Wednesday, January 26, 2011

What Job Creators and Economists are Saying About the Democrats’ Health Care Law and Jobs

As the Ways and Means Committee holds its first health care hearing of the 112th Congress – focusing on the impact of the Democrats’ health care law on employers and workers – here is a look at what many employers and economists are saying about the law:

Small Business Coalition for Affordable Health Care
“The self‐employed and small business community could not be more honest about the destructive effects the PPACA places on the nation’s job creators. This law is loaded with new mandates, new taxes and perverse incentives that will forever harm the workplace and the relationship between employers and their employees.”

National Federation of Independent Business (NFIB)
“Small business owners understand that PPACA is a fatally-flawed solution that they do not want and cannot afford. NFIB recently balloted its members, and 93% agreed that Congress should repeal the new law.”

Retail Industry Leaders Association (RILA)
“The health care reform bill signed into law last year fell short of our core needs as health care costs continue to escalate, the ability to custom tailor plans affordable for employees has diminished dramatically, and the government now has an unprecedented role in what was once a voluntary offering by our companies. For these reasons, we urge members of both parties to build upon the successes of the new law and rewrite.”

“We are opposed to any unforgiving mandate which levies a penalty should even one employee fall below an arbitrary threshold. We also cannot stand for a law that will subject employees to a “revolving door” effect of employer-sponsored and exchange-based plans.”

National Retail Federation (NRF)
“NRF has worked closely with the Obama Administration where possible to help smooth implementation of the law. We appreciate the Administration’s cooperative efforts to date. Nevertheless, we are convinced that the health reform law is in the whole misplaced and will hazard future job and economic growth. We strongly support this effort to repeal and replace the health reform law with more job-friendly health care reform that will concentrate first on reducing the cost of medical care.”

Letter from 200 Economists
“A Barrier to Job Growth: The Patient Protection and Affordable Care Act contains expensive mandates and penalties that create major barriers to stronger job growth. The mandates will compete for the scarce business resources used for hiring and firm expansion. The law also levies roughly $500 billion in new taxes that will enter the supply chain for medical services, raising the cost of medical services. At the same time that businesses juggle the potential for higher interest rates or higher taxes, these medical costs will translate to higher insurance premiums, further increasing the cost of operating a business in the United States.”

Monday, January 24, 2011

Cost to Treat Heart Disease in United States Will Triple by 2030

/PRNewswire/ -- The cost to treat heart disease in the United States will triple by 2030, according to a policy statement published in Circulation: Journal of the American Heart Association.

"Despite the successes in reducing and treating heart disease over the last half century, even if we just maintain our current rates, we will have an enormous financial burden on top of the disease itself," said Paul Heidenreich, M.D., chair of the American Heart Association expert panel issuing the statement.

The panel estimated future medical costs based on the current rates of disease and used Census data to adjust for anticipated population shifts in age and race. The rigorous methods they devised didn't double count costs for patients with multiple heart conditions.

"These estimates don't assume that we will continue to make new discoveries to reduce heart disease," Heidenreich said. "If our ability to prevent and treat heart disease stays where we are right now, costs will triple in 20 years just through demographic changes in the population."

The panel said effective prevention strategies are needed to limit the growing burden of cardiovascular disease -- the leading cause of death in the United States that accounts for 17 percent of overall national health expenditures.

"Unhealthy behaviors and unhealthy environments have contributed to a tidal wave of risk factors among many Americans," said Nancy Brown, American Heart Association CEO. "Early intervention and evidence-based public policies are absolute musts to significantly reduce alarming rates of obesity, hypertension, tobacco use and cholesterol levels."

Currently, 1 in 3 Americans (36.9 percent) have some form of heart disease, including high blood pressure, coronary heart disease, heart failure, stroke and other conditions. By 2030, approximately 116 million people in the United States (40.5 percent) will have some form of cardiovascular disease, the panel said. The largest increases are anticipated in stroke (up 24.9 percent) and heart failure (up 25 percent).

Between 2010-30, the cost of medical care for heart disease (in 2008 dollar values) will rise from $273 billion to $818 billion, the authors predicted. "We were all surprised at the remarkable increase in costs that are expected in the next two decades," Heidenreich said. "We need to continue to invest resources in the prevention of disease, the treatment of risk factors and early treatment of existing disease to reduce that burden."

Heart disease will also cost the nation billions more in lost productivity, increasing from an estimated $172 billion in 2010 to $276 billion in 2030. Productivity losses include days missed from home or work tasks because of illness and potential lost earnings due to premature death.

