CMS and ONC Issue Regulations Proposing a Definition of 'Meaningful Use' and Setting Standards for Electronic Health Record Incentive Program

The Centers for Medicare & Medicare Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) encourage public comment on two regulations issued today that lay a foundation for improving quality, efficiency and safety through meaningful use of certified electronic health record (EHR) technology. The regulations will help implement the EHR incentive programs enacted under the American Recovery and Reinvestment Act of 2009 (Recovery Act).

A proposed rule issued by CMS outlines proposed provisions governing the EHR incentive programs, including defining the central concept of "meaningful use" of EHR technology. An interim final regulation (IFR) issued by ONC sets initial standards, implementation specifications, and certification criteria for EHR technology. Both regulations are open to
public comment.

"Widespread adoption of electronic health records holds great promise for improving health care quality, efficiency, and patient safety," said, National Coordinator for Health Information Technology David Blumenthal, M.D., M.P.P. "The Recovery Act's financial incentives demonstrate Congress' and the Administration's commitment to help providers adopt and make meaningful use of EHR technology so they can give better care and their patients' experience of care will improve. Over time, we believe the EHR incentive program under Medicare and
Medicaid will accelerate and facilitate health information technology adoption by more individual providers and organizations throughout the health care system."

"These regulations are closely linked," said Charlene Frizzera, CMS acting administrator. "CMS's proposed regulation would define and specify how to demonstrate 'meaningful use' of EHR technology, which is a prerequisite for receiving the Medicare incentive payments. Our rule
also outlines the proposed payment methodologies for the Medicare and Medicaid EHR incentive programs. ONC's regulation sets forth the standards and specifications that will enhance the interoperability, functionality, utility and security of health information technology."

CMS and ONC worked closely to develop the two rules and received input from hundreds of technical subject matters experts, health care providers, and other key stakeholders. Numerous public meetings to solicit public comment were held by three Federal advisory committees:
the National Committee on Vital and Health Statistics (NCVHS), the Health IT Policy Committee (HITPC), and the Health IT Standards Committee (HITSC). HITSC presented its final recommendations to the National Coordinator in August 2009. These recommendations, along with all other input were considered to help inform the development of the regulations announced today.

The IFR issued by ONC describes the standards that must be met by certified EHR technology to exchange healthcare information among providers and between providers and patients. This initial set of standards begins to define a common language to ensure accurate and secure health information exchange across different EHR systems. The IFR describes standard formats for clinical summaries and prescriptions; standard terms to describe clinical problems, procedures, laboratory tests, medications and allergies; and standards for the secure transportation of this information using the Internet.

The IFR calls for the industry to standardize the way in which EHR information is exchanged between organizations, and sets forth criteria required for an EHR technology to be certified. These standards will support meaningful use and data exchange among providers who must use
certified EHR technology to qualify for the Medicare and Medicaid incentives.

Under the statute, HHS is required to adopt an initial set of standards for EHR technology by Dec. 31, 2009. The IFR will go into effect 30 days after publication, with an opportunity for public comment and refinement over the next 60 days. A final rule will be issued in 2010.
"We strongly encourage stakeholders to provide comments on these standards and specifications," Dr. Blumenthal said.

The Recovery Act established programs to provide incentive payments to eligible professionals and eligible hospitals participating in Medicare and Medicaid that adopt and make "meaningful use" of certified EHR technology. Incentive payments may begin as soon as October 2010 to
eligible hospitals. Incentive payments to other eligible providers may begin in January 2011.

The proposed rule would define the term "meaningful EHR user" as an eligible professional or eligible hospital that, during the specified reporting period, demonstrates meaningful use of certified EHR technology in a form and manner consistent with certain objectives and
measures presented in the regulation. These objectives and measures would include use of certified EHR technology in a manner that improves quality, safety, and efficiency of health care delivery, reduces health care disparities, engages patients and families, improves care
coordination, improves population and public health, and ensures adequate privacy and security protections for personal health information.

The proposed rule would define meaningful use for the Medicare EHR incentive programs. It proposes one definition that would apply to eligible professionals participating in the Medicare fee-for-service and the Medicare Advantage EHR incentive programs as well as a proposed
definition that would apply to eligible hospitals and critical access hospitals. These definitions also would serve as the minimum standard for eligible professionals and eligible hospitals participating in the Medicaid EHR incentive program. The rule proposes that states could
request CMS approval to implement additional meaningful use measures, as appropriate, but could not request approval of fewer or less rigorous meaningful use measures than required by the rule.

This rule proposes a phased approach to implement the proposed requirements for demonstrating meaningful use. This approach would initially establish reasonable criteria for meaningful use based on currently available technological capabilities and providers' practice
experience. CMS will establish stricter and more extensive criteria for demonstrating meaningful use over time, as anticipated developments in technology and providers' capabilities occur.

CMS provides a 60-day comment period on the proposed rule. "The definition and requirements for demonstrating meaningful use of EHR technology are proposals. CMS welcomes and will give serious consideration to comments that improve our proposal while achieving the
goals Congress established for the EHR incentive programs," Frizzera said.

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New Study Shows That American Public is Willing to Accept Major Reforms in Medicare Program

/PRNewswire/ -- Although Americans see Medicare as a key part of the country's social contract and want to preserve it in some recognizable form, they are willing to consider significant changes in the program to hold down its costs as the U.S. population ages.

In day-long "Choice-Dialogues" in which Americans from all walks of life considered the pros and cons of a range of choices for reforming Medicare, common ground was found in several key areas:

-- Allow Medicare to negotiate prices for prescription drugs (94 percent
support).
-- Encourage hospice care instead of heroic end-of-life measures (85
percent support).
-- Only cover treatments that are scientifically proven to be effective
(68 percent support).
-- Emphasize preventive care and personal responsibility (89 percent
consider preventive care very important or essential).
-- Gradually increase the Medicare eligibility age from 65 to 67 (68
percent support).


If additional money is needed to maintain Medicare in a way that is familiar in the future, Americans would rather see the government raise taxes than increase the federal debt.

These are among the central findings in a report released today by The Concord Coalition and Viewpoint Learning, Inc. The report is entitled "Medicare: It's Not Just Another Program."

The report, which was written by Viewpoint Learning, also underscores public dismay at the health care system in general. It comes as Congress and the Obama administration are working on massive changes in the entire system.

"Participants repeatedly expressed concerns over what they saw as a Byzantine and unaccountable health care system," the Medicare report says. "Most felt that the medical industry (especially the pharmaceutical companies) puts profits before people."

Robert L. Bixby, executive director of The Concord Coalition, says the report shows that Americans are prepared to accept significant changes in the program that plays a central role in the federal government's long-term fiscal problems.

"Medicare is on an unsustainable path and must be reformed," Bixby said. "According to conventional wisdom, however, the public is not ready to accept any change in the status quo. The good news from these Choice-Dialogues is that the conventional wisdom is wrong; the public is ready and willing to consider some very fundamental Medicare reforms so long as the program is preserved as a vital part of the social contract."

"Politicians who are truly interested in saving Medicare should stop the scare tactics and start engaging the public in a dialogue on the real trade-offs that must be confronted," Bixby added. "Changes will still be difficult, but the results will be more acceptable."

Viewpoint Learning conducted the dialogues with randomly selected representative samples of 35-40 citizens in Oak Brook, Illinois; Columbia Maryland; Phoenix and Houston. This project builds on the findings of a broader two-year project, "The America We Want," that examined public opinion on a broader range of federal programs and budget issues.

The new report found that many Americans lacked a strong understanding of the Medicare program, how it is funded, and the severity of the fiscal challenges facing the United States in the years ahead.

Yet most participants in the dialogues, after studying these issues in depth and spending much of a day discussing the problems and possible solutions with others, were able to agree on a set of Medicare changes.

But to win public support, the report cautions, "proposals for major reform to Medicare need to recognize the extent to which Americans see Medicare as an essential part of the social contract and not just as another government program."

Steven Rosell, president of Viewpoint Learning, said "The findings from these daylong dialogues with Americans from very different backgrounds and perspectives reveal deep disconnects between how Washington talks about Medicare and health care reform and how the public talks about them. In case after case, the report shows how leaders and the public are talking past each other, and how this deep disconnect and misunderstanding lead to the heat and the rancor that have made advancing real reform so difficult."

When most people talk about the "cost of health care," for example, they are focused on what they pay in premiums, co-pays and drug expenses. When health care experts talk about costs, however, they usually focus on the costs to businesses, government and other institutions.

Rosell also noted that many Americans do not realize that they are essentially paying for the cost of care for the uninsured already.

The new report, he said, provides insight for leaders about how best to bridge such disconnects and begin to create a learning curve that could lead to public support for significant Medicare reform.

Some elements in the new report also echo the findings of The Concord Coalition's fiscal advisory councils that met in early December in Washington. Working in six different parts of the country on Concord's Fiscal Stewardship Project, these advisory councils called for sweeping reforms in the health care system and some changes in Medicare to put the government on a more sustainable fiscal path. More information on the advisory councils' work is available at:

http://concordcoalition.org/fiscal-stewardship-project/fiscal-stewardship- project.

The full report, entitled "Medicare: It's Not Just Another Program," is available at: http://www.concordcoalition.org/files/uploaded-pdfs/Medicare_Report_Dec09_PRIN T.pdf

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FDA Approves a High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.

