Medicare confirms payment for prostate cancer drug (AP)

WASHINGTON � Medicare officials confirmed Thursday that the program will cover the $93,000 price tag for prostate cancer drug Provenge, an innovative therapy that typically gives men suffering from an incurable stage of the disease an extra four months to live.

The decision from the Centers for Medicare and Medicaid essentially reiterates an earlier proposed ruling that the biotech drug, made by Dendreon Corp., is a "reasonable and necessary" medicine. As expected, the government will cover the cost for men who meet the drug's approved criteria: those with prostate disease that has spread throughout the body and has not responded to hormone therapy or radiation. The government will not pay for alternate, or so called "off-label," use.

"We do not believe there is any persuasive evidence for the off-label use," of Provenge, the agency concluded in the ruling, posted online late Thursday.

About 240,000 new cases of prostate cancer are diagnosed each year in the U.S. and the disease claims over 33,000 lives annually, according to the American Cancer Society. The decision ensures that tens of thousands of men will be able to take the drug through the government-backed health care plan that covers seniors. With government reimbursement, analysts estimate Provenge could rack up $1 billion in sales next year. The decision is important for Dendreon because most prostate cancer patients are 65 or older.

The infused drug is a first-of-a-kind treatment in that each dose is customized to work with each individual patient's immune system. The drug is given in three infusions over the course of one month.

Medicare is legally prohibited from considering price when deciding whether to pay for a new treatment. But Provenge's steep price tag had generated debate about the cost of new drugs and the government's role in paying for them, especially against the political backdrop of health care reform and the rising cost of Medicare given the large number of baby boomers.

Seattle-based Dendreon says Provenge's price reflects the more than $1 billion spent researching and developing the drug. And prostate cancer patients point out that the median survival time with Provenge is double that of chemotherapy, which is about two months and is marked by painful side effects.

Each regimen of Provenge must be tailored to the immune system of the individual patient using a time-consuming formulation process. Doctors collect special blood cells from each patient that help the immune system recognize cancer as a threat. The cells are mixed with a protein found on most prostate cancer cells and another substance to rev up the immune system, and then given back to the patient as three infusions two weeks apart.

Provenge is the first federally-approved cancer drug that uses the body's own immune system to fight the disease, offering an alternative to chemotherapy drugs that attack cancerous and healthy cells at the same time.

On Wednesday, Dendreon announced it received federal regulatory approval to open a second manufacturing facility in Los Angeles, in addition to its primary facility in New Jersey. The company hopes to open a third facility in Atlanta by the end of August.

Shares of Dendreon rose 96 cents, or 2.4 percent, to $40.40 in afterhours trading. The stock had closed the regular session down $1.06, or 2.6 percent, at $39.44.

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17 infants die in 48 hours at 1 Indian hospital (AP)

NEW DELHI � At least 17 infants have died in the last 48 hours at a government-run hospital in eastern India and the state is investigating, media reported Thursday.

Television news channels showed images of weeping and wailing parents outside the B.C. Roy Hospital for Children in Kolkata, the capital of West Bengal.

The hospital head D. Pal told Press Trust of India the babies were either premature, suffering from septicemia or had low birth weight problems. He denied any negligence by the hospital.

PTI quoted the state's top elected official, Mamata Banerjee, as saying her government had ordered an investigation.

In 2006, 22 infants died in three days at the same hospital because of prematurity or acute forms of either meningitis, encephalitis or septicemia, the hospital said at the time.

State-run hospitals in India are often overcrowded and ill-equipped to manage the large number of patients that come to them desperate for medical care.

India's infant mortality rate is higher than the world average. It ranks 50th of 222 countries and territories, with about 48 deaths per 1,000 live births estimated this year, according to the CIA World Factbook.

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AP Exclusive: Fuzzy math in health law formula (AP)

WASHINGTON � Older adults of the same age and income with similar medical histories would pay sharply different amounts for private health insurance due to what appears to be an unintended consequence of the new health care law.

