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This year's meeting of the Hematology/Oncology Carrier Advisory Committee Network brought new meaning to the word “networking,” as participants prepare for the transition from state to regional Medicare carrier jurisdictions known as Medicare Administrative Contractors (MACs).1
At the annual network meeting in July, CAC members and leaders of state oncology/hematology societies heard updates and perspectives from the Centers for Medicare & Medicaid Services (CMS), Carrier Medical Directors (CMDs), and leaders from ASCO and the Society for Gynecologic Oncology Oncologists (SGO). ASCO and SGO cohosted the meeting.
Presentations about Medicare coverage for new cancer drugs and off-label use of drugs sparked keen interest among participants. Audience members described problems oncologists face in seeking reimbursement for such drugs, such as denial by local carriers who state they do not have the latitude to approve such use, and long delays in updating the compendia Medicare uses for coverage decisions of drugs.
John Cox, DO, immediate past chair of ASCO's Clinical Practice Committee, described ASCO initiatives to facilitate Medicare approval of off-label drug use. ASCO has asked CMS to add the NCCN (National Comprehensive Cancer Network Drugs and Biologics) Compendium to the list of compendia Medicare must use for approval of off-label drug indications. ASCO has stressed to CMS that the NCCN Compendium qualifies for inclusion because it is based on NCCN guidelines, which are already recognized by CMS as an established resource, and it provides specific recommendations, making explicit both the level of evidence and the degree of consensus supporting each recommendation. In addition, the NCCN Compendium has a timely process for reviewing new drugs and off-label use of drugs. Participants commented that the NCCN Compendium adds new listings much faster after their use is reported than do the current Medicare compendia.
Commenting on ASCO's request to add the NCCN Compendium, Rogers characterized it as “reasonable,” especially given that AMA Drug Evaluations, previously included as an accepted Medicare publication, has ceased publication.
Cox also reported that ASCO has asked CMS to add eight oncology journals to the list of those designated to determine whether new uses of anticancer drugs should be covered. The list of 15 journals currently included in the Medicare Carriers Manual for this purpose has not been updated since 1993. ASCO has requested that Medicare contractors be required to consider peer-reviewed literature from the eight additional journals in making coverage decisions about off-label use of drugs.
Local carrier approvals of off-label drug use are another area that can create an obstacle for oncologists filing claims. Alton Wagnon, MD, a CMD for the carrier Noridian Administrative Services, emphasized the importance of providing evidence for a drug's use from the peer-reviewed literature. He pointed out that abstracts or presentations delivered at meetings are not sufficient evidence for coverage decisions, giving as an example the adjuvant use of trastuzumab in HER+ breast cancer. Data about trastuzumab had been presented at the ASCO annual meeting, but until scientific evidence is published in a peer-reviewed journal, it could not be approved for use. Wagnon recommended that when sentinel data about a new therapy are announced, publication of a paper should be expedited to help provide evidence for coverage.
Wagnon noted that CMDs do have some latitude to use information from individual claims as the basis for making determinations about reasonable and necessary use. As an example, although data on certain uses of bevacizumab are not yet published, some carriers are nevertheless covering the drug's use off-label. He acknowledged that, unfortunately, with such individual claim determinations, coverage can vary from state to state, resulting in different treatments for different patients.
Facilitating local coverage determinations (LCDs) about drug use is another area ASCO has addressed, according to Dr Cox. As an example, he provided copies of letters ASCO had sent earlier this year to the Noridian and Empire Medicare Services, in response to proposed LCDs from each of those carriers. In each case, ASCO analyzed the proposal and urged changes to make the LCDs consistent with Medicare statutes and policy. For example, ASCO commented strongly against a Noridian proposal that would have curtailed the carrier's requirement to review relevant literature presented by a physician supporting an off-label drug indication if not already included in the two drug compendia used for review.
David Regan, MD, presented an overview of a number of drugs newly approved by the US Food and Drug Administration, as well as recent evidence supporting new off-label uses of drugs. He noted that in some cases carriers have responded differently to variations from the Food and Drug Administration–approved and labeled route and schedule of administration. For example, carrier responses have varied for claims submitted for administration of decitabine, a new drug for treating patients with myelodysplastic syndromes. Decitabine is directed to be given every 8 hours, and thus, it has been assumed that it is administered only in hospital settings. However, some physicians have had to lower the dose or frequency of administration to accommodate a patient's low tolerance to the drug. Audience members pointed out that oncologists have traditionally been able to reduce dosages and simply provide documentation of the deviations from the US Food and Drug Administration scheduled regimen. Regan said that CMDs usually require supporting documentation from the peer-reviewed literature, adding that just one good article would usually suffice for adequate support.
Bill Rogers, MD, Director of the CMS Physicians Regulatory Issues Team (PRIT), reported that billing for consultations is an area of concern currently being addressed by the PRIT, following the finding by Medicare's Inspector General that, in 2001, Medicare allowed approximately $1.1 billion more than it should have for services billed as consultations. Problems included consultations not meeting program requirements, being billed as the wrong type or wrong level of consultation, or not being substantiated by documentation.
Consultations billed at the most complex level and follow-up inpatient consultations were particularly problematic: approximately 95% of those were miscoded. As an example, Rogers pointed out that many split or shared visits were inappropriately reported as consultations.
Noting that the Inspector General found that almost every level 5 consult was inappropriate, Richard Whitten, MD, a CMD for Noridian, said that confusion centers around the definition of a consultation. A true consultation generally means that a second opinion or analysis is reported back to the referring physician for consideration in planning care. Whitten commented that a complete transfer of care does not constitute a consultation but should be billed as a new patient office visit. He suggested that both the referring physician and the consulting physician try to make clear the intent of the service; for example, whether it is a transfer of care or a consultation. Whitten indicates that CMS's initial investigations of consultation codes will look most closely at outliers.
ASCO will be working to develop additional guidance for oncologists on consultations while CMS conducts its review of the consultation codes.
The ASCO Web site has lists of CAC representatives and CMDs, and information about Medicare regulations on local and national coverage isssues. Visit www.asco.org/cac for details.