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HCV Advocate Newsletter

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November 2012 HCV Advocate

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In This Issue:

Abbott All Oral Results: Up to 99%
Alan Franciscus, Editor-in-Chief

HCV Snapshots
Lucinda K. Porter, RN

HealthWise: - Faith and the Liver
Lucinda K. Porter, RN


Type 2 Diabetes and Insulin Resistance in People with HCV – Part 2: Managing Diabetes
Liz Highleyman


Dsability & Benefits: Medicare Enrollment – Hidden Traps
Jacques Chambers, CLU




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Abbott All Oral Results: Up to 99%
—Alan Franciscus, Editor-in-Chief

On October 15, 2012, Abbott announced the SVR12 results from a phase 2b study of their three direct acting antiviral (DAA) medications in combination with ribavirin—there was no interferon used in these studies. 

The Aviator Study
The phase 2b trial was designed to evaluate the safety and efficacy of a 4-drug combination to treat HCV genotype 1 treatment-naïve and prior pegylated interferon and ribavirin null responders—prior null responders represent a group of people who are the least likely to achieve a viral cure.  

The three DAA drugs include:

  • ABT-450* (100 or 200 mg once daily (QD))  with low dose ritonavir (100 mg QD) to boost the ABT-450 drug blood levels – protease inhibitors

  • ABT-333 (400 twice daily (BID)) –polymerase inhibitor

  • ABT-267 (25 mg QD) – NS5A inhibitor

*ABT-450 is Enanta’s DAA that is being developed in collaboration with Abbott.

Ribavirin was dosed by body weight.  The treatment duration was either 8 or 12 weeks.  The highest SVR12 results were found in the group that was treated for 12 weeks (below).
SVR 12 rates ranged from 98% to 100% in the treatment naïve patients and 89 to 100% in the null-responder patients.  The results are list below:

  • Treatment naïve:  99% (76 out of 77 patients)—there were no viral breakthroughs on treatment; SVR12 by subtype – 1a (98%); 1b (100%)

  • Prior null responders:  (38 out of 41 patients) – there were 3 viral breakthroughs on treatment; SVR12 by subtype –1a (89%); 1b (100%)

Note:  there were 2 treatment-naïve and 1 null responder patients who were either lost to follow-up or have not yet reached treatment week 12. 

Four out of 448 patients (1%) discontinued treatment due to side effects.  The most serious side effect believed to be caused by the experimental drugs was joint pain.  Less serious side effects included fatigue (27-31%) and headache (28-29%) in the treatment naïve and null- responders respectively.

Abbott also announced that more data on this trial and other studies will be presented at the upcoming American Association for the Study of Liver Diseases (AASLD) meeting in Boston, MA on November 9 through 13, 2012. 

Abbott has been approved to begin a Phase III study of this combination in HCV genotype 1 patients with cirrhosis—www.clinicaltrials.gov—identifier:  NCT01704755.  Stay tuned for more Phase III studies of this combination in other populations. Abbott estimates that this combination will be approved by the Food and Drug Administration (FDA) in 2015—that is if there are no unexpected problems between then and now.  It is also possible that Abbott will co-formulate (combine) these drugs, which could result in a smaller pill burden.    

At this stage in drug development there appears to be 3 companies that are neck and neck for the first interferon-free drug approval for HCV genotype 1 patients.  The first interferon-free therapy that will be approved will most likely be Gilead’s GS-7977 in combination with ribavirin for HCV genotypes 2 and 3. 

Regardless of who is first to receive approval we are moving that much closer to a viral cure for all of those infected with hepatitis C and a therapy that does not include interferon.

AASLD 2012
In addition to more information about this study there will be many more studies of DAAs presented including:

Next wave of HCV DAAs plus PEG/RBV

  • Boehringer Ingelheim:

    • Addition of the NS5B polymerase inhibitor BI 207127 to PEG/RBV for 4 weeks followed by PEG/RBV for 44 weeks improves SVR24 rates in treatment-naïve patients with HCV Genotype 1 and is well-tolerated

  • Tibotec:

    • Efficacy and tolerability of TMC435 150mg once daily with PEG/RBV for the treatment of HCV genotype 1 infection with Metavir score F3 and F4 (PILLAR and ASPIRE trials)

DAA Combinations:

  • Boehringer Ingelheim:

