Panel suggests U.S. medical priorities

An influential scientific advisory panel has recommended that federal officials give top priority to comparing the effectiveness of competing medical strategies in areas that include treating prostate cancer, reducing hospital infections and lowering the rate of unwanted pregnancies. In a highly anticipated report, released Tuesday morning, a panel assembled by the Institute of Medicine released a list of 100 health topics that it said should get high priority as the Obama administration proceeded with a plan to spend $1.1 billion in comparing the effectiveness of competing drugs, medical devices, operations and other treatments for specific health conditions.

The report is one of the first concrete steps in a broad effort by administration officials and health experts to shift the focus of medical practice toward scientific evidence — rather than a physician’s personal views or treatments promoted by medical product companies. Currently, though, in many areas of medicine there is scant data that compare competing strategies. And systems for gathering such data by mining hospital or insurance industry records are also very limited.

Supporters of comparative effectiveness reviews include many medical researchers, consumer groups, unions and insurers. They say such studies are essential to curbing the widespread use of ineffective treatments and to helping control healthcare costs, which totaled $2.2 trillion in 2007, or 16 percent of the nation’s gross domestic product.

But the effort has come under attack by critics, including some conservative commentators and medical products companies, who warn that the process could lead to inadequate treatment for some patients and even the rationing of healthcare. There also may be sharp Congressional debate in the weeks ahead on issues like whether a new federal entity should be created to oversee government-financed comparative research and what role private industry might play in the effort.

While medical products manufacturers pay for clinical trials of their own products, such studies often compare a drug or device’s effectiveness in treating an illness against a placebo or no treatment, rather than against a competing product or treatment. In addition, people selected for clinical trials often do not represent the many different types of patients who will receive a drug or device after it is approved by federal regulators for sale.

In many areas of medicine, there is frequently more than one treatment with no clear winner. To treat prostate cancer, for example, a patient is faced with strategies ranging from watchful waiting to surgery to the use of radioactive implants. A similar conundrum faces patients diagnosed with abnormal heart rhythm known as atrial fibrillation. In such cases, a doctor may recommend drugs or a surgical procedure known as ablation, with little evidence as to which strategy works better or has fewer side effects. The Institute of Medicine panel said studying both those conditions should be among the top priorities.

The panel also urged that the government subsidize the training of a new generation of researchers skilled in doing comparative effectiveness reviews. While most of health areas cited by the panel involved medical treatments, others included topics like the best way to reduce hospital-based infections or to compare the effectiveness of differing medical imaging technologies. (NY Times) Read the full story.

IAHCSMM: July 13, 2009 deadline for submissions!

The International Association of Healthcare Central Service Materiel Management (IAHCSMM) announces it's Call for Presentations for their 2010 Annual Meeting in San Diego, California. The Meeting will be held May 2-5, 2010. Presentations must be: Related to the Field of Central Service and/or Materiel Management; Non-commercial; and Original (never presented before).

If you have knowledge to share and are able to meet speaker requirements and deadlines, IAHCSMM encourages you to submit a presentation proposal for San Diego. Presenters will receive a complimentary registration for the annual San Diego meeting. To find out more about speaker requirements, or to submit your Presentation Proposal online, visit: http://iahcsmm.org/CallForPresentations/callForPresentations1.html

Cost-effective medical practices deployed in poor nations deliver good results, but can they work in the U.S.?

When doctors running the AIDS clinic at the University of Alabama at Birmingham wanted to increase the number of patients who showed up for treatment, they turned to an unusual place for help: southern Africa. "Project Connect" is based on a program used in AIDS clinics in Zambia. In the Alabama program, patients were given appointments with doctors within five days of calling the clinic. Blood tests were taken during the first visit. A social worker did an interview, trying to identify and address any issues that might prevent patients from coming back. The no-show rate dropped from 31% in 2007 to 18% through June 2009.

With healthcare costs soaring in the U.S. and more than 50,000 new HIV infections every year, many are starting to ask: If it can be done over there, why can't we do it here? The obstacles range from the complexities of insurance reimbursement to regulations designed to protect patients. Another hurdle is cultural: There is a deep-seated reluctance to accept that simpler and less expensive treatments like those used abroad might be good.

Bruce Walker, director of the Partners AIDS Research Center at Massachusetts General Hospital, worries that imported practices -- and possibly lower standards -- would be adopted only for disadvantaged patients in the U.S. But Dr. Walker believes it will be too costly for the U.S. to continue to rely on current practices.

