Medicare national coverage determinations
New list offers sneak peek into agenda of device, pharmaceutical industries
By Jeffrey Young
The Hill
July 31, 2008
The Centers for Medicare and Medicaid Services (CMS) has published its first-ever quarterly list of drugs, medical devices and procedures that Medicare patients may no longer be able to access.
The list, posted on CMS’s website this week, provides an unprecedented glimpse into what companies or sectors might be celebrating or mourning in the months ahead. It’s the Medicare national coverage determinations, or NCDs, that can be the difference between whether a drug- or device maker sees a huge return on research and development or a crushing bust.
And in an effort to improve transparency and public input, all members of the public — whether business interests, healthcare providers or patients — will able to provide CMS with comments.
CMS lists 19 potential topics for national coverage determinations in the next quarter-year. These topics include drugs to treat anemia, “proton beam therapy” to treat prostate cancer, and tiny, implantable devices that keep coronary arteries open while dispensing medication, called drug-eluting stents.
Not only does Medicare command a large portion of the healthcare marketplace, private insurance companies regularly adopt the same or similar coverage policies based on Medicare’s decisions.
CMS’s regional contractors make the vast majority of coverage determinations. In most cases when the agency’s headquarters steps in, it is in response to a request by manufacturers or medical providers seeking greater clarity on Medicare’s coverage policies based on variations in the locally made decisions. Other times, CMS will initiate a national coverage determination based on agency staff recommendations when they see, for example, new clinical evidence that they believe merits a reconsideration of an old decision.
Based on the statutory standard of whether the new technology or procedure is “reasonable and necessary,” the resultant policy then applies to Medicare providers and patients across the country.
(CMS Chief Medical Officer Barry) Straube stressed that the actual NCD process will not change and that CMS does not intend to centralize coverage determinations. “We have no plans right now to change the national coverage-versus-local coverage decision process,” he said, noting that CMS lacks the financial resources to take over for the regional contractors.
Comment:
By Don McCanne, MD
Medicare national coverage determinations (NCDs) are inevitably controversial. Decisions on what procedures, devices and drugs are to be covered must balance the wishes of patients to have unlimited access to all possible care, regardless of demonstrated benefit or lack thereof, with the responsibility of the stewards of our tax funds to not waste them on care that is of no benefit and often is detrimental.
The ethics are fairly straightforward. Medicare, being a publicly-financed program, has an obligation to fund appropriate care, but also has an obligation to prevent misuse of our public funds. Inappropriate care should never be considered to be a right of an individual when the taxpayer would have to pick up the tab.
Generally, a national health program would macro-manage the health care funds, whereas micromanagement of the patient’s care would be provided by the patient’s personal health care professionals. But high-tech care has been the largest contributor to the continuing escalation in health care costs. We are at a point where we should no longer permit the unquestioned use of public funds for unlimited, expensive high-tech care that has not been demonstrated to be of benefit, and sometimes causes harm.
Opponents of government health programs frequently charge that such coverage decisions deny patients life-saving care. Care that might be reasonably expected to reduce suffering or even save a life is not the care that is denied. A cancer drug that has a reasonable probability of providing a significant remission or even a cure is never withheld. Rather, an expensive cancer drug that has not been demonstrated to provide improved outcomes might well be denied. Spending $100,000 of taxpayer funds to provide a false sense of hope where there is no hope is not only wasteful, but it is also cruel because of the adverse effects of such therapies, and the dashed hopes that follow. “Well, we don’t know whether this $100,000 drug will do any good, but let’s try it anyway” should no longer be adequate justification for using public funds for therapeutic whims, even in tragic cases.
It is often said that a national health insurance program should be administered on a regional basis rather than nationally. But this does not necessarily mean that national coverage determinations must rest with regional contractors as they now often do in the Medicare system. Some of the complaints about Medicare stem from the inconsistencies in coverage decisions.
Claiming that CMS lacks the financial resources to centralize national coverage determinations is certainly a feeble excuse for not providing taxpayers with oversight of spending on expensive, unproven, high-tech services. Hopefully 2009 will bring us more enlightened national leaders.