    • SOUND-C2:  SVR4, 12 AND 24 concordance in genotype 1 HCV patients receiving interferon-free treatment with the HCV NS3/4A protease inhibitor and the NS5B inhibitor BI 207127

  • Bristol-Myers Squibb:

    • 94% SVR4 result of an all oral DAA clinical trial that does not include interferon or ribavirin  

    • SVR12 results from a study of daclatasvir and asunaprevir with and without interferon/ribavirin to treat HCV genotype 1 null responders

    • SVR12 results of Peg Lambda in combination with ribavirin with either daclatasvir or asunaprevir

  • Genentech/Roche:

    • SVR24 results of danoprevir (booster with ritonavir) plus PEG/RBV to treat HCV genotype 1 and 4 patients

    • Up to 100% SVR4 rate with ritonavir-boosted danoprevir, mericitabine and ribavirin with and without PEG in HCV genotype 1 partial and null responders:  results from the MATTERHORN study.

  • Gilead:

    • Interim results that showed high efficacy of sofosbuvir (GS-7977) in combination with low and full dose ribavirin for a treatment period of 24 weeks

    • Once daily sofosbuvir plus ribavirin to treat genotype 1, 2, and 3 – results from the ELECTRON Trial.

    • Once daily sofosbuvir plus PEG/RBV—early response rates are maintained post treatment in Genotype 1, 4, and 6—ATOMIC Study

  • Merck:

    • Safety and SVR of MK-5172 for 12 weeks plus PEG/RBV for 24 weeks – HCV genotype 1 treatment-naïve non-cirrhotic patients



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HCV Snapshots
—Lucinda K. Porter, RN

Article: Predicted Effects of Treatment for HCV Infection Vary among European Countries by Deuffic–Burban S, Deltenre P, Buti M, et al.
  Source: Gastroenterology October 2012; Volume 143, Number 4, Pages 974-985

This research assessed the differences between screening and therapy practices of HCV patients in Belgium, France, Germany, Italy, Spain, and the United Kingdom from 2002-2011. Researchers were curious about the impact of HCV treatment (IFN and ribavirin) on HCV-related cirrhosis and mortality, and the impact of newer direct-acting antiviral drugs (DAAs) in the future.

The Bottom Line: HCV treatment reduced the incidence of cirrhosis by 7% and deaths by 3.4% from 2002 to 2011. Scientific extrapolation presumes that advances in antiviral therapy using DAAs, along with improved screening to identify patients with HCV will yield even higher numbers than those seen from 2002 to 2011.  

Editorial Comment: Although this is a European study, it mirrors the situation in the U.S. With the Centers for Disease Control and Prevention’s new recommendations for one-time HCV screening of all persons born from 1945 through 1965, improved testing, and treatments with higher efficacy rates, we will see a difference in morbidity and mortality, assuming we keep moving forward.

Article: Excess Body Weight and the Risk of Primary Liver Cancer: An Updated Meta-Analysis of Prospective Studies by Chen Y, Wang X, Wang J, et al.
  Source: European Journal of Cancer September 2012; Volume 48, Issue 14, Pages 2137-2145

This study looked at scientific literature on the relationship between primary liver cancer and excess body weight published from 1966 through 2011. There were 26 prospective studies and more than 25,000 cases of primary liver cancer.

The Bottom Line: Excess body weight was strongly associated with an increased risk of primary liver cancer.

Editorial Comment: I am not sure which is more difficult—hepatitis C treatment or losing weight. However, studies drive home the point that we continually hear—excess weight increases the risk of many health problems. Since HCV-related cirrhosis increases the risk of liver cancer, then obesity would add to this risk.

Article: All-Cause and Liver-Related Mortality in HIV Positive Subjects Compared to the General Population: Differences by HCV Co-Infection by Hernando V, Perez-Cachafeiro S, Lewden C, et al.
  Source: Journal of Hepatology October 2012; Volume 57, Issue 4, Pages 743-751

This Spanish study compared mortality rates in HIV-positive and HIV/HCV co-infected patients to the general population of the same gender and age from 1997-2008. There were 5914 HIV+ subjects; 37% were HIV/HCV co-infected.

The Bottom Line: Compared to the general population, HIV+ subjects had increased risk of mortality from all causes, included liver-related. Risk of death increased for HIV/HCV co-infected patients. Injection drug users had a higher mortality risk than men having sex with men and heterosexuals with AIDS who denied injection drug use.

