May 6, 2010 David Blumenthal, MD, MPP Office of the National Coordinator for Health Information Technology (ONCHIT) Attn: Certification Programs Proposed Rule Hubert H. Humphrey Building, Suite 729D 200 Independence Avenue, SW Washington, DC 20201 Dear Dr. Blumenthal: On behalf of the 74,000 members of the American Physical Therapy Association (APTA), I appreciate the opportunity to comment on the proposed rule to establish a permanent testing and certification program for health information technology published in the Federal Register on March 10, 2010. APTA members are physical therapists, physical therapist assistants, and students of physical therapy practicing in a variety of clinical settings including inpatient and outpatient hospitals, skilled nursing facilities, home health, rehabilitation agencies, comprehensive outpatient rehabilitation facilities, and private practice. Physical therapists are health care professionals with extensive clinical experience who examine, diagnose, and then prevent or treat conditions that limit the body s ability to move and function in daily life. As a result of the clinical expertise and training of physical therapists, they are integral members of the healthcare team and offer a wealth of expertise that could be valuable to ONCHIT as it works to create a testing and certification program for health information technology (HIT), including electronic health records (EHRs). APTA has been actively engaged in the process ONCHIT and the Centers for Medicare and Medicaid Services (CMS) has undertaken to develop a definition of meaningful use and certification criteria. As we noted in our comments on the meaningful use proposed rule and the certification standards interim final rule, APTA has been actively involved in an effort to improve healthcare quality and safety through the use of HIT. APTA has developed an EHR for use by physical therapists in partnership with Cedaron Medical, Inc and a National Outcomes Database. The EHR is specifically designed for physical therapists and has been an approved registry under the Physician Quality Reporting Initiative (PQRI) for the past two years. The database will consist of aggregated data from APTA CONNECT and other EHRs and will be used by clinical sites, APTA, and independent researchers to answer questions designed to improve the care of individuals receiving physical therapy services. In addition, APTA has been actively engaged in other initiatives that would benefit significantly from HIT adoption. Examples include Medicare s Physician Quality Reporting Initiative (PQRI) and Provider Value-Based Purchasing (PVBP) projects that have specific components related to EHRs; working with CMS and its contractors on payment reform for therapy services; preparing our
members for the transition to ICD-10 and the implementation of the revised Health Insurance Portability and Accountability Act (HIPAA) provisions. Establishment of a Temporary and Permanent Testing Program APTA appreciates ONCHIT recognition of an immediate need for a testing and certification process for the meaningful use incentives program. Because the first payments could be issued as early as October 2010, EHR developers and the provider community need adequate time to understand what is required of them and make any necessary adjustments to meet such requirements. ONCHIT s decision to accept applications for the temporary program immediately is an important step to ensure the rapid development of this program. We urge ONCHIT to finalize the proposals for both programs as soon as possible. We also appreciate that ONCHIT has made an effort to make many aspects of the temporary and permanent testing and certification programs the same to avoid confusion and ease the transition to the permanent program. Permanent Testing and Certification Program Separation of Testing and Certification Processes Unlike the temporary certification program, ONCHIT has proposed to separate the testing and certification processes under the permanent program. Separation of these processes will likely increase the number of entities with the capabilities of meeting the respective requirements of these two processes therefore increasing market competition. This market competition will likely reduce costs for EHR developers who may in turn pass these cost savings on to the healthcare providers who purchase their products. Additionally, with more entities in the market place, developers will likely experience shorter wait times to have their product tested and certified. For these reasons, we encourage ONCHIT to adopt its proposal to separate testing and certification between two entities. One Accreditation Body ONCHIT proposes to have only one accreditation body approved during a three year period. APTA is concerned that this will narrow the market which could prevent the development of accreditation processes that recognize the different capabilities and needs of different EHR products. For example, inpatient and ambulatory EHRs are recognized as being designed in different ways because the needs of the providers and facilities that use these products and the patients they serve are different. Additionally, products designed for health care specialists, such as physical therapists, are different from those developed for other health care providers. One accreditor may not be able to adequately address the unique needs of each specialty and/or health care provider. This could lead to a situation similar to that experienced by EHR developers during the period of time when only one certification body was recognized by the federal government. If multiple certification bodies are unable to meet the accreditation standards 2
