Pennsylvania Medicaid Opens HCV Treatment to Virtually All HCV Patients

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

On May 16th, 2017, Pennsylvania’s Department of Human Services (DHS) announced changes to the state’s Medicaid policy that will expand coverage to treat virtually all enrolled clients living with Hepatitis C (HCV). Beginning July 1st, 2017, HCV-infected beneficiaries with liver scoring of F1 will become eligible for treatment coverage for the newer Direct Acting Agents (DAAs) that are highly effective, easily tolerate, and also very expensive. Beginning January 1st, 2018, clients with liver scoring of F0 will become eligible for treatment coverage. Prior to the July 1st policy change, treatment coverage will be available only to clients whose liver scoring ranges F2 to F4, unless other mitigating complications exist that warrant immediate treatment.

These changes come in response to a number of factors, most notably the 290% increase in new HCV infections between 2014 and 2015 reported by the CDC earlier this month. The deciding factor in this case, as in many other state Medicaid decisions, was the threat of a class action lawsuit. Attorneys from the Center for Health Law & Policy Innovation at Harvard Law School, the Pennsylvania Health Law Project, Community Legal Services, and Kairys, Rudovsky, Messing, & Feinberg, LLC sent a formal demand letter in late 2016 on behalf of their clients, Pennsylvania Medicaid recipients. This letter notified DHS that unless it agreed to remove “categorical coverage exclusions” of HCV medical cures from its Medicaid policy, the state could face a Federal class action law suit (Harvard Law School, 2017).

For the uninitiated, a little explanation is likely in order on the topic of “F scoring.” The “F” stands for fibrosis – the thickening and scarring of connective tissue, usually the result of injury. In relation to the liver, F scoring describes the length in expansion of fibrotic areas between portal tracts (also known as “portal triads”), and these changes are staged at F0 (No fibrosis) to F4 (Cirrhosis) (Hepatitis C Online, 2015). Patients with F4 Cirrhosis is characterized by a loss of liver cells and irreversible scarring of the liver. A healthy liver regulates the composition of blood, including the amounts of sugar (glucose), protein, and fat that enter the bloodstream. It also removes bilirubin, ammonia, and other toxins from the blood (WebMD, n.d.). A cirrhotic liver cannot properly perform these functions, leaving the patient susceptible to numerous painful and life threatening illnesses and side effects of failing or failed liver function.

The changes to Pennsylvania’s Medicaid program make it one of the first in the nation to adequately address the burgeoning HCV epidemic by treating patients early in the disease cycle. While the newer DAA drugs are all very expensive, the cost of curing patients outright, rather than continuing to pay for their long-term health degradation while waiting for their liver to become scarred enough to treat their HCV. Aside from being costly, it is also inhumane. While HIV patients underwent similar treatment in relation to the recommendation of when they begin Antiretroviral Therapies (ARTs), eventually we came to the realization that treating the disease early would result in fewer long-term complications for HIV patients. This way of thinking in terms of HCV patients is likelier to come more quickly, now that we have medically curative treatments.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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A Conversation About HCV in Incarcerated and Post-Incarceration Settings

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

On Thursday, May 11th, the Community Access National Network (CANN) hosted a Community Roundtable on Linkages to Care for Current/Former Incarcerated Citizens Living with Hepatitis C (HCV). Three speakers, including myself, gave presentations detailing the various barriers, opportunities, and complications that surround ensuring that incarcerated citizens receive the car to which they are legally entitled under the 8th Amendment’s “…cruel and unusual punishment” provision.

State/Federal HCV-Related Lawsuits Involving Prisons (2007-2017). At least 18 Class-Action and Civil Rights Action lawsuits were filed in 11 states between 2007-2017.

