Gaps in medical knowledge are getting new attention as the federal government prepares to invest $1.1 billion in "comparative effectiveness" research and evaluate potential therapies head-to-head.
The Institute of Medicine is reviewing priorities for this type of research and preparing to issue recommendations this summer. A new 15-member panel overseeing the government's initiative has been asking for public input. The hope is that by identifying which treatments are most effective, doctors and patients will make better-informed decisions and avoid therapies that don't measure up.
More people are seeking care in Massachusetts hospital emergency rooms, and the cost of caring for ER patients has soared 17% over two years. This is despite efforts to direct patients with nonurgent problems to primary care doctors instead, according to new state data.
Visits to Massachusetts emergency rooms grew 7% between 2005 and 2007, to 2,469,295 visits. The estimated cost of treating those patients jumped from $826 million to $973 million.
Yesterday's internal Food and Drug Administration meeting was routine and not specifically focused on its troubled device review process as suspected, according to an agency spokesperson.
"[It] was a staff meeting within the Office of Device Evaluation (ODE) at the FDA's Center for Device and Radiological Health," said FDA spokesperson Peper Long. "The director of ODE holds these with her staff as many other staff directors in other agencies and businesses do from time to time."
Premonitions about a more focused meeting are not unfounded. In January, the U.S. Government Accountability Office recommended that the FDA take another look at the safety and effectiveness of a number of already approved class III devices. These devices ranged from pacemaker programmers to a spinal screw system. (A complete list of these devices is available on the FDA's Web site.)
The FDA divides medical devices into three categories; class III categories carry the most risk for patients.
Medical staffs are still waiting to see how the FDA's review process will evolve as a result of the GAO report. Critics say it's too soft, yet hospitals see FDA approval as a safety gold stamp when approving new technologies and granting practitioner privileges to use them.
Despite the current review, hospitals should remain confident that the devices they're using have been well-reviewed by the agency, says one trade group. "The FDA has an unparalleled record in the review of medical technology and that's why it's a model for other governments as they go about their process," said Wanda Moebius, vice president for policy and communication at AdvaMed [www.advamed.org], the trade association for advanced medical technology. "I think that if there are concerns to be addressed, they are concerns of resources and we support a well-resourced FDA."
In the meantime, hospitals and other facilities that use any of the devices under review should continue to report adverse events to the FDA, says Long.
The healthcare market is more competitive than ever, and physician practices have a growing number of strategic options—from traditional ancillary services to retail service lines—to increase revenue and remain competitive. Choosing the right service line or project can greatly enhance a practice's financial stability, but the choice isn't always easy because each option comes with direct and indirect risks and rewards.
When examining the new business venture, practices should ensure that the new service maintains high quality while remaining economically viable.
"Assess that the venture that you are considering is feasible, develop a business plan, and by all means prepare a budget that goes through the economic ramifications," says Max Reiboldt, CPA, president and CEO of The Coker Group, based in Alpharetta, GA.. "Present this to your doctors; make sure they understand that there are risks."
Questions practice managers should ask include:
Will the service add to or detract from patient comfort and security?
Will patients be compliant with the care plan?
Will the physician be able to supervise delivery of services?
Will care be of comparable quality to the traditional way the service is provided?
Will the service be reimbursed by third-party payers?
What will be the revenue possibilities?
Is there the possibility of an acceptable return on investment?
"One of the underlying themes that we've looked at as we looked at various services that we have is how effectively can they meet the marketplace," says Jack Reed, president and CEO of ProHealth Physicians, Inc., a group practice in Connecticut that recently developed an ancillary sleep program. "We needed to take the community-based practices and enable them to go out and meet the marketplace based on consumer needs."
Reed suggests outlining metrics for business development and risk tolerance when developing the program so its success can be tracked effectively. "We found, too, in our initiative that it is important to have very specific goals for the program," he says. "This is really important in how you monitor its success."
A feasibility analysis can be very helpful as well. In this analysis, consider market competition, patient demand, and provider support for the service.
"One of the most important things to start your program or expand your program is to test how complementary it is to your core business," Reed says. "You have to take this opportunity to look at how much money you are willing to put into this particular initiative, what the timeline is, how you are going to get reimbursed, and how much profit will it actually generate."
This article was adapted from one that originally appeared in the April 2009 issue ofThe Doctor's Office, a HealthLeaders Media publication.
A Colorado company that approved a fake medical study in a congressional sting operation said it will close, according to the Wall Street Journal. Coast IRB said the disclosure of the sting and an April 14 warning letter from the Food and Drug Administration describing the company's violations led several high-profile customers to pull their business. As a result, "Coast IRB's owners decided, through counsel, to cease future company operations," a company statement said.
A Colorado doctor was sentenced to nine months in jail for practicing medicine in California without a license when he prescribed a generic form of Prozac over the Internet to a Stanford student, who later committed suicide. Christian Hageseth, 68, pleaded no contest to the felony charge in February in San Mateo County Superior Court. Judge James Ellis granted prosecutors' request for a jail sentence, which Hageseth will serve in Colorado while recovering from heart surgery.