Comment: Many commenters stated that the cost estimates on the effect of the proposed regulation on small businesses were understated or incomplete.
Response: The Department conducted a thorough review of potential data sources that would improve the quality of the analysis of the effects on small business. The final regulatory flexibility analysis below is based on the best data available (much of it from the Small Business Administration) and represents a reliable estimate for the effects on small entities in various segments of the health care industry. It is important to note that the estimates are for small business segments in the aggregate; the cost to individual firms will vary, perhaps considerably, based on its particular circumstances.
Comment: The cost of implementing privacy regulations, when added to the cost of other required HIPAA regulations, could increase overhead significantly. As shown in the 1993 Workgroup on Electronic Data Interchange (WEDI) Report, providers will bear the larger share of implementation costs and will save less than payors.
Response: The regulatory flexibility analysis below shows generally the marginal effect of the privacy regulation on small entities. Collectively, the HIPAA administrative standards will save money in the health care system. As important, given the rapid expansion of electronic commerce, it is probable that small entities would need to comply with standards for electronic commerce in order to complete effectively, even if the standards were voluntary. The establishment of uniform standards through regulation help small entities because they will not have to invest in multiple systems, which is what they would confront if they system remained voluntary.
Comment: One respondent believed that the initial and ongoing costs for small provider offices could be as much as 11 times higher than the estimates provided in the proposed rule. Other commenters stated that the estimates for small entities are "absurdly low".
Response: Although there were a number of commenters highly critical of the small business analysis, none provided alternative estimates or even provided a rationale for their statements. Many appeared to assume that all costs associated with medical record confidentiality should be estimated. This represents a misunderstanding of the purpose of the analysis: to estimate the incremental effects of this regulation, i.e., the new costs (and savings) that will result from changes required by the regulation. The Department has made substantial changes in the final small entities analysis (below), reflecting policy changes in the final rule and additional information and data collected by the Department since the issuance of the proposal last fall. We believe that these estimates reasonably reflect the costs that various types of small entities will experience in general, though the actual costs of particular providers might vary considerably based on their current practices and technology.
Comment: A respondent expressed the belief that small providers would bear a disproportionate share of the regulation's administrative burden because of the likelihood of larger companies incurring fewer marginal costs due to greater in-house resources to aid in the legal and technical analysis of the proposed rule.
Response: As explained below, the Department does not agree with the assertion that small entities will be disproportionately affected. Based on discussions with a number of groups, the Department expects many professional and trade associations to provide their members with analysis of the regulation, including model policies, statements and basic training materials. This will minimize the cost for most small entities. Providers that use protected health information for voluntary practices, such as marketing or research, are more likely to need specific legal and technical assistance, but these are likely to be larger providers.
Comment: Several commenters took issue with the "top-down" approach that we used to estimate costs for small businesses, believing that this methodology provided only a single point estimate, gave no indication of the variation around the estimate, and was subject to numerous methodological errors since the entities to which the numerator pertained may not have been the same as the denominator. These respondents further recommended that we prepare a "bottom-up" analysis using case studies and/or a survey of providers to refine the estimates.
Response: The purpose of the regulatory flexibility analysis is to provide a better insight into the relative burden of small businesses compared to larger firms in complying with a regulation. There may be considerable variance around average costs within particular industry sectors, even among small businesses within them. The estimates are based on the best data available, including information from the Small Business Administration, the Census Bureau, and public comments.
Comment: A commenter stated that the proposal's cost estimate does not account for additional administrative costs imposed on physicians, such as requirements to rewrite contracts with business partners.
Response: Such costs are included in the analysis below.
Comment: Numerous public comments were directed specifically at the systems compliance cost estimates for small businesses. One respondent maintained that the initial upgrade cost alone would range from $50 thousand to more than $1 million per covered entity.
Response: The cost estimates for systems compliance varied enormously; unfortunately, none of the commenters provided documentation of how they made their estimates, preventing us from comparing their data and assumptions to the Department's. Because of concern about the costs in this area, however, the Department retained an outside consultant to provide greater expertise and analysis. The product of this effort has been incorporated in the analysis below.