Fluzone High-Dose was approved via the accelerated approval pathway. FDA's accelerated approval pathway helps safe and effective medical products for serious or life-threatening diseases become available sooner. In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response compared with Fluzone in individuals 65 and older.

As part of the accelerated approval process, the manufacturer is required to conduct further studies to verify that the Fluzone High-Dose will decrease seasonal influenza disease after vaccination.

"As people grow older, their immune systems typically become weaker," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research. "This is the first influenza vaccine that uses a higher dose to induce a stronger immune response that is intended to better protect the elderly against seasonal influenza."

Fluzone High-Dose, manufactured by Sanofi Pasteur Inc., is formulated so that each 0.5 mL dose contains a total of 180 micrograms (mcg) of influenza virus hemagglutinin (HA) which is made up of 60 mcg of each of the three influenza virus strains.

Other currently licensed seasonal influenza vaccines for adults are formulated to contain a total of 45 mcg of influenza virus hemagglutinin (15 mcg HA from each of the three influenza strains per dose). Sanofi Pasteur, also manufactures Fluzone, a seasonal vaccine for the United States approved for use in individuals ages 6 months and older.

As expected, because of the higher HA content, non-serious adverse events were more frequent after vaccination with Fluzone High-Dose compared with Fluzone. Common adverse events experienced during clinical studies included pain, redness and swelling at the injection site and headache, muscle aches, fever and malaise. The rate of serious adverse events was comparable between Fluzone High-Dose and Fluzone.

People with hypersensitivity to egg proteins or life-threatening reactions after previous administration of any influenza vaccine should not be vaccinated with Fluzone High-Dose.

Fluzone High-Dose is administered as a single injection in the upper arm and is available in single dose pre-filled syringes without preservative.

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Care Management Improves Physical Health of Patients with Mental Illness

Connecting mental health patients with care managers responsible for coordinating their health care significantly improves their overall health and wellbeing, according to a study by Emory University public health researchers.

The study, the first of its kind, tested a population-based medical care management intervention aimed at improving medical care in community mental health settings. Recent studies show that people with severe mental illness die 25 years younger than the general population largely due to medical causes such as heart attacks.

"There is a growing concern about the epidemic of premature morbidity and mortality among persons with serious mental illnesses," says lead study author Benjamin Druss, MD, MPH, professor of health policy and management and the Rosalynn Carter Chair in Mental Health at Emory's Rollins School of Public Health. "This model provides one of the first evidence-based approaches for addressing that problem by helping patients access high-quality medical care."

A total of 407 people with severe mental illness at an urban community mental health center were randomly assigned to either the medical care management intervention or usual care. The patients were all ages 18 and older, considered economically disadvantaged, and experienced serious and persistent mental illness.

For individuals in the intervention group, care managers provided communication and advocacy with medical providers, health education and support in overcoming system-level fragmentation and barriers to primary medical care. Patients in the usual care group were given a list with contact information for local primary care medical clinics and were permitted to obtain any type of medical care or other medical services without the assistance of a care manager.

At a 12-month follow-up evaluation, researchers found that medical care management was associated with significant improvements in the quality and outcomes of primary care. The intervention group received an average of 58.7 percent of recommended preventive services compared with a rate of 21.8 percent in the usual care group.

In addition, patients in the intervention group received a significantly higher proportion of evidence-based services for cardiometabolic conditions (34.9 percent versus 27.7 percent) and were more likely to have a primary care provider (71.2 percent versus 51.9 percent). The group showed significant improvement in mental health functioning, and at one-year follow-up, had a substantially lower risk for heart disease than those in the usual care group.

These findings suggest that care management is a promising approach for improving quality and outcomes of medical care for patients with serious mental illnesses, says Druss.

The study titled, "A randomized trial of medical care management for community mental health settings: The Primary Care Access, Referral, and Evaluation (PCARE) study," was published in the Dec. 15 online edition of The American Journal of Psychiatry. It was funded by a grant from the National Institute of Mental Health of the National Institutes of Health.

In addition to Druss, study authors were: Silke Von Esenwein, PhD, director of research projects, Kimberly Rask, MD, PhD, associate professor of health policy and management, and Liping Zhao, MSPH, senior biostatistician, of the Rollins School of Public Health; and Michael Compton, MD, MPH, assistant professor of psychiatry and Ruth Parker, MD, professor of medicine, of the Emory School of Medicine.

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Study Redefines Placebo Effect as Part of Effective Treatment

/PRNewswire/ -- Researchers used the placebo effect to successfully treat psoriasis patients with one quarter to one half of their usual dose of a widely used steroid medication, according to an early study published online today in the journal Psychosomatic Medicine. Early results in human patients suggest that the new technique could improve treatment for several chronic diseases that involve mental state or the immune system, including asthma, multiple sclerosis and chronic pain.

By designing treatment regimens that mix active drug and placebo, researchers at the University of Rochester Medical Center hope to maximize drug benefits, reduce side effects, increase the number of patients who take their medicine and extend the use of drugs otherwise limited by addiction risk or toxicity. Using a fraction of the usual drug dose to get the same effect could also make possible a dramatic and timely reduction in healthcare costs, according to the authors.

The publication is a product of decades of research in the emerging field of "psychoneuro-immunology," which holds that the ability of the human immune system to fight disease is closely linked with a person's mind. Thoughts and moods are captured in neurochemicals that cause the release of hormones which interact with disease-fighting cells.

The current research team chose psoriasis for their first human experiments because it is chronic, gets worse when patients feel stress and involves the immune system. The condition causes pain and disability in four million Americans as inherited traits and irritants cause the immune system to trigger the too fast production of skin cells, resulting in red, scaly patches of dead skin.

"Our study provides evidence that the placebo effect can make possible the treatment of psoriasis with an amount of drug that should be too small to work," said Robert Ader, Ph.D., M.D. (hc), distinguished university professor in the University of Rochester School of Medicine & Dentistry. "While these results are preliminary, we believe the medical establishment needs to recognize the mind's reaction to medication as a powerful part of many drug effects, and start taking advantage of it," said Ader, professor of Psychiatry and principal investigator of the study. The placebo effect, obviously, cannot help unconscious patients, or replace substances that the body itself is unable to produce, he added. In the absence of functioning islet cells, for example, placebos cannot stimulate the release of insulin in a Type l diabetic.

Study Details

A description of the current findings requires expanding the definition of placebo effects to include phenomena that are not fully understood by modern medicine, Ader said. Although placebos, "dummy pills" that have no therapeutic effect by themselves, are prescribed by many physicians today, their use still carries a stigma. It's as if the effect of a pill containing no medication is not "real," part magic and part deception.

To accurately define and study the placebo effect, Ader and colleagues chose to frame it as an example of a well-established psychological phenomenon: the conditioned response. Nineteenth century Russian physiologist Ivan Pavlov was the first to study the phenomenon of conditioning. By ringing a bell (a conditioned stimulus) each day before giving his dogs food (an unconditioned stimulus), Pavlov found that the dogs would eventually salivate (a conditioned response) at the sound of the bell alone.

In the current study, Ader and colleagues sought to determine if a drug's therapeutic effect could be triggered by qualities associated with the drug, like its shape, color, smell and packaging, as well as by its administration by an authority figure in a white lab coat. These repeated associations, Ader argues, create conditioned responses, drug-like therapeutic effects of treatment caused, not by a drug's ingredients alone, but elicited by stimuli associated with the effects of active drug treatment. The results provide the first evidence that conditioned responses might be harnessed to influence the design of drug regimens in humans.

Research teams at the University of Rochester Medical Center and Stanford University conducted an 11 to 14-week, double-blind, randomized clinical trial in 46 patients with mild-to-moderate psoriasis. Patients were on no other medications during the study, and had signed consent forms after being informed they might receive a reduced dose of topical steroid.

At the start of the study, researchers randomly selected two "target" psoriatic lesions or sores on each patient. Twice each day during a three-week baseline period, all patients spread a lotion containing a full dose of steroid medication (0.1% Aristocort A, triamcinolone acetonide) onto one of their two study lesions. The second lesion was coated with a moisturizing cream. Medicated and unmedicated creams were distributed in coded syringes to make them indistinguishable.

Nearly all past drug studies divided patients into two groups only. One would get the full dose of the drug all of the time (a 100 percent reinforcement schedule). The other would get zero drug all of the time (zero percent reinforcement). The current study asks for the first time: what if we treat patients with something in between drug and placebo? After the three-week baseline period, patients were randomly assigned to one of three groups.

The first continued to receive 100 percent of the treatment drug at each administration for the rest of the study on his or her study lesion. A second, the partial reinforcement group, also continued to receive a full dose, but only 25 or 50 percent of the time, and a steroid-free emollient the rest of the time. The study was designed so that this second group could benefit from exposure to cues they had previously associated with active drug treatment (a conditioned therapeutic effect). A third group, the "dose control group," received active drug at every administration, but at 25 or 50 percent of the full dose used in the first and second groups. Thus, the partial reinforcement and "dose control" groups received the same total amount of active medication, but in different patterns.

Results were measured in two ways. First, a "blinded" dermatologist measured the severity of a patient's psoriasis lesions weekly using the Psoriasis Severity Scale (PSS), a standard tool used to track the redness, hardening and thickening of skin. The second measure was whether a patient experienced a "relapse" in lesion severity, defined arbitrarily as a return to a PSS score within two units of a patient's initial score.

