III. Summary of Revisions to Regulations Text
We added a definition for ''Covered healthcare provider'' at § 162.402. In addition to the changes discussed above, minor organizational or conforming changes were made to other sections of the regulations text.
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), agencies are required to provide a 30-day notice in the Federal Register and solicit public comment on a collection of information requirement submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate
whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues:
- Whether the information collection is necessary and useful to carry out the proper functions of the agency.
- The accuracy of the agency's estimate of the information collection burden.
- The quality, utility, and clarity of the information to be collected.
- Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
§ 162.410(a)(1) Through (a)(6)
Implementation Specifications: healthcare Providers
A healthcare provider who is a covered entity must obtain, by application if necessary, an NPI from the NPS and must use the NPI it obtained to identify itself on all standard transactions where its provider identifier is required. A covered healthcare provider must ensure that its subpart(s), if assigned an NPI(s), does the same. A covered healthcare provider must disclose its NPI, when requested, to any entity that needs the NPI to identify that healthcare provider in a standard transaction. A covered healthcare provider must ensure that its subpart(s), if assigned an NPI(s), does the same. A covered healthcare provider that has been assigned an NPI must notify the NPS of any changes in its required data within 30 days of the change. A covered healthcare provider must ensure that its subpart(s), if assigned an NPI(s), does the same. A covered healthcare 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. A covered healthcare provider must ensure that its subpart(s), if assigned an NPI(s), and if the subpart(s) uses one or more business associates to conduct standard transactions, does the same.
§ 162.412
Implementation Specifications: Health Plans
A health plan must use the NPI of any healthcare provider or subpart in any standard transaction that requires the
standard unique health identifier for healthcare providers. A health plan may not require a healthcare provider
that has been assigned an NPI to obtain an additional NPI.
§ 162.414
Implementation Specifications: healthcare Clearinghouses
A healthcare clearinghouse must obtain and use the NPI of any healthcare provider or subpart in any standard
transaction that requires the standard unique identifier for healthcare providers.
Applicability of the PRA to the Requirements
The emerging and increasing uses of healthcare EDI standards and transactions have raised the issue of the applicability of the PRA. The Office of Management and Budget (OMB) has determined that this regulatory
requirement (which mandates that the private sector disclose information and do so in a particular format) constitutes an agency-sponsored third-party disclosure as defined under the PRA. HIPAA requires the Secretary to adopt standards that have been developed, adopted, or modified by a standard setting organization, unless there is no such standard, or unless a different standard would substantially reduce administrative costs. OMB has concluded that the scope of its review under the PRA would include the review and approval of our decision to
adopt or reject an established industry standard, based on the HIPAA criterion of whether a different standard would substantially reduce administrative costs. For example, if OMB concluded under the PRA that a different standard would substantially reduce administrative costs as compared to an established industry standard, we
would be required to reconsider our decision under the HIPAA standards. We would be required to make a new
determination of whether it is appropriate to adopt an established industry standard or whether we should enter into negotiated rulemaking to develop an alternative standard (section 1172(c)(2)(A) of the Act). The burden associated with the requirements of this final rule, which is subject to the PRA, is the initial one-time burden on healthcare providers who are covered entities to apply for an NPI and later, as necessary, to furnish updates, and on the covered entities identified above to modify their current processes to implement the NPI. However, the burden associated with the routine or ongoing use of the NPI is exempt from the PRA as defined in 5 CFR 1320.3(b)(2). Based on the assumption that the burden associated with systems modifications that need to be made to implement the NPI may overlap with the systems modifications needed to implement other HIPAA standards, and the fact that the NPI will replace the use of multiple identifiers, resulting in a reduction of burden, commenters should take into consideration when drafting comments that:
- One or more of these current identifiers may not be used;
- systems modifications may be performed in an aggregate manner during the course of routine business; and/or
- systems modifications may be made by contractors such as practice management vendors, in a single effort for a multitude of affected entities.
