HOUSTON -- (September 30, 2008) -- Twelve Baylor College of Medicine researchers have been awarded funding through the U.S. Department of Health and Human Services along with researchers from six additional Texas institutions, Senator Kay Bailey Hutchison (R-TX) announced.

"This funding will help Texas health institutions expand their knowledge and understanding of science and medicine," said Hutchison.

"The research represented by these grants covers many important fields of study at Baylor College of Medicine," said Dr. Peter G. Traber, president and CEO at BCM. "We appreciate Senator Hutchison's leadership in support of biomedical science."

Researchers at BCM receiving funding include:

• Dr. Jue (Jade) D. Wang, assistant professor of molecular and human genetics, received $2,302,500 for her project, The Molecular Interface of Replication Elongation and the Cellular Environment from the Office of the Director at the National Institutes of Health. Wang also received the 2008 National Institutes of Health Director's New Innovator Awards, a program to support young scientists early in their careers, earlier this year.
• Dr. Aleksandar Milosavljevic, associate professor of molecular and human genetics, received $1,364,573 for his project, Epigenomics Data Analysis and Coordination Center at BCM from the National Institute on Drug Abuse.
• Dr. Olivier Lichtarge, professor of molecular and human genetics, received $423,459 for his project, Functional Determinants in G Protein-Coupled Receptors from the National Institute of General Medical Sciences.
• Dr. H. Daniel Lacorazza, assistant professor of pathology and immunology, received $383,750 for his project, Transcriptional Regulation of Development and Maintenance of Memory T Lymphocytes from the National Institute of Allergy and Infectious Diseases.
• Dr. Jenny Chang, associate professor of medicine and medical director of the Lester and Sue Smith Breast Center at BCM, received $475,325 for her project, Targeting Notch, PI3K-AKT and other novel pathways in breast cancer stem cells from the National Cancer Institute.
• Dr. David Corry, associate professor of medicine-immunology, received $697,014 for his project, Molecular Phenotypes for Lung Diseases from the National Heart, Lung, and Blood Institute.
• Dr. Karen Cullen, associate professor of pediatrics-nutrition, received $360,449 for her project, Family Eats: Cancer Prevention for Families from the National Cancer Institute.
• Dr. Graeme Mardon, professor of pathology, received $274,764 for his project, Molecular Genetics Emphasizing Vision Research from the National Eye Institute.
• Dr. Mary Mariscalco, associate professor of pediatrics-critical care, received $183,632 for her project, Research Training in Pediatric Critical Care Medicine from the National Heart, Lung, and Blood Institute.
• Dr. Hardeep Singh, assistant professor of medicine-health services research, received $421,506 for his project, Using Electronic Data to Improve Care of Patients with Known or Suspected Cancer from the Agency for Healthcare Research and Quality.
• Dr. Susan Marriott, professor of molecular virology and microbiology, received $223,295 for her project, Transforming Potential of Emerging Human Retroviruses from the National Institute of Allergy and Infectious Diseases.
• Dr. Virginia Moyer, professor of pediatrics, received $299,764 for her project, Safe Passages: A Toolkit to Ensure Quality Transitions from NICU to Ambulatory Care from the Agency for Healthcare Research and Quality.

HOUSTON -- (September 30, 2008) -- Three injections of anthrax vaccine given into the muscle stimulate comparable antibody responses and cause fewer adverse reactions than four doses given under the skin, said a consortium of researchers that included those from Baylor College of Medicine in a report in the current Journal of the American Medical Association.

"We expect that reducing the number of adverse reactions will lead to a higher level of acceptability of the vaccine," said Dr. Wendy Keitel, professor of molecular virology and microbiology at BCM and director of the Vaccine Treatment and Evaluation Unit at BCM. "And reducing the number of times the vaccine is given will reduce the cost and complexity of delivering the entire program."

Eliminating second dose

Anthrax vaccine is primarily given to people who are at risk for repeated exposure to anthrax spores, such as military personnel deployed to areas where they face an increased risk of infection with the bacteria and people who work with the organism in the laboratory. Eliminating the second dose of the currently recommended schedule would make it easier to fully vaccinate someone, said Keitel.