In terms of the overall PSS severity scores, results were mixed. The Stanford study site found no group differences in PSS scores that could be attributed to the different treatment regimens. Ader believes that elevated baseline PSS scores in the randomly selected Dose Control subjects at Stanford might have obscured the differences between the dose control and partial reinforcement groups. For instance, results could have been influenced by differences in the amount of sun patients were exposed to in Upstate New York and California (ultraviolet light is an established treatment for psoriasis).

In Rochester, there were no differences between the PSS values of the Partial Reinforcement and Dose Control groups at the point in the study where experimental treatment began. In this case, partial reinforcement brought about a greater reduction in lesion severity during the experimental period than continuous reinforcement (dose control) with the same cumulative amount of drug.

The relapse results were clearer. Four of 18 patients (22.2 percent) in the 100 percent reinforcement group (full dose all the time) relapsed within the eight-week experimental period. Among patients treated with a full dose of drug, but one half or one quarter of the time (50 or 25 percent reinforcement schedule), four of 15 patients (26.7 percent) relapsed. Thus, the incidence of relapse did not differ substantially between patients receiving a full dose of drug all the time and those treated under the partial reinforcement schedules, researchers said. In contrast, eight of the 13 patients (61.5 percent) in the dose control group who received active drug each time, but not the full does, relapsed in the same period of time.

Thus, the incidence of relapse in the partial reinforcement group (26.7 percent) was significantly less than in dose control patients (61.5 percent) that received the same cumulative amount of drug. Further studies are underway, and others are planned, to confirm the effect, answer the questions raised and explore the effect in other autoimmune diseases.

The study was conducted jointly by the Departments of Psychiatry and Dermatology within the School of Medicine & Dentistry at the University of Rochester and the Stanford University School of Medicine. Along with Ader, the study was authored in Rochester by Mary Gail Mercurio, James Walton and Deborra James. Leading the effort at Stanford were David Fiorentino, Alexa Kimball, Michael Davis and Valerie Ojha. The study was funded by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health (NIH).

"The pharmaceutical industry may choose to ignore the conditioning component of drug treatment regimens," Ader said. "Alternatively, they may now consider exploring ways to exploit conditioning in the design of drug treatment protocols, especially in chronic conditions where patients acquire conditioned responses over time. I believe industry will eventually support this approach because it promises to increase safety and reduce production costs."

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Healthcare Bills Will Hamper Medicare Services for Seniors and the Disabled

/PRNewswire/ -- The following is news about the Medicare power mobility benefit from Support Mobility Now Volume 1 Issue 2:

Significant changes are needed in healthcare reform legislation to prevent senior citizens and the disabled from facing a difficult time obtaining homecare products through Medicare. The current legislation would likely prevent or delay many Medicare beneficiaries from receiving critical medical equipment that helps sustain their lives and allows them to live independently in their homes for longer periods of time.

Unfortunately, in piecing this historic legislation together, lawmakers may have overlooked the fact that some of the changes for medical equipment providers would adversely impact their ability to deliver timely and quality service to Medicare beneficiaries.

To be sure, America's healthcare system must be improved. But there should also be a responsibility to ensure that the changes don't place additional burdens upon Medicare beneficiaries, who are already some of the most vulnerable men and women in our society.

Medicare's power mobility benefit would be hit especially hard.

Currently, Medicare allows a beneficiary to purchase power wheelchair in the first month it is prescribed or rent the equipment for 13 months. The legislation eliminates a beneficiary's early purchase option. Seniors and people living with disabilities, who qualify for power wheelchairs, usually suffer from long-term, chronic conditions so they overwhelming chose the early purchase. Without the first month purchases, providers say they won't have the cash flow to pay the wheelchair manufacturers or provide other services required. Many equipment suppliers anticipate that they may go out of business or no longer offer power wheelchairs, a development that would make it more difficult for beneficiaries to find providers in their area.

Some in Congress recognize the potential danger from ending the early purchase.

Pennsylvania Sen. Arlen Specter proposed an amendment to preserve the first-month purchase option while obligating suppliers to pay back Medicare when equipment isn't used full term. The Congress, however, quickly showed how much financial concerns are out weighing practical ones: The Specter amendment essentially died when the Congressional Budget Office (CBO) contended that only $200 million would be saved over 10 years with his proposal, while lawmakers sought $800 million in savings. The industry maintains that the CBO was wrong, and that much more than $200 million would be saved with Specter's amendment.

Aware that the Congress is fixated on finding savings to pay for healthcare reform, providers are willing to accept further, yet agonizing, reductions in the reimbursement rates for power wheelchairs in exchange for keeping the purchase option and sustaining a process that would at least allow companies to stay in business.

The Senate legislation also accelerates the implementation of the competitive bidding program for Durable Medical Equipment (DME), which includes oxygen, power wheelchairs and other homecare products. Competitive bidding for these products was first implemented last year, but the program was flawed to the point that patients' lives were endangered because of confusion and delays in getting life-sustaining equipment to beneficiaries, hospitals and other institutions. Congress stepped in, and temporarily halted the program in July 2008. The Centers for Medicare and Medicaid Services (CMS) has re-launched the bidding program, but providers say that many of the original problems have not been corrected. The healthcare reform legislation makes matters worse by ordering a rapid expansion of the competitive bidding process before stakeholders can gauge whether the program can avoid putting some of the most vulnerable people in our society at risk.

Once again, some lawmakers recognize that the rush to pay for healthcare reform legislation could have a devastating impact on their constituents. Competitive bidding is projected to save millions of dollars. But Florida Rep. Kendrick Meek is more concerned about his constituents: he has sponsored legislation in the House that would end the competitive bidding experiment and obtain savings for the government by cutting the reimbursement rate for homecare products by 0.25% from 2010 to 2012 and an additional 0.5% in 2015. Moreover, the industry wants to work with CMS to establish a system that allows providers to deliver quality service and products to Medicare beneficiaries at a fair price to the government.

Comprehensive healthcare reform is long overdue, but we must ask our Representatives and Senators in Congress whether the cost of enacting this legislation should include placing new burdens on seniors and people with disabilities. One would hope that this population would benefit from reform, and not be its victims. It's clear that the current legislation delivers critical blows to the companies committed to providing medical equipment to Medicare beneficiaries.

What's unclear is whether enough lawmakers in Congress will recognize the consequences for their constituents back home when there are significant delays in providing medical equipment for Medicare beneficiaries, or only a few companies left to supply the products. There are ways to fix healthcare reform legislation so that the seniors, who built and protected our nation, can live with dignity and independence in their homes during their twilight years.

Let's hope Congress understands how much this means to them.

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Cancer Treatment Centers of America Receives Georgia Certificate of Need for Hospital Serving Patients in Southeast

All-digital Georgia facility to offer new choice in cancer treatment, boost local economy

Cancer patients throughout the Southeast will have another choice for treatment now that the Georgia Department of Community Health (DCH) approved the Certificate of Need (CON) for Cancer Treatment Centers of America (CTCA) to build and operate its fifth regional treatment center in Newnan, Ga. CTCA announced its plans for the Coweta County site in June.

“I am so excited to welcome CTCA to our local community,” said Ginny Walley, a Senoia, Ga., resident and cancer patient who received treatment at CTCA in suburban Chicago. “The new hospital in Newnan will provide easier access to this unique, patient-centered model of care for patients across the Southeast battling this disease.”

CTCA, a national network of destination cancer hospitals, offers cancer patients a fully integrated care model combining the best traditional medical care to treat the cancer with scientifically supported complementary therapies to help manage side effects, strengthen the immune system and improve each patient’s quality of life.

“On behalf of the entire CTCA family, I would like to thank the many members of the State and local community who have supported our entry into this area and recognized the value of a CTCA location in Georgia for cancer patients and their families,” said Bob Mayo, CTCA vice chairman. “Cancer patients throughout the Southeast asked us to build a facility closer to them and with the support of the Georgia General Assembly, the Metro Atlanta Chamber of Commerce, the Coweta County Development Authority and Board of Commissions, and the City of Newnan, we’re one step closer to making that a reality. Ultimately, we have even found new friends in the Georgia hospital community and we are excited to partner with them to enhance patient care and the business of health. We look forward to becoming a valued member of the community.”

Over the next several months, CTCA will complete building drawings, secure necessary building permits and commence construction activity. Upon completion, the fully digital hospital will have more than 200,000 square feet and 50 inpatient beds. With more than two-thirds of its patients expected to come from outside the state of Georgia, patients and their families will contribute to the growth and vitality of the local economy. CTCA expects the new facility to generate 500 news jobs and $500 million in economic activity over the first five years of operation.

“We are very pleased to welcome CTCA to the community,” said David Brown, chairman of the Coweta County Development Authority. “They’ll provide access to high-quality cancer care for patients close to home and across the Southeast, significantly fuel our economy and bring much-needed new jobs to the area.”

About Cancer Treatment Centers of America
Cancer Treatment Centers of America (CTCA) is a national network of hospitals providing a comprehensive, fully integrative approach to cancer treatment. CTCA serves patients with advanced cancer from all 50 states at facilities located in suburban Chicago, Philadelphia, Tulsa and suburban Phoenix. For more information about Cancer Treatment Centers of America, go to cancercenter.com, or visit http://www.cancercenter.com/cancer-center-news/southeastern-project.cfm for information and developments regarding the new hospital serving patients in the Southeast.

