hipaa unique identifiers rule

As stated in the previously published impact analysis in 65 FR 50312, we do not have sufficient information to provide estimates of the impact of the administrative simplification standards on local governments. Health care providers that are covered entities must begin to use NPIs in standard transactions no later than 24 months after the effective date of this regulation; and they must ensure that their subparts, if assigned NPIs, do the same. Response: As discussed in section II. Apply through a web-based application process. Covered health care providers must require their business associates, if they use them to conduct standard transactions on their behalf, to use their NPIs and the NPIs of other health care providers and subparts appropriately as required by those transactions. Only to individuals and entities that furnish health care. Response: As stated earlier in this section, billing services do not meet our regulatory definition of health care provider and, therefore, will not be eligible for NPIs. HHS may need to communicate with a health care provider at any time during the implementation period or after. Credit card orders can also be placed by calling the order desk at (202) 512-1800 or by faxing to (202) 512-2250. The number of health care providers needing to update their data in any year is a percentage of the number of health care providers. We would estimate that for health care providers, the NPI would represent 5 percent of the costs and 10 percent of the savings. (b) Collect and maintain information about each health care provider that has been assigned an NPI and perform tasks necessary to update that information. It is also possible that the subparts may not align precisely with the designated health care components. Health care providers who are not covered entities under HIPAA, but who prescribe medications, order services for patients, refer patients to other providers, or who otherwise need to be identified in HIPAA standard transactions that are conducted by other health care providers, will need (but are not required) to obtain NPIs so that those other providers can use that number to identify them in HIPAA standard transactions. The NPS will be designed to be easy to use. The remaining 39 entities listed in the data dictionary processed fewer than a million electronic transactions per month. If a health care provider agrees to permit an EFIO to apply for the NPI, the EFIO will provide instructions regarding the information that is required to complete the process. Response: Work on the millennium is complete. The large number of members of some groups and the frequent moves of individuals among groups would make national maintenance of group membership burdensome and expensive. Data that are not required for enumeration or legitimate administrative purposes should not be collected. Another commenter suggested that HHS consider electronic data interchange (EDI) addresses for inclusion in the NPS. The name suffix is a generation-related suffix, such as Jr., Sr., II, III, IV, or V, The abbreviations for professional degrees or credentials used or held by the provider, if the provider is an individual. Because they are health care providers, medical students, interns, residents, and fellows are eligible for NPIs. Because EDI addresses are not standardized at this time, they will not be included in the NPS. 23nY#aAvw?83$z?qCWiFf -hugwZ(8cj(5@ + On the other hand, the concepts of ownership, control, and structure are of no significant value or importance in determining the health care providers that may be eligible to obtain NPIs, which is why those concepts are not discussed in this final rule. This regulation is expected to address all but perhaps the last concern of these commenters. The NPS will be designed, wherever feasible, to take advantage of technologies that will make its operation efficient. A health care provider that is a covered entity must obtain, by application if necessary, an NPI from the NPS. Response: We agree in concept with the recommendations made by WEDI. There also may be situations where a new NPI is necessary because the current NPI was used for fraudulent purposes. There are many advantages in using a single entity, which were discussed in the comment and response section above. website belongs to an official government organization in the United States. Comments were strong in suggesting that the NPI be an all-numeric identifier, be 10 positions in length, and include a check-digit in the 10th position. Many of these commenters believed that costly dual systems would have to be maintained (one for health care providers with NPIs and one for those without) and confusion in the marketplace would be created if paper processors did not also receive NPIs within the same time frame as electronic processors. If the health care provider is similar (but not identical) to an already-enumerated health care provider, the situation will be investigated. Secure .gov websites use HTTPS We recognize that mapping between DEA numbers and NPIs is very important for the conversion of retail pharmacy files during NPI implementation. of the preamble should be kept in mind in reading this section. They are eligible to receive NPIs because they are health care providers. 