Editorial Comment: This study adds weight to previous studies showing increased mortality risk for HIV/HCV co-infected patients. It also raises the question about increased risk of mortality from all causes, not just liver-related ones. September 2012 “Snapshots reported an increased risk for death from liver and non-liver diseases for those with HCV. This brings into light whether patients and physicians need to consider overall health, and not just the health of the liver, when making decisions about HCV treatment.

Article: Bipolar Patients Can Safely and Successfully Receive Interferon-Based Hepatitis C Antiviral Treatment by Kelly E, Corace K, Emery J, et al.
  Source: European Journal of Gastroenterology and Hepatology July 2012; Volume 24, Issue 7, Pages 811-6

This retrospective analysis evaluated the risk of antiviral treatment on HCV patients with bipolar disease from 2000-2008. Of 38 bipolar patients with HCV at The Ottawa Hospital, 16 underwent antiviral therapy.

The Bottom Line: Stable bipolar patients had similar rates of on-treatment psychiatric complications as patients with a history of depression. The researchers concluded that with suitable intervention and clinical monitoring, stable bipolar patients can successfully complete treatment with similar results compared to non-bipolar patients.

Editorial Comment: Bipolar patients are often not considered for HCV treatment, especially in the clinical trial setting because of the risk of interferon-induced exacerbation of their mood disorder. This study challenges this long-standing practice, and opens the door for HCV+ bipolar patients who are considering treatment.

 


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HEALTHWISE: Faith and the Liver
—Lucinda K. Porter, RN

Twenty-five years ago while on the brink of death, I was told to say good-bye to my family. My liver had failed and my kidneys were next. Death hanging over my shoulder, I panicked, and then did something completely uncharacteristic—I prayed. The only way to put this sounds overdramatic, but after I prayed, I felt a sense of peace never before experienced. I knew that all would be well, whether I lived or died. I left the hospital two weeks later; the hospital staff said my recovery was a miracle.

I don’t know if it was a miracle, but it was a turning point. My story ended well, but I can’t say with conviction that my prayers were answered, particularly because I didn’t ask for anything. I simply gave myself over to a power greater than myself. What I do know is that prayer helped me to focus on something other than fear. Fear activates physiological responses that hinder the body’s ability to heal. Did I get well because prayer diverted me from feeling fear or was my recovery due to medical intervention? Did I survive because of divine intercession or just plain luck?

Scientists, theologians and philosophers have been debating the issue of faith and health since the dawn of civilization. While the religious have long believed in the power of prayer, scientists rely on evidence rather than belief. Looking for proof, Leanne Roberts and colleagues reviewed ten databases for research on the use of intercessory prayer (praying for someone else) during illness.1 Writing for the evidence-based Cochrane Collaboration, they looked at medical outcomes for those who were prayed for compared with those who weren’t.

The Cochrane Review authors found ten clinical trials with a total enrollment of over 7800 subjects. Everyone received treatment for their illness, but some were also randomized to groups where they were prayed for. One trial had three groups: Group A wasn’t being prayed for; Group B’s participants knew they were being prayed for; Group C’s participants were unaware that prayers were being said for them.

The results varied. Generally, there were no differences in illness recovery rates between those who were prayed for and those who weren’t. In one study, those who were at high risk of dying had a significantly higher survival rate if prayers were said for them. Those who were not being prayed for had a higher risk of certain medical complications. Overall, there were fewer post-operative complications in the group whose members knew prayers were being offered.

Studies such as these can be problematic. Is it possible to design a clinical trial that can really measure prayer? For instance, how do we know that the people who were in the non-prayer group weren’t receiving prayers from other sources? Are all prayers equally as powerful? What if the person doing the praying was not feeling well and prayed in a half-hearted manner? Are the Pope’s or your mother’s prayers more effective than those from someone who volunteers to pray as part of a study?

Roberts and colleagues concluded that there was insufficient evidence either for or against the use of intercessory prayer. They recommended that this subject not be further investigated—that resources should be used to study other medical issues.

Spirituality
Dr. Franco Bonaguidi of the Institute of Clinical Physiology of the National Research Council in Italy did not follow the Cochrane Review’s recommendation. Franco is a psychologist who assesses patients considered for liver transplantation. He noted that these patients live between life and death and was interested in how they cope with the stress of their condition.

