By Lori Tighe
Evidence-based medicine is key to reimbursement
Coming up with a technology that improves patient outcomes should receive reimbursement, but according to G. Gregory Raab, Ph.D., a consultant in reimbursement and health policy, it doesn’t work that way. “You think you’re in, but you’re not,” Raab noted in his recent talk, “Evidence-based medicine — the key to new technology reimbursement,” sponsored by the American Association for Clinical Chemistry. The conference told the inside story on how Medicare and private payers decide to cover (or not to cover) new diagnostic tests and technologies and, how much to reimburse for each procedure. Medicare coverage, which largely drives private payer decisions, “has been a closed process for 20 years, and there have been horror stories,” Raab said. “It’s a mess.”
Technology assessment experts from Blue Cross Blue Shield (BC/BS), and Kaiser Permanente see trends toward evidence-based medicine and greater rigor in assessing it. But just because top doctors recommend a technology, doesn’t guarantee its adoption.
“The big message is that there needs to be a more standardized process for making coverage and payment decisions,” said Vince Stine, government affairs director for AACC. At the June 8 conference, luminaries from the healthcare technology assessment arena discussed their processes for determining the validity of a new test. Manufacturers shared their problems in bringing devices to market. Payers, such as Kaiser, described the processes for determining which innovations make the grade. A Medicare spokesman shared the agency’s views on evidence-based medicine and how it makes decisions.
“It’s a mystery to a lot of people how this process works, because those decisions have been made in private. Lately, an effort has been made to open up the decision-making process,” Stine said.
The news flash in all this, according to Raab, is the pending legislation in Congress that seeks to shine some light on Medicare’s traditionally private decision-making process. It also proposes raising the current low carrier rates to a uniform national level with yearly Consumer Price Index (CPI) updates. The major problem, stemming back to the Balanced Budget Act of 1997, is that providers have not been reimbursed properly, according to Rep. Jim McDermott (D-Wash.), who introduced the “Medicare Patient Access to Preventive and Diagnostic Tests Act,” (H.R. 1798) on May 10. McDermott and Rep. Jennifer Dunn (R-Wash.), who are gathering more co-sponsors for the bill, envision attaching it to a large Medicare reform bill for momentum. McDermott expects it will take another year to pass. A companion bill, S. 1066, has been introduced in the Senate by Sens. John Kerry (D-Mass.) and Orrin Hatch (R-Utah).
“There is no way to fix errors, no way to change anything, no way to get feedback from experts,” said Raab, who helped draft the reform legislation. “We need to make the rules of payment open, consistent and provide for expert participation.”
A former senior advisor to Washington, D.C.-based AdvaMed, the Advanced Medical Technology Association, Raab analyzed HCFA’s (renamed CMS) “remarkable” recent decision to add 57 new tests to its fee schedule. If Medicare determined a new test was similar to a test already covered, it “cross-walked” its reimbursement to the old test. But some of the new “cross-walked” tests were reimbursed for the same amount as the old test. And some were paid less with no explanation. If Medicare decides a new test is unique, which happened to only one of the 57 new tests, it is identified with a new code or what they term “gap filled.” Carriers are asked to price it, and then a National Limitation Amount is calculated based on the carrier-set rates. The way Medicare “connected the dots as it cross-walked,” lacked uniformity, Raab explained, and regional carriers vary widely in their payment for the same tests. The reimbursement method for new tests, cross-walked to existing tests with low carrier-set payment rates, raises questions about how rates are set in the first place. For example, no procedures currently exist to correct errors in carrier rates or fee schedules. This inhibits innovation, Raab noted, asking, “Why would a manufacturer invent a new better test for faster and more precise results if Medicare isn’t going to adequately pay for it?”
Nevertheless, evidence-based medicine continues to make inroads in the private sector. Compared with years past, Kaiser Permanente’s discussions on which procedures, tests, drugs and devices to use are a lot more thoughtful. They demand that clinical results be there.
“The trend is toward a more rigorous assessment,” said Agnes Cronin, manager of new medical technology for The Permanente Medical Group, Inc. in Oakland, Calif. “We’re more study-based and expert-opinion based than anecdotal. We’re better able to distinguish between weak evidence and strong evidence. Technology assessment is evolving and gaining sophistication, and we’re embracing it.”
Patient needs drive the Kaiser process. It begins with physician requests to review the evidence of a new technology. Cronin and her peers review clinical studies and any prior assessments of a technology and then write a report evaluating the technology. A 15-member panel led by Kaiser physicians and administrators gather together quarterly to review the reports and decide on the half-dozen technologies of greatest interest. They assess each technology for its medical appropriateness. Their recommendations are circulated among doctors; however, the panel does not make coverage decisions. The health plan covers what is deemed medically appropriate by treating physicians, Cronin said.
From inventors to patients, interest in evidence-based technology assessment is growing. The links between private technology assessment, government, manufacturers and the public continue to strengthen from the cross-sharing of recommendations, said BC/BS’s Carole Redding Flamm, M.D., M.P.H.(left), senior consultant at the Technology Evaluation Center (TEC) in Chicago. The federal Agency for Healthcare Research and Quality, for example, through its own initiative, began to outsource private sector assessments in 1997. It developed 12 Evidence-based Practice Centers around the country to systematically review scientific literature (www.ahrq.gov). BC/BS Association TEC became a center, and has reported on a half-dozen technologies for AHRQ, which passes on its information to the public and HCFA.
“There’s also an interest in taking technology assessment findings directly to the end consumers, to make technology assessment public through Web links in a reader friendly format,” Flamm said.
Manufacturers with innovative technologies have increased interest in private sector assessments, Flamm said. The private sector is encouraging it. “They’re telling manufacturers, you need to consult with us early on in the process because we’re going to be conducting the evidentiary studies that will serve as the basis for many payment decisions,” Stine said. “Manufacturers want information on how tech assessments are done.”
BC/BS Association TEC uses five criteria to evaluate new technologies: 1) final approval from the appropriate governmental regulatory bodies, i.e. be legally marketable; 2) The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes; 3) The technology must improve the net health outcome; 4) The technology must be as beneficial as any established alternative; and 5) The improvement must be attainable outside the investigational settings. “All links of evidence need to be well understood and connected to patient outcome, which is a challenge for diagnostic testing,” Flamm said.
One example shared at the conference involved a technology that failed to pass BC/BS’s TEC assessment, despite heavy pressure favoring it. The Home Uterine Activity Monitor (HUAM) was designed to measure a pregnant-woman’s contractions at home to indicate pre-term labor. But available evidence shows no significant changes in moms’ or babies’ outcome as a result of the monitors in use.
Through the late ‘80s and early ‘90s studies continued. “This was a controversial issue with enormous pressure on health plans and obstetricians to adopt the technology. TEC did reports in ‘85, ‘87, ‘89, ‘92 and ‘96. Each of those years, TEC found that HUAM didn’t meet the TEC criteria due to lack of conclusive evidence. Several national organizations also issued similar statements. Then in 1998, a large randomized trial showed HUAM had no apparent benefit in preventing pre-term births. Measuring uterine contractions and instituting more intense medical treatment didn’t change the end result. The bottom line, pretty pictures alone don’t cut it in today’s environment.
The goal, Flamm said, is to get everyone — manufacturers, government , doctors — on the same page to do the right thing for patients. “The more we work together, ask the right questions and conduct good studies, the better patient outcomes will ultimately be.”
Lori Tighe is a freelance writer based in Timonium, Md.
