October 20, 2008 The Honorable Michael O. Leavitt Secretary U.S. Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201 Re: HIPAA Administrative Simplification: Modification to Medical Data Code Set Standards to Adopt ICD-10-CM and ICD-10-PCS Dear Mr. Secretary: On behalf of the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), the American Gastroenterological Association (AGA), and the American Society for Gastrointestinal Endoscopy (ASGE), representing over 16,500 physicians, scientists and other healthcare professionals dedicated to the care of patients with digestive disorders, we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) proposal to adopt ICD-10-CM and ICD-10-PCS for the coding of diagnoses and inpatient hospital procedures. While we are pleased with the Department s interest in ensuring the capacity of the ICD code set to accurately reflect current medical practice, we have significant concerns with the proposal. Physicians, hospitals, and other types of facilities and providers currently report diagnoses using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) Volumes 1 and 2. This rule proposes to replace ICD-9-CM Volumes 1 and 2 with ICD-10-CM. Currently, inpatient hospital procedures are reported using ICD-9-CM Volume 3. This rule proposes to replace ICD-9-CM Volume 3 with the International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD- 10-PCS). All HIPAA covered entities are required to use these codes when reporting diagnoses and hospital inpatient procedures need to be coded using HIPAA compliant transactions. This proposed rule will also establish an ICD-10 CM/PCS Coordination and Maintenance Committee to consider new codes and revisions to existing codes.
Page 2 of 7 Our comments are focused on the following issues: We strongly disagree with the rationale outlined in the proposed rule that is the basis for the transition from ICD-9 to ICD-10. We believe the impact analysis significantly underestimates the burden on physician practices to transition to the new coding system. We believe the timing for the update of standards for electronic transactions from version 4010 to 5010 is insufficient. We believe this proposal has the potential to cause substantial disruptions in timely claims processing, resulting in critical cash flow shortages to physician practices. Based on our assessment of the significant burden of the transition, we believe that the proposed timeline with an October 1, 2011 compliance date for all covered entities is unreasonable. We propose an alternative for the Department s consideration, namely to leave ICD-9 for physician use, to adopt a method of extending the code set to accommodate greater granularity, and to pursue a longer timeline for the transition of electronic standards to version 5010. Estimating the Burden of Adoption to ICD-10 ICD-9 has been in use in the US for approximately 27 years. During this time the coding set has been updated to reflect current medical practice. The Department has identified three key issues that it believes necessitates the need to update the coding system from ICD-9-CM to ICD-10-CM and ICD-10-PCS: ICD-9-CM is out of date and running out of space for new codes, ICD-10 is the international standard to report and monitor diseases and mortality, making it important for the US to adopt ICD-10 classifications for reporting and surveillance; and ICD codes are core elements of many health information technology (HIT) systems, making the conversion to ICD-10 necessary to fully realize benefits of HIT adoption. While we acknowledge that there may be some limitations to the current system, we disagree with the Department s perception of urgency of the need for the transition as depicted in the rule, as well as the overall general conclusion that ICD-9 needs to be replaced. ICD-9 continues to serve the needs of the gastroenterologist and those who provide care to patients with digestive disorders. We believe that any of the perceived limitations can be addressed through modifications to the current system. We favor this conservative approach because not only do we not see benefits from the proposed changes, but we believe they represent an enormous burden as well as significant risks to a health care practitioner. We were very disappointed to see that these issues were not accurately captured in the impact analysis. ICD-9 codes are a part of all aspects of a practice s business, both the administrative as well as clinical. As a result, this proposed change will impact everyone in the office including front-line staff, clinical staff, billing and coding, quality and operations personnel to the general administrative and support staff. The importance of acknowledging the enormity of this proposed
Page 3 of 7 transition must be considered when determining an appropriate and reasonable timeline for the transition, and we urge CMS to consider the issues we raise below. The impact analysis in the proposed rule was based on a number of assumptions that we believe are inaccurate. We were surprised to see that CMS expected that maintenance contracts would cover the cost of system upgrades. In our review of this issue with physicians who practice in academic and community settings throughout a variety of urban, suburban and rural settings, we found that this will not be the case. Few companies include this as part of their maintenance contracts. Not only does the cost of the upgrades need to be considered in the impact analysis, but we believe there is a serious concern with the capacity of the vendor community to meet the demands of upgrades during a very short period of time. Over 25% of gastroenterologists still practice in solo settings, and almost 50% of gastroenterologists practice in settings of 1-5 physicians. With a very short and compressed transition timeline, we fear that smaller practices may not be able to obtain the attention of vendors as easily as larger