Bonaguidi was curious if religiosity (belief in God) was associated with the survival rate of liver transplant patients. Before researching this, Bonaguidi analyzed prior research on the connection between religiosity and health. Surveying nearly 126,000 people in 42 studies, his team controlled various factors, such as socioeconomic and physical health. The results showed that those who were actively involved in religion had a 26% increased chance of being alive during the study compared to those who were less or not active in a religion.

Following this analysis, Bonaguidi and colleagues studied 179 liver transplant candidates, before and after transplantation. Participants completed questionnaires about their religious beliefs, and were grouped by religiosity. Patients were followed for three years. The results were published in the October 2010 issue of Liver Transplantation.2

Patients, who believed in fate or passively accepted the existence of God but did nothing to foster spiritual growth, had a three-fold higher risk of death compared to active searchers. This study is interesting because it measured individual relationships with God, rather than church-attendance or particular religions. In fact, participants could have a high level of religiosity and not belong to a particular religion.

I asked Dr. Bonaguidi why he conducted this study.

 “In this situation patients become true and essential and discover the values of life. Material aspects of life (career, money etc.), which they pursued before, lose their importance... patients become sensitive to the suffering of others. Many return to God, a personal, private, intimate God that infuses them with a feeling of revival and of beauty toward the world and the mystery of life. Patients come out of the dark and recover new energy and desire toward life. Because of these manifestations, I tried to understand whether this attitude to religiosity could be related to psychological frailty and therefore be a risk factor, or on the contrary, could be a psychological resource and hence a protective factor for the liver transplant outcome.”

I appreciate Bonaguidi’s insight, and although I am drawn to research on the relationship between health and spiritual matters, I wonder if it really matters. For instance, I may want to know the latest research about hepatitis C medications before using them, but the results of a study would not influence whether I prayed or not. Scientific study requires proof beyond belief, but spiritual belief does not rely on facts.

When Dr. Bonaguidi was asked if he had advice for patients who may be facing liver failure or other serious illness, he replied:

 “I would like patients to consider what has occurred to them: the anguish at the discovery of the disease, anger and their fragility, the absolute terror of dying before having lived well, and the resort to God. I would also like them to consider the loss of their self-absorption and discovery of a new relationship with others.”

In this light, it seems that spiritual connection may be more than just physically and mentally therapeutic—it may also help heal relationships. A patient told Dr. Bonaguidi, “I found myself ready for a new approach to people I before considered enemies. Now I’m interested in evaluating also the good in these persons.” These therapeutic benefits even extended to Dr. Bonaguidi. “With them (the patients in his study), I have also discovered in myself some aspects I had ignored before, which have contributed to changing my professional approach to them.”

My experience was similar. In the beginning, prayer helped me to focus on something other than my fear. Eventually, prayer helped me to focus on someone other than myself. When I stopped fretting about me, I found freedom. In freedom, I found true health.

Lucinda K. Porter, RN, author of Free from Hepatitis C is a long-time contributor to the HCV Advocate. Her blog is http://lucindaporterrn.com

Recommended Reading:
The Anatomy of Hope: How People Prevail in the Face of Illness by Jerome Groopman

Endnotes
1 Roberts L, Ahmed I, Hall S, Davison A. Intercessory Prayer for the Alleviation of Ill Health. Cochrane Database of Systematic Reviews 2009, Issue 2.
2 Bonaguidi, F., Michelassi, C., Filipponi, F. and Rovai, D. Religiosity Associated with Prolonged Survival in Liver Transplant Recipients. Liver Transplantation, October  2010

 

Further Reading:

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Type 2 Diabetes and Insulin Resistance in People with HCV – Part 2: Managing Diabetes
—Liz Highleyman

People with type 2 diabetes can live relatively healthy and symptom-free lives if they take good care of their health and carefully manage their disease. This involves establishing a healthy diet and exercise routine, treatment with oral medications or insulin, and regular blood glucose monitoring.

Diet and Excercise
The first steps in managing insulin resistance, pre-diabetes, and diabetes are a balanced diet and adequate exercise, with the goal of achieving and maintaining a healthy body weight. Studies have shown that people with pre-diabetes who lose weight and increase their physical activity can prevent or delay progression to type 2 diabetes, and in some cases blood glucose levels may return to normal.

Fresh fruits and vegetables, whole grains, and lean protein are the mainstays of a healthy diet. A food’s glycemic index indicates how much its carbohydrates raise blood glucose levels. Some research indicates that foods with a high glycemic index are associated with obesity and type 2 diabetes. A dietitian can help develop an appropriate personalized eating plan.

