Soaring Health Costs Pinned On Medical Devices

June 7, 2011 · Posted in cholesterol too low · Comment 

United States (KaiserHealth) – While squabbles over the rules for approving new medical devices rarely attract much attention outside the insular world of manufacturers, regulators and medical professions, a fight is brewing that could have a major impact on efforts to control health-care spending.

The device industry has launched an aggressive campaign to avoid tighter Food and Drug Administration rules that would help generate the information needed to show whether newer devices are actually superior to the ones they replace. The latest devices – from heart valves and defibrillators to artificial knees and hips – are usually significantly more expensive than older devices, and the intense marketing surrounding the introduction of new devices has become a major driver of rising health care costs.

Many medical specialists say tighter rules are needed to ensure newer devices are safe and effective, which could help hold down costs. “Better regulation of medical devices has the potential to reduce health care costs,” said Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. “New devices are often more complex and expensive than existing products, but may not offer any improvements in health outcomes. The current regulatory approach allows these devices to reach the market with little or no clinical data.”

“Requiring evidence of benefit of effectiveness for patients before device approval would prevent billions of dollars from being spent on technologies that are not helpful for patients and are even harmful,” said Rita Redberg, editor of the Archives of Internal Medicine and a cardiologist at the University of California, San Francisco. “There are many examples, such as vertebroplasty and kyphoplasty for back pain [compression fractures], on which Medicare spends approximately $1 billion annually. After they were FDA-approved, randomized clinical trials showed they were no more effective than a sham procedure in relieving symptoms.”

Despite the cry for tighter rules, think tanks funded by industry in recent weeks have released several studies claiming that the FDA is standing in the way of improved devices getting to market. Congress is holding hearings to investigate the issue. And a third of the members of the House has signed a letter calling for legislation that would roll back a small excise tax that proponents claim is choking off “innovation.”

The 2.3 percent tax projected to generate $20 billion over the coming decade was part of the health care reform law and was similar to excise taxes slapped on the drug and insurance industries, which have not launched similar campaigns. All three industries are among the most profitable in America.

The controversy has important regional political significance because many of the device manufacturers are major employers in the Midwest – especially in Minnesota, Ohio, and Indiana. With the backing of Midwestern lawmakers, the industry is fighting back. Rep. Erik Paulsen, R-Minn., whose district abuts the headquarters of industry giant Medtronic, last week released a letter with 154 co-signers, including four Democrats, that called for repealing the $2 billion-a-year tax.

“Device manufacturers will have to cut R&D or may be forced to lay off employees due to this disastrous tax,” the letter said.

Proponents of the industry warn that what they describe as hostile government action could lead to a loss of jobs. Moreover, some manufacturers claim that they are looking overseas for a more permissive regulatory environment. There are over 8,000 medical device companies in the U.S.; they generated about $136 billion in sales and employed over 422,000 last year, according to industry officials.

While the industry did better than the economy as a whole through the recession, losing only 1.1 percent of its jobs compared with nearly 5 percent of all manufacturing workers, its job performance lagged behind the rest of the health-care economy, which added employment throughout the downturn.

Two years ago, the medical device industry, which manufactures everything from heart valves to ace bandages, came under tougher scrutiny. The FDA had become more aggressive overseeing the industry in response to criticism that it had repeatedly caved to corporate and political pressure when approving new products. After health-care reformers targeted the industry for higher taxes to help pay for covering the uninsured, Democratic leaders in Congress asked the prestigious Institute of Medicine (IOM) to convene a blue-ribbon panel to determine if the industry needed tougher regulations to ensure the safety and effectiveness of its products. With the IOM’s final report due later this month, the industry is mounting a major public relations offensive to blunt calls for stronger oversight.

The Institute for Health Technology Studies, which is primarily funded by the industry, late last month released an industry survey showing American companies are increasingly going to Europe to get new devices approved. Industry executives also claimed that the FDA in the last few years has arbitrarily toughened its standards for new devices that are similar to products already on the market. In the past, those look-alike products usually received a less rigorous review than brand new medical innovations.

“As the FDA considers regulatory revisions, what’s at stake is the ability of companies to attract investors in order to continue developing innovative, life-saving products and sustaining American competitiveness in the global marketplace,” said John Linehan, a professor of biomedical engineering at Northwestern University and lead author of the survey.

