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Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule

Creation/Revision Date: March 15, 2010

March 15, 2010 

Charlene Frizzera 
Acting Administrator 
Centers for Medicare & Medicaid Services 
Department of Health and Human Services 
Room 445–G, Hubert H. Humphrey Building 
200 Independence Avenue, SW 
Washington, DC 20201 

Subject: CMS-0033-P; Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule 

Dear Ms. Frizzera: 

The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with renal disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with renal disease. We are writing to provide comments on selected portions of the Electronic Health Record Incentive Program Proposed Rule. 

RPA’s comments will focus on the following areas: 

• Overview 
• Insurance Eligibility and Claims Requirements 
• Computerized Provider Order Entry (CPOE) 
• Clinical Quality Measures 
• Outcomes Policy Priorities 
• Reporting Period 
• Transitions of Care 
• Patient-System Interaction 
• Privacy and Security Audit Requirements 
• Laboratory Results Management 
• Summary of Care Record 

Overview 

In general, RPA appreciates the magnitude of CMS’ task in implementing the provisions of the American Recovery and Reinvestment Act of 2009 (ARRA) providing incentive payments to eligible professionals in Medicare and Medicaid that adopt and meaningfully use certified electronic health record (EHR) technology, and we support the Agency’s efforts to address the broad scope of issues raised by the ARRA mandate. 

It is RPA’s responsibility, however, to note that there are areas in the proposed rule where we believe that the objectives of the regulation will: (1) duplicate work accomplished today by existing systems and practice methods; (2) require the creation of additional steps in the eligible professional’s (EPs) workflow solely for the purpose of providing a mechanism to measure performance of the objective; (3) whose measurement creates a burden on the EP by requiring the EP to “count” missed opportunities occurring outside of the EHR functionality; and (4) impact clinical quality of care and patient safety and thus could have unintended consequences in the application of these objectives. Having acknowledged the difficulty inherent in developing regulation of this nature and scope, we do urge CMS to address these issues of duplication, increased administrative overhead and reporting burden, and potential for adverse impact on quality of care. 

Further, we share the opinion of other groups within organized medicine that there are provisions worthy of support in the NPRM but which have wholly unrealistic timelines (such as making electronic records available to patients). RPA also believes that the proposed rule establishes requirements that physician practices must satisfy that are dependent on other sectors or parties providing information or otherwise fulfilling another requirement that is beyond the practice’s control. Finally, we believe that there is a lack of clarity or definition in many provisions in the proposed rule. 

Insurance Eligibility & Claims Requirement 

RPA believes that the requirement to check insurance eligibility electronically from public and private payers and the requirement to submit claims electronically to public and private payers are problematic from the perspective of eligible professionals such as practicing nephrologists and other physicians. Use of these requirements exponentially expands the number of insurer and claims processing systems with which the EPs must be able to communicate, and thus by themselves these requirements significantly increase the administrative and reporting burdens for the physician practice. It should also be noted that the requirements of physicians regarding insurance eligibility are predominantly occurring today within the practice management and billing systems used by providers and that requiring this functionality within the EHR is duplicative. 

Further, it is our opinion that such requirements are far beyond the EHR scope as outlined within the ARRA legislation. While we recognize the desire to prospectively establish criteria by which EPs must abide in order to maintain eligibility for incentives, we believe that if these criteria far exceed the ability of practices to comply, rather than encouraging providers to participate, it will have the opposite effect of disincenting provider participation. RPA therefore urges CMS to remove the insurance eligibility and claims requirements as they pertain to all insurers to minimize duplicative work and reduce the reporting burden on EPs. 


Computerized Physician Order Entry 

RPA shares the concerns of organized medicine at large that provisions in the proposed rule pertaining to computerized physician order entry (CPOE) create requirements with which physician practices will have an exceptionally difficult time complying. As an alternative, we would urge CMS to use a step-wise process in establishing criteria for compliance with CPOE requirements. 

