February 13, 2014

More Obamacare insurers in Louisiana reject AIDS patients

NEW YORK Fri Feb 14, 2014 4:42am IST

(Reuters) - The only three insurance companies in Louisiana that sell healthcare policies under President Barack Obama's healthcare law throughout the state are rejecting payments from a federal program intended to help low-income HIV patients, advocacy groups said on Thursday.

The Louisiana Health Cooperative and Vantage Health Plan, two smaller insurers, made the move following a decision by the state's largest insurer, Blue Cross and Blue Shield of Louisiana, late last year to reject the payments.

Lambda Legal, a non-profit group, filed a civil rights complaint about the two smaller carriers' action with the Obama administration on Thursday, following a similar complaint about Louisiana Blue last week.

"Additional carriers are jumping on the discrimination bandwagon," said Susan Sommer, director of constitutional litigation for Lambda Legal, which works to protect the civil rights of lesbians, gay men, and people with HIV. "The worst nightmare for people with HIV-AIDS is coming true in Louisiana: they're being turned away in what's become a race to the bottom by insurers."

The issue involves the federal Ryan White HIV/AIDS Program which, for 23 years, has made grants to states, cities and nonprofit organizations to help low-income people with HIV purchase health insurance.

The organizations assumed the federal money could be used to pay premiums for Ryan White beneficiaries who purchased private coverage on insurance exchanges created by the Affordable Care Act (ACA), just as the funds had been used to pay premiums previously.

In recent weeks, however, Blue Cross and Blue Shield of Louisiana began rejecting Ryan White payments sent on behalf of impoverished HIV-AIDS patients who had enrolled in one of its Obamacare plans, as did Blue Cross Blue Shield of North Dakota.

The insurers told healthcare advocates that guidance issued by the Centers for Medicare and Medicaid Services, the lead Obamacare agency, prevented them from accepting third-party payments for the new health plans, even when the funds came from a government program.

That guidance, issued in November, was meant to prevent self-dealing or even fraud. "The worry was that a hospital, for instance, would sign up and pay (Obamacare) premiums for their uninsured patients," said law professor Mark Hall of Wake Forest University. If a hospital also steered patients toward an insurer that includes it in its network, the hospital would turn a charity patient into a paying one, something CMS regards as a form of prohibited self-dealing.

Last week, CMS said the ban on third-party payments "does not apply" to those made on behalf of Obamacare enrollees by "state and federal government programs or grantees (such as the Ryan White HIV/AIDS Program)."

Over the weekend, CMS went further, said it "is considering amending the rules to require," and not merely allow, "issuers to accept these (Ryan White) payments."

On Thursday, Louisiana Blue nevertheless said it will stop honoring Ryan White and other third-party payments for premiums beginning March 1. The policy, it said, is "a safeguard against ... patient steering and other fraudulent activity," adding that it knows "from experience that there are people who want to game the system."


Louisiana Health Cooperative has said it "will not be accepting third-party insurance premium payments either," said Lucy Cordts of the NO/AIDS Task Force. Her group, which advocates on behalf of people with AIDS, has an estimated 350 Louisiana residents who chose Coop plans. "They'll all now need to consider another company."

Other healthcare advocates said they had informed Louisiana Health Cooperative officials that CMS allows Ryan White payments to be used for Obamacare insurance premiums, and were told that "they would not change their policy unless required," said Moriba Karamoko, director of the Louisiana Healthcare Coalition.

Coop spokeswoman Anisha Williams declined to comment.

The third carrier selling Obamacare insurance throughout Louisiana, Vantage Health Plan, informed the state that it, too, will not accept Ryan White payments. A spokesperson for the physician-founded company did not return messages seeking comment.

Insurance experts point out that once one carrier in a market institutes policies that drive away potentially high-cost customers such as people with HIV-AIDS, other carriers feel pressure to do the same for fear of being the only one to cover them, a situation called adverse selection.