practices. These practices will be very vulnerable, likely pushed to the back of the line in a sellers market. Rural and geographically isolated practices may also face difficulties in finding vendors to upgrade their systems in a timely manner. Any implementation timeline must acknowledge the reality of the access to timely system upgrades for different practices. In our survey of practices, we have determined that the Department s estimate of the cost of training coders ($550/per coder) was woefully undervalued. Similarly, the number of physicians who would need to be trained in coding (1 in 10) was underestimated by an order of magnitude. We believe that each and every physician, nurse practitioner and physician assistant will require substantial training in ICD-10 principals and details, a process that will take significant time away from patient care at a substantial cost in lost revenue, fees for training and lost access for patients. We estimate that each health care practitioner will require several sessions of 2-4 hours apiece in order to become familiar with such a massive change in nomenclature. Superbill conversions will be an enormous burden for all practices. While the rule estimated that this conversion will take two hours, the reality is that it will take much longer and cost much more than the $50 estimated in the proposed regulations. It was also mentioned in the rule that many practices will receive superbills from their specialty societies. Even if a specialty society prepares a superbill for its membership, these serve only as starting points or templates for practices. Each practice will need to perform additional work in order to customize and finalize any template to meet their individual needs. Based on input from experienced clinicians and practice administrators, superbill changes of this complexity will take administrative staff time of at least 6 hours, clinician review of 4-6 hours by at least one physician within any given practice, costs of $500- $1,000 for editing and new batch printing, and the costs of disposal of unusable old superbills. In addition, while it is clear that not all physicians update their ICD-9 books every year; with ICD-10 they will have no choice. ICD-10 is a significantly more detailed and granular coding system than ICD-9. This granularity creates a need for greater documentation. In view of this greater complexity,
Page 4 of 7 CMS expects that there will be a temporary loss of productivity and a temporary spike in rejected claims but it expects the situation to stabilize after a period of time. We disagree with the conclusion that productivity losses and increase in rejected claims will be temporary. The complexity of ICD-10 is going to cause enormous confusion with providers and their staff. Even after overcoming the initial confusion, the complexity in ICD-10 will require a permanent increase in the level of documentation and a permanent increase in the time needed to code per case. This increase in documentation time and coding is not simply a matter of meeting some learning threshold of a new coding system and then things will return to what they once were. The inherent detail and complexity of the system will result in a permanent increase in time invested in documentation and coding. The utility of ICD-10 can only be achieved if providers apply it appropriately. To properly select ICD-10 diagnosis codes for the principal reason for an encounter AND for all pertinent co-morbidities, which the Department is appropriately utilizing in its severity-adjustment methodologies, would require 5 to 8 minutes PER VISIT, reflecting the fact that most smaller practices will rely on code-lookups from paper sources, not electronic search methods built into their work flow. For a physician seeing 20 patients a day, this implies up to 2 extra hours of work per day. This is not a realistic expectation, even for a period of implementation. The result will be physicians coding non-specific symptoms or the least specific minimally applicable diagnosis sufficient to get a claim paid; and a failure to code any co-morbid conditions. In practice, the utility of ICD-10 over ICD-9 will significantly diminish. It is not realistic, or appropriate for our overburdened healthcare system, for physicians to reduce scheduled visits per day in order to implement ICD-10. We have found that many practices have no choice but to reduce scheduled visits when implementing an electronic medical record for documenting their encounters. Any practice which has done this will attest to the disruption, economic loss and loss of access this has entailed. An additional problem is the substantial embedding of ICD-9 sets within the coverage edits and Local Coverage Determinations policies. The process of Medicare s MAC and DME contractors to work with their Carrier Advisor Committees to prepare, review and implement entirely new policies to accommodate ICD-10 will require substantial time and effort by payors, physicians and practice administrators. Failure to conduct this process appropriately will markedly disrupt the revenue cycle of practices and add enormous administrative burdens to practices where claims are denied. The rule also stated that ICD-10 implementation was necessary to maximize the potential of health information technology (HIT). We were confused by this and feel that these are separate issues. ICD-9 is nimble enough to take advantage of the benefits of HIT. We are concerned that with practices having limited resources to implement HIT, the costs of ICD-10 implementation may end up siphoning off resources that would have been otherwise used towards HIT improvements. To impose a complex and timeconsuming mandatory adoption of data standards and new code sets on vendors and users will likely cause many solo and small group physicians to postpone purchase or implementation of electronic medical records for their practice.
