[Please label written and e-mailed comments about this section with the subject: Implementation]
We would implement the NPI through a central electronic enumerating system, the national provider system (NPS). This system would be a comprehensive, uniform system for identifying and uniquely enumerating health care providers at the national level, not unlike the process now used to issue social security numbers. HCFA would exercise overall responsibility for oversight and management of the system. Health care providers would not interact directly with the NPS.
The process of identifying and uniquely enumerating health care providers is separate from the process health plans follow in enrolling health care providers in their health programs. Even with the advent of assignment of NPIs by the NPS, health plans would still have to follow their own procedures for receiving and verifying information from health care providers that apply to them for enrollment in their health programs. Unique enumeration is less expensive than plan enrollment because it does not require as much information to be collected, edited, and verified. We welcome comments on the cost of provider enrollment in a health plan.
NPIs would be issued by one or more organizations to which we refer in this preamble as “enumerators.” The functions we foresee being carried out by enumerators are presented in section B. Enumerators in this preamble. The NPS would edit the data, checking for consistency, formatting addresses, and validating the social security number. It would then search the database to determine whether the health care provider already has an NPI. If so, that NPI would be displayed. If not, an NPI would be assigned. If the health care provider is similar (but not identical) to an already-enumerated health care provider, the information would be passed back to the enumerator for further analysis. Enumerators would also communicate NPIs back to the health care providers and maintain the NPS database. The number of enumerators would be limited in the interest of data quality and consistency.
Because the Medicare program maintains files on more health care providers than any other health care program in the country, we envision using data from those files to initially populate the NPF that is being built by the NPS and would be accessed by the enumerator(s). The data we are considering for inclusion in this file are described in section IV. Data in this preamble.
The enumerator(s) would carry out the following functions: assist health care providers and answer questions; accept the application for an NPI; validate as many of the data elements as possible at the point of application to assure the submitted data are accurate and the application is authentic; enter the data into the NPS to obtain an NPI for the health care provider; research cases where there is a possible match to a health care provider already enumerated; notify the health care provider of the assigned NPI; and enter updated data into the NPS when notified by the health care provider. Some of these functions would not be necessary if the enumerator(s) is an entity that enrolls health care providers in its own health plan and would be enumerating health care providers at the time they are enrolling in the entity’s health plan. For example, if a Federal health plan is an enumerator, some of the functions listed above would not have to be performed separately from what the health plan would do in its regular business.
The major issue related to the operation of this process is determining who the enumerator(s) will be.
We had several choices in deciding who should enumerate health care providers. There are advantages and disadvantages to each of these choices:
· A registry:
A central registry operated under Federal direction would enumerate all health care providers. The Federally-directed registry could be a single physical entity or could be a number of agents controlled by a single entity and operating under common procedures and oversight.
For: The process would be consistent; centralized operation would assure consistent data quality; the concept of a registry is easy to understand (single source for identifiers).
Against: The cost of creating a new entity rather than enumerating as part of existing functions (for example, plan enrollment) would be greater than having existing entities enumerate; there would be redundant data required for enumeration and enrollment in a health plan.
· Private organization(s):
A private organization(s) that meets certain selection criteria and performance standards, which would post a surety bond related to the number of health care providers enumerated could enumerate health care providers.
For: The organization(s) would operate in a consistent manner under uniform requirements and standards; failure to maintain prescribed requirements and standards could result in penalties which could include suspension or debarment from being an enumerator.
Against: A large number of private enumerators would compromise the quality of work and be difficult to manage; the administrative work required to set up arrangements for a private enumerator(s) may be significant; the cost of creating a new entity rather than enumerating as part of existing functions (for example, plan enrollment) would be greater than having existing entities enumerate; there might be redundant data required for enumeration and enrollment in a health plan; the legality of privatization would need to be researched.
· Federal health plans and Medicaid State agencies:
Federal programs named as health plans and Medicaid State agencies would enumerate all health care providers. (As stated earlier under the definition of “health plan”, the Federal Employees Health Benefits Program is comprised of numerous health plans, rather than just one, and does not deal directly with health care providers that are not also health plans. Thus, the program would not enumerate health care providers but would still require the NPI to be used.)
For: These health plans already assign numbers to their health care providers; a large percentage of health care providers do business with Federal health plans and Medicaid State agencies; there would be no appreciable costs for these health plans to enumerate as part of their enrollment process; a small number of enumerators would assure consistent data quality.
