Seniors have a stake in childrens bill
Fri, 27 Jul 2007 21:53:02 GMT
By KEVIN FREKING, Associated Press Writer
WASHINGTON - Efforts to expand health insurance for children could greatly affect their grandparents, not entirely positively.
House Democrats want to eliminate Medicare participants' share of the costs when they get cancer screenings such as mammographies and colonoscopies — an approach designed to promote disease prevention.
They also would lower seniors' share of the cost from 50 percent to 20 percent when they see a psychiatrist for treatment of depression and other mental illnesses — the same cost-sharing that would occur for a physical illness.
And, many of the poorest seniors would newly qualify for extra help in paying for their medicine or monthly premiums, thanks to changes that let them maintain more assets.
But the legislation, likely to be considered in the House next week, has parts that will upset millions of seniors.
Around the country, about 8.2 million elderly and disabled Americans are enrolled in private health plans through Medicare. The plans often charge lower premiums than what's available through traditional Medicare, or they offer extra benefits, such as dental care or free annual eye exams.
The federal government subsidizes seniors' care, on average, at a greater rate in the private plans than it does in traditional Medicare.
The children's health bill would gradually end that practice. It would lower payments to the insurers administering those health plans, sometimes substantially, depending upon the location of the plan.
Overall, payments would drop from about $587 billion to $537 billion during the next five years, a reduction of 8.5 percent. As a result, some insurance plans will scale back benefits. Some plans can be expected to drop out of certain states altogether, particularly in rural areas.
Peter Orszag, director of the Congressional Budget Office, told lawmakers Thursday that the number of seniors participating in private plans will drop to about 5.5 million by 2012 if the House bill becomes law.
The reduced access to the private plans will be a critical aspect of the debate over children's health insurance. Critics of the proposed changes want to make the debate less about payments to insurance companies and more about seniors' losing benefits.
"Hold on to your wallet," said Rep. Marsha Blackburn, R-Tenn., during a hearing on the children's bill. "This committee is on a spending frenzy at the expense of the nation's seniors."
Blackburn's committee, the House Energy and Commerce Committee, reviewed the bill on Thursday and Friday. The hearing was acrimonious, to say the least.
Republicans accused the Democrats of rushing through a 465-page health bill without giving them adequate opportunity to review its contents. They refused to agree to a customary waiver of the reading of the bill. When a clerk began reading the bill and missed the word "a," Republicans objected and asked that she read the bill correctly. She started over. She began Thursday afternoon and was still at it Friday afternoon when the committee adjourned without even voting on the bill.
The partisan rancor began early in the members' opening statements when Rep. Ed Markey, D-Mass., said: "I think if you kick a Republican in the heart, you're going to break your toe."
To which, Rep. Cliff Stearns, R-Fla, replied: "I submit that if you kick a Democrat in the heart, you would break the bank."
The bill would increase spending on children's health insurance by about $50 billion over five years, raising total spending to $75 billion. The program is designed to provide health coverage to children whose income is too great for Medicaid but not enough to pay for private insurance. President Bush had recommended total spending of $30 billion.
Another committee with jurisdiction over the health legislation did vote — about 2 a.m. The House Ways and Means Committee approved the Children's Health and Medicare Protection Act by a 24-17 vote strictly along party lines.
Payment cuts to health insurers pay for the biggest chunk of the new benefits for children and for Medicare beneficiaries. However, a 45-cent increase in the tax on a pack of cigarettes would also generate about $27 billion over five years.
Scores of other Medicare providers would also face payment reductions over the coming five years. Their opposition to the proposed cuts complicates prospects for the bill's passage.
For example, nursing homes stand to lose about $2.7 billion over the next five years. That money would come out of about $111 billion they would get from Medicare during that time.
"When funding is unstable, as it surely would be if the proposed cuts are enacted into law, quality undoubtedly will suffer," said Alan Rosenbloom, president of the Alliance for Quality Nursing Home Care.