That is why solutions deployed in developing countries are getting more attention. "We learned from Africa that in a very resource-limited setting, you can do very effective chronic care delivery that doesn't have to be overmedicalized," says Mark Dybul, who was the U.S. Global AIDS Coordinator under President George W. Bush. "These are models we can learn a lot from."

For Heidi Behforouz, it has been an education. Dr. Behforouz started running the Prevention and Access to Care and Treatment Project in Boston based on a program first used successfully in rural Haiti. PACT trains community health workers to persuade AIDS patients to adhere to treatment regimens. The hope is this will reduce rates of emergency-room use and hospitalizations, big drivers of health costs. The strategy appears to work; according to data PACT collected, total medical expenses for 20 patients fell 40%. But PACT, which is expanding to sites in New York, still pays for the program out of private donations and fund raising, since insurers don't cover it.

Similar barriers exist for low-cost health technologies, which are easier to launch in the developing world than in the U.S. Daktari Technologies in Cambridge, MA, developed a hand-held, $8 device that takes a critical blood test in six minutes to determine when to start AIDS treatment. That is much faster and cheaper than the more sophisticated version of the test performed in the U.S., which can cost more than $50, requires an expensive machine and takes a couple of days to get results back. Daktari will begin rolling out the device next year in India, Brazil, Rwanda, Botswana and South Africa -- but not in the U.S.

William Rodriguez, who founded Daktari after leaving his job as chief medical officer for the William J. Clinton Foundation, says that when he started to raise money for the venture, "the first question investors asked us is why we were not marketing this in the U.S." One of the main reasons was that Daktari's test is less accurate, at 90% precision, than the version used in the U.S., which is as high as 97%. Even if a trial demonstrated that the test was accurate enough to offer good clinical care -- something Dr. Rodriguez and some AIDS doctors say is the case -- the company's founders worried that it would be too difficult and too costly to convince insurers, labs and doctors to switch to the Daktari test.

In Alabama, Dr. Michael Saag notes that the high rate of new HIV infections in rural parts of the state -- estimated 1% to 2% annually -- is lower than in Zambia. But it is on a par with some African countries, such as Niger and Benin. And the challenges of poverty and stigma associated with AIDS are the same in rural Alabama as they are in parts of Africa, he says. "There are spots here where you can't tell if it's Zambia or Alabama."

This fall, a Zambian group that developed a novel program to increase AIDS testing will travel to Alabama. Dr. Saag wants his team to study their model to possibly adapt it in Alabama. He calls the project "Zambama." (Wall Street Journal) Read the full story.

CMS proposes payment, policy changes for physicians’ services to Medicare beneficiaries in 2010

The Centers for Medicare & Medicaid Services (CMS) announced proposed changes to policies and payment rates for services to be furnished during calendar year (CY 2010) by over 1 million physicians and nonphysician practitioners who are paid under the Medicare Physician Fee Schedule (MPFS). The MPFS sets payment rates for more than 7,000 types of services in physician offices, hospitals, and other settings.

CMS is making several proposals to refine Medicare payments to physicians, which are expected to increase payment rates for primary care services. The proposals include an update to the practice expense component of physician fees. For 2010, CMS is proposing to include data about physicians’ practice costs from a new survey, the Physician Practice Information Survey (PPIS), designed and conducted by the American Medical Association. 

While working with Congress to develop a more appropriate mechanism for updating physician payment rates, CMS is proposing to remove physician-administered drugs from the definition of “physician services” for purposes of computing the physician update formula in anticipation of enactment of legislation to provide fundamental reforms to Medicare physician payments. While the proposal will not change the projected update for services during CY 2010, CMS projects that it would reduce the number of years in which physicians are projected to experience a negative update.

CMS is also proposing to stop making payment for consultation codes, which are typically billed by specialists and are paid at a higher rate than equivalent evaluation and management (E/M) services. Practitioners will use existing E/M service codes when providing these services instead. Resulting savings would be redistributed to increase payments for the existing E/M services.  

CMS is proposing to increase the payment rates for the Initial Preventive Physical Exam (IPPE), also called the “Welcome to Medicare” visit to be more in line with payment rates for higher complexity services. In addition, CMS is proposing to refine how Medicare recognizes the cost of professional liability insurance in its payment system. 

Taken together, refining the practice expenses, eliminating payment for the consultation codes and revising the treatment of malpractice premiums would increase payments to general practitioners, family physicians, internists, and geriatric specialists by between 6 and 8 percent (before taking into account the proposed update and other proposed changes to the fee schedule).

