Tag Archives: Veterans Affairs

U.S. Department of Veterans Affairs Requests Increase in HCV Funding

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

Cover of the FY 2018 Budget Submission

Source: U.S. Department of Veterans Affairs

The United States Department of Veterans Affairs (VA) has laid out plans to continue their open treatment policy for eligible veterans living with Hepatitis C (HCV) into 2019 and beyond. The budget request sent to Congress – Fiscal Year (FY) 2018 and FY 2019 Advance Appropriations – highlights some of the successes the program has achieved in delivering comprehensive HCV treatment using Direct Acting Agents (DAAs) to cure HCV, as well as puts forth a request for an additional $751 million in funding specifically for HCV treatment. This is a $151.2 million increase from the 2018 Advance Appropriations requested in the previous year’s document.

The VA began offering treatment to all veterans in its health system regardless of their disease stage in March 2016 (Kime, 2016), a major step forward for the program, as the high cost of newer DAA drugs have proven prohibitive to decisively moving to eradicate HCV within other government healthcare programs enrollees. This also allowed veterans who were “…waiting on an appointment for community care through the Choice program [to] turn to their local VA facility for this treatment or elect to continue to receive treatment through Choice.” The Veterans Choice Program – introduced in 2015 – is a temporary benefit that allows veterans who were enrolled in VA health care prior to August 01, 2014, or who are eligible to enroll as a recently discharged combat veteran, to receive care in their communities, rather than waiting for a VA appointment or traveling to a VA facility (Peterson, 2015).

In the document recently sent to Congress, the VA also touted some of the successes of the program:

  • As of December 2016, 78.8% of Veterans in care in the 1945-1965 Birth Cohort – those most likely to have HCV in the U.S. – were screened for HCV, and the VA estimates that an additional 15,500 veterans in VA care remain undiagnosed.
  • From January 2014 through March 2017, the VA has treated over 84,000 veterans with cure rates over 90%.
  • As of February 2017, 61,000 veterans diagnosed with HCV were potentially eligible for treatment.
  • The VA estimates that approximately 80% of all veterans with HCV enrolled in VA care will be treated by 2020. Veterans remaining in the untreated pool at that time are estimated to be more difficult to engage in care due to issues like homelessness, mental health, and substance use comorbidities, or may be uninterested or unwilling to receive HCV treatment.
  • The number of total national HCV treatments increased from approximately 2,800/year in 2011-2013, to over 30,000 in 2016. This growth reflects the additional demand for HCV treatment with DAAs, beginning the second quarter of 2014 through the present.

The VA’s approach to treating veterans is a success story that CAN be repeated by other government-run healthcare programs, but doing so will require state and Federal governments to exponentially increase funding in order to eradicate HCV within the populations most likely to become infected. The Centers for Disease Control and Prevention (CDC) estimates that the vast majority of new HCV infections is a result of Injection Drug Use (IDU) among rural and suburban white men and women aged 18-35 (Dwyer, 2017). The populations are likely to also have lower incomes that may make them eligible for coverage under state Medicaid programs (in Medicaid Expansion states).

The full VA Budget Request can be viewed at the following link:

Department of Veterans Affairs – FY 2018 and FY 2019 Advance Appropriations

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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What is WAC and is it Outdated?

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

Every time we mention Hepatitis C (HCV) drugs, we talk about price; specifically, we speak about “Wholesale Acquisition Costs” (WACs), and how that company-designated measure sets the baseline for pricing throughout the healthcare landscape. But, the reality of pharmaceutical pricing is far messier than just the WAC cost. In response to last week’s HEAL Blog entry regarding HCV drugs and Medicare, one quite savvy worker within the public healthcare arena rightly noted that “nobody really pays that price,” which brings up a couple of equally (if not more important) questions: (1.) If nobody pays that price, why is it even used; and (2.) Why does no one actually pay those prices?

A WAC “…is, with respect to a pharmaceutical or biological, the manufacturer’s list price for the pharmaceutical or biological to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of pharmaceutical or biological pricing data (PharmaLink, n.d.).” That definition is pretty loaded, because it really spells out the ingredients (and the problems) in the drug pricing sausage that is so frustrating to advocates and patients, alike. What one program, insurer, or individual pays for drugs may or may not be the same price paid by another, and that makes determining the actual cost of drugs problematic.