2021-2031, and sec. Enabling the receipt of Web-based applications and the limited validation will make the cost of enumerating a health care provider far less than enrolling a health care provider in a health plan. Our data dissemination strategy and the process by which it will be carried out will be described in detail at a later date and published in a notice in the Federal Register. The majority of commenters believe that, as a result of the removal of the data elements not needed for enumeration and communication, the NPS would be easier and less expensive to maintain and would operate more efficiently. It can be an SSN, assigned by the Social Security Administration, or an IRS Individual Taxpayer Identification Number (ITIN), assigned by the IRS, or an EIN, assigned by the IRS. Response: We expect that the update process will be designed in a way that will allow the system to process updates within a reasonable timeframe (for example, 10 business days from receipt). Standard unique health identifier for health care providers. HIPAA Code Sets Some commenters pointed out that Federal and Medicaid health plans do not maintain all of the information about health care providers that would be required to assign NPIs; thus, if those health plans' prevalidated health care provider files were to be used to populate the NPS, costs might exceed $50 per health care provider in order to obtain the missing information needed to assign NPIs. In January 2004, HHS published a final rule in which the Secretary adopted the NPI as the standard unique health care provider identifier and adopted requirements for obtaining and using the NPI. In section II. The new identifier, known as the National Provider Identifier (NPI), did not have the limitations of the existing identifiers, and it met the criteria that had been recommended by the Workgroup for Electronic Data Interchange (WEDI) and the American National Standards Institute (ANSI). In the National Provider System Data Elements table at the end of this section, repeating fields are noted as such. The Employer Identifier was adopted as that standard effective July 30, 2002. Comment: Several commenters suggested that data element names, qualifiers, and definitions be consistent with the X12N HIPAA data dictionary. Another commenter believes it to be even higher. (2) Applying for an NPI is a one-time burden on a health care provider. Response: This comment will be considered in the design of the NPS; if it is determined to be feasible, this access will be made available. The NPS will not establish location codes. As stated in section II. Otherwise, in order to be assigned NPIs, covered health care providers must apply for NPIs. We computed the weighted average of the percentages of health care providers that would require updates that were used in the proposed rule (using 15 percent for these health care providers). Any inconsistencies or errors that are present in health care provider files that are considered to be used to populate the NPS would be imported into the NPS as part of that process. Communicate to the NPS any changes to its required data elements in the NPS within 30 days of the change. Seventy-two percent of all pharmacies, 88 percent of medical laboratories, 100 percent of dental laboratories, and 90 percent of durable medical equipment suppliers are assumed to be small businesses as well. The NPS was intended to be designed so it could be used by other Federal and State agencies, and by private health plans, if deemed appropriate, to enumerate their health care providers that did not participate in Medicare. Information about this document as published in the Federal Register. Therefore, we find good cause to waive the notice and comment procedure and the 30-day Start Printed Page 3436delay in the effective date as being contrary to the public interest. This table of contents is a navigational tool, processed from the Unique Identifiers Rule The HIPAA unique identifier rule is part of HIPAA administrative simplification regulation and defines how unique identifiers work for covered entities while making HIPAA transactions. The definition of health care clearinghouse specifically lists these entities as examples of health care clearinghouses. After publication of the May 7, 1998 proposed rule, we reexamined the existing Medicare provider files in anticipation of using them to populate the NPS. We asked how the NPS could be designed to make it useful, efficient, and low-cost. Q: How do I submit a HIPAA complaint in writing for possible noncompliance with the transaction, operating rule, code set, or unique identifier rules? Bulk enumeration would eliminate the need for those health care providers to apply for NPIs. Until the ACFR grants it official status, the XML National Provider Identifier (NPI) Below are our estimates for the annual burden hours associated with these requirements. Other comments regarding States reflected the need for clarification as to when State agencies were subject to the standards. The NPS will collect the same data from group health care providers as it will collect from organization health care providers. Populating the NPS with existing files that lack certain required NPS data elements increases the cost of enumeration because additional resources would be needed to collect the missing information. C. 2. of this preamble, Data Elements and Data Dissemination.. At this time, bulk enumeration of health care providers is not expected to occur. All costs of NPS development and operation (which include the costs of enumerating health care providers and maintaining their information in the NPS, and the costs of disseminating NPS data to the health care industry and others, as appropriate) are Federal costs. National Provider Identifier (NPI) Final Rule Published - The Final Rule adopting the HIPAA standard unique health identifier for health care providers was published in the Federal Register on January 23, 2004. It is possible and, indeed, likely that subparts as described earlier in this preamble may be health care components of a hybrid entity. Response: We find the stated advantages of a 10-position numeric identifier convincing. It may require considerable time to update and reformat these files for NPS purposes. They will also have to obtain and use the NPIs of other health care providers if those NPIs are needed on those transactions. The May 7, 1998, proposed rule proposed the compliance dates for the standard unique health identifier for health care providers. Section 1173(b) of the Act requires the Secretary to adopt standards providing for a standard unique health identifier for each individual, employer, health plan, and health care provider for use in the health care system and to specify the purposes for which the identifiers may be used. We expect to make routinely available, via the Internet and on paper, HHS-formatted data sets that will contain general identifying information, including the NPI, of enumerated organization health care providers and subparts of such health care providers (as described earlier in this preamble). Removal of a health care provider's records at some point after the health care provider's death is reasonable, as long as there are guarantees that the health care provider's NPI will never be used by another health care provider or re-issued to another health care provider. When a user retrieves the NPS record of a health care provider, either of those fields may contain data. We believe that these costs will be offset by future savings (see the impact analysis of 65 FR 50350). The message will request that the problem be resolved and the information be resubmitted. Some commenters believed that usage fees should not be limited to the cost of producing the data but should be linked to the costs and value of establishing and using the NPS. The majority of commenters did not support the use of the SSN as the standard unique health identifier for health care providers for individuals. A few examples of these health care providers are registered nurses employed by hospitals or other facilities, X-ray and other technicians, and dental hygienists. Covered entities (except for small health plans) must begin using the NPI in standard transactions no later than 24 months after the effective date. We solicited comments on the inclusion and exclusion of those data elements and the inclusion of other data elements that the public believed appropriate. We will be proposing standards for the unique health plan identifier and claims attachments. These costs are characterized as follows: software conversion, cost of automation, training, implementation, and cost of documentation and implementation guides. Implicit in enumeration are the costs of software, licenses, salaries, training, and overhead. The table does not include systems maintenance or similar fields. Secs. Specifically, we codified the definition of health care provider at 45 CFR 160.103. The NPS will contain a date (Last update date) that will indicate when a change was made to a health care provider's record. 1320d-2 (note)). A: The NPI final rule defines organization health care providers as providers who are not individuals (persons). The organization health care provider is also responsible for applying for NPIs for its subparts or for instructing its subparts to apply for NPIs themselves. While each standard may not have a significant impact on a substantial number of small businesses, the combined effects of all the standards are likely to have a significant effect on a substantial number of small businesses. The NPI is a 10-position, intelligence-free numeric identifier (10-digit number). A modification to the NPI format would be accomplished through rulemaking. The address where service was furnished (if different from the billing or pay-to provider's address and if not at the patient's home) is accommodated in the X12N 837 Professional Claim in the Service Facility Location loop. Data in addition to those which are published in the Unique Physician Identification Number (UPIN) Directory should not be released. Comment: Several commenters stated the estimate that 5 percent of health care providers participating in Federal health plans and Medicaid would have updates each year is conservative and that the number is more like 12 to 15 percent. A lock (LockA locked padlock) or https:// means youve safely connected to the .gov website. Some commenters asked if on-line access charges would be based on time or on a per file access basis. A new NPI will not be required when there is a change in an organization health care provider's name, Employer Identification Number, address, Healthcare Provider Taxonomy classification, State of licensure, or State license number. Many of these components or separate physical locations are separately certified or licensed by States as health care providers. Covered health care providers and all health plans and health care clearinghouses use the NPIs in the administrative transactions adopted under HIPAA. One of those considered was the DEA number. A covered health care provider that uses one or more business associates to conduct standard transactions on its behalf must require its business associates to use its NPI and other NPIs appropriately on standard transactions