceral systems similarly
prioritized patients for DAA treatment based on disease progression,84 but also imposed
barriers to treatment untethered to medical guidance or disease progression. For example,
some systems required a year or more left on one’s sentence before beginning treatment85—an
outdated timeframe seemingly tied to the long period previously required to complete interferon-based treatment. Other systems apparently precluded treatment based on disciplinary
record,86 or required completion of lengthy alcohol- and drug-treatment programs before
initiating treatment.87 Although cost alone cannot justify denial of necessary medical care, it
is true that the high price of DAAs at that time functionally precluded universal treatment88:
for many carceral systems, the cost of universal DAA treatment would have outstripped
entire healthcare budgets.89
But even as DAA costs began to fall and medical guidance shifted away from prioritization
toward universal testing and treatment, testing and DAA access in carceral settings have
continued to lag. To provide some of many examples: In the Indiana prison system between
April 1, 2017 and January 19, 2018, only 41 of approximately 3,476 people identified as having
chronic HCV had completed or were receiving DAA treatment.90 In Tennessee, as of July
2019, only approximately 10% of people known to have HCV in the custody of the Tennessee
Department of Corrections had been prescribed DAAs.91 In 2021, only 13% of the more than
900 incarcerated people known to have HCV in the Missouri prison system received DAA

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treatment,92 New Hampshire treated only 22 of an estimated 250 incarcerated people with
HCV, and only 4% of people with HCV in state custody in Iowa received DAA treatment.93
South Dakota treated just seven incarcerated people in 2021, out of at least 382 known to
have the virus.94 Indeed, recent reporting on this issue indicates that as of 2021, at least a
dozen states were treating fewer than 20% of people with HCV in their custody.95 Today,
many systems maintain policies that prioritize treatment for those with the most advanced
liver disease,96 despite evidence that treatment is likely to be most effective when offered
in the earliest stages of the disease,97 and many continue to impose barriers to treatment
unrelated to disease progression.98
The failure to scale up HCV testing and treatment in prisons and jails is a missed opportunity
to cure people with HCV and to prepare to meet the needs of future incarcerated populations.
A “test all, treat all” approach when combined with linkage to care at release substantially
reduces liver fibrosis severity and lifetime cumulative prevalence of cirrhosis, and meaningfully increases the proportion of lifetime sustained virological response.99 Prisons and jails
offer a prime setting to identify and treat the virus in a high-risk, high-prevalence population,
often at a time of relative stability from active substance abuse and with support for adherence to treatment, which in turn can reduce community transmission.100 When prisons and
jails endeavor to test for and treat HCV, outcomes demonstrate that DAA treatment can be
provided safely, effectively, and with cure rates comparable to community care.101 Successful models have included telehealth linkages to specialists,102 including Project ECHO in
New Mexico, through which health care providers in rural settings are linked to specialists
at the University of New Mexico to support HCV care,103 as well as training for primary care
on-site practitioners.104 Numerous studies confirm that early-stage DAA treatment is a more
cost-effective approach than treating advanced disease only, as it improves quality of life
and decreases health care costs over the long term.105 From a public health perspective, then,
expanding testing and treatment in carceral settings is essential.

FUNDING FOR DAA TREATMENT
The price of DAAs has been a high barrier to universal treatment in prisons and jails.
Although DAA drugs are now many-fold less expensive than they were a decade ago,
the medications remain costly.106 Therefore, even as costs continue to decline, it is vital
that states direct additional funding to support testing and treatment in prisons and jails
and that efforts are made on the state and federal level to reduce DAA drug costs.107
Universal testing and early-stage DAA treatment are cost-effective for communities in
the long term.108 States are likely to bear the downstream burden of health care costs
as people are released back into the community, potentially spreading the virus and/
or suffering the individual health consequences of untreated disease progression. In
this context, it is economically rational for states to support prisons and jails in efforts

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to scale up testing and early-stage treatment.109 That said, although universal testing
and treatment is essential, it must not come at the cost of other essential jail and
prison medical services.110
Fortunately, the falling costs of DAAs combined with innovations in payment strategies
can support efforts to fund universal treatment. For example, carceral systems might
partner with entities exempt from the “best price” floors typically imposed on price
negotiations under section 340B of the Public Health Service Act, such as federally
qualified health centers and disproportionate share hospitals, for DAA purchases,111 as
Texas, Alaska, Utah, and several other states have done.112 Under such arrangements,
people with HCV in state/local custody can be considered patients of the entity eligible
for the program and receive significant discounts on DAAs.113 As another possibility,
researchers have recommended pursuing a nominal pricing approach, seeking special
permission from the U.S. Department of Health and Human Services for carceral
facilities as “safety-net providers” within the meaning of Section 1927(c)(1)(D)(i)(VI)
of the Social Security Act, which would enable prisons to purchase DAAs at less than
10% of market rate, if pharmaceutical companies were willing to provide them at that
price.114 State departments of correction might also consider coordinating for pooled
procurement with increased purchasing power,115 working with county or state agencies to receive lower prices, or pushing for increased federal funding, as the federal
government may ultimately bear much of the downstream cost of untreated HCV.116
Alternatively, states could negotiate directly for a discounted price in exchange for
purchasing from a single provider, as Virginia has done.117 Finally, states might seek
to support pre-release treatment and transition to community care by applying for
a Section 1115 waiver to waive the Medicaid exclusion for incarcerated people and
permit the provision of a targeted set of Medicaid funded services, in some cases up
to 90 days before release.118 The Centers for Medicaid and Medicare Services intends
soon to release guidance to states on the scope of services that may be paid for using
Medicaid funding while an individual is incarcerated, including medications provided
during the incarceration period as well as medications to have in-hand upon release.
Following the release of that guidance, the Clearinghouse intends to release a template
1115 waiver that will describe options and considerations for including Hepatitis C testing
and treatment as part of the set of targeted services.

8 | Expanding Hepatitis C Testing and Treatment | I. Hepatitis C Virus in United States Prisons and Jails

II. The Legal Landscape
Over the last several years, people with HCV in United States prisons (and in at least two
unified correctional systems119) have filed lawsuits seeking DAA treatment and challenging
prison policies that prioritize DAA treatment for the people who are sickest or have the most
advanced liver disease. The lawsuits principally argue that there is no medical justification
for delaying or denying curative DAA treatment and that doing so violates medical standards
of care and federal law. Many of these lawsuits have resulted in settlement agreements
that change policy and practice and make significant strides in expanding HCV testing and
treatment in carceral settings.

A. The Eighth Amendment Standard: Deliberate
Indifference to Serious Medical Need
Longstanding case law explains that under the Eighth Amendment’s Cruel and Unusual
Punishments Clause, each state and local government has an “obligation to provide medical
care for those whom it is punishing by incarceration.”120 People in custody “must rely on prison
authorities to treat [their] medical needs; if the authorities fail to do so, those needs will not
be met,” resulting in unconstitutional infliction of suffering.121 Under this standard, everybody
in custody, regardless of their crime or behavior, is entitled to adequate medical care.
A prison official violates the Eighth Amendment if he or she acts with “deliberate indifference”
to an incarcerated person’s “serious medical needs.”122 The standard has both an objective
and a subjective component: the medical need must be objectively serious,123 and the official must have a sufficiently culpable state of mind, akin to recklessness, acting or failing to
act while actually aware of a substantial risk that serious harm will result.124 Put differently,
the official “must both be aware of facts from whic and h the inference could be drawn that
a substantial risk of serious harm exists, and he must also draw the inference.”125 Courts
applying this standard have held that delaying or failing to provide treatment for a non-medical reason may violate the Eighth Amendment,126 and that effects on a person’s current and
future health must be considered.127 But mere medical malpractice or disagreement as to
proper course of treatment does not support an Eighth Amendment claim.128 Instead, to
be actionable, the challenged action must significantly depart from accepted professional
practice or standards.129
A state must provide sufficient funds to ensure that its prison system operates in compliance
with the Constitution.130 If a particular treatment or intervention is required under the Eighth
Amendment, it cannot be withheld because of cost alone. Courts considering this issue in
the context of DAA treatment align in reasoning that a treatment decision “based exclusively
on nonmedical considerations such as cost or administrative convenience rather than any
medical justification” may violate the Eighth Amendment.131 Although at least one appellate
court has held that cost can be considered in determining what type of medical care an

9 | Expanding Hepatitis C Testing and Treatment | II. The Legal Landscape

incarcerated person receives, it emphasized that cost is “never . . . an absolute defense to
what the constitution requires”—that is, if a particular course of treatment is essential to
“minimally adequate care,” governmental poverty is not an excuse for failure to provide it.132

LEGAL CHALLENGES TO HCV TESTING AND TREATMENT FOR PATIENTS
IN PRE-TRIAL DETENTION
This paper generally uses “jails” to describe detention facilities for people who have not
yet been sentenced and “prisons” to describe carceral facilities for people who have
already been sentenced. Most lawsuits seeking DAA treatment in carceral settings
have been filed by people incarcerated in state prison systems after sentencing, rather
than people detained pre-trial in state and local jail facilities. (Note, though, that two of
the lawsuits described herein arose in states with unified systems, comprising pre-trial
detention and post-sentencing incarceration.133) There are likely many reasons for this,
including that length of stays in jail tend to be uncertain and, usually, shorter than
prison stays, complicating efforts to seek medical care and meaningfully challenge
barriers to access.
The legal analysis in this paper, and in most of the cases described in this section,
focuses on the Eighth Amendment, which applies to incarcerated people who have
already been sentenced. The Fifth and Fourteenth Amendment Due Process Clauses
provide similar rights for people detained pre-trial (federal and state/local, respectively).
These rights may even be a bit more robust, although the precise contours are currently
contested, with some federal courts of appeal applying the Eighth Amendment deliberate indifference standard exactly, and others setting a less onerous standard in the
pre-trial context.134

B. Litigation Challenging the Prioritization
of DAA Treatment
Lawsuits seeking HCV testing and DAA treatment in custody have typically argued: (1) HCV is
an objectively serious medical condition, and (2) the failure to provide curative DAA treatment
constitutes deliberate indifference.135 Often, the parties do not dispute that HCV is a serious
medical condition, even in the earliest stages of the disease, satisfying the objective component of the Eighth Amendment standard.136 Thus the contested issue is whether the failure
to provide universal or early-stage DAA treatment constitutes deliberate indifference to that
serious medical need. Courts addressing that question have come to varying conclusions.
Several courts have failed to hold prison systems accountable for delaying or denying DAA
treatment. Typically, the policies at issue in those cases involve regular monitoring of disease

10 | Expanding Hepatitis C Testing and Treatment | II. The Legal Landscape

progression, with DAA treatment offered at a certain stage of liver disease and the flexibility
to treat sooner on a case-by-case basis.137 In denying liability, courts analyzing these policies
reason that such a system does not withhold treatment, but rather offers treatment “in the
form of diagnosing and monitoring HCV-infected inmates,”138 and that disagreement with
course of treatment is not cognizable under the Eighth Amendment.139 These courts have
also favorably cited the flexibility to treat those with immediate need, regardless of place in
the priority system.140 Ultimately, these courts conclude that the failure to provide a curative
course of treatment (DAAs), without more, does not rise to the level of deliberate indifference.
But as other courts have recognized, such decisions miss the mark. There is no longer a range
of acceptable treatments for HCV. Rather, DAA therapy is the medically accepted treatment
at every stage of the disease. Thus in considering a case in which the plaintiff developed
cirrhosis while waiting for DAA treatment in prison, the U.S. Court of Appeals for the Third
Circuit recently held: “monitoring a condition rather than treating with an available medication”
may constitute unconstitutional deliberate indifference.141 Several other courts to address
the issue have properly recognized that monitoring HCV until a person’s health deteriorates
is not adequate medical care, and that such deferment of DAA treatment may violate the
Eighth Amendment. See, e.g., Barfield v. Semple, No. 3:18-cv-1198 (MPS), 2019 WL 3680331,
at *12 (D. Conn. Aug. 6, 2019) (denying in part motion to dismiss Eighth Amendment claim
because “where, as alleged here, the CT DOC knew that delay in treatment would cause harm
yet still chose merely to monitor the condition or provide only supporting care, it has exhibited
deliberate indifference”); Postawko v. Missouri Dep’t of Corr., No. 2:16-cv-04219-NKL, 2017 WL
1968317, at *7 (W.D. Mo. May 11, 2017) (“similarly denying in part motion to dismiss Eighth
Amendment claim, explaining that a “‘wait and see’ policy of relying solely on APRI scores
and delaying DAA treatment until the disease has progressed to a far more serious level
contravenes the applicable medical standard of care without any medical justification”).142
As these courts and others have recognized, prioritizing treatment for those with the most
advanced fibrosis is shortsighted, dangerous, and contrary to prevailing medical standards
and public health indicia. Although the course of fibrosis progression may be slow, patients
with chronic HCV are at risk for other serious conditions even in the early stages of the
disease.143 In addition, fibrosis progression is unpredictable, and estimates of progression
may be inexact.144 Furthermore, later-stage treatment may be less effective in curing the
disease, and may not reverse the liver damage incurred while waiting for care.145 As medical
guidance and practice continues uniformly to support universal, early-stage DAA treatment,
the litigation tide may turn toward cases finding that delaying or denying such treatment
violates the Eighth Amendment.146

C. Class Action Settlement Agreements:
Toward Universal Testing and Treatment
The litigated outcomes described above are inconsistent, often out of step with clear medical
consensus, and, in some cases, stymy efforts to expand testing and treatment.147 Sometimes,
however, the parties have been able to reach agreements to change testing and treatment
11 | Expanding Hepatitis C Testing and Treatment | II. The Legal Landscape

protocols. In seeming recognition of the urgency and opportunity of the moment,148 settlement agreements in several states have resulted in widespread expansion of HCV testing
and treatment in state correctional systems.149 For example:
• In Indiana, implementation of a 2020 settlement agreement pursuant to which
approximately 3350 people with HCV in Indiana Department of Corrections’ custody
will receive DAA treatment by 2023 is proceeding apace with the agreement’s
phased-in universal treatment approach.150
• Litigation and a resulting settlement agreement in Connecticut resulted in more
than 20,000 people in the custody of the Connecticut Department of Correction
tested for HCV in a three-year period, and DAA treatment, so far, for at least 977 of
the 2,123 people who tested positive during that period.151
• Pursuant to a 2018 settlement agreement, the Colorado Department of Corrections
agreed to spend $41 million over two years to provide DAA treatment to more than
2,000 people with HCV in its custody—up from 20-25 treated per year previously—
and removed pre-treatment requirements such as completion of drug and alcohol
classes and deterioration of the liver.152
• A 2021 settlement in Maine resulted in universal opt-out testing at intake and
near-universal eligibility for treatment. The state provided DAA treatment to 205
people in Maine Department of Corrections custody in 2021.153
• In Texas, a 2021 settlement will phase in near-universal DAA treatment, with initial
priority determined by disease progression but eventual eligibility for almost everyone with HCV, with the state agreeing to treat at least 1,200 people in state custody
each year through January 1, 2028.154
• In Vermont, a 2021 settlement agreement requires adherence to a policy providing
for opt-out testing for all people in its unified corrections system, as well as treatment “as soon as possible” for incarcerated people with sufficient time remaining
on their sentence to complete a course of DAA treatment.155
These settlement agreements offer a starting point for prisons and jails, and those providing
health care in those settings, to implement testing and treatment in line with the accepted
medical standard of care.
The recommendations in this white paper derive from these and other settlement agreements
and are intended to guide proactive implementation that might avoid some of the pitfalls
of litigation. Indeed, although litigation can draw the attention and resources necessary to
make important change—including, crucially, funding to scale up DAA treatment—there may
also be significant downsides. Litigation is expensive for all involved, and often slow. Once
a lawsuit has been resolved, problems may linger, or new problems may arise, with no clear
path to resolution. The adversarial nature of litigation may frustrate cooperation between
state and local carceral systems, advocates, and persons with HCV. And procedural barriers
to litigation may frustrate reform. In this context, policy change outside of, but informed by,
litigation outcomes including settlement agreements seems a promising path forward.
12 | Expanding Hepatitis C Testing and Treatment | II. The Legal Landscape