Flow chart demonstrating the confusing nature of the Wholesale Acquisition Costs

Photo Source: National Academy of Sciences

Pharmaceutical companies like to bandy about the phrase, “What the market will bear,” in relation to how they price their products, which isn’t really a fair statement, because they essentially have a captive market. They know that the products they manufacture are going to be purchased by government healthcare programs like Medicare, Medicaid, Ryan White Part B, and the Veterans Affairs (V.A.), and that those programs are essentially (and sometimes literally) required to provide their products to their clients. Outside of the U.S., in more civilized First World healthcare climes, private insurers are essentially nonexistent, as Universal Healthcare Coverage is the norm, and they can set the price they’re willing to pay, manufacturer be damned. So, “what the market will bear” really ends up meaning, “How much we can get U.S. government programs to pay without kicking up too much of a fuss.”

When the aforementioned reader says that we know it to be the case that “nobody really pays that price,” he’s 100% correct. Medicare programs are Federally-funded, state-administered programs, meaning that all fifty states, the District of Columbia, and the territories all have the ability to individually negotiate directly with manufacturers to get drug rebates and discounted prices, meaning that each individual program may pay entirely different prices, and those prices are not public information, due to existing Trade Secrets laws that prevent that data from being released from official sources. The V.A. automatically gets the “best price,” meaning that they’ll ostensibly pay the lowest price, so they’re not really in the equation. Medicare Part D, however, is a different kettle of fish, because it is essentially a market of private insurers who are reimbursed through the national Medicare program for their expenditures, and price negotiations are, for better or worse, left up to those private insurers’ employees. According to research, while having more insurers on the Part D marketplace lowers costs to consumers, the Medicaid approach of state employees doing the negotiating actually works out to be cheaper than those “Free Market” solutions.

Because the WAC is a baseline measure against which all discounts and rebate agreements are measured, it makes determining the actual end price of drugs very difficult to determine publicly, and frankly, it’s a terrible model for the U.S. to continue participating in if programs are expected to exist in perpetuity. At some point, “what the market will bear” will become “What tuned-in Americans are willing to tolerate.”

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 Disservice to Veterans and a Time to Rethink Opioid Distribution

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

Data obtained by the Associated Press (AP) from the Federal government indicates that drug theft from Veterans Affairs and other Federal hospitals have jumped nearly tenfold since 2009, with 2,457 incidents of reported theft in 2016 (Associated Press, 2017). What is unsurprising to those of us living in rural and Appalachian states is that most of the drugs stolen are prescription opioids. So great is the problem that two Congressional representatives – Congressman Phil Roe (R-TN) and Senator Ron Johnson (R-WI) – have asked the Department of Veterans Affairs (V.A.) to better explain its efforts to stem drug theft and loss in light of data being made public (Yen, 2017).

Logo: U.S. Department of Veterans Affairs

Source: U.S. Department of Veterans Affairs

Opioid drugs have always been highly addictive substances, with reports of physicians and others who have easy access to them becoming addicted stretching back well into the 19th Century. That access has, over the past twenty years, become far greater in no small part due to the popularization of OxyContin and its maker, Purdue Pharma. The Connecticut-based pharmaceutical company has repeatedly faced accusations that its products and its push to make prescription opioid drugs the first choice to treat virtually any type of pain, regardless of severity, the norm in the United States. The company went to great lengths to ease access restrictions to their products and, in 2007, pleaded guilty to purposely misleading the public about the addictive nature of OxyContin, agreeing to pay $600 million in one of the largest pharmaceutical settlements in history (Lindsay, 2007). Since that time, states and cities have sued Purdue Pharma, alleging that the company put profits over citizens’ welfare (AP, 2015 & Ryan, 2017).

The recent data obtained by the AP are just another example of how addiction to prescription opioid drugs can lead otherwise upstanding and respectable members of society – those in whose hands we, as citizens, place our very lives and wellbeing – to commit felony theft in order to either satisfy their addictions or to make money off of selling these drugs to other addicts. Other relatively recent examples of opioid theft and addiction in hospitals have led to highly publicized (and costly) outbreaks of Hepatitis C in patients who were not habitual drug users, but patients under hospital care, and yet, despite the clear need to make substantive changes to our nation’s prescription opioid policies, there seems little political will to do so.

Pain advocacy groups (sometimes funded by drug manufacturers) and pharmaceutical companies have repeatedly put undue pressure on state and Federal lawmakers whenever the specter of restrictions or regulations that might restrict or reduce access to prescription opioids makes its way into statehouses. Reports have frequently been made where lawmakers have been approached, bribed, or extorted in order to block or vote against these legislative measures, even if they merely serve as Harm Reduction, rather than outright restrictions. Worse, much of the literature used in prescriber and physician education courses is written by these companies, who go to great lengths to downplay the high risks of addiction by placing the onus not upon the prescribers, physicians, or pharmacists, but upon the patients (i.e. – the patient’s body knows what’s best). The science of opioid drugs, however, contradicts these assertions.

