In a notice in the Federal Register, CMS also issued the draft model agreement that drug manufacturers of applicable Part D drugs will sign in order to participate in the discount program. These agreements with manufacturers represent an unprecedented partnership to help millions of Medicare beneficiaries. Discounts will apply when the beneficiary reaches the coverage gap. Eligible beneficiaries will see the discount when they buy their drugs at their local pharmacy counter.

CMS will host a public meeting on June 1 to discuss and collect public feedback about the draft manufacturer agreement, and to gather feedback about the final Part D guidance released today. As part of the June 1 meeting, CMS is encouraging drug manufacturers, Part D plan sponsors, and representatives from the beneficiary advocacy community to provide input and comments. All stakeholders can register online at: http://cmsconference.hcmsllc.com/Conf06012010/register.aspx

Closing the coverage gap is an important part of the Patient Protection and Affordable Care Act of 2010, (the Affordable Care Act) signed by President Obama earlier this year, beginning with a one-time check for $250 in 2010 for those that reach the donut hole in 2010 and are not eligible for low-income assistance, the 50 percent discount for brand-name and some authorized generic drugs beginning in 2011 and additional savings until drugs are covered throughout the coverage the gap by 2020.

“The documents we are releasing today facilitate the implementation of the Affordable Care Act’s provisions to help Medicare beneficiaries with the high costs of their prescription medicines,” said CMS Deputy Administrator and Director of the Center for Medicare Jonathan Blum.

The Part D plan guidance released today was finalized after receiving comments on the draft guidance that was issued on April 30. This guidance clarifies how the discount program will be implemented and that CMS will coordinate the manufacturers’ reimbursement for discount payments that Part D sponsors provide on their behalf to applicable beneficiaries under this program through a third-party administrative contractor. The third-party administrator will also help to verify the accuracy of the manufacturer discounts reported by Part D sponsors.

The researchers studied more than 350 patients, aged 18 to 85, who had uncontrolled high blood pressure — hypertension. The study participants were randomly assigned to receive ordinary treatment or take part in a monitoring program in conjunction with the American Heart Association’s Heart360.org Web site, which helps people manage their heart health at no cost.

Those who took part in the online program transmitted blood pressure readings via a home computer to their physicians. Pharmacy specialists reviewed the numbers and adjusted the medications of the patients accordingly, the study authors explained.

After six months, 58 percent of those in the program had lowered their blood pressure to healthy levels, compared to just 38 percent of those in the other group, Dr. David Magid of Kaiser Permanente Colorado and colleagues found.

The study findings are scheduled to be presented Friday at the American Heart Association’s Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke 2010 Scientific Sessions, in Washington D.C.

The implication is that standard efforts to treat the disease by targeting the androgen receptors might be missing the real “smoking gun,” a University of Michigan Comprehensive Cancer Center team suggests.

“We need to begin to think about targeting prostate cancer by targeting the gene fusion, and not confining our approaches to androgen receptors,” study author Dr. Arul Chinnaiyan, director of the Michigan Center for Translational Pathology, said in a news release. “If we’re going to find a more durable therapy, we need to get at the gene fusion.”

Chinnaiyan and his colleagues report their findings in the May 18 issue of Cancer Cell.

The authors note that typical prostate cancer treatments focus on drugs that attempt to slow production of androgen, the male hormone that regulates healthy prostate growth. However, such efforts usually become less effective over time as cancer cell resistance mounts, making recurrent cancer much less amenable to similar treatments.

But having earlier identified a so-called “on switch” for prostate cancer development in the form of the initial fusion of a prostate gene with a cancer-causing gene, Chinnaiyan and colleagues now have launched a new investigation into what happens post-fusion.

By using high-tech genetic mapping techniques, the research team found that once fusion takes place, androgen receptors get blocked, in turn cutting off normal prostate cell growth while permitting cancer to spread.

“Our study shows the underlying problem in prostate cancer is the presence of a gene fusion, not the androgen receptor,” Chinnaiyan said in the news release. “In many contexts, androgen signaling is actually a good thing, but the presence of the gene fusion blocks androgen receptor signaling, which alters normal prostate cell development. While current treatments for advanced prostate cancer are focused on hormone deprivation and are quite effective, at least initially, future therapies need to be developed that target the prostate cancer gene fusion.”