DRAWING POLICY LESSONS FROM LITIGATION DOCUMENTS
This white paper relies on litigation documents among its major sources. Settlement
agreements in particular are valuable because they codify collaboratively developed
solutions to problems. But other types of litigation documents can be similarly
informative.
Topic

Type of document

Conditions, problems, needs

Complaint, expert reports, monitoring
reports

What the law requires

Opinions, briefs

Training

Post-settlement reports, exhibits

Reforms, policies

Settlements, post-settlement reports

Results of reforms

Post-settlement reports, enforcement

Of course, litigation documents may also have drawbacks: they are static and therefore
may become outdated; they may prioritize the views of lawyers and omit the voices of
non-parties; and they may offer an incomplete picture of what works in practice. For
this reason, we have supplemented the litigation documents, relying on conversations
with and feedback from people working on these issues to help us fill in gaps and
account for more recent developments.156

13 | Expanding Hepatitis C Testing and Treatment | II. The Legal Landscape

III. Model Policies
The following model policies guide expansion of HCV testing and treatment in United States
prisons and jails. They derive from settlement agreements in recent litigation addressing
this issue, updated to comport with current medical guidance as well as to incorporate input
from medical professionals and advocates working on these issues.

Statement of Purpose and Guiding Considerations

These model policies are intended to serve as a starting point for prisons and jails, and
those providing health care in those settings, to implement current clinical standards and
best practices, promote robust compliance with federal law, and strengthen efforts toward
HCV elimination.
Of course, implementation of these policies will necessarily differ based on the particular
characteristics and capacities of the myriad systems that might seek to implement them.
To that end, we have written these policies so that they can be easily copied and pasted into
a document that refines and adapts them for a particular facility or system. We make them
available at https://clearinghouse.net/resource/3838/ in an unfootnoted word processing
text format to facilitate such copying and tailoring.
We understand that resource limitations, including inadequate funding, staffing, and community supports, may impede full and immediate implementation in certain systems. In those
circumstances, we intend that these policy recommendations serve as a starting point for
meaningful expansion of HCV testing and treatment. They might also inform requests for
and designation of resources to support fuller implementation in the future.
The following considerations are essential for meaningful implementation of these policies.
• Access and Accessibility: Policies implementing HCV testing and treatment must
apply and be accessible to all people in custody, including people in segregation
or other restricted housing as well as people with disabilities who might require
interpreter services, mobility support, or other modifications and accommodations
to ensure equal access.157
• Community Partnerships: Collaboration with local health departments and other
community health providers is crucial to support successful outcomes, especially
for people with HCV who are released while on treatment or prior to being initiated
on treatment. These community entities may be essential for, among other things:
disseminating test results to people released before receiving them; initiating or
continuing DAA treatment; assessing and confirming cure; and/or providing counseling, substance abuse treatment, and other support. Such partnerships may be
especially important for jail systems, because people detained in jails are more
likely to have shorter stays or uncertain terms of detention that might necessitate
community care to begin or complete treatment.158 Prison and jail systems should
work proactively to develop robust partnerships with community providers.
14 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

• Timeframes for Implementation: The timeframes for implementation proposed
herein represent what we understand to be reasonable and advisable in a well-resourced prison or jail system. Prompt testing and initiation of treatment is essential
to reducing transmission and supporting cure. As discussed in the note accompanying Policy 3.1, however, we acknowledge that given resource constraints, some
systems may need to modify the proposed timeframes to align with what is more
immediately practicable.

1. Universal Opt-Out Screening for HCV
1.1 Universal Opt-Out HCV Screening159
A. All patients without a current documented HCV infection shall be offered HCV
screening:
1. If no documented test results within the last 12 months, at intake or, if not
tested at intake, at first clinical evaluation; and
2. If no documented test results within the last 12 months, at the time of
the patient’s first clinical evaluation, and/or any medical appointment or
consultation thereafter; and
3. If no documented test results within the last 12 months, at any time
requested by the patient; and
4. Every 12 months, for patients with ongoing HCV risk factors as identified
by the Centers for Disease Control and Prevention; and
5. At any time, regardless of previous testing, as is clinically indicated (e.g. if
risk factors are reported since last testing) or recommended by medical staff.
HCV testing shall be offered, ordered, and performed in accordance with (C) and (D)
unless the patient affirmatively and voluntarily opts out of such testing.
B. At the time of offering HCV testing, staff shall make practicable efforts to provide
to the patient information about signs and symptoms of HCV, risk factors, modes
of transmission, prevention, treatment options, and potential complications if left
untreated.
C. Whenever available, [entity] shall implement reflex testing, through which a sample
for HCV RNA testing is sent concurrently with an antibody test to enable confirmation of active HCV infection with a single test order.
D. When reflex testing is not available, entity shall first order an HCV antibody test
and, if the HCV antibody test is positive, [entity] shall provide, within three business
days of receiving results or as soon as is practicable thereafter, a reflexive HCV
RNA viral load test.

15 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

E. [Entity] medical staff shall promptly review positive antibody and RNAtest results
with the patient. [Entity] medical staff shall also review with the patient recommended immunizations (Hepatitis A and B, influenza, and pneumococcal), information about transmission and risks, available counseling, education, and other
resources, and treatment options.
«For jails, add: If a patient is released before test results are
available, [entity] shall make reasonable efforts to provide test
results after release, which may include coordination with local
health departments and/or other community health providers.»
F. [Entity] shall make available, at no cost, copies of any HCV antibody and RNA test
results in accordance with existing [entity] policies for provision of medical records.
G. Under no circumstances shall a patient be disciplined or otherwise disadvantaged
for requesting or inquiring about HCV testing or treatment.

Commentary
Clinical guidance uniformly recommends universal one-time testing for all adults.160 The
CDC recommends routine testing for people with ongoing risk factors, including: people
who currently inject drugs and share needles, syringes, or other equipment, and people with
certain medical conditions including people who have ever received maintenance hemodialysis.161 And the AASLD/IDSA guidance recommends periodic, repeat testing for people with
risk activities, and annual testing for people who inject drugs, among other risk categories.162
Given the high prevalence of HCV and risks associated with incarceration, the policy recommendations above seek to maximize HCV testing access in prisons and jails by offering
testing at various contact points with broad ranging healthcare staff (e.g. nurses, physician’s
assistants, and physicians) with the aim of ensuring one-time testing for all and promoting
routine testing as appropriate.
Diagnosing a current HCV infection is currently a two-step process.163 First, a screening
test for HCV antibodies provides information about past exposure to HCV. A negative HCV
antibody result indicates that the person has never been exposed to the virus, ruling out HCV
infection.164 A positive HCV antibody result indicates prior exposure and should be followed
by an HCV RNA test for current infection. An HCV RNA test may include a qualitative nucleic
acid test to detect the presence of HCV RNA in the bloodstream, to diagnose current infection,
as well as a quantitative nucleic acid test to detect levels of HCV RNA.165 Under the reflex
testing model, the laboratory performs the antibody test first and, if positive, immediately
performs an HCV RNA test on the same specimen.166 This streamlined option enables prompt
diagnosis from a single blood draw, and may be especially useful in the jail setting to ensure
prompt test results for people in short-term detention.

16 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

Widespread HCV testing in prisons and jails is essential to identify active infections so that
people with HCV can promptly be treated.167 In prison, universal testing enables identification
and treatment of those with current HCV infections, reducing spread inside the facility, as well
as in the community upon release. In jail, universal testing also provides an opportunity to
identify current infection even among those with short stays, which may be a crucial first step
in connecting HCV positive patients to treatment opportunities in jail or in the community.168
In addition, universal testing reduces the stigma that may accompany risk-based, selective
testing.169 Moreover, universal testing in carceral settings has a high yield, given the high
prevalence of HCV compared to the general population, presenting a prime opportunity to
identify (and initiate treatment) in a high-risk population as an essential part of any strategy
to eliminate HCV infection in the United States.170
It is essential that prisons and jails have policies in place that maximize opportunities for
testing and that encourage people to test. To that end, facilities should reevaluate any policies
or practices that might discourage testing, and should promote testing at any point at which
a person comes in non-emergency contact with medical staff—for example, during medical
appointments, upon intake or transfer, at the time of performing other medical tests, and the
like. An opt-out testing approach, pursuant to which all are tested, absent affirmative refusal,
after receiving information, is most likely to maximize willingness to be tested.171 Universal
opt-out testing has been found to be the most effective, and cost effective, testing method.172
A testing strategy modeled on this approach informs people that it is the facility’s policy to
test as part of routine medical care, unless they explicitly decline to be tested (“I will be testing you unless you decline” or even “Our policy is to test everyone for HCV, is that okay with
you?,” rather than, for example, “Would you like to be tested?”).173
Finally, note that, especially in the high-volume, quick-turnover jail setting, cooperation with
community health providers and/or patient navigators is likely necessary to support delivery
of test results. For example, if a person is released from detention before receiving the results
of an HCV test, it may become the responsibility of a community health provider to follow
up with that person to share test results and discuss next steps.

2. Medical Evaluation and Consultation
2.1 Medical Evaluation and Consultation for Patients with HCV Viremia174
A. Within 4 weeks of diagnosis, or as soon as practicable, every patient with a positive
HCV RNA test shall be provided appropriate consultation, testing and assessment,
unless the patient affirmatively and voluntarily opts out of such evaluation. Evaluation shall include, at minimum:
1. Initial consultation with a medical provider, including:
a. A targeted medical history;
b. A physical exam;

17 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

c. An order for immunization for Hepatitis A and B, if indicated;
d. Order for pneumococcal vaccine and influenza vaccine, if indicated;
e. Explanation of the process for scheduling periodic evaluations, treatment eligibility and options, including the benefits of DAA treatment,
the importance of adherence, and the risks of refusing treatment; and
f. Explanation about the natural history of the infection, dangers of high-risk
behaviors, risks and modes of transmission and specific measures to
prevent transmission during incarceration and upon release, and treatment options.
2. Laboratory testing performed prior to or during the initial consultation,
including:
a. Complete blood count (CBC);
b. Complete metabolic profile (CMP);
c. Prothrombin time (PT) with International normalized ratio (INR), if
indicated;
d. HIV testing;
e. Hepatitis B surface antigen, surface antibody, and Hepatitis B core total
antibody testing;
f. Hepatitis A antibody testing;
g. HCV genotyping, though not necessary where pangenotypic DAAs available; and
h. Any additional testing that [entity] medical staff determines is indicated.
3. Assessment for advanced fibrosis and cirrhosis, which may include some
or all of the following:
a. Examination for symptoms and signs of cirrhosis, including: low albumin
or platelets; elevated bilirubin or INR; ascites; and hepatic encephalopathy;
b. Calculation of an AST-Platelet Ratio Index (APRI) score from the results
of the AST and the platelet count;
c. Other fibrosis tests, such as elastography where available;
4. Patients with cirrhosis shall receive surveillance for hepatocellular carcinoma with liver ultrasound examination every 6 months.
5. Patients who have decompensated cirrhosis (i.e. Child-Turcotte-Pugh (CTP)
class B or class C) shall be managed under the guidance of a liver specialist.

18 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

B. [Entity] shall make available to each patient, at no cost, copies of all records related
to that patient’s HCV work up and related test results in accordance with existing
[entity] policies for provision of medical records.
C. Any patient with an active HCV infection who has not yet completed DAA treatment resulting in cure shall be reevaluated and, as medically indicated, retested
pursuant to part (A) at least every 6 months.

2.2 Enrollment in Substance Use Treatment and Support
A. If evaluation and consultation indicate that a patient will benefit from counseling
and/or treatment support for substance use disorder, medical staff shall make
appropriate referrals and [entity] shall facilitate the appropriate appointments
and/or enrollment.
B. Under no circumstances shall DAA treatment offered by [entity] be conditioned on
enrollment in or successful completion of such programs, or on abstention from
substances for any period of time.

Commentary
Prior to the emergence of DAA therapy, the post-diagnosis, pre-treatment workup required
more extensive testing and counseling to safely initiate treatment and prepare patients for
treatment-related adverse effects. But, with the advent of DAA drugs that can be safely and
effectively administered in most patients, this has changed. Now, the essential components
of the pre-treatment workup are more limited, and include: counseling on the importance of
adherence to the treatment regimen; assessment of drug-drug interactions; and preventive
care including vaccination. Counseling on the importance of adherence to treatment protocols, and support for such adherence, is perhaps the most crucial component in achieving
HCV cure, as studies demonstrate that better adherence results in greater likelihood of
treatment success (although adherence does not need to be 100% for that to be true).175
Patients should also be educated on the proper administration of DAA medications, such
as the dose and frequency, effects of administering with or without food, missed doses, and
adverse events. Prior to treatment initiation, interacting co-medication should be stopped or
switched to an alternative with less risk for potential interaction during HCV treatment, and
the patient should be counseled on the need to inform the healthcare provider about any
changes to their medication regimen. For complicated drug interactions (such as those with
antiepileptics where cessation of the interacting drug could lead poor medical outcomes),
consultation with specialists may be necessary.
Given the safety and tolerability of DAA therapy, studies are emerging that suggest that additional laboratory testing and staging of liver fibrosis can be minimal—DAA treatment can be
started even while much of this follow-up testing is in progress. For example, in a recent study,
conducted in multiple resource-limited settings, a 95% sustained virological response (SVR,

19 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

or cure) was achieved with participants receiving no pre-treatment genotyping, receiving the
entire treatment course at entry, having no scheduled visits or laboratory monitoring, and
having only two points of remote contact: at week four to assess adherence and at the end
of the study to assess SVR.176 Therefore, while full workup is still recommended as part of
holistic care for a patient with HCV, evidence suggests that only a minimal workup is required
before DAA treatment can be safely and effectively initiated.

