BRT is very supportive of the new provisions in the Affordable Care Act relating to the sharing of Medicare claims data and is very pleased that the proposed rule reflects many of the detailed comments BRT submitted on September 27, 2010, in conjunction with the CMS Listening Session held on September 20, 2010.

BRT generally supports the proposed rule and commends CMS for the timeliness with which it has been issued.  Key areas where BRT is supportive of the proposed ruled include:

The effective date for the sharing of data appears on track if the rulemaking process moves expeditiously.  BRT has previously urged that the January 1, 2012 effective date for the sharing of Medicare claims data be a firm one.  With the issuance of this proposed rule, it appears that the agency is potentially on course to meet that effective date, provided that the final regulations are not unduly delayed after the current comment period closes.  BRT again urges that the January 1, 2012 effective date be met, given the urgent need for data from Medicare to advance the measurement of performance by providers in terms of cost and quality.

The proposed eligibility criteria for qualified entities (QEs) are reasonable.  In response to the request for comments, BRT believes that three years of demonstrated experience in handling claims data and calculating performance is sufficient.  In addition, BRT agrees that applicants with less than 3 years experience should be considered if they have sufficient experience in other related areas.  In addition, BRT supports requiring submission of prototype reports along with the application for QE status, as it will indicate how the applicant plans to disseminate information to the public.  We also suggest, however, that if CMS finds the submitted prototype report to be wanting, it would be helpful if CMS also suggested specific changes to the prototype report that would potentially otherwise make the applicant a qualified QE.  We also support and have recommended that QEs be required to submit a description of the methodologies to be used for evaluating providers, as it will help establish whether an applicant is using acceptable methods to analyze data.

The stringent privacy protections when handling patient data are well founded.  The proposed rule would require QEs to apply privacy and security protections similar to those required when CMS makes beneficiary claims data available to external organizations for research purposes.  That system has worked quite successfully.

The proposed appeals process for providers or suppliers that disagree with the results shown in the pre-publication report by the qualified entity is fair and allows for sufficient time for providers to make an appeal.  The QE must inform providers and suppliers that reports will be made public after a specified date (30 business days after sharing with providers and suppliers) regardless of the status of a provider’s or supplier’s appeal for error correction.  Also under the proposed rule, if the appeal is outstanding at the time the reports are being made public, if feasible, QEs should note that an appeal is pending and describe the nature of the appeal.  

We certainly agree that providers must have the opportunity to identify and correct errors in the report prepared by the QE.  Indeed, inaccurate data can cause harm.  By the same token, however, the correction and appeals process should also not become an open-ended process that may inadvertently create incentives or opportunities for certain providers to use these procedures to block or delay issuance of an accurate report that shows marginal or poor performance by the provider.  The proposed rule strikes the right balance.  BRT also agrees that CMS should monitor the number of provider appeals for each QE to make sure providers or suppliers are not abusing the process.

In addition, BRT has the following suggestions for clarifications and modifications to the proposed rule.

Encouraging Innovation in Quality Measures

BRT appreciates that CMS in the proposed rule is encouraging the use of alternative measures where there is no standard measure.  We note that for QEs who wish to use alternative measures, the agency proposes to adopt an alternative measure selection process through future notice and comment rulemaking.  In advance of such rulemaking, BRT suggests that in the event that there is no standard measure, it would be helpful if the rules explicitly allow the use of alternative measures.  Further, the required justifications and approvals for the use of alternative measures should not be overly burdensome.  There will be valid measures that the National Quality Forum (NQF) has not yet evaluated or endorsed.  Yet under the proposed rule, any new measure has to be approved by the Secretary and made available to all QEs, which could be time-consuming and inhibit investment by QEs in developing new measures.  Accordingly, BRT suggests that CMS develop an expedited process for the review and approval of new measures and encourage QEs to innovate by making use of the new measures exclusive to the QE that developed them and then only made available to all QEs after NQF endorsement.

Patient Privacy

According to the preamble, CMS evaluated three potential options for sharing beneficiary names with QEs, and by extension, with providers of service and suppliers.  Under the first option, QEs would be provided with a “crosswalk file linking all encrypted beneficiary identifiers to the patients’ names for their Medicare data.”  The second option would only provide beneficiary names to QEs on a transactional basis.  A third option would be for a provider of services or supplier to request encrypted claims data from the QE and then submit a request to CMS for the beneficiary names for those specific claims.  BRT supports the second option.  We prefer it to the first option because it limits the extent of sharing of Medicare beneficiary names to only such instances where it is absolutely necessary.  We also prefer it to the third option because if providers request CMS data directly, QEs will still need to link the CMS data with other data sources for the same individual patient.

Provider Identification

In order to measure the performance of providers the provider ID is a minimum requirement and it is critically important that the ID should be unique to that provider in order to match the claims data from all sources.  BRT suggests that the Unique Physician Identification Number (UPIN) now used by Medicare for voluntary reporting would be well suited for that purpose.