that the business associate conducts on its behalf. Some health care providers, particularly ones that do not do business with large health plans, may be resistant to obtaining NPIs and providing data about themselves to a national database. The NPS will ensure the uniqueness of the NPI by assigning only one NPI to a health care provider with a distinct string of data in the NPS. The NPI will not contain intelligence about the health care provider. L. 104-191, which was enacted on August 21, 1996, required the adoption and use of a standard unique identifier for health care providers, CMS and the other project participants accepted the NPI as the standard unique health identifier for health care providers. Should the NPS Capture Practice Addresses of Health Care Providers? (Privacy Act-protected data are those that reveal or could reveal the identity of a specific individual when used alone or in combination with or linked to one or more data elements.). Response: We agree with the comment and have replaced the term medical care with health care in our discussion of individual and organization health care providers. Response: The NPI application forms will contain a statement whereby the signer attests to the accuracy of the information on the application. Summary of Effects on Various Entities, Comments and Responses on NPS Data Structure Concepts. States continue to hold memberships on the National Uniform Claim Committee and the National Uniform Billing Committee, and continue to be represented in the X12N and Health Level Seven standards development organization workgroups and committees. Therefore, it is appropriate to discuss these concepts and their relationship, if any, to the assignment of NPIs as established by this final rule. Response: In most situations, a health care provider's pay-to address is its mailing address. Response: WEDI is named in the Act as an external group with which the Secretary must consult in certain circumstances in standards development. 264 of Pub. Comment: Many commenters stated that all health care providers should be able to obtain NPIs, whether they conduct health care transactions electronically or on paper. For providers with more than one physical location, this is the primary location. Health care providers may apply for NPIs beginning on the effective date of this final rule. C. 2. of this preamble, Data Elements and Data Dissemination, we describe the information that we expect will be collected and stored in the NPS. The(se) entity(ies) would have direct access to the NPS and to all the data elements in the NPS; and, (2) Level IITo the general public. In FY 2007, we estimate there will be 1,157,821 covered health care providers to be assigned NPIs. For purposes of this rule, we consider group health care providers to be organization health care providers. Because health care providers must keep health plans apprised of updates to their data, the requirement that covered health care providers apprise the NPS of updates should not be a significant burden on those health care providers. The NAICS made several important changes to the Health Care industries listed in the SIC System: it revised terminology, established a separate category (Health Care and Social Assistance) under which many health care providers are located, and increased the number of Health Care industries to 30 NAICS industries from 19 Health Services SIC industries. In addition, data integrity problems have been identified, and reformatting some of the Medicare files to make them consistent with the structure of the NPS may be more difficult than first expected. A. These factors make a single enumerator the more efficient option. The NPS will run various edits and consistency checks and will check for duplicate records to ensure that only one NPI is assigned to a health care provider and that the same NPI is not assigned to more than one health care provider. These covered health care providers must obtain an NPI and use this number in all HIPAA transactions. However, this final rule will affect small businesses, such as small health care providers, health plans, and health care clearinghouses, in much the same way as it affects large businesses. Comment: Some commenters expressed concern that the professional claim or equivalent encounter information transaction be able to accommodate address or location information associated with billing, pay-to, and furnishing health care providers. 7500 Security Boulevard, Baltimore, MD 21244, HHS ADOPTS A HIPAA STANDARD FOR A UNIQUE HEALTH PLAN IDENTIFIER, http://www.cms.gov/apps/media/press_releases.asp. Comment: We received many comments concerning the length of time a health care provider should be allowed before it must notify the NPS of changes to its NPS data. In the case of the NPI, covered entities will have to convert because this identifier is not in use presently. Be supported by an ANSI-accredited standards developing organization or other private or public organization that will ensure continuity and efficient updating of the standard over time. For example, we have found that some Medicaid and Medicare provider files do not contain all of the information required to assign an NPI. We continue to use the impact analysis previously referenced as the set of total costs and savings. The proposed rule that proposed the NPI as the standard unique health identifier for health care providers was published prior to the signing of that Executive Order. Some of those revisions in size standards affected some of the