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In This Issue:
USPSTF: Test All Baby Boomers
& At-Risk Adults!
Alan Franciscus, Editor-in-Chief
Lucinda K. Porter, RN
HEALTHWISE: When A and E Meet Hepatitis C
Lucinda K. Porter, RN
DISABILITY & BENEFITS: Medicaid & the Affordable Care Act (ACA)
Jacques Chambers, CLU
HCV Advocate Eblast
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USPSTF: Test All Baby Boomers & At-Risk Adults!
—Alan Franciscus, Editor-in-Chief
“The USPSTF (US Preventive Services Task Force) is an independent panel of non-Federal experts in prevention and evidence-based medicine and is composed of primary care providers (such as internists, pediatricians, family physicians, gynecologists/obstetricians, nurses, and health behavior specialists).
The USPSTF conducts scientific evidence reviews of a broad range of clinical preventive health care services (such as screening, counseling, and preventive medications) and develops recommendations for primary care clinicians and health systems. These recommendations are published in the form of ‘Recommendation Statements.’”
USPSTF recommendations carry a lot of weight with medical societies, medical providers and insurance coverage and reimbursement. If a particular condition receives a low recommendation (Grade C, D or I Statement) it would mean that very few people would be tested or receive care. Insurance coverage (or no coverage) would be made on an individual case by case basis and different insurance companies might or might not provide reimbursement. A strong Grade of A or B would translate to the recommendations being implemented on a national level among medical societies and providers. And importantly, a high recommendation means that medical insurance companies and the Affordable Care Act would provide reimbursement.
In 2012, the CDC made recommendations for a one-time HCV antibody test for everyone born between 1945 and 1965 (Baby Boomers) as well as to test at-risk populations. Regarding testing Baby Boomers and at-risk populations for HCV, USPSTF analyzed the data, spoke to medical providers, patients, advocates and governmental people. Subsequently, USPSTF issued a draft recommendation for testing Baby Boomers with a Grade C, and Grade B for testing at-risk adults who self-disclose a high risk factor.
A Grade C is defined as follows: “The USPSTF recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small.” Testing self-disclosed injection drug users received a Grade B – “The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.”
The Grade B rating, which recommended HCV testing for people who admitted injection drug use or those who received a blood transfusion, was unlikely to make a dent in identifying HCV in people who had ever injected drugs, even just once. Most people who are currently injecting drugs or who had in the past would be very reluctant to acknowledge this without being asked the question—have you ever injected drugs—and with good reason. While this was given the higher Grade B it would have had limited effectiveness.
The Grade C for Baby Boomer testing would mean that few people would be offered the one-time test and insurance coverage would be unlikely—most likely on a case-by-case basis and insurance companies might or might not have covered the test.
Both of these recommendations missed the mark.
After the draft recommendations were published, the public had the opportunity to comment. The response was overwhelming, in large part due to the local, state, and national advocacy efforts. In addition, both data that the USPSTF had missed and new data was offered up to USPSTF for evaluation. Based on the huge advocacy efforts and the additional information USPSTF reviewed, the Baby Boomer recommendation was changed to Grade B. The recommendation originally for those who ever injected drugs and those who received a blood transfusion before 1992 remained Grade B, but the language of the recommendation was changed to “USPSTF recommends screening for hepatitis C (HCV) infection those at high risk for infection.” This was another win since providers should be prompted to talk with the patients about risk factors rather than the discussion being prompted by the patient.
The chances of the draft recommendations for Baby Boomers and new language for at-risk adults being implemented were slim to none—so great big kudos to all the advocates who made the changes possible. The tremendous advocacy efforts mean that HCV advocacy has finally come of age!
The USPSTF recommendations carry a lot of weight. Now, medical societies and providers will be very likely to recommend that all Baby Boomers and at-risk adults should be offered a one-time HCV antibody test. In addition, medical insurance should cover the test, especially with the implementation of the Affordable Care Act (ACA aka Obamacare).
USPSTF has a huge influence on medical care in the United States. Now, insurance coverage (public and private) is required for any recommendation made by USPSTF with a Grade A or B. Given that HCV is the most common blood-borne pathogen infection in the United States and results in over 15,000 deaths a year it is imperative that we tackle HCV to help slow down or prevent the future consequences. These recommendations will certainly have a profound effect on the future of HCV and the prevention of unnecessary suffering and death.