Against: Not all health care providers do business with any of these health plans; there would be the question of which health plan would enumerate the health care provider that participates in more than one; we estimate that approximately 5 percent of the State Medicaid agencies may decline to take on this additional task.
· Designated State agency:
The Governor of each State would designate an agency to be responsible for enumerating health care providers within the State. The agency might be the State Medicaid agency, State licensing board, health department, or some other organization. Each State would have the flexibility to develop its most workable approach.
For: This choice would cover all health care providers; there would be a single source of enumeration in each State; States could devise the least expensive mechanisms (for example, assign NPI during licensing); license renewal cycles would assure periodic checks on data accuracy.
Against: This choice would place an unfunded workload on States; States may decline to designate an agency; there may be insufficient funding to support the costs the States would incur; State licensing agencies may not collect enough information during licensing to ensure uniqueness across States; States may not be uniform in their definitions of “providers.”
· Professional organizations or training programs:
We would enlist professional organizations to enumerate their members and/or enable professional schools to enumerate their students.
For: Individuals could be enumerated at the beginning of their careers; most health care providers either attend a professional school or belong to an organization.
Against: Not all health care providers are affiliated with an organization or school; this choice would result in many enumerators and thus potentially lower the data quality; schools would not be in a position to update data once the health care provider has graduated; the choice would place an unfunded workload on schools and/or organizations.
· Health plans:
Health plans in general would have access to the NPS to enumerate any of their health care providers.
For: Most health care providers do business with one or more health plans; there would be a relatively low cost for health plans to enumerate as part of enrollment; this choice would eliminate the need for redundant data.
Against: Not all health care providers are affiliated with a health plan; this choice would be confusing for the health care provider in determining which health plan would enumerate when the health care provider is enrolled in multiple health plans; there would be a very large number of enumerators and thus potentially serious data quality problems; the choice would place unfunded workload on health plans.
· Combinations:
We also considered using combinations of these choices to maximize advantages and minimize disadvantages.
If private organizations, as enumerators, could charge health care providers a fee for obtaining NPIs, this enumeration option would be attractive and more preferable than the other choices or combinations, as it would offer a way to fund the enumeration function. In researching the legality of this approach, however, we were advised that we do not have the authority to (1) charge health care providers a fee for obtaining NPIs, or (2) license private organizations that could charge health care providers for NPIs. For these reasons, we chose not to recommend private organizations as enumerators.
The two most viable options are described below. We solicit input on these options, as well as on alternate solutions.
Option 1: Registry enumeration of all health care providers.
All health care providers would apply directly to a Federally-directed registry for an identifier. The registry, while under Federal direction, would probably be operated by an agent or contractor. This option is favored by some health plans, which believe that a single entity should be given the task of enumerating health care providers and maintaining the database for the sake of consistency. It would also be the simplest option for health care providers, since enumeration activities would be carried out for all health care providers by a single entity. The major drawback to this option is the high cost of establishing a registry large enough to process enumeration and update requests for the 1.2 million current and 30,000 new (annually) health care providers that conduct HIPAA transactions. The costs of this option are discussed in section J.2.d., Enumerators, in the impact analysis in this Federal Register document. The statute did not provide a funding mechanism for the enumeration/update process. Federal funds, if available, could support the registry. We seek comments on funding mechanisms for the registry.
This option does not offer a clear possibility for funding some of the costs associated with the operation and maintenance of the NPS as it becomes national in scope (that is, as the NPS enumerates health care providers that are not Medicare providers). We solicit comments on appropriate methods for funding the NPS under this option.
Option 2: A combination of Federal programs named as health plans, Medicaid State agencies, and a Federally-directed registry.
Federal health plans and Medicaid State agencies would enumerate their own health care providers. Each health care provider participating in more than one health plan could choose the health plan by which it wishes to be enumerated. All other health care providers would be enumerated by a Federally-directed registry. These latter health care providers would apply directly to the registry for an identifier.
The number of enumerators, and the number of health care providers per enumerator, would be small enough that each enumerator would be able to carefully validate data received from and about each of its health care providers. Moreover, enumerators (aside from the registry) would be dealing with their own health care providers, an advantage both in terms of cost equity and data quality. This option recognizes the fact that Federal plans and Medicaid State agencies already assign identifiers to their health care providers for their own programmatic purposes. It would standardize those existing processes and, in some cases, may increase the amount of data collected or validation performed. We have concluded that the cost of concurrently enumerating and enrolling a Medicare or Medicaid provider is essentially the same as the cost of enrollment alone because of the high degree of redundancy between the processes. While there would probably be additional costs initially, they would be offset by savings in other areas (e.g., there would be a simplified, more efficient coordination of benefits; a health care provider would only have to be enumerated once; there would be no need to maintain more than one provider number for each health care provider; and there would be no need to maintain more than one enumeration system).