Last week, Lambda Legal filed an administrative complaint with the Office of Civil Rights of the U.S. Department of Health and Human Services, CMS's parent agency, against Louisiana Blue. On Thursday it filed complaints against Vantage and Louisiana Health Cooperative, arguing that their refusal to accept Ryan White payments flouted a key provision of the ACA, namely its requirement that insurers accept any customer regardless of health status.

"What we're seeing in Louisiana is a crisis for low-income people with AIDS," said Lambda Legal's Sommer. "These are exactly the people the Affordable Care Act was designed to provide a safety net for."

One patient who enrolled in a Louisiana Blue plan learned in December that the insurer would not accept Ryan White checks for his premiums.

"So now I am without insurance," said Mark, 44, a former high-school teacher who is unemployed and asked that his last name not be published. He was able to obtain HIV medications from the NO/AIDS Task Force, through the Ryan White program. But he cannot afford medications for high cholesterol and high blood pressure that are common side effects of HIV drugs.

"My health is in danger at this point," he said. "If we sit back and let them do this, it goes against everything the Affordable Care Act is about."

(Reporting by Sharon Begley; Editing by Michele Gershberg and Richard Chang)


Also See: Exclusive: AIDS Patients in Obamacare Limbo as Insurers Reject Checks

FDA Hepatitis Update - Label update for Victrelis (boceprevir)

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The Victrelis (boceprevir) label has been updated to include the following information under Section 5 Warnings and Precautions:

5.4 Pancytopenia (Use with Ribavirin and Peginterferon Alfa)

Serious cases of pancytopenia have been reported postmarketing in patients receiving VICTRELIS in combination with peginterferon alfa and ribavirin. Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate.

Refer to the Package Inserts for ribavirin and peginterferon alfa for guidelines for discontinuation of therapy based on laboratory parameters.

Additionally section 6.2 Postmarketing Experience was updated to include agranulocytosis, pancytopenia, thrombocytopenia, pneumonia and sepsis.

The corresponding patient information and Medication Guide were also updated to reflect these changes.

The complete revised label can be viewed at Drugs@FDA.

Victrelis is a product of Merck Sharp & Dohme Corp.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

If you are interested in receiving information about a broader range of FDA topics, consider subscribing to the FDA Patient Network News, a twice monthly newsletter containing FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates. Or check out the FDA pages designed specifically for patients at www.PatientNetwork.fda.gov.

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Muscle Loss Ups Mortality and Sepsis Risk in Liver Transplant Candidates


Liver Transplantation

Press Release

February 13, 2014

Japanese researchers have determined that sarcopenia—a loss of skeletal muscle mass—increases risk of sepsis and mortality risk in patients undergoing live donor liver transplantation. Findings published in Liver Transplantation, a journal of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, suggest that post-transplant sepsis was reduced in candidates with sarcopenia who received early nutritional support with a feeding tube, known as enteral nutrition.

While sarcopenia, defined as loss of muscle connected to bones, is associated with aging, studies have shown it can occur in patients with chronic diseases such as cancer, liver disease, and malnutrition. In fact, research by Montano-Loza et al. found that more than 40% of those with liver cirrhosis also had sarcopenia, which was linked to higher mortality rates in these patients regardless of the degree of liver injury.

The present study, led by Ken Shirabe, MD, PhD from Kyushu University in Fukuoka, Japan evaluated 204 patients prior to living-donor liver transplantation between November 2003 and December 2011. Computed tomography (CT) scans were taken of patients to measure muscle mass along the lower back region (psoas muscle).

Close to 50% of subjects were diagnosed with sarcopenia; 58% in men and 36% in women. Analyses indicate that patients with sarcopenia had a 2-fold higher risk of death than those without muscle loss. Sarcopenia was independently linked to overall survival and a predictor of sepsis following transplantation.

