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HCV Advocate Newsletter

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August 2010 HCV Advocate

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In This Issue:

Advances in HCV Diagnostics: OraQuick® HCV Rapid Antibody Test; The Bisosensor
Alan Franciscus, Editor-in-Chief

Disability & Benefits: Coverage Under Multiple Health Plans
Jacques Chambers, CLU

HealthWise: Words that Wound, Words that Heal
Lucinda Porter, RN


The Gene that Predicts
Alan Franciscus, Editor-in-Chief



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Advances in HCV Diagnostics:  OraQuick® HCV Rapid Antibody Test; The Bisosensor
—Alan Franciscus, Editor-in-Chief

In July 2010 the Food and Drug Administration approved the first rapid HCV antibody test in the United States—OraQuick® HCV Rapid Antibody Test.  The approval is for the venous whole blood test that will be used in medical clinics.  Orasure is expected to file for marketing approval of their ‘finger prick’ and ‘oral swab’ at the end of 2010 or the beginning of 2011.  The finger prick and oral swab antibody tests are the most eagerly awaited tests because they will allow for testing high risk populations at testing events and outreach programs such as needle exchanges.

The venous whole blood test kit will require a phlebotomist to draw the blood, but the advantage of this test over current HCV antibody tests is that the test results will be available after 20 minutes.  This means that in addition to providing people pre- and post-test counseling messages, now the clinic can provide confirmatory testing and aftercare.  One of the most important follow-up tests to a positive HCV antibody test is the HCV RNA or viral load test to confirm that the hepatitis C virus is actively replicating in the body or if the body’s immune system has been able to clear the virus.  This is vital because about 25 to 45% of people acutely infected with hepatitis C are able to naturally rid the body of the hepatitis C virus.  Testing for hepatitis C in clinics will also mean that patients receive follow-up care for medical testing, monitoring, and treatment. 

Although the price and availability of the kits has not been confirmed, the kits are expected to be available by the end of 2010.  The kit will include Orasure’s collection Loop (for the blood sample), developer solution (mixed with the blood sample), and a device that has a window to interpret the results.  The various OraQuick HCV Rapid Antibody Tests have the potential to dramatically change the landscape of HCV testing, diagnosis, management and treatment.

The Biosensor
Another exciting development is a hand-held device that is capable of testing HIV, hepatitis and other pathogens.  The device is called the Biosensor and was developed by the University of New Mexico Health Sciences Center and Sandia National Laboratories.  It is estimated that the device will cost approximately $5,000 and the chips will cost about $10 each.  Here’s how it works:

  • The chip is loaded into the device
  • The fluid  (blood, saliva, urine) is injected into a small hole in the device
  • Results are ready in as little as 5 seconds. 

Here’s the most interesting part – the device works by weighing the fluid sample – specific viruses and bacteria have DNA or RNA that is a certain weight.  The device is able to measure the weight of the DNA and RNA samples and give off a signal, and the results are transferred to a computer or smartphone.  The potential for this device is enormous for HCV and other pathogens.  The scientists are already working on using the device to identify cancer cells.   According to the article published in the Albuquerque Journal (July 9, 2010) it is expected that the device will be available in about 2 years. 


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Disability & Benefits: Coverage Under Multiple Health Plans
—Jacques Chambers, CLU

The major problem today regarding payment for health care is that too many people don’t have access to good health insurance. However, another problem experienced by many is that they have access to more than one health insurance policy.

Should a person accept and pay for more than one health insurance plan? Should all insurance carriers be informed of each other? How are medical bills handled? Can someone make a profit off of health insurance?

First, it is surprisingly easy to end up covered under more than one health plan:

  • You may be covered as an employee where you work and covered as a dependent under your spouse or domestic partner’s employer provided health plan.
  • You may have individual health insurance and continued it after enrolling in your employer’s plan.
  • You may be on Medicare and your employer’s plan is continuing to cover you because you are 65 or older and still working, or they may have a policy of continuing health insurance for disabled employees.
  • You may be covered under a guild or union plan as well as under an employer’s plan or Medicare.