What is frustrating about this issue is that politicians talk a big game about “solving the opioid crisis,” but they appear to be hamstrung as to what to do about the issue. Doctors, nurses, and addiction specialists have frequently presented these lawmakers with detailed, well-reasoned, and affordable plans to combat the crisis, and yet, these legislators seem more concerned about potential threats to their reelection campaigns and coffers than they do about the very real life and death addiction issues facing their constituents. It seems more important to them that Purdue Pharma and other opioid manufacturers continue to support their reelection, than it is important to help save the lives of the people they’re elected to represent.

Theft from veterans is, beyond just a sad commentary on the state of opioid addiction, unconscionable. The men and women in whose debt we all stand for defending our nation’s interests can ill afford for the drugs meant to treat them to go missing, much less for that theft to be perpetrated by those tasked with their care. At some point, lawmakers are going to have to take a stand against pharmaceutical company influence, or simply cede their seat to them, altogether. The time has come for comprehensive reform related to opioid drugs, whether or not that negatively impacts the bottom lines of these companies.

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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Veteran’s Administration $1.5 Billion for HCV to Expand Coverage

By: Marcus J. Hopkins, Blogger

Veterans Administration logo

Photo Source: VA

The Veteran’s Administration (VA) has requested $1.5 billion in the Fiscal Year 2017 (FY2017) budget in order to treat more veterans for Hepatitis C (HCV). This move comes after the announcement in March that the VA would be expanding treatment protocols to include all veterans in its health system with the virus, regardless of age or progression into liver cirrhosis (Kime, 2016). This coverage expansion was covered in the HIV/HCV Co-Infection Watch Report in April, and was recently reported in the Journal of the American Medical Association (JAMA) in the September edition.

With more than $2 billion appropriated for new HCV drugs during the past two years, the VA has treated 65,000 veterans for the virus (Wentling, 2016). One of the primary concerns expressed by veterans’ groups – Disabled Veterans (dot) Org, in particular – has been the rationing of care to only those whose liver fibrosis scores met what they feel are arbitrary measures that focus more on saving money, rather than saving lives. Tom Berge, head of the Vietnam Veterans of America (VVA) health care panel, went so far as to say the following: “When I found out that they were prioritizing the treatments, that’s when I said they were death panels (Krause, 2016).” The “death panels” claim is reminiscent of political arguments against single-payer or Universal healthcare coverage, wherein bureaucrats essentially decide which people would live or die, based on a set of predetermined markers.

The rationing of treatment to the sickest or most financially able to pay is nothing new – public and private insurers and payers, alike, have utilized these formulae and markers in an effort to reduce costs while still maintaining the visage that they “cover” drugs, even if actual utilization on the part of patients is low. With HCV drugs, in particular, many Medicaid and ADAP programs have indicated in their respective Preferred Drug Lists (PDLs) and formularies that they cover the new Direct Acting Agents (DAAs) that are currently considered to be the Standard of Care (SOC) for HCV, only to have the Centers for Medicare and Medicaid Services (CMS) release a guidance in November 2015 reminding Medicaid programs that “cost” was not an acceptable reason to deny coverage. Certain states – Arizona, for example – openly stated that they would not be following said guidance.

The VA currently estimates that 107,000 vets have undiagnosed or untreated HCV (Wentling, 2016), with Vietnam War-era veterans born between 1945 and 1965 being one of the demographics most likely to have been infected, as this generation (generally referred to as “Baby Boomers”) may have been the recipients of blood transfusions and organ transplants prior to the discovery and screening of blood for HCV. It wasn’t until 1992 that widespread screening of the blood supply began in the United States.

While this demographic is a target for HCV screening, most new HCV infections occur as a result of sharing syringes or other equipment to inject drugs (Centers for Disease Control and Prevention, 2016). Veterans are particularly susceptible to prescription opioid and heroin addiction. According to VA officials, roughly 60% of those returning from deployments from current engagements in the Middle East and 50% of older veterans suffer from chronic pain. That’s compared to about 30% of Americans, nationwide. Additionally, veterans are twice as likely to die of accidental opioid overdoses than non-veterans. Prescriptions for opioid drugs rose by 270% over a twelve-year period by 2013 (Childress, 2016). This places veterans at particular risk of contracting HCV as a result of Injection Drug Use (IDU).