The proposed rule would also add new Medicare benefit categories for cardiac and pulmonary rehabilitation services, and for chronic kidney disease (CKD) education, beginning January 1, 2010. 

In addition, CMS is proposing two changes to address concerns about rapid growth in high cost imaging services. First, CMS is proposing to reduce payment for services that require the use of expensive equipment which would produce a redistribution of the resulting savings to increase payments for other services, including primary care services. The current payment rates assume that a physician who owns this type of equipment will use it about 50 percent of the time, but recent survey data suggest this expensive equipment is being used more frequently. As the use of this type of equipment increases, the per-treatment costs for purchasing, maintaining and operating the expensive equipment declines, making a reduction in payment appropriate.

Second, CMS is proposing to implement a requirement that suppliers of the technical component of advanced imaging services be accredited beginning January 1, 2012 by designating accrediting organizations (AOs) for these suppliers and utilizing the imaging quality standards that have been developed by the AOs. The accreditation requirement would apply to mobile units, physicians’ offices, and independent diagnostic testing facilities that create the images, but would not apply to the physician who interprets them. 

The proposed rule contains a number of provisions to promote improvement in quality of care and patient outcomes through revisions to the Electronic Prescribing Incentive Program (e-Prescribing Program) and the Physician Quality Reporting Initiative (PQRI). Eligible professionals or group practices that meet the requirements of each program in CY 2010 will be eligible for incentive payments for each program equal to 2.0 percent of their total estimated allowed charges for the reporting periods.

CMS will accept comments on the proposed rule until August 31, and will respond to all comments in a final rule to be issued by November 1, 2009. Unless otherwise specified, the new payment rates and policies will apply to services furnished to Medicare beneficiaries on or after January 1, 2010. For more information on the proposed rule, which went on display July 1 and will be published on Monday, July 13, see  www.federalregister.gov/inspection.aspx#special

FDA warning Lantus (insulin glargine)

FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects. 

FDA is currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus. Discussions are also ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. View the complete MedWatch Safety summary. 

FDA: Boxed warning on serious mental health events to be required for Chantix and Zyban

The U.S. Food and Drug Administration announced that it is requiring manufacturers to put a boxed warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (buproprion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Similar information on mental health events will be required for buproprion marketed as the antidepressant Wellbutrin and for generic versions of buproprion. These drugs already carry a boxed warning for suicidal behavior in treating psychiatric disorders.

Woodcock said healthcare professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. She added that patients should immediately contact their healthcare professional if they experience such changes.

The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.

Neither Chantix nor Zyban contain nicotine and some of these symptoms may be a response to nicotine withdrawal. People who stop smoking may experience symptoms such as depression, anxiety, irritability, restlessness, and sleep disturbances. However, some patients who were using these products experienced the reported adverse events while they were still smoking. Chantix is manufactured by New York-based Pfizer Inc. Zyban is manufactured by GlaxoSmithKline, Brentford, Middlesex, United Kingdom. For more information read the FDA news release.

Findings from Cost and Quality in Healthcare Logistics survey to be released at AHRMM09

The Association for Healthcare Resource & Materials Management (AHRMM) and the Center for Innovation in Healthcare Logistics (CIHL) at the University of Arkansas conducted an online survey of healthcare supply chain professionals to assess the current state of the healthcare supply chain from a cost and quality perspective in December 08 and January 09. The report findings will be released at the AHRMM09 Conference and Exhibition in July.

Starting in 2008, Heather Nachtmann and Edward Pohl, associate professors at the university and researchers from CIHL, partnered with AHRMM to conduct an industry-wide survey of healthcare supply chain professionals to evaluate the current state of the healthcare supply chain. The survey focuses on six areas of the supply chain; readiness and progress towards data standardization, collaboration among supply chain partners, implementation and benefits of strategic initiatives, supply chain-related expenditures, inventory and order management, and supply chain performance. 

The initial findings of the Cost and Quality in Healthcare Logistics survey will be presented at AHRMM09 Conference and Exhibition in Tampa, Florida on Wednesday, July 22, 2009.  The report will be provided to all attendees at the conference and will also be available on the AHRMM (www.ahrmm.org) and CIHL (cihl.uark.edu) websites. 

Happy 4th of July from the entire staff at HPN

Healthcare Purchasing News staff would like to wish you and your families a wonderful and safe 4th of July weekend. We’ll be spending time with our families and friends this weekend and will publish our next HPN Daily Update on Monday, July 6th.