My presentation covered the legal aspect of treating HCV in prisons and jails, much of which I detailed in last week’s HEAL Blog; as such, I will spend this blog discussing the information presented by my peers:

Wayne Turner, Senior Attorney with the National Health Law Program, delivered an excellent and thorough explanation of how Medicaid-eligible incarcerated persons can have their treatment paid for through the Medicaid program if they are taken to an outside facility for care. What this means is that, using a provision written into the Medicaid law, so long as the prisoner is treated at a hospital outside of their incarceration facility, their treatment and care can be covered and paid for through the Medicaid program, rather than relying upon the prison healthcare and pharmacy budgets.

This has the potential to be a hugely beneficial resource for prisons, as treating HCV is very costly. It also raises an interesting question – would this mean that prisoners can be taken to hospitals, be prescribed one of the new Direct Acting Agents (DAAs) to treat their HCV at the hospital, and fill that prescription at the hospital pharmacy and have the drug covered by Medicaid, rather than the prison pharmacy budget? It’s an interesting question, and could be the solution needed to ensure that inmates receive the care they need.

A. Toni Young, President and CEO of the Community Education Group, also delivered a rousing call to action, discussing her work in trying to figure out how to improve access to Medicaid and HCV education both inside the prison system and for the general population. What this really requires, she posits, is that medical professionals as well as Federal, state, and local governments dramatically increase education campaigns to teach people about HCV, and most importantly, how to avoid contracting the disease, both inside and outside of prison settings.

What makes this approach vitally important is that HCV education is something that is sorely lacking in the areas that are hardest hit; not just HCV education, really – healthcare literacy in general is an issue. As such, we must, as Toni suggested, work on ways to get people to actually care about what we’re trying to teach; get them to understand that learning about and preventing the spread of HCV will save their lives.

Another fantastic point brought to the fore by Elizabeth Paukstis, Public Policy Director at the National Viral Hepatitis Roundtable, was that, despite advocates calls for prisons to treat everyone, the reality is stark – the budgets are what they are, and no matter how often or loudly we insist that they treat inmates with HCV, many states simply do not have the resources to do. At that point, litigation is really the only route that many inmates can take to ensure that they receive treatment.

This Community Roundtable was a fantastic event, and I look forward to participating in future roundtables to figure out the best ways in which we can help combat the HCV epidemic.

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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Linkages to Care for Current/Former Incarcerated Citizens Living with Hepatitis C

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

The Community Access National Network (CANN) will be hosting a roundtable at the headquarters of the Pharmaceutical Research and Manufacturers of America (PhRMA) on Thursday, May 11th, 2017, on the topic of Hepatitis C (HCV) in Incarcerated Populations. The roundtable will focus on various aspects of treated HCV in prison and jail settings, including the Constitutional requirement that all inmates receive treatment, as well as various barriers that prevent inmates from receiving screening and treatment.

Invite for the Community Roundtable on Linkages to Care for Current/Former Incarcerated Citizens Living with Hepatitis C

Current estimates indicate that between 10-35% of inmates are infected with HCV, and that roughly half of those inmates don’t know that they’re infected. These estimates are, however, limited by inconsistent or non-existent screening protocols, reporting requirements, and various bureaucratic hurdles that prevent inmates from being screened. Furthermore, there are no penalties in place that hold prison and jail systems accountable for failing to screen inmates, which often results in costly lawsuits.

The Federal Bureau of Prisons released a new set of screening guidelines for HCV in October 2016, which included the recommendation that all prisons and jails adopt an “Opt-Out” screening process (Federal Bureau of Prisons, 2016). This strategy requires that HCV screening becomes part of a routine practice, and that inmates must provide “informed refusal” in order not to be screened. This strategy would be instrumental in combating the HCV epidemic running rampant among inmate populations, as well as for data gathering purposes.

Implementing this strategy across all prisons and jails in the U.S. in a difficult proposal, in no small part because it will be expensive. What makes it so expensive is that screening, itself, isn’t cheap – at least not the confirmatory tests; additionally, if prisons and jails discover that an inmate has HCV, or any other life-threatening illness, they are required under the 8th Amendment of the U.S. Constitution to treat that inmate’s illness (Estelle v. Gamble). That last part can cost prison systems tens of thousands of dollars fear each infected inmate – costs that will explode pharmacy and healthcare budgets in the short-term, but will save money in the long-term.