Page 5 of 7 We support a transition to the 5010 standard, which will bring benefits to practices and to third parties which receive health care electronic data. However, we strongly urge the Department to retain ICD-9 for physicians to code diagnoses. It should be feasible, where appropriate, to transition certain 5 th digit code sets to alphanumeric, e.g. a format of 123.4A(-Z), where there is greater granularity required within a subset of codes and where the current coding system has insufficient room for additions. This could be accomplished with minimal software changes and small retooling costs that could be easily accommodated within practices and by payors. There is no reason that cross-walks could not exist for translation of ICD-9 codes into the applicable ICD-10 code, for those parties requiring ICD-10 for data analysis. We urge CMS to consider all of the issues we raised above when finalizing the implementation plan for ICD-10. Proposal of Alternative Timeline for Transition While the discussion surrounding ICD-10 implementation has been occurring for years, the publication of the Notice of Proposed Rule Making (NPRM), which initiates the regulatory process, occurred on August 22, 2008. The proposed rule has a compliance date of April 2010 for an update to version 5010 and a compliance date of October 2011 for ICD-10. In the proposed rule, CMS emphasized that a single compliance date for both diagnosis and procedure codes made the most sense for all parties involved. CMS believes that this approach will reduce the burden on both providers and insurers who will be able to edit on a single new coding system. We have significant concerns with the timelines and propose an alternative timeline that we believe addresses the shortcomings of the proposed timeline. Our central concern is the timing between the update of version 5010 and ICD-10. As the current standards do not support ICD-10, a smooth transition to ICD-10 is dependent on the successful completion of the testing and compliance of version 5010. While it would be ideal to be able to identify April 2010 as the deadline for the update to version 5010, recent experience with updates and changes to administrative rules has illustrated that this is not always possible. The transition to 4010 has been fraught with delays as was the recently implemented NPI rules. Forcing strict timelines on these types of inherently complex system changes is just not possible. Our societies note several other concerns with the proposed timeline. Significant work needs to be done in the development and testing of systems for both the upgrade to version 5010 and the adoption of ICD-10. An assumption within the proposed timeline is that industry began working on system changes with the publication of the proposed rule. This is not the case. Given the long history of the debate surrounding ICD-10 implementation and a general sense of uncertainty regarding the process, industry will be waiting until the publication of the final regulations before devoting significant resources to the research and development of system changes. In reality, industry and providers will wait until the publication of the final regulations before committing significant resources to the transition and upgrades. We believe a more practical approach would be to propose a compliance date of 36 months after the publication of the final rule for the
Page 6 of 7 update to version 5010, and a compliance date of 24 months after version 5010 has been achieved for the transition to ICD-10. Finally we are concerned that the amount of time provided for the transition to ICD-10 is not sufficient. This is a major regulatory burden, for the resources and time needed for system upgrades, training of staff and development of internal systems and processes is significant. More time will be needed to ensure that all providers have sufficient time to transition to ICD-10, even if ICD-9 were to be retained for diagnosis code reporting of physician services. We strongly urge CMS to consider an alternative timeline that addresses the concerns we have outlined above. We recommend: a compliance date of 36 months from the publication of the final rule for the update to version 5010, and a compliance date of 24 months after the compliance of version 5010 has been achieved for the transition to ICD-10. A similar alternative timeline has been recommended to the Department by the National Center for Health Statistics (NCHS) and is being promoted by a broad spectrum of stakeholders. We believe that this alternative timeline will provide adequate transition time for industry, providers and other involved entities to allow for a smooth transition. We appreciate the opportunity to provide continued input on this important issue. Thank you once again for your attention to our comments on the proposed regulations to adopt ICD-10. If you have any questions or need additional information, please contact Erika Miller, Consultant to AASLD, at 202-484-1100, or emiller@dc-crd.com, Julie Cantor- Weinberg, Vice President, Public Policy, ACG, at 301-263-9000, or jcantorw@acg.gi.org, Anne Marie Bicha, Director of Regulatory Affairs, AGA, at 240-482-3223, or abicha@gastro2.org; and Randy Fenninger Consultant to ASGE, at 202-833-0007, or randy@marcassoc.com. Sincerely, Arthur J. McCullough, MD President, American Association for the Study of Liver Diseases Eamonn M. M. Quigley, MD, FACG President, American College of Gastroenterology
Page 7 of 7 Nicholas F. LaRusso, MD, AGAF Chair, American Gastroenterological Association John L. Petrini, MD, FASGE President, American Society for Gastrointestinal Endoscopy