Co-authors writing on behalf of the various councils are: Justin G. Trogdon, Ph.D.; Olga A. Khavjou, M.A.; Javed Butler, M.D.; Kathleen Dracup, R.N., D.N.Sc.; Michael D. Ezekowitz, M.B.Ch.B., D.Phil.; Eric Andrew Finkelstein, Ph.D.; Yuling Hong, M.D., Ph.D.; S. Claiborne Johnston, M.D., Ph.D.; Amit Khera, M.D.; Donald M. Lloyd-Jones, M.D.; Sue A. Nelson, M.P.A.; Graham Nichol, M.D.; Diane Orenstein, Ph.D.; Peter W.F. Wilson M.D. and Y. Joseph Woo, M.D.

Author disclosures are on the manuscript.

The American Heart Association/American Stroke Association receives funding mostly from individuals. Foundations and corporations donate as well, and fund specific programs and events. Strict policies are enforced to prevent these relationships from influencing the association’s science content. Financial information for the American Heart Association, including a list of contributions from pharmaceutical companies and device manufacturers, is available at .

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Saturday, January 22, 2011

FDA Approves Viibryd to Treat Major Depressive Disorder

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.

Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person's lifetime, although some may experience only a single occurrence.

Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. All people with major depression do not experience the same symptoms.

"Major depressive disorder is disabling and prevents a person from functioning normally," said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression."

The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.

The drug will be available in 10, 20 and 40 milligram tablets.

Viibryd and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.

The warning also says data did not show this increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.

Viibryd is manufactured by PGxHealth, New Haven, Conn.

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Wednesday, January 19, 2011

U.S. Rep. Tom Price and Grace-Marie Turner, Galen Institute President, To Speak at Georgia Public Policy Foundation Luncheon Event on Feb. 4

You are invited to attend a Georgia Public Policy Foundation Policy Briefing Luncheon at noon on Friday, February 4, 2011, at the Georgian Club, featuring Georgia Congressman Tom Price and Grace-Marie Turner, president of the Galen Institute.

The event, “Health Care Prognosis and Prognostications,” launches a yearlong series of events in celebration of the Foundation’s milestone 20th anniversary in 2011. It focuses on the status of health care legislation and reform efforts in Washington and what they mean to Georgia.

U.S. Representative Tom Price, an outspoken advocate for patient-centered health care reform in Washington, was elected to Congress in November 2004 to represent Georgia’s Sixth District and serves on the House Ways and Means and Budget committees. Before that, he served four terms in the Georgia State Senate and became the first Republican Majority Leader in the history of Georgia in 2002.

Congressman Price, an orthopedic surgeon, was Medical Director of the Orthopedic Clinic at Grady Memorial Hospital in Atlanta before his election to Congress. His signature legislation in Congress, the Empowering Patients First Act, would bring about positive changes to provide access for all Americans to affordable, quality health care. He is chairman of the House Republican Policy Committee, considered the principal forum for the development of GOP legislative initiatives.

Grace-Marie Turner is president of the Galen Institute, a public policy research organization she founded in 1995 to promote an informed debate over free-market ideas for health reform. She has been instrumental in developing and promoting ideas for reform that transfer power over health care decisions to doctors and patients. She speaks and writes extensively about incentives to promote a more competitive, patient-centered marketplace in the health sector.

Grace-Marie testifies regularly before Congress and advises senior government officials, governors and state legislators on health policy. She served a three-year term as a member of the National Advisory Council of Healthcare Research and Quality and served as a member of the Medicaid Commission. She is founder and facilitator of the Health Policy Consensus Group, a forum where analysts from market-oriented think tanks around the country analyze and develop policy recommendations. She is the editor of “Empowering Health Care Consumers through Tax Reform” and produces a widely read weekly electronic newsletter, Health Policy Matters.

In the mid-1990s, Grace-Marie served as executive director of the National Commission on Economic Growth and Tax Reform. For 12 years, she was president of Arnett & Co., a health policy analysis and communications firm.

This event is $35 to attend. The deadline to register is Wednesday, Feb. 2, 2011. To register, click on this link: Difficulty registering? E-mail Media interested in attending this event please contact Benita Dodd at or 404-256-4050.

Who: U.S. Rep. Tom Price (R-Ga.) and Grace-Marie Turner, President of the Galen Institute
What: “Health Care Prognosis and Prognostications,” a Georgia Public Policy Foundation Policy Briefing Luncheon
When: Noon, Friday, February 4, 2011
Where: The Georgian Club, 100 Galleria Parkway, Suite 1700, Atlanta, GA 30339

About the Georgia Public Policy Foundation: The Foundation is an independent, state-based think tank that proposes practical, market-oriented approaches to public policy to improve the lives of Georgians. The Foundation’s regular events include Leadership Breakfasts and Policy Briefing Luncheons. Weekly publications are the Friday Facts and Friday Idea commentaries. Visit to read about innovative solutions to the state’s challenges or to watch streaming online video of Foundation events. Join the Foundation’s Facebook Page, discuss state issues on our community site, The Forum, or follow us on Twitter at
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FDA Approves Head Lice Treatment for Children and Adults

The U.S. Food and Drug Administration today approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older.

