McKesson Corporation Ann Richardson Berkey
One Post Street Senior Vice President, Public Affairs San Francisco, CA 94104-5296
April 9, 2010
David Blumenthal, M.D. Director
Department of Health and Human Services
Office of the National Coordinator for Health Information Technology Attention: Certification Programs Proposed Rule
Hubert H. Humphrey Building, Suite 729D 200 Independence Avenue, S.W.
Washington, DC 20201
Re: Comments on Proposed Establishment of Certification Programs for Health Information Technology (Health IT); Proposed Rule
Dear Dr. Blumenthal:
On behalf of McKesson Corporation (hereinafter “McKesson”), I am pleased to submit comments to the Office of the National Coordinator for Health Information Technology (ONC) on the proposed rule for the establishment of a temporary certification program for health IT. For 177 years, McKesson has led the industry in the delivery of medicines and healthcare products. As the largest health IT company in the world, we are actively engaged in the transformation of healthcare from a system burdened by paper to one empowered by
interoperable electronic solutions that improve patient safety, reduce the cost and variability of care, and improve healthcare efficiency.
McKesson has decades of experience serving the health IT needs of the largest and most diverse provider customer base in the industry, including 50 percent of all health systems, 77 percent of health systems with more than 200 beds, 20 percent of all physician practices and 25 percent of home care agencies, which support more than 50,000 home care visits annually. Our perspective on these recommendations is based on our extensive experience with health IT and the quality, safety and efficiency improvements that can be realized by the hospitals, health systems, physicians and pharmacies that adopt such technology.
Overview
McKesson appreciates the opportunity to provide public comments on this proposed rule. We share concerns raised by ONC about the limited time available to create and implement:
• A streamlined temporary certification program that reduces the complexity and the length of time to authorize intermediate bodies and facilitates the ability of providers and hospitals to attain Stage 1 meaningful use status; and
McKesson Comments on Proposed Establishment of Certification
Programs for Health Information Technology Page 2 of 6 We also agree with concerns that have been expressed regarding the tight timeframes for the implementation of the provisions of the HITECH Act. Given the limited time for Stage 1 certification, health IT vendors must move at an unprecedented pace to modify existing technologies or develop new solutions to enable eligible hospitals and providers to qualify for Stage 1 meaningful use. Since the meaningful use requirements are not yet final, a rush to develop the required functionality and implement EHR systems could jeopardize patient safety and the quality of care.
McKesson offers the following recommendations to streamline and strengthen the temporary certification program.
Term of initial certification should tie to Stage 1 meaningful use
A certified EHR technology is a prerequisite for eligible providers and hospitals to achieve meaningful use. Today, many eligible providers and hospitals are not sufficiently prepared to begin the qualification process. As part of their planning to achieve Stage 1 meaningful use status, providers are relying on certification as a guide for the solutions they should acquire. While the proposed rule attempts to remove some of the current ambiguity confronting providers, uncertainty still remains with meaningful use, certification criteria and the certification process. In order for this process to offer stability and certainty to the marketplace, McKesson
recommends that, once certified for Stage 1, providers and hospitals should be able to remain certified for that stage through 2015, and therefore be qualified for Stage 1 financial incentives under ARRA.
Meaningful use stage should determine software upgrade requirements
As currently proposed, providers will be forced to upgrade to Stage 2 certified software, even though they may still be pursuing Stage 1 meaningful use objectives. McKesson believes that this mandate places an undue burden on providers who are seeking to qualify for incentives under Stage 1 criteria, and may prove quite disruptive to those who are managing the deliberate and delicate process change involved in migrating clinicians to the EHR. We recommend the elimination of this requirement and suggest that ONC allow eligible providers to determine the timing of upgrades to their certified EHR software, as long as they use EHR technology certified for the relevant stage of meaningful use.
The certification process should have the capacity, standardization and responsiveness to produce a robust marketplace for EHRs
Market access to an abundant variety of certified EHR technologies will depend on a certification program that can accommodate a variety of technology platforms and implementation options. The certification process should have the capacity, standardization and responsiveness to produce a robust marketplace for EHRs in a timely and transparent fashion.