New Department (DBHDD) Cutting Back on Expenses

With Georgia’s economy still struggling, the new Department of Behavioral Health and Developmental Disabilities (DBHDD)is cutting back on expenses while working to maintain services for people with mental illness, developmental disabilities, and substance use disorders. By the end of the fiscal year in June, all of the agency’s staff not involved in direct clinical care at one of the state’s seven psychiatric hospitals will have taken twelve unpaid furlough days. Some comparatively expensive programs are being scaled back or eliminated. A five-percent reduction in contracts to the state’s Community Service Boards that’s been in place since July will be sustained through the end of the fiscal year. Where necessary, the people being served by DBHDD will be connected to alternative services offered through the department.

“We’re launching a new department at a particularly challenging time,” acknowledged Dr. Frank Shelp, Commissioner of DBHDD. “But just as Georgia families are making tough financial decisions every day, we too have to find ways to cut expenses to match declining income. What makes that especially difficult is that the obvious fat has been cut from the budget long ago. Now, wherever we scale back, people are going to be affected. Our job is to be strategic and thoughtful while living within our means.”

DBHDD was created by Governor Sonny Perdue and the General Assembly in the 2009 legislative session and began operations on July 1. Carved out of the former Department of Human Resources, the agency was tasked with building a new organization and beginning to correct long-standing deficiencies in Georgia’s behavioral health system while receiving no additional funding. When a round of budget cuts was required of state agencies the month after it was launched, DBHDD was exempted in part because of its already disadvantaged position.

Under scrutiny by the federal Department of Justice, which has questioned the safety and effectiveness of the state’s psychiatric hospitals, the department has moved aggressively to hire new staff, bring in badly-needed expertise, and build new partnerships that will improve care at the facilities. Some of these moves, such as DBHDD’s innovative partnership with the Medical College of Georgia in Augusta, have been nearly revenue-neutral, allowing the state to improve services at little or no additional cost. But some, such as plans to implement an electronic medical records system, will require new investments at a time when state revenues are declining.

Despite tough economic times - and in some cases because of them - providers and populations served by the department continue to call for more resources, about which Shelp remains realistic.

“State revenues are down sixteen-percent, so we know that every additional dollar we receive has to be taken from some other state program or service,” he said. “That’s why we have to be strategic about the way we use the dollars we have already to get the most out of them. We’re using better practices and technology to reduce costs, be more efficient, and improve care. And above all, we’re making sure that the investments and partnerships we do make bring benefits far beyond the sum of their parts.”
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CSTE National Assessment Finds Critical Public Health Disease Surveillance Capacity Lacking

/PRNewswire/ -- Today, CDC's Morbidity and Mortality Weekly Report (MMWR) released a report showing that the number of state-level epidemiologists has decreased steadily since 2004, with a marked decline of over 10% since 2006. There was also a substantial decrease in core epidemiology capacity over this same period, including epidemiology capacity for bioterrorism and emergency response. For some important subject areas such as occupational health, substance abuse, and oral health, basic epidemiology capacity in most states is described as minimal to non-existent, and many states still lack the 21st century technology capacity needed for state-of-the-art surveillance. Dr. James Hadler, the lead author of this article, concluded that "The current condition of national epidemiology is a preparedness and public health vulnerability." States indicated a substantial need for more epidemiologists in all program areas. The deterioration of state epidemiology capacity is a consequence of declines in funding for bioterrorism preparedness and emergency response as well as an effect of the economic downturn on state budgets.

CSTE's 2009 Epidemiology Capacity Assessment (ECA) is the most recent in a series of epidemiology capacity assessments that enumerate and characterize epidemiologists, measure core epidemiology capacity, and assess competency-specific training. The 2009 ECA also conducted initial assessments of surveillance system technologic capacity and substance abuse program capacity. The 2009 ECA builds on the previous ECAs of 2004 and 2006. This year's assessment indicates a substantial decline in overall epidemiology capacity across the nation.

Epidemiologists are best known for their "disease detective" work with infectious diseases that are naturally occurring or intentionally released, but they are mainly involved in everyday surveillance/monitoring and study of many diseases and conditions that affect the health of the their state's population. These activities can range from food and waterborne disease investigations to disease monitoring for environmental health conditions, chronic diseases, maternal and child health, injury, occupational and oral health and substance abuse.

"State, federal and local agencies need to work together to address the understaffed epidemiology workforce, the downward trends in capacity and the looming epidemiology workforce shortage. Public health needs to achieve a full, well-trained and competent workforce prepared with the appropriate tools and skills for the 21st century," says co-author Matthew Boulton from the University of Michigan School of Public Health, Center of Excellence in Public Health Workforce Studies. Access to the full report, 2009 Epidemiology Capacity Assessment: Findings and Recommendations, can be found at www.cste.org.

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Park Springs to Expand Health Care Center at Retirement Community

Cobblestone to add two memory care rooms, 18 skilled nursing rooms, two prep kitchens

Park Springs, the Southeast’s premier continuing care retirement community announces that it is renovating Cobblestone, the community’s health care center, expanding the facility by 12 rooms. The expansion will include two phases of construction. Phase one is slated to begin in early January, while phase two is scheduled to begin in mid-February.

Renovations during phase one construction will include adjusting eight assisted living suites into 14 memory care suites. A new memory care dining area with a new warming and preparation kitchen will also be added. A new wandering control system is also planned to increase Members safety. Updated finishes in the new common area will also occur at this time.

Phase two will consist of renovating 12 memory suites into 18 skilled nursing rooms. Construction will also include the addition of a new preparation kitchen as well as upgrades to the existing skilled nursing preparation kitchen. Renovations to the common areas, a new skilled family area, and offices for the community’s physician and assistant director of nursing will also be added at this time.

“We are excited about expanding Cobblestone,” said Joan Carlson, Park Springs’ vice president of quality, innovation and culture. “We currently offer the highest quality services, medical care, nursing and rehabilitative care in a residential environment in the Southeast and our expansion will allow us to increase the level of care we provide. It will also allow us to provide outside short term admission to our Medicare skilled unit.”

Cobblestone’s Resident Centered model provides Members flexibility in their daily activities embracing individuality while focusing on all aspects of wellness. Staffing ratios are approximately two times greater than the state average. A full time doctor trained as a geriatrician whose sole responsibility is the health of our Members is employed on site. A clinic staffed by a full time Licensed Nurse Practitioner performs routine check ups, tests and lab work. The community doctor, clinic and skilled care are all Medicare certified. Home care services are provided by trained staff employed directly by the Park Springs and are licensed by the state, bonded and insured only after undergoing a strict screening process.

About Park Springs
The Southeast's premier CCRC, Park Springs enhances life for active seniors by providing independent residences alongside extensive amenities and on-site wellness and private health care facilities. The 398-home campus-style community is situated on 54 acres surrounded by Stone Mountain Park. A 64-suite health center provides assisted living, skilled nursing and dementia/Alzheimer's care. The campus style community boasts a 50,000 square foot Clubhouse serving meals in four themed dining rooms daily and a 12,000 square foot fitness center with an indoor swimming pool. The Seniors Housing Council of the National Association of Home Builders named Park Springs a Platinum winner. Park Springs is developed by Isakson Living and managed by Life Care Services LLC (LCS), a leader in senior living communities. LCS today serves more than 23,000 residents daily in over 80 communities nationwide. For more information on Park Springs, call 678-684-3300 or visit www.parkspringscommunities.com.
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HHS Announces $27 Million from Recovery Act to Help Older Americans Fight Chronic Disease

HHS Secretary Kathleen Sebelius has announced the availability of $27 million to help older individuals with chronic conditions to improve their health and reduce their use of costly medical care. These funds are made possible through the American Recovery and Reinvestment Act, which has provided up to $650 million to HHS for the Communities Putting Prevention to Work initiative launched earlier this fall to promote evidence-based prevention strategies in communities and states across the country.

"This program is about getting money to communities to help seniors manage chronic conditions that threaten their ability to remain in their own homes. Through HHS' national aging-services network which reaches into nearly every community in America, we are helping people living with chronic conditions and others better manage their own health," Secretary Sebelius said.

Research has shown that prevention programs can improve the quality of life for older individuals, including frail seniors with multiple chronic conditions, and also reduce health care costs. The Recovery Act funds will put the results of HHS' research investments into practice at
more than 1,200 community-based sites across the country -- reaching tens of thousands of older Americans and their families.

"The American Recovery and Reinvestment Act has been about helping families in need during challenging economic times, " said Assistant Secretary for Aging Kathy Greenlee. "This innovative program will give at-risk older people and their caregivers the tools they need to make their own decisions so they can live longer, healthier and more independent lives."

This competitive initiative gives every state Aging and Health Department and U.S. territory the opportunity to implement rigorously tested Chronic Disease Self-Management Programs (CDSMP), one of the most prominent being the Stanford University model. The CDSMP is a six-week peer-led training program that covers topics such as healthy eating, exercise, managing fatigue and depression, and communicating effectively with health care professionals. While further research is underway, rigorous evaluations have suggested that the program improves
participants' overall health and energy levels and result in savings to Medicare through fewer hospital stays. CDSMP are specifically designed to be delivered by non-health professionals in community settings, such as senior centers, congregate meal programs, faith-based organizations and senior housing projects.

