May 18, Dear Director Verdugo,

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1 May 18, 2010 Director Georgina Verdugo U.S. Department of Health and Human Services, Office for Civil Rights Attention: HITECH Accounting of Disclosures Hubert H. Humphrey Building, Room 509F 200 Independence Avenue, SW Washington, DC Dear Director Verdugo, On behalf of the 74,000 members of the American Physical Therapy Association (APTA), I would like to thank you for the opportunity to respond to the request for information related to the accounting for disclosures for treatment, payment, and health care operations made through electronic health records (EHRs) as published in the Federal Register on May 3, APTA is a professional association representing physical therapists, physical therapist assistants, and students of physical therapy. As covered entities and users of EHRs, physical therapists will be significantly impacted by any requirement for an accounting of disclosures made via an EHR. Of particular concern is the administrative burden that would be placed on healthcare providers, such as physical therapists, to maintain an accounting of disclosures made for the purposes of treatment, payment, and health care operations. The extent of this burden will be largely determined by how any regulations implementing a requirement for an accounting of disclosures for treatment, payment, and health care operations define these terms. For instance, if disclosures for treatment purposes include activities such as obtaining a required referral or certification of a plan of care, this type of accounting may not prove to be extensively burdensome. However, if disclosure for treatment purposes includes informal discussions between providers regarding a patient s care, this could prove tremendously burdensome. For example, if a physical therapist treating a patient with a traumatic brain injury informally discusses with a fellow physical therapist who works in the same practice setting, the patient s characteristics, treatment plan, and initial outcomes of the treatment in order to better meet the patient s need, will this be a form of disclosure the physical therapist will be required to include in an accounting? Consider the number of such informal discussions which may occur on a daily basis. The regulatory process that first implemented the provisions of the Health Insurance Portability and Accountability Act (HIPAA) recognized the potentially significant administrative burden of accounting for disclosures for these three purposes and it was ultimately determined that it would be extremely burdensome for providers to manage such an accounting system. The burdens associated with accounting for disclosures made for treatment, payment, and healthcare operations are not self-imposed by the healthcare provider or, perhaps more importantly, uniform. Rather these obligations are imposed as a condition of payment established by the payer or state law. The variations in the conditions for payment can therefore lead to a variation in the need to account for disclosures based on payer or applicable laws. As a result, the burden is not only in

2 maintaining an accounting and the development of a mechanism to do so but the maintenance of effort to ensure that the accounting takes into consideration the requirements of a particular payer or law. For example, Medicare requires as a condition of payment for physical therapy services provided under the Part B benefit that a physical therapist obtain the certification of the physician for the plan of care developed by the physical therapist that maps the patient s course of treatment over the episode of care. Because this is a disclosure made for treatment purposes, this would likely be a disclosure for which an accounting must be made. However, a private insurer might not require the certification of the plan of care by a physician as a condition for payment. A variation in state law also raises concerns about the accounting of disclosure requirements. Some states require a referral from a physician for physical therapy services. If a physical therapist practices in two states, it could require accounting for the disclosure associated with a referral for the state which requires the referral while this same accounting for disclosure would not be required for the state in which a referral was not a requirement of law. Also important to consider is the burden of maintaining an accounting of each time a physical therapist submits a claim, or documentation to support the submission of the claim, for a particular patient. In many instances a physical therapist in an outpatient setting provides services to a patient multiple times a week as part of an established plan of care. This could require an audit log which captures payment and treatment disclosures multiple times per week per patient. If, through the regulatory process, the definitions of treatment, payment, and health care operations is so broad, and the subsequent administrative burden is highly increased, it could undermine the significant efforts the federal government has undertaken to encourage the adoption and use of EHRs. If providers will be required to account for these types of disclosures via an EHR but not via a paper record, they may very well elect to walk away from an EHR to avoid the administrative burden. This further speaks to the need for a delicate balance and careful consideration of how these terms will be defined and under what circumstances an accounting of disclosures for these reasons will be required. For physical therapy patients, an accounting of disclosures for one episode of care could be lengthy and confusing. For instance, consider a patient who is eligible for both Medicare and Medicaid. If a patient is seen by a physical therapist three times a week for six weeks, there could be at least 18 disclosures related to payment. Then consider the need for the certification of the plan of care, communication with the physician related to the ordering of related services or items such as power mobility equipment, and the disclosures currently required under HIPAA. It is not clear if this amount of information could truly benefit the patient. Again, determining under what circumstances an accounting of disclosures for treatment, payment, and healthcare operations is crucial to ensuring the information collected is meaningful and useful. 2