Head lice are parasitic insects found on people’s head, eyebrows, and eyelashes. They feed on human blood several times a day but are not known to cause disease. Head lice are spread mainly by direct head-to-head contact with a person who already has head lice. Lice move by crawling and can easily travel from child to child because children play closely together and often in large groups.

“Natroba provides another option for the topical treatment of head lice infestations, which are especially prevalent in the pediatric population,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Head lice is a common problem among school children in the United States.”

Natroba is a topical drug product and should be applied only to the child’s scalp or hair. The product should be used exactly as prescribed by a health care professional.

The safety and effectiveness of Natroba Topical Suspension 0.9 %, has been established in two multicenter, randomized, active-controlled studies. A total of 552 subjects received a 10-minute treatment with Natroba. If live lice were seen a week later, a second treatment was applied. The proportion of subjects who were lice-free fourteen days after the final treatment of Natroba was approximately 86 percent compared to 44 percent of the control group.

Common adverse events reported include redness or irritation of the eyes and skin.

Safety in pediatric patients below the age of 4 years has not been established. Although Natroba is not approved for use in children younger than 4 years, it is especially important not to use in infants because the product contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions, including death, when applied topically to the skin of children younger than 6 months.

Natroba is manufactured for ParaPRO LLC of Carmel, Ind.

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Thursday, January 13, 2011

Surveys show significant proportions of hospitals and doctors already plan to adopt electronic health records and qualify for federal incentive payments

Four-fifths of the nation's hospitals, and 41 percent of office-based physicians, currently intend to take advantage of federal incentive payments for adoption and meaningful use of certified electronic health records (EHR) technology, according to survey data released today by the Office of the National Coordinator for Health Information Technology (ONC). The survey information was released as the registration period opened for the Medicare and Medicaid EHR Incentive Programs.

David Blumenthal, M.D., M.P.P., the National Coordinator for Health Information Technology, said the survey numbers represent a reversal of the low interest in EHR adoption in previous years. He credited leadership from the medical community and the federal government for the improved prospects for adoption and use of health information technology (health IT).

"For years we have known that electronic health records would improve care for patients and bring about greater cost effectiveness in our health sector, yet adoption rates by health care providers remained low," Dr. Blumenthal said. "In 2009, Congress and the President authorized major new federal support for EHR adoption and use, and in combination with medical professional and hospital leadership, I believe we are seeing the tide turn toward widespread and accelerating adoption and use of health IT."

The data released today comes from surveys commissioned by ONC and carried out in the course of regular annual surveillance by the American Hospital Association (AHA) and the National Center for Health Statistics (NCHS), an agency of HHS' Centers for Disease Control and Prevention (CDC).

The AHA survey found that 81 percent of hospitals plan to achieve meaningful use of EHRs and take advantage of incentive payments. About two-thirds of hospitals (65 percent) responded that they will enroll during Stage 1 of the Incentive Programs, in 2011-2012.

The NCHS survey found that 41 percent of office-based physicians are currently planning to achieve meaningful use of certified EHR technology and take advantage of the incentive payments. Four-fifths of these, or about a third of all office-based physicians (32.4 percent), responded that they will enroll during Stage 1 of the programs. Only 14 percent of respondents said they were not planning to apply for meaningful use incentives.

Additional survey data from NCHS show that significantly increasing numbers of primary care physicians have already adopted a basic EHR, rising by 50 percent from 19.8 percent of primary care physicians in 2008 to 29.6 percent in 2010. Basic EHRs provide a beginning point for use of electronic health records in physician offices, but most physicians would need to further upgrade their EHR systems or their use of the systems in order to qualify for meaningful use incentive payments.

Incentive payments for the adoption and meaningful use of certified EHR technology were authorized in the Health Information Technology Economic and Clinical Health Act (HITECH) in 2009. Incentive payments will be made through the Medicare and Medicaid programs. High rates of adoption and meaningful use could result in as much as $27 billion in incentive payments over 10 years.

Non-hospital-based physicians and other eligible professionals can obtain incentive payments of as much as $44,000 under Medicare or $63,750 under Medicaid. Under both Medicare and Medicaid, eligible hospitals may receive millions of dollars for implementing and meaningfully using certified EHR technology.

Provider registration for the Medicare EHR Incentive Program and some Medicaid EHR Incentive Programs opened Jan. 3, 2011. Most states will allow provider registration to begin for their Medicaid EHR Incentive Programs during the spring and summer of 2010.