Paulsen, the Minnesota lawmaker, cited the example of Xtent, a Menlo Park, Calif., device maker that tried to gain approval to start a U.S. clinical trial for its coronary stent. Surgeons had already inserted the company’s stent in hundreds of European patients. When the FDA refused to consider data from the European experiences and insisted on a prospective clinical trial, the company closed its doors and sold the technology to foreign investors.

Last week, the House Oversight and Government Reform Committee called in the FDA’s top device regulator to explain the changes underway at the agency, which Republican members claimed had gone too far. “In some cases, the conveyor belt for medical devices has come to a grinding halt,” charged Rep. Trey Gowdy, R-SC., who chairs the health subcommittee.

Jeffrey Shuren, a lawyer and physician who 18 months ago replaced the previous head of the troubled Center for Devices and Radiological Health at FDA, promised to “do a far better job to make the process more efficient without compromising our standards for safety and efficacy.”

Earlier this year, the FDA proposed new rules that would give companies more certainty about what would be expected from them when bringing new products to the agency. But it postponed consideration of any major changes in the oversight process pending the IOM report, which could propose companies do more clinical trials proving efficacy for follow-on devices.

The current rules are a product of the 1976 law that ushered in the modern era of medical device regulation. They require any new device whose failure would pose a serious risk to public health to go through rigorous clinical trial testing in humans for both safety and effectiveness before going on the market. But the law also set up a regulatory scheme, known as the 510(k) process, which allows follow-on devices deemed substantially similar to something already on the market to get approved without the same level of testing. Regulators have discretionary power to order more tests.

The vast majority of new devices use the follow-on process, even though their manufacturers often claim superior performance to the older models and charge accordingly. The result is a lack of scientific data for making those comparisons, which leaves Medicare, private insurers and physicians in the dark as to their relative worth.

The regulatory framework for potentially life-saving devices differs from drugs, where follow-on products – say, the four or fifth statin to come to market for lowering cholesterol – must still go through rigorous clinical trial testing. While that doesn’t meet the gold standard of head-to-head comparisons between competing products, at least that gives medical analysts sufficient information to know if one drug is significantly better or worse than another product in the same class.

Safety issues can arise when there are no clinical trials for follow-on devices. And that also contributes to rising health care spending, since it can result in costly recalls or even follow-on operations to replace faulty devices. The updated devices often change materials or tweak the engineering, which can alter their performance once put in the body or deployed in health care settings.

A study published earlier this year in Archives of Internal Medicine found that of 113 major product recalls between 2005 and 2009, only’ percent had gone through the more rigorous clinical trial testing required for new products, while 71 percent had used the follow-on process. There had been only 49 major recalls in the prior five years.

“Yes, the FDA’s getting tougher and it’s long overdue,” said the study’s lead author, Diana Zuckerman, executive director of the National Research Center for Women and Families. “Too many things were sailing through without clear evidence they were safe and effective.”

She cited last December’s recall of 359 million glucose test strips manufactured by Abbott Laboratories, whose malfunction could give diabetics false readings and lead to under or over-medication. Last week Redberg of UCSF told the oversight subcommittee to reject calls for speeding up the regulatory review process in the name of fostering greater innovation. She cited a 2009 Government Accountability Office report that found that a majority of high-risk devices do not go through clinical trial testing prior to marketing. “Only high-quality clinical trials can assure safety and effectiveness, especially when it comes to high risk devices that are used with invasive procedures,” she said.

– Provided by Kaiser Health News.

Article © AHN – All Rights Reserved

View full post on Health Stories

Soaring Health Costs Pinned On Medical Devices

June 7, 2011 · Posted in cholesterol too low · Comment 

United States (KaiserHealth) – While squabbles over the rules for approving new medical devices rarely attract much attention outside the insular world of manufacturers, regulators and medical professions, a fight is brewing that could have a major impact on efforts to control health-care spending.

The device industry has launched an aggressive campaign to avoid tighter Food and Drug Administration rules that would help generate the information needed to show whether newer devices are actually superior to the ones they replace. The latest devices – from heart valves and defibrillators to artificial knees and hips – are usually significantly more expensive than older devices, and the intense marketing surrounding the introduction of new devices has become a major driver of rising health care costs.

Many medical specialists say tighter rules are needed to ensure newer devices are safe and effective, which could help hold down costs. “Better regulation of medical devices has the potential to reduce health care costs,” said Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. “New devices are often more complex and expensive than existing products, but may not offer any improvements in health outcomes. The current regulatory approach allows these devices to reach the market with little or no clinical data.”