Furthermore, prisons appear to be extremely inconsistent about what prices they pay for drugs. The Wall Street Journal (WSJ) published a report in September 2016 per-patient cost paid by state prisons to treat HCV using Gilead’s Harvoni: the prices ranged from $46,021 in North Dakota to $91,014 in Georgia (Loftus & Fields, 2016). These numbers indicate the need for more price stabilization in the U.S. prison systems, or at the very least, consolidated price negotiation.

While the roundtable is open to the public, seating is limited. Interested parties can sign up for the event at the following address: http://tiicann.org/events.html

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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Emory University and CDC Reveal HepVu

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

The latest tool in Viral Hepatitis advocacy has arrived: HepVu (www.hepvu.org). A project of Emory University’s Coalition for Applied Modeling for Prevention (CAMP) – supported by the Centers for Disease Control and Prevention (CDC) – HepVu is an interactive website that provides various data related to Viral Hepatitis (VH), with the greatest emphasis being placed upon Hepatitis C (HCV), the least accurately reported variant in the U.S.

The website features interactive maps detailing estimated prevalence data, rates of infection, mortality data, and regional impacts and comparisons on both the national and state levels. While HCV data released by the annual National Health and Nutrition Examination Survey (NHANES) conducted by the CDC produces national estimates, HepVu is the first analysis that uses a more nuanced formula that includes NHANES data, but also examines state-level reporting and statistics that includes electronic medical records (EMRs), insurance claims, and HCV-related mortality.

Other site features include infographics, explanations about the various types of VH, and the ability to print and download maps and data for use in advocacy efforts and reports. Dr. Patrick Sullivan, one of the researchers associated with creating the project, stated that making the site a resource for HCV-related advocacy and reporting efforts was an essential step in creating HepVu. This is the first HCV-related website (of which I am aware) that makes these data easily available for reprinting and citation purposes.

The contributing researchers to the website admit that this reporting is likely well below the actual prevalence and rates of infection, because screening, reporting, and tracking vary in quality and amount of data from state to state, in no small part because of a lack of Federal and state funding for HCV reporting, as well as adequate and standardized reporting requirements set by the CDC. Part of what makes this data so important is that it serves as a great starting point for advocating for increased funding for reporting and tracking – something that Congress has been slow to address, despite large increases in funding to address America’s opioid and heroin abuse crisis, the leading contributor to the rise in new HCV infections.

The primary limitation of the data presented on HepVu (and in general) is age: the vast majority of the data centers on 2010 and 2014 – seven and three years old, respectively. This complaint has been a sticking point for advocates and HCV-related organizations for several years, particularly because of the release of easily tolerated and highly effective Direct Acting Agents (DAAs) that serve as a curative treatment for HCV. Now that we have these tools to eradicate HCV, it is imperative that we begin operating on current information, rather than relying upon data that predates two presidential elections. This means that both Federal and state governments are going to have to step up to the plate and begin adequately funding screening, reporting, and tracking efforts, regardless of the high cost of these drugs.

HepVu is an excellent starting point, despite the data limitations, and so long as the statistics and information are regularly updated with more current information, it has the potential to become an invaluable tool in combating HCV and hopefully eradicating the virus from the U.S., entirely.

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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Treating HCV in Pediatric Patients

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

In April of this year, the Food and Drug Administration (FDA) approved the use of Sovaldi and Harvoni (Gilead) for use in treating Hepatitis C (HCV) in pediatric patients aged 12-17. This is an important step in treating HCV in no small part because children and teenagers are considered a vulnerable population. They are, for the most part, not properly equipped to make well-informed decisions about their health, leaving treatment decisions in the hands of the adults who care for them.