The Federal Government is responsible for 75 percent of Medicaid State agency costs to enumerate and update health care providers. Because we believe that, on average, the costs incurred by Medicaid State agencies in enumerating and updating their own health care providers to be relatively low and offset by savings, there are no tangible costs involved.
Allowing these health plans to continue to enumerate their health care providers would reduce the registry workload and its operating costs. We estimate that approximately 85 percent of billing health care providers transact business with a Medicaid State agency or a Federal health plan. We estimate that 5 percent of Medicaid State agencies may decline to enumerate their health care providers. If so, that work would have to be absorbed by the registry. This expense could be offset by the discontinuation of the UPIN registry, which is currently maintained with Federal funds. The costs of this option are discussed in section J.2.d., Enumerators, of the impact analysis.
We welcome comments on the number of health care providers that would deal directly with a registry under this option and on alternative ways to enumerate them.
This option does not offer a clear possibility for funding some of the costs associated with the operation and maintenance of the NPS as it becomes national in scope (that is, as the NPS enumerates health care providers that are not Medicare providers). We solicit comments on appropriate methods for funding the NPS under this option.
We believe that option 2 is the most advantageous and the least costly. Option 1 is the simplest for health care providers to understand but has a significant Federal budgetary impact. Option 2 takes advantage of existing expertise and processes to enumerate the majority of health care providers. This reduces the cost of the registry in option 2 to a point where it would be largely offset by savings from eliminating redundant enumeration processes.
Because the statute did not provide a funding mechanism for the enumeration process, Federal funds, if available, would be required to finance this function. We seek comment on any burden that various financing options might impose on the industry.
We welcome comments on possible ways to reduce the costs of enumeration.
While the NPS has been developed to date by HCFA with Federal funds, issues remain as to sources of future funding as the NPS becomes national in use. We welcome your comments on sources for this funding.
We intend to implement the NPI in phases because the number of potential health care providers to be enumerated is too large to enumerate at one time, regardless of the number of enumerators. We describe in a., b., and c. below how the process would work if option 2 were selected and in d. below how implementation of option 1 would differ.
a. Health care providers that participate in Medicare (including physicians and other suppliers that furnish items and services covered by Medicare) would be enumerated first because, as the managing entity, HCFA has data readily available for all Medicare providers. Health care providers that are already enrolled in Medicare at the time of implementation would be enumerated based on existing Medicare provider databases that have already been reviewed and validated. These health care providers would not have to request an NPI -- they would automatically receive one. After this initial enumeration, new and non-Medicare health care providers not yet enumerated that wish to participate in Medicare would receive an NPI as a part of the enrollment process.
b. Medicaid and non-Medicare Federal health plans that need to enumerate their health care providers would follow a similar process, based on a mutually agreed-upon timetable. Those health plans’ existing prevalidated databases could be used to avoid requiring large numbers of health care providers to apply for NPIs. If a health care provider were already enumerated by Medicare, that NPI would be communicated to the second program. After the initial enumeration, new health care providers that wish to participate in Medicaid or a Federal health plan other than Medicare would receive an NPI as a part of that enrollment process. Health care providers that transact business with more than one such health plan could be enumerated by any one of those health plans. This phase would be completed within 2 years after the effective date of the final rule.
c. A health care provider that does not transact any business with Federal health plans or Medicaid but that does conduct electronically any of the transactions stipulated in HIPAA (for example, submits claims electronically to a private health plan) would be enumerated via a Federally-directed registry. This enumeration would be done concurrently with the enumeration described in b., above. Health care providers would apply to the registry for an NPI.