The CDC conservatively estimate that the following outcomes will result from Baby Boomer testing:
About 800,000 people with HCV will be identified
More than 400,000 people will be treated with antiviral medications
Over 200,000 cases of cirrhosis will be prevented
About 73,000 cases of decompensated cirrhosis will be prevented
Over 47,000 cases of liver cancer will be prevented
More than 15,000 liver transplants will be prevented
Most importantly, over 120,000 deaths will be prevented
Another benefit of identifying the 800,000 people with HCV is that we will have that many more advocates who can raise their voices to demand more services and support for everyone affected by hepatitis C. In my opinion, this ranks up there with the realization that HCV can be cured, and the newer therapies that hold the promise of a much higher cure rate, but without the side effects of the current therapy. Good news all around and a real milestone in the history of hepatitis C.
For more information on ACA, Medicaid and health insurance exchanges read Jacques Chambers’ column in this issue.
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To Order the Baby Boomer Postcard Go to: www.hcvadvocate.org/hepatitis/materials.asp
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—Lucinda K. Porter, RN
Article: Hepatitis C-Associated B-Cell Non-Hodgkin Lymphomas: Epidemiology, Molecular Signature and Clinical Management – J. Peveling-Oberhag, et al.
Source: Journal of Hepatology July 2013
Clinical evidence shows an association between chronic hepatitis C virus (HCV) infection and B-cell non-Hodgkin lymphoma (B-NHL). Data suggests a causal relationship between the two, notably because B-NHL occurrence is reduced in those who have a sustained response (SVR) to HCV treatment. This article was a review of the data on the epidemiology, interventional studies, and molecular mechanisms of HCV-associated B-NHL.
The Bottom Line: HCV patients have a moderately increased risk of B-cell non-Hodgkin lymphoma. Patients who are in remission from B-NHL, should be considered for HCV treatment in order to prevent B-NHL recurrence. The authors of this article encourage the inclusion of patients with B-NHL in HCV studies.
Editorial Comment: I chose this paper because it is a sharp reminder that HCV patients are at increased risk of other comorbidities, and these risks are yet another reason to consider HCV treatment.
Article: Dermatological Side Effects of Telaprevir-Based Triple Therapy for Chronic Hepatitis C in Phase III Trials in Japan – H. Torii, et al.
Source: Journal of Dermatology June 5, 2013 [Epub ahead of print]
Rashes are a common, frustrating, and potentially life-threatening side effect of telaprevir-based triple therapy. This Japanese study followed 126 treatment-naïve patients and 141 treatment-failure patients who were taking triple therapy using telaprevir, peginterferon and ribavirin for 12 weeks, followed by 12 weeks without the telaprevir (T12/PR24 group). To compare, there were 63 treatment-naïve patients taking peginterferon and ribavirin for 48 weeks (PR48 group).
The Bottom Line: More than 80% of the patients had dermatological side effects. Most were mild to moderate. However, there were more moderate to severe reactions in the T12/PR24 group, and the reactions began much earlier. In the T12/PR24 group, there were two cases of Stevens-Johnson syndrome and one case of drug rash with eosinophilia and systemic symptoms.
Editorial Comment: According to the package insert for telaprevir-based triple therapy, rashes occurred in 56% of patients vs. 34% among those taking peginterferon and ribavirin. In the pre-triple therapy days using peginterferon and ribavirin, the package insert lists less than 20% of patients reporting rashes. Here is what I wonder: Is the 80% because of population differences (Japan vs U.S-based) or because the registration trials used far more people (746)? Alternatively, is the number of rashes actually higher than reported in the package insert? A French study released earlier this year on the real life safety of telaprevir had dermatological problems at 70%, with nearly 7% as severe.
As for discontinuation rates due to skin problems, the data from the Japanese study roughly matched the package insert (<1%). However, a poster using U.S-based data presented at the June 2013 Asian Pacific Association for the Study of the Liver Conference (Reasons for Treatment Discontinuation among Hepatitis C Patients Treated in Clinical Practice – M. Ulcickas Yood) showed discontinuation rates for skin-related problems from ~ 250 patients to be between 4 and 6% for both combination and triple therapy.
