Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.

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Alan Franciscus

Editor-in-Chief

HCV Advocate



Tuesday, August 18, 2015

Balance Billing by Out-of-Network Providers —Jacques Chambers, CLU

You may think you do not need this information because you “always use In-Network Providers? Surprise! Not necessarily so. Surprise Balance Billing is growing.

Balance Billing is becoming an important health insurance issue and is causing substantial problems to insured people and is occurring more often now that insurance companies offer Managed Care health insurance policies almost exclusively, and at the same time are reducing the number of “preferred” providers in their provider networks.

For Example: Let’s say you have good health insurance, and it is a Managed Care Plan such as an HMO or PPO, as almost all plans are today. You need to go into the hospital for some minor surgery. You are a wise user of healthcare so you check your plan’s network provider directory to be sure your surgeon and the hospital are in your provider network.

The surgery goes well. The bills come, and you wait for the insurance company to process the claim before making any payments. The hospital and surgery discount their bills as in-network or preferred providers so that you only owe the remaining portion of the guaranteed amount, either a co-pay or percentage of a smaller amount that is contracted between your plan and the provider.  As long as it is a network provider, you are only legally obligated to pay your portion of the contracted amount. The provider is prohibited by their contract with the insurance company for billing you for any additional amount.

But then, you receive more bills, this time from an Assistant Surgeon and an Anesthesiologist, two doctors you never encountered before, at least not while conscious. The insurance plan processes their claims and, when the Explanations of Benefits arrive; you suddenly learn those doctors were not “preferred” providers. They were out-of-network doctors who had no contract with your insurance company. Those doctors bill you for a substantial amount of money that the insurance did not cover.

If you are in an HMO; which requires you to use network providers, the HMO will pay $0 of those bills. If you are in a PPO that provides some coverage for out-of-network providers, the plan may pay a small portion of the bills. However, without a contract with the insurance company those two doctors can bill you their full rate and you will be legally on the hook to pay them. By using out-of-network providers, you lost the ability to have your portion of the bills limited.

But wait! That’s not fair! You were never given a chance to make sure those treating physicians were part of the insurance network. I agree, it is not fair, but, unfortunately, it is legal and is happening more frequently. You must pay the bill in full, work out a discounted payment with each doctor, or risk having your credit rating affected.

Do You Have Any Protection from Balance Billing?
Actually, there is very little protection from Balance Billing, although some states have passed legislation to provide some relief. Prevention is the best way to avoid Balance Bills.

The Affordable Care Act does include a provision that helps people who must use out-of-network Emergency Rooms (ERs). It requires insurance plans to cover charges in an ER, even if out-of-network. In those cases, it must pay out-of-network providers no less than what Medicare would pay for such services regardless of what the plan normally pays out-of-network providers. Usually, the providers will accept that payment without balance billing. However, that does not guarantee that out-of-network providers will not still bill you for the balance.

You should also be aware that even though a hospital may be in-network, the doctors staffing the ER may not be. Note that in most jurisdictions, although coverage in an out-of-network ER is limited to “life-threatening” emergencies, courts have interpreted that to be “life-threatening is a condition which appears to be life-threatening by a reasonable lay person.” That means if you have chest pains that are later determined to be bad indigestion, it would still be considered “life-threatening” for insurance purposes.

In addition to Balance Billing in a hospital or an emergency room, another possible source is when you are referred for a consultation to a specialist. This can happen when the health plan’s provider directory is inaccurate or outdated. It can also occur when the referring physician makes the referral without realizing it is to an out-of-network provider. This happens more frequently that you would expect since most doctors belong to several “networks.”

Finally, of course, some people will opt to intentionally go out-of-network to see the medical provider of his or her choice for specific reasons, realizing that they will have to pay more out-of-pocket.

Can I Avoid Getting a Surprise Balance Bill?
Unfortunately, there is no way to guarantee you will never receive a Balance Bill, but there are several things you can do to help prevent them:
  1. Do your homework. Before seeing any provider, do not rely on the provider directory. Contact the provider’s billing/insurance department, and confirm they are in the specific network that you belong to. Note that many insurance providers use different networks for different plans; make sure the provider is in your specific plan’s network. Also write down the date, time, department, and name of the person you speak with.

  2. If you know you will be going into a facility, see if your doctor can give you the names of any other providers you will be seeing, such as radiologists, pathologists, assistant surgeons, anesthesiologists, etc. Check their network status before entering the facility by the same methods.

  3. If your Managed Care Plan does not provide a network specialist you need, or, if an out-of-network provider is a leader in the specific area of the specific procedure you need or in the specific condition you have, see if the Plan will agree to authorize your visit and charge you only your in-Network portion of the bill. This will be easier if your Network physician supports the referral.

