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BRIEFLY:
Partnership for Value-driven Health Care releases Purchaser Guide
The NAM, as members of the Partnership for Value-driven Health Care (the "Partnership") and working with HHS Secretary Leavitt, developed a Purchaser Guide to aid employers in complying with the "four cornerstones" of value-drive health care. This guide is a "how to" for employers and includes a checklist, sample templates and examples of the many ways employers can meet the objectives of supporting interoperable health IT, transparency of quality and price and incentives for high value health care. Visit
http://www.leapfroggroup.org/news/leapfrog_news/Purchaser_Guide to access the Purchaser Guide.
EPA announces new human health research Website
EPA's Human Health Research Program launched a new Website on the latest information on its research to protect public health. The program's science looks at such questions as why some people are more sensitive to pollution and how
exposure to chemicals affects people's health.
"The best decisions are informed decisions," said George Gray, assistant administrator for the Office of Research and Development. "The site provides easy access to research and results on methods, tools, and data needed to improve risk assessments to protect the public."
Visitors to the site will find an overview of the research, information on how research has contributed to decision making, and resource materials available in journal publications and reports. Visit the new human health research Website at
http://www.epa.gov/hhrp.
Senator Obama's plans
Democratic presidential hopeful Barack Obama told New Jersey labor unionists that he will make health insurance available to all Americans. Obama's contention, during a town hall meeting, that universal health care was possible by the end of his first term brought cheering union workers to their feet. The discussion was part of the New Jersey AFLCIO presidential endorsement process.
Obama said affordable health insurance can be funded by saving $75 billion per year by having more people use regular doctor checkups instead of more expensive emergency room visits.
Illinois Covered — the Blagojevich health care plan
Governor Rod Blagojevich proposed in March to push a new health care initiative that would be among the most comprehensive in the country. It would offer not only insurance to everyone in Illinois, but also wellness training, special attention to chronic disease and streamlined administration.
Unlike efforts in other states, the plan would not simply shift or borrow money from existing programs but would be financed largely by a three percent payroll tax and a new tax on gross business receipts.
With his reelection last November and with the sizeable democratic majorities in both the Illinois House and Senate, Blagojevich determined the timing was right to push ahead with the proposal.
In this case, timing may not be everything. Despite Democratic control of the General Assembly, legislators have had a lukewarm response to the health plan, and several leaders who usually find themselves allied with the governor have expressed outright opposition to the gross receipts tax. Among them are the Governor's running mate, Lieutenant Governor Pat Quinn, Treasurer Alexi Giannoulias and Comptroller Dan Hynes.
The proposed tax would apply to the gross receipts of businesses that make more than $2 million a year, and would range from 1.0 percent for businesses like retailers or wholesalers to 2.0 percent for service businesses. (Retail sales of food and medicine are exempt at the point of final purchase.)
In addition to his health care plan, the Governor says he would like to use part of the revenue from the tax to finance improvements in education. He estimates that the tax would generate more than $8 billion a year in net revenue.
The tax proposal has created outrage in the business community, and its unpopularity is threatening to doom the entire health care initiative.
Recently Lieutenant Governor Quinn told reporters he had told the Governor it was time for ‘Plan B,' or a plan that can win legislative approval, and urged retreat from the GRT proposal which he believes is the wrong remedy for a serious issue.
Some corporations have threatened to move out of the state should the tax become real. The Illinois Manufacturers' Association has been a leader of a statewide campaign against both the health care plan and the tax. In addition, Treasurer Giannoulias, an early critic of the gross receipts tax, said his office has gotten a number of complaints from angry taxpayers.
National health care advocates are not surprised by the backlash. From California to Pennsylvania, states, in the absence of federal action, have taken on health care issues, searching for ways to expand insurance coverage for the nation's nearly 46 million uninsured. While many proposals are being talked about, only three states have been able to reach the kind of consensus necessary to enact sweeping change: Maine, Massachusetts and Vermont.