"We are pleased to see this evidence of an enthusiastic early response, and we believe participation will continue to grow, especially as the Nation's physicians become more familiar with this one-time opportunity to improve care while helping to offset the costs of adopting EHR systems," said Donald Berwick, M.D., Administrator of the Centers for Medicare & Medicaid Services (CMS).

To qualify for incentive payments, under the Medicare EHR Incentive Program, providers must achieve meaningful use of certified EHR technology, under regulations issued by CMS and ONC. Medicaid providers can receive their first year's incentive payment for adopting, implementing, and upgrading certified EHR technology but must demonstrate meaningful use in subsequent years in order to qualify for additional payments.

Dr. Blumenthal said the meaningful use process has contributed to the increased willingness of providers to adopt EHR systems, especially because it guides providers through staged objectives for the productive use of EHRs, and because providers can now be assured that Complete EHRs and EHR Modules certified under ONC criteria by ONC-authorized testing and certification bodies can be relied upon to support the meaningful use objectives.

He also pointed to the technical support programs created under the HITECH Act and now operating under ONC, which offer support to providers as they switch from paper records to EHRs. In particular, 62 Regional Extension Centers (RECs) across the nation will offer customized, on-the-ground assistance, especially for smaller-practice primary care providers and for small hospitals and clinics.

"We know that adoption of EHRs and conversion to EHR-based care is expensive and challenging, especially for smaller providers," Dr. Blumenthal said. "With HITECH, we are able to provide unprecedented funding and technical support programs to help providers make the transition and to help our nation achieve the improvements in health care quality, safety and cost effectiveness EHRs will bring about."

Dr. Blumenthal also praised medical professional organizations and hospital leaders, who have encouraged members to act soon in taking advantage of HITECH support programs and adopting EHR systems.

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FDA Limits Acetaminophen in Prescription Combination Products; Requires Liver Toxicity Warnings

/PRNewswire/ -- The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule.

The FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

Acetaminophen, also called APAP, is a drug that relieves pain and fever. It is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin).

"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use," said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research (CDER). "Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death."

The elimination of higher-dose prescription combination acetaminophen products will be phased in over three years and should not create a shortage of pain medication. Patients and health care professionals are being notified of the new limitation on acetaminophen content, and of the labeling change, in a drug safety communication issued by CDER. The FDA believes that prescription combination products containing no more than 325 mg of acetaminophen per tablet are effective for treating pain.

"There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider," said Kweder. "The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period."

Acetaminophen also is widely used as an over-the-counter pain and fever medication, and is combined with other OTC ingredients, such as cough and cold ingredients. The actions FDA is taking for prescription acetaminophen products do not affect OTC acetaminophen products.

Because of continued reports of liver injury, FDA proposes that boxed warnings, the agency's strongest warning for prescription drugs, be added to all acetaminophen prescription products. Most of the cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time, or drank alcohol while taking acetaminophen products.

An FDA advisory committee discussed the issue at a meeting in June, 2009, and recommended strengthening the warning about severe liver injury on the drug labels of prescription products containing acetaminophen.

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Monday, January 10, 2011

FDA approves opioid analgesic to help cancer patients manage pain

The U.S. Food and Drug Administration today approved Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gums, tongue), or the nasal passages or throat where they dissolve and are absorbed.

“This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” said John Jenkins, M.D., director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research.

Abstral is indicated for the management of breakthrough pain in patients with cancer, ages 18 years and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Breakthrough pain is pain that comes on suddenly for short periods of time and is not alleviated by a patient’s normal pain management plan. These patients are considered opioid tolerant because of their current opioid medication use. Only health care professionals skilled in the use of Schedule II opioids to treat pain should prescribe this drug product.

Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction and overdose. Under this program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense and distribute this product. FDA has standardized key components of the REMS program to facilitate the adoption of a single shared system. These components include the REMS document, the Patient-Prescriber Agreement, and the enrollment form. These components can be used by all sponsors of immediate release transmucosal fentanyl products to develop individual REMS programs such as the program approved for Abstral. FDA has also directed the sponsors of this class of products to work together on a single shared system to implement the REMS.

“This approval is also a significant step toward reducing the burden on the health care system of implementing REMS programs,” added Dr. Jenkins. “When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate release transmucosal fentanyl products will be able to use standardized materials and a single shared system to implement the REMS.”

The safety of Abstral was evaluated in 311 opioid-tolerant cancer patients with breakthrough pain. Two hundred and seventy of these patients were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from 1-405 days with an average duration of 131 days and with 44 patients treated for at least 12 months.

