March 15, Dear Dr. Blumenthal:

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1 March 15, 2010 David Blumenthal, MD, MPP National Coordinator Office of the National Coordinator for Health Information Technology (ONCHIT) Department of Health and Human Services ATTN: HITECH Initial Set Interim Final Rule Hubert H. Humphrey Building, Suite 729D 200 Independence Avenue, SW Washington, DC Dear Dr. Blumenthal: On behalf of the American Physical Therapy Association (APTA), I would like to thank you for the opportunity to comment on the Interim Final Rule (IFR) for the Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record (EHR) Technology as published in the Federal Register January 13, APTA is a professional association representing more than 74,000 physical therapists, physical therapist assistants, and students of physical therapy. 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. Physical therapists practice in a number of settings, are integral members of the healthcare team and offer a wealth of expertise that could be valuable to ONCHIT as it works to create certification criteria for EHR technology and implement the provisions of the American Recovery and Reinvestment Act (ARRA). While APTA recognizes that ONCHIT s interpretation of its legislative authority related to the EHR certification criteria is limited to physicians and eligible hospitals, we are committed to advancing the safety and quality of healthcare through health information technology (HIT) innovation. We are eager to work with ONCHIT as it develops the initial set of standards, implementation specifications, and certification criteria for EHR technology. We recognize that the use of HIT will ultimately improve quality of patient care. Over the last decade, APTA has promoted the importance of the use of health information technology to physical therapists and undertaken activities aimed at facilitating implementation of EHRs. These efforts include the addition of HIT educational tools on the APTA website, collaboration with internal and external stakeholders on HIT issues, partnership with Cedaron Medical, Inc to develop an EHR, called APTA CONNECT, and the development of National Outcomes Database for physical therapy. APTA CONNECT is specifically designed for physical therapists and has been an approved registry under the PQRI program for the past two years. In addition, we are planning improvements to APTA CONNECT to increase its clinical decision-making capabilities. The National Outcomes 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.

2 APTA is actively involved 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. We would like to thank ONCHIT for facilitating a transparent process consisting of numerous public hearings that have allowed stakeholders the opportunity to provide feedback. We recognize the tremendous effort that went into developing this IFR and the level of coordination required between Federal government agencies. Developing a process that allows eligible professionals and hospitals to increase the capabilities of their EHRs over three stages, as outlined in the IFR, is an important feature. We also appreciate the flexibility provided via the IFR and the meaningful use proposed rule developed by the Centers for Medicare and Medicaid Services (CMS) that allows for the certification of EHR technology, including complete EHRs and EHR modules, as this could provide for a greater level of participation while minimizing expense for providers. However, APTA has identified some areas of concern and a need for clarification on some of the provisions outlined in the IFR. Certification Criteria We are in support of many of the criteria adopted in the IFR, such as the capability to exchange key clinical information among providers and patient-authorized entities electronically, because we believe these criteria have the potential to improve patient care and eliminate unnecessary costs. As ONCHIT develops certification criteria, we urge ONCHIT to ensure that EHR products that are developed for both physicians and nonphysicians, such as physical therapists, be able to meet these criteria. We also urge ONCHIT to consider the adoption of standards that encourage submission of information from the EHR to a registry. Information from registries has many important uses including quality improvement, public health surveillance, and improved data sets for research. It is important that ONCHIT recognize the implications the adoption of EHRs by eligible professionals and hospitals will have for clinicians, such as physical therapists and postacute care providers, who are not eligible for the incentive payments. Those eligible for incentives will be making a significant investment to adopt EHRs and will expect to be able to exchange health information electronically with all other health care professionals, regardless of whether they qualify for incentive payments. Clearly, it is important for this information exchange to occur between all providers. However, it will be costly for providers who do not qualify for incentive payments to implement EHRs in their facilities, particularly small practices. We are concerned about certain criteria set forth in the IFR that would not be relevant for all provider types and may result in unnecessary costs for certain provider types. For 2