If it became law, the Illinois proposal, officially called Illinois Covered, would be among the most ambitious, according to health care experts. It addresses not only the state's 1.4 million uninsured, but also those who may be underinsured, regardless of health status.
Blagojevich's proposal creates a statewide pool of low-rate, government financed insurance plans. It also offers rebates for middle-income families to help them pay premiums for the state's program or private coverage, and extends access to coverage for those of very low income through a mechanism similar to Medicaid. It would also allow parents to keep adult children on their family policies until age 29.
The big question is whether the state can afford the proposal in the wake of a crucial House vote on May 10th. Legislators there unanimously voted against imposing the gross receipts tax in a non-binding resolution. The governor's proposal relies in large measure on the revenues generated by the tax, and without them, is probably doomed.
Blagojevich seems undeterred by the House action and has vowed that he will consider no alternatives other than his proposal; a significant line in the sand considering there are just weeks to go in the scheduled spring session. If Blagojevich is counting on an eleventh-hour conversion of rank and file members to give him the support he needs, he has much work ahead of him and right now the Governor is not considered a welcome sight by many in his own political party.
Still, if lawmakers vote later this spring in favor of such a massive tax increase, they will be hard pressed to explain to constituents why they changed their votes.
Nonetheless, the governor has won unlikely battles in the past. In 2005, he defeated critics and signed into law a measure that was, at the time, the broadest plan to insure children by any state. And his health care proposal is not without some private sector supporters.
AARP, a lobby for older Americans, supports the Blagojevich plan as does the Illinois Hospital Association and the Illinois Pharmacists Association.
Support exists for many options to expand health insurance coverage, but not all
Half of all U.S. adults with health insurance coverage worry that their expenses will be so high that they won't be able to afford it. Just as many worry that their coverage will be drastically reduced or eliminated because of costs; one in five adults worries a great deal about these issues.
Three in four U.S. adults support a variety of initiatives to expand insurance coverage, including employer mandates, government subsidies for the uninsured and tax credits to help individuals afford health insurance. All of these options are viewed with equal favor by individuals who currently have employer-sponsored coverage and those who are uninsured. By contrast, only 26 percent of those polled said they are willing to pay more in taxes to cover more people under Medicare or Medicaid.
These are some of the results of an online survey of 2,402 U.S. adults, ages 18 and older, conducted by Harris Interactive® between April 13 and 17, 2007 for The Wall Street Journal Online's Health Industry Edition (www.wsj.com/health).
Seventy-four percent of U.S. adults polled said they would support a measure requiring employers to provide insurance for all of their employees. However, the question of employer mandates often raises concerns about the impact this might have on smaller employers. The public is of two minds on this issue. Two-thirds of all adults believe that requiring smaller employers to provide health insurance might force some employers out of business. But, when asked if the benefits of such mandates would outweigh these risks, 47 percent say they would and 53 percent say they would not.
Katherine Binns, President of Healthcare Research at Harris Interactive, said, "As the Democrats establish their agenda on Capitol Hill and the Presidential candidates launch their campaigns, a variety of proposals have been made to expand health insurance to cover more of the uninsured. These findings suggest that the public is willing to back proposals that do not rely on big government or higher taxes. With large numbers of insured people worrying about the affordability and security of their benefits, its not surprising to see that support for these types of programs is equally strong among the insured as well the uninsured."
Employer survey points to need for health management, including incentives for employees
How do you structure an employee health benefit incentive program? What incentives do you use to change health behavior?
Companies that combine "consumer-directed health plans" with other health-related tactics are more effective than others at controlling health care costs, according to a recent independent survey.
A report issued in March by Watson Wyatt Worldwide and the National Business Group on Health found that companies that are best at controlling costs are focused on adopting approaches that involve quality, health improvement and productivity (including the use of incentives), data and evidence, and the appropriate use of health care services.
Managing and improving the health of a work force is a critical component of controlling health costs. A robust incentive strategy leveraging plan-design or other incentive models is critical to the success of any health and disease management program.