Back in the 1950s, duplicate coverage starting creating a problem for insurance companies, and it was increasing in significance as more and more families had both spouses in the workforce. While they realized that two premiums were being paid for coverage, the insurance companies did not want to nor did they believe it was right to pay full benefits under both, which would permit the insured person to actually make a profit from medical charges and insurance reimbursement.

They worked with the National Association of Insurance Commissioners to resolve the problem in a manner they hoped would be fair to all, and the result was the industry-wide Coordination of Benefits Provision. While the Coordination of Benefits prevents a person from making a profit from two or more health insurance policies, the program did provide the incentive:  by working together the two plans would pay up to 100% of the medical bills, wiping out any deductibles or co-insurance for the claimant to pay. 

Coordination  of Benefits
The insurance industry adopted this uniform provision, which was added to virtually all group health policies, including those health policies purchased by employers and unions for their employees and members. This provision determines how duplicate coverage is handled in all instances where there are two or more insurance policies, not counting when Medicare or Medicaid is involved. They are addressed later in this article.

The general concept was simple: One plan will pay its full, normal benefits. The other plan will pay what is remaining of the total medical bill, up to the maximum amount it would have paid if it were the only insurance company involved. By this method, the insured can have his medical bills paid 100% by the two companies, but will not receive more.

The provision says that the Primary Plan will pay its full benefits, and the Secondary Plan will pay the remainder of the entire bill. Clean, simple; the insurance company doesn’t pay double, and the insured person gets their claim paid at 100% of the total bill, leaving him/her to pay nothing out of pocket.

The difficulty lay in determining which plan would pay its full benefit, or be Primary. A complete chart of determining the order of payment is at the end of this article, but here is a summary of the rules used to determine which plan pays first:

  • Group plans that do not bother to add the Coordination of Benefits provision to their policy will always pay first or be Primary. There are still a few union plans that have not added the provision.
  • The group health plan covering the insured as an employee pays first.
  • To determine who pays first on dependent children’s claims, the endorsement originally had the male “breadwinner’s” plan pay first, but times change. Now the plan covering the parent whose birthday is earlier in the calendar year is Primary.

Note that these rules only apply to GROUP policies. Individual health insurance policies as well as Medicare and Medi-Cal do not come under these rules.

Health Maintenance Organization (HMO)
The rational order of payment gets more complicated when one of the plans is an HMO. For example, HMOs pay nothing if the insured goes outside their network, so there is nothing to coordinate. Inside the network, usually the only expense is the copay which is paid directly to the treating provider, and it is usually low enough that neither the patient nor the doctor’s office is willing to invest the time and paperwork necessary to get reimbursed for that by the Secondary payer.

Medicaid
Medicaid plans for the medically needy do not often become involved in duplicate coverage issues, however when they do, Medicaid, by law, is always the payer of last resort and so would always be “Secondary” to any other insurance plan including Medicare. Reimbursement rates by Medicaid plans is frequently so low that anything paid by the insurance company will usually exceed what Medicaid would have paid anyway.

Medicare
Medicare has its own set of rules about which plan becomes Primary. For a complete explanation of the rules, they publish a booklet, Medicare and Other Health Benefits: Your Guide to Who Pays First (Publication No. CMS-02179). It covers types of insurance more than just group health policies. It also covers Workers’ Compensation, Veterans’ benefits, special government programs like Black Lung, coverage under no-fault or liability insurance, or Medicare due to End Stage Renal Disease or ALS (Lou Gehrig’s Disease). Table 2 below shows how Medicare works with group health plans.

Individual Health Insurance
The Coordination of Benefits endorsement on group health policies does not apply to individual health insurance policies so they generally pay their full benefits regardless of other group health policies in force.

It is important that you review the provisions of an individual health insurance policy because it will sometimes include its own provisions about other insurance.