The speed with which such a process must take shape for 2011 meaningful use payments to be made raises concerns about the capacity for certification over the next 18 months. If there is inadequate capacity and/or access to an ONC-Authorized Testing and Certification Body (ONC-ATCB) for the certification process, there is potential risk of creating a backlog that could freeze industry progress. We recommend that ONC ensure that there are sufficient numbers of
McKesson Comments on Proposed Establishment of Certification
Programs for Health Information Technology Page 3 of 6 McKesson is also concerned about the variability in testing methods and tools that may be used by different authorized testing centers. We recommend that ONC and National Institute of Standards and Technology (NIST) collaborate to develop standardized tools and methods to ensure a consistent and uniform certification process across all authorized testing centers. Additionally, all EHR technologies that are ready for testing and certification should be able to complete the process and receive certification test results in six months or less from the time the process commences.
Moreover, determination of a specific date for when ONC-ATCBs are “open for business” is critical for planning purposes for health IT vendors and eligible providers and hospitals, who must implement the technologies that will enable them to meet quality and efficiency objectives within a constrained timeframe. McKesson recommends and urges that all ONC-ATCBs be named by June 1 and fully operational by July 1.
A variety of testing options should be available for certifying EHRs
As a vendor with multiple technology platforms and a variety of deployment options, McKesson is concerned about the establishment of “in vitro” laboratory testing as the primary means of EHR testing. This represents a significant departure from the certification programs previously
recognized by the Department of Health and Human Services (HHS) and may create an unmanageable backlog that prevents qualified vendors from even entering the certification process. We are concerned that the time and expense for technology suppliers to travel to remote locations and re-create existing technology environments as a prerequisite to software testing will ultimately slow the availability and variety of certified products in the marketplace. This
requirement also significantly increases time, resource and expense burdens for testing and certification laboratories, as well as for providers.
To be clear, our concern is not with “in vitro” testing itself, but with such a testing model being the only one that is ONC-approved, especially in 2010 and 2011. In addition to utilizing this testing methodology, we urge ONC to support three other acceptable primary testing methods, including:
• Web-based or remote testing; • Testing at development sites; and • Testing at live customer sites.
Greater protections are needed if ONC revokes authorization of temporary bodies
As currently proposed, the regulations stipulate that the return of testing fees to an EHR vendor represents an adequate remedy if an ONC-ATCB’s accreditation is revoked. We disagree and recommend that health IT vendors that have achieved or applied for certification with this ONC-ATCB should be given the following considerations:
• If an EHR has been certified by a suspended ONC-ATCB, the certification should stand; • If the certification of the EHR is in progress, all fees should be repaid within five days,
and ONC or governing body should assist with the prioritization and reassignment to an alternate ONC-ATCB within 14 days; and
• If a health IT vendor has applied for certification with an ONC-ATCB but has not started the certification process, all fees should be repaid within five days.
Finally, if there is an insufficient number of testing and certification organizations, the loss of a single ONC-ATCB could significantly impede the certification process.
McKesson Comments on Proposed Establishment of Certification
Programs for Health Information Technology Page 4 of 6 II. Provisions of the Temporary Certification Program
D. Temporary Certification Program Application Process for ONC-ATCB Status
1. Application for ONC-ATCB Status
b. Types of ONC-ATCB Authorization
McKesson believes that all authorized certification bodies should have the capabilities to conduct certification testing of both EHR Modules and Complete EHRs. Additionally, McKesson supports the designation of certification bodies that would specialize in certifying EHR technologies for either eligible providers or hospitals, provided that an adequate number of organizations exist and that their availability could be assured for both ambulatory and inpatient technology certification.
E. ONC-ATCB Performance of Testing and Certification and Maintaining Good Standing as an ONC-ATCB
2. Authorization to Test and Certify EHR Modules a. Certification Criterion Scope
b. When Privacy and Security Certification Criteria Apply to EHR Modules
ONC requests comment on a potential approach that establishes when ONC-ATCBs should be required to test and certify EHR Modules against the privacy and security certification criteria adopted by the Secretary, in addition to the capability or capabilities the EHR Module may be specifically designed to provide.
McKesson recognizes the challenges in designing a single testing process to ensure the privacy and security of both Complete EHRs and EHR Modules. We believe that some certification criteria can not be easily applied to certain EHR Modules that meet only a small number of meaningful use requirements. As a result, we recommend the following:
• Privacy and security criteria should be included as part of the overall EHR certification process;
• All privacy and security criteria should apply only to certification of Complete EHRs, not individual EHR Modules;
• If components of a Complete EHR are sold as EHR Modules, then each module should be deemed certified as meeting required privacy and security criteria without further testing;
• ONC should establish a core set of criteria that all EHR Modules must address; and • The certification label should clearly indicate the privacy and security standards that have
been met.