Article: Baseline Viral Load Thresholds Predicting Virological Response to Peginterferon Alfa-2a/Ribavirin in HCV G2 and G3 Patients: PROPHESYS Cohort Sub-Analysis – M.L. Shiffman, et al.
Source: Reported at the 23rd Conference of the Asian Pacific Association for the Study of the Liver June 2013
The standard of care for treating HCV patients with genotype 2 or 3 is peginterferon and ribavirin for 24 weeks. This study analyzed the response rates among 1076 patients in these groups, finding that baseline viral loads are associated with response rates. In both genotypes, undetectable virus by week 4 (rapid virologic response/RVR) is the best predictor of SVR.
The Bottom Line: RVR seems to be a stronger predictor of SVR than baseline viral load is.
Editorial Comment: The response rates of genotype 2 and 3 are attracting a lot of attention. Recent data shows that genotype 3 is somewhat resistant to HCV-protease inhibitors, compared to genotype 1 which has higher SVR rates. A poster presented in June at the International Workshop on HIV & Hepatitis Virus Drug Resistance and Curative Strategies in Toronto showed lab data supporting this resistance. (In Vitro Efficacy and Resistance Profiling of Protease Inhibitors against a Novel HCV Genotype 3a Replicon).
Article: Key Drivers and Barriers to Treatment Initiation and Adherence in Individuals with Hepatitis C – S. Virabhak, et al.
Source: Presentation at Digestive Diseases Week (DDW), Orlando Florida May 2013
The purpose of this survey was to assess the reasons that HCV patients would undergo interferon-based treatment (combination or triple therapy). There were 151 participants who answered an online survey, followed by 12 interviews.
The Bottom Line: The top reasons that patients gave for undergoing HCV treatment were:
The top reasons patients gave for not seeking treatment were:
Fear of side effects
Asymptomatic/ Doctor recommendation against treatment
Low chance of success
Waiting for new treatment
Fear of the impact on daily life
Length of treatment
Editorial Comment: This is a small survey, and since it used volunteers, it is impossible to make broad conclusions about the findings. From an advocacy standpoint, I believe that there is a need for better education and support for HCV patients. It will be interesting to see next year if new HCV treatments and the Affordable Care Act will affect how we think about HCV treatment.
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HEALTHWISE: When A and E Meet Hepatitis C
—Lucinda K. Porter, RN
Living with chronic hepatitis C virus infection (HCV) is problematic enough, but if the liver has to contend with an additional virus, this presents an enormous burden. This month, I discuss two types of viral hepatitis—A and E. Both are global problems, considerably bigger health issues outside of the U.S. However, history has taught us that global diseases can become local problems.
This summer, nearly 145 people in eight states were stricken with hepatitis A virus (HAV) linked to “Townsend Farms Organic Antioxidant Blend” frozen berry and pomegranate mix purchased at Costco. No deaths were reported, but at least 63 people were hospitalized.
Here is the good news: there was only one report of an HAV infection in a child. Since smoothies are popular among children, why weren’t more children infected? Vaccination. The HAV vaccine has been protecting children since 2006. The one reported child in this recent HAV outbreak was not immunized.
Prior to the vaccine, about one-third of the HAV cases in the U.S. occurred in children 5 to 14 years of age. According to the Centers for Disease Control and Prevention (CDC), in the U.S. there were 31,582 HAV cases in 1995. In 2010, there were 1,670.
HAV is a highly contagious virus that infects the liver, and although it is rarely life threatening, it needs to be taken seriously. HAV may be more severe for those with other liver diseases, such as HCV, and for those with compromised immunity, such as with HIV. The virus is most often transmitted when an infected food handler passes the disease to people who eat or handle infected food. Although some people have no symptoms, many have fever, fatigue, nausea, vomiting, and abdominal and joint pain. In severe cases, it can cause liver failure and require a transplant.
HAV vaccination is recommended for:
Travelers to countries that have high prevalence of HAV
Men who have sex with men
Those who use injection and non-injection recreational drugs
People with chronic liver diseases, such as hepatitis B or C
People who are treated with clotting-factor concentrates
People who work with HAV, such as in research
Others who are at higher risk for HAV, and for whom vaccination should be considered are:
Employees of child day care centers
People who care for or live in facilities such as nursing homes, prisons, etc.