SOURCE: Cancer Cell, news release.

“These findings provide hope for the way we manage this disease. Rituximab maintenance therapy is likely to become a new standard of care for these patients,” study author Dr. Gilles Salles, a professor of medicine at the University of Lyon in France, said in a news release. Typically, he noted, patients often relapse within a few years of their initial treatment.

The researchers reached their conclusions after randomly assigning patients with follicular lymphoma to two years of treatment with the drug (505 patients) or no treatment with the drug (513 patients).

After a median of 25 months, 34 percent of those who didn’t take the treatment had recurrence of the disease, compared to 18 percent of those who did take it.

However, more than a third of the rituximab patients suffered from a side effect — infections.

In another study, researchers report that an interim analysis of a final-stage drug study suggests that lenalidomide (Revlimid) slows progression of multiple myeloma by 54 percent in certain patients — those who underwent high-dose chemotherapy and an autologous stem cell transplant.

“These results are very promising. If confirmed in the final analysis, they suggest that maintenance therapy with lenalidomide can improve quality of life in patients with myeloma by delaying the need for more intensive therapy to treat a relapse,” study author Michel Attal, a professor of hematology at Purpan Hospital in Toulouse in France, said in a news release.

University of Iowa researchers showed clips of happy and sad movies to five patients with memory loss. The patients couldn’t remember what they had watched, but they did retain the emotions triggered by the movie clips.

“Sadness tended to last a bit longer than happiness, but both emotions lasted well beyond [the patient's] memory of the films,” lead author Justin Feinstein, a student in the graduate programs of neuroscience and psychology, said in a university news release. “With healthy people, you see feelings decay as time goes on. In two patients, the feelings didn’t decay; in fact, their sadness lingered.”

The findings, published in the this week’s online edition of the Proceedings of the National Academy of Sciences, have implications for Alzheimer’s disease patients, their families and caregivers.

“A simple visit or phone call from family members might have a lingering positive influence on a patient’s happiness even though the patient may quickly forget the visit or phone call. On the other hand, routine neglect from staff at nursing homes may leave the patient feeling sad, frustrated and lonely even though the patient can’t remember why,” Feinstein said in the news release.

“What this research suggests is that we need to start setting a scientifically informed standard of care for patients with memory disorders,” Feinstein added. “Here is clear evidence showing that the reasons for treating Alzheimer’s patients with respect and dignity go beyond simple human morals.”

SOURCE: University of Iowa, news release.

Researchers asked more than 2,100 New York City residents aged 65 and older about their dietary habits. Over the course of about four years, 253 developed Alzheimer’s disease.

Those whose diets included the most salad dressing, nuts, fish, tomatoes, poultry, cruciferous vegetables (such as cauliflower and broccoli), dark and green leafy vegetables, and the least red meat, high-fat dairy, organ meat and butter had a 38 percent lower risk of developing Alzheimer’s than those whose diets included fewer fruits, vegetables and poultry and more red meat and high-fat dairy.

“Following this dietary pattern seems to protect from Alzheimer’s disease,” said senior study author Dr. Nikolaos Scarmeas, associate professor of neurology at Columbia University Medical Center in New York City. But he added that “this is an observational study, not a clinical trial,” meaning that researchers cannot say with certainty that eating a certain way helps prevent the disease.

The study was published online April 12 in the Archives of Neurology, and will appear in the journal’s June print issue.

While similar to the well-known Mediterranean diet, the diet that seemed to be beneficial in this study is not identical because researchers didn’t want to restrict themselves to considering only one culinary tradition. The Mediterranean diet included nine food groups; this study included 30, Scarmeas said.

The foods in those 30 groups are those that impact a list of seven fatty acids and nutrients, which previous research has associated with Alzheimer’s disease risk. The nutrient combination included: saturated fatty acids, monounsaturated fatty acids, omega-3 fatty acids, omega-6 fatty acids, vitamin E, vitamin B12 and folate.

“We found there was a combination of foods that affected the levels of these fats and vitamins, and by doing so, also affected the risk for getting Alzheimer’s disease,” Scarmeas said.