  4. If you go into an Emergency Room or are in a hospital and an unknown physician wants to treat you, try to find out their status with your plan. This may be difficult, as many physicians do not personally keep track or even know to which networks they belong.

  5. Check with your state’s Department of Insurance to see if there is legislation that provides you some protection from Balance Billing. A few states have added some protection, but the level of protection substantially varies among the states.
What Do I Do If I Get An Unexpected Balance Bill?
  1. Do Not pay any bill from a medical provider until you receive the Explanation of Benefits (EOB) from the insurance company explaining how they processed the bill. If the EOB is slow in coming, you may want to inform the provider’s billing office so they will not think you are ignoring the bill.
  2. Call the phone number on the EOB and review it with a Claims Representative. If it does concern an out-of-network provider, there could be several possibilities:
a. Hopefully, the provider was actually in-network and it was just a coding error; which will be corrected when the bill is reprocessed.
b. If it is not a coding error, ask about your appeal rights. Appeal rights are also listed in your plan booklet. This is especially valid if it is due to an error that is at least partially the plan’s fault, or if it is a surprise Balance Bill from a provider you had no option in choosing.
c. Also, ask what the carrier is willing to do to help resolve the situation. Ideally, they should contact the provider and take you out of the middle, but admittedly, that may not happen.
  1. Call the out-of-network provider and try to arrange a reduced payment. This will be easier if the insurance company agrees to make some payment.
Following those guidelines should reduce your chances of getting a Balance Bill to a minimum. Health insurance is wonderful to have, but you should not assume it will take care of itself and always be correct in its processing. Remember, to all the people handling your bills and insurance claims only you have a stake in making sure it is processed accurately.


http://hcvadvocate.org/news/newsLetter/2015/advocate0815_mid.html#2

Monday, August 17, 2015

HCV Drugs: AbbVie, BMS, Merck —Alan Franciscus, Editor-in-Chief

AbbVie:

TECHNIVIE:
On July 24, The Food and Drug Administration (FDA) approved the first interferon-free combination therapy to treat HCV genotype 4. The combination called TECHNIVIE (ombitasvir, paritaprevir and ritonavir) is taken with ribavirin and for 12 weeks.  There was a total of 135 patients in the study—91 received TECHNIVIE with ribavirin and 41 received TECHNIVIE without ribavirin.  None of the trial participants had cirrhosis.  In the group that received TECHNIVIE with ribavirin there was a 100% cure rate; in the group that did not receive ribavirin there was a 91% cure rate.  Since the study did not include people with cirrhosis the FDA did not approve TECHNIVIE for the treatment of genotype 4 with cirrhosis.  AbbVie has indicated that there are on-going studies of genotype 4 cirrhotic patients and they will pursue an indication for cirrhotic patients on the TECHNIVIE product label. 

Genotype 4 is uncommon in this country—the estimated prevalence is between 1.3% to 2.3%.  There are some higher populations in areas around New York City, Los Angeles and Southern California estimated between 2 to 3%.   Genotype 4 is the fourth most common genotype worldwide.  It also accounts for 90% (6,030,000) of the hepatitis C population in Egypt.  The remaining HCV population is genotype 1.  The total HCV population of Egypt is 6.7 million. 

Source:  FDA Press Release (The total HCV population of Egypt is 6.7 million.

Be sure to check out our fact sheet on hepatitis C in Egypt: http://hcvadvocate.org/hepatitis/factsheets_pdf/HCAW_Egypt.pdf  

New Combo:
A new phase 2 study of ombitasvir, paritaprevir and ritonavir—once-a-day  combination of AbbVie drugs to treat 181 genotype 1b patients for a treatment period of 12 weeks ( without cirrhosis) or 24 weeks (with cirrhosis).   The cure rates among the groups are listed below:
  • No-cirrhosis group: 95.2% cure rate among people who had never been treated (treatment naïve (42 patients); 90% cure rate among people who had been previously treated (treatment experienced  (40 patients))
  • Cirrhosis group: 97.9% cure rate among treatment naïve (47 patients);  96.2% cure rate in the treatment-experienced group (52 patients)
The most common side effects were headache, lack of energy, itching, and diarrhea. There was one treatment discontinuation due to treatment-related side effects.

This combination without interferon or ribavirin in a once-a-day pill for people with HCV genotype 1b would be a welcome addition to the landscape of hepatitis C treatment. 

Source: Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-label Study of Patients With Genotype 1b Chronic Hepatitis C Virus, With and Without Cirrhosis—Erica Lawtz– et al. http://dx.doi.org/10.1053/j.gastro.2015.07.001

Bristol-Myers Squibb
On July 24, 2015, the FDA approved BMS’s Daklinza (daclatasvir) in combination with Gilead’s sofosbuvir to treat HCV genotype 3.  In the phase 3 studies of patients who were treated with Daklinza and sofosobuvir for 12 weeks the cure rates broken down by cirrhosis and prior treatment response are listed below:
  • Without Cirrhosis:  Treatment naïve—98%;
    Treatment experienced—92%
  • With Cirrhosis:  Treatment naïve—58%;
    Treatment experienced—69%
The most common side effects were fatigue and headache.