Comment: One commenter stated that just the development and documentation of new health information policies and procedures (which would require an analysis of the federal regulations and state law privacy provisions), would cost far more than the $396 cited in the Notice of Proposed Rulemaking as the average start-up cost for small businesses.
Response: As explained below in the cost analysis, the Department anticipates that most of the policies and procedures that will be required under the final rule will be largely standardized, particularly for small businesses. Thus, much of the work and cost can be done by trade associations and professional groups, thereby minimizing the costs and allowing it to be spread over a large membership base.
Comment: A number of comments criticized the initial estimates for notices, inspection and copying, amendments and correction, and training as they relate to small businesses.
Response: The Department has made substantial revisions in its estimates for all of these areas which is explained below in the regulatory flexibility analysis.
Comment: One commenter noted that there appeared to be a discrepancy in the number of small entities cited. There is no explanation for the difference and no explanation for difference between "establishments" and "entities."
Response: There are discrepancies among the data bases on the number of "establishments" and "entities" or "firms". The problem arises because most surveys count (or survey) establishments, which are physical sites. A single firm or entity may have many establishments. Moreover, although an establishment may have only a few employees, the firm may have a large number of workers (the total of all its various establishments) and therefore not be a small entity.
As discussed below, there is some discrepancy between the aggregate numbers we use for the regulatory impact analysis (RIA) and the regulatory flexibility analysis (RFA). We concluded that for purposes of the RFA, which is intended to measure the effects on small entities, we would use Small Business Administration data, which defines entities based on revenues rather than physical establishments to count the number of small entities in various SIC. This provides a more accurate estimate of small entities affected. For the RIA, which is measuring total effects, we believe the establishment based surveys provide a more reliable count.
Comment: Because small businesses must notify patients of their privacy policies on patients' first visit after the effective date of the regulation, several commenters argued that staff would have to search records either manually or by computer on a daily basis to determine if patients had been seen since the regulation was implemented.
Comment: A commenter stated that the definitions of small business, small entity, and a small health plan are inconsistent because the NPRM includes firms with annual receipts of $5 million or less and non-profits.
Response: The Small Business Administration, whose definitions we use for this analysis, includes firms with $5 million or less in receipts and all non-profits as "small businesses." We recognize that some health plans, though very large in terms of receipts (and insured lives), nonetheless would be considered "small businesses" under this definition because they are non-profits. In the final regulatory flexibility analysis, we generally have maintained the Small Business Administration definitions because it is the accepted standard for these analyses. However, we have added several categories, such as IRBs and employer sponsored group health plans, which are not small entities, per se, but will be effected by the final rule and we were able to identify costs imposed by the regulation on them.
Comment: The same commenter wanted clarification that all non-profit organizations are small entities and that the extended effective date for compliance applies to them.
Response: For purposes of the regulatory flexibility analysis, the Department is utilizing the Small Business Administration guidelines. However, under HIPAA the Secretary may extend the effective compliance date from 24 months to 36 months for "small health plans". The Secretary is given the explicit discretion of defining the term for purposes of compliance with the regulation. For compliance purposes, the Secretary has decided to define "small health plans" as those with receipts of $5 million or less, regardless of their tax status. As noted above, some non-profit plans are large in terms of revenues (i.e., their revenues exceed $5 million annually). The Department determined that such plans do not need extra time for compliance.
Comment: Several commenters requested that "small providers" [undefined] be permitted to take 36 months to come into compliance with the final regulation, just as small health plans will be permitted to do so.
Response: Congress specified small health plans, but not small providers, as needing extra time to comply. The majority of providers affected by the regulation are "small", based on the SBA definitions; in other words, granting the delay would be tantamount to make the effective date three years rather than two. In making policy decisions for the final regulation, extensive consideration was given to minimizing the cost and administrative burden associated with implementing the rule. The Department believes that the requirements of the final rule will not be difficult to fulfill, and therefore, it has maintained the two year effective date.