Researchers studied the ability of a reduced dose schedule to stimulate immune responses and reactions at the vaccine injection site in 1,005 healthy adults between the ages of 18 and 61 years who had not previously received the anthrax vaccine. Study participants were placed at random into one of six groups. Some groups received four scheduled doses at weeks 0, two and four weeks and six months; some groups received placebo as the second dose at two weeks; and some received only placebo injections.

Muscle vs. under the skin

Researchers evaluated antibody responses to the vaccine in the study participants seven months after they received the first dose and found that giving fewer injections into the muscle was comparable to the usual schedule of four given under the skin. They also noted fewer and milder side effects in those who received injections into the muscle rather than under the skin.

Other BCM researchers contributing to the study are Dr. Hanaa El Sahly, assistant professor of molecular virology and microbiology, Nanette Bond, P.A.C., study coordinator, and staff from the Vaccine Research Center. Contributing institutions include University of Alabama at Birmingham, Walter Reed Army Institute for Research, Mayo Clinic, and Emory University School of Medicine.

The study was funded and sponsored by the Centers for Disease Control and Prevention. The CDC was responsible for the development, study protocol and for statistical analyses.

The study can be found at www.jama.ama-assn.org/.

Washington -- Medicare's flagship Physician Quality Reporting Initiative has left in its wake a sea of annoyed physicians who say the pay-for-reporting program is being poorly managed by an unresponsive administration.

In July, more than a year after nearly 100,000 doctors started reporting quality measures to Medicare for the first time, the Centers for Medicare & Medicaid Services started sending out the first of more than 55,000 bonus checks to those who reported enough measures to qualify in 2007. In August, CMS began allowing participants access to confidential reports to let them know if they achieved the reporting threshold for the measures they chose -- or by how much they fell short. So far, the reviews from doctors on both processes have been largely dismal.

For starters, nearly half of the physicians who tried for a 1.5% bonus failed to get one, prompting doctors who never received the anticipated check to download their reports and find out why. But many who tried to access the documents were defeated by stringent security measures, and some gave up before they could see their performance. Those who did found the data useless in telling them how to improve quality.

If any physician participants were going to qualify for a bonus, William L. Rich III, MD, figured he would. The Falls Church, Va., ophthalmologist was an early and enthusiastic supporter of the pay-for-reporting initiative. He not only persuaded members of his own practice to participate but also helped bring on board many members of his profession through his role as the American Academy of Ophthalmology's medical director of health policy.

That's why Dr. Rich was shocked to find he was not one of the members of his practice who received a check for the 2007 run. He meticulously had researched the minimum three quality measures to report and changed his billing software to send data to Medicare automatically. Still, his feedback showed he reported measures for only about half of applicable patients instead of the required 80%.

93% of practices reported problems accessing Medicare's PQRI reports.

"I'm the poster boy for this program, and even I could not manage to get a bonus," he said. He suspects that CMS may have used faulty algorithms that assumed he should have reported more measures than were applicable.

Jeffrey E. Kaufman, MD, a urologist in Santa Ana, Calif., still doesn't know why he didn't qualify. The key section of his confidential feedback document that would tell him the answer contained no data. And he reached this point only after frustrating steps to access the report, a multistage approval process that requires each practice to designate a separate security officer and user group administrator. "You'd think you were getting CIA clearance," he said.

Jeffrey L. Kaufman, MD, a vascular surgeon in Springfield, Mass., is still trying to figure out if he even received a bonus because his practice is in the midst of a reorganization and the check possibly was sent elsewhere. But he cannot track that down until he accesses his report, and so far, the process has stymied him.

The situation is particularly frustrating because of his long history with Medicare, he said. "They know me, and yet they're making me go through all this rigmarole, and I still can't get the data."

Physician practices nationwide have similar gripes with the 2007 round of the Medicare PQRI and complain that CMS has been of little help.

In a survey released Sept. 8 by the Medical Group Management Assn., nearly 93% of practice managers said they had difficulty accessing quality feedback reports. Practices spent an average of five hours obtaining the documents from the CMS Web site. Of those who were successful in downloading the information, nearly 70% experienced no or low satisfaction with the reports in terms of helping to improve quality.