3. Provision of Treatment and Linkage to Community Care
3.1 Provision of DAA Treatment177
A. Any patient with a current HCV infection is a candidate for treatment with DAAs
and shall be offered DAA treatment within 12 weeks* from initial medical evaluation unless medical considerations, in accordance with Policy 3.2, indicate that
treatment with DAAs is not medically appropriate at that time.
B. All patients eligible for DAA treatment shall be informed of the safety and efficacy
of DAA treatment as well as the risks of delaying or refusing treatment. All patients
offered DAA treatment shall have the opportunity to discuss treatment in person
with a member of [entity] medical staff.
C. All eligible patients shall receive DAA treatment, unless, after receiving the information and counseling in (B), the patient affirmatively and voluntarily declines the
treatment. Any such refusal shall be documented.
D. Any eligible patient who initially declines DAA treatment may request such treatment at any time, through the typical process for requesting medical care, and
shall be provided treatment within 12 weeks* after making such a request unless
additional work up is required.
E. [Entity] medical staff shall confirm HCV cure (sustained virological response) 12
weeks after treatment completion. If the patient is released from custody before
that time, [entity] staff shall make all practicable efforts to link that patient to
community care to obtain confirmation of cure.
F. [Entity] shall ensure that any patient who enters custody or shifts location while
undergoing DAA treatment is maintained on the prescribed medication without
interruption through completion of the course of treatment, unless medical staff
affirmatively determine that it is medically necessary to discontinue or change
the treatment or the patient affirmatively and voluntarily declines to continue the
treatment.
G. Under no circumstances shall a patient be disciplined or otherwise disadvantaged
for requesting or inquiring about HCV treatment.

20 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

*A NOTE ON THE PROPOSED TIMEFRAME FOR INITIATING TREATMENT
We propose a policy requiring that DAA treatment be offered and, unless declined,
initiated within 12 weeks of a positive HCV test result. This policy aligns with our
understanding of what is possible in a well-resourced carceral health care setting and
supports the goal of expanding treatment to patients with shorter periods of detention
or incarceration. Moreover, a 12-week timeframe is on the short end, but not entirely
out of step with, the timeframes enshrined in relevant settlement agreements.178 But
we acknowledge that this timeframe may require some modification to better match
the needs and resources of a particular setting.
For example, in the jail setting, it may be preferrable to implement a policy that promotes
an even shorter turnaround time between testing and treatment in order to maximize
the number of patients who can complete a course of treatment before release. A
policy written for jails might read, instead:
Any patient with a current HCV infection is a candidate for treatment
with DAAs and shall be offered DAA treatment within 12 weeks, and
ideally within 4 weeks, from initial medical evaluation unless medical
considerations, in accordance with Policy 3.2, indicate that treatment
with DAAs is not medically appropriate at that time.
Conversely, a setting that doesn’t yet have sufficient staffing or resources may opt
to start with a policy that permits a period longer than 12 weeks before initiating
treatment. We urge that such a system aim to eventually implement (and formalize)
a 12-week timeframe.

3.2 Proper and Improper Considerations for Treatment179
A. The decision whether or not to offer direct acting antiviral treatment shall be based
solely on medical considerations.
B. Under no circumstances shall the crime of conviction, prior or present substance
abuse, completion or failure to complete particular programs, or disciplinary record
be a factor in determining treatment or providing medication.
«For jails: replace “crime of conviction” with “nature of charges”»
C. The following medical considerations may be appropriate reasons for deferring
or declining treatment:
1. Contraindications based on drug interactions or concurrent medical
conditions;

21 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

2. Planned medical treatment, such as surgery, that may interfere with the
medication or continuity of treatment with DAAs;
3. Life expectancy less than 18 months that cannot be remediated by HCV
therapy, liver transplantation, or another directed therapy;
4. Current pregnancy, which should be considered on a case-by-case basis,
taking into account the lack of data on DAA safety during pregnancy and
the risk of transmitting HCV to the baby.

3.3 Linkage to Community Care180
A. A patient expected to be released before completing a full course of DAA treatment
shall not be disqualified from beginning treatment while in [entity] custody. Instead,
[entity] staff shall take all practicable measures to attempt to link to community
programs for continuity of care at the time of release. [Entity] medical staff shall
consider the availability and likelihood of community care in determining whether
to commence treatment in this circumstance, including whether to provide the
full remaining doses of DAA treatment to the patient upon release or work with
discharge planning staff and community providers to ensure the patient is able
to receive prescriptions to continue treatment in the community.
B. A patient otherwise eligible for DAA treatment who is released before beginning
treatment shall receive all practicable support from [entity] staff in connecting
to community programs for prompt initiation and supervision of treatment upon
release.
C. A patient who has been treated for and cured of HCV while in custody but who
has cirrhosis shall receive all practicable support from [entity] staff in connecting
to follow-up care in the community upon release, including referrals as necessary.
D. [Entity] staff shall make all practicable efforts to provide discharge planning for
all patients with treated or untreated HCV and comorbid substance use disorder,
including resources for commencing or continuing substance abuse treatment
in the community, if medically appropriate.
E. [Entity] staff shall provide patients who have tested positive for HCV and who are
released from [entity] custody without receiving DAA treatment and/or achieving
SVR information about:
1. the progression of HCV infection and potential health complications;
2. community treatment options and payment mechanisms;
3. Medicaid, as well as assistance enrolling, if eligible;
4. how to make an appointment with a community medical professional to
discuss HCV and treatment options;

22 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

5. behaviors that may increase risk of transmission or increase progression
of HCV; and
6. that [entity] medical files may be provided to medical doctors and clinics
in the community, and how to request those records in accordance with
[entity] policies.

Commentary
Universal, early-stage DAA treatment aligns with current medical guidance and best practice,
including the predominant guidance for HCV care in United States jails and prisons. The
AASLD/IDSA guidance recommends early-stage DAA treatment for all, and FBOP guidance
provides that any person in federal custody wi or its absence th HCV is eligible to be considered for DAA treatment regardless of stage of disease.181 The benefits of DAA treatment are
clear: SVR rates of 90% (or more) result in significant improvements to individual patient and
community health. HCV treatment improves individual health outcomes by reducing risk of
liver fibrosis, hepatocellular carcinoma, and extrahepatic manifestations.182 It is also important
as a form of treatment as prevention in high-risk populations. DAA treatment is effective in
carceral settings, resulting in meaningful reduction in HCV transmission in jails, prisons, and
the community.183 In short: offering DAA treatment to all patients with HCV, without restriction
and even at the earliest stages of the disease, aligns with medical guidance and maximizes
health benefits at the individual, facility, and community levels.
Under a universal treatment model, anyone with an active HCV infection is eligible for DAA
treatment without restriction, except in the rare circumstance that DAA treatment cannot be
administered, such as the presence of drug-drug interactions. Disease stage is irrelevant to
determining eligibility for treatment. Similarly, conduct before or during incarceration, including
prior or current substance use, must not be considered in determining whether treatment
is appropriate. The AASLD/IDSA guidance makes clear that “data do not support exclusion
of HCV-infected persons from consideration for hepatitis C therapy based on alcohol intake
or use of illicit drugs.”184 Moreover, studies of injection-drug use and alcohol use have found
no impact of abstinence for any duration on sustained virological response 12 weeks after
completing a course of DAA treatment.185
Comprehensive DAA treatment in prisons and jails is possible for a subset of the population
that spends enough time before release or transfer to complete a course of oral therapy, typically 8-12 weeks,186 with 12 additional weeks for follow up and to assess sustained virological
response. Most people detained in United States jails, however, will not spend enough time
there to complete a course of DAA therapy and follow up.187 Therefore, linkage to community
care is a crucial part of treatment. With adequate community support, impending release
should not preclude initiating DAA treatment. Following a holistic model also implemented
to support patients with HIV, jails can rely on discharge planners or care navigation teams
to assess predicted length of stay and then to connect patients to community partners to
initiate or continue treatment and/or to assess SVR upon release.188 These programs tend

23 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

to be most effective when they include linkage to mental health, substance use, and housing services, and when combined with community services such as mobile clinics, needle
exchange centers, and drug rehabilitation programs.189 The success of community care linkage also requires promoting awareness about HCV and the safety, efficacy, and tolerability of
DAA treatment in carceral settings.190 Crucially, and especially with community supports in
place, DAA treatment can effectively be initiated in jail or prison even if release is likely before
the course of treatment will be completed. Indeed, in one recent study, people who were
released during the course of DAA treatment achieved 75% cure rate.191 Shortening the time
between jail admission and initiation of DAA treatment is crucial to maximizing successful
treatment,192 and minimizing risks of failed treatment and viral resistance to treatment.193
Finally, staffing, financial, and other resource limitations may mean that it is impossible for a
carceral system to offer DAA treatment to everyone with HCV immediately and all at once.
At the outset of a program to scale-up HCV testing and treatment, a system might opt to
stage initial treatment, within a relatively short time frame, to manage capacity for what is
likely to be a frontloaded treatment burden. Such prioritization decisions may appropriately
be guided by medical need, and may include consideration of: advanced hepatic fibrosis;
liver transplant; hepatocellular carcinoma; comorbid medical conditions associated with HCV
and/or associated with more rapid progression of fibrosis; evidence of progressive fibrosis;
chronic kidney disease; age; and continuity of care for people who began treatment prior to
entering custody.194 Ultimately, everyone with HCV must receive prompt treatment, with the
goal of quickly gaining the capacity to treat everyone soon after diagnosis.

4. Education for Patients while Incarcerated and upon Release
4.1 HCV Education195
A. [Entity] shall provide to all people entering custody education about HCV signs
and symptoms, risk factors, modes of transmission, prevention, screening options,
including how to request testing, and treatment options, including how to request
treatment and that treatment is available to all patients with current HCV infections. Education materials shall explain that the virus is more prevalent in carceral
settings and that the public health recommendation is to test all incarcerated
people.
B. At least annually, [entity] shall review and update all information and materials
disseminated under this policy.

Commentary
The AASLD/IDSA guidance recommends that people with current HCV infection be educated
about how to prevent liver damage, including the potentially deleterious effects of alcohol.196 In many states, state and local entities as well as non-governmental organizations

24 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

offer education and training in carceral settings on topics including disease transmission
and prevention, opportunities for treatment, and resources for support.197 And some such
programs capacitate peer educators to share information about HCV risks, prevention, and
harm reduction.198 Numerous studies have demonstrated that formal education about HCV,
such as provision of resources and live trainings, has real benefits, including increased willingness to undertake and comply with treatment regimens.199 Formal education can also
help reduce stigma about the virus.200

5. Recordkeeping
5.1 Maintenance of Records201
A. [Entity] shall maintain HCV testing records that include, for every person in custody:
1. Date(s) that HCV testing was offered, if applicable;
2. Date(s) that HCV testing was refused, if applicable:
3. Date(s) that HCV testing was requested, if applicable;
4. Date(s) that HCV antibody testing was performed;
5. Results of HCV antibody testing;
6. Date(s) that HCV RNA testing was performed; and
7. Results of HCV RNA testing.
B. [Entity] shall maintain records for every patient diagnosed with HCV, including:
1. Date and results of any HCV diagnostic testing;
2. Date and results of other relevant tests such as HAV and HBV serologies,
HIV testing, and liver fibrosis testing;
3. Date(s) DAA treatment was offered;
4. Date(s) DAA treatment began, if applicable;
5. Date(s) DAA treatment was refused, if applicable;
6. Date(s) DAA treatment ended and whether SVR was achieved;
7. Estimated release date; and
8. Documentation of efforts to coordinate community care for patients released
or anticipating release before beginning or completing DAA treatment.
C. [Entity] shall record, every six months, and make publicly available:
1. The total number of patients tested for HCV in the six-month period;

25 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

2. The total number of patients who tested positive for HCV in the six-month
period;
3. The total (cumulative) number of patients with current HCV infection in
[entity] custody, including total (cumulative) number of patients with current
HCV infection at each facility;
4. The total number of patients with current HCV infection who, during the
six-month period, met the following criteria:
a. Began a course of DAA treatment;
b. Completed a course of DAA treatment;
c. Were deemed ineligible for DAA treatment;
d. Refused DAA treatment.
D. [Entity’s] quality improvement committee or equivalent shall undertake ongoing
assessment of the HCV testing and treatment program and protocols to identify
issues and recommend improvements.

6. Staffing and Staff Training
6.1 Staffing to Support HCV Care
A. [Entity] shall ensure sufficient medical staff, with the requisite training and expertise to screen for and diagnose HCV, to evaluate disease progression, and to meet
testing and treatment needs.
B. [Entity] shall ensure sufficient staff with the requisite training and expertise to
provide reentry support and linkage to HCV treatment in the community for patients
released before starting or completing treatment.

6.2 Staff Training202
A. [Entity] shall provide and support training to medical staff—including on-site,
through community partnerships, and/or via continuing medical education opportunities—as needed to ensure sufficient expertise to screen for, diagnose, evaluate,
and treat HCV.
B. [Entity] shall provide training to all staff about HCV, including risk factors, transmission, signs and symptoms, and available testing and treatment.

26 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

7. Updates to Guidance and Protocols
7.1 Regular Updates to Guidance and Protocols203
A. [Entity] shall regularly update the HCV testing and treatment protocols contained
herein to align with updates to future testing and treatment recommendations
established by nationally recognized authorities, including, but not limited to,
AASLD/IDSA Guidance, the Federal Bureau of Prisons, the National Commission
on Correctional Health Care, National Institutes of Health, the Centers for Disease
Control and Prevention, and others, as deemed medically appropriate.
B. [Entity] shall designate at least one member of medical staff to be responsible,
annually, for surveying relevant resources and updating guidance and protocols
as appropriate.

8. Definitions
8.1 [Entity]: As used throughout this policy, [entity] refers to the prison or jail system
and/or to those responsible for providing healthcare in those settings. The term is
used generally to mean the entity or any staff member(s), as defined in Policies 8.2
and 8.3.

8.2 Medical Staff: As used throughout this policy, “medical staff” means any person
with medical training performing duties for [entity], including as an employee,
contractor, or volunteer, including carrying out [entity] services, programs, and
activities.

8.3 Staff: As used throughout this policy, “staff” means any person performing duties
for [entity], including as an employee, contractor, or volunteer, including carrying out
[entity] services, programs, and activities.

27 | Expanding Hepatitis C Testing and Treatment | III. Model Policies

Endnotes
1

Hepatitis C Information, Viral Hepatitis, Centers for Disease Control and Prevention (July 28,
2020), https://www.cdc.gov/hepatitis/hcv/index.htm.

2

The American Association for the Study of Liver Disease & Infectious Diseases Society of
America, HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C, at
20 (Oct. 24, 2022), [hereinafter “2022 AASLD/IDSA Guidance”], available at https://www.hcvguidelines.org/sites/default/files/full-guidance-pdf/AASLD-IDSA_HCVGuidance_October_24_2022.
pdf.

3

See 2022 AASLD/IDSA Guidance, supra note 2, at 149-150; Hepatitis C, Cleveland Clinic (Dec.
9, 2022), https://my.clevelandclinic.org/health/diseases/15664-hepatitis-c.