Medicare’s Coordination of Benefits does not apply to individual health insurance policies either. Many individual health plans do include a coordination provision in their contracts regarding Medicare, however.

Claims Processing
When there is more than one health insurance plan, the processing of claims can get complicated, however, that is an issue for the people doing the medical billing rather than the claimant. It is important that you notify all medical providers of the two plans so the person sending out medical bills can determine the primary and secondary carriers.

The paperwork is first sent to the Primary insurance company. Once they process the claim, the billing office will then send the claim, along with the Primary carrier’s processing information, to the Secondary carrier, who will then determine their payment.

On pages 8 and 9 are two tables that show the order of payment for group health policies with Medicare – Table 1, and with other group and individual health insurance policies – Table 2.

 

Table 1: Medicare and Group Health Plans

If you... Condition Pays first Pays second
Are age 65 or older and covered by a group health plan because you are working or are covered by a group health plan of a working spouse of any age The employer has 20 or more employees Group Health Plan Medicare
The employer has less than 20 employees or is part of a multi-employer plan Medicare Group Health Plan
Have an employer group health plan after you retire and are age 65 or older Entitled to Medicare Medicare Retiree Coverage
Are disabled and covered by a large group health plan from your active work, or from a family member who is working The employer has 100 or more employees Large Group Health Plan Medicare
The employer has less than 100 employees and isn’t part of a multi-employer trust Medicare Group Health Plan
Are disabled and covered by a group health plan either on COBRA or covered because employer continues coverage due to disability Entitled to Medicare Medicare Group Health Plan

 

Table 2: Coordination of Benefits Endorsement



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Healthwise: Words that Wound, Words that Heal
—Lucinda K. Porter, RN

Sometimes well-intended words can cause pain, which brings to mind a story about my mother. She had a blood disorder that eventually converted to leukemia. When it was clear that nothing more could be done, she broke the news to friends. One replied, “I can’t believe it. You look so good!” My mother was annoyed by the remark, noting that it was insensitive. She said, “How am I supposed to look? Do people think I am making this up?”

This is the nature of illness. Sometimes people don’t look sick even when they are gravely ill. People with chronic hepatitis C virus infection (HCV) frequently express that no one knows how lousy they feel, because on the outside they appear well. This is especially true when patients go through HCV treatment.  The prevalence of this was evident in my HCV support group after we confessed how irritating it was when people remark, “You look so good.” 

These comments are well-intended, but simultaneously invalidating. I recall late in my treatment, someone saying to me, “You don’t look sick.” My hair was thinning, my fingernails ghastly, and I had a nasty, visible rash. I was nauseous, depressed and irritable. It took every ounce of restraint not to say, “And you don’t look stupid or careless.”

We tell people they look good in order to encourage them, rather than to question their health. It is a way of expressing admiration and support when someone is going through turmoil. Perhaps if we tell our sick friends that they look good, they will be lifted out of their misery.

Denial may be at play here. We don’t want to see our loved ones suffer, so we accentuate the positive.  In my mother’s case, you’d have to be legally blind to miss the fact that she was on oxygen, bruised, weighed less than Calista Flockhart, and was so anemic that her skin looked like chalk. Did I tell my mom that she looked horrible? Of course not, but neither did I tell her she looked good. I told her I loved her and stayed away from conversations about her appearance.

When I was on HCV treatment, I assume that people didn’t notice that my skin looked like a plate in a dermatology textbook, or that my hair had lost its shine. Instead they noticed the weight loss and my slimmer body, so naturally they complimented me. Unfortunately, HCV medications were messing up my thinking in addition to my skin, so I reacted defensively, when I should have said, “Thank you.”

Sometimes we conceal how we feel. Susan Milstrey Wells, author of A Delicate Balance: Living Successfully with Chronic Illness, examines some of the complexities of living with a chronic illness.  She points out that society values beauty, strength, and productivity. When we can’t live up to those standards we may blame or shame ourselves.  When asked, “How are you?” Milstrey observes that we’ll often reply that we are fine—even if we aren’t.