Common adverse reactions include nausea, constipation, drowsiness and headache. Serious adverse events, including deaths, have been reported in patients with other immediate-release transmucosal fentanyl products. The deaths occurred as a result of improper patient selection and/or improper dosing.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of Abstral to the FDA's MedWatch Adverse Event Reporting program at or by calling 800-332-1088.

Abstral is manufactured by ProStraken Inc., based in Bedminister, N.J.

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Sunday, January 9, 2011

A Nod Towards Regulating Tobacco Products Similar to a Medical Device: The Significance of the Menthol Review

/PRNewswire/ -- A recent article in Inside Health Policy entitled New Tobacco Review Process states:

"A new tobacco approval process that mimics device 510(k) clearance procedures could also require that industry supply clinical trial data and other information as the agency implements a mandate from the 2009 law that brought tobacco regulation under FDA's purview."

"Companies will have until March 11 to submit information comparing their products to a predicate product grandfathered into the system before February 2007 to prove that they are as safe or safer than tobacco products already on the market."

The determination regarding "safe or safer" is a scientific decision. It is likely that the FDA tobacco advisory committee, TPSAC, will be involved in reviewing a number of these determinations.

The menthol review will establish the precedent for the role scientific data will play in the regulation of the tobacco industry and its attendant products, whether or not they are regulated under a section that mimics Section 510(k) clearances.

The menthol review has already established one important precedent. The TPSAC is writing its own reports in lieu of editing drafts prepared for them by the FDA. The menthol review is about to establish another precedent–how the Center for Tobacco Products addresses petitions filed under the Data Quality Act, in particular the petition filed by CRE at

Recognizing that TPSAC will be the gatekeeper to ensure that the regulation of the tobacco industry is based upon sound science -- not polemics -- the Center for Regulatory Effectiveness will make a major statement to TPSAC on January 10 regarding a serious omission in its review of the impact a ban on the sale of menthol cigarettes will have on contraband cigarettes.

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Friday, January 7, 2011

HHS Announces Health Center Planning Grant Opportunity

/PRNewswire/ -- HHS Secretary Kathleen Sebelius today announced up to $10 million in funding for a Health Center Planning Grant (HCPG) opportunity for organizations across the country that would like to become a Community Health Center. The HCPG opportunity is intended to support organizations in the future development of a health center and will support approximately 125 HCPGs in FY 2011.

The Health Resources and Services Administration (HRSA) administers the Health Center Program. Health centers improve the health of the Nation's underserved communities and vulnerable populations. They assure access to comprehensive, culturally competent, quality primary health care services at more than 7,900 service delivery sites around the country to patients regardless of their ability to pay; charges for services are set according to income.

"This funding opportunity in the Affordable Care Act will help nurture organizations that answer the noble call to assist those who are medically underserved, underinsured and uninsured," said Secretary Sebelius.

"The HCPG grants help organizations qualify to become CHCs, which increases HRSA's ability to serve more people," said HRSA Administrator Mary K. Wakefield , Ph.D., R.N. "From oral health, behavioral health, to maternal wellness and serving those in rural communities, community health centers increase access for those in need of high quality preventive and primary health care."

Eligible entities for the FY 2011 HCPG include public or nonprofit private entities, including tribal, faith-based and community-based organizations that currently do not receive the following section 330 funding awards:

* Planning Grants
* Community Health Centers
* Migrant Health Centers
* Health Care for the Homeless
* Public Housing Primary Care Programs
* Primary Care Associations

For more information about eligibility, guidance and application submission for the HCPG, visit For more information on HRSA's community health center program, visit For more information about Affordable Care Act investments in community health centers, visit

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HHS and EPA announce new scientific assessments and actions on fluoride

The U.S. Department of Health and Human Services (HHS) and the U.S. Environmental Protection Agency (EPA) today are announcing important steps to ensure that standards and guidelines on fluoride in drinking water continue to provide the maximum protection to the American people to support good dental health, especially in children. HHS is proposing that the recommended level of fluoride in drinking water can be set at the lowest end of the current optimal range to prevent tooth decay, and EPA is initiating review of the maximum amount of fluoride allowed in drinking water.

These actions will maximize the health benefits of water fluoridation, an important tool in the prevention of tooth decay, while reducing the possibility of children receiving too much fluoride. The Centers for Disease Control and Prevention named the fluoridation of drinking water one of the ten great public health achievements of the 20th century.

“One of water fluoridation’s biggest advantages is that it benefits all residents of a community—at home, work, school, or play,” said HHS Assistant Secretary for Health Howard K. Koh, MD, MPH. “Today’s announcement is part of our ongoing support of appropriate fluoridation for community water systems, and its effectiveness in preventing tooth decay throughout one’s lifetime.”