4

Hepatitis C Questions and Answers for the Public, Centers for Disease Control and Prevention
(July 28, 2020), https://www.cdc.gov/hepatitis/hcv/cfaq.htm#:~:text=Hepatitis%20C%20is%20
often%20described,infection%20leads%20to%20chronic%20infection.

5

Haesuk Park et al., Chronic Hepatitis C Virus (HCV) Increases the Risk of Chronic Kidney Disease
(CKD) While Effective HCV Treatment Decreases the Incidence of CKD, 67 Hepatology 492 (2017),
available at https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.29505#:~:text=Conclusion%3A%20HCV%2Dinfected%20individuals%20in,significant%20for%20all%2Doral%20
therapy.

6

Curtis L. Cooper et al., HCV-Infected Individuals Have Higher Prevalence of Comorbitity and
Multimorbidity: A Retrospective Cohort Study, 19 BMC Infectious Diseases (2019), available
at https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-019-4315-6.

7

Id.

8

Id.

9

See 2022 AASLD/IDSA Guidance, supra note 2, at 28-29 (describing extrahepatic manifestations
of chronic HCV infection).

10

E.g., G W McCaughan & J George, Fibrosis Progression in Chronic Hepatitis C Virus Infection, 53(3)
Gut. 318 (Mar. 2004), available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1773949/.

11

Anne C. Moorman et al., Long-Term Liver Disease, Treatment, and Mortality Outcomes Among
Persons Diagnosed with Chronic Hepatitis C Virus Infection: Current Chronic Hepatitis Cohort
Study Status and Review of Findings, 32:2 Infectious Disease Clinics N. Am. 253 (2018)
(describing findings from a longitudinal study of more than 17,000 people with HCV in the
United States, including “very high death rates” in the period from 2006-2010, a 15-year lifespan
reduction, and a 3.7-fold increase in hospitalizations), available at https://www.ncbi.nlm.nih.
gov/pmc/articles/PMC6211170/.

12

Viral Hepatitis in the United States: Data and Trends, Office of Infectious Disease and HIV/
AIDS Policy, U.S. Dep’t of Health and Human Services (June 7, 2016), https://www.hhs.gov/

28 | Expanding Hepatitis C Testing and Treatment | Endnotes

hepatitis/learn-about-viral-hepatitis/data-and-trends/index.html.
13

Id.

14

For example, between 2006 to 2012, acute HCV infections increased 364% in Kentucky, Tennessee, Virginia, and West Virginia. Id.

15

Press Release: Increase in Hepatitis C Infections Linked to Worsening Opioid Crisis, Centers for
Disease Control and Prevention (Dec. 21, 2017), https://www.cdc.gov/nchhstp/newsroom/2017/
hepatitis-c-and-opioid-injection-press-release.html; see also David Powell et al., A Transitioning
Epidemic: How the Opioid Crisis is Driving the Rise In Hepatitis C, 38:2 Pharmaceuticals &
Medical Technology Health Affairs (Feb. 2019), https://www.healthaffairs.org/doi/10.1377/
hlthaff.2018.05232 (tying tripling of rates of new HCV infection between 2010 and 2014 to
uptick in opioid injections).

16

Press Release: Less Than 1/3 of People Diagnosed with Hepatitis C Receive Timely Treatment
for the Deadly, Yet Curable, Infection, Centers for Disease Control and Prevention (Aug. 9, 2022),
https://www.cdc.gov/nchhstp/newsroom/2022/2022-Hepatitis-Vital-Signs-press-release.html.

17

Liton Chandra Deb et al., Epidemiology of Hepatitis C Virus Infection Among Incarcerated
Populations in North Dakota, 17(3) PLOS ONE, at 2 (March 29, 2022), available at https://doi.
org/10.1371/journal.pone.0266047.

18

See 2022 AASLD/IDSA Guidance, supra note 2, at 179; Hepatitis C Online, Treatment of HCV
in a Correctional Setting, (Oct. 9, 2022), at 1, https://www.hepatitisc.uw.edu/pdf/key-populations-situations/treatment-corrections/core-concept/all; see also Aiden K. Varan et al., Hepatitis
C Seroprevalence Among Prison Inmates Since 2001: Still High but Declining, 129(2) Public
Health Rep.187 (2014) (estimating that carceral populations represented 28.5% to 32.8% of
the total HCV cases in the United States in 2006, down from 39% in 2003), available at https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC3904899/.

19

Matthew J Akiyama et al., Hepatitis C Elimination Among People Incarcerated in Prisons: Challenges and Recommendations for Action Within a Health Systems Framework, 6 Lancet Gastroenterol Hepatol, 391 (2021), available at https://pubmed.ncbi.nlm.nih.gov/33857445/.

20

Andreea Adelina Artenie et al., Diversity of Incarceration Patterns Among People Who Inject
Drugs and the Association with Incident Hepatitis C Virus Infection, 96:103419 Int. J. Drug
Policy (Oct. 2021), available at https://pubmed.ncbi.nlm.nih.gov/34452807/.

21

2022 AASLD/IDSA Guidance, supra note 2, at 179.

22

Nicholas Florko, Hundreds of incarcerated people are dying of hep C—even though we have a
simple cure, STAT (Dec. 15, 2022), https://www.statnews.com/2022/12/15/hundreds-incarcerated-people-dying-hepatitis-c-despite-simple-cure/. In Texas alone, more than 60 people have
died of HCV in prisons since 2020. Id.

23

Libin Rong & Alan S. Perelson, Treatment of Hepatitis C Virus Infection with Interferon and Small
Direct Antivirals: Viral Kinetics and Modeling, 30 Critical Rev. Immunology 131 (2010), available
at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2882097/.

29 | Expanding Hepatitis C Testing and Treatment | Endnotes

24

2022 AASLD/IDSA Guidance, supra note 2, at 24.

25

Philipp Solbach & Heiner Wedemeyer, The New Era of Interferon-Free Treatment of Chronic
Hepatitis C, 31 Viszeralmedizin 290, 290 (2015), available at https://www.ncbi.nlm.nih.gov/
pmc/articles/PMC4608630/.

26

See, e.g., Ahmed El-Shamy & Hak Hotta, Impact of Hepatitis C Virus Heterogeneity on Interferon
Sensitivity: An Overview, 20 World J. Gastroenterol 7555 (2014) (explaining that “HCV genotype is an important determinant of both treatment strategy and outcome”), available at https://
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.22509.

27

Id.; see also Robert Katz, Hepatitis C Litigation: Healing Inmates as a Public Health Strategy, 29
Annals Health L. & Life Sci. 127, 152 n. 69 (2020); Lotfollah Davoodi et al., Psychiatric Side
Effects of Pegylated Interferon-[] and Ribavirin Therapy in Iranian Patients with Chronic Hepatitis
C: A Meta-Analysis, 16(2) Experimental & Therapeutic Medicine 971 (2018).

28

Solbach & Wedemeyer, supra note 25, at 290.

29

Jennifer A. Tan et al., Treating Hepatitis C in the Prison Population is Cost-Saving, 48:5 Hepatology (October 2008) (citing Federal Bureau of Prisons recommendations issued in 2005 that
suggested liver biopsies for some and genotyping for all prospective treatment candidates,
and noting that liver biopsies were mandatory in certain states at that time) available at https://
aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.22509.

30

See, e.g., Iseley v. Talaber, 232 Fed. App’x 120, 123-124 (3rd Cir. 2007) (describing prison protocols requiring psychological screening before initiating interferon treatment), available at https://
clearinghouse.net/doc/136961/

31

Tan et al., supra note 29.

32

Bender v. Regier, 385 F.3d 1133, 1135 (8th Cir. 2004) (ultimately concluding that prison physician did not act with deliberate indifference in failing to provide interferon treatment before
patient’s release), available at https://clearinghouse.net/doc/136963/; see also Coleman-Bey
v. United States, 512 F. Supp. 2d 44, 48 (D.D.C. 2007) (explaining that under then-governing
FBOP policy, priority candidates for treatment included “patients with abnormal ALT values,
with liver biopsy results showing significant fibrosis, and who are willing to undergo treatment
and conform to treatment requirements (including abstention from alcohol and drug use)” and
that “patients with a ‘history of psychiatric illness or with signs or symptoms of mental illness’
must be assessed, and, if necessary, treated and stabilized prior to [HCV] treatment”), available
at https://clearinghouse.net/doc/136965/.

33

Tan et al., supra note 29.

34

Marie-Louise Vachon and Douglas T. Dieterich, The Era of Direct-acting Antivirals has
Begun, 31(4) Seminars in Liver Disease 399 (2011), available at https://www.medscape.
com/viewarticle/756591.

35

V. Basyte-Bacevice and J. Kupcinskas, Evolution and Revolution of Hepatitis C Management:
From Non-A, Non-B Hepatitis Toward Global Elimination, 38 Digestive Diseases 137 (2020),
available at https://www.karger.com/Article/FullText/505434.

30 | Expanding Hepatitis C Testing and Treatment | Endnotes

36

Alison B. Jazwinski & Andrew J. Muir, Direct-Acting Antiviral Medications for Chronic Hepatitis C
Virus Infection, 7(3) Gastroenterol Hepatol 154 (2011), available at https://www.ncbi.nlm.nih.
gov/pmc/articles/PMC3079144/; Leon L. Seifert, Ryan B. Perumpail, and Aijaz Ahmed, Update
on Hepatitis C: Direct-acting Antivirals, 7(28) World J. of Hepatology 2829 (2011), available
at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4670954/.

37

“What is the treatment for chronic hepatitis C?”, Hepatitis C Questions and Answers for Health
Professionals, Centers for Disease Control and Prevention (Aug. 7. 2020), https://www.cdc.
gov/hepatitis/hcv/hcvfaq.htm#d8.

38

See Behzad Hajarizadeh et al., Evaluation of Hepatitis C Treatment-As-Prevention Within Australian Prisons (SToP-C): A Prospective Cohort Study, 6 Lancet Gastroenterol Hepatol 533
(2021), https://pubmed.ncbi.nlm.nih.gov/33965006/; see also Jason Grebely, et al., Reinfection and Risk Behaviors After Treatment of Hepatitis C Virus Infection in Persons Receiving
Opiod Agonist Therapy, Annals of Internal Medicine (Sept. 2022), https://www.acpjournals.
org/doi/10.7326/M21-4119.

39

See, e.g., Sabrina A. Assoumou et al., Cost-Effectiveness and Budgetary Impact of Hepatitis C
Virus Testing, Treatment, and Linkage to Care in US Prisons, 70(7) Clinical Infectious Diseases
1388 (Apr. 1, 2020), available at https://pubmed.ncbi.nlm.nih.gov/31095676/.

40

See e.g., Nicholas Florko, With a Promising New Play to Pay for Pricey Cures, Two States Set
Out to Eliminate Hepatitis C. But Cost hasn’t Been the Biggest Problem, STAT (Sept. 13, 2022)
https://www.statnews.com/2022/09/13/louisiana-washington-hep-c-investigation/ (noting
that as of September 2022, medication for a course of DAA treatment retailed for roughly
$24,000, down from highs of as much as $94,500); Nicholas Florko, Prisons Say They Can’t
Afford to Cure Everyone With Hepatitis C. But Some Are Figuring Out a Way, STAT (Dec. 15, 2022)
(citing Harvard professor Jagpreet Chhatwal to explain that DAA treatment at current pricepoints has reached the point of cost effectiveness) https://www.statnews.com/2022/12/15/
prisons-cant-afford-hep-c-drugs-but-some-figured-out-a-way/.

41

See, e.g., 2022 AASLD/IDSA Guidance, supra note 2, at 24; see also Atkins v. Parker, 972 F.3d
734, 736 (6th Cir. 2020), cert. denied sub nom. Atkins v. Williams, 209 L. Ed. 2d 547, 141 S. Ct.
2512 (2021) (“The antivirals are so effective that for the most part doctors have stopped using
interferons entirely.”), available at https://clearinghouse.net/doc/109713/.

42

2022 AASLD/IDSA Guidance, supra note 2, at 4.

43

2022 AASLD/IDSA Guidance, supra note 2, at 179.

44

2022 AASLD/IDSA Guidance, supra note 2, at 1.

45

Hepatitis C, Viral Hepatitis, Centers for Disease Control and Prevention, supra note 1.

46

Clinical Guidance, Evaluation and Management of Chronic Hepatitis C Virus (HCV) Infection,
Federal Bureau of Prisons (Mar. 2021), at 1 [hereinafter “FBOP Guidance”], available at https://
www.bop.gov/resources/pdfs/hcv_guidance.20210513.pdf.

31 | Expanding Hepatitis C Testing and Treatment | Endnotes

47

See, e.g., Buffkin v. Hooks, No. 1:18-CV-502, 2019 WL 1282785, at *6 (M.D.N.C. Mar. 20, 2019)
(“this court finds that the guidance provides some evidence of a preferred public health policy
but does not necessarily constitute the standard for judging deliberate indifference”), available
at https://clearinghouse.net/doc/136648/; Atkins v. Parker, 412 F. Supp. 3d 761, 782 (M.D.
Tenn. 2019), aff'd, 972 F.3d 734 (6th Cir. 2020) (same), available at https://clearinghouse.net/
doc/109712/.

48

See, e.g., Barfield v. Semple, No. 3:18-CV-1198 (MPS), 2019 WL 3680331, at *2 (D. Conn. Aug. 6,
2019) (“The American Association for the Study of Liver Diseases (“AASLD”) and the Infectious
Disease Society of America (“IDSA”) set forth the medical standard of care for the treatment
of HCV.”), and *11 (citing failure to adhere to the standard of care for HCV treatment in denying
defendants’ motion to dismiss Eighth Amendment claim), available at https://clearinghouse.net/
doc/112607/; Postawko v. Missouri Dep’t of Corr., No. 2:16-CV-04219-NKL, 2017 WL 1968317,
at *2 (W.D. Mo. May 11, 2017) (explaining that “[t]he CDC encourages health professionals to
follow the evidence-based standard of care developed by the Infectious Diseases Society of
America (“IDSA”) and the American Association for the Study of Liver Diseases (“AASLD”), which
constitutes the medical standard of care,” and citing numerous failures to follow this standard
in denying motion to dismiss in part), available at https://clearinghouse.net/doc/89145/.

49

2022 AASLD/IDSA Guidance, supra note 2, at 12.

50

2022 AASLD/IDSA Guidance, supra note 2, at 180-182.

51

2022 AASLD/IDSA Guidance, supra note 2, at 13.

52

2022 AASLD/IDSA Guidance, supra note 2, at 14.

53

2022 AASLD/IDSA Guidance, supra note 2, at 14-15.

54

2022 AASLD/IDSA Guidance, supra note 2, at 14.

55

Screen All Patients for Hepatitis C, Centers for Disease Control and Prevention (June 14, 2021),
https://www.cdc.gov/knowmorehepatitis/hcp/Screen-All-Patients-For-HepC.htm.