The researchers controlled for demographic factors such as age, education and ethnicity; genetic factors; smoking, body mass index and other medical conditions.

Dr. Samuel Gandy, a neurologist and cell biologist at Mount Sinai School of Medicine in New York City, said the findings are consistent with other epidemiological studies that have found that people who stick to a diet that is good for the heart also have a lower risk of Alzheimer’s disease.

“Everything that increases the risk for heart disease — high cholesterol, obesity, high blood pressure, uncontrolled diabetes — all of these things also increase the risk for Alzheimer’s,” Gandy said.

The reasons for the connection are not fully understood. One possibility is that factors that impact the health of the blood vessels throughout the body may also impact the health of the blood vessels in the brain.

Doctors used to believe there were two separate causes of dementia: vascular dementia, due to blood vessel disease; and Alzheimer’s disease, a neurodegenerative process. “We now know that most people with dementia have some of both,” Gandy said.

Still, while eating a “heart healthy” diet is probably a good idea and certainly can’t hurt, what’s not clear is just how much, say, broccoli a person has to eat to see benefits, Gandy added.

As for other lifestyle habits that can lower risk of Alzheimer’s, exercise is the only intervention that has been demonstrated to be beneficial in randomized clinical trials, Gandy said.

A second study in the April issue of the same journal found that people with Alzheimer’s disease lose lean mass as the disease progresses. Lean mass includes weight from the bones, muscles and organs.

People with Alzheimer’s often lose weight unintentionally. The weight loss often begins prior to noticeable memory loss, according to background information in the article.

Researchers from the University of Kansas School of Medicine in Kansas City, assessed the body composition in 70 people aged 60 and older with early-stage Alzheimer’s disease and 70 without the disease. Participants also had their brains scanned using MRI and neuropsychological testing.

Those with Alzheimer’s disease had less lean mass, as well as decreases in the volume of the brain and white matter.

“Our data are consistent with other studies suggesting that brain pathology may contribute to decline in body composition, perhaps by disrupting central nervous system regulation of energy metabolism and food intake,” the study authors wrote.

The strategy appears to make it more likely that the heart will retain the cells, potentially boosting the power of cardiac stem cell therapy.

“Stem cell therapies show great promise as a treatment for heart injuries, but 24 hours after infusion, we found that less than 10 percent of the stem cells remain in the injured area,” Dr. Eduardo Marban, director of the Cedars-Sinai Heart Institute in Los Angeles, said in a news release from the institute. “Once injected into a patient’s artery, many stem cells are lost due to the combination of tissue blood flow, which can wash out stem cells, and cardiac contraction, which can squeeze out stem cells. We needed to find a way to guide more of the cells directly to the area of the heart that we want to heal.”

Marban and colleagues developed a technique in which they loaded cardiac stem cells with microscopic bits of iron. Then they injected the cells into rats that had heart attacks and tried to manipulate the cells with a toy magnet.

The researchers found that magnetism attracted the stem cells to injured areas, tripling the retention rate in the heart.

“Tissue viability is enhanced and heart function is greater with magnetic targeting,” Marban said. “This remarkably simple method could easily be coupled with current stem cell treatments to enhance their effectiveness.”

Marban and his wife, Linda, are founders of a company that has filed patents for the techniques.

The study was published online in the journal Circulation Research.

When asked in a national survey why they might order this potentially hazardous procedure that measures blood flow to the human heart, even when it might not be called for clinically, the top two reasons that cardiologists around the country gave were the fact that other doctors do it routinely and that patients might sue if the test wasn’t done.

“We didn’t say unnecessary,” noted study author Frances Lee Lucas, an epidemiologist with the Maine Medical Center in Portland, whose report was published in the April 13 online edition of Circulation: Cardiovascular Quality and Outcomes. “We said how often for non-clinical reasons. We didn’t want to say unnecessary because we knew nobody would ever say they ordered an unnecessary test.”

The study of 598 cardiologists didn’t attempt to determine the number of catheterizations performed that weren’t really needed — an important issue in an era of rising worry about medical costs. That would be a very difficult study to do, and it would have to include errors in both directions, people who need one and don’t get it as well as people who get one and don’t need it, Lucas said.

