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Some changes in the Medicare program brought about by passage of the Medicare Modernization Act (MMA) are familiar to oncologists, especially the reduction in reimbursement for chemotherapy drugs. But other major changes the act brought are positive ones for oncologists and their patients, according to Barry Straube, MD, acting chief medical officer for the Centers for Medicare and Medicaid Services (CMS). As a result of the MMA and a policy initiative, the coverage decision process is far more transparent and speedy, and access to care for emerging therapies and technologies is improving.
Today, coverage decisions remain unaffected by economic considerations. As the Congress struggles with the predicted shortfalls in Medicare funds, economic considerations may factor into coverage decisions. Cost effectiveness could become an important test for coverage. Determining what is cost effective, however, is a daunting challenge with which policy analysts and CMS have just begun to grapple.
Straube outlined those positive changes in the national coverage decision process. First, the agency has made the process much more transparent by issuing guidance documents to the public and practitioners that explain in detail how coverage decisions are made, how to initiate them, and how to be involved in the process. All coverage decisions—national and local—are posted on the CMS Web site (www.cms.hhs.gov), as are all related comments, and comments can be submitted through the Web site on any decision or reconsideration that is open for comment.
National coverage decisions were notoriously slow, sometimes taking several years to get through the agency. But now, MMA has mandated that coverage decisions be made within 6 months after being opened, although the act allows an additional 3 months if the agency sends the decision out for technology assessment, usually through the Agency for Healthcare Research and Quality. Once the decision is drafted, it must be posted for 30 days of public comment before the final decision is made, which is then binding within 60 days after the comment period closes.
Similarly, local coverage decisions have been made more transparent and faster, with more opportunities for comment and reconsideration, said Straube. Usually, the local process is faster than the national one.
But local or national, coverage decisions have been all or nothing. A new policy allowing what CMS calls “coverage with evidence development” is something in between. It expands access to emerging therapies and technologies that don't yet have a solid evidence base, but with monitoring and analysis at the same time to determine whether outcomes are indeed better. One of the cancer care decisions based on the new policy was to cover, in part, off-label use of drugs for colorectal cancer—but only in National Cancer Institute–sponsored trials.
Obviously, if CMS continues to make coverage decisions on the basis of effectiveness only as treatments and technology explode, we won't be able to afford them without a politically impossible ballooning of health care appropriations. That's why, Straube said, Congress has pressured CMS, especially the Office of Clinical Standards and Quality, which he heads, to come up with quality measures. Pay-for-performance projects that focus on quality are already in progress, and today, oncologists can take advantage of one of those programs that reimburses an additional $130 per encounter for assessing patients' pain, nausea and vomiting, and fatigue.
The administration's push for electronic health records and information technology are a step toward improving performance. That, said Straube, “is going to help us a lot.” But pay for performance and information technology will go only so far, which Congress recognizes. “In the next couple of years,” Straube noted, “Congress would like to see us measuring efficiency, too.”
That's a tall order because health economists are only beginning to struggle with how to measure efficiency. Today, there seem to be more questions than answers. One is determining who is responsible for efficiency when patients have more than one illness and more than one physician is involved in their care, which is typical of Medicare patients. Another is who will make treatment decisions. Traditionally, that's been between the physician and patient, but they don't always make the best or most cost-effective decisions. On the other hand, shifting the decision to the payer is fraught with problems.
One of the first steps toward measuring efficiency is calculating the money required for the therapy to produce one additional year of life—with quality—and comparing that with an efficiency benchmark. In cancer prevention, for example, the benchmark is considered to be $50,000 or less per quality-of-life year. Mammography at $17,259, colorectal cancer screening at $9,424 to $26,228, and cervical cancer screening at $4,535 all fall well below it. But these analytic methods are also controversial, especially in determining medical necessity and the evidence of benefit.
Clearly, said Straube, the issues are “very, very complicated and we have a lot of work ahead on this.”
In all these efforts, he said, CMS is determined not to lose sight of the importance of cancer care. “A couple decades ago, it was very common to see cardiovascular disease at midlife, and people were dying at younger ages. But now, we're seeing more and more cancer, so cancer treatment is really important to all of us in this society. We're very aware and doing our utmost to make sure we don't do anything with our policies that could produce barriers to people getting the best quality of cancer care.”
“Obviously,” he concluded, “we can't afford everything that technology can produce. But there's so much coming that we can afford a lot of good things, and we will make health care better regardless.”