In addition to promoting healthy weight and improving cardiovascular health, studies suggest that regular exercise can help the body use insulin more efficiently. The CDC recommends that adults age 18 and older should get at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic exercise per week, along with muscle strengthening exercises at least two days per week.

Anti-diabetic Medications
Type 2 diabetes cannot always be fully managed with diet and exercise alone. While there is no cure for diabetes, various treatment options can keep it under control.

Oral anti-diabetic medications only work for people who are able to produce some insulin, which is usually the case with type 2 diabetes. The aim of treatment is to help the body produce more insulin and use it as efficiently as possible.

Two classes of diabetes medications work by stimulating increased production and release of insulin from beta cells in the pancreas. Sulfonylurea drugs include the older chlorpropamide (Diabinese) and tolbutamide (Orinase), as well as second-generation agents such as glipizide (Glucotrol), glyburide (several brand names including Diabeta, Glynase, and Micronase), and glimepride (Amaryl). Metglitinides include repaglinide (Prandin) and nateglinide (Starlix).

Alpha-glucosidase inhibitors are oral anti-diabetic drugs that interfere with digestion of carbohydrates such as starches and certain sugars, resulting in a slower increase in blood sugar after eating. These include acarbose (Precose) and miglitol (Glyset).

Biguanides help lower blood glucose by decreasing the amount of sugar produced by the liver. The only drug currently used in this class is metformin (Glucophage).

Finally, thiazolidinediones or “glitazones” make cells more sensitive to insulin. Drugs in this class include pioglitazone (Actos) and rosiglitazone (Avandia). Both are under usage restrictions in the U.S. and Europe due to risk of serious adverse events (cancer and cardiovascular events, respectively).

Another drug of this type, troglitazone (Rezulin), was withdrawn from the market due to fatal liver toxicity. Thiazolidinediones should be used with caution in patients with pre-existing liver disease. While treatment guidelines say they should not be used by people with very high transaminase liver enzyme levels, they are not contraindicated overall for people with hepatitis C.

Some anti-diabetic drugs are metabolized by CYP450 enzymes in the liver, which means they have the potential to interact with other drugs processed by the same pathways. The new HCV protease inhibitors boceprevir (Victrelis) and telaprevir (Incivek) do affect CYP450, but so far there have been no reported drug-drug interactions between diabetes medications and these direct-acting antivirals.

On a related note, some studies have found that HIV protease inhibitors appear to contribute to the development of insulin resistance and type 2 diabetes. No such effect has yet been reported with HCV protease inhibitors, and the risk would seem to be much lower because they are used for only six to 12 months, compared with potentially lifelong antiretroviral therapy for people with HIV.

Oral anti-diabetic drugs alone do not work for everyone. Even if they reduce blood glucose levels somewhat, they may not bring them within the optimal range for good health. If oral drugs do not adequately control blood sugar, some people with type 2 diabetes may also need injected insulin, like those with type 1 disease. In some cases oral drugs may be combined with insulin, allowing lower insulin doses or less frequent administration.

Blood Glucose Monitoring
The key to managing diabetes is maintaining a stable normal blood glucose level, aided by frequent blood sugar measurement. Traditionally, blood glucose has been monitored by drawing a drop of blood from the finger using a lancet and placing it on a test strip inserting it into a meter that will indicate glucose levels. New methods that are less inconvenient and invasive are under development, however, including monitors that can measure glucose levels through the skin.

Keeping daily records of blood glucose levels — and how they change in relation to meals, exercise, medications, and other factors — is an important step in keeping diabetes under control.

Control is Key
Controlling blood sugar is a key to good health. This involves maintaining a healthy weight, eating right, exercising, and regularly monitoring glucose levels. Treatment is available for people who need more intensive therapy, and new agents are in the pipeline.

Beyond medication, people with insulin resistance or diabetes should take steps to minimize related complications, including regular monitoring of blood pressure, lipid levels, kidney function, and vision. Practice good oral hygiene, get regular dental checkups, and learn about proper foot and skin care. Consult a healthcare provider promptly in case of sores that do not heal or other usual symptoms.

Although people with hepatitis C are at higher risk for type 2 diabetes, research shows that they can successfully manage it. Poorly controlled diabetes is associated with numerous long-term medical complications — an added concern for people who are already facing problems related to liver disease — making conscientious management all the more important.