"Too many seniors do not receive the recommended preventive and primary care they need," said Assistant Secretary for Health, Dr. Howard K. Koh. "This program will strengthen the health care that our seniors need and deserve by coordinating and integrating care in the community."

Eligible entities include all 50 states and U.S. territories. States will identify the communities and the organizations that will be involved locally in the delivery of this program. The deadline for applications is Feb. 12, 2010.

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FDA Approves First Generic Aricept to Treat Dementia Related to Alzheimer’s Disease

The U.S. Food and Drug Administration approved the first generic versions of Aricept (donepezil hydrochloride) orally disintegrating tablet s on Dec. 11. Donepezil hydrochloride is indicated for the treatment of dementia related to Alzheimer’s disease.

Although other generic versions of donepezil hydrochloride are already available, the orally disintegrating tablets dissolve on the tongue, without having to be swallowed whole. This may make it easier to take the medication for older or disabled patients who have difficulty swallowing.

“Generics offer greater access to health care for all Americans,” said Gary Buehler, director of the FDA’s Office of Generic Drugs. “Health care professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug and are the same as the branded in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”

Alzheimer’s disease is an irreversible, progressive brain disease that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks of daily living. In most people with Alzheimer’s disease, symptoms first appear after age 60. Alzheimer’s disease is the most common cause of dementia among older people, but it is not a normal part of aging.

Dementia refers to a decline in cognitive function that interferes with daily life and activities. Alzheimer’s disease starts in a region of the brain that affects recent memory, then gradually spreads to other parts of the brain.

The generic donepezil hydrochloride orally disintegrating tablets, manufactured by Mutual Pharmaceutical of Philadelphia, have been approved in 5 milligram and 10 mg strengths.

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Haemonetics Files a New Legal Action to Stop Fenwal Inc.'s Continued Patent Infringement

/PRNewswire/ -- Haemonetics Corporation (NYSE:HAE) announced today that it has filed a new legal action to stop Fenwal Inc.'s continued patent infringement resulting from Fenwal's just released red cell collection kits, using a modified separation chamber. Fenwal allegedly modified its separation chamber to circumvent Haemonetics' patent and the injunction entered by the Court prohibiting Fenwal's continued sale of infringing products after December 1, 2010. According to statements made by Fenwal's counsel today in the United States District Court, Fenwal is determined to proceed with commercialization without 510(k) clearance from the U.S. Food & Drug Administration.

On December 7, 2009 Fenwal announced that it began shipping a red cell collection kit with a modified separation chamber, and that it is discontinuing sales of its original kit. Ten months ago, on January 31, 2009, a federal jury had determined that Fenwal's original collection kit infringes a Haemonetics patent, and found Fenwal liable to Haemonetics for over $15 million in damages. The United States District Court for the District of Massachusetts later added millions of dollars in pre-judgment interest and ordered the product removed from the market by December 1, 2010. The District Court also ordered that between January 31, 2009 and December 1, 2010, Fenwal must pay Haemonetics a 10% royalty on the offending product's sales. The damages have not been paid, and the royalties are being escrowed pending decision on Fenwal's appeal to the United States Court of Appeals for the Federal Circuit. A decision by the appellate court is not expected before late 2010 at the earliest.

Haemonetics filed a new lawsuit against Fenwal on account of the modified collection kit, requesting another jury trial that seeks multiple damages for willful infringement, and a permanent injunction. The new matter has been assigned to the same federal judge who issued the permanent injunction on Fenwal's original red cell kit.

Brian Concannon, Haemonetics' President and CEO said, "We commit to supporting blood collectors who wish to assure an orderly transition away from infringing product well in advance of the December 2010 injunction. It is our genuine desire to protect customers from involvement in this commercial dispute between competitors. As we continue to make multi million dollar investments to bring new technologies and blood management offerings to the blood community, we are likewise committed to protect our intellectual property, which is the foundation of the business we've built."

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Health Reform Needs Enforceable National Workforce Strategy

/PRNewswire/ -- Congressional leaders must ensure that health reform includes a health workforce planning body with sufficient authority to ensure implementation of an integrated, coordinated national health workforce policy, according to Dr. Steven A Wartman, president and CEO of the Association of Academic Health Centers (AAHC). "With each step in the legislative process, the Congress has progressed toward a more effective health workforce planning process," Wartman said. "Still missing from both House and Senate bills is a mechanism -- such as national health workforce commission recommendations that automatically go into effect unless overridden by Congress -- to ensure timely implementation of the recommendations," added Wartman, urging Congress to address this concern before finalizing the legislation.

An updated analysis of the current House and Senate bills released today by the AAHC identifies additional strengths and weaknesses in the bills when measured against the AAHC's own health workforce recommendations:

-- The AAHC recommends that development and implementation of an
integrated, coordinated, strategic national health workforce policy be
the primary objective of any advisory committee or national
commission. The House bill contains a clear statement that the
purpose of its advisory committee is "to develop and implement an
integrated, coordinated, and strategic national health workforce
policy reflective of current and evolving health workforce needs,"
while the Senate bill only lists national health workforce policy as
one of several priorities.
-- The AAHC recommends the list of enumerated issues to be addressed by
the advisory committee or national commission include the
harmonization of conflicting national and state-based regulatory and
private self-regulatory standards (e.g., licensure, scope of practice,
accreditation). The Senate bill expressly directs its national
commission to "identify barriers to improved coordination at the
Federal, State, and local levels," but the House bill does not
expressly address the need for harmonization.
-- The AAHC recommends the creation of a permanent, independent advisory
committee or national commission that serves as a continuously
available policy research and consultative resource. The Senate bill
creates an independent national commission composed of members
appointed by the Comptroller General, while the House bill only
creates an advisory committee appointed by and reporting through the
Secretary.

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UGA Study finds significantly worse outcomes in cancer patients with cognitive impairment

A new study published by researchers from the University of Georgia and the Moffitt Cancer Center in Tampa, Fla., has found that cancer patients with dementia have a dramatically lower survival rate than patients with cancer alone, even after controlling for factors such as age, tumor type and tumor stage.

But the study, published in the early online edition of the journal Critical Reviews in Oncology/Hematology, also argues that a diagnosis of dementia shouldn’t discourage the use of cancer screenings and appropriate cancer treatments.

“As the population ages and as treatments improve, we’re going to see more patients with both dementia and cancer,” said lead author Claire Robb, assistant professor in the UGA College of Public Health. “And right now there are no guidelines for oncologists as to how to treat these patients.”

Robb and her co-authors in the Senior Adult Oncology Program at Moffitt compared the outcomes of 86 cancer patients with cognitive impairment to a control group of 172 patients with cancer alone. They found that cancer patients with dementia survived an average of four fewer years.

Robb, who is also a researcher in the UGA Cancer Center, said that the reason for the disparity is unclear. She notes that the patients in both groups received similar treatment and that the survival gap persists even after controlling for age, tumor type and tumor stage.

But Robb pointed out that within the cognitively impaired group, there was a dramatic difference in survival time between those with mild cognitive impairment and those with moderate to severe impairment. People with mild cognitive impairment often have problems with thinking and memory yet can still live independently; those with moderate to severe dementia forget details about current events, lose awareness and have difficulty with basic tasks such as preparing meals or choosing proper clothing. The researchers found that while patients with moderate to severe dementia had an average survival time of eight months, those with mild dementia had an average survival time of nearly four and a half years.

“Some people would argue against treating patients with mild cognitive impairment because they’re going to have a shorter survival,” Robb said. “But, you know, 53 months—almost 4 and a half years—is a pretty significant amount of time to live.”

The patients in the UGA/Moffitt study generally received the same treatment regardless of cognitive status, but other studies have found that patients with dementia often receive fewer cancer screenings and undergo less aggressive treatment. One study found that physicians were significantly less likely to recommend a mammogram for a woman with dementia than without, while another found that patients with dementia were twice as likely to have colon cancer reported only after death. Another study of breast cancer patients found that those with dementia were 52 percent less likely to have the tumor removed surgically, 41 percent less likely to undergo radiation therapy, 39 percent less likely to undergo chemotherapy and nearly three times more likely to receive no treatment.

“The fact that cognitively impaired patients seen in our Senior Adult Oncology Program received treatments similar to unimpaired patients while epidemiologic data show a marked difference in treatment provides food for thought,” said study co-author Dr. Martine Extermann, associate faculty member at Moffitt. “Although this might reflect a referral bias in which those who volunteered to participate in the study are different from the general population, it might also indicate that such patients benefit from a specialized evaluation and management in a geriatric oncology program.”

Robb emphasized that she does not advocate overly aggressive treatment for patients who are in the late stages of dementia, but urges the creation of guidelines to help ensure that cognitively impaired cancer patients receive appropriate treatment.

“People have thought about the impact of the aging population on rates of cancer and dementia, but not much attention has been paid to what happens when the diseases coincide,” Robb said. “We’re going to be seeing more cases like these, and, if anything, I hope our research raises awareness of this situation.”

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NCPA Commends Pentagon Decision to Cover Pharmacist-Administered Vaccinations

(BUSINESS WIRE)--The Department of Defense today issued an interim final rule designating pharmacies as providers for H1N1, seasonal flu and pneumonia vaccinations under its TRICARE program. The policy change, effective today and expected to be fully implemented later this month, brings the program in line with other insurers that have covered pharmacist-administered vaccinations for years. TRICARE is also seeking comments on additional vaccines that should be covered through community pharmacies.