“Requiring evidence of benefit of effectiveness for patients before device approval would prevent billions of dollars from being spent on technologies that are not helpful for patients and are even harmful,” said Rita Redberg, editor of the Archives of Internal Medicine and a cardiologist at the University of California, San Francisco. “There are many examples, such as vertebroplasty and kyphoplasty for back pain [compression fractures], on which Medicare spends approximately $1 billion annually. After they were FDA-approved, randomized clinical trials showed they were no more effective than a sham procedure in relieving symptoms.”

Despite the cry for tighter rules, think tanks funded by industry in recent weeks have released several studies claiming that the FDA is standing in the way of improved devices getting to market. Congress is holding hearings to investigate the issue. And a third of the members of the House has signed a letter calling for legislation that would roll back a small excise tax that proponents claim is choking off “innovation.”

The 2.3 percent tax projected to generate $20 billion over the coming decade was part of the health care reform law and was similar to excise taxes slapped on the drug and insurance industries, which have not launched similar campaigns. All three industries are among the most profitable in America.

The controversy has important regional political significance because many of the device manufacturers are major employers in the Midwest – especially in Minnesota, Ohio, and Indiana. With the backing of Midwestern lawmakers, the industry is fighting back. Rep. Erik Paulsen, R-Minn., whose district abuts the headquarters of industry giant Medtronic, last week released a letter with 154 co-signers, including four Democrats, that called for repealing the $2 billion-a-year tax.

“Device manufacturers will have to cut R&D or may be forced to lay off employees due to this disastrous tax,” the letter said.

Proponents of the industry warn that what they describe as hostile government action could lead to a loss of jobs. Moreover, some manufacturers claim that they are looking overseas for a more permissive regulatory environment. There are over 8,000 medical device companies in the U.S.; they generated about $136 billion in sales and employed over 422,000 last year, according to industry officials.

While the industry did better than the economy as a whole through the recession, losing only 1.1 percent of its jobs compared with nearly 5 percent of all manufacturing workers, its job performance lagged behind the rest of the health-care economy, which added employment throughout the downturn.

Two years ago, the medical device industry, which manufactures everything from heart valves to ace bandages, came under tougher scrutiny. The FDA had become more aggressive overseeing the industry in response to criticism that it had repeatedly caved to corporate and political pressure when approving new products. After health-care reformers targeted the industry for higher taxes to help pay for covering the uninsured, Democratic leaders in Congress asked the prestigious Institute of Medicine (IOM) to convene a blue-ribbon panel to determine if the industry needed tougher regulations to ensure the safety and effectiveness of its products. With the IOM’s final report due later this month, the industry is mounting a major public relations offensive to blunt calls for stronger oversight.

The Institute for Health Technology Studies, which is primarily funded by the industry, late last month released an industry survey showing American companies are increasingly going to Europe to get new devices approved. Industry executives also claimed that the FDA in the last few years has arbitrarily toughened its standards for new devices that are similar to products already on the market. In the past, those look-alike products usually received a less rigorous review than brand new medical innovations.

“As the FDA considers regulatory revisions, what’s at stake is the ability of companies to attract investors in order to continue developing innovative, life-saving products and sustaining American competitiveness in the global marketplace,” said John Linehan, a professor of biomedical engineering at Northwestern University and lead author of the survey.

Paulsen, the Minnesota lawmaker, cited the example of Xtent, a Menlo Park, Calif., device maker that tried to gain approval to start a U.S. clinical trial for its coronary stent. Surgeons had already inserted the company’s stent in hundreds of European patients. When the FDA refused to consider data from the European experiences and insisted on a prospective clinical trial, the company closed its doors and sold the technology to foreign investors.

Last week, the House Oversight and Government Reform Committee called in the FDA’s top device regulator to explain the changes underway at the agency, which Republican members claimed had gone too far. “In some cases, the conveyor belt for medical devices has come to a grinding halt,” charged Rep. Trey Gowdy, R-SC., who chairs the health subcommittee.

Jeffrey Shuren, a lawyer and physician who 18 months ago replaced the previous head of the troubled Center for Devices and Radiological Health at FDA, promised to “do a far better job to make the process more efficient without compromising our standards for safety and efficacy.”

Earlier this year, the FDA proposed new rules that would give companies more certainty about what would be expected from them when bringing new products to the agency. But it postponed consideration of any major changes in the oversight process pending the IOM report, which could propose companies do more clinical trials proving efficacy for follow-on devices.