56

Screening for Hepatitis C Virus Infection in Adolescents and Adults, US Preventative Services
Task Force Recommendation Statement, US Preventative Serv’s Task Force (March 2, 2020),
https://jamanetwork.com/journals/jama/fullarticle/2762186.

57

2022 AASLD/IDSA Guidance, supra note 2, at 24.

58

2022 AASLD/IDSA Guidance, supra note 2, at 25.

59

2022 AASLD/IDSA Guidance, supra note 2, at 25-26.

60

2022 AASLD/IDSA Guidance, supra note 2, at 26.

61

2022 AASLD/IDSA Guidance, supra note 2, at 180, 182.

62

World Health Organization publishes updated guidance on hepatitis C infection with new
recommendations on treatment of adolescents and children, simplified service delivery and diagnostics, World Health Org (June 24, 2022), https://www.who.int/news/

item/24-06-2022-WHO-publishes-updated-guidance-on-hepatitis-C-infection; Press Release:
Less Than 1/3 of People Diagnosed with Hepatitis C Receive Timely Treatment for the Deadly,
Yet Curable, Infection, Centers for Disease Control and Prevention (August 9, 2022), https://
www.cdc.gov/nchhstp/newsroom/2022/2022-Hepatitis-Vital-Signs-press-release.html.
63

2022 AASLD/IDSA Guidance, supra note 2, at 24.

64

Margot Sanger-Katz, $1,000 Hepatitis Pill Shows Why Fixing Health Costs Is So Hard, N.Y. Times
(Aug. 2, 2014).

65

Melissa J. Barber et al., Price of A Hepatitis C Cure: Cost of Production and Current Prices for
Direct-Acting Antivirals in 50 Countries, 6:3 J. of Virus Eradication (Sept. 2020), https://www.
sciencedirect.com/science/article/pii/S2055664020300017#bib28; Press Release: Gilead
Subsidiary to Launch Authorized Generics of Epclusa (Sofosbuvir/Velpatasvir) and Harvoni
(Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C, Gilead (Sept. 24, 2018),
https://www.gilead.com/news-and-press/press-room/press-releases/2018/9/gilead-subsidiary-to-launch-authorized-generics-of-epclusa-sofosbuvirvelpatasvir-and-harvoni-ledipasvirsofosbuvir-for-the-treatment-of-chronic.

66

Barber et al., supra note 65, at Table 1.

67

See WHO highlights progress in accelerating access to hepatitis C diagnostics and treatment in
low- and middle-income countries, World Health Org., (Jan. 27, 2021) (“Low- and middle-income countries can now aim to achieve a price as low as US$ 60 per patient for a 12-week
course of treatment with WHO-prequalified generic sofosbuvir and daclatasvir.”), https://www.
who.int/news/item/27-01-2021-who-highlights-progress-in-accelerating-access-to-hepatitisc-diagnostics-and-treatment-in-low-and-middle-income-countries. Manufacturing cost-based
prices for DAA treatment are far below United States market prices. See Barber et al., supra
note 65 (“The estimated manufacturing cost-based prices for a 12-week course were US$28
for sofosbuvir, US$31 for ledipasvir, US$58 for velpatasvir, and US$4 for daclatasvir. . . .For
fixed-dose combinations, estimated cost-based prices were US$58 for sofosbuvir/ledipasvir,
US$85 for sofosbuvir/velpatasvir, and US$31 for sofosbuvir/daclatasvir.”). Indeed, even in
the earliest days of DAA treatment, predicted manufacturing costs were generally less than
a couple hundred dollars per course of treatment. See Andrew Hill et al., Minimum Costs for
Producing Hepatitis C Direct-Acting Antivirals for Use in Large-Scale Treatment Access Programs
in Developing Countries, 58 Clinical Infectious Diseases 928 (2014) ("Predicted manufacturing
costs (US dollars) for 12-week courses of HCV DAAs were $21-$63 for ribavirin, $10-$30 for
daclatasvir, $68-$136 for sofosbuvir, $100-$210 for faldaprevir, and $130-$270 for simeprevir",
available at https://pubmed.ncbi.nlm.nih.gov/24399087/.

68

See Florko, Prisons say, supra note 40.

69

See Sanger-Katz, supra note 64.

70

By 2018, the National Academies of Sciences, Engineering, and Medicine’s report on A National
Strategy for the Elimination of Hepatitis B and C recommended that all insurers should cover
DAA Therapy for chronic HCV without restriction, in line with the then-AASLD/IDSA guidance

describing the standard of care as DAA treatment for all, without reference to fibrosis score.
See Phil Waters & Tina Broder, Rationing Care: Barriers to Direct-Acting Antiviral Treatment in
Medicaid Treatment Criteria, 12(5) Clin. Liver Dis. (Hoboken) 122 (Nov. 2018), https://www.
ncbi.nlm.nih.gov/pmc/articles/PMC6385924/#cld751-bib-0007.
71

Id.

72

Id.

73

Id.

74

2022 AASLD/IDSA Guidance, supra note 2, at 30-31.

75

2022 AASLD/IDSA Guidance, supra note 2, at 180.

76

2022 AASLD/IDSA Guidance, supra note 2, at 182.

77

CMS, Assuring Medicaid Beneficiaries Access to Hepatitis (HCV) Drugs, Dep’t of Health & Human
Servs., Release No. 172, at 2–3 (Nov. 5, 2015), https://www.medicaid.gov/medicaid-chip-program-information/by-topics/prescription-drugs/downloads/rx-releases/state-releases/staterel-172.pdf.

78

For a more comprehensive discussion, with examples, see Brief of Drs. Joseph Goldenson,
Robert B. Greifinger, Homie Razavi, Marc Stern, and Stacey B. Trooskin, The Hepatitis Education
Project, the International Network on Hepatitis in Substance Users—Prisons Network, and the
National Viral Hepatitis Roundtable as Amici Curiae in Support of Plaintiff-Appellant and in
Support of Reversal, Melnik v. Aranas, No. 20-15471 (9th Cir. Oct. 15, 2020), available at https://
clearinghouse.net/doc/136956/.

79

See, e.g., B.E. v. Teeter, No. C16-227-JCC, 2016 WL 3033500, at *1, *6 (W.D. Wash. May 27, 2016)
(requiring Washington’s Medicaid program to provide coverage for prescription medication to
treat HCV without regard to fibrosis score); see also, e.g., Ryan v. Birch, No. 17–cv–00904–KLM,
2017 WL 3896440 (D. Colo. Sept. 5, 2017) (denying motion to dismiss claim of improper denial
of coverage for DAA treatment as medically necessary for every Medicaid enrollee with HCV).

80

Hepatitis C: The State of Medicaid Access, Center for Health Law and Policy Innovation, Harvard
Law School & National Viral Hepatitis Roundtable (Jan. 2022), at 3 (as of January 2022, no
fibrosis restrictions in 48 states, DC, and Puerto Rico; coverage only for F2 or higher in South
Dakota and F3 or higher in Arkansas), https://stateofhepc.org/wp-content/uploads/2022/01/
HCV_State-of-Medicaid-Access_Jan-2022_v2.pdf. States are also trending toward eliminating
sobriety requirements for coverage. As of January 2022, 29 states and Puerto Rico had no
sobriety restrictions, and another 13 states and DC required screening and counseling only.
Id. at 5. Trends toward eliminating sobriety restrictions continue. For example, in December
2022, the United States executed a settlement agreement with Alabama’s Medicaid Agency to
“ensure that Alabama Medicaid recipients with Hepatitis C (HCV) who also use alcohol or illicit
drugs, including those with a substance abuse disorder (SUD), will be provided equal access to
medications to treat their hepatitis,” under which Alabama withdrew its previous requirement of
6-months sobriety for DAA coverage. Press Release: Justice Department Secures Agreement

34 | Expanding Hepatitis C Testing and Treatment | Endnotes

with Alabama Medicaid to Remove Unlawful Sobriety Mandate for Health Care Access, Civil
Rights Division, U.S. Department of Justice (Dec. 5, 2022), https://www.justice.gov/opa/pr/
justice-department-secures-agreement-alabama-medicaid-remove-unlawful-sobriety-mandate-health.
81

K. Maurer et al., Hepatitis C in Correctional Settings: Challenges and Opportunities (2015); Adam
L. Beckman et al., New Hepatitis C Drugs Are Very Costly and Unavailable to Many State Prisoners, 35 Health Affairs (Oct. 2016), available at https://www.healthaffairs.org/doi/10.1377
/hlthaff.2016.0296; 2022 AASLD/IDSA Guidance, supra note 2, at 179-180.

82

2022 AASLD/IDSA Guidance, supra note 2, at 179-180.

83

Beckman et al., supra note 81.

84

E.g., Alan Prendergast, Hep C: The Deadliest Killer in Colorado’s Prisons Is a Curable Virus, Westword (Dec. 13, 2016) (as of 2016, the Colorado Department of Corrections offered DAA treatment to 20-25 people a year—just over 1% of incarcerated people known to have HCV at that
time—and gave top priority to patients with the highest level of liver scarring or at higher risk
of complications from liver disease), https://www.westword.com/news/hep-c-the-deadliestkiller-in-colorados-prisons-is-a-curable-virus-8591316; Abu-Jamal v. Kerestes, No. 3:15-cv-00967,
2016 WL 4574646, at *9 (M.D. Pa. Aug. 31, 2016) (describing treatment protocol of the Pennsylvania Department of Corrections, pursuant to which DAAs were not provided until HCV had
progressed to advanced compensated cirrhosis or early decompensated cirrhosis manifested
by esophageal varices, and finding that the protocol constituted deliberate indifference to the
known risks of untreated HCV), available at https://clearinghouse.net/doc/84782/.

85

E.g., Class Action Complaint, West v. Gobeille, No. 2:19-cv-00081 (D. Vt. May 21, 2019),
¶ 86 (describing existing requirement of 12-18 months remaining on sentence to qualify for
treatment), available at https://clearinghouse.net/doc/112626/; Third Amended Class Action
Complaint, Geissler v. Stirling, No. 4:17-cv-01746 (D.S.C. Aug. 21, 2018), ¶ 67 (describing policy
requiring 12 months left on sentence to initiate DAA treatment), available at https://clearinghouse.net/doc/112690/; Class Action Complaint, Buffkin v. Hooks, No. 1:18-cv-00502 (M.D.N.C.
June 15, 2018), ¶¶ 87-88 (same), available at https://clearinghouse.net/doc/130429/.

86

E.g., Class Action Complaint, West, supra note 85, ¶¶ 88, 90 (describing policies precluding
treatment for incarcerated people with “chronic disciplinary issues” and requiring “a responsibility to learn from past behaviors and interact with society positively”); First Amended Class
Complaint, Aragon v. Raemisch, No. 1:17-cv-1744 (D. Colo. Sept. 11, 2017), ¶ 41 (describing
CDOC policy denying treatment to anyone who has engaged in “high-risk behavior” including
any disciplinary offense involving alcohol, prescription drugs, illegal drugs, sexual activity, or
tattooing within the past twelve months), available at https://clearinghouse.net/doc/97201/;
Class Action Complaint, Buffkin, supra note 85, ¶¶ 89-90 (noting policy denying treatment and
evaluation to anyone with a drug or alcohol infraction within the last twelve months).

87

See, e.g., Prendergast, supra note 84 (describing experience of person incarcerated in Colorado
who did not qualify for DAA treatment unless, among other barriers, he completed alcohol and
drug education programs that could last up to a year).

35 | Expanding Hepatitis C Testing and Treatment | Endnotes

88

See generally Beckman et al., supra note 81 (describing relevant findings from a 2015 survey of
departments of correction and concluding that “the substantial price of treatment prevents many
state corrections departments from purchasing the quantities of medications necessary to treat
all of those in need,” resulting in triaging). As A.T. Wall, then-Director of the Rhode Island Department
of Corrections, explained in 2016: “Patients and prison officials alike want to cure hepatitis C infections. That requires financial resources and discounts we don’t have. What we desperately need are
less costly drugs and more funding.” Study: Modern Hepatitis C Drugs are Very Costly and Unavailable to Many State Prisoners, Yale Law School (Oct. 4, 2016), https://law.yale.edu/yls-today/
news/study-modern-hepatitis-c-drugs-are-very-costly-and-unavailable-many-state-prisoners.

89

See Anne C. Spaulding et al., Funding Hepatitis C Treatment in Correctional Facilities by Using
a Nominal Pricing Mechanism, 25:1 J. Correctional Health Care 15, 16 (Jan. 2019), available
at http://doi.org/10.1177/1078345818805770; see also Florko, supra note 22, (noting that in
2019, Missouri estimated that it would have cost the prison system $90 million, almost 70%
of its medical budget, to treat every incarcerated person with HCV).

90

Stafford v. Carter, No. 117CV00289JMSMJD, 2018 WL 4361639, at *10 (S.D. Ind. Sept. 13, 2018),
available at https://clearinghouse.net/doc/103098/.

91

Atkins v. Parker, 412 F. Supp. 3d at 765 (M.D. Tenn. 2019).

92

Florko, supra note 22.

93

Nicholas Florko, These 8 States Are Doing the Worst Job of Treating Hepatitis C in Prisons, STAT
(Dec. 15, 2022).

94

Id.

95

Florko, supra note 22.

96

E.g., Clinical Service Division Procedure 4.5.11A, Mont. Dep’t of Corr. (April 9, 2021) (restricting
DAA treatment to those with a Fib-4 score of 1.45 of greater, those with a lower score instead
“receive education regarding healthy lifestyle choices and annual monitoring”); State of Iowa
Department of Corrections, Policy and Procedures. Chapter 6: Health Services, Sub Chapter:
Infection Control, Subject: Hepatitis C Management. Policy Number HSP-912, Part IV(E) (restricting treatment to those with evidence of advanced disease, such as Fibrosure score of at least
F2 or cirrhosis, or with other signs of advanced disease or high-risk coinfections). These and
other policy documents referenced in this paper are available in .pdf form in a Google drive folder
at this link: https://clearinghouse.net/resource/3840/. South Dakota prioritizes for treatment
incarcerated people with F3 fibrosis or other serious risk factors, like HIV. See Florko, supra note
93. Although the FBOP guidance does not mandate a rigid prioritization system, it notes that
certain conditions “may require more urgent consideration for treatment,” including advanced
hepatic fibrosis (defined as APRI greater than or equal to 2.0, Metavir or Batts/Ludwig stage 3
or 4 on liver biopsy, or known or suspected cirrhosis.). See FBOP Guidance, supra note 46, at
13.