Two doses of HAV vaccine are needed for lasting protection. For adults also needing hepatitis B (HBV) immunization, the HAV vaccine is available in a formulation that protects against both. It is called Twinrix, and is given in a series of three injections over a six-month period. Those with HIV may be safely vaccinated against HAV and HBV.
The HAV vaccine has been used in millions of cases worldwide, with no reports of serious adverse events. In very rare cases, a person may be allergic to some component of the vaccine, such as a preservative. Roughly half of those who receive the vaccine will have mild side effects, such as soreness at the injection site (56%), headache (14%), or temporary weakness (7%). When these problems occur, they usually happen 3-5 days after vaccination and last for 1 or 2 days.
Those who have had HAV are immune to getting it again. Those who aren’t immune naturally or through vaccination, and who are exposed to HAV might benefit from a shot of either immune globulin or HAV vaccine, if given within the first 2 weeks after exposure. Immune globulin is made from plasma that contains antibodies that protect against infection.
Healthy travelers who are not immune to HAV may benefit from even a single dose of HAV, given at any time before departure. This provides some protection, and they can have the other HAV dose when they return. Unprotected travelers can minimize their HAV risk by avoiding potentially contaminated water or food, undercooked shellfish, and uncooked fruits or vegetables not peeled or prepared by the traveler.
Hepatitis E virus (HEV) infection is uncommon in the U.S. Worldwide, HEV is probably the most common cause of acute hepatitis, perhaps infecting up to one third of the world’s population.
HEV transmission is related to poor sanitation in large areas of the world. HEV is a waterborne disease, and contaminated water or food supplies have been implicated in major outbreaks. It may be spread via raw or uncooked shellfish and pork, from animals to humans, transfusion of infected blood products, and vertically from a pregnant woman to her fetus. Preliminary research suggests that men who have sex with men may be at risk for HEV.
HEV risk reduction is similar to that of HAV. When traveling internationally in high-risk areas, avoid potentially contaminated water or food, such as undercooked pork. China has produced an HEV vaccine, but it isn’t available in the U.S.
HEV infection is fatal about 4% of the time. Liver transplant recipients may be at a greater risk for HEV infection. Fatality increases to 20% among pregnant women. Liver failure in infected pregnant women is high. Treatment for HEV is largely supportive—rest, alcohol avoidance, fluids, and a nutritious diet.
Although HEV prevention is not as straightforward as HAV prevention is, the fact that HEV prevalence remains low in the U.S., suggests that precautions generally work to protect travelers. If you plan to travel to an area with a high prevalence of HEV, or other potentially infectious diseases, begin your travel with a stop at the CDC’s Travelers’ Health website: wwwnc.cdc.gov/travel
Centers for Disease Control and Prevention:
Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of Free from Hepatitis C and Hepatitis C One Step at a Time (September 2013) Her blog is http://lucindaporterrn.com
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DISABILITY & BENEFITS: Medicaid & the Affordable Care Act (ACA)
—Jacques Chambers, CLU
Medicaid is one of the least understood of any government health programs, and it has always been complicated. Unfortunately, it is about to get even more complicated, although mechanisms are being put in place that will hopefully simplify it for beneficiaries.
A lot of the original confusion surrounding Medicaid starts with the fact that, although Medicaid was created under the federal Social Security Act, there are really 50 separate Medicaid programs. Implementation of Medicaid is the responsibility of each state. In some states, it’s not even always called Medicaid, e. g., Medi-Cal in California, TennCare in Tennessee.
While the federal government provides some basic requirements for determining eligibility for coverage and benefits to be provided, each state can expand Medicaid beyond that level. As a result of this flexibility, each state’s Medicaid program covers a slightly different group of people with a slightly different set of benefits.
Under the Affordable Care Act, Medicaid is expanding and many more people will be eligible for it, but only in some states. The expansion will take place on January 1, 2014 as the private insurance rules take effect also.