PRA Burden on Covered healthcare Providers
A healthcare provider that is a covered entity must obtain, by application if necessary, an NPI from the NPS. It must use its NPI to identify itself on all standard transactions that it conducts where its provider identifier is required. In addition, the covered healthcare provider must communicate to the NPS any changes to its required NPS data elements within 30 days of the change. To comply with these requirements, these healthcare providers will complete the NPI application/update form. This form serves two purposes: it enables a covered healthcare provider to apply for an NPI and to furnish updates to the NPS. Application for an NPI is considered to be a one-time action: an NPI is considered a permanent identifier for a healthcare provider. (See section II. A. 2., of this preamble, ''Definition of healthcare Provider,'' for a discussion of the permanent nature of the NPI.) Most covered healthcare providers will not have to furnish updates in a given year; we estimate, based on information in the Medicare program, that approximately 12.6 percent of those healthcare providers will need to complete and submit the NPI application/update form in a given year. Below are our estimates for the annual burden hours associated with these requirements.
Applications for NPIs: Estimated Annualized Burden
Notes: (1) Existing healthcare providers that are covered entities would be able to apply for NPIs over a 2-year period. For the estimated annualized burden, we have divided the number of these healthcare providers by 2 to estimate the annual burden. (2) Applying for an NPI is a one-time burden on a healthcare provider. In future years, this burden would apply only to new healthcare providers that are covered entities. (3) The number of healthcare providers will increase by 1.56 percent annually. This is not a''net'' percentage; it represents strictly the percentage of new healthcare providers coming into business annually. (4) We estimate it will take 20 minutes to complete the application/update form. (5) We estimate an hourly rate of $10.87, rounded to $11, for office staff to complete the application/update form. New healthcare providers come into business every year. The first two years would have increases of 36,124 and 37,251 in new covered healthcare providers, respectively. The number of new covered healthcare providers is 1.56 percent of the number of existing healthcare providers in the previous year.
Updates of NPS Data: Estimated Annualized Burden
Notes: (1) We estimate that 12.6 percent of covered healthcare providers would need to furnish updates in a given year. The number of healthcare providers needing to update their data in any year is a percentage of the number of healthcare providers. (2) A healthcare provider that is a covered entity that does not have changes to its NPI data would not furnish updates and would, therefore, experience no burden. (3) We estimate it will take 10 minutes to complete the application/update form. (4) We estimate an hourly rate of $10.87, rounded to $11, for office staff to complete the application/update form. In FY 2007, we estimate there will be 1,157,821 covered healthcare providers to be assigned NPIs. One could argue that no updates will need to be made in FY 2007 because no covered healthcare provider would have been enumerated prior to FY 2007. (Note: No healthcare provider is required to have an NPI before 2007.) However, for FY 2007, we have factored in updates by adding 12.6 percent of the 1,157,821 covered healthcare providers to represent-in a worst case scenario-a full year's worth of updates if the full 12.6 percent of the enumerated covered healthcare providers needed to provide updates within that same year. Table 1 below shows the estimated annualized burden for the PRA.
| TABLE 1. - PAPERWORK REDUCTION ACT ESTIMATED ANNUALIZED BURDEN. ESTIMATED ANNUALIZED BURDEN |
||||||
| Year | 2007 | 2008 | 2009 | 2010 | 2011 | Total |
| Cost (Burden Hours for Total Providers) | $5,419,027 | $5,641,062 | $183,050 | $192,798 | $204,079 | $11,640,015 |
| Cost (Update Hours) | $670,165 | $719,050 | $759,519 | $800,337 | $847,167 | $3,796,237 |
| Total Annualized Cost | $6,089,192 | $6,360,111 | $942,568 | $993,135 | $1,051,246 | $15,436,252 |
If feasible, to further reduce burden and plan for compliance with the Government Paperwork Elimination Act, we are considering the acceptance of applications and updates electronically over the Internet. We explicitly solicit comment on how we might conduct this activity in the most efficient and effective manner, while ensuring the integrity, authenticity, privacy, and security of healthcare provider information.
As required by section 3504(h) of the Paperwork Reduction Act of 1995, we have submitted a copy of this document to the Office of Management and Budget (OMB) for its review of these information collection requirements. If you comment on these information collection and recordkeeping requirements, please e-mail comments to Paperwork@ cms.hhs.gov (Attn: CMS-0045-F) or mail copies directly to the following two addresses:
Centers for Medicare & MedicaidServices,Office of Strategic Operations and Regulatory Affairs,
Regulations Development and Issuances Group, Room C5-14-03,
7500 Security Boulevard,
Baltimore, MD 21244-1850,
Attn: James Bossenmeyer, CMS-0045-F;
and
Office of Information and Regulatory Affairs,Office of Management and Budget, Room 10235,
New Executive Office Building,
Washington, DC 20503,
Attn: Brenda Aguilar, CMS- 0045-F, CMS Desk Officer.