Monthly Archives: October 2015

Terms and Conditions Apply

By: Marcus J. Hopkins, Blogger

Over the past year, we, here at HEAL Blog, have often spoken of the onerous process that is “Prior Authorization.” We’ve discussed the burden it places on patients, physicians, pharmacists, and even claims processing staff – it’s an all around hassle, for all parties involved. What we haven’t done, however, is actually go into detail about how the process works – the steps involved, the prerequisites to even be considered for treatment, and the various hoops through which all parties involved must jump.

Magnifying Glass over print text, which reads

Photo Source: Classic FM

Let’s start with the basics:

A Prior Authorization is a check run by insurance companies and other third-party healthcare payers to determine whether or not a specific treatment, test, or medication is necessary for a client (otherwise known as a “patient”) and whether or not that necessity meets their standards for paying for the service. Essentially, if I am a patient whose excessive weight has become a serious health concern, does the doctor’s recommendation for gastric bypass surgery?

Each service requiring a Prior Authorization (PA) comes with its own stipulations, prerequisites, and checklists of steps taken in order to qualify for approval. Beyond that, each third party payer has its own interpretation of each step of the process, which means that a physician who regularly recommends his patients for undergoing a regimen of Harvoni (Gilead) may have to follow an entirely different set of steps, guidelines, and markers in order to process each patient’s insurance claim.

At its core, the reasoning behind PAs is both reasonable and sound logic – if a patient is not in need of a specific service, there’s no sense in wasting money for an unnecessary expenditure. This very basic tenet of cost containment is perfectly acceptable, in virtually every other marketplace, and, in truth, has its place in the healthcare arena, as well. Particularly at the price points for the newer HCV medications, every $10,000 counts, especially when each patient could potentially cost a company nearly (or more than) $100,000 for a single round of treatment.

Let us, however, move beyond the basic issue of cost containment, for a moment, and look at an actual example of some of the stringent requirements set forth by a state with one of the highest addiction and potential HCV infection rates in the United States – Illinois.

In researching Illinois’ Medicaid coverage for newer Direct-Acting Antivirals (DAAs) for treating HCV, I ran across the paperwork for the PA process. Reading the documents, themselves, is tedious, regardless of my penchant for reading detailed medical research papers. That said, I managed to slog through them with all the enthusiasm generally reserved for a Small Pox vaccination.

The first document to catch my eye was the following: General Criteria for Prior Approval of Newer Direct-Acting Antivirals (DAA) for Hepatitis C.

What starts out as being a normal, run of the mill PA form soon becomes a very pointed attempt to ascertain that the individual in question is as sick as possible, as clean of substances as possible, and just desperate enough for the treatment, but not too desperate. Allow me some examples:

  1. The patient must have evidence of Stage 4 hepatic fibrosis documented with one of the following: a. Liver biopsy confirming a Metavir score of F4; OR b. Transient elastography (Fibroscan) score ≥ 12.5 kPa; OR c. FibroTest score ≥ 0.74; OR d. APRI score ˃ 2.0; OR e. Radiological imaging consistent with cirrhosis (e.g. evidence of portal hypertension); OR f. Physical findings or clinical evidence consistent with cirrhosis

This basically translates to “The patient’s liver must have substantial scarring, hepatic fibrosis, or evidence of cirrhosis.” While this seems like a reasonable request, on its face, if you consider other life threatening conditions, this type of requirement is becoming terribly unique.

Imagine, for example, if we told cancer patients that, until their cancerous tumor progress to Stage 3 or 4, they were ineligible for treatment; or if we told women who had miscarried that, until they entered sceptic shock, they could not receive dilation and curettage or vacuum aspiration. This type of selective prerequisite endangers a patient’s wellbeing, and may prove to be life threatening.

  1. The patient has not been denied Hepatitis C therapies from another insurance carrier. If approved for coverage by another carrier, HFS will only pay as a secondary payer after the primary payer has paid.

Essentially, if another payer decided that you didn’t meet their requirements, don’t bother with asking the Illinois Department of Healthcare and Family Services. What makes this requirement more ridiculous is that there’s no timeframe given for rejection. Does that mean if, last year, their liver was not damaged enough to meet one payer’s requirement, that despite the increased presence of hepatic fibrosis and cirrhosis, they cannot apply for coverage under Illinois’ Medicaid program?

  1. The patient does not have evidence of active substance abuse diagnosis or treatment in the past 12 months.
  1. A documented negative standard urine drug screen report is required within 15 days before initiation of treatment

These two pack a double-whammy. So, if a patient has a substance abuse problem and successfully completes a rehabilitation program within the past year, they won’t be approved. Oh, and if they have any evidence of drug use fifteen days prior to beginning their treatment, go ahead and count them out, too.

  1. The patient has no history of a full or incomplete course of treatment with newer DAAs (“Once in a lifetime treatment policy.”) Patients who were not cured of hepatitis C following treatment with newer DAA’s will not be considered for repeat treatment. (Newer DAAs do not include telaprevir and boceprevir regimens.)

This is a topic over which I’m torn – “Once in a lifetime treatment” policies. On the one hand, I understand their position – $87,000 for twelve weeks of Sovaldi is a lot to fork over for it not to provide a sufficient Sustained Virologic Response (SVR). If the patient simply fails to adhere to the regimen or becomes re-infected, for whatever reason, it’s difficult to justify multiple treatments for someone who is likely to need multiple instances of treatment.