The current rules are a product of the 1976 law that ushered in the modern era of medical device regulation. They require any new device whose failure would pose a serious risk to public health to go through rigorous clinical trial testing in humans for both safety and effectiveness before going on the market. But the law also set up a regulatory scheme, known as the 510(k) process, which allows follow-on devices deemed substantially similar to something already on the market to get approved without the same level of testing. Regulators have discretionary power to order more tests.

The vast majority of new devices use the follow-on process, even though their manufacturers often claim superior performance to the older models and charge accordingly. The result is a lack of scientific data for making those comparisons, which leaves Medicare, private insurers and physicians in the dark as to their relative worth.

The regulatory framework for potentially life-saving devices differs from drugs, where follow-on products – say, the four or fifth statin to come to market for lowering cholesterol – must still go through rigorous clinical trial testing. While that doesn’t meet the gold standard of head-to-head comparisons between competing products, at least that gives medical analysts sufficient information to know if one drug is significantly better or worse than another product in the same class.

Safety issues can arise when there are no clinical trials for follow-on devices. And that also contributes to rising health care spending, since it can result in costly recalls or even follow-on operations to replace faulty devices. The updated devices often change materials or tweak the engineering, which can alter their performance once put in the body or deployed in health care settings.

A study published earlier this year in Archives of Internal Medicine found that of 113 major product recalls between 2005 and 2009, only’ percent had gone through the more rigorous clinical trial testing required for new products, while 71 percent had used the follow-on process. There had been only 49 major recalls in the prior five years.

“Yes, the FDA’s getting tougher and it’s long overdue,” said the study’s lead author, Diana Zuckerman, executive director of the National Research Center for Women and Families. “Too many things were sailing through without clear evidence they were safe and effective.”

She cited last December’s recall of 359 million glucose test strips manufactured by Abbott Laboratories, whose malfunction could give diabetics false readings and lead to under or over-medication. Last week Redberg of UCSF told the oversight subcommittee to reject calls for speeding up the regulatory review process in the name of fostering greater innovation. She cited a 2009 Government Accountability Office report that found that a majority of high-risk devices do not go through clinical trial testing prior to marketing. “Only high-quality clinical trials can assure safety and effectiveness, especially when it comes to high risk devices that are used with invasive procedures,” she said.

– Provided by Kaiser Health News.

Article © AHN – All Rights Reserved

View full post on Health Stories

FDA finds no link between common blood pressure pill and cancer

June 3, 2011 · Posted in cholesterol too low · Comment 
David Goodhue – AHN News Reporter

Washington, D.C., United States (AHN) – Good news for people taking blood pressure medication. The U.S. Food and Drug Administration said this week that a common class of hypertension drugs does not increase the risk of developing cancer.

The FDA evaluated 31 randomized clinical trials comparing patients taking angiotensin receptor blockers and those not taking the drugs.

The review of the 155,000 patients revealed no evidence that the ARBs increased a patient’s risk of cancer.

ARBs are used alone or in combination to treat high blood pressure and other heart-related conditions. Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, Teveten and Several.

 

Article © AHN – All Rights Reserved

View full post on Health Stories

Germany to complete dismantling of nuclear plants by 2022

May 30, 2011 · Posted in cholesterol too low · Comment 
Windsor Genova – AHN News News Writer

Berlin, Germany (AHN) – The German government will stop the operation of all nuclear power plants by 2022, Environment Minister Norbert Roettgen announced on Monday. The government will replace nuclear power with renewable energy.

The move was in response to public clamor against nuclear energy due to the danger it poses to health. The clamor intensified after the March 11 earthquake and tsunami in Japan damaged the Fukushima nuclear reactors causing radioactive leaks.

Eight nuclear power plants in Germany have already been shut down and the rest will be phased out by 2021. But three nuclear plants will be on standby and will be operated in case an energy shortage occurs.

The announcement makes Germany the first developed country that will stop using nuclear energy.

Article © AHN – All Rights Reserved

View full post on Health Stories

Study: Too much hand sanitizer use can give a test positive for alcohol consumption

May 26, 2011 · Posted in cholesterol too low · Comment 
Ayinde O. Chase – AHN News Editor

Gainesville, FL, United States (AHN) – Using alcohol-containing hand sanitizer may result in testing positive in a urine test for alcohol consumption, according to a recent University of Florida study,

In the study, 11 volunteers who had not consumed alcohol in five days repeatedly applied a popular brand of hand sanitizer, Purell, to their hands. According to the manufacturer, 62 percent of Purell consists of ethyl alcohol.