Instead, they were just asked what outside factor might put them over the edge if they thought that a catheterization wasn’t really essential.

Fewer than 1 percent of those responding said that the added income from doing the procedure might be a motive, a low number that didn’t surprise Lucas. “I was astonished that anyone said it, but a few did,” she said.

One leading reason turned out to be fear of malpractice suits, which was cited by nearly 24 percent of the cardiologists. That response varied when the answers were broken down according to the intensity of treatment in a given region — that is, the level of health-care services in a region.

Only 12 percent of the cardiologists listed fear of malpractice in the regions of lowest intensity, compared to 35 percent in the highest-intensity regions.

About 27 percent of the cardiologists said they would do the procedure because of peer pressure, a number that varied unpredictably, from 20 percent in some regions to 35 percent in others, Lucas said.

But unlike the fear of malpractice, the effect of peer pressure did not rise in step with the intensity of treatment, Lucas said. “It isn’t a nice, neat gradation,” she said. “It bounces around a lot more.”

The study won’t help anyone who wants to point to one region of the country as a hotbed of unnecessary procedures, Lucas noted. It looked at data from 306 hospital referral regions, which could show a lot of variability in the larger, conventional geographical designations.

“Maine is very conservative, New York is very high-intensity,” Lucas said. “So saying northeast isn’t a very good tool.”

Changing current rules on malpractice might help relieve the pressure on medical costs, the report concluded, but it didn’t say what kind of change might be beneficial. Malpractice was specifically not mentioned in the health-care bill just signed into law by President Barack Obama, despite requests by medical organizations for more limits on what lawsuits physicians might face.

The American Heart Association has not taken a position on malpractice reform, said Dr. Clyde W. Yancy, president of the association and medical director of the Baylor Heart and Vascular Institute in Dallas, because “the association’s prime concern is the quality of patient care and research.”

The findings should be interpreted with caution, Yancy noted, because they were based on responses to proposed medical scenarios by a relatively small number of cardiologists. And “if the wording of the vignettes were changed, the responses might have been different,” he added.

“To use these data as a ‘Eureka event’ is not justified,” Yancy said. “I’m not convinced that the evidence we have justifies us to say we know what influences medical costs on the basis of defensive measures.”

SOURCES: Frances Lee Lucas, Ph.D., epidemiologist, Maine Medical Center, Portland, Me.; Clyde W. Yancy, M.D., medical director, Baylor Heart and Vascular Institute, Dallas;

Researchers found that among 12 New York State primary care practices, the six that had adopted “e-prescribing” systems reduced their prescribing errors by nearly seven-fold over one year. Errors included mistakes like giving patients the wrong dose, wrong duration of use or incorrect or missing usage directions.

Electronic prescribing has been widely seen as a way to improve efficiency, save money and cut medication errors, such as cases where a pharmacy dispenses the wrong drug due to a doctor’s illegible handwriting. The systems also typically provide doctors with a drug’s allergy warnings, potential for interacting with other medications and other information that could help prevent adverse effects.

President Barack Obama has promoted greater use of e-prescribing and electronic patient records as part of healthcare reform, and the economic stimulus package passed last year included funds to encourage more doctors to adopt e-prescribing — which as of 2009, only an estimated 13 percent of U.S. doctors had done.

But it is unclear how the commercially available e-prescribing systems have so far performed in the real world, in solo and small-group medical practices, according to the researchers on the new study, led by Dr. Rainu Kaushal of Weill Cornell Medical College in New York City.

To study the question, the researchers focused on a dozen small practices in a largely suburban and rural area of New York. According to their report in the Journal of General Internal Medicine, half of the practices adopted e-prescribing systems, while the other six stayed with paper prescribing.

Kaushal’s team found that over one year, the e-prescribing practices cut their average prescribing error rate from 42.5 per 100 prescriptions to 6.6 for every 100 prescriptions.

In contrast, practices that stayed with paper saw their error rate remain nearly the same; at the outset, about 37 percent of prescriptions contained an error, and one year later that figure was 38 percent.

As expected, e-prescribing eliminated the problem of poor handwriting, Kaushal’s team found. At the outset, 88 percent of written prescriptions from practices that adopted e-prescribing had some illegible information, according to the researchers.