4. The Testing and Certification of ‘‘Minimum Standards’’
McKesson recommends aligning testing and certification of minimum standards with the meaningful use stages. As we have previously suggested, the testing cycle should be no more than six months in duration. Therefore, we recommend that minimum standards be updated no more than annually. Providing stability and certainty in the industry will lead to timely and effective deployment of technology for providers and assurances of compliance for vendors and testing and certification bodies.
5. Maintaining Good Standing as an ONC-ATCB; Violations That Could Lead to the Revocation of ONC-ATCB Status; Revocation of ONC-ATCB Status
b. Type-2 Violations c. Proposed Revocation
McKesson Comments on Proposed Establishment of Certification
Programs for Health Information Technology Page 5 of 6 In response to ONC’s request for comments on potential revocation of an ONC-ATCB’s status for repeated Type-2 violations, McKesson recommends that health IT vendors that have achieved or applied for certification should be given the following considerations:
• If an EHR has been certified by a suspended ONC-ATCB, the certification should stand; • If the certification of the EHR is in progress, all fees should be repaid within five days
and ONC or governing body should assist with the prioritization and reassignment to an alternate ONC-ATCBs within 14 days; and
• If a health IT vendor has applied for certification with an ONC-ATCB, but has not started the certification process, all fees should be repaid within five days.
i. Opportunity to Respond to a Proposed Revocation Notice
McKesson suggests suspension of an ONC-ATCB’s operations only when a final revocation decision has been made and not in response to a proposed revocation notice. Additionally, if an ONC-ATCB is issued a proposed revocation notice, all health IT vendors engaged with that body should be notified within 48 hours by ONC.
d. Extent and Duration of Revocation under the Temporary Certification Program
If an ONC-ATCB’s accreditation is revoked and it does not issue a complete refund to health IT vendors previously certified or in process, McKesson recommends that ONC-ATCB be
suspended from the temporary certification process and eliminated from consideration for the permanent program. If ONC-ATCB does issue complete refunds to the health IT vendors, it should be allowed to apply for the permanent certification program only after making the required improvements.
6. Validity of Complete EHR and EHR Module Certification
In order to ensure greater clarity in the certification of Complete EHRs and EHR Modules, McKesson recommends that certification designations be stage-specific and expire only at the conclusion of eligibility for financial incentives under ARRA. A certified EHR supplier should be granted a use license for a uniform label that designates the meaningful use stage for which it is certified, such as Stage 1 Meaningful Use Certified. Use of such a designation would reflect modular or complete certification for use by eligible providers or hospitals as well as the stage for which the product is certified.
F. Sunset
McKesson recommends that ONC consider the following when establishing a sunset date for the temporary certification program:
• The conclusion of the temporary certification program should be tied to the date when providers can no longer qualify for Stage 1 incentives; and
• The temporary program should not be terminated until a fully operational certification program is in place for Stage 2, including all criteria, testing methods and sufficient testing and certification bodies to address the demand for the next stage.
Conclusion
McKesson applauds the efforts of ONC to establish certification programs for the purpose of testing and certifying health IT and appreciates its recognition of the industry’s need for certainty and stability in this process.
In summary, we recommend that the following be incorporated into the final temporary certification program rule:
McKesson Comments on Proposed Establishment of Certification
Programs for Health Information Technology Page 6 of 6 • Stage 1 certification should be valid for the entire period during which eligible providers
and hospitals can qualify for the associated financial incentives;
• Eligible providers should be allowed to determine the timing of upgrades to their certified EHR software, as long as they use EHR technology certified for their respective stage of meaningful use;
• The certification process should have the capacity, standardization and responsiveness to produce a robust marketplace for EHRs;
• Certification methodology should include remote, development and live site testing in addition to independent laboratory testing; and,
• In the event that ONC revokes the authorization of an ONC-ATCB, ONC will ensure notification and adequate remedies to impacted vendors.
We hope these comments provide constructive insights as ONC finalizes the temporary testing and certification requirements. Should you have questions or need further information, please contact me at (415) 983-8494 or [email protected].
Sincerely,