97

2022 AASLD/IDSA Guidance, supra note 2, at 25-26.

36 | Expanding Hepatitis C Testing and Treatment | Endnotes

98

E.g., Woodcock v. Correct Care Sols., 861 F. App’x 654, 656, 658 (6th Cir. 2021) (describing
pre-2020 policy in Kentucky DOC that disqualified from DAA treatment incarcerated people who
did not have a clear conduct record for 12-months prior or “had demonstrated an unwillingness
or inability to adhere to rigorous medication regimes,” and noting 2020 clarifications that “the
no-disciplinary-infractions-within-twelve-months exclusionary factor applies only to conduct
that would compromise treatment”.), available at https://clearinghouse.net/doc/112003/; FBOP
Guidance, supra note 46, at 13 (“Inmates must demonstrate a willingness and an ability to adhere
to a rigorous treatment regimen.”); Clinical Service Division Procedure 4.5.11A, Mont. Dep’t of
Corr. (April 9, 2021), (providing inclusion criteria for treatment, including “no evidence of HCV
risk behavior or correctional issues in previous six months, including prison tattoos and illicit
drug use”), available at https://clearinghouse.net/resource/3840/; State of Iowa Department of
Corrections, Policy and Procedures. Chapter 6: Health Services, Sub Chapter: Infection Control,
Subject: Hepatitis C Management. Policy Number HSP-912, Part V(F)(3) (setting out criteria for
deferring DAA treatment for otherwise qualifying candidates for reasons including instances
of substance abuse or other high risk behavior, such as tattoos, within the last 12 months),
available at https://clearinghouse.net/resource/3840/. Nebraska even requires incarcerated
people to sign a consent form before receiving treatment that claims “a diversity of medical
opinion as to what constitutes the best way to manage HCV infection,” in an apparent effort
to dissuade DAA treatment. See Florko, supra note 93.

99

See Sabrina A. Assoumou et al., Cost-effectiveness and Budgetary Impact of Hepatitis C Virus
Testing, Treatment, and Linkage to Care in US Prisons, 70(7) Clinical Infectious Diseases 1388
(2020), available at https://pubmed.ncbi.nlm.nih.gov/31095676/.

100

E.g., Tianhua He et al., Prevention of Hepatitis C by Screening and Treatment in U.S. Prisons, 164
Annals of Internal Medicine 84, (2016); Akiyama et al., supra note 13, at 394.

101

See, e.g., Justin Chan et al., Outcomes of Hepatitis C Virus Treatment in the New York City Jail
Population: Successes and Challenges Facing Scale Up of Care, 7(7) Open Forum Infectious
Diseases (2020), available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7580175/; Shan
Liu et al., Sofosbuvir-based Treatment Regimens for Chronic Genotype 1 Hepatitis C Virus Infection in U.S. Incarcerated Populations: A Cost-Effectiveness Analysis, 161 Annals of Internal
Medicine 546 (2014), https://pubmed.ncbi.nlm.nih.gov/25329202/.

102

See e.g., Richard K. Sterling et al., Treatment of HCV in the Department of Corrections in the
Era of Oral Medications, 24 J. Corr. Health Care 127 (2018); John Scott, A Population-Based
Intervention to Improve Care Cascades of Patients With Hepatitis C Virus Infection, 5 Hepatology
Commc’ns 387 (2021).

103

See e.g., Sanjeev Arora et al., Project ECHO: Linking University Specialists with Rural and Prison-Based Clinicians to Improve Care for People with Chronic Hepatitis C in New Mexico, 122
Pub. Health Reports 74 (2007); About the ECHO Model, Project Echo, https://hsc.unm.edu/
echo/what-we-do/about-the-echo-model.html.

104

See e.g., Sanjeev Arora et al., Outcomes of Treatment for Hepatitis C Virus Infection by Primary
Care Providers, 364 New Eng. J. Med. 2199 (2011); Viral Hepatitis C ECHO Programs, Project
ECHO, https://hsc.unm.edu/echo/partner-portal/programs/new-mexico/hcv-community/.

37 | Expanding Hepatitis C Testing and Treatment | Endnotes

105

See Benjamin P. Linas et al., Cost Effectiveness and Cost Containment in the Era of Interferon-Free
Therapies to Treat Hepatitis C Virus Genotype 1, 4(1) Open Forum Infectious Disease (Dec.
2016) (suggesting that approaches to cost savings should focuses on negotiating for lower
drug prices and not on delaying or rationing treatment), available at https://www.ncbi.nlm.nih.
gov/pmc/articles/PMC5414108/; Janet Weiner & Benjamin P. Linas, Issue Brief: Cost-Effective
Screening and Treatment of Hepatitis C, Penn Leonard David Institute of Health Economics
and Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV (Sept. 14, 2018) (summarizing studies confirming the cost-effectiveness
of widespread early-stage DAA treatment), https://ldi.upenn.edu/our-work/research-updates/
cost-effective-screening-and-treatment-of-hepatitis-c/; David E. Kaplan et al., Cost-Effectiveness of Direct-Acting Antivirals for Chronic Hepatitis C Virus in the United States from a Payer
Perspective, 28 J. Managed Care & Specialty Pharmacy 1138 (2022), (demonstrating that early
DAA intervention is not only more cost-effective than other forms of HCV treatment, but that
cost savings are seen quickly after treatment, making early treatment the most cost-effective
option), available at https://www.jmcp.org/doi/full/10.18553/jmcp.2022.28.10.1138.

106

See Section I(3) supra.

107

DAA prices far outstrip manufacturing costs. See, e.g., Andrew Hill et al., supra note 67.

108

See, e.g., Adam L. Beckman et al., Follow California’s Lead: Treat Inmates with Hepatitis C, Health
Affairs Blog (July 24, 2018) (describing California budget allocating $105.8 million to treat
incarcerated people with HCV in state prisons, explaining reasons why universal screening
and treatment is cost-effective for states), https://www.healthaffairs.org/do/10.1377/forefront.20180724.396136/full/; see also, generally, John T. Nguyen et al., A Budget Impact Analysis
of Newly Available Hepatitis C Therapeutics and the Financial Burden on a State Correctional
System, 92(4) J. Urban Health 635 (Aug. 2015), available at https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC4524840/.

109

See Spaulding et al., supra note 89, at 16. In the settlement agreement between the Nevada
Department of Corrections and plaintiff classes seeking universal DAA treatment, the parties
cited recent remarks of Governor Sisolak, in 2020: “[I]f not treated in prison, treatment will most
likely occur after the inmate has been released. A large percentage of inmates are on Medicaid
and treatment later in the disease lifecycle is more costly than treatment in the early stages. As
a result, treatment in prison is less costly to the State.” See Consent Decree, In Re HCV Prison
Litigation, No. 3:19-cv-00577 (D. Nev. Oct. 29, 2020) ¶14 [hereinafter “Consent Decree, In Re
HCV”], available at https://clearinghouse.net/doc/112688/.

110

Interview with Samuel Weiss, Executive Director, Rights Behind Bars (October 12, 2022).

111

Matthew J Akiyama et al., Drug Purchasing Strategies to Treat People with Hepatitis C in the
Criminal Justice System, 108 Am. J. Pub. Health 607 (May 2018), available at https://www.
ncbi.nlm.nih.gov/pmc/articles/PMC5888063/.

112

See Florko, supra note 68.

113

See Beckman et al., supra note 81, at 1899 (describing the program and noting that, as of 2015,

38 | Expanding Hepatitis C Testing and Treatment | Endnotes

at least sixteen state departments of corrections were pursuing such an approach, resulting
for some in the lowest DAA prices among the departments).
114

See Spaulding et al., supra note 89, at 20-22.

115

The Minnesota Multistate Contracting Alliance for Pharmacy, for example, is a group purchasing organization for government facilities to negotiate reduced prices, in which several states
participate. See Anne C. Spaulding et al., Five Questions Concerning Managing Hepatitis C in
the Justice System, at 337, https://par.nsf.gov/servlets/purl/10066200.

116

See Beckman et al., supra note 81, at 1899.

117

See Florko, supra note 68.

118

See, e.g., Sweta Haldar and Madeline Guth, State Policies Connecting Justice Involved Populations to Medicaid Coverage and Care, Kaiser Family Foundation (December 17, 2021),
https://www.kff.org/medicaid/issue-brief/state-policies-connecting-justice-involved-populations-to-medicaid-coverage-and-care/.

119

Two of the lawsuits that inform the recommendations in this white paper arose in states—
Connecticut and Vermont—that administer unified corrections systems, encompassing both
people in pre-trial detention and incarcerated people who have already been sentenced. For
more information about the Connecticut case, see Barfield v. Cook: https://clearinghouse.net/
case/18232/. For more information about the Vermont case, see West v. Gobeille: https://
clearinghouse.net/case/18238/.

120

Estelle v. Gamble, 429 U.S. 97, 103 (1976).

121

Id.

122

See, e.g., Erickson v. Pardus, 551 US 89, 90 (2007).

123

E.g., Hoffer v. Sec’y, Fla. Dep’t of Corr., 973 F.3d 1263, 1270 (11th Cir. 2020), available at https://
clearinghouse.net/doc/111607/.

124

E.g., Bernier v. Allen, 38 F.4th 1145, 1151 (D.C. Cir. 2022), available at https://clearinghouse.net/
doc/136957/.

125

Farmer v. Brennan, 511 U.S. 825, 837 (1994).

126

See, e.g., Hathaway v. Coughlin, 841 F.2d 48 (2d. Cir. 1988) (reversing grant of summary judgment
because alleged delay of more than two years to arrange needed surgery may show deliberate
indifferent to serious medical needs).

127

E.g., Helling v. McKinney, 509 U.S. 25, 33-35 (1993). For a more nuanced discussion of the
challenges of proving future harm given the often slow course of HCV progression and variable
clinical consequences, see Alexandra M. Daniels & David M. Studdert, Hepatitis C Treatment in
Prisons—Incarcerated People’s Uncertain Right to Direct-Acting Antiviral Therapy, 383 N. Eng. J.
Med. 611, 612 (Aug. 2020).

128

Estelle, 429 U.S. at 105-106.

39 | Expanding Hepatitis C Testing and Treatment | Endnotes

129

See Youngberg v. Romeo, 457 U.S. 307, 323 (1982) (“[T]he decision, if made by a professional, is
presumptively valid; liability may be imposed only when the decision by the professional is
such a substantial departure from accepted professional judgment, practice, or standards
as to demonstrate that the person responsible actually did not base the decision on such a
judgment.”).

130

At least one court, however, has rejected the argument that an individual physician’s failure to
obtain additional funding from the legislature for HCV treatment violated the Eighth Amendment.
See Atkins, 972 F.3d at 740.

131

Bernier, 38 F.4th at 1151–52 (assuming without deciding, but noting that “other courts appear
to agree at least that cost or other nonmedical rationale cannot be the only justification for
prison officials’ treatment decisions—including decisions affecting inmates with Hepatitis C”);
see also Thomas v. Allen, 679 F. App’x 216, 220 (3d Cir. 2017) (holding that incarcerated person
plausibly alleged Eighth Amendment violation against prison medical providers in light of claim
that he was denied DAA treatment solely because of cost), available at https://clearinghouse.
net/doc/136954/.

132

Hoffer, 973 F.3d at 1277.

133

See id.

134

See, e.g., Kingsley v. Hendrickson, 576 U.S. 389 (2015) (holding that to prove an excessive force
claim, a person in pre-trial detention must show that the officers’ use of force was objectively
unreasonable, citing, inter alia, the differences between pre-trial detention and post-sentencing
incarceration to reject a more stringent subjective standard). For an example of a current circuit
split on the scope of the right in the pretrial context, compare Darnell v. Pineiro, 849 F.3d 17, 35
(2d Cir. 2017) (“[T]o establish a claim for deliberate indifference to conditions of confinement
under the Due Process Clause of the Fourteenth Amendment, the pretrial detainee must prove
that the defendant-official acted intentionally to impose the alleged condition, or recklessly
failed to act with reasonable care to mitigate the risk that the condition posed to the pretrial
detainee even though the defendant-official knew, or should have known, that the condition
posed an excessive risk to health or safety,” a less stringent standard than under the Eighth
Amendment) with Strain v. Regalado, 977 F.3d 984, 990 (10th Cir. 2020) (requiring, instead,
plaintiff to establish that the official “knows of and disregards and excessive risk to inmate
health or safety,” a subjective test more akin to that under the Eighth Amendment, pursuant
to which the official must be aware of the facts from which the inference could be drawn and
that a substantial risk of serious harm exists, and must draw the inference).

135

The Civil Rights Litigation Clearinghouse has collected dozens of class action and putative
class action lawsuits bringing Eighth Amendment challenges in this context. Those cases are
available here: https://clearinghouse.net/search/case/?special_collection=33558.

136

E.g. Turner v. Wetzel, No. 21-2879, 2022 WL 3572693, at *2 (3d Cir. 2022), available at https://
clearinghouse.net/doc/136959/; Hoffer, 973 F.3d at 1270. Where defendants have disputed
that early-stage HCV is a objectively serious medical condition, courts have rejected the argument. See, e.g., Chimenti v. Wetzel, No. CV 15-3333, 2018 WL 3388305, at *12 (E.D. Pa. July 12,

40 | Expanding Hepatitis C Testing and Treatment | Endnotes

2018) (“We conclude that the record contains evidence that patients who have chronic HCV
and whose Metavir scores are less than F2 have serious medical needs, as they may suffer
from fatigue and other nonhepatic symptoms of their infections and, if not treated with DAAs
before their disease progresses, may suffer from liver inflammation, liver fibrosis, liver cancer
and liver-related mortality that they would not suffer if they were treated with DAAs while their
Metavir scores are in the F0 to F1 range.”), available at https://clearinghouse.net/doc/99138/
137

E.g. Woodcock, 861 F. App’x at 660-661; Hoffer, 973 F.3d at 1272.

138

Woodcock, 861 F. App’x at 660.

139

Id; see also Hoffer, 973 F.3d at 1272 (reasoning that the Florida Department of Corrections
provided some medical care to incarcerated people not eligible for DAA treatment based on
fibrosure score, namely: “diagnosing their illnesses, assessing their risk of future harm, and
regularly monitoring and managing their disease progression,” and explaining that “diagnosing,
monitoring, and managing conditions—even where a complete cure may be available—will often
meet the ‘minimally adequate medical care’ standard that the Eighth Amendment imposes.”).

140

Woodcock, 861 F. App’x at 660-661.

141

E.g. Turner 2022 WL at *3 (vacating and remanding district court’s grant of summary judgment
on Eighth Amendment claim).

142

See also Stafford v. Carter, No. 117CV00289JMSMJD, 2018 WL 4361639, at *22 (S.D. Ind.
Sept. 13, 2018) (granting summary judgment for plaintiffs on their Eighth Amendment claim,
reasoning that “the undisputed evidence in this case establishes that Plaintiffs' need for medical
treatment is toward the high end of the range, and Defendants' deliberate refusal to provide that
treatment constitutes a violation of the Eighth Amendment”), available at https://clearinghouse.
net/doc/103098/; Chimenti v. Pennsylvania Dep't of Corr., No. CV 15-3333, 2017 WL 3394605,
at *7 (E.D. Pa. Aug. 8, 2017) (“[T]he Amended Complaint sufficiently alleges that the DOC's use
of its Hepatitis C Protocol to ration medical treatment with DAAs based solely on cost, even
though there is no other recommended medical treatment for Chronic Hepatitis C, disregards
an excessive risk to the health of the infected inmates and thus constitutes deliberate indifference to a serious medical need.”), available at https://clearinghouse.net/doc/99134/; Melnik v.
Aranas, No. 20-15471, 2021 WL 5768468, at *2 (9th Cir. Dec. 6, 2021) (reversing district court’s
grant of qualified immunity to a physician, reasoning that a reasonable official should have
been on notice that delaying HCV treatment for non-medical reasons and contrary to existing
department of corrections policy would violate the Eighth Amendment), available at https://
clearinghouse.net/doc/136955/.