Aware of the problem, the administration says it is exploring options to address a potential disparity that could mean added controversy for President Barack Obama's health care overhaul. The law expands coverage to more than 30 million uninsured people and would require most Americans to carry insurance.

The glitch mainly affects older adults who are too young for a Medicare card but have reached 62, when people can qualify for early retirement from Social Security. Sixty-two is the most common age at which Americans start taking Social Security, although their monthly benefit is reduced.

As the health care law is now written, those who take early retirement would get a significant break on health insurance premiums. That's because part or all of their Social Security benefits would not count as income in figuring out whether they can get federal subsidies to help pay for coverage until they become eligible for Medicare at 65.

"There is an equity issue here," said Robert Laszewski, a former health insurance executive turned policy consultant. "If you get a job for 40 hours a week, you're going to pay more for your health insurance than if you don't get a job."

The Obama administration says it is working on the problem.

"We are monitoring this issue and exploring options that would take into account the needs of Social Security beneficiaries, many of whom are disabled or individuals of limited means," Emily McMahon, a top Treasury Department policy official, said in a statement to The Associated Press.

Other officials, speaking on condition of anonymity because the issue is politically sensitive, said the administration is concerned because the situation could create a perception that some people are getting a worse deal compared with their less-industrious peers.

McMahon doubted that what amounts to a hefty health care discount would start a stampede toward early retirement at a time when many experts are urging older Americans to stay on the job longer. Only a "limited number of individuals" would decide they're better off not working, she said.

To see how the Social Security wrinkle would work, consider a hypothetical example of two neighbors on the same block.

They are both 62 and have the same income of $39,500 a year. But one gets all his income from working, while the other gets $20,000 from part-time work and $19,500 from Social Security.

Neither of them gets health insurance on the job. Instead, they purchase it individually.

Starting in 2014, they would get their coverage through a new online health insurance market called an exchange. Millions of people in the exchanges would get federal tax credits to make their premiums more affordable. Less-healthy consumers could not be charged more because of their medical problems.

The neighbor who is getting Social Security would pay an estimated $206 a month in premiums.

Half of his income from Social Security, or $9,750, would not be counted in figuring his federal health insurance tax credit. On paper, he would look poorer. So he would get a bigger tax credit to offset his premiums.

But the neighbor who makes all his income from work would not be able to deduct any of it. He would pay $313 for health insurance, or about 50 percent more.

The estimates were produced using an online calculator from the nonpartisan Kaiser Family Foundation.

The disparities appear to be even greater for married couples and families in which at least one member is getting Social Security. With a bigger household, both the cost of coverage and the federal subsidies involved are considerably larger.

The glitch seems to be the result of an effort by Congress to make things simpler. Lawmakers decided to use the definition of income in the tax code, which protects Social Security benefits from taxation.

"The practical effect is if more of your income is in the form of Social Security benefits, you are going to be eligible for bigger tax credits in the exchange," said Chapin White, a senior researcher at the nonpartisan Center for Studying Health System Change.

It's unclear whether the Obama administration can fix the problem with a regulation, or whether it will have to go back to Congress. In case of the latter, it will have to deal with Republicans eager to repeal the health care law.

The decision to use the tax code's definition of income for the health care law has created other problems.

Medicare's top number-cruncher is warning that up to 3 million middle-class people in households that get at least part of their income from Social Security could suddenly become eligible for nearly free coverage through Medicaid, the federal-state safety net program for the poor. Chief Actuary Richard Fosters says that situation "just doesn't make sense."

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Online:

Kaiser Health Reform Subsidy Calculator: http://tinyurl.com/ydopqx7

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Study suggests UN force brought cholera to Haiti (AP)

PORT-AU-PRINCE, Haiti � Evidence "strongly suggests" that a United Nations peacekeeping mission brought a cholera strain to Haiti that has killed thousands of people, a study by a team of epidemiologists and physicians says.