“Today both HHS and EPA are making announcements on fluoride based on the most up to date scientific data,” said EPA Assistant Administrator for the Office of Water, Peter Silva. “EPA’s new analysis will help us make sure that people benefit from tooth decay prevention while at the same time avoiding the unwanted health effects from too much fluoride.”

HHS and EPA reached an understanding of the latest science on fluoride and its effect on tooth decay prevention and the development of dental fluorosis that may occur with excess fluoride consumption during the tooth forming years, age 8 and younger. Dental fluorosis in the United States appears mostly in the very mild or mild form – as barely visible lacy white markings or spots on the enamel. The severe form of dental fluorosis, with staining and pitting of the tooth surface, is rare in the United States.

There are several reasons for the changes seen over time, including that Americans have access to more sources of fluoride than they did when water fluoridation was first introduced in the United States in the 1940s. Water is now one of several sources of fluoride. Other common sources include dental products such as toothpaste and mouth rinses, prescription fluoride supplements, and fluoride applied by dental professionals. Water fluoridation and fluoride toothpaste are largely responsible for the significant decline in tooth decay in the U.S. over the past several decades.

HHS’ proposed recommendation of 0.7 milligrams of fluoride per liter of water replaces the current recommended range of 0.7 to 1.2 milligrams. This updated recommendation is based on recent EPA and HHS scientific assessments to balance the benefits of preventing tooth decay while limiting any unwanted health effects. These scientific assessments will also guide EPA in making a determination of whether to lower the maximum amount of fluoride allowed in drinking water, which is set to prevent adverse health effects.

The new EPA assessments of fluoride were undertaken in response to findings of the National Academies of Science (NAS). At EPA’s request, in 2006 NAS reviewed new data on fluoride and issued a report recommending that EPA update its health and exposure assessments to take into account bone and dental effects and to consider all sources of fluoride. In addition to EPA’s new assessments and the NAS report, HHS also considered current levels of tooth decay and dental fluorosis and fluid consumption across the United States.

The notice of the proposed recommendation will be published in the Federal Register soon and HHS will accept comments from the public and stakeholders on the proposed recommendation for 30 days at HHS is expecting to publish final guidance for community water fluoridation by spring 2011. You may view a prepublication version of the proposed recommendation at ­­­­­­­­­­­­­­­­­­­ Comments regarding the EPA documents, Fluoride: Dose-Response Analysis For Non-cancer Effects and Fluoride: Exposure and Relative Source Contribution Analysis should be sent to EPA at The documents can be found at

For more information about community water fluoridation, as well as information for health care providers and individuals on how to prevent tooth decay and reduce the chance of children developing dental fluorosis, visit For information about the national drinking water regulations for fluoride, visit:

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Thursday, January 6, 2011

Detecting Esophageal Cancer with Light

A tiny light source and sensors at the end of an endoscope may provide a more accurate way to identify pre-cancerous cells in the lining of the esophagus.

Developed by biomedical engineers at Duke University and successfully tested on patients during a clinical trial at the University of North Carolina at Chapel Hill, the device holds the promise of being a less invasive method for testing patients suspected of having Barrett’s esophagus, a change in the lining of the esophagus due to acid reflux. Acid reflux occurs when stomach acid splashes, or refluxes, up into the esophagus.

Long periods of acid reflux can change the cells that line the esophagus, making them appear more like intestinal cells than esophageal cells. These cellular changes can also be a precursor to cancer. As in most cancers, early identification of these pre-cancerous cells often leads to better outcomes for patients. Barrett’s esophagus afflicts more than one percent of the U.S. population, with most patients above the age of 50.

Using an endoscope to reach the esophagus via the nose, physicians shine short bursts of this light at locations of suspected disease and sensors capture and analyze the light as it is reflected back. In particular, they are trying to spot characteristic changes within the layer of cells known as the epithelium, which line cavities and surfaces throughout the body.

“By interpreting the way the light scatters after we shine it at a location on the tissue surface, we can the spot the tell-tales signs of cells that are changing from their healthy, normal state to those that may become cancerous,” said Neil Terry, a Ph.D. student working in the laboratory of Adam Wax, associate professor of biomedical engineering at Duke’s Pratt School of Engineering, who developed the device.

The team published their findings online in the January issue of the journal Gastroenterology.

“Specifically, the nuclei of pre-cancerous cells are larger than typical cell nuclei, and the light scatters back from them in a characteristic manner,” Terry continued. “When we compared the findings from our system with an actual review by pathologists, we found they correlated in 86 percent of the samples.”

UNC gastroenterologist Nicholas Shaheen, M.D., conducted the preliminary clinical trial of the device on 46 patients with Barrett’s esophagus.