They sanitized every five minutes, for 10 hours a day, three days in a row, approximating how much sanitizer a nurse would do during typical days on the job.

However, by the end of the first day the urine in eight of the subjects contained levels of an alcohol-breakdown product that would indicate they had recently consumed alcohol.

Doctor Gary Reisfield of the University of Florida College of Medicine conducted the study. He said, “The levels of one of the biomarkers we found was consistent with the use of moderate amounts of alcohol consumed over the past couple hours to the past couple days.”

Resfield says humans break down ethyl alcohol in hand sanitizers the same way they break down alcoholic drinks.

“Anyone out there who needs to abstain from alcohol needs to be cognizant about alcohol that may be hidden in products in hand washing gels, hair sprays, food stuffs, and cosmetic products,” he said.

Article © AHN – All Rights Reserved

View full post on Health Stories

FDA Warns Not to Feed SimplyThick to Premature Infants

May 22, 2011 · Posted in cholesterol too low · Comment 

Washington, DC, United States (AHN) – Do not feed the thickening product called SimplyThick to infants born before 37 weeks because it may cause a life-threatening condition.

This advice to parents, caregivers, and health care providers from the Food and Drug Administration (FDA) is based on reports of infants with necrotizing enterocolitis (NEC) in which tissue in the intestines becomes inflamed and die

SimplyThick is a brand of thickening agent—available to consumers and medical centers—to help manage swallowing difficulties. It is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.

Benson M. Silverman, M.D., director of FDA’s Infant Formula and Medical Foods Staff—himself a neonatologist—explains that the thickening agent is added to infants’ formula to help the premature babies swallow their food and keep it down, without spitting up. The product is also used in older children and adults with swallowing problems caused by trauma to the throat, he notes.

The Problem

FDA first learned of bad side effects possibly linked to SimplyThick on May 13, 2011. Silverman says he was alerted by two reports in FDA’s MedWatch Adverse Event Reporting system. He followed up with the physicians who filed those reports and subsequently with a network of other neonatologists.

Karl Klontz, M.D., a medical officer in FDA’s Center for Food Safety and Applied Nutrition, says the severity and scope of the problem soon became apparent. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick mixed with mothers’ breast milk or infant formula products. The mixture was fed to infants for varying amounts of time.

At least four different medical centers around the U.S. have reported the illness in infants who became sick over the past six months.

This situation is unusual because NEC most often occurs in babies while they are in the hospital early in their premature course. But some of the ill babies that FDA is aware of got sick after they had been discharged from the hospital and sent home on a feeding regimen that included SimplyThick.

At this time it is not known what about SimplyThick is making babies sick. FDA is actively investigating the link between SimplyThick and these illnesses and deaths.

In the meantime, adds Klontz, parents should stop using the product even if their babies don’t appear to be sick. “Why take the risk?” he asks.

Symptoms to Watch for

  • bloated stomach
  • greenish-tinged vomiting
  • bloody stools

Do not feed SimplyThick to premature infants, including those in the hospital and those sent home from the hospital within the past 30 days.

Contact your health care professional if your baby has any of the symptoms listed above or if you have other concerns related to using SimplyThick.

You or your health care professional may report side effects related to using SimplyThick to FDA’s MedWatch Safety Information and Adverse Event Reporting Program by:

Completing and submitting the report online: www.fda.gov/MedWatch/report.htm;

Downloading the pre-addressed, postage-paid FDA Form 3500 (or calling 1-800-332-1088 to request the form), completing it and faxing it to 1-800-FDA-0178; or Mailing the completed form to MedWatch 5600 Fishers Lane, Rockville, MD 20857.

What FDA Is Doing

FDA is actively investigating the link between SimplyThick and the illnesses and deaths. FDA will provide updates as information is made available.

Article © AHN – All Rights Reserved

View full post on Health Stories

Health professionals challenge McDonald’s to stop marketing to kids

May 18, 2011 · Posted in cholesterol too low · Comment 
Ayinde O. Chase – AHN News Editor

Chicago, IL, United States (AHN) – More than 550 health professionals and activists from across the country have challenged McDonald’s to stop marketing junk food to kids.

Currently the fast food retailer uses a proven marketing campaign that makes parents virtually powerless over the allure of their products and brand images.