Stamp marked, "Approved" next to the initial, "FDA"

Photo Source: 3Dprint.com

Treating pediatric patients is a much riskier prospect, because people outside of the medical community consider children to just be “small adults;” virtually every treatment regimen for every disease must be modified to achieve commensurate outcomes. There are a variety of reasons why this is so, from bodyweight variances between children and adults, to the various ways that physical and chemical changes that occur during the growth and development process from childhood to adulthood can impact how medications behave in pediatric patients. Essentially, “results may vary.”

The new FDA ruling that expands treatment to pediatric patients allows patients weighing at least 77 lbs. to take an unmodified regimen. While access to treatment in adults has proven fraught with hurdles to overcome before being approved by payers, children covered by Medicaid may, in fact, face fewer hurdles than adults. This is due to the following provision: under Federal law, state Medicaid programs must cover “…early and pediatric screening, diagnostic, and treatment services” for children under age 21 that are necessary to correct or ameliorate physical and mental illnesses (Andrews, 2017). While that’s great for patients covered by Medicaid, those covered by private insurers may have a tougher road to hoe, as most within the industry expect the latter payers to largely maintain similar restrictions in pediatric clients as adults.

One of the reason pediatric patients are so vulnerable is that the majority of HCV-infected patients acquire the disease in the womb; only about 20% acquire it through drug use (Andrews). That said, the likelihood is very low – only a 6% chance that babies will acquire HCV if the mother has it.

Hopefully, pediatric patients will face an easier time gaining access to Sovaldi and Harvoni than adults, but only time will tell.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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HCV Prescribing Lags While Prices Soar

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

An article in Newsweek in March 2017 talked about a “…crowded and confusing” landscape for treating Hepatitis C (HCV) that prevents many Primary Care Physicians (PCPs) from prescribing the new Direct Acting Agents (DAAs) to treat the disease (Wapner 2017). The argument posed is that, physicians are “…still too unfamiliar with the regimens to speak with confidence about them,” according to Ira Jacobson, a hepatologist who leads the department of medicine at Mount Sinai Beth Israel Hospital in New York. He posits that this discomfort leads them to send patients to liver specialists, or to delay treatment until more severe symptoms arise, the latter of which is a regular pre-requisite on virtually every Prior Authorization (PA) request form.

This argument caught my eye, as someone who writes about and researches coverage for these DAA drugs, as has done so since 2013. One of the most frequent conversations I heard when Sovaldi (Gilead) and Olysio (Janssen) were first released on the market was that there was confusion over which doctors could prescribe them. Unlike HIV, treatments for HCV largely lagged in the ‘completely intolerable’ realm, with patients dropping out of treatment like flies and a success rate of only around 50%. Things, however, have radically changed; the question, then, becomes, “Have doctors?”

Prescription Pad

Realistically, we have a considerable problem, in the United States, with aspiring doctors choosing to specialize, rather than going into general practice, in no small part because it guarantees them higher incomes. Higher incomes for them, however, means higher costs to consumers, in the same way that higher-priced drugs to treat chronic conditions get shunted into the highest pricing tiers. This gets passed along to consumers in the form of higher co-pays for visits ($25 for PCPs; $75 for Specialists), and higher co-pays for medications ($3 for blood pressure medication; $250 for HIV).

This problem extends, also, to prisons and jails – the high cost of treatment serves as a significant barrier to providing inmates with treatment, which presents a larger issue, because inmates have an exponentially higher incidence and prevalence of HCV than the general population (Gloucester Times, 2017). Testing prisoners is expensive, as well, as inmate populations swell, while prison healthcare budgets remain relatively stagnant. Once those prisoners are released back into the general population, if they’re unaware of being infected with HCV or whose infections have gone untreated, they can go on to infect those who are not part of the prison system, are also unlikely to be tested and treated.

Beyond just the cost of co-pays are the long-term costs of PCPs being reticent to screen or prescribe for HCV: failing to address HCV will lead to liver decompensation, liver cancer, kidney diseases and failure, higher HCV viral loads that make spreading the disease easier, jaundice, digestive illnesses, and thyroid issues, none of which are particularly cheap to treat. The host of accompanying side effects of leaving the disease untreated far outweigh the admittedly outlandish prices set by HCV drug manufacturers.