143

See, e.g., Samuel Weiss, The Other Infectious Disease Ravaging America’s Prisons and Jails, The
Appeal (May 14, 2020), https://theappeal.org/hepatitis-c-prison/.

144

See id.; see also Daniels & Studdert, supra note 127, at 611.

145

E.g., Weiss, supra note 143.

146

Numerous lawsuits have also alleged that delay or denial of DAA treatment violates Title II

41 | Expanding Hepatitis C Testing and Treatment | Endnotes

of the Americans with Disabilities Act (ADA) and/or Section 504 of the Rehabilitation Act,
which prohibit exclusion or discrimination on the basis of disability in federally conducted or
supported services, and state and local government services, respectively. 29 U.S.C. § 794(a);
42 U.S.C. § 12132. Lawsuits bringing ADA and/or Rehabilitation Act claims in this context
principally argue that chronic Hepatitis C is a disability within the meaning of the statute(s),
and that the prison system subjects incarcerated people with that disability to discrimination
by withholding medical treatment in line with the recommended standard of care, while offering standard-of-care treatment to persons with different disabilities or who are not disabled.
E.g., Third Amended Complaint, Ligons v. Minn. Dep’t of Corr., No. 0:15-cv-02210, ¶¶162-174
(D. Minn. Dec. 1, 2017), available at https://clearinghouse.net/doc/98906/; Corrected First
Amended Complaint, Barfield v. Semple, No. 3:18-cv-01198, ¶¶ 359-370 (D. Conn. Dec. 21, 2018),
available at https://clearinghouse.net/doc/112606/; Amended Class Action Complaint, In Re
HCV Prison Litigation, No. 3:19-cv-00577, ¶¶ 135-143 (D. Nev. Dec. 9, 2019), available at https://
clearinghouse.net/doc/112675/; Class Action Complaint for Declaratory and Injunctive Relief,
Hoffer v. Jones, No. 4:17-cv-00214, ¶¶ 152-163 (N.D. Fla. May 11, 2017), available at https://
clearinghouse.net/doc/88705/. ADA and Rehabilitation Act claims have not met much success,
however, with some courts distinguishing between claims that a person is not treated for their
disability (not actionable) as compared to not treated because of their disability (actionable),
E.g., Ruling on Motion to Dismiss, Barfield v. Semple, No. 3:18-CV-1198, at 32-35 (D. Conn. Aug.
6, 2019), available at https://clearinghouse.net/doc/112607/, or concluding ADA and Rehabilitation Act claims are poorly suited to class action lawsuits, e.g., Hoffer v. Inch, 382 F. Supp. 3d
1288, 1296-1298 (N.D. Fla. 2019), rev’d in part, vacated in part sub nom. Hoffer v. Sec’y, Fla. Dep’t
of Corr., 973 F.3d 1263 (11th Cir. 2020), available at https://clearinghouse.net/doc/107239/.
147

See, e.g., Hoffer, 973 F.3d at 1279 (reversing district court rulings requiring universal DAA treatment regardless of level of fibrosis).

148

See, for example, the Consent Decree for Chronic Hepatitis C Treatment in Geissler v. Stirling,
No. 4:17-cv-01746 (D. S.C. June 8, 2020), which, in its introduction, explains: “This Court and
the Parties recognize the need to test inmates of the South Carolina Department of Corrections (“SCDC”) for HCV and to provide treatment to those inmates who have the disease. Such
a commitment is necessary to: (a) treat inmates diagnosed with HCV with Medication that
substantially increases the chances of the diagnosed inmate being cured of HCV; (b) significantly reduce the spread of HCV among the SCDC inmate population; and (c) significantly
reduce the spread of HCV among the general population of South Carolina as inmates are
released from incarceration.” Id. § I(2), available at https://clearinghouse.net/doc/131291/.

149

Class action settlement agreements have been adopted in: Colorado, see ACLU and Colorado
Department of Corrections Reach Historic Settlement to Treat All Colorado Prisoners with
Hepatitis C, ACLU (Sept. 12, 2018), https://www.aclu.org/press-releases/aclu-and-colorado-department-corrections-reach-historic-settlement-treat-all-colorado; Connecticut, see Proposed
Superseding Settlement Agreement and Release, Barfield v. Cook, No. 3:18-cv-01198 (D. Conn.
Mar. 11, 2022) [hereinafter “Superseding Settlement Agreement, Barfield”], available at https://
clearinghouse.net/doc/133751/; Indiana, see Stipulation to Enter Into Settlement Agreement,
Stafford v. Carter (S.D. Ind. Aug. 9, 2019) [hereinafter “Settlement Agreement, Stafford”], available

42 | Expanding Hepatitis C Testing and Treatment | Endnotes

at https://clearinghouse.net/doc/103100/; Massachusetts, see Settlement Agreement, Fowler v.
Turco, (D. Mass. Mar. 9, 2018), available at https://clearinghouse.net/doc/101643/; Minnesota,
see Settlement Agreement and Release, Ligons v. Minn. Dep’t of Corr., No. 0:15-cv-02210 (D. Minn.
Mar. 15, 2019) [hereinafter “Settlement Agreement, Ligons”], available at https://clearinghouse.
net/doc/106687/; Missouri, see Private Settlement Agreement, Postawko v. Missouri Dep’t of
Corr., No. 2:16-cv-04219 (W.D. Mo. Oct. 26, 2020) [hereinafter “Settlement Agreement, Postawko”],
available at https://clearinghouse.net/doc/111454/;Nevada, see Consent Decree, In Re HCV,
supra note 109; North Carolina, see Consent Decree, Buffkin v. Hooks, No. 1:18-cv-00502 (M.D.
N.C. Mar. 8, 2021) [hereinafter “Consent Decree, Buffkin”], available at https://clearinghouse.
net/doc/131006/; South Carolina, see Consent Decree, Geissler, supra note 148; Pennsylvania,
see Settlement Agreement and General Release, Chimenti v. Pennsylvania, No. 2:15-cv-03333
(E.D. Pa. Nov. 19, 2018) [hereinafter “Settlement Agreement, Chimenti”], available at https://
clearinghouse.net/doc/102382/; Texas, see Settlement Agreement, Roppolo v. Linthicum, No.
2:19-cv-262 (S.D. Tex. Mar. 1, 2021), available at https://clearinghouse.net/doc/133979/; and
Vermont, see Settlement Agreement and Release of All Claims, West v. Gobeille, No. 2:19-cv00081 (D. Vt. June 11, 2021) [hereinafter “Settlement Agreement, West”], available at https://
clearinghouse.net/doc/130168/. In Idaho, a class action settlement agreement is pending
court approval. See Private Settlement Agreement and Release, Turney v. Atencio, No. 1:18-cv00001 (D. Ida. Aug. 31, 2021) [hereinafter “Proposed Settlement Agreement, Turney”], available
at https://clearinghouse.net/doc/133977/.
150

See Settlement Agreement, Stafford, supra note 149.

151

See Lisa Backus, 977 CT Prison Inmates Receive Hepatitis C Treatment As Part of Lawsuit Settlement, CT Insider (June 1, 2022), https://www.ctinsider.com/hartford/article/977-CT-DOC-inmates-receive-Hepatitis-C-treatment-17213342.php; see also Superseding Settlement
Agreement, Barfield, supra note 149.

152

Alan Prendergast, State Settles Prison Hep C Lawsuit With $41 Million Treatment Plan, Westword (Sept. 12, 2018), https://www.westword.com/news/
colorado-settles-prison-hepatitis-c-lawsuit-with-41-million-treatment-plan-10775724.

153

Nicholas Florko, Getting Hepatitis C Treatment Opens New Doors for the Incarcerated, STAT (Dec.
15, 2022), https://www.statnews.com/2022/12/15/hepatitis-c-treatment-new-doors-for-incarcerated/; see also case information about Loisel v. Clinton, 1:19-cv-00081 (D. Maine), at https://
clearinghouse.net/case/18240/.

154

See Exhibit 1: Settlement Agreement, Plaintiffs’ Motion to Approve Settlement, Roppolo
v. Linthicum (S.D. Tex. March 1, 2021), available at https://clearinghouse-umich-production.s3.amazonaws.com/media/doc/133979.pdf; see also Matthew Clarke, Texas Agrees
to Settlement Providing Prisoners Hep C Treatment, Will Pay $950,000 in Attorney Fees,
Prison Legal News (Jan 1. 2022), https://www.prisonlegalnews.org/news/2022/jan/1/
texas-agrees-settlement-providing-prisoners-hep-c-treatment-will-pay-950000-attorney-fees/.

155

See Settlement Agreement, West, supra note 149; see also Exhibit 2: Hepatitis C Virus Treatment
Program, VitalCore Health Strategies Health Services Policy and Procedure (January 1, 2021),
https://clearinghouse.net/doc/136284/.

43 | Expanding Hepatitis C Testing and Treatment | Endnotes

156

The co-authors collectively conducted seven interviews, via Zoom, between October 2022 and
February 2023. Interviewees included attorneys who have worked on the cases described herein,
public health educators and advocates, and physicians working in and with carceral facilities. In
addition, both co-authors conducted a workshop, via Zoom, receiving feedback on the proposed
policies, from numerous people with experience working on these issues, and solicited written
comments from practitioners on various versions of the draft. See Acknowledgments.

157

Indeed, Section 504 of the 1973 Rehabilitation Act, 29 U.S.C. §§ 794 et seq., and Title II of the
ADA, 42 U.S.C. §§ 12131 et seq., prohibit exclusion or discrimination on the basis of disability
in federally conducted or supported services, and state and local government services, respectively. Between the two statutes, every prison and jail in the United States is covered. The ADA’s
Title II covers all nonfederal jails and prisons—its definition of “public entity” includes state
and local government agencies, without respect to federal support. See 24 U.S.C. § 12131(1).
The Rehabilitation Act also covers all federal facilities and also covers most state and local
jails and prisons because they receive federal financial assistance. See 29 U.S.C. § 794(b)(1)
(A). Moreover, the Supreme Court has held specifically that Title II of the ADA’s reference to
“services, programs, or activities” encompasses the operation of jails and prisons. Pa. Dep’t of
Corr. v. Yeskey, 524 U.S. 206, 209 (1998). Private prisons operated under contract with federal,
state or local entities are covered by the “directly or through contractual, licensing, or other
arrangements” language found in both the ADA and Rehabilitation Act regulations. See, e.g., 28
C.F.R. § 35.130(b)(1); 28 C.F.R. § 39.130(b)(1); see also Marks v. Colo. Dep’t of Corr., 976 F.3d
1087, 1097 (10th Cir. 2020) (holding that the Rehabilitation Act applied to private prisons that
receive federal funding).

158

Note, however, that jails may increasingly house people who have already been sentenced and
as to whom the traditional framework of a short stay and more complex treatment framework
may not apply. See E. Ann Carson, Prisoners in 2020—Statistical Tables, Bureau of Justice
Statistics, U.S. Dep’t of Justice (Dec. 2021), at 25 tbl. 12 (6% of sentenced incarcerated people
held in local jails in 2020), https://bjs.ojp.gov/content/pub/pdf/p20st.pdf.

159

Consent Decree, Geissler, supra note 148, ¶¶ 42-45; Settlement Agreement, Ligons, supra note
149, § I(B)(1); Settlement Agreement, Postawko, supra note 149, §§ I(R); III(B)(1); Conn. Dep’t
of Corr. Administrative Directive 8.18 § 5(b) (Aug. 7. 2019), available at https://clearinghouse.
net/resource/3840/; Maine Dep’t of Corr. Policy 18.8.3: Management and Treatment of Hepatitis
C (March 16, 2021), Proc. B-C available at https://clearinghouse.net/resource/3840/; see also
Policy Directive 670.000 § II(B), Wash. Dep’t of Corr. (“Screening will be conducted for incarcerated individuals at intake, unless refused, for . . . hepatitis C”), available at https://clearinghouse.
net/resource/3840/; Policy Statement 13.2.1 §§ 8-02(4)(b), 20-1(B)(a), Penn. Dep’t of Corr.
(April 4, 2022), available at https://clearinghouse.net/resource/3840/; Kristin Walsh & Maya
Yoshida-Cervantes, Hepatitis C Screening in the Santa Clara County Jail: Update and Progress,
Presentation: 7th Annual National Hepatitis Corrections Network Meeting (2019), https://www.
hcvinprison.org/images/stories/Walsh_-_HCV_Screening_in_the_Santa_Clara_County_Jail_-_
Updates_and_Progress.pdf; Viral Hepatitis: Testing Recommendations for Hepatitis C Virus
Infection, Centers for Disease Control and Prevention (July 29, 2020) (describing ongoing risk
factors supporting routine testing, including people who currently inject drugs and share needles,

44 | Expanding Hepatitis C Testing and Treatment | Endnotes

syringes, or other drug preparation equipment, and people with particular medical conditions),
https://www.cdc.gov/hepatitis/hcv/guidelinesc.htm; 2022 AASLD/IDSA Guidance, supra note
2, at 182-183.
160

See Section I(C), supra.

161

Viral Hepatitis: Testing Recommendations for Hepatitis C Virus Infection, supra note 159.

162

AASLD/IDSA Guidance, supra note 2, at 12-13.

163

Hepatitis C Questions and Answers for Health Professionals, Centers for Disease Control and
Prevention, supra note 37.

164

Id.

165

Id.

166

See, e.g., Hepatitis C Reflex Testing, New York State Department of Health (Sept. 2020), https://
www.health.ny.gov/diseases/communicable/hepatitis/hepatitis_c/providers/reflex_testing.htm.

167

See He et al., supra note 100 (“Our results suggest that the universal opt-out screening of
inmates for HCV is highly cost-effective for at least 10 years and would reduce ongoing HCV
transmission, the incidence of advanced liver diseases, and liver-related deaths. The majority of
the benefits of interventions in prisons would accrue in the community, as a larger proportion
of releasees to the community would have been cured of the disease.”); see also Akiyama et
al., supra note 19, at 391.

168

See, e.g., Ben T. Schoenbachler et al., Hepatitis C Virus Testing and Linkage to Care in North
Carolina and South Carolina Jails, 2012-2014, 131 Pub. Health Reports 98 (2016) (describing
testing and linkage-to-care programs in North Caroline and South Carolina jails, noting that
“because behaviors that place people at risk for HCV infection (e.g., injection drug use) are
associated with incarceration, correctional facilities are strategic venues for HCV testing and
linkage to care”), available at https://journals.sagepub.com/doi/epdf/10.1177/00333549161
310S215.

169

Treatment of HCV in a Correctional Setting, Hepatitis C Online, supra note 18, at 2.