Suppliers of oxygen equipment for patients with chronic breathing problems would lose about $1.8 billion over five years, or about 15 percent of their total Medicare payments during that time, says the American Association for Homecare.
The suppliers serve about 1.5 million beneficiaries by setting them up with their oxygen tanks and educating them on how to use it. They also service the equipment to make sure it's working properly. Employees are on-call at all hours to help patients and can save the Medicare system money by keeping the patients at home for their treatment.
Among other Medicare providers, home health agencies would see payments reduced by about $2.2 billion over five years. That's about a 3 percent cut in overall payments.
About 3 million seniors and disabled Medicare participants get care at home, such as speech therapy for strokes, or rehabilitation therapy for patients with hip replacements.
Profit margins vary greatly depending upon the agency. Some may have problems taking on patients because their costs would exceed what they're being paid, said Theresa Forster, vice president for policy at the National Association for Home Care and Hospice.
AARP, the advocacy group for seniors, has endorsed the bill. The organization says that, overall, seniors would see their premiums go down as a result of payments to insurers being lowered.
The Senate will also take up its version of the children's health bill next week. The Senate bill relies strictly on a tobacco tax to increase funding for the children's health program.
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On the Net:
House Energy and Commerce Committee: http://energycommerce.house.gov/
House Ways and Means Committee: http://waysandmeans.house.gov/
Judge expects Vioxx stroke cases
Fri, 27 Jul 2007 21:55:45 GMT
By JANET McCONNAUGHEY, Associated Press Writer
NEW ORLEANS - Next year's federal Vioxx trials may focus on people who had strokes after taking the once popular painkiller, the judge assigned to handle pretrial matters in all 8,575 federal lawsuits said Friday.
"We may carve out five or six stroke cases and try them," U.S. District Judge Eldon E. Fallon told attorneys for plaintiffs and manufacturer Merck & Co., which pulled the blockbuster drug from the market in 2004 after studies indicated it doubled cardiovascular risks.
The five cases heard so far in federal court all involved people who had heart attacks after taking Vioxx. Merck won four of them.
The judge said arguments on two disputes may wait on testimony from the governors of Mississippi and Indiana about their consultations with the U.S. Food and Drug Administration as new drug label rules took effect.
Plaintiffs' lawyers have subpoenaed Gov. Haley Barbour, R-Miss., a former lobbyist whose clients included major drug companies, and Gov. Mitch Daniels, R-Indiana, a former executive for Eli Lilly and Co.
Fallon said he would schedule hearings later on Merck's requests for a new trial in a case it lost and for permission to immediately appeal Fallon's ruling on the FDA label question.
Merck faces about 26,950 lawsuits from people who claim the drug caused heart attacks or strokes and Merck failed to provide enough warning about cardiovascular dangers. A 16,400 are in state court in New Jersey, with additional cases in other states.
The suits include about 45,225 plaintiffs, and Merck has agreed to let another 14,450 potential claimants sue after their statute of limitation expires.
Lawyers for individuals and companies suing Merck subpoenaed the governors for videotaped testimony about their responses when asked by the FDA whether the new label rules would violate states' rights.
That will have a direct bearing on Merck's request for permission to immediately appeal a ruling that the FDA's approval of a label does not protect drug makers from lawsuits claiming a label's warnings were inadequate, plaintiffs' lawyer Russ Herman of New Orleans said Friday.
The FDA made that claim in the preamble to rules that took effect in January 2006. Fallon ruled early this month that the arguments are "entirely unpersuasive" and two trials may proceed.
After the hearing Friday, plaintiffs lawyer Arnold Levin of Philadelphia said FDA was supposed to get states' opinions about whether a proposed rule would violate states' rights.
"The FDA forgot to do that. After the rule took effect, they said, `Whoops! How about talking to the governor of Indiana? He's OK, he used to be CEO for a drug company. How about talking to the governor of Mississippi? He's OK; he used to be a drug lobbyist.'"
But, Levin said, the FDA never made their responses public.