We may have good reasons for not wanting to admit that we don’t feel well. It may be inappropriate in social or professional situations to be overly honest. President George H.W. Bush probably didn’t tell the Prime Minister of Japan that he wasn’t feeling well before vomiting on Miyazawa. We expect our president to be invincible; we don’t want to see him sick, and he is unlikely to admit as such.

Although we aren’t heads of state, we may not want our bosses, neighbors, or casual acquaintances to know that we have HCV. We are vulnerable when we are ill and admitting we are sick makes us feel more vulnerable. Acting like we are fine is a way to exert control in a situation over which we feel powerless.

Milstrey believes that it takes courage to admit being unwell, but we don’t need to tell the world. She writes, “When we accept the fact that we’re sick, it’s less important that everyone else does, too.”

Admitting we are sick is one thing, but sick with HCV is another. HCV is a communicable virus, and somewhat stigmatized.  It’s best to think about it before disclosing one’s HCV status. If you do disclose, start with close friends and those who will not announce it on Facebook. 

I am comfortable telling people that I have HCV. When I went public with it there was no turning back, especially since the HCV Advocate’s website gets more than a half million hits every week. However, I rarely tell people when I don’t feel well. This information I only share with those close to me. I don’t like the fuss that comes when people know I feel poorly. When I am under the weather and people ask me how I am, I say, “Hanging in there,” a response that Milstrey endorses.

If someone says you look great when you’ve admitted feeling awful, Milstrey says, “Looking good while feeling bad takes talent!” and she proposes simply saying thank you. If they express that you look far too good to be feeling sick, then Milstrey suggests, “Yes, it’s even hard for me to understand how I can feel so bad when I look so good.”

The other side of this equation is how we talk to others when they are ill. It would be simple if we could speak to others as we would want them to speak to us, but we are all so different. Let’s start with what not to do:

  • Don’t judge – Even if you think the person is exaggerating, remain compassionate.
  • Don’t tell them about a worse experience – You may think it helpful to tell someone who is struggling through HCV treatment about how you scaled Mt. Everest without oxygen during your treatment, but it may make them feel inadequate and hopeless. Keep your experiences to yourself unless you think they will help.
  • Don’t tell them how to feel – “Get over it, you’ll be fine” is the last thing we want to hear when we are ill.
  • Don’t over-sympathize – Pity doesn’t help and it is demeaning.

Here’s what you can do instead:

  • Listen – Sometimes we communicate far more with sincere, attentive listening, than we do with words.
  • Offer support –  You can give on-the-spot support, such as “I don’t want to pry, but if there is something going on and you want to talk about it, I’m happy to listen” or offer help, such as, “Is there anything I can do?” Don’t offer to help if you aren’t prepared to follow through with a “yes” or a firm, “I’m not able to do that, but I can do such-and-such.”
  • Relate – If you had similar experiences, and your intention is solely to show empathy, then it is fine to relate your experiences, as long as you aren’t trying to show one-upmanship.

No matter which side of the thermometer you are on, we can choose words that inflict pain or soothe the soul; it just takes awareness, thoughtfulness, and practice.

For More Information:

 

Be Sure to Check Out Our Latest Guide:
Easy C Guide to Depression



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The Gene that Predicts
—Alan Franciscus, Editor-in-Chief

In last month’s HCV Advocate newsletter, I wrote an editorial about whether it is safe to wait for the new HCV therapies.  The decision to treat or not to treat is a very difficult one, but a new test may be available shortly that will help people with the decision—at least for people with HCV genotype 1.  The new test detects a variation in one of our genes that predicts HCV treatment response and it does this with a high degree of accuracy.  Best of all it might be commercially available by August 2010.    