Though the cost of treating HCV are currently astronomical, on a national scale, the VA does benefit from a requirement that drug manufacturers provide the system with the “best price,” though those discounts are currently shielded by Trade Secrets laws that specifically forbid programs from publicizing any deals, discounted prices, or pricing arrangements struck between pharmaceutical companies and payer programs. But, we have asked of our veterans that they make sacrifices to ensure our continued freedom and safety; is any price too high to ensure their continued health and wellbeing if and when they return from battle? I think not.
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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 Harm Reduction Focus Helps Bring Light

By: Marcus J. Hopkins, Blogger

The HIV/HCV Co-Infection Watch — published by the Community Access National Network (CANN) — recently added two new sections to its monthly report: the first focuses on the coverage offered by the Veterans Administration (VA); the second, and perhaps more involved research, focuses on Harm Reduction efforts.

HIV/HCV Co-Infection Watch

HIV/HCV Co-Infection Watch

The VA section is extremely cut and dry; they recently announced that they will effectively cover all veterans who are currently eligible for benefits for HCV treatment using Direct Acting Agent (DAA) HCV therapies. The Harm Reduction section, however, requires a more nuanced approach, as each state has its own interpretation of how they implement each aspect of Harm Reduction.

For those unfamiliar with the term, “Harm Reduction” is a set of practical strategies and ideas aimed at reducing negative consequences associated with drug use, as well as for expanding, protecting, and respecting the rights of drug users. The specifics, again, vary from state to state in their implementation, but there are overarching ideals that are used to shape these programs. In our research, we’re focusing on several very important Harm Reduction strategies:

  • Syringe Exchanges;
  • Expanded Naloxone Access;
  • Good Samaritan Laws;
  • Mandatory Prescription Drug Monitoring Programs;
  • Doctor Shopping Laws;
  • Physical Examination Requirements;
  • ID Requirements for Purchase;
  • Required/Recommended Prescriber Education; and
  • Lock-In Programs.

If this list seems exhaustive, it’s really only the tip of the iceberg. Harm Reduction strategies have a consistent track record of bringing about positive health outcomes, but little attention gets paid to them, unless there is a well-publicized health crisis – a sudden explosion of new HIV infections resulting from injection drug use, for example – that essentially forces the hand of state legislators to act. The most recent example of legislative Harm Reduction publicity came from Maine, which we covered two weeks ago, when Republican Governor Paul LePage vetoed a bill that provided expanded access to Naloxone by allowing it to be purchased from pharmacies without a prescription; his veto was quickly overturned by both Maine’s House and Senate on April 29th.

While Harm Reduction strategies have a proven record of net positive outcomes, there are always unintended consequences to any well-intentioned law. The U.S. has been in the throes of a prescription opioid addiction problem since the late 1990s, and state and federal governmental intervention is desperately needed and vitally important to help quell the ever-increasing addiction and overdose rates, HIV and HCV infection rates, and the unfortunate increase in criminal activities (such as varies classifications of theft) that tend to accompany an increase in opioid drug use. One such unintended consequence is the reduced access to prescription opioid drugs for patients whose healthcare needs truly necessitate their occasional use of a validly prescribed opioid.

I was recently asked by a very good friend if I knew of any doctors who would prescribe opioid pain relievers. This person knows the type of research I conduct, and his question stemmed from the fact that his doctor has repeatedly tried the same methods of pain relief that provide only short-term results to a chronic issue despite repeated requests to move past the less effective approach to a longer-lasting solution. My friend’s predicament is that any doctors outside of West Virginia University’s healthcare system are outside of his insurance plan’s network, which leaves him with few good options on a fixed income.

While I understand my friend’s predicament, I was unable to provide him with the answer he was seeking. What makes this problem difficult to address is that WV has one of the most vigorous legislative approaches to Harm Reduction strategies, largely because the state has been coping with a massive opioid addiction problem for at least two decades that has all but ravaged the state. It is my belief that this doctor properly using the context of WV’s opioid addiction problem to inform his overall approach to pain relief, and rightly so. For my friend, I suggested the use of a healthcare mediator or advocate during their next appointment; someone to speak on his behalf, and to try to come to a pain management approach that will allow him to better address his needs and to help the doctor understand his patient’s position – that the regimen he’s prescribing may not be the best solution for his patient.

My position, however, remains unchanged – Harm Reduction strategies are the most effective way to achieve net positive healthcare outcomes related to prescription opioid use, abuse, and addiction. While there will always be unintended consequences for some, the good of the many outweighs the complications that can arise from more stringent prescribing requirements. There is little doubt that we are facing a crisis of unprecedented scale; how we choose to deal with that, as a nation, will be of the utmost importance.