After the first two phases of enumeration (that is, enumeration of health care providers enrolled or enrolling in Federal health plans or Medicaid or health care providers that do not conduct business with any of those plans but that conduct any of the HIPAA transactions electronically), the health care providers remaining would be those that do not conduct electronically any of the transactions specified in HIPAA. We refer to these health care providers as “non-HIPAA-transaction health care providers.” The non-HIPAA-transaction health care providers would not be enumerated in the first two phases of enumeration. We do not intend to enumerate these health care providers until all health care providers requiring NPIs by statute are enumerated and funds are available. In some cases, these health care providers may wish to be enumerated even though they do not conduct electronic transactions. Health plans may prefer to use the NPI for all health care providers, whether or not they submit transactions electronically, for the sake of processing efficiency. In addition, some health care providers may wish to be enumerated even though they conduct no designated transactions and are not affiliated with any health plan. Additional research is required on the time table and method by which non-HIPAA-transaction health care providers would be enumerated.
d. If option 1 were selected, the Federally-directed registry would enumerate all health care providers. With a single enumeration point (although it could consist of several agents controlled by a single entity, as stated earlier), we would envision enumeration taking place in the following phases: Medicare providers; Medicaid providers and other non-Medicare Federal providers; health care providers that do not transact any business with the aforementioned plans but that process electronically any of the transactions stipulated in HIPAA; and all other health care providers (i.e., non-HIPAA-transaction health care providers).
The law requires that we specify the appropriate uses of the NPI.
Two years after adoption of this standard (3 years for small health plans) the NPI must be used in the health care system in connection with the health-related financial and administrative transactions identified in section 1173(a). The NPI may also be used as a cross reference in health care provider fraud and abuse files and other program integrity files (for example, the HHS Office of the Inspector General sanction file). The NPI may be used to identify health care providers for debt collection under the provisions of the Debt Collection Information Act of 1996 and the Balanced Budget Act of 1997, and for any other lawful activity requiring individual identification of health care providers. It may not be used in any activity otherwise prohibited by law.
Other examples of approved uses would include:
We summarize here how the implementation of the NPI would affect health care providers, health plans, and health care clearinghouses, if option 2 were selected. Differences that would result from selection of option 1 are noted parenthetically.
a. Health care providers interacting with Medicare, another Federal plan, or a Medicaid State agency would receive their NPIs from the NPS via one of those programs and would be required to use their NPIs on all the specified electronic transactions. Each plan would establish its own schedule for adopting the NPI, within the time period specified by the law. Whether a given plan would automatically issue the NPIs or require the health care providers to apply for them would be up to the plan. (For example, the Medicare program would issue NPIs automatically to its currently enrolled Medicare providers and suppliers; data on its future health care providers and suppliers would be collected on the Medicare enrollment application.) The Federal or State plan may impose requirements other than those stated in the regulations.
The health care providers would be required to update any data collected from them by submitting changes to the plan within 60 days of the change. Health care providers that transact business with multiple plans could report changes to any one of them. (Selection of option 1 would mean that the health care provider would obtain the NPI from, and report changes to, the Federally-directed registry.)
b. Health care providers that conduct electronic transactions but do not do so with Federal health plans or Medicaid would receive their NPIs from the NPS via the Federally-directed registry and would be required to use their NPIs on all the specified electronic transactions. Each health plan would establish its own schedule for adopting the NPI, within the time period specified by the law. The health care providers would be required to update any data originally collected from them by submitting changes within 60 days of the date of the change to the Federally-directed registry.
c. Health care providers that are not covered by the above categories would not be required to obtain an NPI. (These health care providers are the non-HIPAA-transaction health care providers as described in section 4.c. of section B. Enumerators earlier in this preamble.) They may be enumerated if they wish, depending on availability of funds, but they would not be issued NPIs until those health care providers that currently conduct electronic transactions have received their NPIs. As stated earlier, the timetable and method by which the non-HIPAA-transaction health care providers would be enumerated must be determined. After the non-HIPAA-transaction health care providers are enumerated, they would be required to update any data originally collected from them by submitting changes within 60 days of the date of the change. Those providers would report their changes to the registry or to a Federal plan or Medicaid State agency with which they transact business at the time of the change.
a. Medicare, other Federal health plans, and Medicaid would be responsible for obtaining NPIs from the NPS and issuing them to their health care providers. They would be responsible for updating the data base with data supplied by their health care providers. (Selection of option 1 would mean that Medicare, other Federal health plans, and Medicaid would not enumerate health care providers or update their data.)
These government health plans would establish their own schedule for adopting the NPI, within the time period specified by the law. They would be able to impose requirements on their health care providers in addition to, but not inconsistent with, those in our regulations.
b. Each remaining health plan would be required to use the NPI to identify health care providers in electronic transactions as provided by the statute. Each health plan would establish its own schedule for adopting the NPI, within the time period specified by the law. They would be able to impose requirements on their health care providers in addition to, but not inconsistent with, those in our regulations.
Health care clearinghouses would be required to use a health care provider’s NPI on electronic standard transactions requiring an NPI that are submitted on the health care provider’s behalf.