Resources:

  • American Diabetes Association: www.diabetes.org
  • Centers for Disease Control and Prevention:
    www.cdc.gov/diabetes
  • CDC. National Diabetes Fact Sheet: National Estimates and General Information on Diabetes and Prediabetes in the United States, 2011.
  • National Diabetes Information Clearinghouse/NIDDK: www.niddk.nih.gov/health/diabetes
    /diabetes.htm
  • National Diabetes Information Clearinghouse. Diagnosis of Diabetes and Prediabetes. Last updated August 29, 2012.

Part 1 of this article appeared in the October 2012 Issue of the HCV Advocate newsletter.


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DISABILITY & BENEFITS: Medicare Enrollment - Hidden Traps
—Jacques Chambers, CLU

While enrolling in Medicare is not a complicated process, doing it at the wrong time or declining coverage when you should not can make deciding when to enroll and which parts to purchase a real headache— creating financial and coverage problems that can continue indefinitely. Because of this, even people who are not now on Medicare should become familiar with the process so they will be prepared when they become eligible.

A person becomes eligible for Medicare generally when they turn age 65. Medicare also becomes available to persons collecting Social Security Disability benefits before they turn 65. This is a good time to review the enrollment rules in Medicare since the annual Open Enrollment period—when Medicare beneficiaries are able to make changes in their Medicare coverage—is currently ongoing.

In reviewing when a person may enroll or make changes to his or her Medicare coverage, one needs to understand the various parts of Medicare as eligibility periods and rules can vary:

  • Part A – Hospital Coverage: This part covers stays in hospitals, convalescent care facilities, and hospices. Persons who have paid into the Medicare program in their working career through payroll taxes generally pay nothing for this coverage. Persons who have not may purchase Part A and pay for it themselves upon turning 65.

  • Part B – Medical Coverage: This part generally covers the professional charges of physicians and other health care workers; doctors in or out of the hospital; X-rays, laboratory tests, durable medical equipment, etc. This part is considered “voluntary” and a premium, currently $99.90 per month, is charged to everyone enrolled in it.

  • Part C – Medicare Advantage Plans: These are the alternate plans to “original” or “fee-for-service” Medicare. Offered by insurance companies, they include Medicare HMOs, PPOs, and other types of coverage. If elected, the beneficiary must seek medical care only through the plan; their Part A and B coverages are suspended while they are covered under a Part C plan.

  • Part D – Prescription Drug Charges: These are plans that cover only prescription drugs. Authorized by Medicare, they are sold only through private insurance companies and must be purchased separately. Medicare Advantage Plans (Part C) typically include prescription drug coverage within their plans so separate coverage does not have to be purchased.

  • Medigap (Medicare Supplement) Plans: These plans fill in the “gaps” in the original Medicare Parts A & B due to the deductibles and co-insurance of Medicare. Although Medicare designs the plans which can be marketed, they are sold exclusively by private insurance companies. It should be noted that one may enroll in these plans anytime they have Medicare Parts A & B, but if they do not enroll during special open enrollment periods, they will be subject to medical underwriting which allows the carrier to decide whether or not to offer coverage based on an applicant’s medical condition and health history.

Annual Open Enrollment Period
A Medicare beneficiary has the opportunity to make changes to their coverage during the Annual Open Enrollment Period. While the changes are not effective until the following January 1, they must be made between October 15 and December 7. During this period a person may:

  • Change from Original Medicare to a Part C Medicare Advantage Plan;

  • Change from a Part C Medicare Advantage Plan to Original Medicare;

  • Change from one Part C Medicare Advantage Plan to another Part C Medicare Advantage Plan;

  • Purchase a Part D Prescription Drug Plan:
    Late Enrollment Penalty – it should be noted that if you purchase a Part D Prescription Drug Plan some time after first becoming eligible to purchase one, with a few exceptions, your premium will be surcharged 1% for each month you could have been in a drug plan and didn’t purchase one; or 

  • Switch from one Part D Prescription Drug Plan to another Part D Prescription Drug plan. NOTE: Even if your current Drug Plan has been serving you well, it is advisable to re-run the program at www.medicare.gov in case your medications have changed or your drug plan is revising its formulary or premiums for the coming year. The plans for 2013 are already up on the website at www.medicare.gov.  Click on the link “Part D” and choose “Find a health or drug plan.”