The group Corporate Accountability International also is seeking to retire the company’s iconic corporate symbol Ronald McDonald. The clown character who wears oversized red shoes and yellow rompers adorned with the restaurant chain’s “Golden Arches” logo — for decades has been used by McDonald’s as a kid-friendly corporate spokesman.

The open to letter to the company’s CEO found at lettertomcdonalds.org comes just weeks after the Federal Trade Commission (FTC) proposed sweeping new guidelines on junk food marketing to kids.

Wednesday’s move comes a day before McDonald’s annual shareholders’ meeting. During the meeting a resolution calling on the corporation to assess its impact on public health will be voted on.

“Today, our family practice offices, pediatric clinics, and emergency rooms are filled with children suffering from conditions related to the food they eat. These health problems will likely play out over their lifetime through early onset of diabetes, heart disease and arthritis.” said Dr. Steven K. Rothschild, Associate Professor of Preventive Medicine at Rush Medical College. “Through this initiative the public health community is rallying behind a simple message to McDonald’s: stop making the next generation sick – retire Ronald and the rest of your junk food marketing to kids.”

A range of leading health institutions from the Chicago Hispanic Health Coalition to the American Academy of Child and Adolescent Psychiatry have endorsed the letter featured in today’s ads.

The full-page ads can be seen appearing in the Chicago Sun-Times, New York Metro, Boston Metro, San Francisco Examiner, Minneapolis City Pages and Baltimore City Paper urge still more individuals and institutions to sign the open letter and share it with their peers. The ads have sparked debates on morning talk shows and around water coolers.

“This initiative has struck a chord, particularly among health professionals who work in the communities most targeted and impacted by McDonald’s marketing,” said Esther Sciammarella, Executive Director of the Chicago Hispanic Health Coalition. “Children in these communities are not as healthy. Access to healthy food is limited. There is less nutrition education. But we do have more of one thing: McDonald’s junk food and junk food marketing. It’s time that changed.”

In response to the letter McDonald issued a statement:

McDonald’s cares about kids. We are committed to responsible advertising and take our communications to children very seriously.

We understand the importance of children’s health and nutrition, and are committed to being part of the dialogue and solution.

We serve high quality food, and our Happy Meals offer choice and variety in portions just for kids. Parents tell us they appreciate our Happy Meal choices.

As the face of Ronald McDonald House Charities, Ronald is an ambassador for good and delivers important messages to kids on safety, literacy and balanced, active lifestyles.

Researchers say that an increasing amount of studies from the Institutes of Medicine to the National Bureau of Economic Research show that reducing junk food marketing to kids could spare the health of millions of children.

Article © AHN – All Rights Reserved

View full post on Health Stories

Flatulence results in dismissal from school bus for two boys

May 14, 2011 · Posted in cholesterol too low · Comment 
Ayinde O. Chase – AHN News Editor

Canal Winchester, OH, United States (AHN) – Two Ohio boys were kicked off the school bus for passing gas and being a disruption.

The incident happened on Thursday and according to one of the boys’ father caused riders to laugh, heckle and of course roll their windows down.

James Nichols in a report with the Columbus Dispatch said they boys were considered repeat offenders because a driver had warned them after a similar indiscretion weeks ago.

However this time officials at Canal Winchester Middle School intervened and deemed it was an obscene gesture that violated the student code of conduct. They were banned for a day from riding.

Nichols on the other hand calls the whole thing “laughable” the kids would be subject to disciplinary action for something natural and unintentional. His wife who was recently hospitalized with gastro-intestinal issues was offended by the whole thing.

Article © AHN – All Rights Reserved

View full post on Health Stories

Study Finds GOP Plan Would Cut Medicaid Funding By More Than 40% To 8 States

May 10, 2011 · Posted in cholesterol too low · Comment 

United States (KaiserHealth) – Eight states – including Florida, Colorado and Georgia – would lose more than 40 percent of their federal funding for Medicaid over the next decade under the House Republicans’ plan to repeal the 2010 federal health law and convert Medicaid into a block grant program, according to an analysis of the plan’s effects on states released today.

The study found that under the plan authored by House Budget Chairman Paul Ryan, R-Wis., states would lose an average of 34 percent of their federal funding for Medicaid. The drop in funding would range from 26 percent in Washington, Vermont and Minnesota to 44 percent in Florida and Wyoming.

The study was released by the Kaiser Family Foundation’s Commission on Medicaid and the Uninsured and conducted by researchers at the Urban Institute. (KHN is an editorially independent program of the foundation.)