The gene is a variation of IL28B (interleukin 28B) which triggers our body to make more of a type of natural interferon called lambda interferon.  This natural interferon has also been found to help naturally suppress the hepatitis C virus.  In people who take interferon plus ribavirin therapy the presence of a certain variation of IL28B gives them a two-fold increased chance of achieving a sustained virological response (HCV RNA negative 24-weeks post treatment) compared to those who do not have this gene variation.  

The gene variation in IL28B will be added to a list of pre-treatment predictors of treatment response that include HCV genotype, HCV RNA or viral load, age less than 40 yo, insulin resistance and race.

Note:  The term CC genotype used to describe the variation of IL28B is not same as the term used for different strains of HCV (called genotypes) – numbered 1 through 6.  

The Discovery
The discovery of the variation of the IL28B gene was the result of a genome-wide study of more than 1600 treatment naïve HCV genotype 1 patients enrolled in the IDEAL study – a study comparing the FDA approved pegylated interferons combined with ribavirin in people with HCV genotype 1.       

After analyzing the IL28B genes of the study participants, it was found that there was a two-fold greater chance of achieving an SVR when a certain type of gene – CC genotype – was found.  Furthermore, when they looked at the SVR rates among different racial groups there was a definite correlation between the prevalence of CC genotype and higher SVR rates.   This finding explains, in part, the well-known difference in treatment response rates between Asians, Caucasians, Hispanics and African Americans—Asians respond best to current HCV medications followed by Caucasians, and Hispanics with the lowest response rates among  African Americans.

Studies have also looked at the presence of IL28B CC genotype in people treated for hepatitis C who are coinfected with HIV and HCV.   Although the studies included a smaller patient population, they confirmed that the presence of the CC genotype also indicated a higher rate of SVR.  But the possibility of responding to pegylated interferon plus ribavirin was not as high as that which has been seen in people mono-infected with hepatitis C.  This indicates that there is another factor in play that reduces the HCV treatment SVR rates in people coinfected with HIV and hepatitis C virus.

What about Spontaneous Clearance?

Since our bodies produce natural interferon the next logical step was to find out if the CC genotype was found in people who spontaneously (naturally) cleared the virus.  In a study conducted in Spain by MA Mones-Cano and colleagues of 283 HCV patients (genotype 1—210 pts; non-genotype 1—66 pts) it was found that 73% of those who had the CC genotype were able to naturally clear the virus, compared to 46% of those who did not have the CC genotype.  Another part of the same study included people who were treated with HCV medications and the authors tested to find out if the presence of CC genotype was higher in the treatment responders compared to those who did not have the CC genotype.  It was found that 60% of the people with HCV genotype 1 achieved an SVR compared to 32% in the group without the CC genotype.  

Next the authors turned their attention to the presence of CC genotype in people with non-1 genotype.  In this regard there was little difference in the groups.  A recent small study confirmed these results but only found a predictive value in people who did not achieve a rapid virological response (HCV RNA undetectable at 4 weeks).  This may indicate that this gene variation is HCV-genotype specific; however, more studies are needed to confirm these results.

It’s clear from these studies that CC genotype is now the most important predictor of HCV treatment response in people with HCV genotype 1—at least in the studies to date.  This information will have important implications in the treatment decision process for current therapy and possibly for any future therapies that include pegylated interferon and ribavirin.  It remains to be seen whether this effect will carry over to the combination of the new HCV direct acting antivirals (DAA’s) that do not include interferon and ribavirin.  Probably the biggest issue facing the use of a combination of direct acting antivirals (without pegylated interferon and ribavirin) is to find out if using just the DAA’s will be enough to completely suppress the hepatitis C virus at least until the body’s natural interferon can finish and maintain the job of permanently suppressing HCV.  In this respect the test for the CC genotype might play a critical role in those who can take only the direct antivirals or those who will need to have some interferon/ribavirin included in their treatment regime.       

Reference: Genetic variation of IL28B predicts hepatitis C treatment viral clearance  Dongliang Ge and colleagues,  Vol 461/17 September 2009 loi:10.1038/nature08309


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