3 example, one objective for certification is the use of Computerized Provider Order Entry (CPOE). The criteria for this objective would require that the user be able to electronically record, store, retrieve, and manage orders including medications, laboratory, radiology/imaging, and provider referral. Electronic health records used by physical therapists in their practices should record, store, and retrieve orders for medications, laboratory, and radiology/imaging because this type of information is pertinent to help develop an accurate patient medical history and an appropriate plan of care. However, we are not sure what is meant by the term manage. If this term means to order or prescribe items such as medications or imaging, it could preclude physical therapists from meeting meaningful use and obtaining certification for EHR products. Physical therapists and other non-physician healthcare professionals currently have limited authority in many jurisdictions to prescribe medications, perform laboratory tests, or imaging procedures. As a result, an EHR product developed for physical therapists and other healthcare professionals limited by the law in these jurisdictions would not necessarily need to include the ability to manage such orders. We would encourage ONCHIT to consider scope of practice as it develops EHR certification criteria. Requiring unnecessary capabilities in EHRs products designed for physical therapists would only add to the financial and administrative burden of adopting certified EHR technology. The more capabilities built into an EHR product, the greater the cost. Additionally, requiring capabilities that will not be used could be seen as defeating the purpose of meaningful use. Inherent in the concept of meaningful use is leveraging the EHR technology to accomplish specific objectives such as improving patient care. If a specialty or provider type does not require or would not use certain capabilities, then it does not make sense to require it. In other words, a one size fits all process does not make sense. It would be better to allow providers the option of meeting the certification and meaningful use criteria based on the unique attributes of their profession. Many of the objectives and criteria identified in this regulation would be applicable to EHR products developed for physical therapists based on their scope of practice. For instance, it is within the scope of practice (and expected for payment purposes under public and private forms of insurance) that a physical therapist would be aware of the medical diagnosis of the patient as well as develop a rehabilitation or functional diagnosis related to the therapy services he or she would provide. In addition, a physical therapist would need to maintain patient demographics such as preferred language and insurance type and develop a problem list. These objectives demonstrate that physical therapists are capable of meaningful use and could develop an EHR product eligible for certification if the criteria for meaningful use and EHR certification took into consideration the needs of non-physician healthcare providers. Additionally, as mentioned in these comments, physical therapists already participate in initiatives related to the reporting of clinical quality measures including the PQRI program, another objective for the EHR certification process. 3

4 Capabilities vs Implementation Throughout the IFR developed by ONCHIT and the proposed rule developed by CMS it is clear that in Stage I certified EHR technology will be required to have certain capabilities but will not necessarily be required to fully implement such capabilities until later stages. APTA believes that the distinction between the capability to meet certain criteria and actual implementation of these capabilities is critical. Some providers who want to move forward with the EHR certification and meaningful use processes will not only be prepared to demonstrate that their EHR products contain certain capabilities but will also be able, at the early stages of this process, to show that they can implement these capabilities regularly to demonstrate full meaningful use. However, if implementation of these capabilities was required and the trading partners of these providers are not prepared to fully implement these capabilities, it could prevent them from meeting the criteria for the certification of EHR technology and preclude them from earning the incentive payments. Allowing for demonstration of the capability to perform certain functions during Stage I prevents those who have made an early effort to adopt HIT from being penalized while they wait for the rest of the industry to catch up. HIPAA provisions in HITECH Act The HITECH Act requires the Secretary of Health and Human Services to modify the HIPAA Privacy Rule to require that HIPAA covered entities account for disclosures related to treatment, payment, and healthcare operations made through an EHR. While we recognize this provision in mandated by law, APTA has serious concerns about the administrative burden this could place on healthcare providers and that such burdens may discourage adoption of EHRs. Additionally, regulations implementing the provisions related to these disclosures has not been issued. APTA would like to stress the importance of ensuring that as these regulations, and the related certification standards, are developed the Department of Health and Human Services (HHS) should ensure that these requirements do not result in an excessive administrative burden for providers. Implications of Allowing for Flexibility when Adopting Standards One issue which has been raised in meetings of the HIT Standards Committee is the burden of identifying multiple standards that would meet the criteria. For example, for the patient summary data package the IFR allows for the adoption of either the Continuity of Care Document (CCD) or Continuity of Care Record (CCR) as the standard for Stage I. While it appears this level of flexibility was incorporated to prevent eligible professionals and hospitals from having to make what could be costly and time consuming changes to their EHR software, in reality EHR products will need to include both CCD and CCR to foster interoperability. In other words, if one clinician who uses CCD wants to exchange health information with a second clinician using CCR, the EHR products adopted by these clinicians will need to include both CCD and CCR so the information can be exchanged. The more capabilities that are built into these EHR products the higher the cost for the purchaser, in this case a physician or hospital. 4