In addition, the provider IDs should not be encrypted.  In reviewing the proposed rule, we note that for purposes of the Medicare Part D drug event data file, the prescriber ID would be encrypted, as explained in the following excerpt from the preamble.

“Drug Event Database: The drug event database includes the following: encrypted beneficiary identifier, date of service, drug product dispensed, drug quantity, number of days supply of product, drug costs, beneficiary and other payer cost-sharing, formulary tier and utilization management, Part D benefit phase, encrypted pharmacy identifier, encrypted prescriber identifier, and encrypted plan identifier.”

This encryption of prescription drug data could make it difficult or impossible for the QE to link the drug data with the other medical claims data from the same provider, which could create a significant gap in the ability to measure the provider’s overall performance.

Application Procedures

Under the proposed rule, applicants will be evaluated across three areas: organizational and governance capabilities, addition of claims from other sources and data privacy and security.  The proposed rule does not establish formal application procedures for those seeking QE status and only states that prototype reports be submitted with an application.  BRT believes that it would be helpful to CMS and applicants if a common application along with supporting documentation could be submitted electronically.  A common application will provide guidance and ensure all applicants are including the same type of information with their applications. 

Claims Data of Geographic Region Outside of QE’s Region

CMS has requested comments on whether it should provide an option for the release of nationwide Medicare data.  BRT believes that CMS should definitely also release nationwide Medicare data for national norms.

The most likely source of non-Medicare claims data will be health plans and pharmacy benefit managers.  It would be helpful if QEs could receive multi-region data from these payers in a single feed.

Cost is another factor to consider, so as not to make it cost prohibitive for a QE to obtain nationwide claims data.  Judging from the CMS estimates of fees for obtaining the data discussed in the Federal Register, it appears that the approximate cost to QEs for a large data set -- net of the program costs of $125,000 for processing applications, data requests, related technical assistance and monitoring -- breaks down to about $0.03 per beneficiary for the claims data itself for three years of data for 5 million beneficiaries, which could potentially bring the total cost (claims plus program costs) to QEs for a national data set to be in the neighborhood of $1.5 million.  Given the high cost of obtaining nationwide data, we fear that fewer organizations may be able to invest in this program.  Those that do participate will pass the cost down by charging fees for accessing reports.  In the interest of having valid performance data in the public domain and encouraging participation by QEs, CMS should strike the right balance in weighing the important gains that would be derived from national data sets versus the cost of the data acquisition and also consider whether there are additional economies of scale in producing national data sets that could lower the estimated price of obtaining them.  One of the other benefits of national data is that it allows one region to benchmark against another, and further encourages the dissemination and adoption of best practices versus the current, wide regional variations in practice patterns that have been well documented over the years.

Use of Other Claims Data Sources with Medicare Data

The proposed rule would require that the claims data from two or more sources be combined with Medicare claims data by the QE.  The proposed rule states that the QE must “possess” this other data.  BRT suggests that a QE be allowed to satisfy the requirement to combine Medicare with data from other sources even if it does not “possess” the other data at the time of the application if the QE can demonstrate and attest that it has a contractual agreement in place to obtain such other data.  The fact that a QE may not “possess” the data should not inhibit the QE from receiving Medicare claims data if it does have an agreement in place to obtain the other data.

In addition, BRT suggests that notwithstanding the requirement for data from “two or more” other sources CMS create a pathway so that a QE may seek an exception from that requirement in limited circumstances.  For example, in less populated areas of the country, the exception could allow the QE to have fewer than two other data sources if the density of Medicare claims data alone provides statistical validity for the evaluation of provider performance.  In some geographic circumstances, for example, if other data sources cannot be acquired with reasonable effort and expense and/or would not measurably add to the statistical validity of the combined data set, the Medicare claims data alone would be extremely valuable to consumers and employers in those instances.

Definition of Claims Data

The proposed rule provides a list of items that would be considered sources for claims data.  In addition to the items listed in the proposed rule, BRT suggests that the proposed rule’s definition of claims data be expanded to include laboratory test values.  While this may not be available in the CMS data set at the current time, other data sources may include these values and CMS data may expand to include laboratory values in the future.  These values are an important component in measuring a provider’s clinical performance, and should be included under an expanded definition of the data.

Data Use Expiration

Under the proposed rule, QE status is granted for a period of three years.  Based on the duration of QE status, it appears that use of data may expire after three years.  If that is confirmed, BRT would like clarification on how long QEs are permitted to use this data.  As proposed, the rule does not appear to address situations in which QE status is renewed at the end of three years.  In such instances, BRT recommends that entities that obtain QE status renewal be allowed to use up to five years of data for trend analysis. 

In closing, BRT would like to commend CMS for its diligent efforts in producing a workable proposed rule that will allow for greater transparency of price and performance beginning January 1, 2012.  BRT member companies have long supported this effort and we believe there will be ample rewards in improving health care delivery that will flow from the new transparency.

Sincerely,

Maria Ghazal
Director, Public Policy and Counsel
Business Roundtable