The reality is that any medical doctor who has prescribing privileges can prescribe these new treatment regimens. The vast majority of these doctors also have access to smartphones, all of which have any number of apps designed to compare new drug regimens with existing prescriptions to ferret out counter-indications; there is, in fact, an entire website specifically aimed at finding counter-indications (http://www.hep-druginteractions.org/) that also offers mobile apps. The argument that doctors are unsure of the counter-indications is really rendered moot by the existence of these easy-to-use tools.

With that, the biggest hurdle to overcome, for virtually every party involved, is the cost of treatment, and with the current administration’s funding priorities being…questionable, at best…it’s unapparent if even the existing treatment coverage landscape will exist. We’re hoping for more stable conditions, and less erratic proposals. Until then, we’ll just keep plugging to try and find a solution.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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New River Valley Region Reports Sharp Rise in Hepatitis C

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

The New River is 360 miles long that spans three states – North Carolina, Virginia, and West Virginia – flowing from south to north (one of only a handful of rivers in the world to do so) and serves as one of the most scenic rivers in the eastern United States. It’s known for hosting some of the best white water rafting and kayaking in the U.S., and for having the third-longest single-arch bridge in the world. Nestled along some of the most rural parts of the three states in spans, the New River Valley (NRV) region is also home to a growing Hepatitis C (HCV) epidemic.

HEAL Blog has covered the exploding rates of HCV in West Virginia many times since our inception in 2013, as well as having covered those rates in the rest of the Appalachian Mountain Region (AMR). What frustrates many advocates and healthcare workers who live and work in the NRV is that the sharp increase in new HCV infections is largely a product of pharmaceutical companies’ – and healthcare providers’ – making.

Map showing the New River Valley area

Photo Source: Snipview

During the early-1990s, Perdue Pharma using rural towns and counties in the NRV as testing grounds for OxyContin, one of the most widely prescribed opioid drugs of the late-90s and early-00s. HEAL Blog has previously reported on this issue (Cassandra in the Coal Mines), and I stand by the assessment that this region and its population have been systematically targeted by the manufacturers and wholesalers of prescription opioid drugs; wholesalers have, in fact, spent several tens-of-millions of dollars settling cases in West Virginia related to oversupplying the drugs and creating “pill mills” in the state.

There is a direct link between the opioid and heroin epidemics in this region and the vast increase in new HCV infections. In December 2016, Dr. Marissa Levine warned during a meeting of the Virginia Board of Health that the state should expect a “tidal wave” of HCV and HIV primarily related to Injection Drug Use (IDU). The state saw a 21.212% increase in new HCV infections in 2015, from 6,600 in 2014 to 8,000 in 2015 (Demeria, 2016). Dr. Levine also argued that the lack of a dedicated funding stream greatly hinders the ability of the Health Department to accurately capture and track the data accurately, an argument shared by virtually every state in the U.S.

Beyond just opioid drug injection, New River Health District Health Director, Noelle Bissell, M.D., has seen a spike in acute HCV infections (as opposed to chronic conditions) linked to tattoo parlors, the use of homemade tattoo guns at parties, and in people who report more than 10 sexual partners, as well as a trend in cases associated with IDU involving methamphetamine, and in pregnant women and women of childbearing age (SWVA Today, 2017). It should be noted, however, that the Centers for Disease Control and Prevention (CDC) specifically states that the transmission of HCV via sexual activity is “not common” (CDC, 2015). The virus is inefficiently transmitted in this manner, and while it is possible in the manner Dr. Bissell describes, much of the data provided during screening is self-reported by patients – self-reporting may lead patients to purposely omit or skew their answers in an effort to avoid embarrassment or mask other behavioral risk factors.

The rural areas along the NRV are very likely to be hit with a greater explosion of HCV and HIV, and HEAL Blog will be monitoring the situation in the coming months.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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