The health overhaul passed last year increases eligibility in 2014 for Medicaid to anyone with earnings under 133 percent of the federal poverty level, or $14,484 for an individual, with the federal government picking up at least 90 percent of the Medicaid expansion in the first decade, including 100 percent of the expansion the first few years. The GOP proposal, which passed the House last month in a vote along partisan lines, would save the federal government $1.4 trillion over 10 years, including $610 billion from the repeal of the health law and $750 billion from the move to make Medicaid a block grant program. That would be a 34 percent reduction over planned Medicaid spending under current law – including the health overhaul – and 22 percent less than under the existing program, according to the Kaiser study.

States that currently have the tightest Medicaid income eligibility rules and the highest proportion of poor people would gain the most under the Medicaid expansion in the federal health overhaul, and they would be the biggest losers under the Ryan plan, the report said. Under the health law, 16 million additional Americans would be expected to join Medicaid starting in 2014.

As a result of the cuts in funding in the Ryan plan, the Kaiser analysis estimates that between 31 million and 44 million fewer people would be enrolled in Medicaid in the next decade. Most would be left without insurance coverage.

“Under the House Budget plan, the Medicaid block grant would reduce and cap federal Medicaid spending, substantially reducing states’ ability to provide coverage to low-income Americans,” Diane Rowland, executive vice president of the foundation and executive director of the Kaiser Commission on Medicaid and the Uninsured, said in a statement. “The repeal of the ACA combined with the adoption of the Medicaid block grant would add millions more to the number of uninsured Americans and compromise Medicaid’s role as the health safety net in the next recession.”

Republican governors, asking for greater flexibility to design Medicaid programs as their states face massive budget gaps, have supported the Ryan plan for Medicaid block grants. In a letter to Ryan last month, they said, “We appreciate the many innovative reforms this budget will demand; the current path forward is unsustainable. … Chairman Ryan, your Medicaid proposals are far superior to those envisioned in the PPACA.” The governors, upset with the new healthcare reform law’s requirement for states to maintain Medicaid eligibility standards until 2014, said block grants would provide states with the flexibility to tinker with the safety net for the poor in a responsible way.

Democrats who control the Senate and President Barack Obama oppose the Ryan plan.

Hospitals would also be losers in the Ryan strategy. The report found hospitals could expect their Medicaid payments to drop by as much as 38 percent by 2021.

Currently, states and the federal government share the cost of Medicaid, with the federal government paying about two-thirds and the states one third of the total national spending. The percentage varies by state, however.

Under the House plan, states would get increases in federal funding based on general inflation – which tends to rise more slowly than health inflation – and for changes in population size. Currently, the federal match has no such limits.

The other states that would see a more than 40 percent reduction in federal Medicaid payments are Wyoming, Alaska, Oregon, Nevada and Delaware, the study said.

According to the Congressional Budget Office, the Ryan plan would lead to big reductions in most states’ Medicaid allotments: Within a decade, states would get about a third less money than they would otherwise receive by 2022 and by nearly half in 2030.

Ryan’s plan — though it would not achieve a balanced budget year to year until 2040 and would allow the debt to rise to 70 percent of the gross domestic product by 2022 — would bring the debt down to 64 percent, just above its current level, by 2030, down to 48 percent by 2040, and then dramatically down to 10 percent by 2050.

The Kaiser findings closely mirrored a recent report by the left-leaning Center on Budget and Policy Priorities, which found the House plan would have cut federal Medicaid funds to most states by more than 25 percent by 2009 and to several of them by more than 40 percent if it had been in effect starting in 2000. The center found Arizona would have been hit the hardest, receiving 52 percent less in federal Medicaid funding over the 10-year period. The five states that would have experienced the largest percentage reductions – Arizona, Nevada, New Mexico, Alaska and Florida – would have experienced average cuts of 39 percent over 10 years and average cuts of 47 percent in 2009.

The five states with the smallest reductions would have been cut an average of 9 percent over the 10-year period and 17 percent in 2009, according to the center’s study. These states are Connecticut, the District of Columbia, Nebraska, New Hampshire and North Dakota.

– Provided by Kaiser Health News.

Article © AHN – All Rights Reserved

View full post on Health Stories

Medicare ‘Doc Fix’ put on life support by AMA lobby

May 6, 2011 · Posted in cholesterol too low · Comment 

United States (KaiserHealth) – The annual scramble to prevent next year’s scheduled pay cut for doctors who treat Medicare patients kicked off Thursday with physician leaders calling for a five-year program of guaranteed annual raises and a high-ranking House Republican calling for another short-term fix.