There was no significant improvement, the researchers found, in the rate of “near misses” — potentially harmful errors that were either caught or reached patients but did not cause serious problems. Among e-prescribers, such errors were seen in almost 1.5 percent of prescriptions at the outset, and in 1.3 percent one year later.

The rate of near misses increased, however, at practices that stuck with paper prescriptions — from 1 percent to nearly 3 percent.

“Our study is one of the first to demonstrate a reduction in prescribing errors in ambulatory solo and small group community practices, where e-prescribing adoption and usage has lagged,” Kaushal and her colleagues write.

The study has a number of limits, including the small number of doctors involved, the researchers note. The practices were also all using the same e-prescribing system, from the health information service provider MedAllies.

“Future studies,” the researchers write, “should be performed with more providers, at diverse sites, and with multiple systems.”

The study was funded by the federal Agency for Healthcare Research and Quality.

SOURCE: Journal of General Internal Medicine

At a two-day meeting to review blood glucose meters, Food and Drug Administration officials and staff pointed to a number of issues that can prevent people from getting proper treatment and sought input from medical experts and industry on ways to improve test results with the widely used devices.

The FDA gets about 12,000 reports of errors with such meters each year and is currently weighing new industry guidelines, said Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health.

Such errors are likely underreported, but must be weighed against the billions of glucose tests done annually as patients test their sugars several times a day, other FDA staff noted.

“The importance of blood glucose meters in the management and control of diabetes is unquestionable,” Shuren said.

“Some in the clinical and patient communities… have challenged FDA to require tighter performance standards,” he said, while “Others believe… that there is no evidence to support the need for higher standards.

Companies such as Roche, Bayer and others make blood glucose meters used by diabetics on their own or by healthcare providers at doctors’ offices or hospitals to monitor patients. They are not currently FDA-approved to screen for diabetes although they are used to do so.

The devices, which have been around for more than 30 years, use small blood samples to check sugar levels in the blood. If levels are too low, patients may then need to eat something or, depending on their condition, may need insulin.

Accurate readings are key to prevent over-treating or under-treating patients, experts told the FDA. Otherwise, patients can experience sugar levels that are too high or too low and experience complications such as confusion and weakness. Over time, overall improper blood sugar control in diabetics can lead to more serious problems such as ulcers, amputation and even death.

At issue is whether incorrect meter readings stem from problems with the technology or other issues such as patients or doctors and nurses not using the devices properly. Other problems can include trouble with test strips, blood samples, hand washing and other factors that can impact results.

The concerns are particularly important as the number of Americans with diabetes grows. Roughly 24 million people in the United States have the condition — a figure largely expected to double by 2025.

The devices also “have migrated” to wider use in hospitals’ intensive care units even though they are not intended for such critical care use, said Courtney Harper, the head of the FDA’s office that oversees glucose and other testing devices.

Device makers said they support changes to improve meter readings.

The industry’s current standard calls for devices used by patients to be accurate within 20 percent, but companies back changes to tighten that to within 15 percent. Standards should also be set for devices used by doctors and nurses, an industry representative said.

Still, the industry lauded changes over the years that have made monitors easier and more convenient to use, adding that consistent monitoring helps prevent costly complications from diabetes.

“Today’s meters can fit into a patient’s pockets… are virtually pain free, and can produce data in as little as five seconds,” said Steve Brotman, a senior vice president at the industry group Advanced Medical Technology Association.

David Sacks, a pathologist and internal medicine physician at Harvard Medical School, agreed the current standard “is inadequate” and pushed officials to adopt a 10 percent margin of error. A 5 percent range would be even better but is impossible given current technology, he added.

Other experts said more attention must be paid to how medical professionals use the devices, since some studies show that patients who constantly test themselves tend to have fewer error rates.

Additionally, “how much accuracy you need depends on who you are,” said industry consultant Barry Ginsberg. Those with type 2 diabetes who treat their condition with diet changes and oral drugs don’t need to monitor their blood levels as closely as those with type 1 diabetes who take insulin, he said.

Simple steps like better hand washing, patient education and clearer device labels could also reduce errors, experts said.

The FDA on Wednesday will continue its public meeting, focusing on use of the meters in hospitals.