3 We would also like to address specific questions related to the request for information. 1. What are the benefits to the individual of an accounting of disclosures, particularly of disclosures made for treatment, payment, and health care operations purposes? While the sheer volume of information might be confusing or overwhelming to the patient, there are instances in which having access to an accounting of disclosures made for treatment, payment, or healthcare operations could be beneficial. For example, a patient may discover that in the course of collaboration between healthcare providers related to his or her care that incorrect information related to allergies or blood type was disclosed. Obviously, correction of this information is crucial in an effort to reduce medical errors and improve patient health outcomes. 5. With respect to treatment, payment, and health care operations disclosures, 45 CFR (e) currently provides the standard that an electronic health record system record the date, time, patient identification, user identification, and a description of the disclosure. In response to its interim final rule, the Office of the National Coordinator for Health Information Technology received comments on this standard and the corresponding certification criterion suggesting that the standard also include to whom a disclosure was made (i.e., recipient) and the reason or purpose for the disclosure. Should an accounting for treatment, payment, and health care operations disclosures include these or other elements and, if so, why? How important is it to individuals to know the specific purpose of a disclosure i.e., would it be sufficient to describethe purpose generally (e.g., for for treatment, for payment, or for health care operations purposes ), or is more detail necessary for the accounting to be of value? To what extent are individuals familiar with the different activities that may constitute health care operations? On what do you base this assessment? We agree that many of the elements listed above are an important part of the accounting for disclosure. Elements such as time, date, patient identification, user identification, a description of the disclosure, and to whom the disclosure was made would be helpful. However, a detailed description of the purpose of the disclosure could prove burdensome for the provider and an appropriate balance between patient needs and provider burden needs to be found. Perhaps the accounting could provide that further details as to the purpose of the disclosure will be made upon request by the patient. 6. For existing electronic health record systems: a) Is the system able to distinguish between uses and disclosures as those terms are defined under the HIPAA Privacy Rule? Note that the term disclosure includes the sharing of information between a hospital and physicians who are on the hospital s medical staff but who are not members of its workforce. 3

4 The ability to distinguish between a use and a disclosure would depend on the sophistication of the EHR and if the communication function is part of the software. For example, some EHR products track who performed activities, such as accessing information for payment purposes, and when (e.g. date, time). However if the individual disclosing the information prints a report and faxes it to another healthcare professional s office that might not be collected in the EHR. Depending on the capabilities of the EHR, a provider might be required to upgrade or replace the EHR product currently in use leading to additional financial and administrative costs. (c) If the system is able to distinguish between uses and disclosures of information, what data elements are automatically collected by the system for disclosures (i.e., collected without requiring any additional manual input by the person making the disclosure)? What information, if any, is manually entered by the person making the disclosure? The ability of an EHR product to distinguish between uses and disclosures would depend on a few factors. First, as mentioned above, how much of the process is incorporated into the software and under what circumstances is it recorded. For instance, if the information is used for claims submission it might be captured but if a record is printed and faxed, this type of disclosure or use might not be captured. The capability of the EHR product really helps to define cost and practicality. Second, if the program allows for storing specific user elements that would be required (we would want to know this early to provide vender the opportunity to add the data fields to be collected.) The end user would have to take the upfront time to set up the profile for each person that they would send information. 7. The HITECH Act provides that a covered entity that has acquired an electronic health record after January 1, 2009 must comply with the new accounting requirement beginning January 1, 2011 (or anytime after that date when it acquires an electronic health record), unless we extend this compliance deadline to no later than Will covered entities be able to begin accounting for disclosures through an electronic health record to carry out treatment, payment, and health care operations by January 1, 2011? If not, how much time would it take vendors of electronic health record systems to design and implement such a feature? Once such a feature is available, how much time would it take for a covered entity to install an updated electronic health record system with this feature? APTA is concerned that it might not be possible for this requirement to be met by We request that HHS consider extending this deadline. I would like to thank you again for the opportunity to submit these comments. We look forward to working with you as the regulations implementing the provisions of the Health Information for Economic and Clinical Health (HITECH) Act related to the accounting of 4

5 disclosures made via an EHR are developed. If you have any questions, please feel free to contact Sarah Nicholls at or Sincerely, R. Scott Ward, PT, PhD President RSW: sn 5