April 9, 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 temporary 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 in order to implement the incentives payment programs. As we noted in our comments on meaningful use and certification standards, 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 database will consist of aggregated data from APTA CONNECT and other EHRs and that 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. Temporary Testing and Certification Program Requirement to Both Test and Certify Under the temporary certification program, any organization deemed an Authorized Testing and Certification Body (ONC-ATCB) must be able to both test and certify Complete EHRs and/or EHR Modules. ONCHIT acknowledges that requiring an ONC- ATCB to do both testing and certification will limit the number or organizations qualified to serve as an ONC-ATCB. While APTA recognizes the need to get this program initiated in a timely fashion, we are concerned that if a limited number of organizations are capable of conducting both testing and certification it may take a significant amount of time for an EHR developer to have their product tested and certified. This would have serious implications for eligible professionals or hospitals seeking to qualify for the incentive payment. We strongly recommend the Agency to allow more flexibility in the testing and certification process. Specifically, we recommend that the testing and certification process be split into two processes as it currently is under the permanent program. Requirement to Test and Certify Both Inpatient and Ambulatory Products As proposed, an ONC-ATCB will be required test and certify both ambulatory and inpatient EHRs. ONCHIT might find it beneficial to allow an entity applying for ONC- ATCB status to select whether it wants to test and certify an inpatient or ambulatory product as it allows the ONC-ATCB the option to elect to test and certify either a complete EHR or EHR module. By requiring ONC-ATCBs to test and certify both inpatient and ambulatory EHRs, ONCHIT may stifle competition and discover that there are not enough entities with such capability. We recommend that ONCHIT reconsider its proposal. Certification of EHR Modules for Interoperability ONCHIT seeks comment on whether the testing and certification process under the temporary program should include a process by which EHR modules are tested and certified not only as meeting the standards and criteria of the program but also to determine if one module is interoperable with another module. While we recognize the technical challenges of testing and certifying for the interoperability between modules, it could offer a very important mechanism by which the purchaser of the product, the eligible professional or eligible hospital, could verify that they are making a sound investment. In other words, if an eligible professional purchases an EHR module from a developer that has been tested and certified based on the standards and criteria 2
appropriate for that module only to find out it is not interoperable with other modules the professional has purchased it will increase the administrative and financial burden on the professional. It is not likely that a process to test and certify for the interoperability of EHR modules will be developed in the near future. However, if such a process is developed, either during the temporary program or during the permanent program, we encourage ONCHIT to make this a requirement. Location at Which Testing and Certification Takes Place According to the proposed rule, ONC-ATCBs must have the ability to test and certify Complete EHRs and EHR Modules at their facilities and a secondary location such as the developer s facility. Our understanding of how this testing and certification process currently takes place is that the testing and certification body either tests the product remotely or at the developer s location. Testing and certification does not usually take place at the testing and certification body s facility. Requiring ONC-ATCBs to develop a facility to accommodate the testing and 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 testing and certification take place at the ONC-ATCBs location. Instead, we think the ONC-ATCB should have the flexibility to test and certify EHRs at either their location, remotely, or at the developer s location. Sunset of the Temporary Program APTA recommends that if ONCHIT adopts its proposal to sunset the temporary program as soon as one entity is approved under the permanent program that clear communication and education is sent to providers to inform them of the transition to the permanent program. Revocation of ONC-ATCB Status In the proposed rule, ONCHIT states that if an ONC-ATCB s status is revoked, a developer that has already had its product certified by the unauthorized ONC-ATCB would have 120 days to find a new ONC-ATCB 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 temporary 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. In other words, ONCHIT estimates that approximately three entities will apply for ONC-ATCB status. Therefore, we encourage ONCHIT to include a provision extending the 120 day time frame if there are not a minimum of three ONC-ATCBs 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-ATCB 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 3
conspired with the ONC-ATCB to gain certification, the professional or hospital is left to find a new testing and certification organization. This passes along potentially significant and unwarranted costs to the provider. ONCHIT should require that a developer or ONC-ATCB found to be in violation of the proposals contained within the rule, when finalized, should reimburse the provider for the cost of the testing and certification process. If an ONC-ATCB has had repeated Type Two violations, ONCHIT should consider revoking its status, even if in each instance of a violation corrective action was taken. We note that ONCHIT included a requirement that an ONC-ATCB whose status has been revoked is required to refund money to any developer whose product is in the process of being tested and certified. We think this is an important requirement. However, as we stated above, we think the requirement to return funds should also be considered for those who have already been tested and certified by an ONC-ATCB whose status is ultimately revoked, especially considering the expense the developer will be forced to go through to get tested and certified a second time. Recertification When New Certification Criteria is Established Under the temporary certification program, a certified EHR product would need to be recertified whenever ONCHIT adopts new certification criteria. While this is a wholly reasonable requirement, it places some additional burden on the eligible professional or hospital to ensure the EHR product adopted meets the most current certification criteria. As a result, we would encourage ONCHIT to adopt as a requirement for this program that the developer notify the professional or hospital when a change requiring recertification is made to the certification criteria. ONCHIT should also consider the cost and administrative burden to professionals and hospitals for recertification. We would encourage ONCHIT to seriously consider any changes to the certification criteria that would require recertification and to only make these changes when truly necessary. ONCHIT should attempt to make multiple changes at one time versus single changes on a regular basis to reduce cost and ease the administrative burden. We also support ONCHIT s proposal to allow for differential certification. Allowing a developer to be tested and certified only of standards or criteria that are added or changed as opposed to having to complete the testing and certification process in its entirety will reduce the administrative burden and cost. 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