Annual disEnrollment Period
Beginning in 2012, Medicare began offering another annual opportunity for persons who are dissatisfied with their Part C Medicare Advantage Plan. Between January 1 through February 14, a Medicare beneficiary may:

  • Leave a Part C Medicare Advantage Plan and switch to Original Medicare Parts A & B. NOTE: This will trigger an opportunity to add a Part D Prescription Drug Plan without penalty.

  • That is all that can be done during this period. There is no longer an opportunity to switch from one Part C plan to another or switch drug plans as in former years. That must now be done in the October 15 – December 7 Open Enrollment.

Medicare Enrollment opportunities
Turning Age 65 – A person turning 65 has 7 months to enroll in Medicare without penalty, the three months prior to the month he or she turns 65, the month he or she turns 65, and the three months after the month he or she turns 65. It is strongly recommended that you enroll in Medicare in the three months before turning 65; if so, Medicare will be effective on the first of the month that you turn 65. Enrolling in the later four months will delay the Medicare effective date.

At the same time, you should find and enroll in a Part D drug plan as well as Parts A & B of Medicare without penalty. Understand the pitfalls of refusing either Part B or Part D at the time you enroll, outlined below. You also have a guaranteed right (without medical underwriting) to purchase a Medigap policy from a private insurance company.
Once enrolled in Parts A & B of Medicare you will have the opportunity during that seven month period to trade Parts A & B of Medicare for a Part C Medicare Advantage Plan.

Under age 65 and Receiving Social Security Disability Benefits – Medicare benefits start on the 25th month of collecting SSDI benefits. No enrollment is necessary; the Medicare card will arrive in the mail about two months prior to the effective date of coverage. You will be automatically enrolled in both Parts A & B.

Exception: Persons receiving Social Security Disability benefits due to End Stage Renal Disease (permanent kidney failure requiring dialysis or a kidney transplant) or from Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease) do not have the 24 month waiting period to get Medicare. They are eligible for Medicare upon being approved for Social Security Disability benefits.

While you may return the card and refuse Part B coverage, be sure you don’t or won’t need it as there are penalties for enrolling “late” in Part B. You will also have an open opportunity to add a Part D Prescription Drug Plan and also have the right to switch your coverage to a Part C Medicare Advantage Plan.

Federal law does not require insurance companies to accept Medicare beneficiaries under age 65 (disabled beneficiaries) for Medigap coverage on an open enrollment basis as they do for persons turning age 65. Many states, however, have filled that gap with a state statute requiring persons under 65 to be accepted without medical underwriting when first getting Medicare. In states without such legislation, a person under age 65 getting Medicare must go through medical underwriting before getting Medigap coverage.

A Word About Late Enrollment Penalties
Any insurance plan that will let someone join whenever they want without any repercussions won’t last long as most people will simply wait to enroll until they know they will be using the plan benefits. This is the principal behind requiring medical underwriting of persons applying for individual health insurance as well as the Coverage Mandate in the new Affordable Care Act.

Medicare resolves this by imposing substantial financial penalties for someone delaying enrollment into Medicare coverages. For example, if you don’t enroll in Medicare Part A when first eligible, you will pay a 10% surcharge on monthly premiums once you do enroll for as long as you are on Part A. Note this only applies to those persons who will have to pay a premium for Part A.

Medicare Part B is the same except the premium is surcharged 10% for each twelve month period you didn’t enroll. Similar penalties apply to Part D Prescription Drug coverage.

There are Special Enrollment periods during which, due to special circumstances, you will be allowed to enroll late without penalty. However, those rules can be difficult to understand, and very expensive for you if you misread them.

For example, there will be no late enrollment penalties for enrolling late in Medicare Parts A, B, and D IF you were covered under a GROUP health plan through an employer due to the ACTIVE employment of you, your spouse, or other family member AND you enroll in Medicare within the 8 month period beginning the month AFTER the employer-based health insurance is lost. Coverage continued under COBRA Continuation is NOT considered to be active employment.

Before declining or delaying enrollment in any part of Medicare, make sure that the coverage will not later be subject to late enrollment penalties. You can ask Medicare at 800-MEDICARE (800-633-4227). Medicare also has a 12 page publication titled “Understanding Medicare Enrollment Periods.” This can be found by typing the title above in the search box at www.medicare.gov.
Finally, when you are ready to apply for Medicare, in addition to going into a Social Security office, you can apply on line at www.ssa.gov .


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