CLICK HERE to receive the monthly HIV/HCV Co-Infection Watch.
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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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Litigation and Legislation May Force Lower Prices

By: Marcus J. Hopkins, Blogger

The past three years have brought many great tidings for those living with Hepatitis C (HCV): a total of seven new HCV-specific Direct Acting Agent (DAA) regimens have been released onto the market, all of which are far more easily tolerated than the ribavirin and Pegylated interferon-based treatments, and all of which sport Sustained Virologic Response (SVR) rates of above 90% in most HCV patients. We’re now looking at the release of at least one more drug from Gilead, this year, that will be pan-genotypic – it can be used in the treatment of any genotype of HCV – as well as the possibility of injectable treatments that can be used on a regular basis, and reduce reliance upon pills.

Image of a stethoscope wrapped around a $20 bill , laying next to an open medication bottle

Affordable Healthcare

But, the reality is that these medical and technological breakthroughs cost money. Lots of money, really; and there seems to be no one willing to accept responsibility for their part in creating a market where a Wholesale Acquisition Cost (WAC) – the “baseline” for a drug’s price, before discounts and rebates – of $54,000 for twelve weeks of treatment is seen as a welcome reprieve.

Since Sovaldi (Gilead) and Olysio (Janssen) hit the market in 2013, virtually every payer and patient in the medical field has had a beef with the cost of the medications. Public and private payers, both, have essentially gone out of their way to restrict access to these medications to only the sickest of the sick, creating moral and legal arguments that may force those payers to pony up, regardless of whether or not they can “afford” the price.

On the legislative front, both California and Ohio are considering similar pieces of legislation that would require all state-run health agencies to purchase drugs at the lowest price paid by the Veteran’s Affairs (VA), which would mean that the “private” contract between manufacturers and the VA would have to become transparent. This could be either a boon or a bust, as VA prices may not be the cheapest of all the prices being paid, or in some cases, could be significantly less than one agency is paying for treating a large swath of people. Essentially, all public payers would have to pay the same price, whether or not the pharmaceutical company likes it, which could mean both a decrease in profits for them, as well as either an increase or decrease in spending for the payers.

These legislative efforts, both of which are sponsored by the AIDS Healthcare Foundation (AHF), are essentially an effort to force pharmaceutical companies to show their hand on pricing. If they’re giving a significantly lower price to one agency over another, they risk their ability to haggle for higher payments from other agencies. It’s an attempt to essentially level the playing field, and to do away with the “trade secret” nonsense that prevents publicly-funded agencies from openly discussing and publishing the exact details of these agreements.

On the litigation front, two new class action lawsuits have been filed in Washington state, aimed at forcing both private and public payers to provide HCV drugs to patients, regardless of the prices set by the manufacturers. Since Sovaldi and Olysio hit the market in 2013, payers have consistently been accused of establishing and maintaining overly and intrusively strict pre-requisites before providing HCV drugs to patients. The restrictions became so rampant that Gilead effectively severed access to its once very generous Support Path Patient Assistance Program (PAP) in response to private and public insurers refusing to pay for the drugs (despite having reached a pricing agreement with Gilead), and instructing patients to “…just go get it for free from Gilead.”

Private insurers have never been the bastion of ethical business practices; it has long been conventional wisdom that insurance companies will do their best to refuse coverage, just to save a buck, all while jacking up premiums, deductibles, and out-of-pocket costs in the process. It, therefore, comes as no surprise that they would refuse to pay for drugs.

State Medicaid programs face a particularly tough road in this legal battle, as the Centers for Medicare and Medicaid Services (CMS) issued guidance in November 2015 specifically stating that Federal law requires them to provide these drugs regardless of the price. This came after several complaints were filed stating the state Medicaid programs were violating the law by refusing to provide access to these medications on the basis of cost, alone. Arizona’s Medicaid program has reportedly stated that they will not be complying with the CMS guidance. While Washington state’s Medicaid program, Apple Care, has not released any similar responses, it’s not unlikely that they are simply refusing (or unable) to act on it.

The reality is that the high cost of these medications honestly restricts payers from providing access to these medications. In the case of Washington state, were the program to cover treatment for every Medicaid patient with HCV, the cost is estimated to be triple the total pharmacy budget for Fiscal Year 2016 ($1 billion). So, while covering the cost of treatment for everyone is the goal, that goal may simply be unfeasible if current pricing structures remain the same.
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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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