For example, rather than use a percentage of claims as the qualifying event for CPOE compliance, we would urge CMS to initially use a fixed number as has been the case in analogous situations within the Medicare Fee Schedule and other quality reporting incentive programs such as the Physicians Quality Reporting Initiative and Electronic Prescribing incentives. Over time, this number could be ‘ramped up’ as physician practices become progressively more sophisticated regarding the issues surrounding compliance in the EHR incentive program. Similarly, the CPOE requirements could initially be applied only to a single aspect of the practice’s order entries, such as those related to e-prescribing, and thus the physician practice would be able to develop an enhanced facility with the process. RPA believes that modification of the CPOE requirements to provide reachable fixed goals for CPOE is required. Otherwise, the administrative burden created will mean that most physician practices will be virtually unable to adopt an EHR in a timely fashion to meet the meaningful use objectives. 

Clinical Quality Measures 

RPA concurs with CMS that reporting clinical quality data is one of the foundational requirements of meaningful use, and we support the Agency’s efforts to advance the state of the art in this area. However, we also believe that the proposals relating to use of quality measures require substantial clarification before these proposals are implemented. 

Among the issues that RPA urges CMS to address are: 

• The requirement that every EP must report on the core measures set forth in the regulation does not reflect the reality of modern medical practice. While RPA supports the underlying principle of measuring basic patient care indicators, CMS must build in some flexibility in the methodology to account for the heterogeneity of health care delivery. RPA thus urges CMS to eliminate the requirement that EPs submit data on the core measures as indicated in the NPRM. Alternatively, EPs should be required to submit a specialty- or diagnosis-specific set of measures appropriate to their service and patient mix; 
• The proposed rule is insufficiently attentive to the fundamental principles of quality measure development science. To use measures in a manner proposed for the EHR incentive program, they must be tested and vetted to ensure that they are relevant, reproducible, consistent across geographies, predictive, and easy to capture, among other qualities. It is unclear whether all of the measures proposed in the NPRM meet this standard; 
• Additional attention to the ongoing management of measures once they are in place is also necessary. There is a need for further articulation of the measure lifecycle, the process must acknowledge and account for the fact that measure development lags behind the regulatory cycle, and a methodology for ongoing review of existing measures must be outlined; 
• That within the subspecialty measure groups there is reporting required on measures relating to care or services that may not be provided by all physicians (for example, interventional and pediatric nephrologists may not be able to adequately measure some of the indicators required in the nephrology group); 
• Similarly, not all nephrologists necessarily provide both chronic kidney disease (CKD—i.e., pre-dialysis care) and end-stage renal disease (ESRD) care, thus they would be required to report on services that they do not provide. 

In brief, in selecting measures for use in the EHR incentive program, CMS must choose measures that are relevant and must establish a process to ensure that the measures reflect the most recent literature to the greatest extent possible, in order to account for the constant evolution in measure development. RPA asks CMS to specifically define the processes and procedure by which measure development for the meaningful use standards will be updated in a timely fashion that is commensurate with changes in evidence based guidance for particular medical care practices. 

Outcomes Policy Priorities 

RPA believes that both objectives under the “Improve population and public health” Outcomes Policy Priority require clarification, as implementation of each objective has the potential to substantially and adversely impact administrative overhead. These objectives include; (1) the capability to submit electronic data to immunization registries; and its actual submissions where required and accepted; and (2) the capability to provide electronic syndromic surveillance data to public health agencies and actual transmission according to applicable law and practice. 

Further, reciprocal access to public records regarding vaccinations, birth and death records would optimize the ability for the EHR user base to demonstrate HIE in a bidirectional fashion that will enhance coordination of care. As currently constructed, it is RPA’s opinion that the data proposed to be collected is not universally able to be received by the public health entities electronically and that reciprocal delivery of such data to the EHR is not available, thus inclusion of vaccination, birth, and death records should be sequenced in a later stage of the meaningful use matrix and removed as an initial requirement. 

Reporting Period 

In the proposed rule CMS defines the EHR reporting period as “any continuous 90-day period within the first payment year and the entire payment year for all subsequent payment years.” RPA believes that CMS would significantly reduce the reporting burden on EPs by changing the reporting period to any continuous 90 day period for each year (i.e., for CY 2011 as proposed and beyond). Such a change would be particularly important if in fact the Agency decides to retain use of percentages for CPOE rather than a hard number, as reducing the reporting period would make the reporting burden much more manageable. 