The issue – known inside the Beltway as “the doc fix” – is the residue of a law enacted by Congress in the late 1990s that sought to limit the growth of Medicare spending on seniors’ health care. The law limited physician pay increases to same growth levels as the overall economy, which became known as the sustainable growth rate or SGR. Since health care spending over the last decade grew twice as fast as gross domestic product, implementing the SGR would dramatically shrink physician pay as a share of overall Medicare spending.

It never happened. Every year members of the American Medical Association and specialty societies bombard Capitol Hill with demands to restore the old system. And every year, Congress voids the SGR-mandated cuts.

But that means that every year the size of the scheduled pay cut under the original law grows larger. Unless Congress acts before January 1, physician pay next year will be reduced by 29.4 percent. The estimated 10-year cost for the “doc fix,” according to the Congressional Budget Office, is approaching $300 billion.

Rep. David Camp, R-Mich., chair of the House Ways and Means Committee, told a Health Affairs briefing on Thursday that finding $300 billion for a ten-year fix “was untenable in the current situation” when Congress and the White House are struggling to find ways to reduce the $1.5 trillion budget deficit. Rather, he said, the Republican-led House will consider a “several-year fix . . . to get out from under this, and then look to the long-term fix.”

However, even a short-term fix would cost tens of billions of dollars next year, which could wipe out a significant portion of the budget reductions that Republicans are seeking as part of the debt-ceiling negotiations that kicked off yesterday.

Legislators looking for a magic bullet to the physician pay issue received no help from physician lobbying groups who testified on Capitol Hill. At a hearing of the House Energy and Commerce subcommittee on health, the American Medical Association called for scrapping the SGR and instituting a five-year program of regularly scheduled pay increases, during which time the Centers for Medicaid and Medicare Services (CMS) could experiment with alternative payment models like bundled payments — a single payment for all services related to a treatment or condition, rather than a series of separate payments — or special reimbursements for coordinating care.

“The SGR is a failed formula,” said Cecil Wilson, an internist from Winter Park, Florida, who is the current president of AMA. “The longer we wait to cast it aside, the deeper the hole we dig.”

The American Academy of Family Physicians, which represents relatively low-paid primary care physicians, called for higher reimbursement rates for their specialty. The American College of Surgeons, which represents some of the highest paid specialists and would be hurt by a shift in pay toward primary care, also called for SGR’s repeal and setting a “realistic” budget baseline for future payment increases for all specialties, which should reflect the actual cost of providing care.

Mark McClellan, who headed CMS during the George W. Bush administration and now heads the Brookings Institution’s health care policy shop, told the subcommittee “the payment reforms in the Affordable Care Act are a foundation for this.” That was an ironic statement coming from a former high-ranking Republican official, since the House majority, in a vote taken earlier this year, repealed the new health reform act in a largely symbolic gesture.

The special interest scramble to get Congress to ditch the SGR every year is a cautionary tale about strategies from both sides of the aisle for Medicare cost control. The health care reform legislation pushed through by President Obama and the Democrats achieves a half trillion dollars in Medicare savings over the next decade largely by putting a ceiling on the program’s annual growth rate that is one percentage point faster than GDP.

Obama, in his deficit reduction plan announced last month, upped the ante by calling for a ceiling growth rate of GDP plus 0.5 percentage point. The vehicle for achieving these savings in either case will be the reform law’s new Independent Payments Advisory Board, which starting in 2015 is scheduled to send mandatory cuts to Capitol Hill whenever health care grows faster than the target rate. Congress could either approve those cuts, or substitute a package of its own that achieved similar savings.

Camp attacked that approach yesterday, saying it was unacceptable for “a bunch of unelected bureaucrats” to dictate cuts that “will only cut payments to providers.” But the Republican plan for lowering Medicare’s unsustainable growth, which is called premium support because it would give future seniors a voucher to buy private insurance, has a cap of its own. It pegs the growth in the government’s annual contribution of premium support payments to a formula that is one percentage point higher than the consumer price index, which in most years is well below the growth in the economy.

In reality, any such formula could be thrown out the window by future Congresses – just as the SGR will be when Congress passes its next “doc fix” sometime before next January.

– Provided by Kaiser Health News.

Article © AHN – All Rights Reserved

View full post on Health Stories

Next Page »

Powered by Yahoo! Answers