The NBGH/Watson Wyatt report focused on the use of consumer-directed health plans (CDHPs), which generally include a high-deductible plan coupled with a personal savings account such as a health savings or health reimbursement account. These plans are attractive to employers who are seeking to limit their health care expenditures and encourage their employees to pay more attention to health care costs and adopt healthy behaviors.
In a survey of 573 large employers, 38 percent are offering CDHPs, an increase of five percentage points over a year ago. However, employee enrollment in CDHPs remains low at eight percent, an increase of only one percentage point from 2006. This comes despite the fact that CDHPs usually involve lower health insurance premiums for employees.
Broader participation in CDHPs is linked to lower health care cost increases. Employers with 10 percent or more of their covered population in a CDHP are holding health care cost increases to a lower level — 6.5 percent average — than other employers. Some employers are also driving enrollment by offering CDHPs as their only option. Currently, five percent of employers are offering CDHPs on a total replacement basis, and another four percent will do so in 2008.
The survey found that best performers are 17 percent more likely to offer compelling financial incentives to encourage employee education and participation and 11 percent more likely to effectively deliver health care information.
"Focusing on prevention, early intervention, disease management and quality outcomes not only can help employers control health care costs, it can make employees healthier and more productive," said Helen Darling, president of the National Business Group on Health. "Employers are finding that encouraging their employees to maintain healthier lifestyles has great benefit."
Blue Cross and Blue Shield of Illinois announces e-Prescribing Collaborative program to improve patient safety
Innovative program is the first of its kind in the country
In an effort to make prescription medications safer and to improve the quality of care in Illinois, Blue Cross and Blue Shield of Illinois recently announced the implementation of a statewide, collaborative program that will unite the health care industry and expand e-prescribing throughout Illinois.
The Illinois e-Prescribing Collaborative, which went live in early April, is the first of its kind in the nation, as insurers, technology vendors, pharmacies, employer groups, physicians and other organizations involved in the prescription process are working together to increase the use of e-prescribing in the state. The organizations involved in this ground-breaking collaborative are the health plans and pharmacies in Illinois, Midwest Business Group on Health, Chicago Patient Safety Forum, Illinois Academy of Family Physicians, Illinois chapter American Academy of Pediatrics, Illinois Foundation for Quality Healthcare, Illinois State Medical Society, Midwest Business Group on Health, Illinois Healthcare and Family Services, and the Jewish Federation of Metropolitan Chicago.
Initial costs for the implementation of approximately 500 physicians are being funded by Blue Cross and Blue Shield of Illinois. Additionally, the program's innovative service and support model gives every physician throughout the state an opportunity to participate by providing funding and technology support for e-prescribing. "As other health plans join in and as physicians generate e-prescriptions, additional funds will be generated to bring on additional doctors," said Stan Borg, chief medical officer for Blue Cross and Blue Shield of Illinois. "An e-prescription is a safer prescription and our goal is to achieve widespread adoption of the technology throughout Illinois."
This unique program is designed to create value to all parties in the prescription process, including patients, physicians, pharmacies, employers and health plans. "With all members of the collaborative working together, we can take significant steps to help improve the overall quality of care and increase efficiencies in the prescription process while controlling health care costs by reducing medication errors," said Larry Boress, president of the Midwest Business Group on Health.
"UnitedHealthcare is pleased to support this collaborative effort to advance high-tech solutions that will help streamline prescription filling and verification and improve patient safety," said Prentiss Taylor, MD, UnitedHealthcare of Illinois Medical Director. "We believe technology such as (ePrescribing) plays a significant role in enhancing the delivery and quality of health care and improving health care affordability for families and employers."
With access to the e-prescribing software through a PDA or desktop computer, physicians can check eligibility, co-pay and formulary information at the point of care. Access to patient drug history will enable physicians to prescribe the appropriate medication by verifying the patient's allergies and checking for possible drug interactions. Prescriptions would then be sent directly to the patient's pharmacy. Patient waiting time as well as callbacks to physicians for changes or clarifications would thus be greatly reduced. Generic utilization would also be increased along with formulary compliance as a result of cues displayed by the program that would inform the physician of alternatives to brand name drugs.