Enteral nutrition was provided within 48 hours of transplantation in 24% of candidates undergoing live-donor liver transplants from 2003 to 2007, and in 100% of subjects transplanted in 2008 through 2011. After providing routine nutritional support, the incidence of sepsis dropped from 28% (2003-2007) to 11% (2008-2011) in the transplant candidates.

“Our findings indicate that sarcopenia independently predicts mortality and increases sepsis risk in live-donor liver transplant recipient,” concludes Dr. Shirabe. “Sepsis was reduced in patients with sarcopenia when nutritional intervention was used. Treatment of malnutrition in transplant candidates may reduce risk of death following transplantation, but larger studies are needed to confirm this evidence.”


Marijuana May Stop The Spread Of HIV, Study Finds

The Huffington Post  | by  Carly Schwartz

Posted: 02/11/2014 12:11 pm EST Updated: 02/11/2014 5:00 pm EST

Colorado Pot Poll

Marijuana has long been used to effectively treat symptoms associated with HIV, such as chronic pain and weight loss. But a growing body of research suggests the plant may be able to stop the spread of the disease itself.

Adding to these findings is a Louisiana State University study published last week in the journal AIDS Research and Human Retroviruses. For 17 months, scientists administered a daily dose of THC, an active ingredient in cannabis, to monkeys infected with an animal form of the virus. Over the course of that period, scientists found that damage to immune tissue in the primates' stomachs, one of the most common areas in the body for HIV infection to spread, decreased.

"These findings reveal novel mechanisms that may potentially contribute to cannabinoid-mediated disease modulation," Dr. Patricia Molina, the study's lead author, wrote. The report goes on to explain that while HIV spreads by infecting and killing off immune cells, the monkeys that received the daily THC treatments maintained higher levels of healthy cells.

Similar research spearheaded by Molina in 2011 found that infected monkeys treated with THC had a better chance of surviving. And a report published in 2012 pointed to evidence that marijuana-like compounds can fight HIV in late-stage AIDS patients.

Last year, an oncologist from the United Kingdom found that marijuana compounds can kill cancer cells in leukemia patients, and scientists at California Pacific Medical Center in San Francisco have conducted research that suggests those compounds can also effectively combat other forms of aggressive cancer.


New online course helps people manage hepatitis C

Surrey Now
February 13, 2014 12:00 AM

A new self-learning course has been launched in British Columbia to help those at risk of, or affected by, hepatitis C."Go For Care: Hepatitis C Knowledge Series" was developed by the BC Centre for Disease Control and released last week as an interactive module that provides basic information about hepatitis C. "Our interviews with patients and health-care providers uncovered a need for a resource like this - a one-stop source of basic information that's easy to use," said Dr. Gail Butt, clinical lead on hepatitis at BCCDC and an assistant professor at UBC. "The Hepatitis Knowledge Series will help people in their understanding of hepatitis C and help them get the care they need."

Hepatitis C is a virus that is spread when there is bloodto-blood contact with someone who has the disease, such as when drug users share needles and syringes or when someone is accidentally pricked by a needle. Hepatitis C can lead to serious liver disease, liver cancer or premature death, although current treatments can cure about 65 to 75 per cent of infections.

The new online tool includes information about how hepatitis C is spread, how to get tested and how best to live with the disease and manage treatments. Narrated with minimal text, it includes videos, quizzes and downloadable materials. The course is a valuable tool, not only for those with hepatitis C and people at risk, but also for community service providers to use with their clients.

The Canadian Liver Foundation is teaming up with BCCDC on the project.

"There are thousands of Canadians living with hepatitis C who do not know it," said Dr. Morris Sherman, chair of the Canadian Liver Foundation. "Diagnosis often comes as a complete shock, leaving people scared and scrambling for answers. This online course will allow newly diagnosed patients to learn about their disease at their own pace, no matter where they are."

The BCCDC online course is at https://learninghub.phsa.ca/Courses/5935/hepatitis-c-the-basics.