As with all things, however, a failed regimen is not always the only aspect worth consideration. For a handful of patients, a twelve-week regimen many not be sufficient to completely reduce their HCV viral load to sufficient numbers, and they may be one of the handful who require a twenty-four-week course.

Again, I ask you to imagine this type of policy in relation to a cancer patient undergoing treatment, or (more presciently) to think of the thousands of HIV/AIDS patients whom developed multi-drug resistant strains, and had to try something else. It is to these examples I point as we look to reforming the way we think about PA requirements.

  1. Lost or misplaced hepatitis C medications will not be replaced.

Forgive me for seeming impertinent, but if the CDC’s screening guidelines specifically points to the Baby Boomer generation, does this not also suggest the potential for age-related memory loss, dementia, or other mental impairments that may lead to misplacing medication? How, then, if the primary candidate for screening and treatment falls into this category, can we justify refusing to work with a patient in need who is otherwise willing to comply with their regimen?

This document is the basic criteria for PA approval; Illinois also has an additional set of medication-specific guidelines that go above and beyond the first list for Sovaldi, Harvoni, and Viekira Pak. Mind you, these are just the requisite criteria that must be met before submitting the actual PA paperwork.

In the next edition of HEAL Blog, we’ll take a look at the actual paperwork process through which all parties involved must go, and how that process, while in some ways necessary, may create an unnecessary barrier to care that can present greater problems, down the line.

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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Broader Funding for Better Solutions

By: Marcus J. Hopkins, Blogger

Much of what HEAL Blog has focused on, over the past two years, has been related to issues of access and the affordability of recent Hepatitis C (HCV) drugs. We’ve written extensively on the subject of domestic coverage options for HCV, but haven’t paid much attention to some of the fantastic strides that are being made on the international front in terms of financing State and organizational treatment programs. This is largely due to the fact that HEAL Blog is primarily written with the North American – specifically American – audiences in mind.

While it’s true that the high price tags associated with HCV drugs are global, those prices are relative to each country around the world. Because United States citizens largely lack access to the comprehensive universal healthcare models that most First World citizens enjoy, we are continually shocked at the skyrocketing costs of innovative drugs. Many nations with universal healthcare coverage have laws or regulations in place that largely prevent the price gouging that we see in America, and yet, relative to the costs of most treatments in their systems, these nations are still appalled that HCV drugs (in particular) are so prohibitively expensive.

These discussions are vitally important, as they get to the heart of what healthcare is about – healing. How First World nations’ citizens pay for and access these life saving medications is fundamental in comparing the U.S. to other great nations in the world. But, when we leave the First World behind, the landscape for addressing healthcare issues becomes much less rosy in developing countries.

Developing countries have a long and storied history of being recipients of aid for various causes, most notably in relation to HIV/AIDS. As citizens of First World nations, we aren’t so frequently reminded of the critical challenges faced by those less fortunate than ourselves – an endemic symptom of cultural exceptionalism and elitism – and when these critical health disparities are brought to our attention, we have a tendency to want to play the “White Knight.” For some reason, we feel that we need to swoop into these nations and “fix” all of their problems, bringing “Developed” approaches and mindsets into “Undeveloped” cultures, and expecting to save the day. What we often fail to realize is that this kind of approach – “We’re giving you this gift; be grateful, damn it!” – is rarely successful in achieving long-term, sustainable healthcare outcomes.

This is where organizations like the Global Fund step in.

The Global Fund to Fight AIDS, Tuberculosis and MalariaThe Global Fund (TGF) is a 21st-century partnership organization designed to accelerate the end of AIDS, tuberculosis, and malaria as epidemics, raising and investing nearly $4 billion every year to support programs run by local experts in communities and countries most in need. They serve not as a direct caregiving organization, but as a financing institution for new or existing healthcare models and strategies that are locally run. This allows countries the autonomy to take the lead in determining where and how to best fight diseases, how to respond to broader development challenges, and how to coordinate work with international partners in global health (Global Fund, 2015).

In November 2014, the Board of TGF approved an interim measure for continued funding of HCV virus treatment efforts in areas where co-infection is, for whatever reason, high. This allowed for some of the most vulnerable populations to receive drugs to which they might never have otherwise had access. At the Thirty-Third Board Meeting in November 2015, it has become the recommendation that TGF create a more permanent framework for combating HCV co-infection.

This type of action is much welcomed by those of us at the Community Access National Network (CANN) and the HEAL Blog, as it represents a larger commitment to combating HIV/HCV co-infection on a global scale. HIV patients, in particular, face a heightened danger from HCV-related liver cirrhosis, disease, and failure – HCV is now the leading cause of non-AIDS-related death within HIV-infected populations in many countries – and as such, we should embrace with open arms any efforts to adequately address the epidemic.

Organizations and programs funded by TGF have a far higher likelihood of success than foreign-led efforts in developing countries, and their outcomes are often longer sustained and greater impacting, as community members are more likely to become involved with and fight to maintain and sustain these programs in perpetuity. It is the sincerest hope that the Thirty-Third meeting of the Board will see the passage of these recommendations, and we look forward to reporting more on this subject as the information becomes available.

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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