"The Illinois e-Prescribing Collaborative is carving out a unique approach to e-prescribing," said G. Cameron Deemer, President of DrFirst, a national provider of physician connectivity services. "By establishing a balanced contribution of funds, each payer operating in the state of Illinois has an opportunity to participate at a level matching their presence in the state. We are committed to accelerating the adoption of e-prescribing in Illinois and are proud to be part of an innovative self-perpetuating program which relies on transaction fees to fund both existing and new physicians for the program."
"The time is right for broad adoption of e-prescribing based on results measured in several e-prescribing programs throughout the country," said Rick Spurr, chief executive officer for ZixCorp, a provider of hosted email encryption and e-prescribing services. "We are committed to helping the Illinois Collaborative achieve success by doing our part to drive physician adoption so that the goals of medication safety are realized for everyone in Illinois."
FDA advises manufacturers of potential health hazard to consumers
The U.S. Food and Drug Administration (FDA) is warning pharmaceutical manufacturers, suppliers, drug repackers, and health professionals who compound medications to be especially vigilant in assuring that glycerin, a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products, is not contaminated with diethylene glycol (DEG). DEG is a known poison used in antifreeze and as a solvent. The agency recently issued guidance to industry on recommended methods of testing glycerin and other controls to identify any contamination with DEG before use in the manufacture or preparation of pharmaceutical products.
Currently, FDA has no reason to believe that the U.S. supply of glycerin is contaminated with DEG, though the agency is cognizant of reports from other countries in which DEG-contaminated glycerin has caused human deaths. FDA is emphasizing the importance of testing glycerin for DEG due to the serious nature of this potentially fatal problem in combination with the global nature of the pharmaceutical supply chain and problems that continue to occur with this kind of contamination in some parts of the global supply of glycerin.
FDA is working with a variety of manufacturing and pharmacist organizations to raise awareness of this risk and to put into place controls to ensure that this problem does not happen in the U.S. or elsewhere.
The most recent incident occurred in Panama in September 2006 and involved DEG-contaminated glycerin used in cough syrup, which resulted in dozens of hospitalizations for serious injury and more than 40 deaths. In late 1995 and early 1996, at least 80 children died in Haiti due to DEG-contaminated glycerin in acetaminophen syrup. Between 1990 and 1998, similar incidents of DEG poisoning reportedly occurred in Argentina, Bangladesh, India, and Nigeria and resulted in hundreds of deaths. In 1937, more than 100 people died in the United States after ingesting DEG-contaminated Elixir Sulfanilamide, a drug used to treat infections. This incident led to the enactment of the Federal Food, Drug, and Cosmetic Act, which is the nation's primary statute on the regulation of drugs.
FDA reminds pharmaceutical manufacturers, compounders, repackers, and suppliers, as well as brokers and distributors, that all pharmaceutical manufacturing operations, including the re-packaging and re-labeling of ingredients like glycerin, must conform to current good manufacturing practice (CGMP). The guidance provides recommendations for complying with CGMP and is intended to help avoid the use of glycerin that is contaminated with DEG and prevent incidents of DEG poisoning.
For a copy of the guidance, go to http://www.fda.gov/cder/guidance/7654fnl.htm.
FDA clears first respirators for use in public health medical emergencies
The U.S. Food and Drug Administration (FDA) has cleared for marketing the first respirators that can help reduce the user's exposure to airborne germs during a public health medical emergency, such as an influenza pandemic.
These two filtering facepiece respirators, manufactured by St. Paul, Minn.-based 3M Company, will be available to the general public without a prescription.
The devices are also certified as N95 filtering facepiece respirators by the National Institute for Occupational Safety and Health (NIOSH). NIOSH certifies respirators for use in occupational settings in accordance with an appropriate respiratory protection program.
An N95 filtering facepiece respirator is a type of face mask that fits tightly over the nose and mouth. It is made of fibrous material that is designed to filter out at least 95 percent of very small airborne particles.
