June 2, 2015
Neal Kohatsu, MD, MPH, Medical Director
Julia Logan, MD, MPH, Quality Officer
Office of the Medical Director
California Department of Health Care Services
SENT VIA EMAIL
RE: “California Department of Health Care Services DRAFT Utilization and Treatment Policy
for Direct-Acting Antiviral Therapy in the Management of Hepatitis C”
Dear Drs. Kohatsu and Logan,
Project Inform, the National Viral Hepatitis Roundtable, and the undersigned organizations and
medical providers, who represent constituents at risk for and living with the hepatitis C virus
(HCV), thank the Department of Health Care Services for releasing this updated draft utilization
and treatment policy for hepatitis C and for expanding the utilization policy to increase the
number of people living with hepatitis C who are eligible treatment candidates. In particular,
we are pleased that individuals with mild fibrosis (i.e., F2 or equivalent) will have access to
treatment under this policy, as well as individuals with certain co-morbid conditions or critical
circumstances that make them likely to transmit hepatitis C to others without the intervention
of treatment. We appreciate the Department’s efforts in this regard and look forward to
working with you to ensure that Medi-Cal beneficiaries living with hepatitis C have access to
appropriate curative treatments.
We do have some questions and concerns about this draft, which are outlined below.
1. We suggest the addition of the following language to make clear that medical necessity is
the standard on which to base treatment decisions:
Although this policy provides guidelines for treatment of hepatitis C and should meet
the clinical needs of most patients, this document is not a substitute for clinical
judgment. Patients who do not meet these criteria should still be considered for
treatment when it is indicated based on clinical characteristics and circumstances of
the particular patient.
Project Inform & NVHR public comment re: draft DHCS HCV Treatment Utilization Policy
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2. Policies, like this one, that limit treatment only to the sickest patients violate laws that
now ban discrimination against specific patient populations. Treatment should be
available to all patients who are highly motivated to get cured of the virus (i.e., patients
likely to adhere to the treatment regimen) and who are identified by their physicians as
appropriate treatment candidates. Hepatitis C is a chronic infectious disease and everyone
living with the virus has a medical necessity to be treated and cured. Hepatitis C is not just a
liver disease – it is a systemic disease. Denial of care places patients at risk for a variety of
non-liver diseases, such as diabetes and non-liver cancers. Because of the liver and non-liver
complications of hepatitis C, many providers are concerned that denial of care places them
at medical legal risk. The policy also undermines our ability to address health inequities and
disparities, particularly among communities of color, which have disproportionally higher
HCV prevalence. By failing to treat everyone with HCV, the policy will perpetuate health
inequities, and disparities, particularly among African Americans and Native Americans who
are disproportionately burdened by HCV. The policy, based on cost containment concerns
and not clinical evidence, will result in rationing of care and will require doctors to practice
two standards of care, one for Medi-Cal patients and one for everyone else. Requiring most
patients to have evidence of liver disease (i.e., METAVIR F2-4 or equivalent) to receive
treatment authorization means patients have to be already experiencing liver damage from
a chronic, infectious, life-threatening disease before they can be offered the cure. Provider
and patient discretion should be the standard on which to base treatment decisions. While
the Affordable Care Act recently helped millions of Americans gain access to health
coverage, many for the first time, its mandate that no individual be denied insurance based
on a pre-existing condition is meaningless if that coverage restricts access to the treatment
needed to cure that condition.
3. Policies, like this one, that exclude people with HCV who have no or little liver damage
(i.e., F0-F1 or equivalent) and forces people to live with a debilitating illness until their
liver is significantly damaged violates medical necessity per Welfare and Institutions Code
14059.5. (Please see the public comments outlined in the letter from the Health Consumer
Alliance)
4. In Section 2.A.i, please consider adding the FIB-4 score as an acceptable serum
calculation. Many providers have been using the FIB-4 score and patients have already
received this calculation. In cases where FIB-4 has already been completed and is above
3.25, this should be acceptable evidence that a patient has advanced fibrosis and fits into
the criteria of the treatment utilization policy.1
1
The FIB-4 is an easy-to-use, quick, and inexpensive test that provides results immediately. Results are generated
utilizing age, AST, ALT, and platelet count. A threshold value of less than 1.45 has a sensitivity of 74% and specificity
of 80% in excluding significant fibrosis. A threshold value of greater than 3.25 has a specificity of 98% in confirming
cirrhosis. This model was good at excluding or confirming cirrhosis, but values between 1.45 and 3.25 did not fully
discriminate fibrosis and would need an additional method to predict liver fibrosis.
http://www.hepatitisc.uw.edu/go/evaluation-staging-monitoring/evaluation-staging/core-concept/all
Project Inform & NVHR public comment re: draft DHCS HCV Treatment Utilization Policy
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5. In Section 2.A.xi-xiv, please consider adding “health care workers who perform exposureprone procedures” to the list of treatment candidates. We appreciate that a number of
groups at elevated risk for transmitting HCV are listed as treatment candidates regardless of
level of fibrosis. The AASLD/IDSA hepatitis C treatment guidance also includes health care
workers who perform exposure-prone procedures as a group at elevated risk for
transmitting HCV. For this reason, it is appropriate to include this population in the
treatment utilization policy.