When the US Supreme Court upheld ACA, they agreed that it was constitutional EXCEPT they ruled that the federal government could not require every state to expand their Medicaid program as originally proposed. They ruled that each state could either accept the expansion and the additional federal money that went with it, or refuse the expansion and keep their Medicaid program as it is currently.
Because of this decision, many states are choosing to maintain their Medicaid as it is without the ACA expansion, even though the federal government will pay 100% of the expansion costs in the first year and 90% after that.
As of June 14, 2013, 26 states plus the District of Columbia have elected to expand their Medicaid coverage and New York is leaning toward expansion. Thirteen states have decided not to expand their Medicaid and 7 more states are leaning toward declining to expand or are proposing alternative plans. To see where your state stands at present, go to www.advisory.com/Daily-Briefing/2012/11/09/MedicaidMap
The decision not to expand will prevent low-income individuals and families from getting any health insurance, since, other than expanded Medicaid, there is no alternative coverage. As you can see by clicking the above link, most of the states that are not participating in expanded Medicaid are in the south, and many of the declining states have the largest number of uninsured people.
The remainder of this article focuses on the Expanded Medicaid under ACA. If your state is not participating in this expansion, it does not apply to you.
Eligibility for Expanded Medicaid
Medicaid originally covered several groups of people, all of which had to meet fairly stringent income and asset limits. This included single parents with children, the disabled, and persons over age 65.
Under ACA, any individual or family will be eligible under expanded Medicaid if their Modified Adjusted Gross Income (MAGI) is less than 138% of the Federal Poverty Level. Using the Federal Poverty Level released in April 1, 2013 for the 48 contiguous United States (Alaska and Hawaii used slightly higher tables), 138% of FPL for a single person is $15,856 per year, with increases based on the number in the family. A family of four, for example, will be eligible for Medicaid if their annual income is $32,499 or less.
Enrollment in Medicaid will be streamlined and simplified. Anyone seeking health insurance under the new law should first go to their state’s health exchange website. For persons who prefer, counselors will be available by phone and, in many states, in person. For information on the exchange in your state, see: www.healthcare.gov/what-is-the-marketplace-in-my-state
Whether your state uses the federal marketplace or creates its own, you will be able to go through a series of questions concerning your family size and income. If your family income, based on the size of the family, is below 138% of the Federal Poverty Level, you will be referred to a site or person who will enroll you in Medicaid.
The federal government mandates that expanded Medicaid must offer the same set of Essential Services that is required of private insurance plans using the health exchanges:
Ambulatory patient services (outpatient care you get without being admitted to a hospital);
Maternity and newborn care;
Mental health benefits and substance use disorder services;
Prescription drugs (unless on Medicare as well);
Rehabilitative and habilitative services and devices (services and devices to help people with injuries, disabilities, or chronic conditions gain or recover mental and physical skills);
Preventive and wellness services;
Chronic disease management; and
Pediatric services including oral and vision care.
Historically, the quality of care can vary widely under Medicaid. Each state determines the amount it will pay medical providers for their services. In some states the reimbursement level is sufficient enough that many providers will participate. In other states, the reimbursement level is so low that most private physicians will not accept a patient whose only coverage is Medicaid, and Medicaid beneficiaries must seek their medical care at public health clinics, free clinics, government hospitals, and non-profit medical facilities. Under ACA, different pilot programs are working to eliminate this problem.
Most states are moving to Managed Care Programs, usually Health Maintenance Organizations (HMOs) and similar networks, to provide care under Medicaid. In many states, the only option under Medicaid will be an HMO-type plan, which limits your choice of medical providers and requires you to let a Primary Care Physician direct all of your care and authorize referrals to specialists.
Some states will offer a range of plans for Medicaid eligible persons; others will have a single program. Some states will have different programs in different counties. States will also be creating plans specifically for persons covered under both Medicare and Medicaid.
The issues in these programs will be similar to those in private HMO insurance plans. Your choice of providers will be limited to panel hospitals and doctors. Referral to specialists must be authorized by your Primary Care Physician, also called the Gatekeeper for obvious reasons.
There may be co-pays; however, they will be waived for the very low income enrollees. For more information on how Medicaid will work in your state go to: www.healthcare.gov/do-i-qualify-for-medicaid or www.medicaid.gov
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