External Data Submitted by the Public

Background

External data is data from U.S. sources other than data collected by the Department of Health and Human Services in the administration of the Medicare program. It is data that the Centers for Medicare and Medicaid Services (CMS) have used periodically to verify or amend payment rates that are developed on the basis of either MedPAR or outpatient prospective payment system (OPPS) claims data.

CMS has demonstrated willingness to meet with and review external data from the public. However, CMS’s review of external data has been characterized by a lack of predictability as to whether the agency will use the data. Moreover, AdvaMed raised concerns last autumn with CMS’s specified parameters for the use of external data in the outpatient context. In setting the 2005 outpatient rates, CMS decided not to use external data even for the APCs for which it had used external data in the past. AdvaMed members seek greater clarity from CMS on what data is useful to the agency and request that CMS understand that data collection is an expensive and time-intensive undertaking for our companies. Members consulted with multiple data vendors in developing this policy statement.

AdvaMed Position on External Data

• CMS should acknowledge that different types of data are appropriate for different uses. For example, the data needs for DRG development in the inpatient context may be different from the data needs for APC development in the outpatient context, due to different rate-setting methodologies. Furthermore, the data requirements for determining eligibility for a new technology add-on payment should not be the same as for adjusting DRG relative weights. Attached are three examples illustrating how external data could be used in three situations:
  1. application for inpatient new-technology add-on payment;
  2. request for DRG reassignment; and
  3. calculation of APC weight for device-intensive procedures.
• CMS should distinguish between proprietary data and publicly available datawhen requiring that external data be made available for public inspection. External data submitted to CMS, collected from data that any member of the public could purchase through a private data vendor, could be required to be made available for public inspection. Nonetheless, a lower level of disclosure should be considered when only a few companies and/or unique product are involved. For example, such a situation might arise in the context of a new technology add-on payment application, or the initial DRG assignment for a new technology. When using proprietary data from a few individual companies, CMS should release such data only in summary format agreed to by the companies and should not make the data available for public inspection without those companies’ prior consent. An example showing summary data submitted by three companies on implantable cardiac defibrillators is attached. It should be noted that CMS used these data to adjust the relevant APC weights in 2003 and 2004.
• When hospitals cannot be identified due to confidentiality agreements, CMS should be willing to accept external data that are identified by geographic location and a pseudo-identifier. In some circumstances, data vendors may be able to obtain waivers from hospitals to permit identified data to be submitted to CMS on the condition that CMS not release these data to the public with the provider identified. When this is not possible, CMS should not insist on the identification of specific hospitals using actual provider numbers and should accept pseudo-identifiers. CMS should not expect medical technology companies or data vendors to identify the hospital that is the source of their external data if the data was obtained on the condition that the source remains confidential. If confidentiality agreements with hospitals are not honored, the hospitals are unlikely to share data again in the future, cutting off a valuable source of information for CMS. In situations restricted by confidentiality but where CMS needs the external data to be matched to the Medicare program data, such as MEDPAR or the outpatient bill data, the data vendor could create the merged file and give it to CMS with pseudo-identifiers.
• CMS should allow the use of external data from recent timeframes without corresponding MedPAR data, particularly for procedures involving new technologies and codes. Unlike MedPAR or OPPS claims data, external data from private vendors has only a 60-90 day lag. CMS should take advantage of the most recent data available, even in the absence of a CMS claims history during the same time period, in order to allow for appropriate reimbursement for procedures associated with new technologies and codes.
• When a company submits external cost data to CMS, CMS should accept the disclosure of discount and rebate data at the estimated aggregate level. When companies make sales through wholesalers and distributors (as many small companies do), the companies may not know the final price paid by the hospital for a given product. For example, the three companies which submitted invoice cost data on implantable cardiac defibrillators (see attached example) also provided CMS with aggregate rebate information in a separate confidential letter due to the proprietary nature of the information.
• CMS should request that medical technology companies offer the typical devicerelated HCPCS and ICD-9 codes that seem most clinically appropriate to a particular procedure. Companies would like to be permitted to file the information that is most clinically appropriate. Such clinically appropriate information would be most useful to CMS and would allow companies to target their resources in providing the information.

-February 15, 2005