CMS cannot wait 18 months after the program year starts before giving physicians a clue as to whether they are reporting correctly, said William F. Jessee, MD, MGMA's president and CEO. "To truly improve patient care, programs such as PQRI must provide timely, actionable clinical information to physicians. Our data show the program has penalized practices trying to do the right thing for their patients by wrapping them in red tape."

The AMA also called for a much more extensive CMS education campaign, especially given doctors' low success rate. "It is clear from this alarming statistic that there is significant confusion among physicians about how to successfully meet the requirements of the PQRI," said AMA Executive Vice President and CEO Michael D. Maves, MD, MBA.

Preventing an exodus

An official said CMS was sorry doctors were having problems accessing feedback and getting questions answered. "These things ended up being more complicated than thought at first blush," he said, noting this was the first year of a multiyear effort.

Nevertheless, the agency is sure it approved bonuses only for those who legitimately deserved them, the official said. Physicians who expected an award and didn't get one should check with carriers to see if one should have been sent. If not, doctors should review their remittance advice notices to see if all necessary data -- such as quality codes and National Provider Identifiers -- made it to the carriers. No appeals process exists for physicians denied bonuses.

The administration and physicians who are still committed to the quality reporting initiative are now scrambling to urge other doctors not to give up on the PQRI amid the frustrations. Dr. Kaufman, the urologist, said his colleagues are starting to ask why they should bother going through this ordeal when they see such little chances for financial or quality gains.

The fact that doctors are uncovering PQRI's problems late in the game is troublesome because the initiative is ongoing, Dr. Rich said. He has all but given up on qualifying for a bonus in 2008, the first full year of the program, because he hasn't changed tactics from the last half of 2007. Still, he remains confident the process can be fixed before the 2009 cycle, when doctors will be vying for a 2% bonus.

"The percentages had better improve, or this program is in trouble," Dr. Rich said.

Illinois' certificate-of-need law and similar statutes in other states undercut consumer choice, stifle innovation and generally have failed to keep health care costs down, according to a joint statement by the Federal Trade Commission and Dept. of Justice.

The federal antitrust agencies reiterated these long-held positions at a Sept. 15 hearing before the Illinois Task Force on Health Planning Reform, commissioned by the Legislature last year to evaluate the state's law. The report -- which echoed the findings of a 2004 Justice Dept. study -- came after at least 14 states amended certificate-of-need laws earlier this year in the face of ongoing debates over whether such programs work as intended, according to the National Conference of State Legislatures.

Thirty-six states and Washington, D.C., have CON laws, which require physicians and hospitals to demonstrate a community need for new projects and services before receiving state approval to offer them.

"There really is a role for competition in health care delivery that can be quite important for consumers, not just in controlling certain areas of price growth but in all sorts of quality competition in terms of what is available where and to whom," said Daniel J. Gilman, an attorney and adviser in the FTC's Office of Policy Planning.

Task force members will take the joint statement into account when advising state lawmakers on the future of the statute.

36 states and Washington, D.C., have CON laws requiring doctors to demonstrate need for projects or services.

The American Medical Association has long opposed certificate-of-need restrictions, and the Illinois State Medical Society has advocated repealing the state law. The Association provided testimony to the Illinois task force in April echoing the government's stance that little evidence exists to suggest CON regulations effectively rein in health care costs or promote access to care.

The AMA and the government report pointed to a recent growth in specialty hospitals, ambulatory surgery centers and other physician-owned facilities that has brought convenience, lower costs and better technology to patients while spurring hospitals to improve their services.

"With competition, hospitals are going to have to make changes to make sure they take care of patients better, whereas if they have a monopoly, they don't care as much," said Gordon Lang, MD, a Chicago-area nephrologist who testified before the task force. "We have to look at how to best take care of patients. We're not here to make sure these companies continue to make a profit."