established by this one body, providers will not be able to meet a key requirement of the meaningful use incentive payment program, the use of a certified EHR product. Additionally, if ONCHIT receives more applications for ONC-ACB status than it has initially projected in the proposed rule, one accrediting body may not be able to meet the demand for its services. As a result, we recommend that ONCHIT reconsider its decision to only approve one accreditor to accommodate for market demands and the different capabilities of EHR products. Surveillance In the proposed rule ONCHIT seeks comment on whether it should step in and revoke the certification status of an EHR if a pattern of unsatisfactory surveillance emerges and the ONC-ACB has not taken measures to evaluate the poor performance. While we agree that products that do not meet the certification criteria should have their certified status revoked to prevent purchasers from obtaining a product that will not help them achieve meaningful use and earn the incentive payment, this revocation only addresses one aspect of the problem. ONCHIT should also strictly enforce the Principles of Proper Conduct to ensure ONC-ACBs that are not doing their jobs properly are reprimanded accordingly. Certification of Both Inpatient and Ambulatory EHRs As noted in our comments on the temporary certification program, we have concerns about any requirement that would require an ONC-ACB to be able to test both inpatient and ambulatory EHRs. ONCHIT might find it beneficial to allow an entity applying for ONC-ACB status to select whether it wants to certify an inpatient or ambulatory product as it allows the ONC-ACB the option to elect to certify either a complete EHR or EHR module. By requiring ONC-ACBs to certify both inpatient and ambulatory EHRs, ONCHIT may stifle competition and discover that there are not enough entities with such capability. Considering ONCHIT s strong desire to stimulate market involvement, we recommend ONCHIT reconsider any such requirement. Authorized Certification Methods On a related note, we do not agree that certification should take place at the ONC-ACB facility primarily. Our understanding of how the certification process currently takes place is that the certification body either tests the product remotely or at the developer s location because certification does not usually take place at the certification body s facility. Requiring ONC-ACBs to develop a facility to accommodate the certification process at their location could lead to delays and increase the cost of the testing and certification process. It marks a departure from the current operating procedures of testing and certifying bodies. We recommend that ONCHIT reconsider its requirement to have the certification take place at the ONC-ACB s location. Instead, we think the ONC- ACB should have the flexibility to test and certify EHRs at either their location, remotely, or at the developer s location. 3
Revocation of ONC-ACB Status In the proposed rule, ONCHIT states that if an ONC-ACB s status is revoked, a developer that has already had its product certified by the unauthorized ONC-ACB would have 120 days to find a new ONC-ACB to certify the product. In ONCHIT s estimation, 120 days would be enough time to find a new entity to test and certify the product. However, we have concerns that if the permanent program is not functioning at ONCHIT s expected maximum capacity this 120 day period might not be enough time for a developer to repeat the testing and certification process. ONCHIT estimates that approximately six entities will apply for ONC-ACB status. We recommend ONCHIT to include a provision extending the 120 day time frame if there are not a minimum of six ONC-ACBs functioning at the time one entity s status is revoked if the developer can demonstrate a good faith effort that it has contacted and attempted to schedule a date to complete the testing and certification process. On a related note, it is not clear how the eligible professional or hospital will be impacted by an ONC-ACB s violation (either Type I or Type II). If the developer was not part of the process that led to an inappropriate certification but must still be recertified, the developer will likely pass the cost of this process onto providers. If the developer conspired with the ONC-ATCB to gain certification, the professional or hospital is left to find a new product and/or certification organization. This passes along potentially significant and unwarranted costs to the provider. ONCHIT should require that a developer or ONC-ACB found to be in violation of the proposals contained within the rule, when finalized, should reimburse the provider for the cost of the certification process. Differential Certification We appreciate ONCHIT s decision to only require the certification of the EHR for new criteria as meaningful use progresses. This process is referred to in the proposed rule as differential certification. For example, if an EHR has already been tested and certified based on the criteria for meaningful use, stage I and stage II maintains all of the criteria from stage I with the addition of five new criteria. It would be an unreasonable burden, both administratively and financially, for the EHR to undergo the entire testing and certification process again. Therefore, ONCHIT s proposes to allow for the certification of only the five new criteria at a time. APTA believes that this approach appropriately balances the need to ensure the EHR meets the new criteria while reducing administrative burden. We encourage ONCHIT to adopt its proposal to allow for differential certification. 4
Conclusion I would like to thank you again for the opportunity to submit our comments on this proposed rule. We look forward to working with ONCHIT in the future as you develop a testing and certification program that supports meaningful use and improves patient care. If you have any questions, please contact Sarah Nicholls at 703-706-3189 or sarahnicholls@apta.org. Sincerely, R. Scott Ward, PT, PhD President RSW: sn 5