“Currently, we take many random tissue samples from areas we where we think abnormal cells may be located,” Shaheen said. “This new system may make our biopsies smarter and more targeted. Early detection is crucial, because the cure rate for esophageal cancer that is caught early is quite high, while the cure rate for advanced disease is dismal, with a 15 percent survival rate after five years.”

The technology that Wax and his team developed for cancer detection is known as angle-resolved low coherence interferometry (a/LCI). The technique is able to separate the unique patterns of the nucleus from the other parts of the cell and provide representations of its changes in shape in real time.

“This optical approach of sampling allows us to cover more tissue sites in less time and has the potential to significantly improve our ability to spot and monitor these pre-cancerous cells,” Wax said. “This type of approach could be used to improve and perhaps one day supplant the physical biopsies currently being used.”

Wax pointed out that since approximately 85 percent of all cancers begin within the layers of the epithelium in various parts of the body, he believes that the new system could also work in such cancers as those of the colon, trachea, cervix or bladder.

The research was supported by the National Institutes of Health, the National Science Foundation and Oncoscope, Inc., a company Wax founded in 2006, based on the Duke technology. Wax has a financial interest in the company, and Terry is a consultant.

Oncoscope plans a clinical trial of the system for approval, and Wax said there could be a commercially available device as early as 2012.

By Richard Merritt

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HUD and HHS announce joint effort to assist nearly 1,000 non-elderly persons with disabilities to move from institutions to independence

U.S. Housing and Urban Development (HUD) Secretary Shaun Donovan and Health and Human Services (HHS) Secretary Kathleen Sebelius announced today a joint partnership between the two agencies to help nearly 1,000 non-elderly Americans with disabilities leave nursing homes or other healthcare facilities to live independently. This is the first time two federal agencies are offering a combination of rental assistance, health care and other supportive services targeted to this population.

HUD is providing $7.5 million in rental assistance vouchers that will help nearly 1,000 individuals with disabilities rent private apartments. Public housing authorities in 15 states will administer the rental subsidies and will work with state human service agencies to identify eligible individuals who could benefit from the program. For a local breakdown of the funding announced today, visit HUD's Web site.

Individuals receiving rental assistance through the program will also receive health and social supports that will enable them to live independently. These supports are provided through the HHS Centers for Medicare and Medicaid's "Money Follows the Person" (MFP) grant program, which allows individuals who qualify for Medicaid-funded nursing home or other institutional care to receive supports - such as in-home nursing and personal care services - while living in the community instead. In places where the MFP program is not available, services will be provided by a state-sponsored institutional transitional program comparable to MFP that includes dedicated supportive services.

As part of President Obama's Year of Community Living initiative, HUD and HHS launched a joint effort to provide housing support for non-elderly persons with disabilities who are currently receiving long-term care in institutional settings. The interagency collaboration is intended to allow persons with disabilities to live productive independent lives in their communities rather than in institutions.

"The Obama administration is committed to helping Americans with disabilities live independent lives. Housing is a critical piece of the equation when it comes to transitioning out of institutions," said Donovan. "Coordinating this effort with the Department of Health and Human Services is an important step in ensuring that more Americans with disabilities will have the housing and support they need to fully participate in community life."

"Through our collaboration with the Department of Housing and Urban Development, I know that we will be able to dramatically change peoples' lives," said Sebelius. "Individuals with disabilities can have a life in the community that serves their needs and supports them in leading productive, meaningful lives."

The funding announced today is being provided through HUD's Rental Assistance for Non-Elderly Persons with Disabilities Program. It is part of the $40 million HUD made available April 2010 to public housing authorities across the U.S. to fund approximately 5,300 rental assistance vouchers for non-elderly persons with disabilities to promote independent living for this community. Public housing authorities applied for funding under two categories.

Last October, HUD awarded $33 million to support a first round of 4,300 vouchers, making it possible for non-elderly individuals with disabilities and their families to access affordable housing in communities that meet their housing needs and so avoid potential institutionalization. Today's announcement is for the second round funding to provide 948 vouchers targeted for non-elderly individuals with disabilities currently living in institutional settings, such as nursing homes, but who could move into a community with assistance.

These vouchers will augment work already being done by HHS' Centers for Medicare & Medicaid Services (CMS) through its Money Follows the Person (MFP) rebalancing demonstration program. Now in its fourth year, the MFP program has made it possible for almost 12,000 individuals to live more independent lives by providing necessary supports and services in the community. Twenty-nine states and the District of Columbia are currently participating in the MFP program and CMS is expecting a new round of grant applications on January 7th.

State Medicaid agencies and local human service organizations will link eligible families to local public housing authorities that will administer voucher distribution. To improve the connections between the housing authorities and Medicaid agencies, HUD and HHS have launched the Housing Capacity Building Initiative for Community Living Project to assist seniors and individuals with chronic conditions who are at risk of institutionalization or who currently receive care in institutional settings, in finding appropriate housing in order to live more independent lives.