After spending roughly $80,000 going through the certificate-of-need process in 2004, Dr. Lang was defeated in his effort to open a dialysis center in St. Charles after the major local hospital successfully argued it had open capacity. Still, many vulnerable dialysis patients had to drive at least 30 minutes to get to the hospital, Dr. Lang said. Once there, they often faced long wait times for treatment.

The FTC's Gilman noted that the CON process raised the potential for antitrust abuses. The federal report cited enforcement actions against hospitals for allegedly delaying the process intentionally, driving up expenses with their objections or colluding to prevent outside competition.

Hospitals disagree

But hospitals rejected the government's conclusions.

Traditional competition principles do not apply to health care because it is a government-regulated industry in which Medicare and Medicaid fail to pay the full cost of care, said Howard Peters, the Illinois Hospital Assn.'s senior vice president of government relations. His organization testified in favor of keeping the CON law but supports reforms to simplify the process.

Without the CON process to weed out unnecessary duplication, "profiteers can come in and cherry-pick by engaging in only those services where people can pay" using private insurance, he said. That leaves community hospitals with the burden of covering indigent and uncompensated care, and it can undercut hospitals' ability to subsidize emergency or charity services, he added.

Dr. Lang said physician owners continue to provide their fair share of charity care.

Reform or repeal

The Illinois Task Force on Health Planning Reform is expected to submit its recommendations on the CON program to the Illinois Legislature in November.

"If we can't reform the circumstances surrounding certificate-of-need, we need to abolish it," said Sen. Bill Brady, a Republican member of the commission. "The [process] can't be there to maintain a monopoly" over providing health care services.

Brady suggested changes that would reduce the health care services or projects currently subject to the CON process, account for factors such as patient transportation time and require the review board to show the potential adverse effects of a particular proposal before rejecting it. He also recommended including members from the hospital and physician communities on the board.

The Ambulatory Surgery Center Assn. of Illinois supports similar reforms for what it deems one of the most stringent CON statutes in the country. "We're coming from the political reality that if there is going to be a system, it needs to be improved," said Mark Mayo, the organization's executive director.

Washington -- The American Medical Association in September stood with lawmakers from both sides of the aisle calling on Congress and the next president to cover the tens of millions of people without health coverage.

AMA President Nancy H. Nielsen, MD, PhD, joined Sens. Ron Wyden (D, Ore.) and Bob Bennett (R, Utah) and Rep. Michael Burgess, MD (R, Texas), in the U.S. Capitol on Sept. 18 to call for action on the problem of the uninsured, most recently estimated to number 45.7 million.

The AMA used the opportunity to unveil its new broadcast, print and online ads, which will run until the Nov. 4 elections. They are the newest element of the Association's Voice for the Uninsured campaign, which launched a year ago.

In one of the new print ads, a physician's image is accompanied by the statement: "I took an oath to help all patients. Without insurance, the people that need to see me the most don't come to see me." Another ad features a child whose parents can't afford health coverage.

"This is not a problem of the nameless, faceless individual," Dr. Nielsen said. "This affects all of us. It is time now to get to a solution."

Wyden has introduced the Healthy Americans Act, a universal coverage measure that is co-sponsored by Bennett. It would require every American to buy private health insurance and would establish state-run insurance purchasing pools to offer coverage.

The measure would replace the tax exclusion for employer-sponsored health insurance with a standard tax deduction for individuals and families. It would maintain Medicare and military health care but shift most of those covered by Medicaid or the State Children's Health Insurance Program to the new insurance pools.

Although the AMA did not officially endorse the legislation, the bill follows many of the Association's principles for universal health system reform, according to a May 6 letter from AMA Executive Vice President and CEO Michael D. Maves, MD, MBA. It would encourage individual ownership of and personal responsibility for health coverage, subsidies for lower-income individuals, private competition and a leveling of tax benefits for buying health insurance, Dr. Maves wrote.

The Healthy Americans Act, which has bipartisan support in both houses, has attracted increased attention since the Congressional Budget Office in May estimated that the bill would begin to slow the growth of health spending by 2014 if adopted this year.

"You can fix health care without a massive infusion of additional spending," Wyden said.

Wyden hopes to move the universal coverage legislation after the new administration takes over in January 2009.