The FDA contends that since its rules control what is on the labels, they pre-empt state law — the controlling issue even in federal court claims that a warning is inadequate. Merck wants to appeal now, rather than after final rulings in the two specific cases on which Fallon ruled.
Herman said the question also affects Merck's request for a retrial of its only loss in federal court — a suit filed by retired FBI agent Gerald Barnett of Myrtle Beach, S.C., who had a heart attack in 2002.
Fallon said he may hold that hearing after getting Barbour and Daniels to testify or hold the hearing sooner and wait to rule until the depositions are in. The governors' testimony could come by September.
Merck lawyer Phil Wittmann said he didn't think the governors' testimony was relevant to Barnett's case. But Fallon said he had mentioned the issue in a footnote to his ruling. "This issue has come up in every case," he said.
Merck contends Fallon usurped a jury's job when he proposed a $1.6 million award to Barnett to replace the $51 million jury judgment he had found excessive.
Jurors in Barnett's case decided he should get $50 million to compensate him for injuries from a 2000 heart attack and $1 million in punitive damages against Merck. Fallon ruled the compensatory damages were unreasonable, since Barnett was retired and had made a good recovery.
As an alternative to a retrial on damages, Barnett asked the judge to suggest a more reasonable award, and accepted Fallon's recommendation: $1 million in punitive damages, $600,000 in compensatory damages.
Merck contends that by doing so, Fallon usurped a job that should have been done by a jury. And, the company said in court documents, "Because there is no way to determine what damages the jury concluded Mr. Barnett suffered, let alone what compensation it awarded for each component of his damages, there is no way to lop off — or even calculate — the `excessive' part of the jury's award."
FDA hesitant to OK Biogen Elan drugs
Fri, 27 Jul 2007 22:35:20 GMT
By MATTHEW PERRONE, AP Business Writer
WASHINGTON - Federal health officials on Friday said they are hesitant to allow a drug made by Biogen Idec Inc. and Elan Corp. to be used to treat an intestinal disorder because of potentially fatal side effects.
The Food and Drug Administration said it is concerned patients taking Tysabri, which is already approved to treat multiple sclerosis, could develop a rare and incurable nervous system disease that is usually fatal after six months.
Biogen, which codeveloped the drug with Elan, is asking the agency to approve Tysabri to treat Crohn's disease, which causes inflammation of the intestines and affects about 1 million people worldwide.
FDA posted its review of the drug ahead of a Tuesday meeting where outside experts will vote on whether the drug should be approved. The government is not required to follow the experts' advice, though it usually does.
The use of Tysabri to treat multiple sclerosis, a neurological disease, has been restricted since three patients who used the drug developed the rare nervous system disorder known as multifocal leukoencephalopathy, or PML.
The drug was temporarily pulled from the market in February 2005. FDA decided to put the drug back on the market last year under the condition that patients use it alone, and not in combination with drugs used to suppress the immune system. FDA determined that combining Tysabri with these treatments could increase risk of PML.
In its review of Tysabri for the new use, FDA said it would be more difficult to assure the safety of the drug in patients with Crohn's Disease, since they are more likely to take immune-system suppressing drugs as additional therapy.
Government reviewers also said Biogen did not conduct several safety analyses that FDA had requested. And many safety analyses the company did submit only tracked patients over a short time rather than over the long-term.
Despite these safety concerns, FDA said the drug appeared to be effective in preventing inflammation of the intestine wall in Crohn's Disease patients.
If approved for the new use, Tysabri could have sales over $300 million per year, according to Bear Stearns analyst Mark Schoenbaum. The drug would compete with Remicade, the leading Crohn's treatment made by Johnson and Johnson.
Biogen posted a profit of $217.5 million in 2006, while Dublin, Ireland-based Elan Corp. posted a $267.3 million loss.
Shares of Biogen Idec Inc. fell $1.18, or 2 percent, to $57.01 Friday. Shares of Elan Corp. plc fell 73 cents, or 3.7 percent, to $19.