In response, National Community Pharmacists Association (NCPA) Executive Vice President and CEO Bruce T. Roberts, RPh, issued the following statement:

“NCPA strongly supports the Pentagon’s decision to cover the provision of these critical vaccines at community pharmacies. This is truly a case where everyone wins. The 9.5 million TRICARE-eligible patients gain a convenient new vaccination option. Taxpayers and plan administrators will save money when vaccines are administered at pharmacies instead of costlier doctors’ offices or hospitals. And community pharmacists can welcome millions of new patients through their doors.

“This is a shining example of how community pharmacists can help produce better health outcomes at lower cost. We commend the Defense Department for taking this step, which NCPA has long advocated. In addition, as these benefits are realized, we’re hopeful Pentagon officials will expand the program to cover additional vaccinations.”

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FDA Approves First Additive Solution for Platelet Storage Up to 5 Days

/PRNewswire/ -- The U.S. Food and Drug Administration today approved InterSol, the first solution approved to replace a portion of plasma used when storing platelets for up to five days, allowing some of the donor plasma to be used for other purposes.

In the United States, platelets, which are blood components that help with blood clotting, have been stored in donor plasma. About 65% of that plasma is replaced with the InterSol platelet additive solution.

Platelets are used to prevent or treat bleeding in individuals undergoing chemotherapy for cancer, after major trauma, during or after surgery, and in individuals who do not produce platelets. InterSol solution does not have a therapeutic effect by itself but acts to provide nutrients and an appropriate environment in which to store platelets.

"The approval of InterSol is a significant step in the development and marketing of novel processes for the storage of platelets," said Karen Midthun, MD, acting director of FDA's Center for Biologics Evaluation and Research.

The InterSol platelet additive solution is an aqueous solution of various salt components. It replaces a proportion of plasma in the storage of platelets collected by an automated instrument.

InterSol solution is manufactured by Fenwal Inc., Lake Zurich, IL.

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PrimaBella™ - First FDA-Cleared Prescription Device for Non-Invasive, Drug-Free Relief of Morning Sickness - Now Available

(BUSINESS WIRE)--PrimaBella™, the only non-invasive prescription therapeutic device cleared by the U.S. Food and Drug Administration (FDA) for the treatment of nausea and vomiting due to pregnancy (NVP), is now available. Providing a non-invasive, drug-free treatment for morning sickness, PrimaBella™ has been proven to be safe for both mother and developing baby and can offer quick relief -- the majority of patients report an immediate improvement in NVP symptoms.1

PrimaBella™ is a Class II neuromodulation device worn on the wrist, helping pregnant women experience relief from morning sickness without the concern of negative side effects from drugs, such as sedation.

“PrimaBella™ gives patients peace of mind while providing relief from potentially debilitating nausea and vomiting during pregnancy,” said Mike Hulse, MD, an OB/GYN and Chief of Staff at Northside Hospital Cherokee, in Atlanta, Georgia. “PrimaBella provides physicians like me with an effective treatment for managing NVP patients. PrimaBella’s adjustable features helps patients feel in control of their symptoms.”

Nausea may be a result of a dysrhythmic output of the central nervous system, resulting in an erratic stomach rhythm. When activated, PrimaBella™ emits gentle pulses through the median nerve on the underside of the wrist, which travel to the nausea center in the brain. These gentle pulses regulate the nausea signaling process between the brain and stomach (via the vagus nerve), restoring normal stomach rhythm and providing relief of nausea and vomiting.

PrimaBella™ is reimbursable by most insurance plans. For more information, visit www.PrimaBellaRx.com.

About Nausea and Vomiting Due To Pregnancy (NVP)

NVP affects approximately 70-85% of pregnant women and can range from mild symptoms, with a short duration, to severe symptoms that last throughout the pregnancy2. The most severe form of morning sickness (hyperemesis gravidarum) affects approximately 0.5–2% of pregnant women.2 The precise cause of NVP remains unknown.3 Nausea can occur at any time of the day although it is most common upon waking thus earning the common term, morning sickness4.

About PrimaBella™

PrimaBella™ neuromodulation device is intended for use in the treatment of nausea and vomiting due to pregnancy (NVP). PrimaBella™ technology is licensed by Alaven® Pharmaceutical LLC from Neurowave Medical Technologies™. The device is sold through prescription distribution channels and promoted to obstetricians and gynecologists by Alaven’s professional sales force.

IMPORTANT SAFETY INFORMATION

INDICATION: The PrimaBella™ Neuromodulation device is available by prescription only for the treatment of nausea and vomiting due to pregnancy (NVP).

WARNINGS: PrimaBella™ should only be used on the designated area. Nausea and vomiting may be signs of a serious health problem, seek medical attention if symptoms continue. PrimaBella™ is not a curative and should always be used under medical supervision. Treatment outcomes may vary depending on patient characteristics and any medications a patient may be taking. PrimaBella™ should be kept out of reach of children. Pacemaker users: Use this device only as directed on the wrist to prevent possible interference with your pacemaker. Avoid placing the electrodes of the device directly on your chest or near pacemaker. Consult with your physician if you have other implanted devices. PrimaBella™ should not be used above an IV line attached to a patient’s arm. If a patient is using an IV line, PrimaBella™ should be placed on the opposite arm.

CAUTION: PrimaBella™ contains natural rubber latex, which many cause allergic reactions, and is not recommended for use in conjunction with electrocautery or MRI equipment.

SIDE EFFECTS: Skin irritation can occur beneath or around the electrodes. If irritation occurs, move the device to the other wrist. If irritation does not disappear within 24 hours, stop using the device and consult your doctor or pharmacist. Continued use of the device on irritated skin may cause skin injury.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician or other health care professional licensed in the state in which they practice.

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Medicare Expands List of Covered Preventive Services to Include HIV Screening Tests

The Centers for Medicare & Medicaid Services (CMS) today announced its final decision to cover Human Immunodeficiency Virus (HIV) infection screening for Medicare beneficiaries who are at increased risk for the infection, including women who are pregnant and Medicare beneficiaries
of any age who voluntarily request the service. The decision is effective immediately.

Under the recently passed Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), CMS now has the flexibility of adding to Medicare's list of covered preventive services, if certain requirements are met. Prior to this law, Medicare could only cover additional preventive screening tests when Congress authorized it to do so.

"Today's decision marks an important milestone in the history of the Medicare program," said HHS Secretary Kathleen Sebelius. "Beginning with expanding coverage for HIV screening, we can now work proactively as a program to help keep Medicare beneficiaries healthy and take a more active role in evaluating the evidence for preventive services."

Under MIPPA, CMS can consider whether Medicare should cover preventive services that Congress has not already deemed as covered or non-covered by law. Among other requirements, the new services must have been "strongly recommended" or "recommended" by the U.S. Preventive Services Task Force. For instance, the Task Force graded HIV screening as "strongly recommended" for certain groups. More information about the Task Force is available online at
http://www.ahrq.gov/clinic/uspstfix.htm.

"Every adult should know their HIV status," said Dr. Howard K. Koh, HHS assistant secretary for health. "This decision by Medicare should help promote screening and save lives."

CMS uses the national coverage determination (NCD) process to make decisions on these types of preventive services. This process provides transparency about the evidence that CMS considers when making its decisions and allows opportunity for the public to comment on CMS'
proposals.

"Medicare's coverage of HIV screening tests is an important step forward in protecting beneficiaries from the potentially devastating and life-threatening complications of HIV and Acquired immunodeficiency Syndrome (AIDS)," said CMS Acting Administrator Charlene Frizzera.

AIDS is diagnosed when an HIV-infected person's immune system becomes severely compromised or a person becomes ill with an HIV-related infection. Of the more than one million estimated to have the HIV infection, the Centers for Disease Control and Prevention has estimated that about a quarter of them do not realize they are infected. Without treatment, AIDS develops within 8 to 10 years. While there is presently no cure for HIV, screening can help identify infected patients so that they can receive medical treatment that could help delay the onset of AIDS for years.

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Lung Cancer Alliance-Georgia Hails Senate Leadership on Lung Cancer Mortality Reduction Act of 2009

/PRNewswire/ -- Today, Lung Cancer Alliance-Georgia (LCA-GA) acknowledged Senators Saxby Chambliss (R-GA) and Johnny Isakson (R-GA) for their leadership and support in establishing the first ever multi-agency, comprehensive program targeted at lung cancer.

Entitled Lung Cancer Mortality Reduction Act of 2009, S.332 authorizes a five year program to reduce the mortality rate of lung cancer which continues to be the number one cause of cancer deaths both nationally and in the state of Georgia. Lung cancer causes more deaths each year than breast, prostate, colon, kidney, melanoma and liver cancers combined.

"Lung cancer is the leading cause of cancer deaths among men and women. Anything that can be done to increase the parity in funding for this deadly disease will be a significant advance in reducing cancer morbidity and mortality," commented Senator Chambliss. "This legislation is a strong step in the right direction."