6. Sections 2.C and 2.D should be removed. Section 2.B adequately addresses the need for
evaluating patient readiness to initiate treatment and adherence. The sections on substance
use (2.C) and mental health (2.D) (with the exception of the section on mental health and
use of interferon-containing regimens) are redundant of Section 2.B. It should be sufficient
for a provider to assess that a patient is ready to initiate treatment and likely to adhere to
the treatment regimen. Additional requirements related to substance use or mental health
(with the exception of interferon-containing regimens) are not clinically indicated or
necessary.
7. If Section 2.C is not removed, it needs to be reworded to avoid ambiguity and
unnecessary treatment denials. Below are some specific concerns and suggestions in this
regard.
a. Allowing plans to review patients’ histories of substance or alcohol use and make
treatment decisions on a “case-by-case” basis could easily lead some managed care
plans to deny treatment for anyone actively using substances or alcohol. Treatment
for people actively using substances or alcohol should only be denied if there is
evidence that they are not ready for treatment or are unlikely to adhere to the
treatment regimen.
b. The sentence in Section 2.C.i, “Thus, automatic disqualification of patients as
treatment candidates based on length of abstinence is unwarranted and strongly
discouraged” should be strengthened to, “Thus, automatic disqualification of
patients as treatment candidates solely based on length of abstinence is
unwarranted and prohibited.” Denying treatment based on substance or alcohol use
alone is “arbitrary and unreasonable” and violates federal Medicaid law (see letter
with comments regarding this draft policy sent by the Health Consumer Alliance).
c. In Section 2.C.ii, the requirement that some people using substances or alcohol be
referred “to an addiction provider, where available, before treatment initiation…
and care coordinated with substance use treatment providers” is problematic. In
many rural areas of California with high hepatitis C prevalence there are few of
these addiction specialists. Some managed care plans may use the language of this
policy to deny care to anyone using substances or alcohol who does not have their
care coordinated with a substance use treatment provider. This language could put
patients and providers in an untenable position.
d. In Section 2.C.ii, address other substance use besides heavy alcohol use, binge
drinking, and injection drug use. There is no clinical reason to deny anyone using
substances of any type access to hepatitis C treatment if they meet all other criteria.
Project Inform & NVHR public comment re: draft DHCS HCV Treatment Utilization Policy
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e. In Section 2.C.ii, there should be specific language regarding medical marijuana.
Over the last year we have learned of numerous instances in which managed care
plans denied patients hepatitis C treatment on the basis of their use of prescribed
medical marijuana. Consider adding, “Patients who use medical marijuana, as
prescribed by a treating physician, may not be barred from treatment on the basis of
their lawful use of this prescribed therapy.”
8. If Section 2.D is not removed, it needs to be reworded to avoid ambiguity and
unnecessary treatment denials. Allowing plans to review patients’ mental health histories
and make HCV treatment decisions on a “case-by-case” basis could easily lead some
managed care plans to deny HCV treatment for anyone with severe mental health
conditions. Treatment for people with severe mental health conditions should only be
denied if there is evidence that they are not ready for treatment or are unlikely to adhere to
the treatment regimen. The language in this section, that "Patients should be managed in
collaboration with mental health providers to determine the risks versus benefits of
treatment and potential treatment options," is problematic. The new direct acting antivirals
have no neuropsychiatric side effects. This requirement is a barrier to care. The poor and
those living in rural and urban underserved areas have exceptionally limited access to
mental health services. Receiving short-term therapy for a dangerous infectious disease,
with no neuropsychiatric side effects, should not be contingent on mental health care.
Primary care providers provide most of the mental health services in the United States.
Routine medical care as is currently being delivered should be enough to allow for HCV
treatment in people with mental health conditions. The exception to this is, of course,
interferon-containing regimens, which do have neuropsychiatric side effects and are
contraindicated for some individuals with certain mental health conditions.