170

Id.

171

FBOP Guidance, supra note 46, at 6.

172

See note 167, supra; 2022 AASLD/IDSA Guidance, supra note 2, at 180-182. The Federal Bureau
of Prisons’ Clinical Guidance for the Evaluation and Management of Hepatitis C Virus (HCV)
Infection, relying on AASLD/IDSA Guidance, similarly promotes an opt-out approach to testing
for all incarcerated people, including new intakes and those already in the population. FBOP
Guidance, supra note 46, at 6.

173

Scripts like this one, developed to assist in implementing opt-out HIV testing, may be useful.
Implementing Opt-Out HIV Screening in Your Health Center, Health Information Technology, Evaluation, & Quality Center (Nov. 20, 2020) (recommending language like “In my

45 | Expanding Hepatitis C Testing and Treatment | Endnotes

practice, I recommend HIV testing for many of my patients, so I am planning to test you for
HIV today unless you decline to be tested,” supplemented by information about HIV and the
testing process), https://hiteqcenter.org/Resources/HITEQ-Resources/implementing-opt-outhiv-screening-in-your-health-center. Another model (also developed for HIV testing), suggests:
“As part of routine care, we will . . . test for HIV. HIV testing is voluntary so please let me know if
you do not want to be treated.” Opt-Out Testing: Gateway to Treatment & Prevention, High-Impact
HIV Prevention in Healthcare Organizations (2018), https://www.pcdc.org/wp-content/uploads/
Resources/Category-C-PCDC-Opt-out-HIV-Testing-Final-Cleared-3.29.18_R.pdf.
174

Settlement Agreement, Postawko, supra note 149, § III(A)(5); Settlement Agreement, Ligons,
supra note 149, § I(B)(2); Settlement Agreement, Chimenti, supra note 149 § 4; FBOP Guidance
8-11; Medical Directive 319.02, Nev. Dep’t of Corr. (July 2020), available at https://clearinghouse.
net/resource/3840/.

175

Brianna L. Norton et al., Low Adherence Achieves High HCV Cure Rates Among People Who
Inject Drugs Treated with Direct-Acting Antiviral Agents, 7(10) Open Forum Infectious Disease,
(Aug. 2020), https://pubmed.ncbi.nlm.nih.gov/33134406/.

176

Sunil S. Solomon et al., A minimal monitoring approach for the treatment of hepatitis C virus
infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial, 7 Lancet Gastroenterol Hepatol 307 (2022), https://pubmed.ncbi.nlm.nih.gov/35026142/.

177

Maine Dep’t of Corr. Policy 18.8.3: Management and Treatment of Hepatitis C (March 16, 2021),
Proc. D, available at https://clearinghouse.net/resource/3840/; Settlement Agreement, West,
supra note 149, ¶ 6; Settlement Agreement, Stafford, supra note 149, § IV(9); Settlement Agreement, Ligons, supra note 149, §§ I(B)(6), I(C)(3); Settlement Agreement, Chimenti, supra note
149 § 4; CT Doc 8.18(6)a; Consent Decree, Geissler, supra note 148, ¶¶ 37-44; Consent Decree,
In Re HCV, supra note 149, ¶ 38; AALSD/IDSA Guidance at 65; FBOP Guidance at 22; Exhibit 2:
Hepatitis C Virus Treatment Program, VitalCore Health Strategies Health Services Policy and
Procedure (January 1, 2021), available at https://clearinghouse.net/doc/136284/.

178

See, for example, Settlement Agreement, Stafford, supra note 149, § IV(6) (after an initial
phased-in treatment period, requiring treatment “immediately,” regardless of disease stage,
for people newly incarcerated and/or reinfected); Settlement Agreement, Ligons, supra note
149, § I(C)(3) (“Antiviral treatment for prisoners who are eligible for DAAs under the Updated
Guidelines shall begin within 3 months of determination of the prisoner’s fibrosis levels 1-4 or
fibrosis stage 0 and any of the co-occurring conditions. . . .”); Consent Decree, Geissler, supra
note 148, ¶ 39 (requiring treatment to be offered within 120 days of diagnosis).

179

Consent Decree, Geissler, supra note 148, ¶ 37, ¶ 38(h); Settlement Agreement, West , supra
note 149, ¶ 6; Settlement Agreement, Stafford, supra note 149, § IV(9); Settlement Agreement,
Ligons, supra note 149, § I(B)(6); FBOP Guidance, supra note 46, at 12-14.

180

2022 AASLD/IDSA Guidance, supra note 2, at 183-184; FBOP Guidance, supra note 46, at 13.

181

2022 AASLD/IDSA Guidance, supra note 2, at 179-183; see also FBOP Guidance, supra note 46,
at 12.

46 | Expanding Hepatitis C Testing and Treatment | Endnotes

182

FBOP Guidance, supra note 46, at 12.

183

FBOP Guidance, supra note 46, at 12.

184

2022 AASLD/IDSA Guidance, supra note 2, at 21.

185

Treatment of HCV in a Correctional Setting, Hepatitis C Online, supra note 18, at 2.

186

Matthew J. Akiyama et al., Knowledge, attitudes, and acceptability of antiviral hepatitis C treatment among people incarcerated in jail: A qualitative study, 15(12) PLoS One (Dec. 2, 2020), at
2, available at https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0242623.

187

The average length of stay in a United States jail in June 2020 was 28 days. See Todd D. Minton
and Zhen Zeng, Jail Inmates in 2020 – Statistical Tables, Bureau of Justice Statistics, U.S Dep’t
of Just., at 4 (Dec. 2021), https://bjs.ojp.gov/content/pub/pdf/ji20st.pdf.

188

Akiyama et al., supra note 19, at 395.

189

Id. at 395-396.

190

Akiyama et al., supra note 186, at 10.

191

See Chan, supra note 101.

192

Id.

193

2022 AASLD/IDSA Guidance, supra note 2, at 179.

194

FBOP Guidance, supra note 46, at 13-14.

195

Settlement Agreement, Ligons, supra note 149, § II; Consent Decree, Buffkin, supra note 149, §
3(a)(i); see also Exh. C (Hepatitis C Virus (HCV) Educational Pamphlet), Consent Decree, Geissler,
supra note 148.

196

2022 AASLD/IDSA Guidance, supra note 2, at 18-19.

197

See, for example, the Hepatitis Education Project: https://hepeducation.org/programs/
correctional-health-education/.

198

See, e.g., Karla Thornton et al., The New Mexico Peer Education Project: Filling a Critical Gap in
HCV Prison Education, 29 J. Health Care Poor Underserved 1544 (2018); https://pubmed.
ncbi.nlm.nih.gov/30449762/; Peer Education Programs, National Hepatitis Corrections Network,
https://www.hcvinprison.org/resources/71-main-content/content/200-peereducation (listing
and describing examples).

199

See, e.g., Miranda Surjadi et al., Formal Patient Education Improves Patient Knowledge of Hepatitis
C in Vulnerable Populations, 56 Digestive Diseases & Sciences 213 (2011), https://www.ncbi.
nlm.nih.gov/pmc/articles/PMC3008930/; Samali Lubega et al., Formal Hepatitis C Education
Enhances HCV Care Coordination, Expedites HCV Treatment, and Improves Antiviral Response,
33:7 Liver Int. 999 (2013), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3692599/; Diana
Partida et al., Formal Hepatitis C Education Increases Willingness to Receive Therapy in an On-site
Shelter-Based HCV Model of Care in Persons Experiencing Homelessness, 9:4 Open Forum
Infectious Disease (Mar. 2022), https://academic.oup.com/ofid/article/9/4/ofac103/6540486.

47 | Expanding Hepatitis C Testing and Treatment | Endnotes

200

Interview with Mandy Altman, Correctional Health Program Manager, Hepatitis Education
Project, Director, National Hepatitis Corrections Network (Nov. 3, 2022).

201

Consent Decree, Geissler, supra note 148, ¶¶ 46-47; Consent Decree, In Re HCV, supra note
149, ¶ 40; Settlement Agreement, Stafford, supra note 149, § IV(15)(ii); Superseding Settlement
Agreement, Barfield, supra note 149, ¶ 4.

202

E.g., Settlement Agreement, Postawko, supra note 149, § III(D). Some non-governmental organizations may be available to support staff training efforts. Interview with Mandy Altman, supra
note 200.

203

E.g., Conn. Dep’t of Corr. Administrative Directive 8.18, supra note 159, § 4; Proposed Settlement
Agreement, Turney, supra note 149, ¶ 3.5.

48 | Expanding Hepatitis C Testing and Treatment | Endnotes

Acknowledgements
This white paper benefited at every stage from conversations with and feedback from people
working on issues related to HCV in prisons and jails from various vantage points. This
included individual interviews, generous feedback from many reviewers, and a workshop
conducted via Zoom in November 2022 at which participants shared comments on the
policy recommendations in Part III.
In addition to the people acknowledged by name, our work benefited greatly from the insights
and knowhow of physicians who work in or in collaboration with jails and prisons, attorneys
who have litigated these issues, and others with relevant experiences that they generously
shared. This includes the folks from the National Hepatitis Corrections Network, National
Viral Hepatitis Roundtable, Treatment Action Group, and Academic Consortium on Criminal
Justice Health. Members of the Clearinghouse’s Advisory Committee also offered helpful
insights on the white paper series and this topic in particular.
Without intending to imply their endorsement of this paper or its recommendations, but in
order to express our gratitude to them for sharing their expertise, suggestions, and critiques,
we thank: Mandy Altman; Kevin Costello; Corene Kendrick; Kenneth Krayeske; Marsha Levick;
Cindy Mann; Alan Mills; Jamelia Morgan; David Muhammad; Margo Schlanger; Kinda Serafi;
Ronald D. Simpson-Bey; William Snowden; Anne C. Spaulding; Homer Venters; Samuel Weiss;
and Alysse Wurcel.
We are grateful, too, for the invaluable research assistance of University of Michigan Law
School students Elena Meth and Hannah Shilling.

49 | Expanding Hepatitis C Testing and Treatment | Acknowledgements

Appendix: How to Use the Civil
Rights Litigation Clearinghouse
We thought it would be useful to present a how-to for the Civil Rights Litigation Clearinghouse, http://clearinghouse.net, which collects, indexes, and makes publicly available for
research and observation a growing universe of civil rights cases, and the settlements and
court orders those cases have produced, which regulate government and private entities in
myriad important ways.
The Clearinghouse collection comprises thousands of cases and litigation documents. Each
case has a page that includes a summary of the litigation and related dockets, documents,
and resources. And each case has been indexed across various categories, so the database is fully searchable, via the search bar on the homepage, by dozens of criteria including
substantive “case type,” legal “cause of action” and/or “constitutional clause” undergirding
the legal claim; thematic “issues”; class action status; outcome; available documents, and
more. These searches can be run individually or in combination with each other.
The cases relevant to this white paper project form one of the Clearinghouse’s Special Collections, a pre-tagged group of cases: “Hepatitis C Treatment in Jails and Prisons.” To find
particular cases within the special collection, use one or multiple of the search features on
the left side of the special collection page. You can retrieve the same results from the home
page, too, as long as this special collection is selected in the relevant search bar (“Select
special collection”).

Search for: Cases and documents

v

clear search
Search text
Search case name
Select case types
~ elect special collection
Metadata
Foreign Intell igence Surveillance Act - Te lephony
Metadata
Foreign Intell igence Surveillance Court
Healthy Elections COVID l itigation tracker
Hepatitis C Treatment in Jails and Prisons
Immigrant Detention Labor Issues

Year

Filing Number

50 | Expanding Hepatitis C Testing and Treatment | Appendix

Examples of searches within the special
collection may include:

Issues

Select general

To limit a search to cases also involving HCV
testing, select “testing” under the “General”
Issues category.

Strip search policy
Suicide prevention
Terrorism/Post 9-11 issues
Testing
Test or device
Th reatened/endangered fauna
Threatened/endangered flora
Select disability
Select language
Select mental disability
Select voting
Select medic.ii/mental he~lth
Select death penalty
Select immigration/border
Select benefit source

Select discrimination-area

Search

To find cases challenging conditions in
jails, choose “Jail Conditions” under “Select
case types.” (Or, for prison cases, “Prison
Conditions.”)

Search for: Cases and documents

v

clear search
Search
Search case name
~elect case types
Immigration and/or the Border
Indigent Defense
Intellectual Disability (Facility)

Juvenile Institution
Mental Health (Facility)
N;1tinn-:.I C:.Ar.if'i tv

Case D

51 | Expanding Hepatitis C Testing and Treatment | Appendix

To find cases that have settled, under “Outcome,” select both “Court Approved Settlement or
Consent Decree” and “Private Settlement Agreement” in the “form of settlement” box.
Outcome

Outcome

Select prevailing party

Select prevailing party

Select nature of relief

Select nature of relief

Select source of relief

Select source of relief

Select form of settlement

x Court Approved Settlement or Consent Decree
x Private Settlement Agreement

Select content of injunction

Select content of injunction

To find copies of these settlement agreements in our database, under “Document Details,”
select “Settlement Agreement” under “document type.”
Document

Order/Opinion

Details

Other
Search document title
Pleading/ Motion/ Brief
Search document text

Press Release

Select document type

Settlement Agreement
Statute/Ordinance/Regulation

ECFNumber

Transcript
Document ID
Select document type

To limit a search to cases filed, settled, and/or terminated on or after a particular date, use
the “Key Dates” search functions.

Key Dates
Filinc: Date

From

To

Settlement / Judgment Oate

From

To

Terminating Oat•

From

To

Select case ongoing

52 | Expanding Hepatitis C Testing and Treatment | Appendix

..

If you are interested in another group of cases, or in searching the database generally, note: It
is possible to perform similar searches, combining various search criteria, across the entire
Clearinghouse collection (not just limited to a special collection).
For example, if you wanted to replicate (nearly) the contents of this special collection, you
could search for cases by: (a) under case details, in the “select constitutional clause” box,
choosing “Cruel and Unusual Punishment;” and (b) under the “issues” category of “medical/
mental health,” selecting “Hepatitis.”
case Details

~elect medical/men tal health
Dental care

Select cause of action

End ol lile choice and DNR ord ers
~elect constitutional clause

Hepatitis

Commerce Power

HIV/AIDS

Cruel and Unusual Punishment

ICF/MR & HCFA standards

Due Process

Intellectual/Developmental Disability

Due Process: Procedural Due Process

Intellectual disability/mental illness dual

Due Process: Substantive Due Process
Emoluments Clauses
F..n.1.1.rupptfon~q,,us".,

Note, too, that creating an account on the Clearinghouse permits saving searches (as well
as particular cases and documents) to an account-specific “Bookmarks” page for easy
reference later.
U ~ l ' 6 di){Ufflffl~

D
Heyer v. United Statl:'S Bureau of Prisons

Bookmarks

$:11.cl 03l1AIU..$..Ohcrir:tCot,,if.rwtht'
bste,,I\OistM of Horth C1rol~

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53 | Expanding Hepatitis C Testing and Treatment | Appendix

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