"We must make every effort to address lung cancer comprehensively and not overlook the import of earlier detection and better disease management," said Senator Isakson. "This is how we are going to make a difference in lung cancer mortality,"

In thanking the senators for their support, LCA-GA Chair and lung cancer survivor, Ed Levitt said, "Senators Chambliss and Isakson are looked to as leaders on cancer issues and their co-sponsorships of this breakthrough legislation is very significant. We sincerely thank them and look forward to working to continue to improve lung cancer outcomes in Georgia and beyond."

The bill requires the Secretaries of Health and Human Services, Defense and Veterans Affairs to combine forces on a comprehensive, coordinated plan of action with funding authorized for five years to accomplish the mortality reduction goal.

The National Cancer Institute (NCI) is required to review its funding priorities in order to meet the lung cancer mortality reduction goal and more national institutes are called on directly to take part, including the National Institute of Heart, Lung and Blood, the National Institute of Biomedical Imaging and Bioengineering and the National Institute for Environmental Health

To ensure accountability, the bill requires an annual report to Congress and creates an oversight board composed of the three Cabinet Secretaries and representatives from the fields of lung cancer treatment, research and advocacy.

In addition, the bill directs the Secretaries of Department of Defense (DOD) and Veterans' Affairs (VA) to implement an early detection and disease management program for military personnel who are at high risk for lung cancer because of smoking or exposure to carcinogens during active duty.

The bill also:
-- Authorizes the Food and Drug Administration (FDA) to create a new Lung
Cancer Mortality Reduction drug program with incentives for new
treatments, targeted therapies, vaccines and chemoprevention drugs for
precancerous conditions.
-- Requires the Centers for Disease Control and Prevention to carry out
an early disease research program targeted at the high incidence and
mortality rates among minority and low-income populations.


The bill includes specific authorizations of $75,000,000 for certain NIH agencies in FY10 and authorizes such additional sums as may be necessary for all the cited agencies to accomplish the goal for FY 2010 through FY2014.

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Type 2 Diabetes Gene Predisposes Children to Obesity

/PRNewswire/ -- Pediatric researchers have found that a gene already implicated in the development of type 2 diabetes in adults also raises the risk of being overweight during childhood. The finding sheds light on the genetic origins of diabetes and may present an avenue for developing drugs to counteract the disease, which has been on the upswing in childhood and adolescence.

Researchers from The Children's Hospital of Philadelphia and the University of Pennsylvania School of Medicine published the study Nov. 23 in the online version of the journal Diabetes.

"It has been a bit of a mystery to scientists how or even if these adult diabetes genes function during childhood," said study leader Struan F.A. Grant, Ph.D., a researcher and associate director of the Center for Applied Genomics of The Children's Hospital of Philadelphia. "This finding suggests that there may be genetic activity during childhood that lays the foundation for the later development of type 2 diabetes."

Type 2 diabetes occurs either when the pancreas produces too little insulin, or when the body cannot efficiently use the insulin that is produced because the cells have become resistant. Formerly called adult-onset diabetes and still most common in adults, type 2 diabetes has been increasing sharply among children and teenagers.

Grant and study co-leader Hakon Hakonarson, M.D., Ph.D., director of the Center for Applied Genomics at Children's Hospital, investigated 20 gene variants, known as single nucleotide polymorphisms (SNPs), previously reported to be associated with type 2 diabetes. The researchers drew on a cohort of nearly 7,200 Caucasian children, aged 2 to 18 years, in an ongoing genome-wide association study of childhood obesity at Children's Hospital. Dividing the cohort randomly in half allowed the team to follow their discovery study with a replication study.

Researchers continue to unravel the complicated role of different diabetes-related genes in influencing body weight toward both lower and higher ends of the scale. The risk of developing type 2 diabetes in adulthood is often influenced by factors in the first year of life, including lower birth weight, as well as by higher body mass index (BMI) during childhood. Obesity is a well-known risk factor for type 2 diabetes.

A previous study earlier this year by the same study team found that another type 2 diabetes gene, CDKAL1, affects fetal growth and increases the likelihood that a baby will be underweight at birth.

The current study found that the gene HHEX-IDE does not affect birth weight, but makes it more likely that a child will become obese during childhood. The gene does not appear to predispose to obesity in adults, although by contributing to childhood obesity, it may set the stage for type 2 diabetes in adulthood.

Grant cautioned that HHEX-IDE accounts for only a small proportion of the genetic contribution to the risk of type 2 diabetes, so many other gene variants remain to be discovered. However, he adds, HHEX-IDE may represent an important underpinning of the disease. "Previously we thought that this gene affects insulin production during adulthood, but we now see that it may play an early role in influencing insulin resistance through its impact on body size during childhood," said Grant. "One implication is that if we can develop medicines to target specific biological pathways in childhood, we may be able to prevent diabetes from developing later in life."

The National Institutes of Health, the Cotswold Foundation and The Children's Hospital of Philadelphia supported this study.

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FDA, CDC, and States Investigating Norovirus Illnesses Linked to Oysters

The U.S. Food and Drug Administration is advising consumers to avoid eating oysters harvested from the San Antonio Bay on or after Nov. 16 due to reports of norovirus-associated illnesses in some people who had consumed oysters harvested from this area, which is located on the Gulf of Texas.

The FDA, along with the Centers for Disease Control and Prevention (CDC) and the states of North Carolina, South Carolina and Texas, are investigating about a dozen reports of norovirus-related illnesses from South Carolina and North Carolina consumers who ate oysters recently harvested from the San Antonio Bay.

Consumers who purchased oysters on or after Nov. 16 that have a label showing they came from San Antonio Bay are advised to dispose of the oysters and not eat them. At restaurants, consumers can ask about the source of oysters offered as menu items. Restaurant operators and retailers should not serve or offer for sale oysters subject to this advisory. Restaurant operators and retailers who are unsure of the source of oysters on hand should check with their suppliers to determine where the oysters were harvested. No other seafood is affected by this advisory.

The Texas Department of State Health Services has ordered a recall of all oysters harvested from the San Antonio Bay between Nov. 16 and Nov. 25.

Noroviruses are a group of viruses that cause gastroenteritis. Symptoms of illness associated with norovirus include nausea, vomiting, diarrhea and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches and a general sense of tiredness. Most people show symptoms within 48 hours of exposure to the virus. The illness typically lasts one to two days. Norovirus typically is not life-threatening and does not generally cause long-term effects.

Consumers who ate oyster products on or after Nov.16 and have experienced symptoms of norovirus are encouraged to contact their health care provider and local health department.

The implicated oyster beds in the San Antonio Bay were closed by the Texas Department of Health Services on Nov. 26, 2009, and remain closed.

The FDA and CDC will continue working with health officials in the affected states to track any additional cases of norovirus illness.

Persons with weakened immune systems, including those affected by AIDS, and persons with chronic alcohol abuse, liver, stomach or blood disorders, cancer, diabetes or kidney disease should avoid raw oyster consumption altogether, regardless of where the oysters are harvested.

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Studies Investigate Emerging Trends and Treatment Options for Patients With Sickle Cell Disease

/PRNewswire/ -- Sickle cell disease, a condition characterized by deformed and dysfunctional red blood cells, is one of the most common genetic blood disorders affecting millions of people around the world, including more than 70,000 Americans.(1) Research presented today at the 51st Annual Meeting of the American Society of Hematology highlights intriguing studies on the acute danger that the H1N1 pandemic presents for children with this blood disorder, evaluations of both new and standard treatments for common complications of sickle cell disease, and an expansion of the current understanding of hemoglobin expression in red blood cells that may lead to new treatments.

"Treatment for sickle cell disease consists primarily of life-long supportive care, with the only cure being bone marrow transplantation -- a risky procedure that is not readily available for most patients," said Alexis Thompson, MD, PhD, moderator of the press conference and Hematology Section Head at the Children's Memorial Hospital and Associate Professor of Pediatrics, at Northwestern University Feinberg School of Medicine, Chicago. "Therefore, research in this area is particularly important to help ensure that improved therapies continue to be developed and that patients with sickle cell disease have access to the best possible care."

NOTES:

(1) National Heart, Lung, and Blood Institute. Facts About Sickle Cell Anemia. Available at: http://www.nhlbi.nih.gov/health/public/blood/sickle/sca_fact.pdf.

Control of Hemoglobin Switching by BCL11A [Abstract #5]

As infants develop in the womb, the gamma-globin gene produces a fetal form of hemoglobin, the protein inside red blood cells that carries oxygen. Shortly after birth, a switch to beta-globin gene expression normally occurs, which leads to the production of adult hemoglobin. Both fetal and adult hemoglobin function similarly, though fetal hemoglobin has a greater affinity for binding with oxygen.

Patients with sickle cell disease have a defective form of adult hemoglobin that causes their red blood cells to become deformed and sickle shaped. As a result, the cells are unable to efficiently carry oxygen to the body's tissues and often stick together and jam vessels, causing blood flow obstruction and episodes of severe pain. If a patient with sickle cell could continue production of the fetal hemoglobin and produce less of their defective adult sickle hemoglobin, many of their complications could possibly be reduced or eliminated. A team of researchers from Harvard Medical School in Boston studied the therapeutic possibility of turning the genetic "switch" back on for the production of fetal hemoglobin to replace the defective adult hemoglobin and alleviate these devastating symptoms.