"While the exact nature and concentration of the biological agent or germ may not be known in a public health medical emergency, we believe that minimizing exposure will help reduce risk," said Daniel Schultz, MD, director, FDA's Center for Devices and Radiological Health. "These respirators are only one part of a combination of approaches that can be used to help reduce the spread of infection between individuals during such events."
Many companies make N95 respirators for workplaces, including health care settings. However, the 3M respirators are the first devices to receive FDA clearance for use by the public during public health medical emergencies to reduce exposure to airborne germs.
Under Occupational Safety and Health Administration and other occupational health regulations, respirators used in the workplace must be individually selected for each worker and tested to ensure a proper fit. This kind of fit testing is not generally employed outside the workplace now and would probably not be feasible during a public health medical emergency.
FDA is requiring those who want to market respirators for use during public health medical emergencies to assure that they are certified by NIOSH to provide adequate filtration without hampering people's ability to breathe.
3M evaluated fit characteristics in healthy adults to determine that a user could achieve a protective fit following the instructions on the label. They measured how many airborne test particles were able to get inside the respirator through small leaks. While individual results varied, all participants tested achieved some reduction in exposure to airborne test particles.
The 3M respirators are sized for adults and may not form a proper fit on children. The devices are for single use. Wearers should not wash, disinfect, reuse or share their respirator with others. The respirators should be discarded after use.
Inhaling particles is just one route of exposure to disease-causing organisms. Others include touching contaminated surfaces and coming into close contact with those who have infectious diseases. A total approach to personal protection includes hand hygiene, cough etiquette and other protection practices such as avoiding crowded settings.
FDA approves first U.S. vaccine for humans against the Avian Influenza Virus H5N1
The U.S. Food and Drug Administration (FDA) in April announced the first approval in the United States of a vaccine for humans against the H5N1 influenza virus, commonly known as avian or bird flu.
The vaccine could be used in the event the current H5N1 avian virus were to develop the capability to efficiently spread from human to human, resulting in the rapid spread of the disease across the globe. Should such an influenza pandemic emerge, the vaccine may provide early limited protection in the months before a vaccine tailored to the pandemic strain of the virus could be developed and produced.
The H5N1 virus is one version of the influenza A virus commonly found in birds. Unlike seasonal influenza, where infection ranges from mild to serious symptoms in most people, the disease caused by H5N1 is far more severe and happens quickly, with pneumonia and multi-organ failure commonly seen.
While there have been no reported human cases of H5N1 infection in the United States, almost 300 people worldwide have been infected with this virus since 2003 and more than half of them have died. To date, H5N1 influenza has remained primarily an animal disease but should the virus acquire the ability for sustained transmission among humans, people will have little immunity to this virus and the potential for an influenza pandemic would have grave consequences for global public health.
"The timing and severity of an influenza pandemic is uncertain, but the danger remains very real," said Jesse L. Goodman, MD, MPH, Director of FDA's Center for Biologics Evaluation and Research. "We are working closely with other government agencies, global partners and the vaccine industry to facilitate the development, licensure and availability of needed supplies of safe and effective vaccines to protect against the pandemic threat."
The vaccine was obtained from a human strain and is intended for immunizing people 18 through 64 years of age who could be at increased risk of exposure to the H5N1 influenza virus contained in the vaccine. H5N1 influenza vaccine immunization consists of two intramuscular injections, given approximately one month apart. The manufacturer will not sell the vaccine commercially. Instead, the vaccine has been purchased by the federal government for inclusion within the national stockpile for distribution by public health officials if needed.
The vaccine was generally well tolerated. The study showed that 45 percent of individuals who received the 90 microgram, two-dose regimen developed antibodies at a level that is expected to reduce the risk of getting influenza.
With the support of FDA, the U.S. National Institutes of Health, other government agencies and manufacturers are working to develop a next generation of influenza vaccines for enhanced immune responses at lower doses. Meanwhile, the approval and availability of this vaccine will enhance national readiness and the nation's ability to protect those at increased risk of exposure.
For more information on the government's preparedness efforts, visit: http://www.pandemicflu.gov.
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