RPA rebuts the opinion of some in the regulatory community that if the EHR reporting period was based on a hard number, and was of 90 day’s duration, physicians and other EPs would simply fulfill the criteria and stop gathering the data. In our experience this is simply untrue. Once nephrologists for example revise their practice patterns and processes to implement processes that will ensure compliance with the new requirements, it is highly unlikely that these processes will be deconstructed once the criteria were met. 

RPA recommends that the reporting period be a ‘floating’ 90 day reporting period, such that the EP could for example report on data gathered in the first quarter of 2011, but for 2012 report data gathered in a later quarter allowing more time flexibility for the EP to comply with the next required stage of meaningful use. This would allow the EP to gain experience in the data gathering and reporting processes. 

Transitions of Care 

In the proposed rule, the MU objective associated with medication reconciliation identifies transitions of care and relevant encounters as points in time to perform medication reconciliation. While CMS notes in the rule that “greater clarification is needed around the term ‘medication reconciliation’”, RPA believes that the term “relevant encounter” requires clarification as well, and we thus urge the Agency to provide greater clarity in this area. 

Patient and System Interaction 

In the NPRM, the meaningful use objective that defines sending reminders to patients for follow-up permits the patient to select their preferred method of notification. While RPA supports the underlying rationale for providing such flexibility, it is also our opinion that this objective is overly prescriptive, duplicative of existing workflow in many circumstances, and is virtually certain to result in unnecessary administrative overhead. We strongly recommend that CMS scale back this objective, and to not over-regulate on relatively mundane issues of this nature in general. 

CMS also indicates in the NPRM that electronic access to health records is proposed to occur within 96 hours. While RPA is supportive of prompt patient access to their EHR, we are not sure that such a tight turnaround time is feasible, and we do not believe it accounts for old data not necessarily included in the electronic record. As such, CMS should reconsider use of the 96-hour interval for patient access to their records, and perhaps again utilize a stepwise process that progressively shortens the interval over the next several years’ implementation of the EHR Incentive Program. 


Privacy and Security Audit Requirement 

The sole meaningful use objective CMS proposes within the “Ensure adequate privacy and security protections for personal health information” Health Outcomes Policy Priority requires the EP to “conduct or review a security risk analysis and implement security updates as necessary.” CMS must provide extensive clarification on the requirements that EPs must fulfill to meet this objective. RPA believes that this requirement could have unintended consequences on EPs far beyond what the Agency envisions, and thus more detail is necessary to allow providers to determine the ramifications on practice resources of meeting this objective. Further, in implementing this objective CMS must take great care to ensure that these requirements are reasonable do not discriminate against small to mid-size providers, and do not add to the administrative and reporting burden for these EPs. 

Laboratory Results Management 

The meaningful use objective to incorporate all lab-test results into the EHR as structured data has the potential to increase administrative overhead and to add to the reporting burden for the EP if the threshold is not carefully defined and implemented. RPA believes that CMS should reasonably define the metrics and thresholds outlined in this section of the regulation, offer greater specificity on the use of reminders as they pertain to laboratory results, and also provide greater clarity regarding the clinical summary relevant to lab results. 

Summary of Care Record 

Similar to other passages in this regulation, the meaningful use objective addressing the provision of a summary care record for each transition of care and referral requires clarification with respect to summary care component and transition definitions. 

As always, we welcome the opportunity to work collaboratively with CMS in its efforts to improve the quality of care provided to the nation’s kidney patients, and we stand ready as a resource to CMS in its future endeavors. Any questions or comments regarding this correspondence should be directed to RPA’s Director of Public Policy, Rob Blaser, at 301-468-3515, or by email at rblaser@renalmd.org. 

Sincerely, 


Edward R. Jones, M.D. 
President 

Renal Physicians Association

1700 Rockville Pike
Suite 220
Rockville, MD 20852

Phone: 301-468-3515
Fax: 301-468-3511
Email: rpa@renalmd.org

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