The study is the strongest argument yet that newly-arrived Nepalese peacekeepers at a base near the town of Mirebalais brought with them the cholera, which spread through the waterways of the Artibonite region and elsewhere in this impoverished Caribbean country.

The disease has killed more than 5,500 people and sickened more than 363,000 others since it was discovered in October, according to the Haitian government.

"Our findings strongly suggest that contamination of the Artibonite (river) and 1 of its tributaries downstream from a military camp triggered the epidemic," said the report in the July issue of Emerging Infectious Diseases, a journal of the U.S. Centers for Disease Control and Prevention.

The article says there is "an exact correlation" in time and place between the arrival of a Nepalese battalion from an area of its South Asian homeland that was experiencing a cholera outbreak and the appearance of the first cases in the Meille river a few days later.

The remoteness of the Meille river in central Haiti and the absence of other factors make it unlikely that the cholera strain could have come to Haiti in any other way, the report says.

In an email U.N. mission spokeswoman Sylvie Van Den Wildenberg didn't comment on the findings of the article published in the CDC journal, referring only to a study released in May by a U.N.-appointed panel.

That panel's report found that the cholera outbreak was caused by a South Asian strain imported by human activity that contaminated the Meille river where the U.N. base of the Nepalese peacekeepers is located. The study also found that bad sanitation at the camp would've made contamination of the water system possible.

But the U.N. report refrained from blaming any single group for the outbreak. While no other potential source of the bacteria itself was named, the report attributed the outbreak to a "confluence of circumstances," including a lack of water infrastructure in Haiti and Haitians' dependence on the river system.

The panel's report was ordered by U.N. Secretary-General Ban Ki-moon as anti-U.N. protests spread in Haiti and mounting circumstantial evidence pointed to the troops.

Before that, for nearly two months after the outbreak last October, the United Nations, CDC and World Health Organization refused to investigate the origin of the cholera, saying that it was more important to treat patients than to try to figure out the source.

The article published in the CDC journal comes as health workers in Haiti wrestle with a spike in the number of cholera cases brought on by several weeks of rainfall. The aid group Oxfam said earlier this month that its workers were treating more than 300 new cases a day, more than three times what they saw when the disease peaked in the fall.

Cholera is caused by a bacteria that produces severe diarrhea and is contracted by eating or drinking contaminated food or water.

The disease has spread to the neighboring Dominican Republic, where more than 36 deaths have been reported since November.

Epidemiologist Renaud Piarroux, the lead author of the CDC journal article, was initially sent by the French government in late 2010 to investigate the origins of Haiti's outbreak. He authored a report for U.N. and Haitian officials that said the Nepalese peacekeepers likely caused the outbreak, a copy of which was obtained at the time by the AP.

The latest study was more complete and its methodology was reviewed by a group of scientists.

The new study argues it is important for scientists to determine the origin of cholera outbreaks and how they spread in order to eliminate "accidentally imported disease."

Moreover, the study says, figuring out the source of a cholera epidemic would help health workers better treat and prevent cholera by minimizing the "distrust associated with the widespread suspicions of a cover-up of a deliberate importation of cholera."

It also argues that demonstrating an imported origin would compel "international organizations to reappraise their procedures."

After cholera surfaced last fall, many Haitians believed the Nepalese peacekeepers were to blame, straining relations between the population and U.N. personnel and sparking angry protests. On the streets, cholera has become slang for something that must be banished from Haiti.

The new study is acknowledged in a commentary by a pair of public health experts affiliated with the CDC.

"However it occurred, there is little doubt that the organism was introduced to Haiti by a traveler from abroad, and this fact raises important public health considerations," wrote Scott Dowell, director of the CDC's Division of Global Disease Detection and Emergency Response, and Christopher Braden, a medical epidemiologist with the CDC.

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Associated Press writer Trenton Daniel reported this story from Port-au-Prince and Jonathan M. Katz reported from Mexico City.

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Trenton Daniel can be followed at http://twitter.com/trentondaniel; Jonathan M. Katz can be followed at http://twitter.com/KatzOnEarth.

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