entities that are considered covered entities under this final rule. Health plans, health care clearinghouses, and covered health care providers are required to implement the NPI. If it does not, and does not provide other services or supplies that bring it within the definition of health care provider, it would not be a health care provider under HIPAA, and would not be eligible to receive an NPI. The term payer is an industry term and may include a health plan, but may also designate other entities that do not meet the definition of a health plan, such as a third party administrator (TPA). Sign up to get the latest information about your choice of CMS topics in your inbox. Will require less change for systems that currently use a numeric identifier. The general public would be able to request and receive selected data elements, excluding those that are protected by the Privacy Act. If they do not transmit any health data in connection with a transaction for which the Secretary of Health and Human Services has adopted a standard, they are not covered health care providers under HIPAA and are not required to obtain NPIs. Because the compliance dates cover such an extended period of time, we will estimate part of the overall cost and savings for health plans and health care providers that can be attributed to the NPI. Start Printed Page 3444. a. The most significant benefit of the HPID and the OEID is that they will increase standardization within the HIPAA standard transactions. For the estimated annualized burden, we have divided the number of these health care providers by 2 to estimate the annual burden. We agree that the NPS should collect the same data for group and organization health care providers. The volume of updates at any given time may impact system performance. For example, the transaction and code set standards were published in 2000 and must be implemented by October 2003. In this regard, we encourage all health care providers to obtain NPIs and, when requested, to disclose their NPIs to covered entities that need them for inclusion on health care transactions. They would incur implementation costs for converting systems, especially those that generate electronic claims, from current health care provider identifiers to the NPI. This publication is the most comprehensive data directory of its kind that we could find. This process involves reviewing and validating a Start Printed Page 3447paper application containing far more information than will be collected and validated on the NPI application/update form. We proposed that we would charge fees for data and data files, but that the fees would not exceed the costs of dissemination (63 FR 25338). 1. If not, an NPI will be assigned. For purposes of being assigned NPIs, health care providers will be asked voluntarily to supply their SSN or IRS ITIN (if they are individuals who would be assigned an Entity type code 1 NPI), or will be required to supply their EIN (if they are organizations that would be assigned Entity type code 2 NPIs). We have decided to codify the final rules in 45 CFR part 162 instead of part 142. However, as explained in section II. This will be a more significant implementation workload for larger organization health care providers, such as hospitals, that will have to capture the NPIs for each health care provider practicing in the hospital if those health care providers need to be identified on hospital claims. We believe it is appropriate and necessary for the health care providers to notify the NPS of changes in their required NPS data, but, given limits on our statutory authority, we can require such notification only of covered health care providers. The interim final rule is the first installment of a larger rule, known as the Enforcement Rule, the rest of which is to be proposed at a later date. Also, you can decide how often you want to get updates. Official websites use .govA Comment: The National Council for Prescription Drug Programs requested that we make several clarifications regarding our reference to the National Association of Boards of Pharmacy (NABP) number, which we discussed as a candidate identifier in the May 7, 1998, proposed rule. (That is, it is not necessary that an application for an NPI be made by the organization health care provider on behalf of its subpart.). The regulation cannot place requirements on entities that are not covered entities, and the entities involved in the situation described in the last bullet may not be covered entities. Examples of hospital components include outpatient departments, surgical centers, psychiatric units, and laboratories. Federal government websites often end in .gov or .mil. The teams also received comments on the May 7, 1998, proposed regulation from a variety of organizations, including State Medicaid agencies and other Federal agencies. They reap greater savings by not having to keep track of separate identifiers for each health plan and possibly for each location, address, or contractual arrangement. The method of enforcing compliance with the standard should be made public. Health plans would need to make some system changes from their current identifiers to the NPI. Therefore, the information in section II.C.1. The reader should note that we published the Transactions Rule (65 FR 50312) before any of the other HIPAA final rules. We expect that the audit trail would include the date a change was made, the old value, the new value, and the initiator of the change.
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