9. The criteria for reauthorization/continuation of therapy in Section 3 are onerous for
patients and providers. We encourage DHCS to allow for a one-time replacement of lost
medications to ensure that patients do not have to discontinue effective treatment and lose
the opportunity to be cured of HCV in the event of a one-time loss of medication. In
addition, we encourage DHCS to have supportive policies regarding missed medical and lab
appointments in cases where the physician feels the patient is adhering to and responding
well to treatment and the patient has worked with the physician to reschedule missed
appointments or created a plan for closer adherence support. Discontinuing treatment due
to a missed appointment wastes the resources already invested in treatment for no good
medical reason. The language in this section should also make clear that in clinical trials
with the new DAAs there were no stopping rules and that plans may not stop delivering
treatment to patients based on laboratory results for these new regimens. For example, if a
patient is not undetected by week 4 of treatment, there is no data to support stopping the
regimen. We are concerned that some managed care plans may interpret the sentence in
section 3.C.iii 3 "when applicable, relevant laboratory information in support of medical
necessity for duration of therapy” as a way to refuse treatment reauthorization. The
language should make clear that futility rules cannot be implemented without strong data
to back up clinical decision-making.
Project Inform & NVHR public comment re: draft DHCS HCV Treatment Utilization Policy
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10. We are concerned that some of the language in the draft is open to interpretation by
Medi-Cal managed care plans and will lead to confusion and inconsistent implementation
of the policy. Over the last year we have witnessed how individual plans implemented the
original treatment utilization policy and how access to hepatitis C treatment was
inconsistent with the policy and dependent on the plan. We appreciate that this policy does
not restrict prescribers who may want to treat HCV as part of appropriate medical care. In
the last year we have learned of many instances of managed care plans restricting
prescriber networks and we look forward to working with DHCS to ensure that adequate
provider networks exist to treat people for HCV. DHCS may need to clarify in this policy that
all qualified and contracted providers may prescribe HCV treatment. We are very willing to
meet with you to figure out how DHCS can hold managed care plans accountable for
following all aspects of the treatment utilization policy to the letter and the spirit of how it
is intended.
Please contact us if you have questions or require additional information. We appreciate the
improvements to the updated treatment utilization policy and all your efforts to ensure access
to HCV treatment in Medi-Cal. Thank you for allowing us to review and provide comments on
the draft policy. We look forward to your response to our concerns.
Sincerely,
Emalie Huriaux
Project Inform
ehuriaux@projectinform.org
Ryan Clary
National Viral Hepatitis Roundtable
rclary@nvhr.og
Attachment: ORGANIZATIONAL & INDIVIDUAL SIGNATORIES TO THIS PUBLIC COMMENT
cc:
Jennifer Kent, DHCS
Mari Cantwell, DHCS
Margaret Tatar, DHCS
Anastasia Dodson, DHCS
Anna Lee Amarnath, DHCS
Karen Smith, CDPH
Karen Mark, CDPH
Katie Heidorn, CHHS
Project Inform & NVHR public comment re: draft DHCS HCV Treatment Utilization Policy
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ORGANIZATIONAL & INDIVIDUAL SIGNATORIES TO THIS PUBLIC COMMENT
ORGANIZATIONS:
California Hepatitis Alliance (Statewide)
Glide Foundation (San Francisco)
Harm Reduction Coalition (Oakland & National)
Hepatitis Foundation International (National & International)
National Health Law Program (Statewide & National)
San Francisco AIDS Foundation
San Francisco Drug User's Union
San Francisco Hepatitis C Task Force
San Francisco Safety and Wellness Coalition
San Luis Obispo Co. AIDS Support Network
Santa Rosa Community Health Centers
SLO Hep C Project (San Luis Obispo)
STOP Hepatitis Task Force (Sacramento)
MEDICAL PROVIDERS
(Organizations listed for affiliation purposes only and do not indicate organizational
endorsement of this letter):
Alice Asher, RN, PhD (University of California, San Francisco)
Jared Bunde, RN, PHN (LifeLong Medical Care, Oakland)
Misha R. Cohen, OMD, L.Ac. (Chicken Soup Chinese Medicine, San Francisco)
Kellene Eagen, MD (University of California, San Francisco)
Damon Francis, MD, AAHIVM (Alameda County Public Health Department)
Robert G. Gish, MD (Robert G. Gish Consultants, La Jolla)
Jeffrey D. Klausner, MD, MPH (University of California, Los Angeles)
Kim Pelish, NP (San Francisco Department of Public Health)
Lucinda Porter, RN (Hep C Support Project, Grass Valley)
Jocelyn Poulin, RN (San Francisco Department of Public Health)
Christian B. Ramers, MD, MPH, AAHIVS (Family Health Centers of San Diego)
Amy Smith, PA (Highland Hospital, Oakland, CA)
Denise Taylor, MD, AAHIVM (San Luis Obispo)
Danny Toub, MD (Santa Rosa Community Health Centers)
Lisa Ward, MD, MSPH, MS (Santa Rosa Community Health Centers)
Project Inform & NVHR public comment re: draft DHCS HCV Treatment Utilization Policy
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