5 ONCHIT may want to reconsider provisions which allow for the use of multiple standards in light of the burden it could create. Physical Therapy as a Covered Professional Service Although physical therapists are not currently eligible professionals for purposes of incentive payments, physical therapy services are included in the statutory definition of covered professional services. 1 This inclusion indicates that Congress considered therapy services to be a key piece of clinical information in a complete patient record. In the section regarding incentives for eligible professionals, the HITECH Act defines covered professional services as follows: (A) COVERED PROFESSIONAL SERVICES. The term covered professional services has the meaning given such term in subsection (k)(3). 2 The subsection to which this definition refers, 1848(k)(3), states: (3) Covered professional services and eligible professionals defined. For purposes of this subsection: (A) Covered professional services. The term covered professional services means services for which payment is made under, or is based on, the fee schedule established under this section and which are furnished by an eligible professional. (B) Eligible professional. The term eligible professional means any of the following: (i) A physician. (ii) A practitioner described in section 1842(b)(18)(C). (iii) A physical or occupational therapist or a qualified speechlanguage pathologist. (iv) Beginning with 2009, a qualified audiologist (as defined in section 1861(ll)(3)(B)). 3 The additional practitioners referenced in 1842(b)(18)(C) include the following: (C) A practitioner described in this subparagraph is any of the following: (i) A physician assistant, nurse practitioner, or clinical nurse specialist (as defined in section 1861(aa)(5)). (ii) A certified registered nurse anesthetist (as defined in section 1861(bb)(2)). (iii) A certified nurse-midwife (as defined in section 1861(gg)(2)). (iv) A clinical social worker (as defined in section 1861(hh)(1)). 1 Social Security Act 1842(b)(18)(C), 1848(k)(3). 2 HITECH Act 4101(a); Social Security Act 1848(o)(5)(A). 3 Social Security Act 1848(k)(3). 5

6 (v) A clinical psychologist (as defined by the Secretary for purposes of section 1861(ii)). (vi) A registered dietitian or nutrition professional. 4 Thus, for the purposes of the HITECH Act, the definition of covered professional services includes physicians, physical therapists, and selected other health care professionals. 5 APTA consequently believes that the HITECH Act intends for certified EHR to have the capability of capturing all information about relevant covered professional services (as defined by 1848(k)(3)) for which payment is made under, or is based on, the Medicare fee schedule. This is a logical conclusion that can be illustrated by the value of including therapy services in EHRs in instances where such services were provided. Orders for therapy services, a record of medically necessary therapy services rendered, patient functional status, and outcomes are all pieces of key clinical information that constitute a complete patient record and allow for improved coordination of care. We therefore request that CMS revise the proposed rule to add relevant, setting-specific covered professional services to the examples of key clinical information in 42 C.F.R (d)(8)(i) and (e)(5)(i) that must be recordable and exchangeable as a Stage I meaningful use objective for eligible professionals, eligible hospitals, and critical access hospitals. 6 The revised regulations would read: (d) Additional Stage 1 criteria for EPs. An EP must meet the following objectives and associated measures:... (8) (i) Objective. Capability to exchange key clinical information (including documentation of relevant covered professional services specific to the setting) among providers of care and patient authorized entities electronically. (ii) Measure. Perform at least one test of certified EHR technology s capacity to electronically exchange key clinical information. (e) Additional Stage 1 criteria for eligible hospitals or CAHs. Eligible hospitals or CAHs must meet the following objectives and associated measures:... (5) (i) Objective. Capability to exchange key clinical information (for example, discharge summary, procedures, problem list, medication 4 Social Security Act 1842(b)(18)(C). 5 Social Security Act 1842(b)(18)(C), 1848(k)(3) (as incorporated in HITECH Act 4101(a); Social Security Act 1848(o)(5)(A)) Fed. Reg. 1844, 1857, 1865, 1869, 1994 (January 13, 2010). 6

7 Conclusion list, allergies, documentation of relevant covered professional services, and diagnostic test results) among providers of care and patient authorized entities electronically. (ii) Measure. Performed at least one test of certified EHR technology s capacity to electronically exchange key clinical information. I would like to thank you again for the opportunity to submit our comments on this IFR. We look forward to working with ONCHIT in the future as you continue to craft certification criteria for EHR technology that support meaningful use and improve patient care. If you have any questions, please contact Sarah Nicholls at or Sincerely, R. Scott Ward, PT, PhD President RSW:sn 7

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