The FDA press release noted that the response rates were reduced for HCV genotype 3 patients with cirrhosis.  It should also be noted that the treatment duration is only 12 weeks as opposed to 24 weeks with the current standard of care—Sovaldi plus ribavirin.  Still there is an unmet medical need for people with HCV genotype 3 with cirrhosis. 

Source:  FDA press release. 

Merck
On July 28, 2015, Merck announced that the FDA had accepted their New Drug Application for grazoprevir/elbasvir for the treatment of HCV genotype 1, 4 and 6 infection.  Merck has been granted Breakthrough Therapy designation for grazoprevir/elbasvir for the treatment of patients with HCV genotype 1 with end stage kidney disease who are on hemodialysis, and also for those patients with HCV genotype 4.

The cure rates for grazoprevir/elbasvir (one-pill/once-a-day) are impressive:  genotype 1 up to 100%; genotype 4 up to 100% and up to 80% for genotype 6.

Merck stated that they expected a notification for drug approval from the FDA by January 28, 2016.

Source:  Company press release

http://hcvadvocate.org/news/newsLetter/2015/advocate0815_mid.html#1

Demystifying Hepatitis C for Native Americans: Antonio Gonzalez's Story

When Antonio Gonzalez was diagnosed with hepatitis C in Geneva, Switzerland, doctors told him if he didn't get a new liver within five years, he didn't stand a chance at a long life. As he waited for a new liver, Gonzalez thought about all the moments he'd miss. He wanted to be around for his son's graduation.

Gonzalez hadn't even heard of hepatitis C when he was diagnosed, and didn't know how he got it. A Native American and member of the Comcáac nation, he surmised that he was probably infected with hepatitis C while fighting in Vietnam, where he suffered from many major open wounds.

While he was sick, Gonzalez put together a box of things that people could remember him by after he passed away. When he finally got his liver transplant in 2005, he was able to unpack the box and begin living again. "So beautiful to receive a liver and to unpack, like, 'I'm not going anywhere!'" he said.

Read more....

Patient Community Forum on Hepatitis C: Fresno, CA - August 20, 2015

Saturday, August 15, 2015

UK:Hepatitis C patients in England denied lifesaving liver drug

Health experts concerned about decision not to extend Daklinza treatment to patients with genotype 3 strain of virus

Thousands of people in England with a chronic form of liver disease are being denied access to life-saving drugs that are available to patients in Wales, Scotland and Northern Ireland.

Despite being recommended by European regulators and available in countries such as France and Germany, draft guidance recently issued by the National Institute for Health and Care Excellence (Nice), the body that advises NHS England on whether to fund certain drugs, recommends restricting the use of Daklinza in England. The stance will affect the treatment of adult patients with a particular strain of hepatitis C.

The move has dismayed health experts and liver disease charities who say it will mean a large subset of the sickest and most at risk patients in England will not receive the treatment they need to prevent them from potentially fatal liver failure or cancer.

Read more....

Friday, August 14, 2015

Hepatitis C cases prompt public health emergency in Fayette County

FAYETTE COUNTY -State Health Commissioner Jerome Adams, M.D., M.P.H., has declared a public health emergency for Fayette County, allowing the county health department to establish a syringe exchange program as part of a broader effort to reduce the spread of Hepatitis C.

"Fayette County is battling a Hepatitis C epidemic tied to intravenous drug use," said Dr. Adams. "County officials have submitted a comprehensive, multi-pronged plan to combat this epidemic, and a syringe exchange is one part of this effort to help reduce the spread of this devastating disease."

Senate Enrolled Act 461 made syringe exchange programs legal in Indiana for the first time, under certain circumstances. The law lays out a set of procedural and substantive requirements that local communities must meet in order for an emergency declaration to be considered by the state health commissioner. 

Read more....

Thursday, August 13, 2015

Canada: Sydney advocate praises N.S. coverage of hep C drugs

SYDNEY — A Cape Breton health-care advocate is welcoming the province’s decision to cover a new line of hepatitis C drugs.

Christine Porter, who runs the Ally Centre of Cape Breton in Sydney, said any move to lower prescription drug costs for the marginalized is a step in the right direction.

She said the island is home to the highest per capita rates of the disease in both the province and the country.

“It’s a great thing when the government covers medications for any disease, especially with hepatitis C; the cost is exorbitant unless you have a really, really good medical plan,” said Porter.

Read more...