In previous studies, a gene called BCL11A was found to be involved in blocking the expression of fetal hemoglobin in adults. To test these findings in vivo and investigate the role of BCL11A in hemoglobin regulation at different developmental stages, the researchers performed genetic tests in both embryonic and adult mice that were genetically engineered to carry a complete human beta-globin gene cluster capable of producing adult hemoglobin.

In the embryonic mice, inactivation of the BCL11A gene led to a robust expression of gamma-globin (the fetal form of hemoglobin) during late gestation: more than 90 percent of the globin produced was of this type. Tissue-specific deletion of the BCL11A gene in the adult mice (8-10 weeks old) resulted in an increase of more than 1,000-fold in gamma-globin gene expression in the bone marrow erythroblasts (the precursors to red blood cells) of the experimental mice in comparison to control mice. This increase in the gamma-globin expression after inactivation of BCL11A was rapid and persisted during the course of the experiments (up until the mice were 25 weeks old).

"Currently, there are only a limited number of therapies available for patients with sickle cell disease and thalassemia, another disorder involving abnormal hemoglobin," said senior study author Stuart H. Orkin, MD, David G. Nathan Professor of Pediatrics at Dana-Farber Cancer Institute, Children's Hospital Boston, and Harvard Medical School in Boston. "This research opens up a new avenue for treatment, a way to genetically activate healthy fetal hemoglobin in the red blood cells of patients with these lifelong blood disorders."


Hydroxyurea in Children With Sickle Cell Disease: Practice Patterns and Barriers to Utilization

[Abstract #242]

Sickle cell disease is often marked by episodes of severe and incapacitating pain called vaso-occlusive painful events, which can sometimes require hospitalization. Hydroxyurea, an oral drug that is most commonly taken once daily, was approved by the U.S. Food and Drug Administration for use in sickle cell disease patients in 1998. While hydroxyurea remains the standard of care for reducing these painful events in adults, little is known about its practice patterns in children. Researchers from the Medical College of Wisconsin and Children's Research Institute of the Children's Hospital of Wisconsin in Milwaukee investigated the patterns and barriers to hydroxyurea use in children with sickle cell disease.

In this study, researchers surveyed members of the American Society of Pediatric Hematology/Oncology about their practices and patients. Of the 1,128 surveys disseminated, 31 percent (350 surveys) were returned.

To standardize and increase the quality of care for both adults and children with sickle cell disease, the National Heart, Lung, and Blood Institute (NHLBI) provides clinical practice guidelines for the management of this blood disorder. Most of the survey respondents had heard of (87 percent) and read (78 percent) these guidelines, and provider utilization of hydroxyurea correlated with awareness of the NHLBI recommendations.

The survey found that only 8 percent of providers had half or most (50 to 90 percent) of their pediatric patients with sickle cell disease on hydroxyurea. Another 54 percent of providers had 10 to 30 percent of pediatric patients on the therapy, and 10 percent of providers had fewer than 10 percent of pediatric patients on hydroxyurea. Although a majority of providers (90 percent) felt that hydroxyurea was effective or very effective for the prevention of pain, some still did not prescribe the drug to eligible children because of apprehension about future reproductive issues (birth defects and infertility in males), despite insufficient evidence to support this concern. Low patient compliance was cited by 86 percent of providers as another reason they did not prescribe hydroxyurea. Providers reported that children and their families refused hydroxyurea because of a fear of cancer or other possible side effects, concerns that the drug would not work, compliance with required laboratory monitoring, or because they simply did not want to take medication.

The study also found that many providers prescribed hydroxyurea for reasons other than that for which it was intended, despite insufficient evidence of its efficacy for other complications of the disease.

"Our survey suggests a substantial variation in hydroxyurea utilization in children with sickle cell disease with barriers to its use found on the part of both providers and patients," said lead study author Amanda M. Brandow, DO, MS, Assistant Professor of Pediatrics at the Medical College of Wisconsin and the Children's Research Institute of the Children's Hospital of Wisconsin in Milwaukee. "To alleviate this problem, future research in the following areas may help: continued funding of studies to determine the efficacy of hydroxyurea for complications other than pain, evaluating unconfirmed toxicities of the drug that influence practice, exploring how access to care contributes to noncompliance, and research on methods to promote patient adherence to recommended medical care."

Dr. Brandow will present this study during an oral session on Monday, December 7, at 7:15 a.m. in Room 388-390.

Increased Severity of Pandemic H1N1 Influenza in Children and Young Adults With Sickle Cell Disease [Abstract #264]

Patients with sickle cell disease are more susceptible to infection than the general population. In particular, influenza, a viral disease that affects the respiratory system, is more than 50 times more frequent in children with sickle cell disease than in the general population, according to research conducted by John J. Strouse, MD, PhD, the lead author on this study, and colleagues. As H1N1 influenza, which began circulating in the United States in April 2009, has been reported to cause more severe illness in children and young adults than seasonal flu, researchers from The Johns Hopkins University School of Medicine in Baltimore sought to compare the clinical characteristics and complications associated with these infections in sickle cell disease patients under the age of 21 through a prospective analysis of patient discharge and billing records from September 1993 through July 2009.

During the study period, 99 patients who were seen at The Johns Hopkins Hospital in Baltimore were identified as having both sickle cell disease and influenza (89 with seasonal influenza and 10 with H1N1 influenza). Clinical symptoms, such as fever, cough, and runny nose, were similar between the two groups, although those with H1N1 influenza were at an estimated three-fold increased risk for life-threatening complications, such as acute chest syndrome (a severe lung illness), and nine times more likely to require intensive care, such as ventilator support.

"Our findings underscore that receiving a vaccination against H1N1 influenza, in addition to seasonal influenza, is extremely important for the health and safety of children and young adults with sickle cell disease," said lead author John J. Strouse, MD, PhD, Assistant Professor of Pediatrics and Medicine at The Johns Hopkins University School of Medicine in Baltimore.

Dr. Strouse will present this study in an oral session on Monday, December 7, at 8:15 a.m. in Room 220-222.

Safety and Efficacy of Sildenafil Therapy for Doppler-Defined Pulmonary Hypertension in Patients With Sickle Cell Disease: Preliminary Results of the Walk-PHaSST Clinical Trial [Abstract #571]

As patients with sickle cell disease have a high rate of hemolysis (red blood cell destruction), excessive amounts of hemoglobin are released into the blood stream that react with and destroy nitric oxide, a critical regulator that dilates blood vessels and inhibits clotting. This can lead to pulmonary hypertension, or abnormally high blood pressure in the arteries of lungs that also affects the heart. Approximately 10 to 30 percent of patients with sickle cell disease are suspected to have this life-threatening condition.

While the oral drug sildenafil (known as Revatio®) is approved to treat pulmonary arterial hypertension, it is unknown whether it is a safe and effective treatment for pulmonary hypertension in those with sickle cell disease. Therefore, a 16-week, double-blind clinical trial, known as the Walk-PHaSST study (treatment of Pulmonary Hypertension and Sickle cell disease with Sildenafil Therapy) was conducted in 10 medical centers in the United States and United Kingdom to test this application in adults and children over 12 years of age with sickle cell disease.

Before starting treatment, potential study participants were given baseline tests, including a Doppler echocardiogram and a six-minute walk test to measure heart and lung function. Seventy-four patients who had a tricuspid regurgitant jet velocity (TRV) of greater than or equal to 2.7 m/s (a sign of suspected high pulmonary blood pressure) and a six-minute walking distance of only 150-500 meters (reflecting decreased exercise capacity) were included in the study. The researchers then randomly assigned the study participants into two groups of 37 patients each. Half of the patients were treated with sildenafil at escalating doses from 20, 40, and 80 mg three times per day, and the other half received a placebo three times per day. In previous studies of patients with primary pulmonary hypertension, the highest dose of sildenafil (80 mg) had the greatest effect on blood circulation; however, to monitor for possible adverse effects associated with escalating doses, the sildenafil doses in this study were increased slowly, with dose increases made every four weeks.

The study was prematurely stopped when a significant number of the patients in the sildenafil treatment arm (46 percent) began experiencing serious side effects (primarily sickle cell pain crises requiring hospitalization), compared with only 22 percent of those in the placebo arm. Headache and blurred vision, which were expected side effects of sildenafil, were also experienced. The patients in the sildenafil group had more headaches (27 percent versus 14 percent) and more blurred vision (11 percent versus 3 percent) than the placebo group.

Prior to stopping the study, 33 patients had completed the 16-week assessment and were found to have no change in TRV value or in the walking distance test. On pain questionnaires, patients on the sildenafil treatment also reported worsening pain during walking and less enjoyment of life when compared to the patients on placebo.

"Although sildenafil is approved by the U.S. Food and Drug Administration and by the European Medicines Agency for patients with pulmonary arterial hypertension, the Walk-PHaSST study was prematurely stopped for safety concerns. However, these preliminary data should not be interpreted as implying that sildenafil may not be efficacious and safe in select sickle cell patients with documented pulmonary hypertension who are at low risk for vaso-occlusive events," said lead study author Mark Gladwin, MD, Chief of the Division of Pulmonary, Allergy, and Critical Care Medicine and Director of the Vascular Medicine Institute at the University of Pittsburgh Medical Center. "Further investigations are critically needed to find a safe and effective treatment for this patient population at high risk for death from this debilitating condition."

Dr. Gladwin will present this study in an oral session on Monday, December 7, at 2:45 p.m. in Room 220-222.

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