The Community Living Initiative is an outgrowth of the 1999 landmark Supreme Court ruling in Olmstead v. L.C. In that case, the Court ruled that the Americans with Disabilities Act (ADA) protects a person with a disability from being unnecessarily institutionalized. The Court said that such forced institutionalization can lead to isolation and segregation of individuals with disabilities and be a serious and pervasive form of discrimination.

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Monday, January 3, 2011

Piedmont Newnan Hospital Receives Generous Donation

$5.1 million gift is largest in Piedmont Healthcare history.

The Piedmont Newnan Hospital replacement facility on Poplar Road will offer enhanced services in the areas of interventional radiology, surgery, emergency care and women’s and neonatal services thanks to a major boost from Newnan Hospital Inc.  Newnan Hospital Inc. (NHI) has made a historic gift valued at over $5.1 million to Piedmont Newnan Hospital, the largest, private, one-time gift in Piedmont Healthcare’s 105-year history.    

Newnan Hospital Inc. is the legal entity that was the previous owner of Piedmont Newnan Hospital and continues today with a mission to support healthcare-related needs and initiatives to improve the healthcare of the local community.

“We are building a new hospital today because of the vision and perseverance of the Newnan Hospital Inc. Board of Directors,” said Michael Bass, president and CEO of Piedmont Newnan Hospital. “This transformational gift demonstrates loud and clear Newnan Hospital Inc.’s longstanding commitment to improving healthcare for all citizens of Coweta County. We sincerely thank the board for this most generous gift.”

The gift includes $4 million of enhancements and additions, previously not programmed into the scope of the replacement hospital. A major portion of the funds will purchase medical equipment in interventional radiology services and will enable the build-out of two additional surgical suites, including one with enhanced capabilities for urological procedures. The additional rooms will improve scheduling and availability of surgery and other procedures for patients and doctors.

In addition, it will provide further enhancements to the emergency department, including multi-purpose, ceiling equipment booms in the trauma rooms to keep the floors clear of diagnostic equipment; a faster, 64-slice CT scanner; and critical care monitors compatible with future technology.  Additionally, pediatric and infant resuscitation equipment and infant warmers will be purchased for exclusive use in the emergency department, rather than be shared with the labor and delivery unit.  For women’s and neonatal services, the donation will allow the provision of dedicated NICU incubators with resuscitation capability in all rooms, including delivery rooms.

In making the announcement, Tom Moat, president of the Newnan Hospital Inc. Board of Directors, expressed the board’s feeling on how important it is for NHI to be involved in providing the best possible hospital for residents of the Coweta community.

 “Piedmont is going to provide our community with a new, state-of-the-art hospital, and we believe it is important for Newnan Hospital Inc. to take the lead in helping augment vital services in the new facility,” said Moat. “We can help provide enhanced services that will benefit all of us for many years.” 

“Having been in the hospital business for almost 90 years, our board recognizes that community support includes both using services available at our local hospital and supporting it financially,” added Moat. “We are grateful to Piedmont Healthcare for all they are doing by building a new hospital facility. We want to help through these donations and hope this will encourage others to support further development of the new hospital and advance healthcare in our community.”

The gift also includes the property on the court square in downtown Newnan, which serves as the Piedmont Newnan Hospital Wellness Center. Valued at $840,000, Piedmont Newnan Hospital will continue operating the downtown Newnan Wellness Center for the community.

The third element of the gift is an additional $260,000 set aside for the utilization of the original Newnan Hospital campus, located at 80 Jackson Street. This campus currently houses both the Piedmont Newnan Hospital Ambulatory Surgery Center and the Piedmont Heartburn Treatment Center. These services will be relocated to the new facility on Poplar Road, scheduled to open in the spring of 2012.

“This gift from Newnan Hospital Inc. represents the largest one-time gift in Piedmont’s history and sets the stage for fundraising efforts to support the new hospital,” said R. Timothy Stack, president and CEO of Piedmont Healthcare. “To the 500-plus annual donors who already support Piedmont Newnan Hospital, as well as our Auxilians and our community, this contribution makes a bold statement that through philanthropy, we have the ability to make a tremendous impact on the quality of local healthcare in the communities we serve.”

This gift is the largest in a series of recent gifts made by NHI to benefit healthcare in Coweta County.  Earlier this fall, NHI announced a $2 million gift to University of West Georgia’s School of Nursing; a $1 million gift to West Georgia Technical College, benefiting the allied health sciences programs; and another $1 million contribution to the new Coweta Samaritan Clinic.
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